Abstract: Delivery devices for delivering a self-expanding prosthetic heart valve are disclosed. The delivery device includes at least one cord is configured to selectively cinch the self-expanding prosthetic heart valve. The delivery device further includes at least one self-expanding release pin comprising a proximal segment, a distal segment, and an intermediate segment positioned between the proximal segment and the distal segment. The at least one self-expanding release pin includes a normal, expanded condition wherein the intermediate segment extends radially outward relative to a central axis of the spindle from the proximal segment to the distal segment. The delivery device further includes a capsule configured to be distally extended relative to the spindle to collapse the at least one self-expanding release pin from the normal, expanded condition of the at least one self-expanding release pin to a collapsed condition of the at least one self-expanding release pin.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: A packaging system for storing a deployable medical device within a sterilized environment includes a sealed container; a tray disposed within the sealed container; a catheter assembly comprising at least one sheath; a deployable medical device engaged with the catheter assembly; and a sterilizing fluid. The tray comprises a first chamber; a second chamber in fluid communication therewith; and at least a third chamber between the first and second chambers, and in fluid communication with at least the first chamber. The deployable medical device is disposed within the tray in a storage configuration, in which the deployable medical device is disposed within the first chamber in a partially deployed state distally from a distal end of the catheter and the catheter assembly spans between the first chamber and the second chamber. The sterilizing fluid contacts at least a part of the deployable medical device in the storage configuration.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: A packaging system for storing a deployable medical device within a sterilized environment includes a sealed container; a tray disposed within the sealed container; a catheter assembly comprising at least one sheath; a deployable medical device engaged with the catheter assembly; and a sterilizing fluid. The tray comprises a first chamber; a second chamber in fluid communication therewith; and at least a third chamber between the first and second chambers, and in fluid communication with at least the first chamber. The deployable medical device is disposed within the tray in a storage configuration, in which the deployable medical device is disposed within the first chamber in a partially deployed state distally from a distal end of the catheter and the catheter assembly spans between the first chamber and the second chamber. The sterilizing fluid contacts at least a part of the deployable medical device in the storage configuration.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: In some embodiments, a method includes a shaft having a side catheter guide attached thereto via a guide coupler into an inferior vena cava and a superior vena cava such that the guide coupler is disposed in a right atrium, and applying a distal force to a proximal portion of the side catheter guide such that a distal end of the side catheter guide deflects laterally about the guide coupler towards a septum. The method further includes extending a side catheter that is disposed within the side catheter guide distally from the side catheter guide towards and into contact with the septum. The method further includes, with the side catheter in contact with the septum, extending a septum penetrator that is slidably disposed within the side catheter distally from the side catheter such that the septum penetrator pierces the septum.

Abstract: Disclosed herein are minimally invasive systems and methods for intravascularly accessing the heart and performing a transcatheter repair of a heart valve by inserting one or more sutures as artificial chordae into a heart valve leaflet.

Abstract: Delivery devices for a stented prosthetic heart valve. The delivery device includes a spindle, at least one cord, and a lateral control feature. The cord is tensioned to crimp the prosthesis to a compressed condition for delivery to a target site. Tension is lessened to allow the prosthesis to self-expand. In a tethered and expanded state in which the prosthesis has self-expanded and is connected to the spindle by the cord, the lateral control feature directs the spindle to a prescribed location relative to the prosthesis appropriate for a functional evaluation of the prosthesis. In some embodiments, the spindle is directed to a center of the prosthesis; in other embodiments, the spindle is held at a commissure of the prosthesis. The lateral control features of the present disclosure assume numerous forms.

Abstract: A device for isolating tissue in the digestive tract including a biocompatible portion having a surface sized to cover the tissue to be isolated and also includes a plurality of micro-anchors attached to the biocompatible portion and extending from the surface, the micro-anchors sized to penetrate the mucosa of the tissue. A method for isolating tissue in the digestive tract in which an isolation element is delivered to a desired location in the digestive system; the isolation element having fixed thereto a plurality of micro-anchors. The method also includes attaching the isolation element to tissue at the desired location by causing the micro-anchors to penetrate the mucosa of the tissue.

Abstract: A device for isolating tissue in the digestive tract including a biocompatible portion having a surface sized to cover the tissue to be isolated and also includes a plurality of micro-anchors attached to the biocompatible portion and extending from the surface, the micro-anchors sized to penetrate the mucosa of the tissue. A method for isolating tissue in the digestive tract in which an isolation element is delivered to a desired location in the digestive system; the isolation element having fixed thereto a plurality of micro-anchors. The method also includes attaching the isolation element to tissue at the desired location by causing the micro-anchors to penetrate the mucosa of the tissue.

Abstract: A device for isolating tissue in the digestive tract including a biocompatible portion having a surface sized to cover the tissue to be isolated and also includes a plurality of micro-anchors attached to the biocompatible portion and extending from the surface, the micro-anchors sized to penetrate the mucosa of the tissue. A method for isolating tissue in the digestive tract in which an isolation element is delivered to a desired location in the digestive system; the isolation element having fixed thereto a plurality of micro-anchors. The method also includes attaching the isolation element to tissue at the desired location by causing the micro-anchors to penetrate the mucosa of the tissue.

Abstract: An evacuation sheath assembly and method of treating occluded vessels which reduces the risk of distal embolization during vascular interventions is provided. A method of treating a blood vessel, includes providing an elongate member having proximal and distal ends, a lumen therebetween, the distal end having a braided sheath expandable between a reduced and expanded diameter, and a fluid-tight covering. The elongate member is advanced into a blood vessel that supplies blood to the heart. The braided sheath is expanded to engage the endoluminal surface of the blood vessel and stop antegrade flow.

Abstract: A device for sealing a patent foramen ovale (PFO) in the heart is provided. The device includes a left atrial anchor adapted to be placed in a left atrium of the heart, a right atrial anchor adapted to be placed in a right atrium of the heart, and an elongate member adapted to extend through the passageway and connect the left and right atrial anchors. The right atrial anchor preferably includes a plurality of arms and a cover attached to the arms. The left atrial anchor preferably also includes a plurality of arms and preferably does not include a cover. Preferably, the elongate member has a first end fixedly connected to the left atrial anchor and a portion, proximal to the first end, passing through the right atrial anchor. Preferably, the elongate member is flexible.