Conformable balloon

• US 20030014007A1
• Filed: 07/11/2001
• Published: 01/16/2003
• Est. Priority Date: 07/11/2001
• Status: Active Grant

• 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.
• Granted Patent: US 6,605,056 B2
• Time in Patent Office: Days
• 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;

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

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

2. The medical device of claim 1 wherein the first diaphragm is constructed arranged so that on 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.

3. The medical device of claim 2 wherein the retractable sheath in the first portion 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.

13. 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 expandable diaphragm to expand so as to sealingly contact the balloon and sub-divide the balloon into compartments and

inflating the balloon.

10. A medical balloon assembly comprising:

a balloon catheter comprising an inflatable medical balloon;

M expandable diaphragms disposed within the inflatable medical balloon, where M≧

1, each diaphragm expandable from a first position in which the diaphragm does not sealingly contact the balloon to a second position in which the diaphragm sealingly contacts the balloon, the balloon having at least M+1 compartments when the M expandable diaphragms are all in the second position.

11. The balloon assembly of claim 10 wherein M=2.

12. The balloon assembly of claim 10, the balloon disposed about an inner tube, the assembly further comprising

a retractable sheath, the retractable sheath retractable from a first position to a second position, the retractable sheath in the first position disposed about the inner tube and the M expandable diaphragms, the retractable sheath in the second position axially displaced from the M expandable diaphragms.

15. The method of claim 14 wherein the balloon is subdivided into at least 2 compartments.

16. The method of claim 14 wherein following inflation of the balloon, the at least 2 compartments are inflated to different pressures.

17. The method of claim 13 wherein the balloon is subdivided into at least 3 compartments.

19. The medical device of claim 18 comprising at least three balloon elements.

20. The medical device of claim 19 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.

21. The medical device of claim 19 wherein adjacent balloon elements are independently inflatable.

22. The medical device of claim 19 wherein the 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.

24. The medical device of claim 18 wherein each balloon element is disposed about a single inflation port.

25. The medical device of claim 18 wherein the movable sheath has one opening therein.

26. The medical device of claim 18 wherein the movable sheath has a plurality of openings therein.

27. The medical device of claim 18 wherein the inflation lumen forms a part of the catheter tube.

29. The medical device of claim 28 wherein the inflation forms a part of the catheter tube.

14. The method of 13 wherein the balloon is at least partially inflated prior to the retracting step.

18. 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 at least one opening 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.

28. A medical device comprising:

a catheter tube;

a balloon disposed about the catheter tube;

an inflation lumen having an inflation port 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 inflation port to a closed position in which the opening in the sheath is displaced from the infusion port.

30. A medical device comprising:

a catheter tube;

an outer medical balloon disposed about the catheter tube;

a first inflation lumen in fluid communication with the outer medical balloon;

a serpentine medical balloon disposed within the outer medical balloon, the serpentine balloon winding about the catheter tube;

a second inflation lumen in fluid communication with the serpentine medical balloon.

31. The medical device of claim 30 wherein the serpentine medical balloon is spiral shaped.

32. The medical device of claim 31 wherein the serpentine medical balloon extends at least 360°

about the catheter tube.

33. The medical device of claim 31 wherein the serpentine medical balloon extends a plurality of turns about the catheter tube.

34. The medical device of claim 30 comprising a plurality of serpentine medical balloons disposed within the outer medical balloon.

35. The medical balloon of claim 34 wherein all of the serpentine medical balloons are in fluid communication with a single inflation lumen.

37. The medical device of claim 36 wherein the serpentine medical balloons are spiral balloons.

38. The medical device of claim 36 comprising a plurality of serpentine medical balloons.

39. The medical device of claim 36 wherein the outer medical balloon and the one or more serpentine balloon are supplied with an inflation via a single inflation lumen.

40. The medical device of claim 36 comprising a plurality of inflation lumens including a first inflation lumen in fluid communication with the outer medical balloon and a second inflation lumen in fluid communication with the one or more serpentine balloons.

41. The medical device of claim 40 wherein each spiral medical balloon is in fluid communication with a separate inflation lumen.

42. The medical device of claim 36 further comprising a balloon moving device for moving a portion of the serpentine medical balloon to increase the pitch of the serpentine medical balloon.

36. A medical device comprising:

a catheter tube;

an outer medical balloon disposed about the catheter tube; and

one or more serpentine medical balloons disposed within the outer medical balloon, each serpentine medical balloon wound about the catheter tube.

43. A method of centering a catheter tube within a medical balloon comprising the steps of:

providing a medical device as in claim 36;

supplying an inflation fluid to the outer medical balloon;

and supplying an inflation fluid to the one or more serpentine balloons.

44. A method of dilating a stenosis and treating the stenosis with radiation comprising the steps of:

a) providing a brachytherapy device comprising

1) a catheter tube;

2) an outer medical balloon disposed about the catheter;

3) a serpentine medical balloon winding about the catheter tube within the outer medical balloon;

4) a radiation source

b) inserting at least a portion of the brachytherapy device in a bodily vessel;

c) advancing the brachytherapy device to a desired bodily location;

d) expanding the outer medical balloon;

e) expanding the spiral medical balloon; and

f) advancing the radiation source through the inner tube to the stenosis.

46. The medical device of claim 45 further comprising a balloon moving device which is capable of compressing the spiral medical balloon to increase the pitch of the spiral medical balloon.

48. The medical balloon of claim 47 wherein the balloon has a single compartment in the first configuration and at least two compartments in the second configuration.

45. A medical device comprising:

a catheter tube;

at least one spiral medical balloon wound about the catheter tube, the spiral medical balloon characterized by a pitch which may be varied; and

an inflation lumen in fluid communication with said spiral medical balloon.

47. A medical balloon transformable from a first configuration to a second configuration, the medical balloon in the first configuration having a first number of internal compartments, the medical balloon in the second configuration having more internal compartments than in the first configuration.