Devices and methods for treating patent ductus arteriosus
Inventors
McNamara, Edward I. • Finch, Matthew J. • Forcucci, Stephen J. • Devellian, Carol A.
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10932786-B2
Publication Date
2021-03-02
Expiration Date
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. The body portion of the device could also at least partially block the ductus arteriosus, and thereby reduce or obstruct blood flow through the ductus arteriosus. The device includes a delivery profile and a deployment profile. Another aspect of the present teachings provides methods of using a device of the present teachings.
Core Innovation
A ductus arteriosus closure device is provided for a patent ductus arteriosus, including a distal flange portion and a proximal flange portion. Each flange portion has a plurality of flange segments with fixed ends and free ends, where the fixed ends join a body portion at adjacent ends of the body portion. In a deployed configuration, the free ends of the flange segments extend radially outward from the body portion, and in a delivery configuration, the free ends collapse radially inward and align with a longitudinal axis of the body portion.
The device body portion includes a coil section and a non-coiled section, and the device has a tubular lumen extending from the distal flange portion to the proximal flange portion. The distal flange portion and the proximal flange portion are configured to be positioned against a vascular wall outside two ends of a ductus arteriosus, while the body portion is configured to be positioned inside the ductus arteriosus. The non-coiled section applies a compression force along an outside surface of the body portion toward surrounding vascular tissues inside the ductus arteriosus, and the coil section is configured to adjust the length of the body portion.
The deployed geometry includes a diameter of the body portion being about 50-70% of an overall diameter of the distal flange portion. The tubular lumen of the body portion is partially blocked to obstruct a blood flow through the ductus arteriosus. The distal and proximal flange portions together secure the closure device for treating a patent ductus arteriosus in a subject in need thereof.
Claims Coverage
The document contains two independent claims: a device claim and a method claim. Across the independent claims, there are three main inventive aspects: the distal/proximal flange segment arrangement with delivery/deployed configurations, a body portion having a coil section and a non-coiled section that applies compression and adjusts length, and a tubular lumen that is partially blocked to obstruct blood flow together with a defined body-to-flange diameter relationship.
Delivery and deployed flange-segment configuration for ductus wall positioning
A distal flange portion and a proximal flange portion each having a plurality of flange segments with fixed ends and free ends, where the fixed ends join a body portion, with free ends extending radially outward in a deployed configuration and collapsing radially inward aligned with a longitudinal axis in a delivery configuration, and configured to position against a vascular wall outside two ends of a ductus arteriosus.
Coil and non-coiled body portion applying compression and adjusting length
A body portion with a coil section and a non-coiled section, where the body portion is configured to be positioned inside the ductus arteriosus, the non-coiled section applies a compression force along an outside surface of the body portion toward surrounding vascular tissues inside the ductus arteriosus, and the coil section is configured to adjust the length of the body portion.
Partially blocked tubular lumen and defined body-to-flange diameter ratio
A tubular lumen extending from the distal flange portion to the proximal flange portion, wherein the tubular lumen is configured to be partially blocked to obstruct a blood flow through the ductus arteriosus, and wherein a diameter of the body portion is about 50-70% of an overall diameter of the distal flange portion.
Treating a patent ductus arteriosus by securing the distal flange in the descending aorta
A method of treating a patent ductus arteriosus comprising securing a distal flange portion of a patent ductus arteriosus closure device against the vascular wall inside the descending aorta, using a closure device having distal and proximal flange portions with radially deployable free ends, a body portion with a coil section and a non-coiled section applying compression toward surrounding vascular tissue inside the ductus, and a tubular lumen partially blocked to obstruct a blood flow through the ductus arteriosus, with the body portion diameter being about 50-70% of the overall diameter of the distal flange portion.
The independent claims collectively require a ductus arteriosus closure device and a corresponding treatment method that rely on distal and proximal flange portions with fixed and free ends that transition between delivery collapse and deployed radial expansion for positioning against a vascular wall, a body portion having both a coil section that adjusts length and a non-coiled section that applies compression toward intraductal vascular tissue, and a tubular lumen that is partially blocked to obstruct ductal blood flow, together with a stated body-to-flange diameter relationship of about 50-70%.
Stated Advantages
Obstructing blood flow through the ductus arteriosus by partially blocking the tubular lumen.
Applying a compression force along an outside surface of the body portion toward surrounding vascular tissues inside the ductus arteriosus.
Securing the closure device by positioning distal and proximal flange portions against a vascular wall outside two ends of a ductus arteriosus.
Adjusting the length of the body portion using the coil section.
Documented Applications
Treating a patent ductus arteriosus in a subject in need thereof by securing a distal flange portion against the vascular wall inside the descending aorta.
Interested in licensing this patent?