Edwards Lifesciences Corporation

Michael R Bialas

Asher L Metchik

Darshin S Patel

Michael J Popp

Michael C Murad

Amanda Kristine Anderson White

Tamir S Levi

David Mark Taylor

Thanh Van Nguyen

David Maimon

Alexander H Cooper

Gregory Scott Tyler, Ii

Mindy Lee Ann Black

Arvin T Chang

Kim D Nguyen

Gilbert Madrid

Yidong M Zhu

Linda Thai

John Joseph Desrosiers

Jun Liu

Gil Senesh

Zachary R Kowalski

Art Z Kwan

Amanda K Anderson

Vipul P Rajpara

Gonzalo German Angelico

Kristen Hicks

Russ Hunton

Timothy Lee Humphrey

Brian R Lowry

Thanh Huy Le

Tung Thanh Le

Sean Chow

Quang Ngoc Vu

Ilan Tamir

Lien Huong Thi Hoang

Ashley Akemi Ishigo

Taylor Michael Winters

Carla Susana Cerqueira

Victoria Mariko Low

Andrea Fernandez

Karl J Britzman

Haley Nicole Whitehead

Nicholas Brandon Aders

Robert James Gerard

Shannon Nicole Ash

Ii Tyler Gregory Scott

Shannon Nicole Hoye

Vicky Hong Do

Jeannette Jasmine Corona

Gregory Scott Ii Tyler

David M Taylor

A prosthetic implant delivery assembly includes a prosthetic implant and a catheter. The prosthetic implant includes a plurality of apices with apertures. Each apex of the plurality of apices is circumferentially-spaced apart relative to an adjacent apex. The catheter includes a plurality of arms and a plurality of locking elements. Each of the arms includes an opening configured to receive a respective apex of the prosthetic implant. Each of the locking elements is configured to extend through the aperture of a respective apex of the prosthetic implant. A length of at least one of the locking elements is different than a length of another locking element such that when the prosthetic implant is coupled to the catheter by the locking elements, a longitudinal axis of the prosthetic implant can be held at a tilted position relative to a longitudinal axis of the catheter.

Methods for controlled heart valve delivery

Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each including a first portion defining a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon. The balloon cover includes one or more depression members, each having a free end configured to move radially inward toward a central longitudinal axis of the balloon cover, and a tubular sleeve configured to be positioned around the depression members and the first portions of the first and second shell members such that the first and second shell members are held in mating engagement with each other and the free ends of the depression members are depressed radially inward and form a negative radial depression in the balloon.

Balloon cover for a delivery apparatus for an expandable prosthetic heart valve

A delivery apparatus can include a handle, a first shaft extending from the handle and having a proximal end portion coupled to the handle and a distal end portion and a second shaft extending coaxially over the first shaft and having a proximal end portion coupled to the handle and a distal end portion. The delivery apparatus can further include a shoulder coupled to the distal end portion of the second shaft and having a flared end portion configured to abut a prosthetic valve positioned around the first shaft in a radially compressed state, an extension portion extending from the shoulder, and at least one radiopaque marker disposed on the extension portion at a location within the prosthetic valve when the prosthetic valve is in a radially compressed configuration on the first shaft.

Delivery systems for prosthetic heart valve

Balloon covers for a delivery apparatus for a prosthetic valve are disclosed. As one embodiment, a balloon cover includes first and second shell members that are configured to matingly engage with each other, each of the first and second shell members including a first portion and a second portion, the second portion having a larger width than the first portion. The first portions of the first and second shell members define a first cavity configured to receive a distal end portion of the delivery apparatus and at least a portion of an inflatable balloon mounted on the distal end portion of the delivery apparatus. The second portions of the first and second shell members define a second cavity configured to receive a positioning device mounted on the distal end portion of the delivery apparatus, proximal to a valve mounting portion of the distal end portion of the delivery apparatus.

Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a delivery apparatus can include a first shaft configured to rotate around a central longitudinal axis of the delivery apparatus to rotationally align a prosthetic valve mounted on the delivery apparatus with native anatomy, a second shaft extending through the first shaft and having a distal end portion extending distally beyond a distal end portion of the first shaft, an inflatable balloon coupled to the distal end portion of the first shaft, and a distal shoulder mounted on the distal end portion of the second shaft and arranged within a distal end portion of the balloon. The distal shoulder comprises a base portion and a flared portion that extends radially outward from the base portion, and a radiopaque marker is disposed on the flared portion.

Methods and systems for aligning a commissure of a prosthetic heart valve with a commissure of a native valve

Methods and systems for rotationally aligning a commissure of a prosthetic heart valve with a commissure of a native valve are disclosed. In some examples, a method can comprise advancing a distal end portion of a delivery apparatus toward a native valve; visualizing under fluoroscopy and for a selected imaging view, a position of a radiopaque marker on the distal end portion relative to a guidewire extending through the delivery apparatus, the marker circumferentially offset from a selected commissure of the radially compressed prosthetic valve by a predetermined amount that is determined based on the selected imaging view; rotating the delivery apparatus until the marker is centered along the guidewire; and advancing the distal end portion into the native valve and inflating the balloon to radially expand and implant the prosthetic valve in the native valve such that the selected commissure is aligned with a commissure of the native valve.

A method of implanting a prosthetic heart valve includes selecting a prosthetic heart valve. The selected prosthetic heart valve has a nominal diameter that is greater than a native annulus diameter of a native annulus by up to forty percent. The method further comprises compressing the selected prosthetic heart valve to a radially compressed configuration in which the selected prosthetic heart valve has a first diameter that is less than the nominal diameter, positioning the selected prosthetic heart valve within the native annulus, and expanding the selected prosthetic heart valve from the radially compressed configuration to a radially expanded configuration in which the selected prosthetic heart valve has a second diameter which is less than the nominal diameter by up to ten percent and which is greater than the first diameter.

Systems and methods for sizing and implanting prosthetic heart valves

Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Cylindrical implant and balloon

A steerable medical apparatus includes a shaft, a steering mechanism, and an actuation mechanism. The shaft has a proximal portion, a distal portion, a first pull wire, and a second pull wire. The distal ends of the first and second pull wires are coupled to the distal portion of the shaft. The steering mechanism has a first wheel and a second wheel coupled by a differential mechanism. The proximal ends of the first and second pull wires are respectively coupled to the first and second wheels. The actuation mechanism is coupled to the steering mechanism. Actuating the actuation mechanism in a first operational mode causes the distal portion of the shaft to curve in a first plane. Actuating the actuation mechanism in a second operational mode causes the distal portion of the shaft to curve away from the first plane.

Steerable catheter

In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube and a nose cone cap. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. The nose cone cap and the storage tube have mating first and second locking member that can be coupled to selectively secure the nose cone cap to the storage tube.

Storage assembly for prosthetic valve

Devices and methods for crimping a prosthetic heart valve onto a delivery device are described. In some embodiments, valves are crimped over an inflatable balloon and between proximal and distal shoulders mounted on a shaft inside the balloon. Crimping methods can include multiple compression steps with the valve located in different axial positions relative to the crimping jaws at each different step. In some methods, the valve may extend partially outside of the crimping jaws during certain crimping steps, such that the crimping force is only applied to the part of the valve that is inside the jaws. Exemplary crimping devices can include two or more adjacent sets of jaws that close down to different inner diameters, such that different parts of a valve get compressed to different outer diameters at the same time during a single crimping step.

Crimping devices and methods

A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Removable volume indicator for syringe

Disclosed herein are embodiments of a balloon shaped to have one or more enlarged recons to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon&#x2014;reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

In a particular embodiment, the present disclosure provides a prosthetic valve delivery assembly that includes a storage tube. A prosthetic valve having a frame is at least partially disposed within the storage tube. A nose cone is disposed about an elongated shaft. A stylet having at least a first bent portion extends through a lumen of the nose cone. The at least a first bent portion is disposed within the lumen of the nose cone and restricts axial movement of the elongated shaft relative to the prosthetic valve.

In a particular embodiment, the present disclosure provides a delivery apparatus for delivering a medical device. The delivery apparatus includes an elongated component with an engagement portion and a disengagement portion. Rotating the elongated component in a first rotational direction moves the travelling component along the engagement portion in a first axial direction. When the travelling component is located within the disengagement portion, continued rotation of the elongated component in the first rotational direction does not cause further movement of the travelling component in the first axial direction. A biasing member is located proximate the disengagement portion and urges the travelling component to reengage the engagement portion. The delivery apparatus can reduce or prevent damage to the delivery apparatus, or a patient with whom the delivery apparatus is used, by reducing or eliminating torque transfer from the travelling component to an end of the elongated component.

Prosthetic valve delivery apparatus having clutch mechanism

Growing community of inventors

Lake Forest, CA, United States of America

Michael R Bialas