Occlusion bypassing apparatuses and methods for bypassing an occlusion in a blood vessel
AssigneeInvatec S.r.l.
InventorClaudio Silvestro
Life of this patent
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Abstract
Occlusion bypassing apparatuses are disclosed for re-entering the true lumen of a vessel after subintimally bypassing an occlusion in a vessel. The occlusion bypassing apparatuses include a shaft component and a needle component slidably disposed within the shaft component and having an angled configuration when deployed. In embodiments hereof, the needle component has an angled distal tip segment that may be utilized to selectively bend a flexible distal portion of the shaft component in order to extend the flexible distal portion towards the true lumen of the vessel. The needle component is distally advanced relative to the shaft component to pierce through the intima of the vessel and thereafter enter the true lumen.
Claims20
A method for bypassing an occlusion in a blood vessel having a subintimal tract formed in a wall of the vessel adjacent to the occlusion, said method comprising the steps of:
- advancing a guidewire through the subintimal tract from a proximal side of the occlusion to a position where a distal end of the guidewire is positioned in the subintimal tract on a distal side of the occlusion;
- advancing a balloon catheter through the subintimal tract over the guidewire until a distal portion of the catheter is disposed at the distal side of the occlusion;
- inflating a balloon of the balloon catheter to anchor the balloon catheter within the subintimal tract;
- advancing a needle component in a straightened configuration longitudinally relative to the balloon catheter until a distal tip segment of the needle component extends from an opening defined by a distal end of the balloon catheter;
- and
- permitting the needle component to return to an angled configuration in which the distal tip segment bends away from a longitudinal axis of a proximal portion of the needle component, wherein at least the distal tip segment of the needle component has a shape memory to return the needle component to the angled configuration.
A method for bypassing an occlusion in a blood vessel having a subintimal tract formed in a wall of the vessel adjacent to the occlusion, said method comprising the steps of:
- advancing a guidewire through the subintimal tract from a proximal side of the occlusion to a position where a distal end of the guidewire is positioned in the subintimal tract on a distal side of the occlusion;
- advancing an outer shaft component of an occlusion bypassing apparatus over the guidewire until a distal portion of the outer shaft component is disposed at the far side of the occlusion;
- loading an inner shaft component and a needle component of the occlusion bypassing apparatus within the outer shaft component until a flexible distal portion of the inner shaft component is disposed within the distal portion of the outer shaft component, wherein the flexible distal tip portion of the inner shaft component is straight and aligned with a proximal portion of the inner shaft component and the needle component is slidably disposed within the inner shaft component;
- inflating a balloon of the occlusion bypassing apparatus to anchor the occlusion bypassing apparatus within the subintimal tract;
- advancing the inner shaft component relative to the outer shaft component to longitudinally extend the flexible distal portion of the inner shaft component from an opening defined by a distal end of the outer shaft component;
- and
- advancing the needle component of the occlusion bypassing apparatus relative to the inner shaft component until at least a portion of an angled distal tip segment of the needle component is disposed within the flexible distal portion of the inner shaft component to thereby bend the flexible distal portion of the inner shaft component away from a longitudinal axis of the occlusion bypassing apparatus.
A method for bypassing an occlusion in a blood vessel having a subintimal tract formed in a wall of the vessel adjacent to the occlusion, said method comprising the steps of:
- advancing a guidewire through the subintimal tract from a proximal side of the occlusion to a position where a distal end of the guidewire is positioned in the subintimal tract on a distal side of the occlusion;
- advancing an occlusion bypassing apparatus having a shaft component and a needle component through the subintimal tract over the guidewire until a distal end of the occlusion bypassing apparatus is disposed at the distal side of the occlusion, wherein the needle component is slidably disposed within the shaft component and defines a lumen through which the guidewire extends, and wherein an angled distal tip segment of the needle component is held in a straightened form by a reinforced shaft segment of the shaft component during the step of advancing the occlusion bypassing apparatus;
- inflating a balloon of the occlusion bypassing apparatus to anchor the occlusion bypassing apparatus within the subintimal tract, wherein the balloon is mounted on the shaft component proximate of a distal portion thereof;
- and
- bending a distal portion of the shaft component away from a longitudinal axis of the occlusion bypassing apparatus by advancing the needle component relative to the reinforced shaft segment of the shaft component until at least a portion of the angled distal tip segment of the needle component is disposed within the distal portion of the shaft component to thereby bend the distal portion of the shaft component.
Dependencies are inferred from the claim text.