Abstract: Disclosed herein is a combined introducer and expandable sheath having an inner member and an outer elastomeric jacket. The inner member has radially folded tapered segments in an unexpanded state that are mechanically unfolded and moved toward the inner wall of the elastomeric jacket by a medical device moving through the lumen of the inner member. The compressive outer elastomeric jacket returns the expanded inner member back to the radially folded, unexpanded state once the medical device has passed through the expanded lumen of the inner member. The structure can include a distal region that tapers to a rounded tip. The proximal region also tapers to mate with a hemostasis value housing.

Abstract: Disclosed herein is a combined introducer and expandable sheath having an inner member and an outer elastomeric jacket. The inner member has radially folded tapered segments in an unexpanded state that are mechanically unfolded and moved toward the inner wall of the elastomeric jacket by a medical device moving through the lumen of the inner member. The compressive outer elastomeric jacket returns the expanded inner member back to the radially folded, unexpanded state once the medical device has passed through the expanded lumen of the inner member. The structure can include a distal region that tapers to a rounded tip. The proximal region also tapers to mate with a hemostasis value housing.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: A delivery sheath includes an outer tubular layer and an initially folded inner tubular layer. When an implant passes therethrough, the outer tubular layer expands and the inner tubular layer unfolds into an expanded lumen diameter. The sheath may also include selectively placed longitudinal support rods that mediate friction between the inner and outer tubular layers to facilitate easy expansion, thereby reducing the push force needed to advance the implant through the sheath's lumen.

Abstract: Aspects of a sheath are disclosed herein including a radially expandable outer cylinder and including a plurality of sheath fins distributed circumferentially about the inner surface of the central lumen of the sheath. Each of the fins extends along a length of the inner surface of the sheath and when the sheath not expanded, the form a continuous inner surface of the sheath lumen. Each of the sheath fins includes a longitudinally-extending leading edge and a longitudinally-extending trailing edge where the leading edge of each of the sheath fins abuts a trailing edge of an adjacent one of the sheath fins when the sheath is in the unexpanded state, and in an initial unexpanded state adjacent sheath fins are coupled together along their leading edge and trailing edges.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member having longitudinally extending channels that facilitate the sheath's temporary expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of protruding contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the protruding contact surfaces back towards their original positions after the passage of the device.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer includes a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member having longitudinally extending channels that facilitate the sheath's temporary expansion. The channels are positioned in such a way that, upon expansion, they enable the movement of protruding contact surfaces toward the inner and outer surfaces of the annular member, reducing friction between the surface and the passing device. Some embodiments of the expandable sheath include an elastic outer layer that pushes the protruding contact surfaces back towards their original positions after the passage of the device.

Abstract: Inflatable balloons for balloon catheters are disclosed, the inflatable balloons including varying compliance segments. As one example, an inflatable balloon for a medical catheter includes a first segment that has a first compliance and a second segment that has a second compliance, the first compliance higher than the second compliance. The first segment and the second segment extend axially along a length of the balloon and the first segment is configured to rupture prior to the second segment in an axial direction under pressure from an inflation fluid introduced into the balloon.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

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.

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.

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.

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.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member through which the cardiovascular device and its delivery system pass. In an embodiment, the annular inner member can be formed by coextruding a first and second material. The first material includes a fold, and the second material radially spaces the different parts of the fold from each other during fabrication and provides support for maintaining the tubular structure. The second material is removed once the coextrusion process is complete.

Abstract: Disclosed herein are expandable introducer sheaths and methods of making and using the same. The sheaths minimize trauma to a patient's vasculature by allowing for temporary expansion of a portion of the sheath to accommodate passage of a delivery system for a cardiovascular device, then return to a non-expanded state after the passage of the device. The sheath includes an elongated annular member through which the cardiovascular device and its delivery system pass. In an embodiment, the annular inner member can be formed by coextruding a first and second material. The first material includes a fold, and the second material radially spaces the different parts of the fold from each other during fabrication and provides support for maintaining the tubular structure. The second material is removed once the coextrusion process is complete.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

Abstract: An expandable delivery sheath includes an elastic outer tubular layer and an inner tubular layer. The inner tubular layer include a thick wall portion integrally connected to a thin wall portion. The thin wall portion can include longitudinal reinforcing members/rods that facilitate unfolding during the passage of the implant, thus decreasing the push force and increasing the consistency of the push force. The inner tubular layer can have a non-expanded or folded condition wherein the thin wall portion folds onto an outer surface of the thick wall portion under urging of the elastic outer tubular layer. When an implant passes therethrough, the outer tubular layer stretches and the inner tubular layer unfolds into an expanded lumen diameter. Once the implant passes, the outer tubular layer again urges the inner tubular layer into the non-expanded condition with the sheath reassuming its smaller profile.

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.

Abstract: The methods and devices disclosed herein promote temporal control of balloon inflation patterns. The devices include a covering for a portion of the balloon that compresses the balloon portion during the inflation process. This enables the distal portion of a balloon to be inflated prior to the proximal portion of a balloon, creating a tapered shape at lower inflation pressures. This is especially useful during transvascular implantation procedures, as it prevents dislodgement of an implant mounted on the balloon. As inflation continues, pressure exerted on the balloon by the covering is overcome such that the proximal region of the balloon inflates, forming a shape with generally straighter sides than the tapered shape, thereby expanding the cardiovascular device.