ADJUSTABLE-LENGTH DRUG DELIVERY BALLOON

• US 20090105686A1
• Filed: 06/29/2007
• Published: 04/23/2009
• Est. Priority Date: 06/29/2007
• Status: Active Grant

• Current Assignee: JW Medical Systems Ltd
• Original Assignee: XTENT, Inc.
• Inventors: Ruane, Patrick H., Snow, David W.
• Granted Patent: US 9,370,642 B2
• Time in Patent Office: Days
• US Class Current: 604/509
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• 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 2025/1081 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 25/10 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

Abstract

A drug or agent coated balloon having a length which is adjustable in vivo is described herein. The balloon is configured to be coated or coatable with one or more drugs where the coating may be applied prior to advancement into a patient body or prior to balloon expansion within the patient body. The length of the expandable portion of the balloon is adjustable to approximate a length of the tissue region to be treated. Moreover, the drug-coated balloon may be used alone or it may be utilized to deploy luminal prostheses having one or more linked or otherwise coupled segments.

Claims

1. A balloon catheter, comprising:

a catheter having an inflatable balloon positioned thereon;

a sheath positioned over the balloon and which is axially movable with respect thereto, wherein a length of an expandable portion of the balloon is adjustable by positioning the sheath along the balloon so that the expandable portion is exposed while a non-expandable portion is covered by the sheath and constrained from expansion therewith; and

at least one agent disposable upon at least the expandable portion of the balloon.

2. The catheter of claim 1 wherein the catheter comprises an elongate flexible shaft with the inflatable balloon positioned near or at a distal end of the shaft.

3. The catheter of claim 1 wherein the sheath defines at least one lumen therethrough in fluid communication with a reservoir.

4. The catheter of claim 3 wherein the sheath further defines at least one opening along an inner surface of the sheath in fluid communication with the at least one lumen.

5. The catheter of claim. 4 wherein the sheath further defines a plurality of openings along the inner surface.

6. The catheter of claim 5 wherein the plurality of openings along the inner surface are distributed over the length of the balloon when the sheath is disposed over the balloon.

7. The catheter of claim 5 wherein, the at least one opening along the inner surface is positioned over a distal end of the balloon when the sheath is disposed over the balloon.

8. The catheter of claim 5 wherein the at least one opening along the inner surface is positioned over a middle portion of the balloon when the sheath is disposed over the balloon.

9. The catheter of claim 5 wherein the at least one opening along the inner surface is positioned over a proximal end of the balloon when the sheath is disposed over the balloon.

10. The catheter of claim 1 wherein the inflatable balloon defines a plurality of openings over its surface.

11. The catheter of claim 1 wherein the inflatable balloon defines a plurality of openings over its surface, wherein the openings along the expandable portion of the balloon are sized to open from a closed configuration when the expandable portion is deflated to an open configuration when the expandable portion is inflated.

12. The catheter of claim 11 wherein the plurality of openings are in fluid communication with a reservoir.

13. The catheter of claim 1 further comprising a seal positioned at a distal end of the sheath and in sliding contact against a surface of the balloon when the sheath is moved with respect to the balloon.

14. The catheter of claim 1 wherein the at least one agent is selected from the group consisting of Rapamycin, Everolimus, Paclitaxel, analogs, prodrugs, and derivatives thereof, antibiotics, thrombolytics, anti-thrombotics, anti-inflammatories, cytotoxic agents, anti-proliferative agents, endothelial cell attractors or promoters, vasodilators, gene therapy agents, radioactive agents, immunosuppressants, chemotherapeutics and/or stem cells, and combinations thereof.

15. The catheter of claim 1 further comprising at least a second agent disposable upon at least the expandable portion of the balloon.

16. The catheter of claim 1 further comprising a stent positionable over the balloon and expandable therewith.

17. The catheter of claim 16 wherein the sheath comprises a stent engagement mechanism.

18. The catheter of claim 16 wherein the stent is coated with a first agent on outer surfaces of the stent.

19. The catheter of claim 18 wherein the stent is coated with a second agent on inner and/or side surfaces of the stent.

20. The catheter of claim 16 wherein the stent comprises a self-expandable stent.

21. The catheter of claim 16 wherein, the stent comprises a balloon-expandable stent.

22. The catheter of claim 16 further comprising a plurality of expandable stent segments slidably positioned on the catheter.

23. The catheter of claim 22 further comprising a stent engagement mechanism whereby a stent segment to be expanded is separated from an undeployed adjacent stent segment.

24. The catheter of claim 23 wherein the stent engagement mechanism is movable relative to the balloon.

25. The catheter of claim 1 wherein the balloon, comprises a polymeric coating adapted to control the release of the agent.

26. The catheter of claim 25 wherein, the polymeric coating comprises a concentration of nanoparticles dispersed through the coating.

27. The catheter of claim 26 wherein the nanoparticles each comprise a metal shell.

28. The catheter of claim 26 wherein the nanoparticles have a diameter up to about 5 microns.

29. The catheter of claim 26 further comprising an electromagnetic radiation source for irradiating the concentration of nanoparticles dispersed through the coating.

30. The catheter of claim 1 further comprising a perfusion lumen which passes through the catheter from a first location proximal to the balloon to a second location distal to the balloon such that fluid is shunted through the perfusion lumen when the expandable portion of the balloon is inflated within a vessel.

31. The catheter of claim 30 wherein the perfusion lumen passes through the balloon.

32. The catheter of claim 30 wherein the perfusion lumen defines a plurality of openings at the first location proximal to the balloon for the passage of the fluid therethrough.

33. A balloon catheter, comprising:

a catheter shaft having an inflatable balloon positioned thereon;

a sheath positioned over the balloon and which is axially movable with respect thereto, wherein a length of an expandable portion of the balloon is adjustable by positioning the sheath along the balloon so that the expandable portion is exposed while a non-expandable portion is covered by the sheath and constrained from expansion therewith;

at least one agent disposable upon at least the expandable portion of the balloon;

a stent having a total length earned within the sheath; and

a length-adjustment mechanism adapted to adjust the length of an expandable portion of the stent which is less than the total length.

34. The catheter of claim 33 wherein the stent comprises a plurality of stent segments carried by the catheter and movable longitudinally along the catheter.

35. The catheter of claim 34 wherein the length-adjustment mechanism comprises a separating mechanism which is configured to separate a stent segment to be expanded from an undeployed adjacent stent segment.

36. The catheter of claim 33 wherein the stent is positionable over the balloon and is radially expanded by expansion of the balloon.

37. The catheter of claim 33 further comprising a positioner slidable longitudinally along the catheter for moving the plurality of stent segments relative to the balloon from a first proximal position to a second position in which at least one of the stent segments surrounds the expandable portion of the balloon.

38. The catheter of claim 37 wherein the positioner comprises a sliding element configured to slide longitudinally along the catheter and push the plurality of stents distally along the catheter so as to move a stent segment adjacent to the balloon into a position in which it surrounds the balloon.

39. The catheter of claim 38 wherein the sliding element is attached to a shaft extending longitudinally along a length of the catheter and the sliding element slides along the catheter in response to a longitudinal movement of the shaft.

40. The catheter of claim 33 wherein the stent segments are adapted to be deployed in a blood vessel in any order.

41. The catheter of claim 33 wherein the sheath defines at least one lumen therethrough in fluid communication with a reservoir.

42. The catheter of claim 41 wherein the sheath former defines at least one opening along an inner surface of the sheath in fluid communication with the at least one lumen.

43. The catheter of claim 42 wherein the sheath further defines a plurality of openings along the inner surface.

44. The catheter of claim 43 wherein the plurality of openings along the inner surface are distributed over the length of the balloon when the sheath is disposed over the balloon.

45. The catheter of claim 44 wherein the at least one opening along the inner surface is positioned over a distal end of the balloon when the sheath is disposed over the balloon.

46. The catheter of claim 33 further comprising a perfusion lumen which, passes through the catheter from a first location proximal to the balloon to a second location distal to the balloon such that fluid is shunted through the perfusion lumen when fire expandable portion of the balloon is inflated within a vessel.

47. The catheter of claim 46 wherein the perfusion lumen passes through the balloon.

48. The catheter of claim 46 wherein the perfusion lumen defines a plurality of openings at the first location proximal to the balloon for the passage of the fluid therethrough.

49. A method of treating a region of a vessel wall, comprising:

positioning a catheter having an inflatable balloon positioned thereon in proximity or adjacent to the region of vessel wall;

adjusting a position of a sheath with respect to the balloon such that an exposed portion of the balloon is coextensive with the region of vessel wall while a second portion of the balloon is covered by the sheath; and

expanding the exposed portion of the balloon such that at least one agent disposed upon tire exposed portion of the balloon contacts the region of vessel wall.

50. The method of claim 49 wherein positioning a catheter comprises intravascularly advancing the catheter within a patient body.

51. The method of claim 49 wherein adjusting a position comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon.

52. The method of claim 49 further comprising depositing the at least one agent upon a surface of the balloon within the sheath.

53. The method of claim 52 wherein the at least one agent is delivered through a lumen in the sheath.

54. The method of claim 52 wherein depositing the at least one agent comprises delivering the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon.

55. The method of claim 49 further comprising positioning at least one stent segment over the balloon such that the at least one stent segment overlies the exposed portion of the balloon.

56. The method of claim 55 wherein the at least one stent segment is positioned over the balloon prior to expanding the exposed portion of the balloon.

57. The method of claim 55 further comprising expanding the at least one stent segment upon the exposed portion of the balloon into contact against the region of vessel wall.

58. The method of claim 55 wherein the at least one stent segment is expanded after the balloon is expanded without the at least one stent segment thereon.

59. The method of claim 53 wherein the at least one stent segment is expanded before the balloon is expanded without the at least one stent segment thereon.

60. The method of claim 55 wherein the stent earners a therapeutic agent.

61. The method of claim 60 wherein the agent on the balloon is different than the agent on the stent.

62. The method of claim 49 further comprising deflating the exposed portion of the balloon and re-covering the balloon with the sheath.

63. The method of claim 62 further comprising depositing at least an additional agent upon the balloon within the sheath.

64. The method of claim 63 wherein the first agent is a restenosis inhibitor and the additional agent is selected from an anti-platelet agent, a thrombus inhibitor, an endothelial cell promoter, or endothelial cell attractor.

65. The method of claim 63 further comprising re-adjusting the position of the sheath with respect to the balloon such that the exposed portion of the balloon is coextensive with the region of vessel wall.

66. The method of claim 65 further comprising re-expanding the exposed portion of the balloon such that the additional agent disposed upon the exposed portion of the balloon contacts the vessel wall.

67. The method of claim 62 further comprising repositioning the catheter in proximity or adjacent to a second region of vessel wall.

68. The method of claim 67 wherein repositioning comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon.

69. The method of claim 68 further comprising depositing the at least one agent upon a surface of the balloon within the sheath.

70. The method of claim 69 wherein the at least one agent is delivered through a lumen in the sheath.

71. The method of claim 69 wherein depositing the at least one agent comprises delivering the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon.

72. The method of claim 68 further comprising positioning at least one stent segment over the balloon such that the at least one stent segment overlies the exposed portion of the balloon.

73. The method of claim 72 wherein the at least one stent segment is positioned over the balloon prior to expanding the exposed portion of the balloon.

74. The method of claim 72 further comprising expanding the at least one stent segment upon the exposed portion of the balloon into contact against the second region of vessel wall.

75. The method of claim 49 wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of between 10 seconds to 10 minutes.

76. The method of claim 49 wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of between 30 to 150 seconds.

77. The method of claim 49 wherein the exposed portion of the balloon is contacted against the region of vessel wall for a sustained period of time of 60 seconds.

78. The method of claim 49 further comprising shunting blood through the balloon via a perfusion lumen while maintaining contact between the exposed portion of the balloon and the region of vessel wall.

79. The method, of claim 78 wherein shunting blood comprises flowing the blood through the perfusion lumen which extends from a first location proximal to the balloon to a second location distal to the balloon.

80. The method of claim 49 further comprising irradiating the exposed portion of the balloon intravascularly and/or extracorporeally such that a concentration of nanoparticles contained within a carrier upon the balloon is heated.

81. The method of claim 80 farther comprising liquefying the carrier such that the agent is released into the vessel wall.

82. A method of treating a stenosed region of vessel wall previously treated, comprising:

positioning a catheter having an inflatable balloon positioned thereon in proximity or adjacent to the stenosed region of vessel wall;

adjusting a position of a sheath with respect to the balloon such that an exposed portion of the balloon is coextensive with the stenosed region of vessel wall while a second portion of the balloon remains covered by the sheath; and

expanding the exposed portion of the balloon such, that at least one agent disposed upon the exposed portion of the balloon contacts tire stenosed region of vessel wall.

83. The method of claim 82 wherein positioning a catheter comprises intravascularly advancing the catheter within a patient body.

84. The method of claim 82 wherein adjusting a position comprises retracting the sheath with respect to the balloon such that a distal end of the sheath overlies the balloon proximal to the exposed portion of the balloon.

85. The method of claim 82 further comprising infusing the at least one agent upon a surface of the balloon while adjusting the position of the sheath.

86. The method of claim 85 wherein infusing the at least one agent comprises passing the at least one agent through a plurality of openings defined along an inner surface of the sheath upon the surface of the balloon.

87. The method of claim 82 wherein expanding the exposed portion comprises contacting a previously deployed stent disposed along the stenosed region.

88. The method of claim 82 further comprising shunting blood through the balloon via a perfusion lumen while maintaining contact between the exposed portion of the balloon, against the region of vessel wall.

89. The method of claim 88 wherein shunting blood comprises flowing the blood through the perfusion lumen which extends from a first location proximal to the balloon to a second location distal to the balloon.