Abstract: The present invention provides a prosthetic heart valve device with improved fit and/or apposition between the device frame and left atrial tissue and/or the device base and the annular tissue of the left atrium to improve shifting of the implanted device and/or mitigate paravalvular leakage. The improved fit and/or apposition arises in various embodiments by providing or allowing an asymmetrical frame and/or frame base and/or providing a lower lip to aid in conforming to the asymmetrical shape of the atrium and/or ensure firm positioning therein. An additional benefit of these arrangement(s) is mitigation of paravalvular leakage as a result of improved fit and seal. In certain embodiments, the asymmetry of the frame assists with delivery of the device into the atrium.

Abstract: A collapsible and expandable prosthetic heart valve stent is provided and comprising an outer section, a valve support defining a flow channel therethrough, a transition section configured to smoothly transition the outer section to the valve support. The valve support is disposed within an interior defined by the outer section, with the inflow end of the valve support disposed inside the outer section's interior. In some cases, the outflow end of the valve support is at least partially defined by the transition section. The prosthetic leaflets are disposed on the inner surface of the valve support's flow channel and are located at or above the annulus of the heart chamber. A paravalvular leakage mitigation system is attached to the stent to mitigate retrograde blood flow and/or regurgitation.

Abstract: A collapsible and expandable prosthetic heart valve stent is provided and comprising an outer section, a valve support defining a flow channel therethrough, a transition section configured to smoothly transition the outer section to the valve support. The valve support is disposed within an interior defined by the outer section, with the inflow end of the valve support disposed inside the outer section's interior. In some cases, the outflow end of the valve support is at least partially defined by the transition section. The prosthetic leaflets are disposed on the inner surface of the valve support's flow channel and are located at or above the annulus of the heart chamber. A paravalvular leakage mitigation system is attached to the stent to mitigate retrograde blood flow and/or regurgitation.

Abstract: An expandable and collapsible stent comprising prosthetic leaflets attached to an inner valve support section that extends radially upward into an outer stent section. A transition stent section is disposed between the inner valve support section and the outer stent section. Each of the outer stent section, the inner valve support section and the transition stent section may comprise struts or the equivalent that form and define cells having a pattern, wherein each section may comprise a different cell pattern. Transition stent section preferably comprises struts that are of equal curvature, with adjacent struts equally spaced from each other to allow nested collapsing of the transition stent section struts. A boss section extending downstream away from the inner valve support section may be provided to aid in alignment and retention of the expanded stent and may comprise a shape that is complementary to a heart chamber annulus.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: Soft body tissue structure can be remodeled by shortening the distance between first and second portions of that tissue structure. First and second anchor structures are respectively implanted in the first and second portions of the tissue structure. These anchor structures are linked by a linking structure, the length of which between the anchor structures can be shortened to pull the tissue structure portions toward one another. Each of the anchor structures may include two screw structures that are driven into the associated tissue structure portion transverse to the linking structure and with a spacer between the two screws. The entire prosthesis can be implanted percutaneously if desired. An illustrative use of the prosthesis is to shorten the annulus of a patient's mitral valve, with at least a portion of the prosthesis implanted in the patient's coronary sinus.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: A method of making a prosthetic heart valve may include providing an annular stent having a plurality of annularly spaced commissure portions having tips, covering each of the tips with a first fabric cover, covering the first fabric covers and the remainder of the stent with a second fabric cover, covering the second fabric cover with a first tissue membrane, and covering the outside of the first tissue membrane with a second tissue membrane, the second tissue membrane forming leaflet portions that extend inwardly between the commissure portions.

Abstract: An implant structure for use in pulling two soft body tissue areas closer together in a patient (e.g., two points along or adjacent to the patient's mitral valve annulus) includes at least two tissue anchor structures that are respectively implantable into the two tissue areas. A tether structure links the two tissue anchors and can be shortened and held in that condition by a cinch structure. Bracing structures are used between the anchors and the tether to help keep the longitudinal axes of the anchors transverse to the tether axis even when the tether is under tension. The tether may be sheathed in a cushioning sleeve to help protect adjacent tissue from erosion by the tether.

Abstract: A structure that can be used as a gastric band (and that may also have other uses as an implant elsewhere in a patient) includes a plurality of magnetic elements in a serial array that can be implanted so that the array extends in a circumferential direction around the patient's stomach (or other body tissue structure in the patient). Circumferentially adjacent magnetic elements magnetically attract one another to apply radial pressure to the tissue structure encompassed by the array, but those elements can also move apart in response to sufficient outward pressure from the encompassed tissue structure and/or the contents of (e.g., food in) that tissue structure. When used as a gastric band, the device can provide resistance to excessive food intake, which can help promote weight loss.

Abstract: Methods and apparatus are provided that gather a patient's body tissue and then secure the gathered tissue in a reduced area utilizing a securing structure. The securing structure mainly resides on one side of the tissue to minimize or eliminate both foreign material and the amount of manipulation or activity on the other side of the tissue. The securing device is matched to the desired amount of tissue manipulation to minimize the structure. The gathered and secured tissue can surround a septal defect to obstruct or close the defect itself.

Abstract: A structure that can be used as a gastric band (and that may also have other uses as an implant elsewhere in a patient) includes a plurality of magnetic elements in a serial array that can be implanted so that the array extends in a circumferential direction around the patient's stomach (or other body tissue structure in the patient). Circumferentially adjacent magnetic elements magnetically attract one another to apply radial pressure to the tissue structure encompassed by the array, but those elements can also move apart in response to sufficient outward pressure from the encompassed tissue structure and/or the contents of (e.g., food in) that tissue structure. When used as a gastric band, the device can provide resistance to excessive food intake, which can help promote weight loss.

Abstract: Improved dip coating methods and mandrels for forming polymer leaflets and valve prostheses generally involve one or more features on the mandrel that facilitate the processing. The mandrel has a top surface and an outer surface comprising a plurality of ridges and contoured surfaces extending to the ridges. An edge on the mandrel separates the top surface and the contoured surfaces, with the mandrel edge corresponding to the free edge of the leaflet. In preferred embodiments, the edge separating the top surface from the contoured surfaces is sharp. The polymer formed on the top surface can be efficiently separated from the remaining portions of the polymer structure to form the free edges of the leaflets.

Abstract: An improved method for testing a stent for a prosthetic valve includes applying a load with a fluid against a stented test structure in a backward direction with the stented test structure substantially blocking the flow of the fluid. The stented test structure includes a stent and a flexible membrane extending within the lumen defined by the stent with the flexible membrane having a plurality of contours connecting to the stent along the scallops. A corresponding testing apparatus includes a cyclic pressure applicator, a conduit connected to the cyclic pressure applicator, and a stented test structure mounted within the conduit to receive cyclic fluid pressures from the cyclic pressure applicator. The stented test structure includes a stent and a flexible membrane extending within the lumen defined by the stent. The flexible membrane substantially blocks flow of the fluid in a backward direction and does not fully open upon application of the fluid pressure in a forward direction.

Abstract: A patient's soft body tissue can be remodelled by implanting first and second anchor structures in the tissue at respective first and second spaced locations. A linking structure between the anchor structures is then operated to change the distance between the first and second anchor structures. Examples of use are repair of a patient's mitral and/or tricuspid valve(s) and/or remodeling of a patient's left ventricle.

Abstract: A prosthetic heart valve for replacing a native heart valve is provided and includes a generally circular heart valve body having an inner wall defining a lumen configured to allow blood flow therethrough. Occluders are configured to rotate about opposed occluder ends between an open position and a closed position. The minor radius arcs cooperate with the occluders to allow the occluders to block blood flow through lumen when in a closed position yet provide an increased lumen when the occluders are in an open position.

Abstract: Valved prostheses are described with crosslinked leaflets. At least one of the leaflets has a shape corresponding to a contoured surface. The leaflets are individually attached to the prostheses. Furthermore, in some embodiments, the leaflets do not comprise native leaflet tissue. Methods for forming tissue heart valve prostheses can comprise assembling a plurality of leaflets configured to open and close the valve in response to pressure differentials. Each of the plurality of leaflets is preformed individually when at least partially crosslinked in contact with a contoured surface. The individual crosslinked leaflets can be selected and matched for assembly into a valve. In general, the tissue, when it is crosslinked, has a size and shape approximately the size of a single human heart valve leaflet.

Abstract: In some embodiments, a method for processing tissue comprises the application of a directional load to modify the properties of the tissue. In particular, the directional force is sufficient to increase the rigidity of the tissue asymmetrically relative to an unaligned tissue equivalently processed without being subjected to a load. In some embodiments, a sufficient directional load is applied to increase the rigidity of the tissue relative to an unaligned tissue equivalently processed that is not subjected to the load, in which the load is applied with a load applicator. A connector transfers the load from the load applicator to the tissue. Selectively aligned tissue having asymmetric mechanical properties can be used to form a prosthetic valve. The leaflets are matched with respect to each of their properties to have improved coaptation relative to corresponding tissue leaflets with symmetrical mechanical properties.