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US 12,728,228 B2Granted
Axial sharp needle reentry device
AssigneeBentley InnoMed GmbH
InventorsDan Rottenberg, Yossi Pesis, Avraham Matzkin
Life of this patent
Estimating the term…
Abstract
A catheter, such as for use for total occlusion crossing and lumen reentry, incorporate a retractable long flexible nitinol curved needle at the catheter distal end. The needle is straight when withdrawn inside the catheter. When pushed forward, the needle is deployed by protruding axially out, directly from the distal tip, through a mechanism used to direct the curved needle into a specific radial direction. When pushed forward, the needle restores its curved shape and can penetrate the plaque or the media and intimal layers to reenter the true lumen.
Claims8
A method comprising:
- providing a catheter device comprising:
- a straight catheter shaft comprising a lumen that extends straight through a distalmost end of said catheter shaft, wherein said catheter shaft lacks any side port;
- a handle coupled to a proximal portion of said catheter shaft;
- and
- a needle that passes through said lumen in said catheter shaft and said distalmost end, said needle comprising a first straight section coupled to said handle, a curved section that extends distally from said first straight section, a second straight section that extends distally from said curved section, and a sharp distal tip at a most distal end of said needle, wherein said needle is made of an elastic material and, wherein when said needle is inside said lumen, said curved section becomes straight, and when said needle starts to protrude from said distalmost end, said sharp tip protrudes straight through said distalmost end and afterwards said second straight section protrudes straight through said distalmost end, and when said curved section exits said distalmost end, said curved section becomes curved again;
- and
- providing two steps for crossing an occlusion found in a true lumen of a blood vessel, a first step comprising:
- advancing said needle without a guidewire in said catheter shaft so that only said sharp tip or said sharp tip and said second straight section protrude straight through said distalmost end;
- and
- using said sharp tip or said sharp tip and said second straight section of said needle to cross the occlusion without entering a sub-intimal space of the blood vessel;
- and
- a second step comprising:
- further advancing said needle in said catheter shaft so that said curved section exits said distalmost end and said curved section becomes curved again;
- using the curved section of said needle to cross the occlusion if the occlusion is at an angle relative to the catheter axial direction, with or without said curved section entering the sub-intimal space of the blood vessel;
- and
- wherein said needle is selectively advanced to penetrate the occlusion within the true lumen or to cross the occlusion within the sub-intimal space of the blood vessel and to reenter the true lumen.
13 more elements
A catheter device comprising:
- a straight catheter shaft comprising a lumen that extends straight through a distalmost end of said catheter shaft, wherein said catheter shaft lacks any side port;
- a handle coupled to a proximal portion of said catheter shaft;
- and
- a needle that passes through said lumen in said catheter shaft and said distalmost end, said needle comprising a first straight section coupled to said handle, a curved section that extends distally from said first straight section, a second straight section that extends distally from said curved section, and a sharp tip at a most distal end of said needle, wherein said needle is made of an elastic material and,
- wherein when said needle without a guidewire is inside said lumen, said curved section becomes straight, and when said needle starts to protrude from said distalmost end, said sharp tip protrudes straight through said distalmost end and afterwards said second straight section protrudes straight through said distalmost end, and when said curved section exits said distalmost end, said curved section becomes curved again, and
- wherein, said needle is selectively advanceable to penetrate the occlusion within a true lumen of a blood vessel or to cross the occlusion within the sub-intimal space of the blood vessel and to reenter the true lumen.
3 more elements
Dependencies are inferred from the claim text.