Conformable balloon

• US 6,605,056 B2
• Filed: 07/11/2001
• Issued: 08/12/2003
• Est. Priority Date: 07/11/2001
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Eidenschink, Tracee E. J., Mattison, Richard C., Larson, Christopher R.
• Primary Examiner(s): Lazarus, Ira S.
• Assistant Examiner(s): Ragonese, Andrea M.
• Application Number:
  US09/903,103
• Publication Number:
  US 20030014007A1
• Time in Patent Office: 762 Days
• Field of Search: 604/101.01, 604/101.02, 604/101.05, 604/103, 604/103.07, 604/103.09, 604/103.1, 604/104, 604/171, 604/264, 604/523, 604/96.01, 604/103.01, 604/95.01, 604/103.05, 606/191, 606/192, 606/194
• US Class Current: 604/96.01
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A medical device comprises an inner tube and an outer tube disposed about at least a portion of the inner tube. A balloon extends from the distal end of the outer tube. Within the balloon is a first expandable diaphragm, one end of which is attached to the inner tube. The first expandable diaphragm is covered by a retractable sheath disposed about the inner tube. Upon retraction of the retractable sheath, the diaphragm expands to sealingly contact the interior of the balloon in a first contact region and form at least a first compartment and a second compartment in the balloon.

Claims

1. A medical device comprising:

an inner tube having a proximal portion and a distal portion;

an outer tube disposed about at least a portion of the inner tube, the outer tube having a proximal portion and a distal portion;

a balloon disposed about the inner tube, the balloon having a proximal end and a distal end, the proximal end of the balloon extending from the distal end of the outer tube;

a first inflation lumen in fluid communication with the balloon;

at least one first expandable diaphragm having a first end and a second end, the first end attached to the inner tube, the at least one first expandable diaphragm interior to the balloon;

a retractable sheath disposed inside of the balloon about the inner tube, the retractable sheath retractable from a first position in which it is disposed about at least a portion of the at least one first expandable diaphragm to a second position in which the retractable sheath is axially displaced from the at least one first expandable diaphragm.

2. The medical device of claim 1 wherein the first diaphragm is constructed and arranged so that on refraction of the retractable sheath, the diaphragm expands to sealingly contact the interior of the balloon in a first contact region and form at least a first compartment and a second compartment in the balloon.

3. The medical device of claim 2 wherein the retractable sheath in the first position is disposed about the entirety of the first expandable diaphragm.

4. The medical device of claim 2 further comprising a second inflation lumen in fluid communication with the balloon, the first inflation lumen in fluid communication with the first compartment and the second inflation lumen in fluid communication with the second compartment on expansion of the diaphragm.

5. The medical device of claim 2 further comprising a second expandable diaphragm interior to the balloon, the second expandable diaphragm having a first end and a second end, the first end attached to the inner tube, the retractable sheath disposed about at least a portion of the second expandable diaphragm, the second diaphragm expanding to sealingly contact the interior of the balloon in a second contact region on retraction of the retractable sheath to form a third compartment in the balloon.

6. The medical device of claim 5 wherein the retractable sheath in the first portion is disposed about the entirety of the second expandable diaphragm.

7. The medical device of claim 5 further comprising three inflation lumens wherein each balloon compartment is in fluid communication with an inflation lumen on expansion of the first and second diaphragms.

8. The medical device of claim 2 further comprising a stent disposed about at least a portion of the balloon.

9. The medical device of claim 5 further comprising a stent disposed about at least a portion of the balloon.

10. A method of forming a sub-divided balloon in a bodily vessel comprising the steps of:

providing a medical device as in claim 1;

inserting at least a portion of the medical device in a bodily vessel;

delivering the medical device to a desired bodily location;

retracting the retractable sheath and allowing the at least one first expandable diaphragm to expand so as to sealingly contact the balloon and sub-divide the balloon into compartments and

inflating the balloon.

14. The method of claim 10 wherein the balloon is subdivided into at least 3 compartments.

11. The method of 10 wherein the balloon is at least partially inflated prior to the retracting step.

12. The method of claim 11 wherein the balloon is subdivided into at least 2 compartments.

13. The method of claim 11 wherein following inflation of the balloon, the at least 2 compartments are inflated to different pressures.

15. A medical device comprising:

a catheter tube;

a plurality of balloon elements disposed about the catheter tube;

an inflation lumen having a plurality of inflation ports therein, each balloon element disposed about at least one inflation port;

a movable sheath disposed about the inflation lumen, the movable sheath having a plurality of openings therein, the movable sheath movable such that each balloon element may be placed in fluid communication with the inflation lumen by moving the movable sheath to align an opening in the movable sheath with the inflation port about which the balloon element is disposed.

16. The medical device of claim 15 comprising at least three balloon elements.

17. The medical device of claim 16 wherein the balloon elements are formed from a single balloon which has been bonded to the catheter tube in a plurality of locations axially displaced from one another along a portion of the catheter tube.

18. The medical device of claim 16 wherein adjacent balloon elements are independently inflatable.

19. The medical device of claim 16 wherein the plurality of openings in the sheath and the inflation ports are arranged such that no more than one balloon element at a time can be in fluid communication with the inflation lumen.

20. The medical device of claim 15 wherein each balloon element is disposed about a single inflation port.

21. The medical device of claim 15 wherein the inflation lumen forms a part of the catheter tube.

22. A medical device comprising:

a catheter tube;

a balloon disposed about the catheter tube;

an inflation lumen having a plurality of inflation ports therein; and

a movable sheath disposed about the inflation lumen, the movable sheath having at least one opening therein, the movable sheath movable from an open position in which the opening in the movable sheath is at least partially aligned with the plurality of inflation ports to a closed position in which the opening in the sheath is displaced from the inflation ports.

23. The medical device of claim 22 wherein the inflation lumen forms a part of the catheter tube.