Expandable perfusion balloon

• US 8,808,237 B2
• Filed: 04/23/2011
• Issued: 08/19/2014
• Est. Priority Date: 04/26/2010
• Status: Expired due to Fees

• Current Assignee: Joseph Michael Thielen, William Joseph Drasler
• Original Assignee: Joseph Michael Thielen, William Joseph Drasler
• Inventors: Thielen, Joseph Michael, Drasler, William Joseph
• Primary Examiner(s): Price, Nathan R
• Application Number:
  US13/066,717
• Publication Number:
  US 20110264039A1
• Time in Patent Office: 1,214 Days
• Field of Search: 604/101.01, 604/101.02, 604/103, 604/103.02, 604/103.06, 604/103.09
• US Class Current: 604/103.06
• CPC Class Codes: A61B 17/2202 the ultrasound transducer being inside patient's body at the distal end of the catheter
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/22098 Decalcification of valves
• 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 2025/1075 having a balloon composed of several layers, e.g. by coating or embedding
• 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 2025/1084 having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2025/1093 having particular tip characteristics
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter for dilation of stenotic tissue within a tubular member of the body such as a blood vessel provides fluid flow such as blood flow through the balloon while it is being inflated and after it has been inflated. For valvuloplasty applications or for predilitation prior to a TAVI procedure the balloon is placed across the stenotic aortic valve leaflets and inflated to push the leaflets aside to create a greater blood flow area or allow improved subsequent passage of the large TAVI catheter across the stenotic aortic valve leaflets. As the balloon is inflated in diameter, it is required to reduce in length; this length reduction causes a braided inner tubing to also reduce in length. The braided inner tube is thereby required it to increase in diameter during the balloon inflation and create a suitably large blood flow path through the inner tubing. The continuous perfusion through the inner tubing of the balloon allows greater balloon inflation times, improved valvular dilation, and obviates the need for rapid pacing during the valvuloplasty procedure.

Claims

1. A catheter having a distal end and a perfusion balloon positioned near said distal end, said perfusion balloon having an outer tubing with angled filaments contained within, and an inner tubing positioned adjacent said outer tubing, said inner tubing having angled fibers contained within, said outer tubing being attached to said inner tubing at an open proximal end and at an open distal end of said perfusion balloon forming an annular space between said outer tubing and said inner tubing, said open proximal end and said open distal end providing passage for fluid through said inner tubing from said open proximal end to said open distal end;

said outer tubing and said inner tubing being expandable from a smaller diameter delivery state to a larger diameter final state.

2. The catheter of claim 1 wherein said angled filaments form a braided outer tubing and said angled fibers form a braided inner tubing.

3. The catheter of claim 1 wherein said tubing and said inner tubing are formed with flexible polymeric material that is a fluid-tight barrier.

4. The catheter of claim 3 having an equilibrium condition in said smaller diameter delivery state wherein said fluid-tight barrier is formed without axial or circumferential stress.

5. The catheter of claim 3 wherein said fluid-tight barrier is formed with axial stress contained therein in the larger diameter final state.

6. The catheter of claim 5 wherein said outer tubing and said inner tubing get larger in diameter upon exposure of said annular space between said outer tubing and said inner tubing to an inflation pressure.

7. The catheter of claim 3 wherein said angled filaments are braided with a filament angle and said angled fibers are braided with a fiber braid angle, said filament angle and said fiber braid angle in the larger diameter final state forming an equilibrium final shape for perfusion balloon diameter, perfusion balloon length, and inner tubing diameter wherein axial forces are in balance.

8. The catheter of claim 3 wherein said filaments are braided with a filament angle and said angled fibers are braided with a fiber braid angle, said filament angle being approximately equal to said fiber braid angle in the larger diameter final state.

9. The catheter of claim 3 wherein said balloon filaments are braided with a filament angle and said angled fibers are braided with a fiber braid angle, said filament angle being approximately equal to said fiber braid angle in the smaller diameter delivery state.

10. The catheter of claim 3 wherein said angled fibers are braided with a fiber braid angle, said fiber braid angle being greater than 45 degrees in the larger diameter final state.

11. A catheter for providing dilation to a stenotic region of a tubular member of a body, said catheter having a balloon positioned at its distal end and a manifold in fluid communication with said balloon at the proximal end of said perfusion catheter, said catheter comprising;

A. a balloon having an outer portion that is in contact with angled filaments, said angled filaments forming an outer tubing,

B. said balloon having an inner portion that is in contact with angled fibers, said angled fibers forming an inner tubing,

C. said balloon being formed from one or more polymers that form a fluid-tight barrier,

D. said inner tubing being attached to said outer tubing at a proximal end and distal end of said balloon,

E. said balloon configured to be delivered into the tubular member of the body in a smaller diameter state and expandable to a larger diameter state,

F. said inner tubing having an open proximal end and an open distal end, said inner tubing forming a perfusion lumen for blood flow through said balloon.

12. The balloon of claim 11 wherein said angled filaments are braided filaments and said angled fibers are braided fibers.

13. The catheter of claim 11 wherein said balloon is approximately 19-28 mm in diameter to dilate stenotic aortic valve leaflets and provide perfusion from a left ventricle to an aorta of the body during dialation of the stenotic aortic valve leaflets.

14. The catheter of claim 11 wherein said balloon is formed from a polymer that resists further diameter expansion beyond a specified diameter.

15. The catheter of claim 11 further comprising an energy source means to enhance a valvuloplasty procedure.