Devices and methods for coronary sinus pressure relief

Inventors

McNamara, Edward I.

Assignees

Corvia Medical Inc

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Publication Number

US-11759339-B2

Patent

Publication Date

2023-09-19

Expiration Date


Abstract

A method and devices for relieving pressure in the left atrium of a patient's heart is disclosed. The method includes using an ablative catheter in a minimally invasive procedure to prepare an opening from the coronary sinus into a left atrium of the patient's heart. Once the opening is prepared, the opening may be enlarged by a technique such as expanding a balloon within the opening. A stent is then placed within the coronary sinus of the patient, with a transverse portion expanding within the opening, allowing blood to flow from the left atrium to the coronary sinus and then to the right atrium. Pressure within the left atrium is thus relieved.

Core Innovation

The patent describes systems and methods for relieving elevated left atrial pressure in heart failure by creating and using an opening between the left atrium and the coronary sinus. It enables fluid communication between the left atrium and the coronary sinus to address elevated left atrial pressure in a patient.

A T-tube stent is provided for use in a patient to establish left atrium-coronary sinus communication. The stent includes a first cylindrical portion for placement in a coronary sinus and a second cylindrical portion for placement in an orifice made in a wall of a left atrium, with the proximal end of the second cylindrical portion joined to the first cylindrical portion along the tubular surface.

The second cylindrical portion has a delivery configuration where its distal end is folded within the tubular profile of the first cylindrical portion, and a deployed configuration where its distal end extends beyond the tubular surface of the first cylindrical portion in a direction generally perpendicular to an axis of the first cylindrical portion and into the left atrium. Both the first and second cylindrical portions are formed from a network of intersecting struts.

Embodiments further include flow-control elements and mechanical anchoring features, including a one-way restrictive valve, a flange joined to the distal end of the second cylindrical portion for engaging an atrial wall, radiopaque and echogenic markers, an integral filter or a tubular extension, and relative flexibility in which the second cylindrical portion is more flexible than the first cylindrical portion.

Claims Coverage

The documents provide two independent claims directed to a T-tube stent used in a patient. Across the independent claims, the inventive features include a folded delivery configuration, a deployed perpendicular extension into the left atrium, strut-based construction, and atrial wall engagement by a flange.

Perpendicular left atrium-coronary sinus fluid communication using a T-tube stent

A first cylindrical portion for placement in a coronary sinus and a second cylindrical portion for placement in an orifice made in a wall of a left atrium, where the proximal end of the second cylindrical portion joins the first cylindrical portion along its tubular surface; the second cylindrical portion has a delivery configuration where its distal end is folded within the tubular profile of the first cylindrical portion and a deployed configuration where its distal end extends beyond the tubular surface in a direction generally perpendicular to an axis of the first cylindrical portion and into the left atrium, thereby enabling fluid communication between the left atrium and the coronary sinus; both portions are made of a network of intersecting struts.

Delivery-profile folding and deployed perpendicular extension with an atrial wall-engaging flange

A first cylindrical portion for placement in a coronary sinus and a second cylindrical portion for placement in an orifice made in a wall of a left atrium, wherein a proximal end of the second cylindrical portion joins the first cylindrical portion along its tubular surface; a flange joining a distal end of the second cylindrical portion for engaging an atrial wall of the patient; wherein the T-tube stent has a delivery profile where the second cylindrical portion is folded within the first cylindrical portion and a deployed profile where the second cylindrical portion extends beyond the first cylindrical portion in a direction perpendicular to an axis of the first cylindrical portion.

Overall claim coverage centers on a T-tube stent architecture that supports a folded delivery configuration and a deployed configuration in which the second cylindrical portion extends generally perpendicular into the left atrium to establish fluid communication with the coronary sinus, with one independent claim additionally requiring a flange that engages the atrial wall.

Stated Advantages

Enables fluid communication between the left atrium and the coronary sinus.

Relieves elevated left atrial pressure in heart failure by creating and using an opening between the left atrium and the coronary sinus.

Documented Applications

T-tube stent for use in a patient to establish fluid communication between the left atrium and the coronary sinus.

Use in a patient for relieving elevated left atrial pressure in heart failure by creating fluid communication between the left atrium and the coronary sinus.

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