Device for treating hardened lesions

• US 8,870,816 B2
• Filed: 12/01/2008
• Issued: 10/28/2014
• Est. Priority Date: 05/31/2007
• Status: Active Grant

• Current Assignee: Cook Medical Incorporated (Cook Group Incorporated), Global Therapeutics LLC
• Original Assignee: Cook Medical Incorporated (Cook Group Incorporated), Global Therapeutics LLC
• Inventors: Chambers, Sean D., Aggerholm, Steen, Horn, Joe
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US13/130,420
• Publication Number:
  US 20110270177A1
• Time in Patent Office: 2,157 Days
• Field of Search: 604 9601-104, 606/159, 606/167, 606192-194
• US Class Current: 604/103.01
• 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 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 inner balloon,

an expandable outer balloon positioned around the inner balloon and defining an intermediate region between the inner balloon and the outer balloon, the shaft having a delivery lumen extending therethrough and in fluid communication with the intermediate region, and

at least one cutting element on an exterior surface of the inner balloon and positioned entirely within the intermediate region, wherein the at least one cutting element applies cutting or scoring pressure through a wall of the outer balloon,

wherein the outer balloon comprises a plurality of pores providing fluid communication between the intermediate region and the exterior of the balloon catheter and the plurality of pores are configured to deliver a bioactive, and wherein the at least one cutting element is not extendable through any of the plurality of pores.

2. The balloon catheter of claim 1, further comprising a bioactive, wherein the bioactive is contained in the intermediate region.

3. The balloon catheter of claim 2, wherein the bioactive is selected from the group consisting of paclitaxel, rapamycin, a rapamycin derivative, an antisense oligonucleotide, and a mTOR inhibitor.

4. The balloon catheter of claim 3, wherein the bioactive is paclitaxel.

5. The balloon catheter of claim 2, wherein the bioactive is selected from the group consisting of an antiproliferative agent, an antimitotic agent, an antibiotic, a hormone, an anti-inflammatory agent, an immunosuppressive agent, an antibody, a statin, an endothelial progenitor cell and an endothelial cell.

6. The balloon catheter of claim 1, wherein the density of the plurality of pores in the outer balloon varies with position.

7. The balloon catheter of claim 6, wherein the density of pores is higher in regions overlaying the cutting element.

8. The balloon catheter of claim 1, wherein at least one of the plurality of pores is sized between 0.01 and 500 microns.

9. The balloon catheter of claim 8, wherein at least one of the plurality of pores is sized between 0.1 and 100 microns.

10. 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, and a superelastic nickel-titanium alloy.

11. The balloon catheter of claim 1, wherein the cutting element comprises a material selected from the group consisting of carbon, carbon fiber, cellulose acetate, cellulose nitrate, silicone, polyethylene teraphthalate, polyurethane, polyamide, polyester, polyorthoester, polyanhydride, polyether sulfone, polyanhydride, polycarbonate, polypropylene, high molecular weight polyethylene, polylactic acid, polyglycolic acid, polytetrafluoroethylene, polycaprolactone, polyhydroxybutyrate valerate, a biodegradable polymer, a biocompatible polymeric material, and mixtures and copolymers thereof.

12. The balloon catheter of claim 1, wherein at least one of the outer balloon and the inner balloon comprises a material selected from the group consisting of silicone, a biocompatible polymer, polyethyleneterepthalate, polyvinyl chloride, polypropylene, polyethylene, polyurethane, nylon, polyester, latex, natural rubber, synthetic rubber, an elastomer and mixtures and copolymers thereof.

13. The balloon catheter of claim 1, wherein the cutting element is at least partially embedded in a wall of the inner balloon.

14. The balloon catheter of claim 1, comprising a plurality of cutting elements on the inner balloon.

15. A balloon catheter comprising:

a shaft having a distal end and a proximal end;

an 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 inner balloon,

an expandable outer balloon positioned around the inner balloon and defining an intermediate region between the inner balloon and the outer balloon, the shaft having a delivery lumen extending therethrough and in fluid communication with the intermediate region, and

at least one cutting element on an exterior surface of the inner balloon and positioned entirely within the intermediate region, wherein the at least one cutting element comprises a biocompatible polymer, and applies cutting or scoring pressure through a wall of the outer balloon,

wherein the outer balloon comprises a plurality of pores providing fluid communication between the intermediate region and the exterior of the balloon catheter and the plurality of pores are configured to deliver a bioactive, and wherein the at least one cutting element is not extendable through any of the plurality of pores.

16. The balloon catheter of claim 15, further comprising a fluid comprising a bioactive positioned within the intermediate region.

17. The balloon catheter of claim 16, wherein the bioactive is selected from the group consisting of an antiproliferative agent, an antimitotic agent, an antibiotic, a hormone, an anti-inflammatory agent, an immunosuppressive agent, an antibody, a statin, an endothelial progenitor cell and an endothelial cell.

18. The balloon catheter of claim 15, wherein the cutting element and the inner balloon comprise a biocompatible polymer.