CONTROLLED EXPANSION BALLOON CATHETER

• US 20100324648A1
• Filed: 08/26/2008
• Published: 12/23/2010
• Est. Priority Date: 08/29/2007
• Status: Active Grant

• Current Assignee: Invatec Technology Center GmbH (Medtronic Plc)
• Original Assignee: Invatec Technology Center GmbH (Medtronic Plc)
• Inventors: Speck, Ulrich, Scheller, Bruno
• Granted Patent: US 10,532,189 B2
• Time in Patent Office: Days
• US Class Current: 623/1.11
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• 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 2025/1081 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

The invention relates to a drug-coated balloon catheter which has a catheter balloon mounted on its distal end and an expansion protection surrounding the same. The invention is characterized in that the catheter balloon is protected from premature expansion even under strong mechanical stress and in that the catheter balloon folds back more easily after dilation.

Claims

1-19. -19. (canceled)

20. A balloon catheter coated with at least one active substance, the balloon catheter including

a tube shaped protection against expansion

a self expanding stent located inside the tube shaped protection;

and

a catheter balloon,

wherein the tube shaped protection against expansion protects against premature expansion until release of the self expanding stent and protects the balloon catheter against premature loss of the at least one active substance.

21. The balloon catheter of claim 20, wherein the tube shaped protection against expansion has a distal end a proximal end, and the tube shaped protection comprises a radio-opaque marker at the distal end at the proximal end, or at both the distal end and the proximal end.

22. The balloon catheter of claim 20, wherein the tube shaped protection against expansion is a perforated or continuous protective tube.

23. The balloon catheter of claim 22, wherein the protective tube has a proximal end and is movable from the proximal end in a proximal direction and wherein the protective tube, when moved in a proximal direction, completely or partially releases the catheter balloon.

24. The balloon catheter of claim 23, wherein the protective tube has a distal end, and is movable from the distal end in a distal direction after being moved from the proximal end in a proximal direction, and wherein the protective tube, when moved from a proximal direction to a distal direction, surrounds the catheter balloon.

25. The balloon catheter of claim 22, wherein the protective tube further comprises a valve or the protective tube is sealed distally by means of soluble pharmaceutical and physiologically inactive substances.

26. The balloon catheter of claim 20, wherein the tube shaped protection against expansion is removable together with the catheter balloon after expansion of the catheter balloon.

27. The balloon catheter of claim 20, wherein a self expanding stent is a preassembled stent configured to resume a small diameter following expansion of the catheter balloon and the preassembled stent removable with the balloon catheter.

28. The balloon catheter of claim 20, wherein the tube shaped protection against expansion is performed by a self expanding stent which exercises no appreciable supporting function following implantation.

29. The balloon catheter of claim 20, wherein the catheter balloon is longer than the self expanding stent and wherein the self expanding stent is preassembled on the catheter balloon.

30. The balloon catheter of claim 20, wherein the balloon catheter is suitable for localised treatment and prophylaxis of vascular diseases.

31. The balloon catheter of claim 20, wherein the balloon catheter is suitable for treatment of changes to the vascular wall which do not significantly restrict the flow of blood.

32. The balloon catheter of claim 20, wherein the balloon catheter is suitable for treatment and prophylaxis of stenosis, restenosis, in-stent stenosis and arteriosclerosis.

33. A balloon catheter coated with at least one active substance, the balloon catheter including

a tube shaped protection against expansion, wherein a space between a catheter shaft and the tube shaped protection is sealed to protect against penetration of bodily fluids, and

a catheter balloon,

wherein the tube shaped protection against expansion protects the catheter balloon against premature expansion until the expansion takes place and against premature loss of the at least one active substance.

34. The balloon catheter of claim 33, wherein the protection against expansion comprises a self expanding stent.

35. A balloon catheter coated with at least one active substance, the balloon catheter including

an elastic protection against expansion free from any active substances and

a catheter balloon

wherein the elastic protection against expansion protects the catheter balloon from premature expansion until expansion takes place and the elastic protection against expansion assists refolding of the catheter balloon after expansion has taken place.

36. The balloon catheter of claim 35, wherein the elastic protection against expansion is a flexible band, a flexible net, a flexible grid a flexible film or a flexible coil.

37. The balloon catheter of claim 35, wherein when the balloon is expanded the elastic protection against expansion exercises an opposing force on the longitudinal axis of the catheter balloon.

38. The balloon catheter of claim 35, wherein when the balloon is deflated the elastic protection against expansion assists refolding of the catheter balloon and brings the catheter balloon back to a maximum diameter 30% or less larger than the diameter of the balloon catheter before inflation of the catheter balloon.

39. The balloon catheter of claim 35, wherein the elastic protection against expansion substantially corresponds in diameter and length to the diameter and length of the balloon catheter when the balloon catheter is folded up.