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公开(公告)号:US20240216139A1
公开(公告)日:2024-07-04
申请号:US18607271
申请日:2024-03-15
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Nicholas Brandon Aders , Kristen Hicks , Gil Senesh , Michael R. Bialas , Tung T. Le , Sean Chow , Thanh Huy Le
CPC classification number: A61F2/2433 , B23P11/005 , A61F2/9524 , A61F2240/001 , A61F2250/0039
Abstract: 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.
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公开(公告)号:US20230293295A1
公开(公告)日:2023-09-21
申请号:US18134445
申请日:2023-04-13
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Yair A. Neumann , Amir Davidesko , Kristen Hicks , Roy Shitrit
IPC: A61F2/24
CPC classification number: A61F2/2436 , A61M2025/0024
Abstract: An introducer sheath can be used to safely introduce a delivery apparatus into a patient’s vasculature (e.g., via the femoral artery). It is advantageous to visualize the placement of an introducer sheath within the vasculature using an imaging system. The sheaths disclosed herein include radiopaque features that assist with imaging without sacrificing the low profile, expandability, and other advantageous aspects of the introducer sheath.
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3.
公开(公告)号:US20240261089A1
公开(公告)日:2024-08-08
申请号:US18614255
申请日:2024-03-22
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Michael R. Bialas , Kristen Hicks , Michael C. Murad , Gil Senesh , Quang Ngoc Vu , Gonzalo German Angelico , Carla Susana Cerqueira , Victoria Mariko Low , Andrea Fernandez , Karl J. Britzman , Shannon Nicole Ash (formerly Hoye) , Haley Nicole Whitehead
CPC classification number: A61F2/24 , A61B50/30 , A61F2/2418 , A61F2/2436 , A61M25/10 , A61F2/2433 , A61F2/9517 , A61F2002/9583 , A61F2220/0025 , A61F2220/0075 , A61F2230/0002 , A61F2250/0098
Abstract: 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.
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4.
公开(公告)号:US20230190466A1
公开(公告)日:2023-06-22
申请号:US18113552
申请日:2023-02-23
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Michael R. Bialas , Kristen Hicks , Michael C. Murad , Gil Senesh , Quang Ngoc Vu , Gonzalo German Angelico , Carla Susana Cerqueira , Victoria Mariko Low , Andrea Fernandez , Karl J. Britzman , Shannon Nicole Ash (formerly Hoye) , Haley Nicole Whitehead
IPC: A61F2/24
CPC classification number: A61F2/2433 , A61F2/2436 , A61F2/2418 , A61F2250/0098 , A61F2002/9583
Abstract: 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.
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公开(公告)号:US20230053985A1
公开(公告)日:2023-02-23
申请号:US18046078
申请日:2022-10-12
Applicant: Edwards Lifesciences Corporation
Inventor: Kristen Hicks , Michael C. Murad , Michael R. Bialas , Walter Lee
IPC: A61F2/24
Abstract: A delivery apparatus comprises a handle, a first shaft, and a second shaft. The first shaft extends through and is movable axially relative to the second shaft. The delivery apparatus comprises an inflatable balloon having a proximal end portion coupled to the second shaft and a distal end portion of the balloon coupled to the first shaft. An inflation hub assembly comprises an inflation manifold and a piston, wherein the inflation manifold comprises a main body defining a main lumen and an inflation port defining an inflation port lumen. The piston extends into the main lumen and is slidable relative to the inflation manifold. A proximal end portion of the first shaft is coupled to the piston. The piston is moveable relative to the inflation manifold in proximal and distal directions to produce movement of the first shaft and adjust the length of the balloon.
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公开(公告)号:US12171655B2
公开(公告)日:2024-12-24
申请号:US18113552
申请日:2023-02-23
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Michael R. Bialas , Kristen Hicks , Michael C. Murad , Gil Senesh , Quang Ngoc Vu , Gonzalo German Angelico , Carla Susana Cerqueira , Victoria Mariko Low , Andrea Fernandez , Karl J. Britzman , Shannon Nicole Ash , Haley Nicole Whitehead
Abstract: 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.
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7.
公开(公告)号:US20240307172A1
公开(公告)日:2024-09-19
申请号:US18434642
申请日:2024-02-06
Applicant: EDWARDS LIFESCIENCES CORPORATION
Inventor: Michael R. Bialas , Kristen Hicks , Michael C. Murad , Gil Senesh , Quang Ngoc Vu , Gonzalo German Angelico , Carla Susana Cerqueira , Victoria Mariko Low , Andrea Fernandez , Jeanette Jasmine Corona Kelly (formerly Corona) , Taylor Michael Winters , Ashley Akemi Ishigo , Brendan Michael Dalbow , Kim D. Nguyen , Lien Huong Thi Hoang
CPC classification number: A61F2/24 , A61B50/30 , A61F2/2418 , A61F2/2436 , A61M25/10 , A61F2/2433 , A61F2/9517 , A61F2002/9583 , A61F2220/0025 , A61F2220/0075 , A61F2230/0002 , A61F2250/0098
Abstract: 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 include advancing a distal end portion of an assembly toward a native heart valve, the assembly comprising a delivery apparatus and a prosthetic heart valve, and including one or more radiopaque markers, where one radiopaque marker is suspended within a cell of a frame of the prosthetic heart valve and aligned with a commissure of the prosthetic heart valve. The method further includes receiving a fluoroscopic image in a selected imaging view of the prosthetic heart valve on the delivery apparatus, determining, based on the fluoroscopic image and the one or more radiopaque markers, whether the prosthetic heart valve is in a desired rotational orientation, and rotating the assembly until the prosthetic heart valve is in the desired rotational orientation.
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公开(公告)号:US11963871B2
公开(公告)日:2024-04-23
申请号:US18080043
申请日:2022-12-13
Applicant: Edwards Lifesciences Corporation
Inventor: Nicholas Brandon Aders , Kristen Hicks , Gil Senesh , Michael R. Bialas , Tung T. Le , Sean Chow , Thanh Huy Le
CPC classification number: A61F2/2433 , B23P11/005 , A61F2/9524 , A61F2240/001 , A61F2250/0039
Abstract: 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.
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