Balloon folding control mechanism

• US 7,976,496 B2
• Filed: 07/07/2008
• Issued: 07/12/2011
• Est. Priority Date: 07/09/2007
• Status: Active Grant

• Current Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Original Assignee: Cook Medical Technologies, LLC (Cook Group Incorporated)
• Inventors: Carter, Matthew P., Kennedy, Kenneth C. II
• Primary Examiner(s): Lucchesi; Nicholas D
• Assistant Examiner(s): LANDRY II, GERALD ERNEST
• Application Number:
  US12/168,450
• Publication Number:
  US 20090024087A1
• Time in Patent Office: 1,100 Days
• Field of Search: 604 9601- 9701, 604/98.01, 604/99.01, 604/103, 604/103.09
• US Class Current: 604/99.01
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 2025/1068 having means for varying the length or diameter of the deployed balloon, this variations could be caused by excess pressure
• CPC Class Codes: A61M 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 25/1038 Wrapping or folding devices for use with balloon catheters

Abstract

A balloon catheter including an inflatable balloon affixed to a catheter. The proximal end of the balloon is affixed to the distal end of the catheter so as to provide an air tight seal there between. A stiffening member extends distally of the distal end of the catheter and forms a slip joint connection with the distal end of the balloon to permit the distal end of the balloon to axially move or translate relative to the distal end of the catheter. The slip joint allows the axial length of balloon to change during inflation or deflation without transferring tensile or compressive forces between the balloon and the catheter. A balloon folding control mechanism is disposed about the portion of the stiffening member traversing the interior of the balloon, and is configured to promote refolding of the balloon into a predetermined and desired folding configuration upon deflation.

Claims

1. A balloon catheter comprising:

an inflatable balloon comprising a balloon wall defining an interior volume, the balloon further comprising a distal end, a proximal end, and a central portion disposed therebetween;

a catheter comprising an elongated shaft extending along a longitudinal axis between a distal end portion and a proximal end portion, the proximal end portion comprising a connector configured to engage an inflation device, the distal end portion fixedly connected to the proximal end of the balloon, and a lumen extending through the shaft and in fluid communication with the interior volume of the balloon;

an end cap fixedly connected to the distal end of the balloon;

a stiffening member extending distally from the distal end portion of the catheter and through the interior volume of the balloon, the stiffening member being engaged with the end cap; and

a balloon folding control mechanism configured to promote refolding of the balloon into a predetermined folding configuration upon deflation of the balloon,

wherein the balloon folding control mechanism is configured to apply a distally directed biasing force to the distal end of the balloon relative to the proximal end of the balloon,

wherein the balloon folding control mechanism comprises a compression spring that is operably engaged with the distal end of the balloon at least when the balloon is in a deflated state, and

wherein the compression spring is disposed about the stiffening member and is operably engaged between the distal end of the balloon and a stop collar affixed to the stiffening member so as to apply a biasing force therebetween.

2. The balloon catheter according to claim 1 wherein the end cap comprises a sleeve extending partially therethrough, the sleeve being defined by an interior volume of the end cap, and further wherein the stiffening member is slidably engaged with the sleeve of the end cap so as to permit longitudinal movement of the distal end of the balloon relative to the proximal end of the balloon.

3. The balloon catheter according to claim 2 wherein the end cap comprises a polyurethane tube fixedly connected to the distal end of the balloon.

4. The balloon catheter according to claim 2 wherein the sleeve comprises a distal terminus that is spaced away from a distal end of the stiffening member so as to permit axial movement of the distal end of the stiffening member relative to the distal terminus of the sleeve.

5. The balloon catheter according to claim 1 wherein the stop collar is spaced away from the distal end of the balloon when the balloon is in an inflated state.

6. The balloon catheter according to claim 2 wherein the balloon folding control mechanism is disposed within the sleeve of the end cap.

7. The balloon catheter according to claim 1 wherein the compression spring is disengaged from the distal end of the balloon when the balloon is in an inflated state.

8. The balloon catheter according to claim 1 wherein the distally directed biasing force applied by the compression spring to the distal end of the balloon is sufficient to lengthen the balloon upon deflation of the balloon.

9. The balloon catheter according to claim 1 wherein the balloon folding control mechanism is configured to limit proximal movement of the distal end of the balloon relative to the proximal end of the balloon upon deflation of the balloon.

10. The balloon catheter according to claim 1 wherein the balloon folding control mechanism is configured to promote a balloon folding configuration of 3-wings or higher upon deflation of the balloon.

11. The balloon catheter according to claim 1 wherein the balloon wall comprises one of a non-elastic material, a non-compliant material, and a semi-rigid material.

12. The balloon catheter according to claim 1 wherein the stiffening member comprises an elongate proximal portion extending longitudinally through the lumen of the shaft of the catheter.

13. The balloon catheter according to claim 12 wherein the stiffening member comprises an elongate nitinol wire.

14. The balloon catheter according to claim 12 wherein the stiffening member comprises a tapered distal end portion.

15. The balloon catheter according to claim 1 further comprising an inflation device for inflating or deflating said balloon, said inflation device being attached to the connector on the proximal end portion of the catheter.

16. A balloon catheter comprising:

an inflatable balloon comprising a balloon wall defining an interior volume, the balloon further comprising a distal end, a proximal end, and a central portion disposed therebetween;

a catheter comprising an elongated shaft extending along a longitudinal axis between a distal end portion and a proximal end portion, the proximal end portion comprising a connector configured to engage an inflation device, the distal end portion fixedly connected to the proximal end of the balloon, and a lumen extending through the shaft and in fluid communication with the interior volume of the balloon;

an end cap fixedly connected to the distal end of the balloon;

a stiffening member extending distally from the distal end portion of the catheter and through the interior volume of the balloon, the stiffening member being engaged with the end cap; and

a balloon folding control mechanism configured to promote refolding of the balloon into a predetermined folding configuration upon deflation of the balloon,

wherein the balloon folding control mechanism is configured to apply a distally directed biasing force to the distal end of the balloon relative to the proximal end of the balloon,

wherein the balloon folding control mechanism comprises a compression spring that is operably engaged with the distal end of the balloon at least when the balloon is in a deflated state, and

wherein the compression spring is disposed about the stiffening member and is operably engaged with a tubular member, wherein the compression spring and the tubular member are operably engaged between the distal and proximal ends of the balloon so as to apply a biasing force therebetween.

17. The balloon catheter according to claim 16 wherein the end cap comprises a sleeve extending partially therethrough, the sleeve being defined by an interior volume of the end cap, and further wherein the stiffening member is slidably engaged with the sleeve of the end cap so as to permit longitudinal movement of the distal end of the balloon relative to the proximal end of the balloon.

18. The balloon catheter according to claim 17 wherein the end cap comprises a polyurethane tube fixedly connected to the distal end of the balloon.

19. The balloon catheter according to claim 17 wherein the sleeve comprises a distal terminus that is spaced away from a distal end of the stiffening member so as to permit axial movement of the distal end of the stiffening member relative to the distal terminus of the sleeve.

20. The balloon catheter according to claim 17 wherein the balloon folding control mechanism is disposed within the sleeve of the end cap.

21. The balloon catheter according to claim 16 wherein the compression spring is disengaged from the distal end of the balloon when the balloon is in an inflated state.

22. The balloon catheter according to claim 16 wherein the distally directed biasing force applied by the compression spring to the distal end of the balloon is sufficient to lengthen the balloon upon deflation of the balloon.

23. The balloon catheter according to claim 16 wherein the balloon folding control mechanism is configured to limit proximal movement of the distal end of the balloon relative to the proximal end of the balloon upon deflation of the balloon.

24. The balloon catheter according to claim 16 wherein the balloon folding control mechanism is configured to promote a balloon folding configuration of 3-wings or higher upon deflation of the balloon.

25. The balloon catheter according to claim 16 wherein the balloon wall comprises one of a non-elastic material, a non-compliant material, and a semi-rigid material.

26. The balloon catheter according to claim 16 wherein the stiffening member comprises an elongate proximal portion extending longitudinally through the lumen of the shaft of the catheter.

27. The balloon catheter according to claim 26 wherein the stiffening member comprises an elongate nitinol wire.

28. The balloon catheter according to claim 26 wherein the stiffening member comprises a tapered distal end portion.

29. The balloon catheter according to claim 16 further comprising an inflation device for inflating or deflating said balloon, said inflation device being attached to the connector on the proximal end portion of the catheter.