Abstract: Implants and methods for treating diseased heart valves. The implants may include a support member configured for placement near the diseased valve and an anchoring system coupled to the support member. The support member may be used to treat regurgitation and/or support a valve replacement therein. The support member may have an annular shape with an opening configured to generally align with an opening of the diseased valve. In some examples, the support member includes a coaptation structure configured to seal with the native leaflets. The anchoring system may include one or more tethers anchored to tissue of a ventricle, such as a ventricle wall and/or a papillary muscle. In some examples, sufficient tension is applied on the tethers to stabilize or reduce ventricle dilation.

Abstract: Interfaces for delivery systems for delivering and deploying prosthetic heart valves. A prosthetic valve may be secured to a patient's native diseased valve by a spiral-shaped anchor that encircles an outer periphery of the prosthetic valve. In some examples, the interface provides a releasable connection between the anchor and a tether that guides placement of the anchor with respect to the patients native valve. Once the anchor is properly positioned, the prosthetic valve may be positioned and expanded within the patient's native valve and the anchor. The tether-anchor interface can release the anchor from the tether, leaving the anchor and valve prosthesis secured in place within the heart.

Abstract: A system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor is shaped to encircle chordae or leaflets of a native valve. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from a delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

Abstract: Devices, systems, and methods related to heart valve prostheses. The prosthesis includes an anchor and a frame. The anchor is shaped to encircle chordae and/or leaflets of a native heart valve. The frame is configured to sit within the anchor and the native valve such that the anchor encircles and anchors the frame in place. At least a portion of the anchor is configured to be visible using surgical visualization techniques during delivery of the prosthesis within the heart. The anchor can include an echogenic portion configured to enable viewing of the echogenic portion with ultrasound during delivery of the prosthesis.

Abstract: Delivery systems and methods for delivering a valve anchor and a valve prosthesis to a native valve annulus are provided. The anchor can be deployed near the native valve annulus with a tether attached thereto. A portion of the tether can be positioned inferior to the deployed anchor in an inverted configuration for advantageous positioning for adjusting the anchor position and/or deployment of the valve prosthesis. A positioning tool can be tracked over the tether and used to properly position the anchor. The positioning tool can be configured to transition to a stiffened state that includes one or more bends configured to allow efficient positioning of the deployed anchor and to provide room for deploying the valve prosthesis. Once the anchor is properly positioned, the valve prosthesis can be deployed within the native valve annulus and within the valve anchor.

Abstract: A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

Abstract: A system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor is shaped to encircle chordae or leaflets of a native valve. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from a delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

Abstract: A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

Abstract: A device for treating a diseased native valve in a patient is provided, the device including a frame structure and a plurality of leaflets. The device can further include a spiral anchor configured to extend around an outer circumference of the frame structure, the spiral anchor comprising a spiral portion and a proximal portion that extends radially outwards relative to a circumference of the spiral portion. Other embodiments and methods of use are also provided.

Abstract: A replacement heart valve commissure assembly may include: a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage the second locking portion in a deployed configuration, the first locking portion being longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations; and first and second valve leaflets secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion. A second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion. The first fabric sleeve may include first and second end portions, and an elastic central portion configured to engage the first leg.

Abstract: A replacement heart valve commissure assembly may include a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage with the second locking portion in a deployed configuration, wherein the first locking portion is longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations. The commissure assembly may include a first valve leaflet and a second valve leaflet each secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion by a first filament, and a second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion by a second filament.

Abstract: A system for treating a diseased native valve in a patient includes a valve prosthesis and a delivery device. The prosthesis includes an anchor and a frame. The delivery device includes an outer sheath, an inner shaft, an anchor guide, and a tether. The anchor is shaped to encircle chordae or leaflets of a native valve. The frame is configured to sit within the anchor. The inner shaft is positioned within the outer sheath and translatable and rotatable relative to the outer sheath. The anchor guide is attached to a distal end of the inner shaft and has a curved distal section. The tether is configured to detachably couple to the anchor and to longitudinally translate the anchor within the inner shaft and anchor guide. The anchor is configured to be actuated from a delivery configuration to the deployed configuration when the anchor is translated out of the anchor guide.

Abstract: A replacement heart valve commissure assembly may include: a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage the second locking portion in a deployed configuration, the first locking portion being longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations; and first and second valve leaflets secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion. A second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion. The first fabric sleeve may include first and second end portions, and an elastic central portion configured to engage the first leg.

Abstract: A seal member for use with a replacement heart valve implant may include a tubular polymeric seal element configured to be disposed on an outer surface of a replacement heart valve implant, the tubular polymeric seal element defining a central longitudinal axis; and a reinforcement strip fixedly attached to the tubular polymeric seal element proximate a first end of the tubular polymeric seal element, the reinforcement strip extending circumferentially around the central longitudinal axis. The reinforcement strip may include a radiopaque element extending circumferentially around the central longitudinal axis.

Abstract: A replacement heart valve commissure assembly may include a locking mechanism including a first locking portion spaced apart from a second locking portion in a delivery configuration and configured to engage with the second locking portion in a deployed configuration, wherein the first locking portion is longitudinally actuatable relative to the second locking portion between the delivery and deployed configurations. The commissure assembly may include a first valve leaflet and a second valve leaflet each secured to the first locking portion. A first sleeve portion of the first valve leaflet may be fixedly attached to a first fabric sleeve wrapped around a first leg of the first locking portion by a first filament, and a second sleeve portion of the second valve leaflet may be fixedly attached to a second fabric sleeve wrapped around a second leg of the first locking portion by a second filament.