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 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: 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: 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 an implant, then return to a non-expanded state after the passage of the device. The sheath includes a foldable inner member having a detached flap structure at its distal tip that facilitates expansion of the sheath lumen to increased diameters, and an elastomeric distal end that reduces push and retrieval forces therethrough. The sheath can include a hemostasis seal on its proximal end to prevent the leakage of blood out of the sheath and prevent ballooning of outer layer of the sheath.

Abstract: A system for introducing a delivery apparatus into a patient's vasculature. The system may include a sheath having a lumen and configured to be inserted into the patient's vasculature. An introducer has a channel for receiving a guide wire and is configured to be positioned within the lumen of the sheath. A plug is coupled to the introducer and is configured to move from a first position in which the plug has a first diameter to a second position in which the plug has a second diameter that is greater than the first diameter and greater than the interior diameter of the sheath, the plug being configured to slide within the lumen in a direction from the distal end of the sheath towards the proximal end of the sheath to expand the sheath in the direction radially outward from the lumen.

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.

Abstract: A system for introducing a delivery apparatus into a patient's vasculature. The system may include a sheath having a lumen and configured to be inserted into the patient's vasculature. An introducer has a channel for receiving a guide wire and is configured to be positioned within the lumen of the sheath. A plug is coupled to the introducer and is configured to move from a first position in which the plug has a first diameter to a second position in which the plug has a second diameter that is greater than the first diameter and greater than the interior diameter of the sheath, the plug being configured to slide within the lumen in a direction from the distal end of the sheath towards the proximal end of the sheath to expand the sheath in the direction radially outward from the lumen.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and a balloon catheter assembly comprising an elongated balloon catheter shaft extending from the handle portion. The balloon catheter shaft includes a proximal end portion coupled to the handle portion and a distal end portion. The balloon catheter assembly further includes a balloon coupled to the distal end portion and configured to mount a prosthetic heart valve in a radially compressed state. A protective cover encapsulates the balloon, the cover defining a cavity shaped to accommodate the balloon.

Abstract: A delivery apparatus for implanting a radially compressible and expandable prosthetic heart valve in a native heart valve of the heart includes a handle portion and an elongated shaft extending from and movable relative to the handle portion. The shaft includes a proximal end portion coupled to the handle portion and a distal end portion configured to mount a prosthetic heart valve in a radially compressed state. The handle portion includes a control member movable longitudinally with respect to the handle portion, the control member engaging a gear assembly operable to convert longitudinal motion of the control member to rotational motion of the gear assembly. The gear assembly engages the elongated shaft such that rotational motion of the gear assembly causes corresponding longitudinal motion of the elongated shaft relative to the handle portion.

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: 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 variable diameter inner liner wound in a spiral slidable configuration and an outer layer. 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 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.

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.

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: The present disclosure generally relates to systems, devices, and methods for providing control of fluids from a subject, which may be utilized with an introducer system. Such fluids may comprise blood and may be produced during medical operation upon the subject. An expandable sheath may be provided that is configured to cover a portion of an introducer sheath body between the surface of the subject and a housing of the introducer sheath to retain fluid from the subject within the expandable sheath.

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: Embodiments of a balloon assembly are disclosed. The balloon assembly can include an inflatable balloon having an inflated state and a deflated state. The balloon in the deflated state can include a valve retaining portion, a distal tapered portion connected to a distal end of the valve retaining portion, a proximal tapered portion connected to a proximal end of the valve retaining portion, a distal leg connected to the distal end of the distal tapered portion, and a proximal leg connected to the proximal end of the proximal tapered portion. The distal tapered portion can include one or more axial folds. The proximal end of the distal tapered portion can include a first radial fold connected to a second radial fold, the first and second radial folds forming a pocket extending distally at the proximal end of the distal tapered portion.

Abstract: Disclosed embodiments of introducer devices provide hemostatic sealing and allow a delivery catheter to be inserted through the introducer seals without the use of a separate loader device that covers a medical device that is mounted on the catheter. Some disclosed introducers comprise a housing, a distal sheath extending distally from the housing and adapted to be inserted into a patient's vasculature, a distal hemostatic seal mounted within the housing and a proximal hemostatic seal mounted within the housing, and a slidable tube positioned within the housing that is movable longitudinally relative to the distal hemostatic seal between a proximal position and a distal position, wherein in the proximal position a distal end of the tube is positioned proximal to the distal hemostatic seal with the distal hemostatic seal closed, and wherein in the distal position the distal end of the tube extends through the distal hemostatic seal.