Intra-atrial implants made of non-braided material
Inventors
McNamara, Edward • Celermajer, David • Forcucci, Stephen • Sugimoto, Hiroatsu
Assignees
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Publication Number
US-11166705-B2
Publication Date
2021-11-09
Expiration Date
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.
Core Innovation
The invention relates to a device for implanting in an opening that is a septal wall in a heart of a patient, where the device includes a core segment defining a passage through which fluid can flow after implantation. The passage provides flow from one side of the septal wall to another side of the septal wall, and the core segment has a first diameter when deployed. The device further includes a first annular flange contiguous with the core segment and a second annular flange contiguous with the core segment.
The device is collapsible, enabling the core segment to have a second diameter less than the first diameter to enable percutaneous delivery of the device to the heart of the patient. The core segment comprises a non-braided substantially open mesh. The use of the non-braided substantially open mesh passage is a structural aspect of the implanted pressure vent/shunt configuration.
As described, the device is arranged such that it can vent elevated left atrial pressure to the right atrium while limiting reverse flow to reduce thromboembolic risk. Structural configurations in embodiments include flanges and a core segment that can accommodate the septal wall, including flexible or elastic flange behavior and a variable gap for accommodating different septal thicknesses.
Claims Coverage
The independent claim set defines a collapsible septal-wall implant device with a non-braided substantially open mesh core segment having a passage diameter larger than about 5 mm, and first and second annular flanges contiguous with the core segment, for percutaneous delivery. The dependent claims refine flange and imaging features and add a flow control element having pressure-differential operation, with an optional pressure differential threshold.
Collapsible septal-wall implant device with open-mesh core passage
A device for implanting in an opening that is a septal wall in a heart of a patient, the device comprising: a core segment defining a passage through which fluid can flow after implantation of the device, the passage comprising a diameter larger than about 5 mm, the flow being from one side of the septal wall to another side of the septal wall, the core segment having a first diameter when deployed; a first annular flange contiguous with the core segment; and a second annular flange contiguous with the core segment, wherein the device is collapsible, enabling the core segment to have a second diameter less than the first diameter thereby enabling percutaneous delivery of the device to the heart of the patient, and wherein the core segment comprises a non-braided substantially open mesh.
Relative flexibility of flange and core segment
The device of claim 1, wherein at least one of the first annular flange and the second annular flange is more flexible than the core segment.
Radiopaque marker in flange segments
The device of claim 1, wherein the device includes a radiopaque marker in at least one flange segment.
Variable gap for accommodating septal thickness
The device of claim 1, wherein the device includes a variable gap configured to accommodate different septal thicknesses.
Flow control element opens upon pressure differential
The device of claim 10, wherein the device includes a flow control element coupled to the core segment and configured to open when a pressure differential occurs between two sides of the core segment.
Pressure differential threshold of at least 2 mm Hg
The device of claim 12, wherein the pressure differential is at least 2 mm Hg.
Overall, the claim set centers on a collapsible septal-wall implant device with a non-braided substantially open mesh core segment defining a passage larger than about 5 mm, paired with first and second annular flanges contiguous with the core segment for percutaneous delivery. Dependent refinements add relative flexibility between flanges and the core segment, a radiopaque marker in flange segments, and a variable gap to accommodate different septal thicknesses, and further define an optional flow control element that opens based on a pressure differential with an optional quantitative threshold.
Stated Advantages
Enables venting elevated left atrial pressure to the right atrium while limiting reverse flow to reduce thromboembolic risk.
Allows percutaneous delivery of the device to the heart by collapsing the core segment to a second diameter less than the first diameter.
Provides radiopaque markers for imaging.
Allows accommodation of different septal thicknesses using a variable gap.
Supports enhanced retrievability and may reduce thromboembolic material/systemic emboli via thrombus/embolic filtration.
Documented Applications
Treating heart failure by venting elevated left atrial pressure to the right atrium.
Reducing thromboembolic risk during the interatrial pressure vent/shunt by limiting reverse flow and optionally using thrombus/embolic filtration with a tube-like extension into the right atrium.
Use in percutaneous catheter delivery and placement of an intra-cardiac interatrial pressure vent/shunt device through an opening in a septal wall.
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