Multi-layer balloons for medical applications and methods for manufacturing the same

A method for nesting balloons to form a multi-layer balloon for medical applications, comprising the steps of:

• providing a first balloon having a first proximal neck and a first distal neck and a second balloon having a second proximal neck and a second distal neck;
• heating and stretching the first balloon so that the diameter and cross-sectional area of the first balloon is at least partially decreased while the length of the first balloon is at least partially increased;
• fluting and wrapping the first balloon;
• inserting the distal neck of the first balloon at least partially into the proximal neck of the second balloon;
• applying a lubricant to a space defined by the first balloon and the second balloon such that a multi-layer balloon comprises the first balloon, the lubricant, and the second balloon;
• heating, stretching, and inflating the multi-layer balloon;
• and
• securing the first balloon of the multi-layer balloon to the second balloon of the multi-layer balloon.

A multi-layer balloon for medical applications, comprising:

• a first structural layer having a first biaxial molecular orientation;
• a second structural layer having a similar level of biaxial molecular orientation, wherein the degree of biaxial molecular orientation of the first structural layer is substantially similar with the degree of biaxial molecular orientation of the second structural layer;
• and
• a lubricating layer, wherein the lubricating layer is disposed substantially between the first structural layer and the second structural layer.

A method for co-extruding balloons to form a multi-layer balloon for medical applications, comprising the steps of:

• co-extruding a first balloon having at least two structural layers and at least one lubricating layer and a second balloon having at least one structural layer and at least one lubricating layer;
• heating and stretching the first balloon so that the diameter and cross-sectional area of the first balloon is at least partially decreased while the length of the first balloon is at least partially increased;
• inserting the first balloon at least partially into a cavity defined by the second balloon such that a multi-layer balloon comprises the first balloon and the second balloon;
• and
• heating, stretching, and inflating the multi-layer balloon.

A catheter having a multi layer, high pressure balloon, comprising:

• an elongate, flexible catheter body, having a proximal end, a distal end and at least one inflation lumen extending therethrough;
• and
• an inflatable balloon on the distal end, the balloon comprising an inner layer and an outer layer;
• wherein the inner layer and the outer layer have each been stretched to achieve optimum strength.

A catheter having a multi layer, high pressure balloon, comprising:

• an elongate, flexible catheter body, having a proximal end, a distal end and at least one lumen extending therethrough;
• and
• an inflatable balloon on the distal end, the balloon comprising an inner layer and an outer layer;
• wherein the inner layer and the outer layer each have substantially the same calculated burst pressure.

A catheter having a multi layer, high pressure balloon, comprising:

• an elongate, flexible catheter body, having a proximal end, a distal end and at least one lumen extending therethrough;
• and
• an inflatable balloon on the distal end, the balloon comprising an inner layer and an outer layer;
• wherein the inner layer and the outer layer have each been stretched to within about 15% of their calculated optimum stretch.

A method of making a tubular balloon stock for use in fabricating a balloon catheter, comprising the steps of:

• providing a first and a second tubular sections;
• determining the stretch required to optimize the strength at the inner surface of each layer;
• stretching each layer to within approximately 15% of the determined stretch for each layer;
• and
• positioning the first layer concentrically within the second layer to form the tubular balloon stock.