Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: Disclosed herein are reinforced expandable introducer sheaths and methods of using the same. The sheaths minimize trauma to the patient's vasculature by including a reinforcing member to improve the push force of the sheath while reducing the chances of kinking during delivery of a prosthetic device. The sheath can include a plurality of expandable rings aligned along the longitudinal axis of the sheath and coupled together to form an elongated tubular structure. The sheath can also include a plurality of radial members circumferentially arranged to form a tubular support structure. The radial members slidingly interconnected around the circumference of the tubular structure to facilitate radial expansion of the sheath.

Abstract: Disclosed herein are embodiments of a balloon shaped to have one or more enlarged regions to selectively increase expansion forces on an implant. For example, the balloon may have a central portion that is enlarged to exert more force on the center of a stent-mounted prosthetic heart valve. This overcomes the stent-mounted prosthetic heart valve's tendency to expand with flared ends. This forms a more cylindrical or barrel shaped stent frame during expansion of the balloon—reducing or eliminating the instance wherein the cylindrical stent frame has flared ends. Alternatively, the balloon may have conical flares placed to cause or enhance flared ends of the cylindrical implant to enhance its anchoring capabilities.

Abstract: An expandable sheath is disclosed herein, which has a first polymeric layer and a braided layer positioned radially outward of the first polymeric layer. The braided layer includes a plurality of filaments braided together. The expandable sheaths further include a resilient elastic layer positioned radially outward of the braided layer. The elastic layer is configured to apply radial force to the braided layer and the first polymeric layer. The expandable sheath further includes a second polymeric layer positioned radially outward of the elastic layer and bonded to the first polymeric layer such that the braided layer and the elastic layer are encapsulated between the first and second polymeric layers. Methods of making and using the devices disclosed herein are also disclosed, as are crimping devices that may be used in methods of making the devices disclosed herein.

Abstract: A cardiac device comprises a first anchoring element configured to be attached to a first side of a tissue wall, a second anchoring element configured to be attached to a second side of the tissue wall, and a cinching device. The cinching device is configured to attach to the first anchoring element and the second anchoring element and apply force to the first anchoring element to move the first anchoring element towards the second anchoring element and at least partially compress the tissue wall.

Abstract: Valve repair devices are disclosed herein. The valve repair devices are configured to reduce or inhibit regurgitant blood flow through a native heart valve. The valve repair devices are configured to be positioned within the native heart valve orifice and attached to the native heart valve. The device can be connected to leaflets of the native valve by a variety of different types of paddles.

Abstract: Method and devices for displacing leaflets of an existing valvular structure at an aortic valve position away from coronary ostia of an aorta are disclosed. An example method can include implanting a prosthetic heart valve within a native valve or previously implanted heart valve such that a commissure of the prosthetic heart valve is circumferentially aligned with a mid-portion of a leaflet of the native or previously implanted heart valve. The method further includes, during radially expanding the prosthetic heart valve into the native or previously implanted heart valve, applying pressure to the mid-portion of the leaflet with the commissure such that the leaflet is displaced away from the commissure and toward an inflow end of the prosthetic heart valve.

Abstract: An assembly can comprise a prosthetic valve comprising a radially expandable and compressible frame and a rotatable screw connected to the frame, where the screw comprises a screw head having an annular bore with internal threads, and where the screw is rotatable to radially expand the frame. The assembly further comprises a delivery apparatus releasably coupled to the screw, the delivery apparatus comprising a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads configured to engage with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft. The second head is configured to releasably engage with an exterior surface of the screw head and rotate the screw.

Abstract: The active introducer sheath systems disclosed herein are expanded by activating a translation mechanism at the handle. The sheath has an inner cylindrical structure of comingled fixed and mobile elongate rods bound together by an attachment line. Activating the translation mechanism causes the mobile rods to move axially with respect to the fixed rods, changing the internal tension in the attachment line. Increased tension draws the fixed and mobile rods closer together, decreasing the diameter of the cylindrical structure. Decreased tension in the attachment line enables the fixed and mobile rods to move apart, increasing the diameter of the cylindrical structure. A prosthetic device, such as a prosthetic heart valve, can be routed through the expanded sheath and to the implantation site. During implantation, the sheath can be contracted back to its original outer diameter, and expanded again for retrieval of the delivery apparatus.

Abstract: A cardiac device comprises a first anchoring element configured to be attached to a first side of a tissue wall, a second anchoring element configured to be attached to a second side of the tissue wall, and a cinching device. The cinching device is configured to attach to the first anchoring element and the second anchoring element and apply force to the first anchoring element to move the first anchoring element towards the second anchoring element and at least partially compress the tissue wall.

Abstract: A method is provided for pre-stretching implantable biocompatible materials, such as material to be incorporated into an implantable device. A sheet of implantable biocompatible material is attached to one or more tensioning members, where tension is applied along one or more axes. Tension is applied for a period of time, and at an appropriate force, to produce a desired degree of thinning or pre-stretching of the implantable biocompatible material. During the tensioning, the implantable biocompatible material is maintained at an elevated temperature, such as a temperature that is at least substantially a temperature of an environment into which the material will be implanted.

Abstract: A method can comprise deploying a prosthetic valve with a delivery apparatus, where the prosthetic valve comprises a frame and a rotatable screw connected to the frame, and where the screw comprises a screw head having an annular bore with internal threads. The delivery apparatus is releasably coupled to the screw and can comprise a first shaft and a first head disposed at an end of the first shaft, the first head comprising external threads releasably engaged with the internal threads of the screw head, and a second shaft that is coaxial with and surrounds the first shaft, the second shaft comprising a second head disposed at an end of the second shaft, the second head releasably engaged with an exterior surface of the screw head. Deploying the valve includes radially expanding the prosthetic valve by rotating the screw with the delivery apparatus.

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: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.

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: 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: Devices, assemblies, and methods for displacement of leaflets surrounding a prosthetic valve, such as native leaflets or host leaflets of a previously-implanted prosthetic valve, during valve implantation procedures are disclosed herein. As one example, a valve assembly can include a prosthetic valve and a leaflet engagement frame coupled to the frame of the prosthetic valve. The leaflet engagement frame can include a plurality of engagement frame struts defining one or more rungs, and a plurality of spikes that extend in a distal direction from a first rung of struts of the leaflet engagement frame. The distally extending spikes are configured to engage with one or more native or host leaflets positioned outside the valve assembly when the valve assembly is in a partially expanded state, and to distally fold the engaged native or host leaflets when the valve assembly is further expanded.

Abstract: The expandable sheath and methods of use disclosed herein are used to deliver a prosthetic device through a patient's vasculature. The sheath is constructed to be expandable in the circumferential direction, while maintaining sufficient stiffness in the longitudinal direction to withstand pushing and resist kinking. The sheath includes a plurality of curved arms extending outwardly from a longitudinally extending spine. The curved arms move away from the longitudinal axis of the sheath when pushed radially outwardly by a passing prosthetic device, and move back toward the longitudinal axis once the prosthetic device has passed.