NARROW PROFILE COMPOSITION-RELEASING EXPANDABLE MEDICAL BALLOON CATHETER

• US 20120232640A1
• Filed: 11/19/2010
• Published: 09/13/2012
• Est. Priority Date: 11/19/2009
• Status: Abandoned Application

• Current Assignee: Wellinq Medical B.V.
• Original Assignee: Blue Medical Devices B.V.
• Inventors: Horvers, Ronald Adrianus Maria
• Application Number:
  US13/510,400
• Publication Number:
  US 20120232640A1
• 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: A61L 2300/406 Antibiotics
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 29/16 Biologically active materials, e.g. therapeutic substances A61L29/048 takes precedence
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• 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 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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

Abstract

The present invention relates to a composition-eluting balloon catheter (100) having a proximal (20) and distal (15) end, comprising an elongated catheter tube (6) with an inflation lumen (7) extending therewithin and at least one inflatable balloon (4) towards the distal end (15) in fluid communication with the inflation lumen (7), wherein the balloon (4) in the uninflated condition is provided as one or a plurality of folded wings (10′, 10″), and composition (12′, 12″) is provided essentially exclusively within the folds of the wings (10′, 10″), wherein the balloon (4) in the uninflated condition is further provided with a relief structure (30) comprising at least one groove on the outside of the folded wings (10′, 10″), configured to substantially reduce in depth in an inflated state of the balloon (4), and whereby the at least one groove is essentially devoid of composition (12′, 12″).

Claims

1-17. -17. (canceled)

18. A composition-eluting balloon catheter (100) having a proximal (20) and distal (15) end, comprising an elongated catheter tube (6) with an inflation lumen (7) extending therewithin and at least one inflatable balloon (4) having a central longitudinal balloon axis (B-B′

) towards the distal end (15) in fluid communication with the inflation lumen (7), wherein;

the balloon (4) in the uninflated condition is configured as a one or a plurality of folded wings (10′

, 10″

), and

composition (12′

, 12″

) is provided essentially exclusively within the folds of the wings (10′

, 10″

) in such a manner that release of the composition is reduced or prevented until after inflation of the balloon has commenced,

wherein the balloon (4) in the folded condition is further provided with a relief structure (30) comprising at least one groove on the outside of the folded wings (10′

, 10″

), configured to substantially reduce in depth in an inflated state of the balloon (4),

wherein the at least one groove (32) crosses the outer edge of at least one folded wing (10′

, 10″

) and

whereby each and every groove is essentially devoid of composition (12′

, 12″

).

19. Balloon catheter according to claim 18, wherein the at least one groove (32) has a directional component which is transverse to the central longitudinal axis (B-B′

) of the balloon (4).

20. Balloon catheter according to claim 18, whereby the at least one groove (32) extends at a predetermined angle with regard to the longitudinal axis of the balloon (4).

21. Balloon catheter according to claim 18, wherein at least two grooves (33, 34) extend from the distal end (15) to the proximal end (20) of the balloon (4) and cross each other.

22. Balloon catheter according to claim 18, whereby the at least one groove (32) is ring or oval shaped, and has a directional component which is transverse to a central longitudinal axis (B-B′

) of the balloon (4).

23. Balloon catheter according to claim 18, wherein the composition comprises paclitaxel.

24. Balloon catheter according to claim 18, wherein the composition comprises:

one or more of paclitaxel, melatonin, thalidomide, sirolimus, zotarolimus, everolimus, biolimus, 17-β

estradiol, actinomucin D, docetaxel, and/or any derivatives thereof, or

one or more of cis-platin, paclitaxel, etoposide, amasecrine, teniposide, irinotecan, toptecan, doxorubicin, epirubicin, bleomycin, and/or any derivatives thereof, or

one or more of penicillin, erythromycin, ampicillin, clindamycin, tetracycline, streptomycin, amoxicillin, cefaclor, lincomycin, clarithromycin, cephalosporins, azithromycin, doxycycline, ciprofloxacin, cefuroxime, levofloxacin, chloramphenicol, minocycline, penicillins, vancomycin, kanamycin, gentamicins, neomycin, ceftriaxone, bacitracin, oxacillin, cloxacillin, cephalothin, amoxicillin, dicloxacillin, aminoglycosides, methicillin, carbenicillin, gentamicin, trimethoprim, oxytetracycline, rifampin, tetracyclines, polymyxins, cephalexin, chlortetracycline, metronidazole and/or any derivatives thereof.

25. Balloon catheter according to claim 18, wherein the balloon is provided with a hydrophilic coating onto which the composition (12′

, 12″

) is at least partially disposed.

26. Balloon catheter according to claim 25, wherein the hydrophilic coating is any of polyvinylpyrrolidone (PVP) or copolymers containing N-vinylpyrrolidone, poly (meth) acrylic acid or copolymers containing (meth) acrylic acid or (meth) acrylic acid esters, polyacrylamides, polyvinylalcohol and copolymers of partially saponified vinylacetate copolymers, polyethylenglycol, polyvinylmethylether, polyvinylmethylether-maleic anhydride and copolymers containing maleic-anhydride or maleic-acidesters or copolymers containing vinylmethylether, or copolymers thereof, or water soluble polysaccharides or derivatives thereof such as carboxymethylcellulose (CMC) or hydroxyethylcellulose or Xanthane or a derivative thereof to the liquid for wetting a hydrophilic coating.

27. Balloon catheter according to claim 18, further provided with a stent.

28. Balloon catheter according to claim 27, wherein the stent is made from any of stainless steel, tantalum, titanium alloy, nitinol, cobalt alloy, cobalt-chromium-nickel alloy, cobalt-chromium alloy, cobalt-chromium F562, or magnesium alloys.

36. Balloon catheter according to claim any of claims 18 to 28, further provided with a guidewire lumen for a rapid exchange catheter or an over the wire catheter mode of operation.

29. Process for obtaining a composition-eluting balloon catheter (100) having a proximal (20) and distal (15) end, comprising an elongated catheter tube (6) with an inflation lumen (7) extending therewithin and at least one inflatable balloon (4) having a central longitudinal balloon axis (B-B′

) towards the distal end (15) in fluid communication with the inflation lumen (7), wherein the balloon (4) in the uninflated condition is configured as one or a plurality of folded wings (10′

, 10″

) comprising the steps;

a) applying the composition (12′

, 12″

) at least partially over one or both surfaces of the balloon wing;

b) folding the balloon wings (10′

, 10″

) around the central longitudinal balloon axis (B-B′

) such that applied composition (12′

, 12″

) is disposed within the folds of the wings;

c) removing excess composition (12′

, 12″

) from the surface of the folded balloon; and

d) applying a relief structure (30) to the balloon (4) in the folded condition, comprising at least one groove on the outside of the folded wings (10′

, 10″

), configured to substantially reduce in depth in an inflated state of the balloon (4), wherein the at least one groove (32) crosses the outer edge of at least one folded wing (10′

, 10″

) and wherein each and every groove is essentially devoid of composition (12′

, 12″

).

30. Process according to claim 29, wherein:

one or both surfaces of the balloon wings (10′

, 10″

) are at least partially with a hydrophilic coating, prior to application of the composition; and

the composition (12′

, 12″

) is applied in a solution of organic solvent preferably methanol, propanol, acetone, or ethyl acetate, more preferably ethanol, at least partially over the coated surface;

31. Process according to claim 29, wherein the at least one groove (32) has a directional component which is transverse to the central longitudinal axis (B-B′

) of the balloon (4).

32. Process according to claim 29, wherein the at least one groove (32) extends at a predetermined angle with regard to the longitudinal axis of the balloon (4).

33. Process according to claim 29, wherein at least two grooves (33, 34) extend from the distal end (15) to the proximal end (20) of the balloon (4) and cross each other.

34. Process according to claim 29, wherein the at least one groove (32) is ring or oval shaped, and has a directional component which is transverse to a central longitudinal axis (B-B′

) of the balloon (4).

35. A composition-eluting balloon catheter (100) obtainable by a process according to any of claims 29 to 34.