Subintimal re-entry catheter and retrograde recanalization

• US 9,402,981 B2
• Filed: 09/18/2012
• Issued: 08/02/2016
• Est. Priority Date: 09/19/2011
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Anderson, James M.
• Primary Examiner(s): Lynch, Robert
• Application Number:
  US13/622,128
• Publication Number:
  US 20130072957A1
• Time in Patent Office: 1,414 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• 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 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00331 with preformed bends
• CPC Class Codes: A61B 2017/22061 for spreading elements apart
• CPC Class Codes: A61B 2017/22071 Steering
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61B 2017/320733 with a flexible cutting or scraping element, e.g. with a whip-like distal filament member
• CPC Class Codes: A61M 2025/0096 being laterally outward extensions or tools, e.g. hooks or fibres
• CPC Class Codes: A61M 2025/018 Catheters having a lateral opening for guiding elongated means lateral to the catheter
• 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 2025/1043 with special features or adapted for special applications
• CPC Class Codes: A61M 25/0082 Catheter tip comprising a tool
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter for recanalizing a blood vessel having an occlusion therein via a subintimal pathway. The catheter includes a catheter shaft having an inflatable balloon mounted to the distal end portion of the catheter shaft. A flexible tubular member extends from the catheter shaft and along an exterior of the inflatable balloon. Inflation of the inflatable balloon deflects the flexible tubular member into a deflected configuration away from a longitudinal axis of the catheter shaft to effect re-entry into the true lumen distal of the occlusion.

Claims

1. A catheter for recanalizing a blood vessel having an occlusion therein, the catheter comprising:

a catheter shaft having a longitudinal axis, a proximal end, a distal end, and a distal end portion proximate the distal end;

an expandable member coupled to the distal end portion of the catheter shaft, wherein the expandable member includes an inflatable first wing portion and an inflatable second wing portion, each of the first and second wing portions extending laterally away from the longitudinal axis on opposing sides of the longitudinal axis; and

a flexible tubular member extending from the catheter shaft and along an exterior of the expandable member;

wherein expansion of the expandable member deflects the flexible tubular member into a deflected configuration away from a longitudinal axis of the catheter shaft.

2. The catheter of claim 1, wherein in a delivery configuration the flexible tubular member has a central longitudinal axis generally parallel to the longitudinal axis of the catheter shaft.

3. The catheter of claim 2, wherein the expandable member is an inflatable balloon secured to the distal end portion of the catheter shaft.

4. The catheter of claim 3, wherein inflation of the balloon curves the flexible tubular member away from the catheter shaft in the deflected configuration.

5. The catheter of claim 4, wherein the flexible tubular member includes a distal opening at a distal end of the tubular member, wherein the distal opening faces proximally in the deflected configuration.

6. The catheter of claim 1, wherein the expandable member is an inflatable balloon including a bulbous portion located between the first wing portion and the second wing portion.

7. The catheter of claim 6, wherein the bulbous portion of the inflatable balloon is configured to be inflated against the flexible tubular member to deflect the flexible tubular member into a curved configuration.

8. The catheter of claim 1, wherein the flexible tubular member is a metallic tubular member having a helical slit extending therethrough.

9. The catheter of claim 8, wherein the metallic tubular member has an angled tip.

10. A catheter assembly for navigating through a lumen of a blood vessel to an occlusion in an antegrade direction that is configured to redirect an atherectomy device toward the occlusion in a retrograde direction in the lumen of the blood vessel, the catheter assembly comprising:

a catheter shaft having a longitudinal axis, a proximal end, a distal end and a distal end portion proximate the distal end;

an inflatable balloon secured to the distal end portion of the catheter shaft, wherein the balloon includes an inflatable first wing portion and an inflatable second wing portion, each of the first and second inflatable wing portions extending laterally away from the longitudinal axis on opposing sides of the longitudinal axis; and

a tubular member extending distally from a location on the catheter shaft proximal of the inflatable balloon, the tubular member configured to be deflectable away from the catheter shaft into a curved configuration upon inflation of the inflatable balloon.

11. The catheter assembly of claim 10, wherein the tubular member extends along an exterior of the inflatable balloon.

12. The catheter assembly of claim 10, wherein the tubular member defines an atherectomy lumen configured to slidably receive an atherectomy device therein.

13. The catheter assembly of claim 12, further comprising an atherectomy device extendable through the atherectomy lumen.

14. The catheter assembly of claim 10, wherein the tubular member curves through at least 90 degrees in the curved configuration.

15. The catheter assembly of claim 10, wherein the tubular member curves through at least 100 degrees in the curved configuration.

16. The catheter assembly of claim 10, wherein the tubular member includes a distal opening configured to face in a proximal direction in the curved configuration.