Methods and devices for intra-atrial shunts having adjustable sizes
Inventors
McNamara, Edward I. • Sutherland, Michael W. • Finch, Matthew J. • Forcucci, Stephen J. • Mitzel, John • CELERMAJER, David S. • Sugimoto, Hiroatsu
Assignees
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Publication Number
US-9757107-B2
Publication Date
2017-09-12
Expiration Date
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.
Core Innovation
The disclosure describes interatrial pressure-vent/shunt devices for heart failure that reduce elevated left atrial and pulmonary venous pressure while limiting reverse (right-to-left) flow to mitigate thromboembolic risk. The device concept uses an intra-atrial shunt between the left atrium and right atrium through or across the atrial septum, with pressure relief configured to address elevated atrial and pulmonary venous pressure conditions.
The disclosure further emphasizes adjustable shunt sizing/flow rate, including in vivo manual hydraulic-diameter adjustment using expandable/contractible tubular shunt structures and replaceable inserts. It also describes time-dependent or auto-adjusting configurations using features such as biosorbable restraints and transforming valve/orifice elements to vary flow characteristics over time.
Additionally, the disclosure describes an interatrial vent body that includes flexible mesh with annular flanges and a directional flow-control element that provides greater resistance in one direction. The directional resistance is described as limiting reverse flow, and the device structures include interatrial body components, sealable connections, implantation/placement catheter concepts, and material/structure options such as superelastic material structures and plastically deformable material structures, along with retrieval features.
Claims Coverage
The partial content includes one independent claim. It is directed to an expandable, percutaneous cardiac delivery device with a dual-anchor configuration and a composite stent in which an inner plastically deformable cylindrical body expands to a second diameter and remains there to provide a different blood-flow rate across a membrane.
Expandable percutaneous delivery device with first and second anchors
The device comprises first and second anchors adapted to contact, respectively, first and second surfaces of a membrane of a patient's heart, and the device is adapted for percutaneous delivery into a membrane of the patient's heart.
Composite stent with outer superelastic cylindrical body and inner plastically deformable cylindrical body
The device includes a stent having a longitudinal axis connected to the first and second anchors, wherein the stent comprises an outer cylindrical body comprising a superelastic material and a stent-like inner cylindrical body comprising a plastically deformable material disposed within and connected to the outer cylindrical body.
Inner body diameter expansion with natural retention to set different flow rates
The stent-like inner cylindrical body comprises a first diameter and a second diameter expanded from the first diameter, wherein the stent-like inner cylindrical body will naturally remain in the expanded second diameter and permit blood to flow across the membrane at a second rate that is different from the first rate, while permitting blood to flow across the membrane at a first rate.
Across the single independent claim present in the partial content, the core inventive coverage is the combination of first and second anchors with a percutaneous expandable composite stent. The stent uses an outer superelastic cylindrical body and an inner plastically deformable cylindrical body that expands to a second diameter and naturally remains there, thereby enabling blood to flow across the membrane at a different rate.
Stated Advantages
Reduce elevated left atrial and pulmonary venous pressure.
Limit reverse (right-to-left) flow to mitigate thromboembolic risk.
Documented Applications
Interatrial pressure-vent/shunt devices for heart failure, configured to reduce elevated left atrial and pulmonary venous pressure while limiting reverse flow.
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