公开(公告)号：US20230355389A1

公开(公告)日：2023-11-09

申请号：US18354566

申请日：2023-07-18

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Sovanpheap Mak ,  Ilan Tamir ,  Maxwell Harrison Fine ,  Nasser William Saleh ,  Sonny Tran

IPC: A61F2/24

CPC classification number: A61F2/2436 ,  A61F2002/9623

Abstract: An expandable sheath including an elongated inner member defining a central lumen extending therethrough. The inner member includes a first circumferential portion including a first and second longitudinal edges, and a second circumferential portion extending between the first and second longitudinal edges. The wall thickness of the first circumferential portion is greater than the wall thickness of the second circumferential portion. The elongated inner member is configured to transition from an unexpanded configuration to an expanded configuration in response to a radially outward force on an inner surface of the central lumen. In the unexpanded configuration, the elongated inner member is creased proximate the first and second longitudinal edges into a folded configuration such that the second circumferential portion is positioned at least partially radially inward of the first circumferential portion.

公开(公告)号：US20240099843A1

公开(公告)日：2024-03-28

申请号：US18531355

申请日：2023-12-06

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： David Maimon ,  Erik Bulman ,  Sonny Tran ,  Ilan Tamir ,  Jeong Soo Lee ,  Maxwell Harrison Fine ,  Nasser William Saleh ,  Sovanpheap Mak ,  Tien Thi Nguyen

IPC: A61F2/24

CPC classification number: A61F2/2436 ,  A61F2230/0091

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a helical scroll slidable configuration. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during the application of a radial outward force by passage of a medical device through the sheath.

公开(公告)号：US20230263991A1

公开(公告)日：2023-08-24

申请号：US18142179

申请日：2023-05-02

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Maxwell Harrison Fine ,  Nasser William Saleh

IPC: A61M25/00 ,  A61M25/01

CPC classification number: A61M25/0023 ,  A61M25/01 ,  A61M2025/0024

Abstract: The expandable sheaths disclosed herein are adapted to be used in tortuous vessels, such as, but not limited to, the subclavian artery. The sheaths are expandable to facilitate passage of a medical device through a central lumen of the sheath. The sheaths can be used to deliver medical devices, such as implantable heart valves. The methods of delivering a medical device can include transforming a distal region of the expandable sheath to an at least partially bowed configuration and bending a central shaft of the expandable sheath around a bend in vasculature without kinking the sheath.

公开(公告)号：US20230056245A1

公开(公告)日：2023-02-23

申请号：US17981395

申请日：2022-11-05

Applicant: Edwards Lifesciences Corporation

Inventor： Maxwell Harrison Fine ,  Ilan Tamir ,  Jeong Soo Lee ,  Sonny Tran ,  Leah Paige Gaffney ,  Erik Bulman ,  Nasser William Saleh

IPC: A61F2/24

Abstract: Examples of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such examples can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some examples can include a sheath with inner and outer layers, where a folded portion of the inner layer extends through a slit in the outer layer and a portion of the outer layer overlaps the folded portion of the inner layer. Some examples include an elastic outer cover positioned outside the outer layer. Examples of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

公开(公告)号：US20240123182A1

公开(公告)日：2024-04-18

申请号：US18531307

申请日：2023-12-06

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Erik Bulman ,  David Maimon ,  Sonny Tran ,  Ilan Tamir ,  Jeong Soo Lee ,  Maxwell Harrison Fine ,  Nasser William Saleh ,  Sovanpheap Mak ,  Tien Thi Nguyen

IPC: A61M25/00 ,  A61L29/08

CPC classification number: A61M25/0023 ,  A61L29/085 ,  A61M25/0045 ,  A61M25/0052 ,  A61M2025/0024 ,  A61M2025/0047 ,  A61M2025/006 ,  A61M2205/02

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration such that a plurality of protrusions is disposed in an overlapping portion of the sheath. The disclosed sheath is configured to expand from a predetermined rest diameter dr to an expanded diameter de during application of a radial outward force by passage of a medical device through the sheath.

公开(公告)号：US20240099842A1

公开(公告)日：2024-03-28

申请号：US18531202

申请日：2023-12-06

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Erik Bulman ,  David Maimon ,  Sonny Tran ,  Ilan Tamir ,  Jeong Soo Lee ,  Maxwell Harrison Fine ,  Nasser William Saleh ,  Sovanpheap Mak ,  Tien Thi Nguyen

IPC: A61F2/24

CPC classification number: A61F2/2436 ,  A61F2210/0076

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with a tubular inner liner wound in a spiral configuration at least a portion of the outer surface of the sheet comprises a plurality of bonding sites that are at least partially embedded within the sheet and disposed such that the outer surface of the sheet in the overlapping portion is substantially free of the plurality of bonding sites.

公开(公告)号：US20230172715A1

公开(公告)日：2023-06-08

申请号：US18103361

申请日：2023-01-30

Applicant: Edwards Lifesciences Corporation

Inventor： Jeong Soo Lee ,  Leah Paige Gaffney ,  Judy Kim ,  David Mora ,  Elizabeth Anne Anderson ,  Sonny Tran ,  Nasser William Saleh ,  Ilan Tamir ,  Maxwell Harrison Fine ,  Duy Nguyen ,  Kim D. Nguyen ,  Thanh V. Nguyen ,  Erik Bulman

IPC: A61F2/24 ,  A61M25/00 ,  A61L29/12 ,  A61L29/14

CPC classification number: A61F2/2436 ,  A61M25/0009 ,  A61L29/126 ,  A61L29/14 ,  A61L2400/10 ,  B29C48/09

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include various configurations of the sheath that comprise an elongated tube having a disclosed composition that can form an outer jacket or a strain relief jacket or can be used as the outer layer of the sheath. Aspects of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel and reduce the push force needed for passage of the medical device, thus offering advantages over prior art introducer sheaths.

公开(公告)号：US20230054952A1

公开(公告)日：2023-02-23

申请号：US17981699

申请日：2022-11-07

Applicant: Edwards Lifesciences Corporation

Inventor： David Guadalupe Ruiz ,  Leah Paige Gaffney ,  Jeong Soo Lee ,  Ilan Tamir ,  Maxwell Harrison Fine ,  Sonny Tran ,  Nasser William Saleh

IPC: A61M25/00 ,  A61M25/06

Abstract: Aspects of an expandable sheath can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. Such aspects can minimize trauma to the vessel by allowing for temporary expansion of a portion of the introducer sheath to accommodate the delivery apparatus, followed by a return to the original diameter once the prosthetic device passes through. Some aspects can include a sheath with inner and outer layers having at least one folded portion of the inner liner. Some aspects include the inner liner having etched, unetched, and otherwise surface-modified portions. Aspects of the present expandable sheath can avoid the need for multiple insertions for the dilation of the vessel, thus offering advantages over prior art introducer sheaths.

公开(公告)号：US20240299722A1

公开(公告)日：2024-09-12

申请号：US18662004

申请日：2024-05-13

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： David Guadalupe Ruiz ,  Lynne Borowski Shwed ,  Maxwell Harrison Fine

IPC: A61M39/06 ,  A61M25/00

CPC classification number: A61M39/06 ,  A61M2025/0024

Abstract: An introducer sheath system comprising including a gasket disposed around an outer surface of a dual layered sheath. The gasket providing a radially inward force on the sheath to seal the sheath an outer layer of the sheath against an inner layer to prevent fluid flow therebetween.

公开(公告)号：US20240100297A1

公开(公告)日：2024-03-28

申请号：US18531261

申请日：2023-12-06

Applicant: EDWARDS LIFESCIENCES CORPORATION

Inventor： Sonny Tran ,  Ilan Tamir ,  Jeong Soo Lee ,  Maxwell Harrison Fine ,  Nasser William Saleh ,  Sovanpheap Mak ,  Tien Thi Nguyen ,  Erik Bulman ,  David Maimon

IPC: A61M25/00 ,  A61F2/24

CPC classification number: A61M25/0023 ,  A61F2/2427 ,  A61M2025/0024

Abstract: Various systems, devices, and methods are described herein pertaining to expandable sheaths. Sheath aspects are described that include a flexible sheath tip that is expandable and bendable. In some aspects, the sheath includes a radially expandable proximal end and a radially expandable distal end. In some aspects, the sheath tip includes a plurality of layers that expand to accept a medical device traveling axially and bi-directionally therethrough with minimal deformation of the sheath tip.