Expandable perfusion balloon

• US 20110264039A1
• Filed: 04/23/2011
• Published: 10/27/2011
• Est. Priority Date: 04/26/2010
• Status: Active Grant

• Current Assignee: Joseph Michael Thielen, William Joseph Drasler
• Original Assignee: Joseph Michael Thielen, William Joseph Drasler
• Inventors: Drasler, William Joseph, Thielen, Joseph Michael
• Granted Patent: US 8,808,237 B2
• Time in Patent Office: Days
• US Class Current: 604/103.01
• 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 perfusion catheter having a perfusion balloon positioned near its distal end, said perfusion balloon having an outer balloon having a balloon wall with angled structural balloon filaments contained within, and an inner tube positioned within said outer balloon, said inner tube having a tube wall with angled structural tube fibers contained within, said inner tube being attached to said outer balloon at a proximal and distal end of said perfusion balloon, and providing passage for fluid there through from a proximal end of said inner tube to a distal end of said inner tube;

said outer balloon being expandable from a smaller diameter delivery state to a larger diameter final state.

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

3. The perfusion catheter of claim 1 wherein said angled balloon filaments are formed from a machined tube and angled tube fibers are formed from a machined tube.

4. The perfusion catheter of claim 1 wherein said balloon wall and said tube wall each have a flexible polymeric coating that is a fluid-tight coating.

5. The perfusion catheter of claim 4 having an equilibrium condition in the small diameter configuration wherein said fluid-tight coating does not contain significant axial or circumferential stress.

6. The perfusion catheter of claim 4 wherein said fluid-tight coating has significant axial stress contained therein in the larger diameter state.

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

8. The perfusion catheter of claim 4 wherein said balloon filaments are braided with a filament angle and said tube fibers are braided with a fiber braid angle, said filament angle and said fiber angle in the larger diameter final state forming an equilibrium final shape for the perfusion balloon diameter, perfusion balloon length, and inner tube diameter wherein axial forces are in balance.

9. The perfusion catheter of claim 4 wherein said balloon filaments are braided with a filament angle and said tube fibers are braided with a fiber braid angle, said filament angle being approximately equal to said fiber angle in the larger diameter final state.

10. The perfusion catheter of claim 4 wherein said balloon filaments are braided with a filament angle and said tube fibers are braided with a fiber braid angle, said filament angle being approximately equal to said fiber angle in the smaller diameter delivery state.

11. The perfusion catheter of claim 4 wherein said fiber angle is greater than 45 degrees in the final state.

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

A. an outer balloon having a balloon wall with balloon filaments contained therein, said balloon wall having a flexible polymer that forms a fluid-tight coating,

B. an inner tube having a tube wall with tube fibers contained therein, said tube wall having a flexible polymer that forms a fluid-tight coating,

C. said inner tube having a proximal end that is attached to the proximal end of said outer balloon, and a distal end that is attached to a distal end of said balloon, forming an annular space that is in fluid communication with said manifold,

D. said perfusion balloon being delivered into the vessel in a smaller diameter state and expandable to a larger diameter state,

E. said inner tube forming a perfusion lumen for blood flow through said perfusion balloon.

13. The perfusion balloon of claim 12 wherein said balloon filaments are braided balloon filaments and said tube fibers are braided tube fibers.

14. The perfusion balloon of claim 12 wherein said balloon filaments are formed from a machined tube and said tube fibers are machined from a machined tube, at least some of said tube fibers having hinges.

15. The perfusion catheter of claim 12 wherein said perfusion balloon is approximately 2.5-4 mm in diameter to dilate and perfuse a coronary artery.

16. The perfusion catheter of claim 12 wherein said perfusion balloon is approximately 19-28 mm in diameter to dilate stenotic aortic valve leaflets and provide perfusion from the left ventricle to the aorta during dilation of the stenotic leaflets.

17. The perfusion catheter of claim 15 wherein said perfusion lumen provides a flow area of at least 0.3 cm².

18. The perfusion catheter of claim 15 further comprising a temporary valve located in said perfusion lumen.

19. The perfusion catheter of claim 12 further comprising an energy source means to enhance a valvuloplasty procedure taken from a list that includes, an ultrasound transducer, an RF electrode, a cryogenic delivery tube, an electric heating element.

20. The perfusion catheter of claim 12 further comprising at least one drug located on the outside of said outer balloon wall, said drug taken from a list that includes an antirestenotic drug, an anticancer drug, an antithrombotic drug, an anticalcification drug, and an anti-inflammatory drug.

21. The method of performing a valvuloplasty procedure to expand stenotic aortic valve leaflets of the heart comprised of,

A. advancing a perfusion catheter having a perfusion balloon in a small diameter configuration via a trans-catheter procedure across a diseased aortic valve, said perfusion balloon having an outer balloon with structural filaments and an inner tube with structural fibers attached at proximal and distal ends of the perfusion balloon,

B. providing inflation medium into an annular space between said outer balloon and said inner tube to expand said outer balloon in diameter and reduce said outer balloon in length, and thereby reduce the inner tube in length and enlarge said inner tube in diameter,

C. wherein said outer balloon provides dilation force to expand the aortic valve leaflet,

D. and wherein a passage is created for flow of blood through said inner tube during said dilation procedure.

22. The method of claim 21 wherein said perfusion balloon is held in a smaller diameter configuration during delivery via a flexible polymeric coating located in the wall of the outer balloon and located in the wall of the inner tubing.

23. The method of claim 21 wherein said perfusion balloon is held in a smaller diameter configuration during delivery via an external sheath.

24. The method of claim 21 further comprising the steps of applying an energy source that is attached to said perfusion balloon to help allow the leaflets to deform in a more durable manner, said energy source means taken from a list that includes, an ultrasound transducer, an RF electrode, a cryogenic delivery tube, and an electrical heating element.

25. The method of claim 21 further comprising the steps of placing a drug into intimate contact with the aortic leaflets to improve the durability of the valvuloplasty procedure, said drug taken from a list that includes, an antirestenotic drug, an anticancer drug, an antithrombotic drug, an anticalcification drug, and an anti-inflammatory drug.

26. The method of claim 21 further comprising the steps of creating pressure pulses in the balloon in rapid succession ranging from 100 cycles per second to 1 cycle per second.