Transcatheter growth devices and methods for Norwood, Glenn and Fontan therapy

A method for manufacturing a transcatheter growth system for treating congenital illnesses in heart disease patients, comprising:

• forming a first elongated frame being in a first implantation state for facilitating insertion into a first lumen of a patient, the first frame having first proximal and distal end regions and defining a first radial frame periphery about which a first covering member is disposed between the first proximal and distal end regions;
• and
• forming a second elongated frame being in a second implantation state for facilitating insertion into a second lumen of the patient and being configured to cooperate with the first frame, the second frame having first proximal and distal end regions and defining a second radial frame periphery about which a second covering member is disposed and extends from the second distal region axially toward the second proximal end region,
• wherein the first frame is configured to be radially expanded from the first implantation state to a first stable expanded state with the first frame periphery supporting the first lumen at a first dimension and defining a first central axial channel for receiving the second distal region of the second frame, the second frame being configured to be radially expanded from the second implantation state to a primary stable expanded state with the second frame periphery supporting the second lumen at a second dimension and defining a second central axial channel, the first and second axial channels promoting fluid flow between the first lumen and the second lumen, the first and second covering members being configured to provide a seal at an intersection of the first and second frames, and
• wherein the first frame is configured to radially re-expand from the first expanded state to a second stable expanded state and the second frame is configured to radially re-expand from the primary expanded state to a secondary stable expanded state after the patient grows, the first frame periphery supporting the first lumen of the grown patient, the second frame periphery supporting the second lumen of the grown patient.

A method for implanting a transcatheter growth system for treating congenital illnesses in heart disease patients, comprising:

• implanting a first elongated frame being in a first implantation state for facilitating insertion into a first lumen of a patient, the first frame having first proximal and distal end regions and defining a first radial frame periphery about which a first covering member is disposed between the first proximal and distal end regions;
• expanding the first frame from the first implantation state to a first stable expanded state with the first frame periphery supporting the first lumen at a first dimension and defining a first central axial channel;
• implanting a second elongated frame being in a second implantation state for facilitating insertion into a second lumen of the patient and being configured to cooperate with the first frame, the second frame having first proximal and distal end regions and defining a second radial frame periphery about which a second covering member is disposed and extends from the second distal region axially toward the second proximal end region;
• disposing the distal end region of the second frame within the first central axial channel defined by the first frame;
• and
• expanding the second frame from the second implantation state to a primary stable expanded state with the second frame periphery supporting the second lumen at a second dimension and defining a second central axial channel, the first and second axial channels promoting fluid flow between the first lumen and the second lumen, the first and second covering members being configured to provide a seal at an intersection of the first and second frames,
• wherein the first frame is configured to radially re-expand from the first expanded state to a second stable expanded state and the second frame is configured to radially re-expand from the primary expanded state to a secondary stable expanded state after the patient grows, the first frame periphery supporting the first lumen of the grown patient, the second frame periphery supporting the second lumen of the grown patient.