Abstract: Several unique intra-cardiac pressure devices, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure devices presented allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms. The intra-cardiac pressure devices are made of a non-braided material.

Abstract: The present teachings provide a device to close a ductus arteriosus percutaneously. One aspect of the present teachings provides a device comprising at least one flange portion configured to be positioned against a vascular wall outside one end of a ductus arteriosus, and a body portion configured to be positioned inside the ductus arteriosus. The body portion of the device has a length adjustable in order for the device to fit inside patients with various ductus arteriosus lengths. The at least one flange portion of the device has pivotability in order for at least one flange to deflect from the longitudinal axis of the body portion so that the deployed device can be positioned at a treatment site allowing the discs to sit flat against the vascular tissue to promote closure while avoiding disruption of flow within the pulmonary artery and aorta or applying excess pressure to the surrounding vascular tissue.

Abstract: A device for implanting into an atrial septum of a patient. In some embodiments, the device has a core region to be disposed in an opening in the atrial septum; a distal retention region adapted to engage tissue on a left atrial side of the septal wall; a proximal retention region adapted to engage tissue on a right atrial side of the septal wall; and a retrieval region comprising a plurality of retrieval members, each retrieval member comprising a connector at a proximal end, the connector being adapted to connect to a delivery system. The device has a delivery configuration and a deployed configuration, the core region, distal retention region and proximal retention region each having a smaller diameter in the delivery configuration than in the deployed configuration, the retrieval member connectors being disposed proximal to and radially outward from the opening in the deployed configuration.

Abstract: The present teachings generally relate a delivery system having an implant retention mechanism. Specifically, the delivery system includes a delivery sheath, a delivery catheter, and a flexible or a rigid implant retention mechanism. The flexible implant retention mechanism includes an implant retention string having a fixed end and a free end where the free end extends from the fixed end, crosses a retention outlet of an implant, and extends proximally through a lumen of the delivery sheath. The rigid implant retention mechanism includes an implant retention wire having a fixed end and a free end where the free end extends from the fixed end, crosses a retention outlet of an implant, and extends proximally through a lumen of the delivery sheath.

Abstract: The present teachings provide devices for puncturing the atrial septum percutaneously. Specifically, one aspect of the present teachings provides a trans-septal puncturing device comprising one or more of a locating element, a stabilizing element, a puncturing element, a safety element, and optionally a monitoring element, each of which is disposed in a lumen of a sheath. The locating element and the stabilizing element locate a desired puncture site and stabilize the trans-septal puncturing device at or near the site. The puncturing element of the trans-septal puncturing device has a limited puncturing distance due in certain instances to the safety element. The present teachings provide methods of using such device for percutaneously locating a fossa ovalis, stabilizing such device at the fossa ovalis, and piercing tissue across the fossa ovalis.

Abstract: The present teachings provide devices to change the pressure in a chamber of a heart and methods of making and using thereof. One aspect of the present teachings provides a device comprising a distal portion, a middle portion, and a proximal portion. The distal portion and proximal portion of the device are configured to be deployed inside the left and right atrium respectively with a minimum contact with the septal tissue. The middle portion of the device is configured to secure the device across an aperture on the atrial septum. The device further includes at least one retrieval portion with a plurality of struts. The distal end of the struts is connected with a proximal end of the proximal portions. The proximal end of the struts come together at a location near the axial center of the device. The radial expansion of the proximal portion will lead to the radially outward movement of the struts. And a radially inward movement of the struts will cause the proximal portion of the device to collapse radially.

Abstract: The invention is a septal implant that can accommodate variable thicknesses of the patient's atrial septum as well the variable thicknesses of septums across a population. The invention is able to accomplish this result by having flexible annular flanges that define a gap into which the septum fits. Due to the flexible nature of the annular flanges, the gap is adjustable.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter and/or a removable and/or replaceable shunt portion. Devices may include absorbable materials, the absorption of which directly or indirectly causes alterations of the fluid flow capacities the devices.

Abstract: Several unique intra-cardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure vents presented remain partially open under normal intra-cardiac pressures to allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms, and also limit the amount of flow from the right atrium to the left atrium by closing when the pressure in the right atrium exceeds the pressure in the left atrium by a predetermined amount.

Abstract: Several unique intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intracardiac pressure vents presented allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms but also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombus or other embolic material from entering the arterial circulation.

Abstract: The invention is a septal implant that can accommodate variable thicknesses of the patient's atrial septum as well the variable thicknesses of septums across a population. The invention is able to accomplish this result by having flexible annular flanges that define a gap into which the septum fits. Due to the flexible nature of the annular flanges, the gap is adjustable.

Abstract: Devices and methods to enhance the implantation, retrievability, or repositionability are provided. Embodiments of devices include pivotable sections providing the ability to maintain the device's engagement with a delivery system during implantation where the deliver system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. Devices may include an adjustable hydraulic diameter shunt portion which can be manually adjusted in vivo. Methods are provided for adjusting the flow rate of the devices in vivo.

Abstract: Several unique intracardiac pressure vents, placement catheters, methods of placement and methods of treating heart failure are presented. The intracardiac pressure vents presented allow sufficient flow from the left atrium to the right atrium to relieve elevated left atrial pressure and resulting patient symptoms but also limit the amount of flow from the right atrium to the left atrium to minimize the potential for thrombus or other embolic material from entering the arterial circulation.

Abstract: The present teachings provide devices to change the pressure in a chamber of a heart and methods of making and using thereof. One aspect of the present teachings provides a device comprising a distal portion, a middle portion, and a proximal portion. The distal portion and proximal portion of the device are configured to be deployed inside the left and right atrium respectively with a minimum contact with the septal tissue. The middle portion of the device is configured to secure the device across an aperture on the atrial septum. The device further includes at least one retrieval portion with a plurality of struts. The distal end of the struts is connected with a proximal end of the proximal portions. The proximal end of the struts come together at a location near the axial center of the device. The radial expansion of the proximal portion will lead to the radially outward movement of the struts. And a radially inward movement of the struts will cause the proximal portion of the device to collapse radially.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart's pumping cycle.

Abstract: Devices and methods for treating heart disease by normalizing elevated blood pressure in the left and right atria of a heart of a mammal are disclosed. The devices are adapted to permit fluid flow across the membrane in which the device is implanted at first rate, and at a second rate, wherein a difference between the first rate and the second rate is not solely dependent upon variations in blood pressure differential across the membrane due to the heart's pumping cycle.

Abstract: Devices and methods to enhance the implantation, retreivability, or repositionability are provided. Embodiments of devices include pivotable sections providing the ability to maintain the device's engagement with a delivery system during implantation where the deliver system approaches an opening of the septum at an angle. Embodiments of devices also include configurations that allow for improved retrieval into a delivery system in the event that a malfunction or a problem with the patients physiology is detected.

Abstract: Several unique intra-cardiac pressure devices, placement catheters, methods of placement and methods of treating heart failure are presented. The intra-cardiac pressure devices presented allow sufficient flow from the left atrium to the right atrium to enable the relief of elevated left atrial pressure and resulting patient symptoms. The intra-cardiac pressure devices are made of a non-braided material.

Abstract: The present teachings provide a device to close a ductus arteriosus percutaneously. One aspect of the present teachings provides a device comprising at least one flange portion configured to be positioned against a vascular wall outside one end of a ductus arteriosus, and a body portion configured to be positioned inside the ductus arteriosus. The body portion of the device has a length adjustable in order for the device to fit inside patients with various ductus arteriosus lengths. The at least one flange portion of the device has pivotability in order for at least one flange to deflect from the longitudinal axis of the body portion so that the deployed device can be positioned at a treatment site allowing the discs to sit flat against the vascular tissue to promote closure while avoiding disruption of flow within the pulmonary artery and aorta or applying excess pressure to the surrounding vascular tissue.