Abstract: Disclosed herein are implantable medical devices comprising a textile material comprising a first material and a second material having different stretchability and flexibility, where the first and the second materials are at least partially superposed and coupled to each other. The medical devices of the current disclosure can be implantable prosthetic valves. The valves of the present disclosure provide for a reduced crimped profile and improve PVL sealing. In addition, disclosed herein are methods of making the implantable medical devices.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end, an outflow end, and a plurality of struts. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a coaptation edge portion and a cusp edge portion. The cusp edge portion of each leaflet can be folded toward the outflow end of the frame along a bending axis and a reinforcing member extends along an outflow surface of the cusp edge portion along the bending axis. The prosthetic heart valve can include a plurality of connecting skirts, each disposed between the cusp edge portion of an adjacent leaflet and the frame. First stitching secures the reinforcing member and the connecting skirts to the cusp edge portions and second stitching secures the connecting skirts to selected struts of the frame.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: Ultrasound probe systems and methods for using an ultrasound probe to assist during treatment of conditions of the human heart are provided. The method may comprise loading a medical instrument into a guide fastened to the ultrasound probe. The ultrasound probe may be inserted into a patient by way of an incision. The distal end of the ultrasound probe may be navigated to a location adjacent to an exterior surface of the heart. A treatment site may be identified on the exterior surface of the heart based on images obtained from an ultrasound transducer disposed within a distal end of the ultrasound probe. The medical instrument may be advanced within the guide to the treatment site and the medical instrument used for treatment. After treatment, the medical instrument may be withdrawn from the treatment site.

Abstract: An implantable prosthetic device can include a frame that is radially expandable and compressible between a radially compressed configuration and a radially expanded configuration. The frame can include a plurality of struts, each strut comprising a first portion and a second portion separated by a deflection point. Each strut can be curved helically with respect to a first, longitudinal axis of the frame. The first portion of each strut can be curved in a first direction with respect to a first line parallel to a second axis that is perpendicular to the first, longitudinal axis of the frame, and the second portion of each strut can be curved in a second direction with respect to a second line parallel to the second axis.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising a plurality of circumferentially extending rows of angled struts, including first, second, and third rows of angled struts forming rows of diamond-shaped cells, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is disposed between the frame and the cusp edge portions, the skirt being sutured to selected struts of the frame along diagonal paths extending from an inflow end portion toward an outflow end portion. Each diagonal path along which the skirt is sutured to the frame extends along the first, second, and third rows of angled struts.

Abstract: A system can include a delivery catheter comprising a balloon and an implantable prosthetic heart valve. The prosthetic valve can have a plastically expandable and compressible unitary frame comprising first, second, and third rows of angled struts that define two circumferentially extending rows of diamond-shaped cells that extend continuously around the frame, and a valvular structure comprising a plurality of leaflets. A cusp edge portion of each leaflet is connected to the frame by a skirt that is connected to and disposed between the frame and the cusp edge portions of the leaflets, the skirt being connected to consecutive struts in the first, second, and third rows of struts with sutures. The compressed prosthetic heart valve can be mounted around the balloon and radially expanded to the expanded configuration with the balloon inside a patient's body.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: An anchoring system and related methods are provided for treatment of dilated hearts and of functional valve regurgitation, the system comprising one or more self-expandable or manually expandable anchors and associated devices for fixating a valve splint within the heart. For example, a spade-shaped assembly may be configured to be deployed in a right ventricle of the heart and to stabilize a puncturing instrument to puncture the septum. Various puncturing instruments may also be part of the anchoring system, including one or more of a flexible needle having a multiplicity of slits disposed along the length of the needle, a trocar catheter with a retractable head, and a catheter needle having a blunt introducer to protect nearby tissue within the heart during advancing a guidewire. A cutter catheter and puncture location catheter may also be part of the system and be used during treatment.

Abstract: A prosthetic valve has an annular frame including a plurality of strut members that is radially collapsible to a collapsed configuration and radially expandable to an expanded configuration. A leaflet structure is situated at least partially within the frame. The leaflet structure includes a plurality of leaflets, each leaflet having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form a commissure. The commissure tab portions of each leaflet are folded to form a plurality of layers positioned on the inside of the frame. A reinforcement member is positioned between the layers of each commissure tab portion.

Abstract: A prosthetic heart valve includes an annular frame including a plurality of strut members that is radially collapsible and expandable. A leaflet structure is situated within the frame, and includes a plurality of leaflets having opposing commissure tab portions on opposite sides of the leaflet. Each commissure tab portion is paired with an adjacent commissure tab portion of an adjacent leaflet to form one or more commissures. A commissure support element is positioned at each of the commissures, and comprise a first member and a second member that are separable from each other and configured to receive leaflets therebetween. The first and second members are detached from the frame and spaced radially inwardly from the frame such that the members contact the leaflets radially inward from the frame and limit movement of the leaflets so that they articulate at a location that is spaced radially inwardly from the frame.

Abstract: A prosthetic heart valve can include a radially expandable and compressible frame having an inflow end portion and an outflow end portion, the frame comprising a plurality of struts defining openings between them. The prosthetic valve can further include a valvular structure comprising a plurality of leaflets, each leaflet comprising a main body, opposing tabs on opposite sides of the main body, a coaptation edge portion, and a cusp edge portion. Each tab can be paired with an adjacent tab of an adjacent leaflet to form a plurality of commissures that are fixed relative to the frame, and each leaflet can have opposing edge portions between the opposing tabs and the cusp edge portion that are unattached to the frame, each unattached edge portion defining a gap that extends radially into the main body of the leaflet.

Abstract: A prosthetic heart valve can include a radially collapsible and expandable annular frame having a plurality of struts defining openings. The prosthetic heart valve can further include a plurality of leaflets that regulate the flow of blood through the frame. The prosthetic heart valve can also include a sealing member mounted on the frame and having an inner layer and an outer layer. At least the outer layer is mounted on the outside of the frame, and the inner layer covers at least the openings in the frame between adjacent cusp portions of adjacent leaflets and the inner layer does not cover one or more openings in the frame at locations facing the outflow surfaces of the leaflets to permit retrograde blood to flow through the one or more uncovered openings in the frame and into space between the outer layer and the frame.

Abstract: A prosthetic valve assembly includes a radially expandable and compressible annular frame. The frame includes a plurality of interconnected struts, which include a plurality of inner struts and a plurality of outer struts. The inner struts overlap adjacent outer struts at a plurality of pivot joints. Radial expansion or compression of the annular frame causes the inner struts to pivot relative to the outer struts at the pivot joints. The assembly also includes a valvular structure having a plurality of leaflets, each leaflet having a cusp edge portion. The assembly further includes one or more leaflet-supporting cords, each having a plurality of anchoring portions and a plurality of suspended portions, each suspended portion extending between two adjacent anchoring portions. The anchoring portions are affixed to respective anchoring features of the frame adjacent the pivot joints. The cusp edge portions of the leaflets are connected to the suspended portions.

Abstract: Ultrasound probe systems and methods for using an ultrasound probe to assist during treatment of conditions of the human heart are provided. The method may comprise loading a medical instrument into a guide fastened to the ultrasound probe. The ultrasound probe may be inserted into a patient by way of an incision. The distal end of the ultrasound probe may be navigated to a location adjacent to an exterior surface of the heart. A treatment site may be identified on the exterior surface of the heart based on images obtained from an ultrasound transducer disposed within a distal end of the ultrasound probe. The medical instrument may be advanced within the guide to the treatment site and the medical instrument used for treatment. After treatment, the medical instrument may be withdrawn from the treatment site.

Abstract: Ultrasound probe systems and methods for using an ultrasound probe to assist during treatment of conditions of the human heart are provided. The method may comprise loading a medical instrument into a guide fastened to the ultrasound probe. The ultrasound probe may be inserted into a patient by way of an incision. The distal end of the ultrasound probe may be navigated to a location adjacent to an exterior surface of the heart. A treatment site may be identified on the exterior surface of the heart based on images obtained from an ultrasound transducer disposed within a distal end of the ultrasound probe. The medical instrument may be advanced within the guide to the treatment site and the medical instrument used for treatment. After treatment, the medical instrument may be withdrawn from the treatment site.