Subintimal re-entry catheter with actuatable orientation mechanism

Patent metadata

Field	Value
Publication number	US-9451984-B2
Application number	US-201414154774-A
Country	US
Kind code	B2
Filing date	Jan 14, 2014
Priority date	Jan 15, 2013
Publication date	Sep 27, 2016
Grant date	Sep 27, 2016

Abstract

A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space. The recanalization catheter includes first and second mechanically actuatable wings positioned at a distal region of the elongate shaft of the catheter that are actuatable between a retracted position and an expanded position. In the retracted position the mechanically actuatable wings are positioned in first and second elongate channels defined in the elongate shaft, and in the expanded position the mechanically actuatable wings extend outward from the first and second elongate channels. The actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall to automatically orient a lateral port of the elongate shaft toward the true lumen.

First claim

What is claimed is:

1. A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
an elongate shaft extending distally from a hub assembly, the elongate shaft including a guidewire lumen;
first and second mechanically actuatable wings positioned at a distal region of the elongate shaft, the first and second mechanically actuatable wings being actuatable between a retracted position and an expanded position with an actuation mechanism extending through the elongate shaft to the hub assembly;
the distal region of the elongate shaft including first and second elongate channels opening out to an exterior of the elongate shaft;
wherein in the retracted position the first and second mechanically actuatable wings are positioned in the first and second elongate channels, respectively, and in the expanded position the first and second mechanically actuatable wings extend outward from the first and second elongate channels, respectively
wherein in the expanded position, the first mechanically actuatable wing curves away from a first plane, the first plane extending through and parallel to a central longitudinal axis of the elongate shaft and through the first elongate channel, and the second mechanically actuatable wing curves away from a second plane, the second plane extending through and parallel to the central longitudinal axis and through the second elongate channel.

2. The recanalization catheter of claim 1 , wherein the elongate shaft includes first and second auxiliary lumens extending to the first and second elongate channels, respectively.

3. The recanalization catheter of claim 2 , wherein the actuation mechanism includes:
a first wire extending through the first auxiliary lumen to actuate the first actuatable wing; and
a second wire extending through the second auxiliary lumen to actuate the second actuatable wing.

4. The recanalization catheter of claim 3 , wherein the first actuatable wing is formed as a distal portion of the first wire and the second actuatable wing is formed as a distal portion of the second wire.

5. The recanalization catheter of claim 2 , wherein the guidewire lumen is positioned longitudinally between the first and second auxiliary lumens.

6. The recanalization catheter of claim 1 , wherein the guidewire lumen is positioned longitudinally between the first and second elongate channels.

7. The recanalization catheter of claim 6 , wherein the first and second elongate channels are positioned about 180 degrees apart.

8. The recanalization catheter of claim 1 , wherein the distal region of the elongate shaft has an outer periphery, wherein in the retracted position the first and second actuatable wings are positioned radially inward of the outer periphery of the elongate shaft and in the expanded position the first and second actuatable wings are positioned radially outward of the outer periphery of the elongate shaft.

9. The recanalization catheter of claim 1 , wherein the first and second mechanically actuatable wings extend in an arcuate path away from the elongate shaft in the expanded position to be positionable in a circumferential orientation within a subintimal space formed in a vessel wall.

10. The recanalization catheter of claim 9 , wherein the distal region of the elongate shaft includes a lateral port in communication with the guidewire lumen, wherein the first and second actuatable wings curve towards the lateral port in the expanded position such that the lateral port is oriented toward a true lumen of a blood vessel when the first and second actuatable wings are in the expanded position in the subintimal space formed in the vessel wall.

11. A recanalization catheter for facilitating re-entry into a lumen of a blood vessel from a subintimal space, comprising:
an elongate shaft extending distally from a hub assembly, the elongate shaft including:
a guidewire lumen having a distal opening and a lateral opening in a distal region of the elongate shaft proximal of the distal opening;
first and second elongate channels formed in the distal region of the elongate shaft and opening out to an exterior of the elongate shaft; and
first and second auxiliary lumens extending through the elongate shaft to the first and second elongate channels, respectively;

a first mechanically actuatable wing positioned at the distal region of the elongate shaft and being actuatable between a retracted position and an expanded position;
a second mechanically actuatable wing positioned at the distal region of the elongate shaft and being actuatable between a retracted position and an expanded position;
wherein in the retracted position the first and second mechanically actuatable wings are positioned in the first and second elongate channels, respectively, and in the expanded position the first and second mechanically actuatable wings extend outward from the first and second elongate channels, respectively; and
wherein the first and second actuatable wings curve towards the lateral port in the expanded position such that the lateral port is oriented toward the lumen of the blood vessel when the first and second actuatable wings are in the expanded position in the subintimal space formed in the blood vessel;
wherein in the expanded position, the first mechanically actuatable wing curves away from a first plane, the first plane extending through and parallel to a central longitudinal axis of the elongate shaft and through the first elongate channel, and the second mechanically actuatable wing curves away from a second plane, the second plane extending through and parallel to the central longitudinal axis and through the second elongate channel.

12. The recanalization catheter of claim 11 , further comprising:
a first wire extending through the first auxiliary lumen to actuate the first actuatable wing; and
a second wire extending through the second auxiliary lumen to actuate the second actuatable wing.

13. The recanalization catheter of claim 12 , wherein the first actuatable wing is formed as a distal portion of the first wire and the second actuatable wing is formed as a distal portion of the second wire.

14. The recanalization catheter of claim 13 , wherein a distal end of the first wire is affixed to the elongate shaft proximate a distal end of the first elongate channel and a distal end of the second wire is affixed to the elongate shaft proximal a distal end of the second elongate channel.

15. The recanalization catheter of claim 14 , wherein the first wire extends into the first auxiliary lumen proximate a proximal end of the first elongate channel and the second wire extends into the second auxiliary lumen proximate a proximal end of the second elongate channel.

16. The recanalization catheter of claim 11 , wherein the distal region of the elongate shaft has an outer periphery, wherein in the retracted position the first and second actuatable wings are positioned radially inward of the outer periphery of the elongate shaft and in the expanded position the first and second actuatable wings are positioned radially outward of the outer periphery of the elongate shaft.

17. The recanalization catheter of claim 11 , wherein the first and second actuatable wings have a preset circumferential curvature such that the first and second actuatable wings automatically curve from the elongate shaft when actuated to the expanded position.

18. A method of recanalizing a blood vessel having an occlusion therein, the method comprising:
advancing a distal region of a catheter shaft includin

Assignees

• Boston Scient Scimed Inc

Inventors

• Zhou Pu
• Wang Huisun

Classifications

• A61B2017/22044

  with a pointed tip · CPC title

• A61B17/3478 Primary

  Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067) · CPC title

• A61B17/3207 Primary

  Atherectomy devices {working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions (A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016)} · CPC title

• A61B2017/22095

  accessing a blood vessel true lumen from the sub-intimal space · CPC title

• A61B17/22 Primary

  Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for · CPC title