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.

A valve planning tool comprising: (a) a stem having a distal end and a proximal end, (b) an anchor indicator located at the distal end, and (c) a balloon located proximal of the anchor indicator, the balloon including: (i) a retracted state and (ii) a deployed state; wherein the balloon is inflatable from the retracted state to the deployed state and the balloon is substantially non-compliant so that the balloon is only inflatable to one size.

A system is transluminally advanced into the heart of a subject. A first portion of the system is positioned through a native valve of the heart, the system including wires disposed at the first portion. The first portion is stabilized at the native valve by positioning a distal portion of the system within a blood vessel of the subject. While the distal portion of the system remains within the blood vessel, the wires are induced to bow laterally such that the wires press against the native valve. While the wires remain pressed against the native valve, the shape of the wires is radiographically imaged. An anchor is transluminally anchored to tissue of the native valve, facilitated by the imaging. Other embodiments are also described.

A device for measuring heart valve for sizing a heart valve reinforcement ring, includes a first handle having a first shaft an outer ring coupled to the first shaft, wherein the outer ring has an inner surface; and an inner ring having an outer surface, wherein the inner ring is removably couplable to the outer ring. The inner surface of the outer ring and the outer surface of the inner ring further have reciprocal mating surfaces configured and arranged to grip sutures therebetween when coupled together. The device may further have a second handle with a second shaft connected to the inner ring. Alternatively, the first handle may have a second shaft that is connected to a second outer ring.

A ring sizer including a face plate that has markings usable to provide measurements of a valve. The sizer may include a clear face plate on which the markings are provided such that the valve is visible through the face plate facilitating accurate measurements of various valve dimensions and optimal ring sizing.

The present teachings provide devices and methods of locating a mitral valve commissure, and implanting tissue anchors at or near the mitral valve commissure. Specifically, one aspect of the present teachings provides devices and methods for locating a mitral valve commissure percutaneously and allowing a guide wire to be placed across a mitral annulus at the mitral valve commissure. Another aspect of the present teachings provides methods for deploying a tissue anchor across a mitral annulus at a mitral valve commissure, including near the P1 or P3 regions of the posterior mitral annulus. Another aspect of the present teachings further provides methods of plicating a mitral annulus between two or more tissue anchors.

Systems and methods for positioning a transcatheter aortic valve are disclosed. A system can include a first catheter, a second catheter, and a flexible wire all independently movable with respect to each other, and configured to be implanted in respective aortic valve cusps in order to accurately determine a real-time coplanar angle of the nadirs of each of the first aortic valve cusp, the second aortic valve cusp, and the third aortic valve cusp, thereby determining a desired valve implantation depth.

A heart valve prosthetic ring assembly includes an outer ring, and an inner ring configured and arranged to couple to the outer ring. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. Once coupled around sutures, the assembled ring set may be tightened down against the heart valve annulus to test the fit. If there are fit issues, the surgeon can remove the current ring set and replace it with another ring set of a different size/shape to determine a better fit. Once a proper size is determined, the surgeon may utilize the selected paired ring set as the final prosthetic reinforcing ring. The paired ring set may be secured in place with suture clasps which secure the ring sutures in place relative to the annulus and the ring set.

A heart valve prosthetic ring assembly includes an outer ring, and an inner ring configured and arranged to couple to the outer ring. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. Once coupled around sutures, the assembled ring set may be tightened down against the heart valve annulus to test the fit. If there are fit issues, the surgeon can remove the current ring set and replace it with another ring set of a different size/shape to determine a better fit. Once a proper size is determined, the surgeon may utilize the selected paired ring set as the final prosthetic reinforcing ring. The paired ring set may be secured in place with a flanged suture fastener which secure the ring sutures in place relative to the annulus and the ring set.

A catheter for positioning a valve during a transcatheter aortic valve replacement is formed from a resilient hollow body conformable to a guide wire when a guide wire is passed in through an upper opening in the hollow body and through the hollow body. When the guide wire is retracted, the catheter deploys to form a substantially straight upper shaft portion that extends downwardly from the upper opening and a distal ring perpendicular to the upper shaft portion. The distal ring approximates the size and shape of the patient's aortic valve annulus. A lower loop connects the upper shaft portion of the catheter to the distal ring. An outer surface of the distal ring is radiopaque, and the distal ring comprises openings for dispersing radio opaque medium used in imaging of the patient's aortic valve annulus. The deployed catheter is advanced until it snugly contacts the aortic valve with the horizontal loop at the level of the aortic valve leaflets and with the lower loop dipping into one the aortic valve cusps. The distal ring will be viewed as a straight line when an x-ray C-arm is properly aligned with the aortic valve.