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. Aspects also include a sheath that includes a radially expandable cylindrical outer layer a stiff inner member, an inner liner layer coupled to the inner surface of the stiff inner member; and an outer liner layer disposed between an outer surface of the stiff inner member and an inner surface of the outer layer.

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: Methods and tools for implanting prosthetic heart valves and modifying leaflets of an existing valvular structure in a subject are disclosed herein. Prior to or during implantation of the prosthetic heart valve within the existing valvular structure, each tool can be provided in the ascending aorta (or equivalent thereof) of a subject and can be used to pierce, lacerate, slice, tear, cut or otherwise modify a leaflet or commissure of the existing valvular structure. The existing valvular structure can be a native aortic valve or other native heart valve, or a previously-implanted prosthetic heart valve. The modification can avoid, or at least reduce the likelihood of, issues that leaflets of the existing valvular structure might otherwise cause once the prosthetic heart valve has been fully installed, for example, obstruction of blood flow to the coronary arteries and/or improper valve mounting due to a non-circular cross-section.

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: Disclosed is an expandable sheath that can be used in conjunction with a catheter assembly to introduce a prosthetic device, such as a heart valve, into a patient. The disclosed sheaths 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. Also disclosed is a sheath having 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 and where a first polymer is disposed between the outer layer and the folded portion of the inner layer.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart comprises an expandable frame can comprise a central portion defining a lumen, and first and second opposing end portions. The frame is configured to expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can further comprise a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member is configured to permit a medical instrument inserted through the lumen and into the left atrium, such as for performing a subsequent medical procedure in the left side of the heart.

Abstract: A septal closure and port device for implantation in the atrial septum of a patient's heart includes an expandable frame with a central portion defining a lumen, and first and second opposing end portions. The frame can expand and contract between a compressed, tubular configuration for delivery through the patient's vasculature and an expanded configuration in which the first and second end portions extend radially outwardly from the opposite ends of the central portion. The device can also have a valve member supported on the frame and positioned to block at least the flow of blood from the left atrium to the right atrium through the lumen of the frame. The valve member permits a medical instrument to be inserted through the lumen and into the left atrium, for performing a subsequent medical procedure in the left side of the heart.

Abstract: A method of delivering an anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. The anchors can be delivered to be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

Abstract: An assembly includes a holder device and a non-self-expandable prosthetic heart valve. The prosthetic heart valve can be radially compressed from an expanded configuration to a compressed configuration. The holder device is configured to hold the prosthetic heart valve in the expanded configuration and to allow the prosthetic heart valve to be inserted in a crimping device so that the prosthetic heart valve can be crimped onto a valve mounting portion of a delivery apparatus.

Abstract: An anchoring device that can be positioned within a native valve, such as the native mitral valve, to secure a replacement prosthetic valve in place. The anchoring device can comprise a docking station formed of a super elastic wire-like member defining a continuous, closed shape. The docking station can have an upper or atrial ring with at least two ring portions or half rings that are spaced apart across gaps. Descending bends from the ends of the two ring portions lead to a pair of anchors. The anchors can include oppositely-directed rounded V-shaped arms that extend generally parallel to the upper ring. When installed by a delivery device, the anchors can be located in the subvalvular space or the region/vicinity of the native leaflets and pinch the leaflets and the annulus against the upper ring which is located on the other side of the annulus.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: A covering layer for a transcatheter heart valve is in various embodiments configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted. In some cases, prosthetic valves are manufactured with the covering layer attached. Other covering layers are stand-alone accessories that can be mounted onto pre-existing prosthetic valves by an end user. Covering layers that can be mounted by an end user are provided with various features that can facilitate easier attachment of the covering layer to the prosthetic valve, which further reduces the possibility of damage to the covering layer or to the valve. Another covering is provided with two layers in order to insulate and protect the native tissue surrounding the implant from damage due to friction or abrasion, and/or other movement driven wear.

Abstract: Devices, systems and methods are described herein to provide improved steerability for delivering a prosthesis to a body location, for example, for delivering a replacement mitral valve to a native mitral valve location. The delivery system can include a number of advantageous steering and delivery features, in particular for the transseptal delivery approach.

Abstract: A method for treating a heart valve comprises delivering a repositioning device to a ventricle of a heart. The repositioning device comprises an anchoring element and a band. The method further comprises securing a first end of the band to the anchoring element, extending a second end of the band to encircle and at least partially contact a first papillary muscle, tightening the band to cause repositioning of at least a portion of the first papillary muscle, and locking the band in place.

Abstract: A covering layer for a transcatheter heart valve is in various embodiments configured to prevent or reduce damage to the native valve tissue around the site where the prosthetic valve is implanted. In some cases, prosthetic valves are manufactured with the covering layer attached. Other covering layers are stand-alone accessories that can be mounted onto pre-existing prosthetic valves by an end user. Covering layers that can be mounted by an end user are provided with various features that can facilitate easier attachment of the covering layer to the prosthetic valve, which further reduces the possibility of damage to the covering layer or to the valve. Another covering is provided with two layers in order to insulate and protect the native tissue surrounding the implant from damage due to friction or abrasion, and/or other movement driven wear.

Abstract: A volume indicator for a syringe can include an indicator body configured to removably clip onto a syringe body and a window portion extending through a thickness of the indicator body. The volume indicator can include inflation indicia corresponding to a range of expanded diameters for a prosthetic heart valve. The volume indicator can include one or more first engagement elements that correspond to one or more second engagement elements on a syringe.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A prosthetic valve may comprise a radially compressible main body and a one-way valve portion. The prosthetic valve may further comprise one or more ventricular anchors coupled to the main body and disposed outside of the main body. The ventricular anchors may be configured such that a reduced profile of the prosthetic valve is possible. A space may be provided between an outer surface of the main body and the ventricular anchors for receiving native mitral valve leaflets. The prosthetic valve may include an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for receiving the native mitral valve leaflets between the ventricular anchors and the main body are described.

Abstract: Disclosed herein are embodiments of delivery capsules for delivering prosthetic implants around the relatively tight bends of a catheter. In particular, disclosed herein are delivery capsules including a tubular layer for holding the heart valve, a frame enclosing the tubular layer and an elongate element coupled to the frame for allowing the tubular layer and frame to expand. For example, the frame may be biased to expand and withdrawal of the elongate element from openings in the frame can release the frame to expand into a larger diameter. Another embodiment includes a helical wire wrapped around the capsule for easy delivery through bends and a second helical wire that is advanced between windings of the first helical wire to selectively stiffen the capsule for withdrawal. Other embodiments include sock-like capsules that can be crumpled into shorter lengths by pulling a pull line attached to the capsule.