Embodiments of universal self-anchoring prosthetic valves for multi-position transcatheter or surgical implantation within any diseased or malfunctioning native heart valve are provided. An exemplary embodiment of a prosthetic valve includes a radially compressible and self-expanding central core housing a prosthetic valve, with compressible and flexible memory-shaped woven wire anchoring discs at the inflow and outflow ends. Specific design properties allow the prosthesis to be conformable, self-centering and flipped for multiple appropriate physiologic implant orientations. Expansive transverse radial force exerted by the central core, and memory-shape induced directional forces exerted by flexible inflow and outflow discs, capture and compress native peri-annular and leaflet tissues to anchor the prosthesis. Tissue facing frame surfaces may include small tines to enhance anchoring. The prosthetic valve frames may include various biomaterials or polymers as linings, coatings or coverings to enhance sealing. Methods and devices for delivering and implanting the valve based on access are described.

According to the present invention, there is provided an artificial tendon-forming auxiliary instrument in which a valve cusp of a cardiac valve and a papillary muscle can be joined together with an artificial tendon through an easy procedure and the artificial tendon can be finished so as to have a desired length. According to an aspect of the present invention, an auxiliary instrument (100) is used for joining a valve cusp (210) of the cardiac valve and a papillary muscle (212) with an artificial tendon (200). A pair of end-portion support portions (20) and (21) respectively supporting the valve cusp (210) and the papillary muscle (212) is provided at both ends in a longitudinal direction. The auxiliary instrument (100) includes first and second tendon insertion ports through which the artificial tendon (200) is inserted, a tendon guide portion (30), and an instrument holding portion (40). The first and second tendon insertion ports are respectively formed in the pair of end-portion support portions (20) and (21) and have diameters greater than a diameter of the artificial tendon (200). The tendon guide portion (30) is formed so as to extend in the longitudinal direction across the first and second tendon insertion ports. The instrument holding portion (40) is formed in an intermediate portion of the tendon guide portion (30) in the longitudinal direction.

A dynamic, adjustable annuloplasty ring sizer can include an adjustable ring replica, which can be adjusted through a range of sizes corresponding to available prosthetic annuloplasty repair ring sizes. Actuation of an adjustment trigger on a handle portion of the ring sizer can displace tension wires that extend through a malleable shaft and through a plurality of articulating segments that form the ring replica. Displacement of the tension wires causes flexion of the joints between adjacent articulating segments, thereby reducing the overall size of the ring replica. Releasing the tension wires can allow an elastic extension wire to act on the ring replica, enlarging the ring replica to its maximum, at-rest size. In this manner, the appropriate size of annuloplasty ring prosthesis can be determined with a single device, without requiring a plurality of static ring sizers that require individual insertion and placement for the conventional trial-and-error sizing methods.

A bendable medical instrument including: a handle at a proximal end of the bendable medical instrument, a modular distal shaft including a plurality of vertebrae configured to bend and situated near a distal end of the bendable medical instrument, a bendable internal rod disposed through at least some of the plurality of vertebrae, the bendable internal rod having a modular cell structure, and a distal tip coupled to the modular distal shaft at the distal end. The plurality of vertebrae configured to bend to position the distal tip in a patient and the bendable internal rod configured to bend with the plurality of vertebrae.

A method for manufacturing a personalized naturally designed mitral valve prosthesis to precisely fit a specific patient for which the valve prosthesis is made for is provided. The method includes measuring size and shape of a mitral valve of the specific patient by using imaging methods, calculating geometry and dimensions of annular ring, leaflets and chords per the specific patient based on validated algorithms, and cutting and connecting the annular ring, leaflets and chords to form a personalized prosthesis mitral valve.

A system for determining the dimensions of a native valve annulus may include a sensing catheter, a transmitter, and a computing device. The sensing catheter may include a shaft extending in a longitudinal direction; a plurality of splines attached to the shaft, the splines having an expanded condition spaced radially outward from the shaft; and at least one sensing coil located on each of the splines. The transmitter may generate a magnetic field to induce a potential in each of the sensing coils, and the computing device may identify the positions of the sensing coils based on the induced potentials.

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 retracted until it snugly contacts the aortic valve annulus. The distal ring will be viewed as a straight line when the x-ray C-arm is properly aligned with the aortic valve annulus.

A heart valve sizing ring is disclosed. The sizing ring includes an outer ring and an inner ring configured and arranged to couple to the outer ring. A tubular portion extends from the inner ring and has a plurality of suture holders arranged about an upper end thereof. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. When coupled around sutures, the assembled ring may be tightened down against the heart valve to test the fit as if the sizing ring were a similarly sized prosthetic heart valve ring. Commissures of the heart valve may be suspended from the suture holders of the tubular portion. The surgeon can then remove the sizing ring and replace it with a prosthetic ring.

A system includes a medical device for implanting in a valve of a subject, the implantable medical device having a self-expanding frame; and a holder configured to retain the frame of the implantable medical device in a constricted configuration and to control expansion of the frame. The holder has a controllably constrictable and expandable loop, wherein the loop is disposed about at least a portion of the self-expanding frame such that constriction or expansion of the first loop controls constriction or expansion of the frame.

A heart valve sizing ring is disclosed. The sizing ring includes an outer ring and an inner ring configured and arranged to couple to the outer ring. A tubular portion extends from the inner ring and has a plurality of suture holders arranged about an upper end thereof. The outer ring and inner ring having a pair of complementary mating surfaces configured and arranged to grip sutures therebetween when coupled together. When coupled around sutures, the assembled ring may be tightened down against the heart valve to test the fit as if the sizing ring were a similarly sized prosthetic heart valve ring. Commissures of the heart valve may be suspended from the suture holders of the tubular portion. The surgeon can then remove the sizing ring and replace it with a prosthetic ring.