Edwards Lifesciences Corporation

Cardiac Implants LLC

Edwards Lifesciences Ag

Other

Kuck, Karl-Heinz

Alon, David

David Alon

Netanel Benichou

Oded Meiri

Jan Otto Solem

David Leigh Hauser

Dan Rottenberg

David Mishaly

Luca Pesce

Michael J Popp

Jun Liu

Mohammad Jafari

Avraham Zakai

Nimrod Meller

Avraham Zakay

Sergio Delgado

Raz Biran

David Neumark

Karl-Heinz Kuck

Dror Korman

David Michaly

A system for use at an annulus of a valve of a heart of a subject comprises an implant and an implant-positioning device. The implant comprises (i) a wire; (ii) multiple anchors, slidably mounted in series along the wire, each of the anchors having: a slot through which the wire is threaded, and a pointy front end; and (iii) multiple tubes, the wire being threaded through each of the tubes such that the multiple tubes are slidably mounted on the wire alternatingly with the multiple anchors. The implant-positioning device is configured to implant the implant in the heart with the wire positioned along the annulus by, for each of the anchors: (i) positioning the anchor at the annulus, and (ii) using a deployment mechanism of the implant-positioning device, driving the pointy front end of the anchor into the annulus. Other embodiments are also described.

Cardiac valve replacement

A method of treating a native mitral valve without open-heart surgery is disclosed. An expandable prosthesis includes an anchoring portion and an occluding member coupled to the anchoring portion. The prosthesis is loaded into a distal end portion of a delivery catheter and is advanced through a femoral vein and through a pre-made puncture in an atrial septum. The anchoring portion self-expands within the left atrium for anchoring the occluding member in a fixed position. The anchoring portion is preferably a laser cut structure that conforms to the left atrium and uniformly distributes anchoring forces within the left atrium. After deployment, the occluding member prevents blood from flowing from the left ventricle to the left atrium during systole. The occluding member is preferably made from a flexible material, such as pericardial tissue.

Method of implanting valve prosthesis having atrial anchoring

Certain embodiments of the present disclosure provide a prosthetic valve (e.g., prosthetic heart valve) and a valve delivery apparatus for delivery of the prosthetic valve to a native valve site via the human vasculature. The delivery apparatus is particularly suited for advancing a prosthetic heart valve through the aorta (i.e., in a retrograde approach) for replacing a diseased native aortic valve. The delivery apparatus in particular embodiments is configured to deploy a prosthetic valve from a delivery sheath in a precise and controlled manner at the target location within the body.

Prosthetic heart valve delivery apparatus

A device (e.g., an annulus-constricting device) with N anchors may be affixed to a cardiac valve annulus as follows. First, the device is delivered to the vicinity of the annulus via a catheter. Next, the position and layout of the device is adjusted via the catheter. Next, only those anchors which are properly positioned are driven into the annulus or tissue adjacent to the annulus. The remaining anchors remain unlaunched at this point. The unlaunched anchors are subsequently moved into a good position using either a manipulating tool or catheter-steering techniques, after which they are driven into the annulus or tissue adjacent to the annulus.

Reducing the diameter of a cardiac valve annulus with independent control over each of the anchors that are launched into the annulus

A heart valve annulus repair device having a tissue engaging member and a plurality of anchors. The tissue engaging member includes a loop of wire. Each of the anchors has a pointy front end and a back end and a slot that runs in a front-to-back direction. The anchors are distributed about the loop of wire with the front ends of the plurality of anchors facing the heart valve annulus and with the loop of wire passing through the slots. The device further includes means for implanting the anchors into the heart valve annulus tissue so that the tissue engaging member becomes affixed to the heart valve annulus.

A delivery assembly includes a prosthetic device, a catheter shaft, a release wire, a first line, and a second line. The prosthetic device has a first arm and a second arm. The release wire extends through the catheter shaft. The first line includes a first loop. The first line extends from the catheter shaft, through the first arm of the prosthetic device, and to the release wire, where the release wire extends through the first loop. The second line includes a second loop. The second line extends from the catheter shaft, through the second arm of the prosthetic device, and to the release wire, where the release wire extends through the second loop.

Prosthetic heart valve and delivery apparatus

A method of treating a defective heart valve includes inserting a delivery catheter through a small incision in a patient's groin, wherein the delivery catheter has a prosthetic device positioned along a distal end. The prosthetic device includes an insert member and an anchoring member. The insert member self-expands to plug gaps between leaflets of the heart valve. The anchoring member is preferably a stent connected to the insert member by at least one elongate member. The stent is deployed within an adjacent blood vessel for anchoring the insert member. After deployment of the prosthetic device, the leaflets of the heart valve form a tight seal against the insert member for preventing regurgitation when the leaflets are closed and wherein blood passes through the insert member when the leaflets are open.

Method of treating a defective heart valve

A handle for a prosthetic heart valve delivery apparatus includes a housing, a motorized mechanism, and a holding mechanism. The housing is configured to be hand-held by a user and includes a distal opening. The motorized mechanism is disposed within the housing and is configured to be releasably coupled to a proximal end portion of a first shaft of the prosthetic heart valve delivery apparatus. When actuated, the motorized mechanism is configured to rotate the first shaft relative to the housing. The holding mechanism is disposed inside the housing and is configured to engage a proximal end portion of a second shaft of the prosthetic heart valve delivery apparatus such that the second shaft is axially and rotationally fixed relative to the housing, and the first shaft extends through the second shaft.

An assembly for replacement of a native aortic heart valve includes a radially collapsible prosthetic heart valve and a delivery apparatus. The prosthetic heart valve includes an annular frame with attachment posts, wherein each of the posts has an axial post portion and a transverse post portion having a greater circumferential dimension than the axial post portion. The delivery apparatus includes an inner shaft with a valve connection portion for releasably coupling to the attachment posts and an outer shaft having a sheath for maintaining the prosthetic heart valve in a radially compressed state. Rotation of a control knob on a handle causes the sheath to retract for uncovering a portion of the prosthetic heart valve. Further rotation of the control knob allows the posts to decouple from the delivery apparatus such that the prosthetic heart valve self-expands to a fully expanded state.

A constricting cord can be delivered to the vicinity of an annulus using an apparatus that includes a set of support arms, with a respective anchor launcher supported by each of the support arms. An inflatable first balloon is configured to push the support arms away from each other when the first balloon is inflated. An inflatable second balloon is mounted to a shaft and is configured for inflation when the second balloon is disposed distally beyond the first balloon. In some embodiments, the distal balloon is inflated while it is in a ventricle. In some embodiments, the distal balloon is inflated while it is in a pulmonary artery.

Delivering a constricting cord to a cardiac valve annulus using balloon-assisted positioning

Dislodgment of a constricting cord from an annulus can be prevented by delivering the distal loop portion of the constricting cord to the annulus using a percutaneous delivery tool, and launching anchors into the annulus so as to affix the distal loop portion of the constricting cord to the annulus. The percutaneous delivery tool is withdrawn in a proximal direction after the anchors have been launched. A pushing member is pressed in a distal direction so that the pushing member holds a portion of the constricting cord against the annulus with enough pressure to prevent dislodgment of any of the anchors during the withdrawal of the percutaneous delivery tool.

Preventing dislodgement of a constricting cord that has been affixed to a cardiac valve annulus

Prosthetic heart valves and methods of implantation thereof are disclosed herein. In embodiments, a prosthetic heart valve includes a self-expandable frame configured to support of valve member and comprising a plurality of interconnected strut members forming a mesh structure. An inflow end and outflow end portions of the mesh structure respectively define an inflow terminal end and an outflow terminal end of the frame. A portion of the frame tapers inwardly from the inflow terminal end to form a reduced diameter section. In implementations, the frame increases in diameter from the reduced diameter section to an intermediate section. In implementations, the valve member is secured to the frame at the inflow end portion. In implementations, the frame further comprises a plurality of retaining arms that extend from the outflow terminal end and are configured to engage with a valve retaining mechanism of a delivery apparatus.

A cardiac valve annulus may be constricted by using an apparatus to deliver a cord to the annulus, affixing the cord, and subsequently tightening that cord. In some embodiments, this apparatus includes a housing, a spool, and an elongated core with lumens that run through the core. The lumens are dimensioned to slidably accommodate portions of the cord. The cord, the lumens, and the spool are configured so that after a distal loop portion of the cord is anchored to the annulus, movement of the housing in a proximal direction will (a) cause the core to progressively move in a proximal direction with respect to portions of the cord and (b) cause extension sections of the cord to progressively unwind from the spool and be progressively drawn into the lumens.

Growing community of inventors

Zichron Yaacov, Israel

David Alon