Intra-atrial implants having variable thicknesses to accommodate variable thickness in septum
Inventors
McNamara, Edward • Celermajer, David • Forcucci, Stephen J. • Sugimoto, Hiroatsu
Assignees
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Publication Number
US-10413286-B2
Publication Date
2019-09-17
Expiration Date
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.
Core Innovation
The invention relates to an intra-atrial septal pressure-vent implant that directs blood flow across the atrial septum. The device includes a core segment having a length greater than the atrial septum and defining a passage, where the core segment has a first diameter when deployed.
The core segment is attached to flexible annular flanges configured to contact opposite sides of the atrial septum. A first flexible annular flange joins a first end of the core segment and forms a substantially flat surface that contacts one side of the atrial septum, and a second flexible annular flange joins a second end of the core segment and a distal portion of the second flexible annular flange lies at a parallel angle to and contacts the other side of the atrial septum.
The first contacting surface is greater than the second contacting surface to accommodate variable atrial septum thickness across patients and across the septum. The device includes an annular gap defined by at least a portion of the first and second annular flanges, where the annular gap is smaller than the length of the core segment.
The device is collapsible so the core segment can have a second diameter less than the first diameter, enabling percutaneous delivery. A flow control element is attached to the core segment and may provide one-directional blood flow that is biased open at zero/no pressure differential and configured to reduce thromboembolic passage and pressure-related heart failure symptoms by limiting pressure-related passage while permitting flow directionality responsive to pressure differential.
Claims Coverage
The independently claimed device is characterized by four main inventive elements: a core segment longer than the atrial septum with first and second flexible annular flanges forming first and second contacting surfaces with different extents, an annular gap defined by at least a portion of the flanges with a specified size relationship, a collapsible construction for percutaneous delivery, and a flow control element to direct blood flow across the atrial septum.
Core segment longer than the atrial septum defining a passage
A core segment having a length greater than the atrial septum and defining a passage, the core segment having a first diameter when deployed.
First and second flexible annular flanges forming opposite-side contacting surfaces with unequal area
A first flexible annular flange joining a first end of the core segment configured to form a substantially flat surface that contacts one side of the atrial septum forming a first contacting surface; and a second flexible annular flange joining a second end of the core segment configured such that a distal portion lies at a parallel angle to and contacts the other side of the atrial septum forming a second contacting surface; wherein the first contacting surface is greater than the second contacting surface.
Collapsible delivery with an annular gap defined by at least a portion of the flanges
A collapsible device 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, wherein at least a portion of the first and second annular flanges define an annular gap, and wherein said annular gap is smaller than the length of the core segment.
Flow control element attached to the core segment for directing blood flow
A flow control element attached to the core segment for directing blood flow across the atrial septum in a heart of a patient.
In combination, the independent claim covers an intra-atrial septal blood-flow directing device using a core segment longer than the atrial septum with first and second flexible annular flanges that contact opposite sides of the septum with different contacting surface extents, a collapsible configuration for percutaneous delivery, an annular gap defined by portions of the flanges with a specified size relationship, and a flow control element attached to the core segment.
Stated Advantages
Reduces thromboembolic passage.
Minimizes dislodgement.
Reduces septal tissue damage.
Minimizes dislodgement by using flange designs with differing flexibility while maintaining outward force.
Reduces pressure-related heart failure symptoms.
Documented Applications
An intra-atrial septal pressure-vent implant for directing blood flow across the atrial septum in a heart of a patient.
Percutaneous delivery of a device positioned across the atrial septum using a collapsible core segment.
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