Balloon folding technology

• US 6,988,881 B2
• Filed: 03/26/2002
• Issued: 01/24/2006
• Est. Priority Date: 03/26/2001
• Status: Expired due to Term

• Current Assignee: Machine Solutions, Inc.
• Original Assignee: Machine Solutions, Inc.
• Inventors: Motsenbocker, Tom, Goff, Edward, Kasprzyk, Daniel J.
• Primary Examiner(s): Davis, Robert
• Assistant Examiner(s): NGUYEN, THUKHANH T
• Application Number:
  US10/107,768
• Publication Number:
  US 20020163104A1
• Time in Patent Office: 1,400 Days
• Field of Search: 425/392, 425/393, 425/397, 425/403, 425/402, 724/02, 292/37
• US Class Current: 425/392
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters
• CPC Class Codes: B29C 53/086 bending radially, i.e. deformig the cross-section of the tube
• CPC Class Codes: Y10T 29/5367 Coupling to conduit

Abstract

An apparatus for folding a catheter balloon comprises a stationary base member; a rotatable drive hub which is moveable in relation to the stationary base member; and a pleating head aligned with respect to the stationary base member and to the rotatable drive hub. The pleating head includes at least three segments, each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length. Each segment has a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member. The segments are arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a spiral-pleat dimension having at least three channels in communication with a central aperture. Also, the segment centerlines extend therefrom toward the segment distal ends and are oriented away from the central point. The segment distal ends move closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub. A method of pleating and folding a catheter balloon is also disclosed.

Claims

1. An apparatus for pleating a balloon by segmental radial compression, comprising:

a. a pair of aligned, stationary base members separated a predetermined distance;

b. a pair of aligned rotatable drive hubs which are moveable in relation to the stationary base member and in synchronization with each other; and

c. a pleating head aligned with respect to the base members and the drive hubs, and including at least three segments;

i. the segments each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed off the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base members and the distal point being pivotally coupled by pins to the rotatable hub members;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a spiral-pleat dimension having at least three channels in communication with a central aperture, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable hub members in a predetermined direction, whereby the balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub.

2. An system for pleating and folding a balloon by segmental radial compression, comprising:

A. a balloon pleating head device including;

a. a stationary base member;

b. a rotatable drive hub which is moveable in relation to the stationary base member; and

c. a pleating head aligned with respect to the stationary base member and to the rotatable drive hub, and including at least three segments;

i. the segments each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed off the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a spiral-pleat dimension having at least three channels in communication with a central aperture, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the balloon is disposed around a shaft substrate, aligned in the central aperture and pleated around the shaft substrate upon rotation of the rotatable hub; and

B. a pleated balloon folding device including;

a. a stationary base member;

b. a rotatable drive hub which is moveable in relation to the stationary base member; and

c. a folding head aligned with respect to the stationary base member and to the rotatable drive hub, and including at least ten segments;

i. the segments each having a proximal end and an angled distal end with at least one angled side face terminating in an edge of a predetermined length, each segment having a centerline between the proximal and distal ends, each segment having a proximal point and a distal point, the distal point being disposed off the centerline and the proximal point being disposed off the centerline, and the proximal point being pivotally coupled by pins to the stationary base member and the distal point being pivotally coupled by pins to the rotatable hub member;

ii. the segments being arranged so that the segment distal ends are disposed adjacent to and a predetermined distance away from a central point and defining a central aperture with a cylindrical dimension, and that the segment centerlines extending therefrom toward the segment distal ends are oriented away from the central point; and

iii. the segment distal ends moving closer to the central point upon rotation of the rotatable hub member in a predetermined direction, whereby the pleated balloon disposed around a shaft substrate, is aligned in the central aperture and folded around the shaft substrate upon rotation of the rotatable hub.