Valve treatment catheter and methods

• US 20080021382A1
• Filed: 07/16/2007
• Published: 01/24/2008
• Est. Priority Date: 12/30/2002
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Freyman, Toby
• Granted Patent: US 7,780,627 B2
• Time in Patent Office: Days
• US Class Current: 604/99.04
• CPC Class Codes: A61F 2/2403 with pivoting rigid closure members check valves with hinged closure members in general F16K15/03
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2424 Ball valves
• CPC Class Codes: A61F 2/2433 using balloon catheter
• CPC Class Codes: A61F 2/2496 Devices for determining the dimensions of the prosthetic valve to be implanted, e.g. templates, sizers
• CPC Class Codes: A61F 2250/0059 temporary
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0076 Unidirectional valves
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• 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 2025/1072 having balloons with two or more compartments
• CPC Class Codes: A61M 25/0029 characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0075 Valve means
• CPC Class Codes: A61M 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters

Abstract

The invention provides a catheter for insertion into a biological passage which contains a first flowing fluid, the catheter including a tubular member having a proximal end and a distal end; a fluid delivery lumen contained within the tubular member; an inflatable balloon assembly disposed at the distal end of the tubular member, the balloon assembly including an inflatable balloon member having an uninflated state and an inflated state, the balloon assembly including apertures in communication with the fluid delivery lumen; an inflation lumen in communication with the balloon member; and a valve contained within the inflatable balloon assembly. The inflatable balloon is assembly configured such that when the balloon member is in the inflated state: (i) sections of the balloon member contact the biological passage defining at least one containment pocket; (ii) the apertures are disposed in the containment pocket, (iii) a flow lumen is defined through the balloon member to allow the first fluid to flow through the balloon member; and (iv) the valve functions to allow the first flowing fluid to flow through the flow lumen in a physiologic direction, while blocking backflow of the first fluid through the flow lumen.

Claims

1. A catheter, comprising:

an inflatable balloon assembly having an outer cylindrical sheath and an inner cylindrical sheath intermittently sealed to one another at predefined sections to provide an inflation region, where the inner cylindrical sheath defines a lumen that passes through the inflatable balloon assembly, and where the outer cylindrical sheath defines apertures that connect the inflation region to a containment pocket defined by the outer cylindrical sheath;

a cone section defined by an end portion of the outer cylindrical sheath and the inner cylindrical sheath, where the end portions of the outer and inner cylindrical sheaths define both an inflation lumen in fluid tight communication with the inflation region of the inflatable balloon assembly and a cutout that connects with the lumen that passes through the inflatable balloon assembly;

an inner balloon waist that extends from the end portion of the inner cylindrical sheath to couple to an inner shaft of the catheter; and

an outer balloon waist that extends from the end portion of the outer cylindrical sheath to couple to an outer shaft of the catheter;

where the inner balloon waist and inner shaft and the outer balloon waist and the outer shaft define an elongate lumen in fluid tight communication with the inflation lumen through which an inflation medium can flow to inflate the inflation region and pass through the apertures from the inflation region into the containment pocket.

2. The catheter of claim 1, where the outer cylindrical sheath and the inner cylindrical sheath are sealed together at predefined locations to provide two or more annular balloon regions that define the containment pocket.

3. The catheter of claim 2, where the outer cylindrical sheath and the inner cylindrical sheath define a space past a region where they are sealed together to allow the inflation medium to move through the inflation region to the apertures.

4. The catheter of claim 2, where spot welds seal the outer cylindrical sheath and the inner cylindrical sheath at the predefined locations.

5. The catheter of claim 1, where the apertures are about 0.003 inches in diameter.

6. The catheter of claim 1, where the apertures defined by the outer cylindrical sheath are provided by a material that is semi-permeable to the inflation medium.

7. The catheter of claim 1, where the inner shaft of the catheter defines a guidewire lumen.

8. The catheter of claim 1, including a valve contained within the inflatable balloon assembly.

9. The catheter of claim 8, where the valve is a ball valve.

10. The catheter of claim 8, where the valve is a leaflet valve.

11. An inflatable balloon assembly, comprising:

an inner cylindrical sheath that defines a lumen;

an outer cylindrical sheath sealed to the inner cylindrical sheath to define an inflation region, where the outer cylindrical sheath defines two or more containment pockets in fluid communication with the inflation region through apertures defined by the outer cylindrical sheath; and

a cone section defining an inflation lumen in fluid tight communication with the inflation region of the inflatable balloon assembly and defining a cutout to the lumen passing through the inflatable balloon assembly.

12. The inflatable balloon assembly of claim 11, where the outer cylindrical sheath and the inner cylindrical sheath are sealed together at predefined locations to provide two or more annular balloon regions that define the two or more containment pockets.

13. The inflatable balloon assembly of claim 11, where the outer cylindrical sheath and the inner cylindrical sheath define a space past a region where they are sealed together to allow the inflation medium to move through the inflation region to the apertures.

14. The inflatable balloon assembly of claim 11, where a seal extends annularly around at least part of the outer cylindrical sheath and the inner cylindrical sheath to help define each of the two or more containment pockets.

15. The inflatable balloon assembly of claim 11, where the apertures defined by the outer cylindrical sheath are provided by a material that is semi-permeable to the inflation medium.

16. The inflatable balloon assembly of claim 11, where the lumen has a cross sectional area that is about 60 percent to about 80 percent of a total cross sectional area of the inflatable balloon assembly.

17. The inflatable balloon assembly of claim 11, including a valve contained within the lumen of the inflatable balloon assembly.

18. The inflatable balloon assembly of claim 17, where the valve is a ball valve.

19. The inflatable balloon assembly of claim 17, where the valve is a leaflet valve.

20. The inflatable balloon assembly of claim 19, where the leaflet valve has at least two leaflets.