Subintimal re-entry device

• US 9,486,239 B2
• Filed: 05/23/2013
• Issued: 11/08/2016
• Est. Priority Date: 05/24/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Anderson, James, Sutermeister, Derek
• Primary Examiner(s): Tyson, Melanie
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US13/900,717
• Publication Number:
  US 20130317528A1
• Time in Patent Office: 1,265 Days
• Field of Search: 606/159, 606/158, 606/139, 606/153, 606/167, 606/185, 606/213, 604/523, 623/1.23, 600/36, 600/585
• US Class Current: 1/1
• CPC Class Codes: A61B 17/3207 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 Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/22044 with a pointed tip
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0197 for creating an artificial passage within the body, e.g. in order to go around occlusions
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0194 Tunnelling catheters

Abstract

A subintimal recanalization catheter, including an elongate shaft including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member. The penetration member includes a distal tip positioned proximal of a distal nose of the first tubular member. The distal nose of the first tubular member includes a ramp and a guide wire lumen extending through the distal nose of the first tubular member. Longitudinal movement of the penetration member relative to the first tubular member causes the penetration member to contact the ramp to direct the distal tip of the penetration member away from the first tubular member.

Claims

1. A subintimal recanalization catheter, comprising:

an elongate shaft including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member, wherein the penetration member is configured to puncture an intima layer of a blood vessel;

the penetration member including a distal tip, a first guide wire exit port at the distal tip, and a guide wire lumen extending through the penetration member, the distal tip positioned proximal of a distal nose of the first tubular member; and

the distal nose of the first tubular member including a ramp and a guide wire lumen distal of the ramp and extending through the distal nose of the first tubular member;

a guide wire extending through the guide wire lumen of the penetration member and through the guide wire lumen of the distal nose of the first tubular member;

wherein longitudinal movement of the penetration member relative to the first tubular member causes the penetration member to contact the ramp to direct the distal tip of the penetration member away from the first tubular member while the guide wire is routed through the first tubular member proximal of the ramp and the guide wire lumen of the distal nose of the first tubular member distal of the ramp without passing through the first guide wire exit port.

2. The subintimal recanalization catheter of claim 1, wherein the penetration member includes a second guide wire exit port located proximal of the distal tip, wherein the guide wire is permitted to selectively exit the guide wire lumen of the penetration member and extend distally from one of the first guide wire exit port and the second guide wire exit port.

3. The subintimal recanalization catheter of claim 1, wherein the guide wire lumen extending through the distal nose extends from the ramp to a distal tip of the distal nose.

4. The subintimal recanalization catheter of claim 3, wherein the penetration member includes a second guide wire exit port proximal of the distal tip of the penetration member, and the guide wire extends from the second guide wire exit port to the guide wire lumen of the distal nose of the first tubular member.

5. The subintimal recanalization catheter of claim 1, wherein the guide wire lumen of the penetration member is co-axial with the lumen through the distal nose of the first tubular member.

6. The subintimal recanalization catheter of claim 1, wherein the penetration member includes a sharp distal tip.

7. A method of recanalizing a blood vessel having an occlusion therein, the method comprising:

i) advancing a guide wire through a lumen of a blood vessel to a location proximal of a proximal end of an occlusion;

ii) directing a distal end of the guide wire out of the lumen of the blood vessel and between a first tissue layer and a second tissue layer of a wall of the vessel to a location distal of a distal end of the occlusion;

iii) advancing a recanalization catheter along the guide wire with the guide wire passing through a guide wire lumen of the recanalization catheter, the recanalization catheter including a first tubular member and a penetration member slidably disposed in a lumen of the first tubular member, the penetration member including a distal tip and a guide wire lumen extending through the penetration member, the distal tip positioned proximal of a distal nose of the first tubular member, the distal nose of the first tubular member including a ramp and the guide wire lumen located distal of the ramp and extending through the distal nose of the first tubular member;

iv) positioning the distal nose of the first tubular member of the recanalization catheter between the first tissue layer and the second tissue layer at a location distal of the distal end of the occlusion;

v) actuating the penetration member relative to the first tubular member to cause the penetration member to contact the ramp and direct the distal tip of the penetration member away from the first tubular member while the guide wire remains routed through the guide wire lumen of the distal nose of the first tubular member distal of the ramp; and

vi) re-entering the lumen of the blood vessel distal of the distal end of the occlusion with the distal tip of the penetration member while the guide wire remains routed through the guide wire lumen of the distal nose of the first tubular member.

8. The method of claim 7, wherein the guide wire extends through the guide wire lumen of the penetration member while the recanalization catheter is advanced along the guide wire.

9. The method of claim 8, further comprising:

vii) retracting the guide wire proximally of the distal tip of the penetration member.

10. The method of claim 8, wherein the guide wire lumen of the penetration member is co-axial with the guide wire lumen through the distal nose of the first tubular member.

11. The method of claim 8, wherein the penetration member includes a distal end region including a first guide wire exit port and a second guide wire exit port, wherein the first guide wire exit port is located at the distal tip of the penetration member and the second guide wire exit port is located proximal of the distal tip;

and

withdrawing the distal end of the guide wire proximally into the guide wire lumen of the penetration member through the second guide wire exit port; and

then advancing the distal end of the guide wire distally out of the penetration member through the first guide wire exit port.

12. A subintimal recanalization catheter, comprising:

a first tubular member including a lumen, a distal nose, a side opening proximal of the distal nose, and a ramp distal of the side opening, the distal nose of the first tubular member including a guide wire lumen distal of the ramp and extending through the distal nose of the first tubular member;

a penetration member slidably disposed in the lumen of the first tubular member, the penetration member including a guide wire lumen and a sharp distal tip, the distal tip positionable proximal of the distal nose of the first tubular member in a delivery position, the penetration member further including a first guide wire exit port at the distal tip of the penetration member and a second guide wire exit port located proximal of the distal tip and distal of a proximal end of the penetration member, wherein both the first guide wire exit port and the second guide wire exit port are in communication with the guide wire lumen of the penetration member;

a guide wire extending through the guide wire lumen of the penetration member, wherein the guide wire is permitted to selectively exit the guide wire lumen of the penetration member and extend distally from one of the first guide wire exit port and the second guide wire exit port; and

wherein longitudinal movement of the penetration member relative to the first tubular member causes the penetration member to contact the ramp to direct the distal tip of the penetration member out of the side opening of the first tubular member;

wherein the distal tip of the penetration member is deflectable away from the first tubular member while the guide wire is routed through the guide wire lumen of the distal nose of the first tubular member distal of the ramp without passing through the first guide wire exit port at the distal tip of the penetration member.

13. The subintimal recanalization catheter of claim 12, wherein the guide wire is configured to be withdrawn proximally into the guide wire lumen of the penetration member through the second guide wire exit port and then advanced distally out of the penetration member through the first guide wire exit port.

14. The subintimal recanalization catheter of claim 12, wherein the guide wire extends from the second guide wire exit port to the guide wire lumen of the distal nose of the first tubular member when the distal tip of the penetration member is in the delivery position.