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Publication Number
US-11672564-B2
Publication Date
2023-06-13
Expiration Date
Abstract
One embodiment is directed to a system for deploying a device to a distal location across a vessel, comprising an elongate introducer sheath tubing member comprising open-cell fibrous wall material defining a lumen therethrough, wherein in a collapsed configuration the sheath has a first cross-sectional outer diameter and a first lumen inner diameter, and in an expanded configuration, the sheath has a second cross-sectional outer diameter and a second lumen inner diameter; and a substantially non-porous expandable layer coupled to a proximal portion of sheath and configured to prevent fluids present in the lumen from crossing the fibrous wall material. Also disclosed is a delivery assembly comprising an obturator which releasably captures the distal portion of an introducer sheath which obturator can be removed after the sheath is deployed to a desired location.
Core Innovation
The disclosure relates to an expandable introducer sheath system for percutaneous vascular access and device delivery. The system includes an introducer sheath having a proximal rigid section, a distal flex section, and a hub, configured to move between a collapsed configuration and an expanded configuration during use. The distal flex section is placed under tension to collapse, and the hub supports maintaining an axial relationship among a distal tip and a dilator sheath during deployment and transition between configurations.
A dilator assembly within a lumen of the introducer sheath includes a dilator sheath and a distal tip, and the distal region of the distal flex section is gripped between the distal tip and the dilator sheath. A clip attached to the hub maintains the axial relationship and places the distal flex section under tension to assume a collapsed configuration. The distal flex section is configured to expand locally at a delivery location when acted on by a device positioned within the distal flex section, and the disclosure addresses preventing inversion of the distal flex section during passage of the device.
The introducer sheath is described as having an open-cell fibrous/braided wall configured to provide different collapsed versus expanded outer and lumen diameters, together with a proximal substantially non-porous expandable layer positioned to prevent fluid crossing the fibrous wall for improved hemostasis. Additional structural and functional elements described include optional tubular liner to define a reinforced working lumen, radio-opaque markers, tensioning/locking concepts to enable controlled expansion/collapse, and example distal flex section constructions including anti-inversion elements and hemostasis valve constructions. The system is illustrated for delivery of large-diameter prostheses, including transcatheter aortic valves, through a guidewire-based route.
Claims Coverage
The partial content includes three independent claims. Across these claims, the inventive coverage centers on gripping and tensioning a distal flex section with a clip to collapse and align a dilator assembly during sheath deployment, causing only local expansion of a distal flex section at a device delivery location while preventing distal flex inversion, and providing an assembly with a clip that applies tension to place the distal flex section into a collapsed configuration.
Axially aligned gripping and tensioning for distal flex collapse
providing an introducer sheath comprising a proximal rigid section, a distal flex section, and a hub; inserting a dilator assembly through a lumen of the introducer sheath; gripping a distal region of the distal flex section between a distal tip of the dilator assembly and a dilator sheath of the dilator assembly; placing the introducer sheath under tension to collapse the distal flex section; and attaching a clip to the hub to maintain an axial relationship of the introducer sheath, the distal tip, and the dilator sheath.
Local expansion at device position while preventing inversion
deploying an introducer sheath in a blood vessel; passing a device through a proximal rigid section of the introducer sheath into a distal flex section of the introducer sheath; passing the device through the distal flex section to a delivery location within the blood vessel, wherein the device causes the distal flex section to locally expand solely at a location where the device is positioned within the distal flex section; and preventing the distal flex section from inverting during the passing the device through the distal flex section.
Assembly with clip tensioning to place distal flex in collapsed configuration
an assembly comprising: an introducer sheath comprising a proximal rigid section, a distal flex section, and a hub; a dilator assembly within a lumen of the introducer sheath, the dilator assembly comprising a dilator sheath and a distal tip; and a clip attached to the hub to maintain an axial relationship of the introducer sheath, the distal tip, and the dilator sheath, the clip placing the distal flex section under tension to assume a collapsed configuration.
The independent claims cover method and assembly aspects of an introducer sheath system that uses gripping and hub-attached clip tensioning to collapse and align a distal flex section, and that enables device-driven local expansion solely at the device position within the distal flex section while preventing distal flex inversion during passage.
Stated Advantages
Improved hemostasis at the access site by using a proximal substantially non-porous expandable layer to prevent fluid crossing the fibrous wall.
Documented Applications
Delivery of large-diameter prostheses, including transcatheter aortic valves, via a guidewire-based deployment through a blood vessel.
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