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Publication Number
US-10675450-B2
Publication Date
2020-06-09
Expiration Date
Abstract
The present teachings provide a device and methods of making and using thereof. Specifically, one aspect of the present teachings provides a self-expandable device with a braided structure comprising a shunt, a distal retention flange, and a proximal retention flange. Upon the device being deployed at a treatment location, the distal retention flange or the proximal retention flange transitions to have a diameter that is greater than the diameter of the shunt portion. And the shunt portion has a braid angle θ. Another aspect of the present teachings provide that the ratio of flange/shunt diameter equals or greater than 1/sin θ. Yet another aspect of the present teachings provides an axial constraining mechanism to reinforce the shunt portion.
Core Innovation
An implantable medical device is provided that includes a braided structure that is unitary in construction. The device includes a shunt portion having a distal end, a proximal end, and a tubular body, together with a distal retention flange and a proximal retention flange, each having a fixed end and a free end. In a deployed profile, the fixed end of the distal retention flange connects to the distal end of the shunt portion and the free end extends radially outwardly, and the proximal retention flange connects to the proximal end of the shunt portion in a corresponding manner.
The deployed configuration positions the shunt portion within an aperture in an atrial septum so that a hoop strength of the shunt portion keeps the aperture open and allows blood flow from the left atrium to reduce elevated pressure. In the delivery profile, the braided structure uses a first braid angle for the shunt portion, a second braid angle for the distal retention flange, and a third braid angle for the proximal retention flange, where the first braid angle is greater than the second and third braid angles. The distal and proximal retention flanges comprise a diameter of at least 1.2 times that of the shunt portion, and the shunt portion comprises a diameter of about 5-30 mm.
The device also defines quantitative relationships and deployment geometry through the braided construction and flange design. The flange geometry includes an inner tubular surface that transitions between the delivery profile and the deployed profile to form a surface facing away from the shunt portion. In addition, the device includes an axial constraining mechanism comprising an axial constraining wire and a locking feature with a lock receiver to increase shunt stiffness and maintain the expanded configuration.
Claims Coverage
The document includes three independent claims covering an implantable unitary braided atrial shunt device, a corresponding method of treating heart failure, and a device system that includes the implantable medical device and a catheter. Across these independent claims, the main inventive features focus on unitary braided shunt and retention-flange geometry, braid-angle relationships between delivery and deployed configurations, quantitative diameter/angle constraints, and positioning to keep an atrial septum aperture open to reduce elevated pressure.
Unitary braided shunt with distal and proximal retention flanges
A unitary in construction braided structure including a shunt portion with a distal end, a proximal end, and a tubular body; a distal retention flange with a free end and a fixed end connected to the distal end such that in a deployed profile the free end extends radially outwardly and is the most radially outward portion; and a proximal retention flange with a free end and a fixed end connected to the proximal end such that the free end extends radially outwardly.
Atrial septum aperture keeping hoop strength to allow left-to-right blood flow for pressure reduction
The shunt portion is configured to be positioned within an aperture in an atrial septum and comprises a hoop strength sufficient to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure.
Braid-angle relationship across delivery and deployed profile
The implantable medical device comprises a delivery profile and a deployed profile; the shunt portion comprises a first braid angle, the distal retention flange comprises a second braid angle, and the proximal retention flange comprises a third braid angle; the first braid angle is greater than the second and third braid angles.
Retention flange diameter at least 1.2 times shunt diameter with shunt diameter about 5-30 mm
The distal and proximal retention flanges comprise a diameter of at least 1.2 times that of the shunt portion, and the shunt portion comprises a diameter of about 5-30 mm.
Disc-like deployed free end transition with inner tubular surface orientation change
Advancing the distal retention flange at its delivery profile through the atrial septum into the left atrium so that the free end is the distal most portion, and transitioning the free end of the distal retention flange to a generally disc-like shape where the free end extends radially outwardly from the fixed end and the inner tubular surface transitions to form a surface facing away from the shunt portion.
Catheter system with implantable unitary braided atrial shunt device
A device comprising an implantable medical device and a catheter having a distal end, a proximal end, and a lumen extending proximally; wherein the implantable medical device includes the unitary braided shunt portion configured to be positioned in an aperture in an atrial septum to keep the aperture open and allow blood flow from the left atrium to reduce elevated pressure, together with distal and proximal retention flanges having the defined deployed-profile geometry and the braid-angle relationship with the first braid angle greater than the second and third braid angles.
Across the independent claims, the core claim coverage centers on a unitary braided implantable medical device configured for atrial septum aperture placement, where retention flanges deploy radially outwardly relative to the shunt and use specified braid-angle relationships in the delivery profile. The claims further require a quantitative diameter/geometry relationship, including at least 1.2 times retention-flange diameter relative to the shunt and shunt diameter about 5-30 mm, and require hoop strength sufficient to keep the aperture open to allow blood flow from the left atrium to reduce elevated pressure. The independent method claim adds transitioning retention-flange free ends into a generally disc-like shape with inner tubular surface orientation facing away from the shunt.
Stated Advantages
Keeps the atrial septum aperture open.
Allows blood flow from the left atrium to reduce elevated pressure.
Documented Applications
Treating heart failure with an implantable medical device positioned in an aperture in an atrial septum of a patient.
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