BALLOONS AND BALLOON CATHETER SYSTEMS FOR TREATING VASCULAR OCCLUSIONS

• US 20090247945A1
• Filed: 10/22/2008
• Published: 10/01/2009
• Est. Priority Date: 10/13/2006
• Status: Active Grant

• Current Assignee: EndoCross Ltd.
• Original Assignee: EndoCross Ltd.
• Inventors: Hirszowicz, Eran, Levit, Eran
• Granted Patent: US 7,942,850 B2
• Time in Patent Office: Days
• US Class Current: 604/103
• CPC Class Codes: A61M 2025/102 driven by a solenoid-activated pump
• CPC Class Codes: A61M 2025/1022 driven by a rotary motor-activated pump
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/10181 Means for forcing inflation fluid into the balloon
• CPC Class Codes: A61M 25/10188 Inflation or deflation data displays
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A balloon catheter system for the intraluminal advancement of conventional guidewires beyond partially or fully occluded or stenosed lesions in body passages, such as CTOs in the vasculature, is provided. Balloons are provided. In certain embodiments of the invention, a balloon having relatively thickened proximal tapers is provided. In certain embodiments of the invention, balloons having a tapered midsection are provided. The balloons are preferably useful with crossing balloon catheter systems. In certain embodiments of the invention, the balloons preferably reduce or minimize trauma to the vascular wall or wall of other body passage in which it is used.

Claims

1. A balloon apparatus comprising:

a balloon comprising

a conically tapering midsection;

a distal tapering portion tapering from a distal end of the midsection to a proximal end of a distal annular connection; and

a proximal tapering portion tapering from a proximal end of the midsection to a distal end of a proximal annular connection;

wherein proximal tapering portion has a wall thickness greater than the wall thickness of the distal tapering portion;

wherein the wall thickness of the proximal tapering portion tapers from the proximal annular connection to the proximal end of the midsection; and

wherein the wall thickness of the distal tapering portion tapers from the distal annular connection to the distal end of the midsection.

2. The balloon apparatus of claim 1, wherein the midsection has a wall thickness less than the wall thickness of the distal tapering portion.

3. The balloon apparatus of claim 1, wherein the midsection conically tapers from a proximal end to a distal end.

4. The balloon apparatus of claim 1, wherein the midsection conically tapers from a distal end to a proximal end.

5. The balloon apparatus of claim 1, further comprising a hollow outer shaft and a hollow inner shaft within the hollow outer shaft and coaxially slideable with the hollow outer shaft;

and wherein the balloon apparatus is coupled at a distal end of the balloon apparatus to the hollow inner shaft by the distal annular connection and coupled at a proximal end of the balloon apparatus to the hollow outer shaft by the proximal annular connection.

6. The balloon apparatus of claim 1, wherein a guidewire is passed through the hollow inner shaft.

7. A balloon catheter apparatus comprising:

a hollow outer shaft;

a hollow inner shaft within the hollow outer shaft and coaxially slideable with the hollow outer shaft;

a balloon coupled at a distal end of the balloon to the hollow inner shaft by a distal annular connection and coupled at a proximal end of the balloon to the hollow outer shaft by a proximal annular connection, wherein the balloon further comprises;

a conically tapering midsection;

a distal tapering portion tapering from a distal end of the midsection to the distal annular connection; and

a proximal tapering portion tapering from a proximal end of the midsection to the proximal annular connection;

wherein the proximal tapering portion has a wall thickness greater than the wall thickness of the distal tapering portion; and

wherein the midsection has a wall thickness less than the wall thickness of the distal tapering portion.

8. The balloon catheter apparatus of claim 7, wherein the balloon catheter apparatus is a single use catheter.

9. The balloon apparatus of claim 7, wherein the midsection conically tapers from a proximal end to a distal end.

10. The balloon apparatus of claim 7, wherein the midsection conically tapers from a distal end to a proximal end.

11. The balloon apparatus of claim 7, wherein the wall thickness of the proximal tapering portion tapers from the proximal annular connection to the proximal end of the midsection.

12. The balloon apparatus of claim 7, wherein the wall thickness of the distal tapering portion tapers from the distal annular connection to the distal end of the midsection.

13. A method of using a balloon catheter comprising the steps of:

advancing a guidewire within a blood vessel to a vascular occlusion;

providing a balloon catheter comprising;

a hollow outer shaft;

a hollow inner shaft within the hollow outer shaft and coaxially slideable with the hollow outer shaft;

a balloon coupled at a distal end of the balloon to the hollow inner shaft by a distal annular connection and coupled at a proximal end of the balloon to the hollow outer shaft by a proximal annular connection, wherein the balloon further comprises;

a conically tapering midsection;

a distal tapering portion tapering from a distal end of the midsection to a proximal end of a distal annular connection;

a proximal tapering portion tapering from a proximal end of the midsection to a distal end of a proximal annular connection;

wherein proximal tapering portion has a wall thickness greater than the wall thickness of the distal tapering portion;

advancing the balloon catheter over the guidewire so that the distal end of the balloon catheter is in proximity to the vascular occlusion;

inflating the balloon to a first inflation pressure, wherein the first inflation pressure causes the balloon to be anchored within the blood vessel; and

oscillating the pressure in the balloon, wherein the oscillation of the pressure causes a longitudinal distal-proximal oscillation of the inner shaft.

14. The method of claim 13, wherein the midsection of the balloon has a wall thickness less than the wall thickness of the distal tapering portion.

15. The method of claim 13, wherein the wall thickness of the proximal tapering portion of the balloon tapers from the proximal annular connection of the balloon to the proximal end of the midsection of the balloon;

and wherein the wall thickness of the distal tapering portion of the balloon tapers from the distal annular connection of the balloon to the distal end of the midsection of the balloon.

16. The method of claim 13, wherein the method is used to access discrete regions of the vasculature, to cross an occluded vessel, or both.

17. The method of claim 13, wherein the method is used to access discrete regions of the vasculature, to cross a chronic total occlusion, or both.

18. The method of claim 13, further comprising the step of immobilizing the guidewire within the inner shaft.

19. The method of claim 13, further comprising the steps of

ceasing the oscillation of pressure in the balloon;

decreasing the pressure in the balloon, wherein the decreasing of pressure releases the anchoring of the balloon;

advancing the balloon catheter distally within the blood vessel;

inflating the balloon to a first inflation pressure, wherein the first inflation pressure causes the balloon to be anchored within the blood vessel; and

oscillating the pressure in the balloon, wherein the oscillation of the pressure causes a longitudinal distal-proximal oscillation of the inner shaft.