Process for Generating Microwalled Encapsulation Balloons

A process for generating a microwalled encapsulation balloon, comprising, in combination:

• providing a paddle insert having a top side and a bottom side;
• placing a balloon membrane further comprising a first membrane layer on at least a portion of the top side of the paddle insert and a second membrane layer on at least a portion of the bottom side of a paddle insert, such that portions of the first membrane layer and the second membrane layer extending beyond the paddle insert are in contact with each other;
• providing a first support layer on a top side of the first membrane layer and a second support layer on a bottom side of the second membrane layer;
• providing a first paddle die on a top side of the first support layer and a second paddle die on a bottom side of the second support layer;
• and
• pressing the first and second paddle dies together while applying heat to the balloon membrane.

A medical device made by a process comprising, in combination:

• coupling a microwalled encapsulation balloon comprising a balloon membrane, an interior portion, and an opening to a cannula at the opening, wherein the balloon membrane is covered by a releasing agent having a melting point higher than the melting point of the balloon membrane;
• compressing with a die a portion of the balloon membrane to a portion of the cannula, whereby portions of the balloon membrane not compressed by the die maintain a pre-compression form and are not collapsed by interaction of the balloon membrane with the die;
• heating the balloon membrane to a temperature between the melting point of the balloon membrane and the melting point of the releasing agent;
• and
• removing the releasing agent from the balloon membrane.

A method of manufacturing an encapsulation balloon, comprising:

• positioning a first sheet of membrane material between a paddle insert and a contoured interior surface of a first paddle die, the contoured interior surface of the first paddle die being conformal with a first surface portion of the paddle insert, wherein at least a portion of the first sheet of membrane material extends beyond the first surface portion of the paddle insert;
• positioning a first sheet of supportive material between the first sheet of membrane material and the contoured interior surface of the first paddle die;
• positioning a second sheet of membrane material between the paddle insert and a contoured interior surface of a second paddle die, the contoured interior surface of the second paddle die being conformal with a second surface portion of the paddle insert, wherein at least a portion of the second sheet of membrane material extends beyond the second surface portion of the paddle insert;
• positioning a second sheet of supportive material between the second sheet of membrane material and the contoured interior surface of the second paddle die;
• and
• applying heat and compression to the first sheet of membrane material and to the first sheet of supportive material with the first paddle die and the paddle insert, and to the second sheet of membrane material and to the second sheet of supportive material with the second paddle die and the paddle insert, to fuse a portion of the first sheet of membrane material to a portion of the second sheet of membrane material, and to shape a portion of the first sheet of membrane material, at least a portion of the first sheet of supportive material, a portion of the second sheet of membrane material, and at least a portion of the second sheet of supportive material about the paddle insert.