Device for Treating Hardened Lesions

• US 20110270177A1
• Filed: 12/01/2008
• Published: 11/03/2011
• Est. Priority Date: 05/31/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Global Therapeutics LLC
• Original Assignee: Global Therapeutics LLC
• Inventors: Horn, Joe, Chambers, Sean D., Aggerholm, Steen
• Granted Patent: US 8,870,816 B2
• Time in Patent Office: Days
• US Class Current: 604/103.02
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61B 2017/00539 hydraulically
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61M 2025/0057 Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• 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 2025/1061 having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
• CPC Class Codes: A61M 2025/1086 having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• CPC Class Codes: A61M 2025/109 having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter is provided that may be used to dilate hardened regions of a stenosis on a vessel wall. The balloon catheter is provided with cutting elements that extend along a surface of a balloon. At least one bioactive is present, either on the cutting element, within the interior of the balloon, within the material of the balloon or on an outside surface of the balloon. The bioactive is delivered to the vessel wall upon dilation of the balloon.

Claims

1. A balloon catheter comprising:

a shaft having a distal end and a proximal end;

an expandable balloon mounted at the distal end of the shaft, the shaft having an inflation lumen extending therethrough in fluid communication with an interior region of the balloon, wherein at least a length of an outer surface of the balloon comprises a working surface adapted to dilate a vessel wall,

a cutting device comprising at least one cutting element, the cutting element contacting the outer surface of the balloon when the balloon is in an expanded state, and

a composition comprising a bioactive present on or adjacent the cutting element.

2. The balloon catheter of claim 1, wherein said bioactive is not present on regions of the outer surface of the catheter not adjacent to the cutting element.

3. The balloon catheter of claim 1, wherein the cutting device further comprises a proximal coil and a distal coil, the cutting element having a proximal end, a distal end, and a middle portion, the middle portion extending along the outer surface of the balloon at the working surface, the proximal end of the cutting element being affixed to the proximal coil, wherein the proximal coil proximally extends from the working surface of the balloon to the shaft, the distal end of the cutting element being affixed to the distal coil, wherein the distal coil distally extends from the working surface of the balloon to the shaft, the proximal and the distal coils being affixed to the shaft.

4. The balloon catheter of claim 1, comprising a plurality of cutting elements.

5. The balloon catheter of claim 1, wherein the bioactive is releasably attached to the cutting element.

6. The balloon catheter of claim 1, wherein the composition further comprises a bioabsorbable material.

7. The balloon catheter of claim 1, wherein the bioactive is selected from the group consisting of paclitaxel, rapamycin, a rapamycin derivative, an antisense oligonucleotide, and a mTOR inhibitor.

8. The balloon catheter of claim 1, wherein at least a portion of the exterior surface of the or each cutting element has a surface roughness which is greater than the surface roughness of the exterior surface of the balloon, the surface roughness of said portion or portions providing microcavities for the transport of bioactive.

9. The balloon catheter of claim 1, wherein the cutting element comprises a material selected from the group consisting of stainless steel, nickel, silver, platinum, palladium, gold, titanium, tantalum, iridium, tungsten, a superelastic nickel-titanium alloy, and inconel.

10. The balloon catheter of claim 1, wherein each cutting element has an internal cavity for the transport or deliveries of bioactive.

25. The balloon catheter of claim 7, wherein the bioactive is paclitaxel.

11-19. -19. (canceled)

20. A balloon catheter comprising:

a shaft having a distal end and a proximal end;

a expandable inner balloon mounted at the distal end of the shaft, the shaft having an inflation lumen extending therethrough and in fluid communication with an interior region of the balloon, and an expandable outer balloon positioned around the inner balloon to define an intermediate valve between the balloon, the shaft having a bioactive delivery lumen in communication with intermediate valve, and

a cutting device comprising at least one cutting element,

wherein the catheter comprises at least one pore providing fluid communication between the intermediate volume of the balloon and the exterior of the catheter for the targeted delivery of bioactive to a cutting site.

21. The balloon catheter of claim 20, wherein the cutting element is provided on the outer balloon and the said pore is formed in the cutting element.

22. The balloon catheter of claim 21 wherein the cutting element is provided on the inner balloon and the pore is provided in the outer balloon adjacent the location of the cutting element.

23. A method of delivering a bioactive to a vessel wall, the method comprising:

positioning an expandable balloon portion of a balloon catheter at a site within a vessel, wherein the balloon catheter comprises;

a shaft having a distal end and a proximal end;

the expandable balloon mounted at the distal end of the shaft, the shaft having an inflation lumen extending therethrough and in fluid communication with an interior region of the balloon, wherein at least a length of an outer surface of the balloon comprises a working surface adapted to dilate a vessel wall;

a cutting device comprising at least one cutting element, the cutting element contacting the outer surface of the balloon when the balloon is in an expanded state; and

a composition comprising a bioactive reversibly attached to at least a portion of the cutting element;

expanding the balloon to cause the cutting element to contact the vessel wall and to dilate the vessel wall; and

maintaining contact with the vessel wall for a time sufficient to deliver a therapeutically effective amount of bioactive to the vessel wall.

24. The method of claim 23, wherein the bioactive is selected from the group consisting of paclitaxel, rapamycin, a rapamycin derivative, an antisense oligonucleotide, and an mTOR inhibitor.

26. The balloon catheter of claim 24, wherein the bioactive is paclitaxel.