Valve treatment catheter and methods

• US 7,244,242 B2
• Filed: 03/22/2005
• Issued: 07/17/2007
• Est. Priority Date: 12/30/2002
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Freyman, Toby
• Primary Examiner(s): MENDEZ, MANUEL A
• Application Number:
  US11/086,867
• Publication Number:
  US 20050209580A1
• Time in Patent Office: 847 Days
• Field of Search: 604/96.01, 604/30, 604/31, 604/32, 604/101.01, 604/99.02, 604/99.03, 604/99.04, 604/103.01, 604/103.03, 604/103.06, 604/103.07, 604/915, 604/916, 606191-194
• US Class Current: 604/96.01
• 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 for insertion into a biological passage which contains a first flowing fluid, the catheter comprising:

a tubular member having a proximal end and a distal end, the tubular member including a fluid delivery lumen and an inflation lumen;

a sheath adjacent the distal end of the tubular member, the sheath having an aperture in fluid communication with the fluid delivery lumen and a flow lumen for passing the first flowing fluid;

an inflatable balloon member in fluid communication with the inflation lumen, the inflatable balloon member positioned at least partially around the sheath to enlarge the flow lumen of the sheath and to define a containment pocket defined by the inflation balloon member, the sheath, the aperture and the biological passage when the inflatable balloon member is inflated; and

a valve contained within the flow lumen of the sheath, where the valve maintains physiological fluid flow of the first flowing fluid through the flow lumen of the sheath.

2. The catheter of claim 1, wherein the tubular member joins to the sheath eccentrically to form a portion of the flow lumen.

3. The catheter of claim 1, wherein the inflatable balloon member has a helical shape that extends along and around the sheath.

4. The catheter of claim 3, wherein the inflatable balloon member with the helical shape is positioned between a proximal balloon portion and a distal balloon portion on the sheath.

5. The catheter of claim 4, where the proximal and distal balloon portions have a non-helical shape.

6. The catheter of claim 1, wherein the sheath includes two or more apertures positioned between a proximal end and a distal end of the sheath.

7. The catheter of claim 6, wherein each aperture includes a cross-sectional area that increases for each aperture from the proximal end to distal end.

8. The catheter of claim 1, wherein the valve is a leaflet valve.

9. The catheter of claim 1, where the valve is a ball valve.

10. A catheter, comprising:

a tubular member having a proximal end and a distal end, the tubular member including a first lumen and a second lumen;

a sheath coupled to the tubular member, the sheath having a first surface defining a flow lumen and a second surface opposite the first surface, wherein two or more apertures in fluid communication with the first lumen pass across the first surface and the second surface;

an inflatable balloon member in fluid communication with the second lumen, the inflatable balloon member at least partially coupled to the second surface of the sheath to enlarge the flow lumen and to define a region to receive fluid passing through the two or more apertures when the inflatable balloon member is inflated; and

a valve contained at least partially within the flow lumen of the sheath to maintain physiological fluid flow of a fluid moving through the flow lumen of the sheath.

11. The catheter of claim 10, wherein the tubular member joins to the sheath eccentrically to form a portion of the flow lumen.

12. The catheter of claim 10, wherein the inflatable balloon member has a helical shape that extends along and around the sheath.

13. The catheter of claim 12, wherein the inflatable balloon member with the helical shape is positioned between a proximal balloon portion and a distal balloon portion on the sheath.

14. The catheter of claim 13, where the proximal and distal balloon portions have a non-helical shape.

15. The catheter of claim 10, wherein the two or more apertures are positioned between a proximal end and a distal end of the sheath.

16. The catheter of claim 15, wherein each of the two or more apertures includes a cross-sectional area that increases for each aperture from the proximal end to distal end.

17. The catheter of claim 10, wherein the valve is a flap valve.

18. The catheter of claim 10, where the valve is a ball valve.

19. A catheter, comprising:

a tubular member having a first lumen and a second lumen;

a sheath having a proximal end and a distal end, the sheath eccentrically coupled to the tubular member to provide a first surface defining a flow lumen, and including two or more apertures positioned between the proximal end and the distal end of the sheath, where each of the two or more apertures includes a cross-sectional area that increases for each aperture from the proximal end to distal end and are in fluid communication with the first lumen;

an inflatable balloon member having a helical shape, the inflatable balloon in fluid communication with the second lumen for inflating the inflatable balloon member, the inflatable balloon member at least partially coupled to the sheath to enlarge the flow lumen and to define a region to receive fluid from the two or more apertures when the inflatable balloon member is inflated; and

a valve contained at least partially within the flow lumen of the sheath to maintain physiological fluid flow of a fluid moving through the flow lumen of the sheath.

20. The catheter of claim 19, wherein the inflatable balloon member includes a non-helical proximal balloon portion and a non-helical distal balloon portion on the sheath, where the inflatable balloon member with the helical shape is positioned between the single proximal and distal balloon portions along the sheath.