Bifurcated Balloon Folding Method and Apparatus

• US 20090024088A1
• Filed: 07/18/2007
• Published: 01/22/2009
• Est. Priority Date: 07/18/2007
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Arcand, Benjamin, Michael, Stephen, Wang, Woon-Chung, Jagger, Karl A., Pallazza, Stefen M., Tegels, Zack
• Granted Patent: US 7,942,661 B2
• Time in Patent Office: Days
• US Class Current: 604/101.10
• CPC Class Codes: A61M 2025/1045 for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters

Abstract

A balloon folding system specifically configured to reduce a side branch balloon of a bifurcated balloon catheter assembly includes a die that defines at least one chamber for receipt of the sidebranch balloon, and at least one pin sized to fit into the chamber and reduce the balloon to a substantially flattened state. The system also may include a housing for the reduction and folding of a primary branch balloon. The system is configurable to fold and reduce both branches simultaneously or separately.

Claims

1. A balloon folding system for folding the balloons of a bifurcated balloon catheter, the system comprising:

a catheter housing, the catheter housing constructed and arranged to removably receive at least a portion of a balloon catheter including a primary balloon and a side branch balloon, the catheter housing being defined by;

at least three pleat forming members, the pleat forming members being distributed radially about a circumference of the catheter housing, each pleat forming member being movable between a radially open position and a radially closed position along a single axis, each pleat forming member having a pleat forming surface, the pleat forming surface constructed and arranged to engage an external surface of the primary balloon as each pleat forming member moves from the open to the closed position; and

at least three compression members, the compression members being distributed radially about the circumference of the catheter housing and each compression member being positioned between two of the pleat forming members, each compression member being movable between a radially open position and a radially closed position along a single axis, each compression member having a compression surface,

at least one compression surface constructed and arranged to engage an external surface of the side branch balloon, at least two compression surfaces constructed and arranged to engage an external surface of the primary balloon only after the pleat forming members begin moving from their radially open position to their radially closed position.

2. The system of claim 1 wherein the pleat forming surface defines an arc.

3. The system of claim 2 wherein the arc measures less than 120 degrees.

4. The system of claim 2 wherein the compression surface is constructed of an elastomeric material.

5. A system for reducing a side branch balloon and for folding a primary balloon of a bifurcated balloon catheter, the system comprising:

a primary housing, the primary housing constructed and arranged to removably receive and reduce the primary balloon into a folded and wrapped reduced diameter configuration; and

a side branch reducing assembly, the assembly comprising;

a die, the die defining at least one balloon reduction chamber, at least a portion of the at least one balloon reduction chamber having a substantially cylindrical shape and an open top;

at least one pin, each pin having a substantially cylindrical shape, corresponding to the shape of the at least one balloon reduction chamber, such that each pin is constructed and arranged to be removably received into a corresponding balloon reduction chamber;

an actuation mechanism, the actuation mechanism engaged to the at least one pin, the actuation mechanism moving the at least one pin between a position external to the at least one balloon reduction chamber and a position wherein the at least one pin is inserted into the at least one balloon reduction chamber through the open top.

6. The system of claim 5 wherein the die further defines a vacuum chamber, the vacuum chamber being in fluid communication with the at least one balloon reduction chamber.

7. The system of claim 5 wherein at least one of the catheter housing and the assembly being in communication with a heat source, the heat source applying heat to at least one of the primary balloon and the side branch balloon with heat to a temperature of about 35°

C. to about 75°

C.

8. The system of claim 5 wherein the catheter housing is disposed about a primary axis and the assembly is disposed about a secondary axis, the secondary axis forming an angle with the primary axis.

9. The system of claim 8 wherein the angle is about 90 degrees.

10. An assembly for reducing a side branch balloon of a side branch catheter shaft, the assembly comprising:

a die, the die defining at least one balloon reduction chamber, at least a portion of the at least one balloon reduction chamber having a substantially cylindrical shape and an open top;

at least one pin, each pin having a substantially cylindrical shape, corresponding to the shape of the at least one balloon reduction chamber, such that each pin is constructed and arranged to be removably received into a corresponding balloon reduction chamber;

an actuation mechanism, the actuation mechanism engaged to the at least one pin, the actuation mechanism moving the at least one pin between a position external to the at least one balloon reduction chamber and a position wherein the at least one pin is inserted into the at least one balloon reduction chamber through the open top.