Subintimal reentry system

• US 9,579,489 B2
• Filed: 10/28/2015
• Issued: 02/28/2017
• Est. Priority Date: 07/13/2012
• Status: Active Grant

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Inventors: Zhou, Pu, Wang, Huisun, Quillin, Daniel T.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Jamialahmadi, Majid
• Application Number:
  US14/924,914
• Publication Number:
  US 20160045714A1
• Time in Patent Office: 489 Days
• Field of Search: 606/198, 606/194, 606/185, 606/167, 606/159, 606190-192, 604/509, 604/272, 604/96.01, 604/99.01, 604/101.01, 604/424, 600/585, 600/272
• 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 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22095 accessing a blood vessel true lumen from the sub-intimal space
• CPC Class Codes: A61M 2025/0095 being one or more needles protruding from the distal tip and which are not used for injection nor for electro-stimulation, e.g. for fixation purposes
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• 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 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/0155 with hydraulic or pneumatic means, e.g. balloons or inflatable compartments
• CPC Class Codes: A61M 25/0194 Tunnelling catheters
• CPC Class Codes: A61M 25/09 Guide wires
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A subintimal recanalization catheter system for recanalizing a blood vessel. The system includes a support catheter and a balloon catheter configured to extend through the support catheter. The support catheter includes a tubular portion and an extension segment extending distal of the distal opening of the tubular portion. The balloon catheter, having a balloon secured to a distal portion thereof, is positionable through the tubular portion of the support catheter to position the balloon alongside the extension segment. The system is configured to be advanced into a subintimal space between a first tissue layer and a second tissue layer of a blood vessel wall where the balloon may be inflated against the extension segment to cause a distal portion of the catheter shaft of the balloon catheter to deflect toward the vessel lumen within the subintimal space to facilitate reentry into the vessel lumen.

Claims

1. A method of recanalizing a blood vessel having an occlusion in a lumen thereof, the method comprising:

advancing a support catheter into a subintimal space between a first tissue layer and a second tissue layer of a wall of a blood vessel, the support catheter including an elongate shaft including a tubular portion having a lumen extending therethrough to a distal opening and an extension segment extending distal of the distal opening;

positioning a balloon secured to a distal portion of a catheter shaft of a balloon catheter beside the extension segment within the subintimal space between the first tissue layer and the second tissue layer with the balloon catheter extending through the lumen of the support catheter; and

inflating the balloon between the extension segment and the first tissue layer such that the balloon is inflated against the extension segment;

wherein inflating the balloon against the extension segment causes the distal portion of the catheter shaft to deflect toward the lumen of the blood vessel within the subintimal space to facilitate reentry into the lumen of the blood vessel.

2. The method of claim 1, wherein a stiffness of the extension segment is additive to a stiffness of the second tissue layer to preferentially cause the first tissue layer to yield before the second tissue layer yields to cause the distal portion of the catheter shaft to deflect toward the lumen of the blood vessel within the subintimal space.

3. The method of claim 1, further comprising:

advancing a penetration member through the catheter shaft to penetrate through the first tissue layer into the lumen of the blood vessel distal of the occlusion.

4. The method of claim 3, wherein the catheter shaft extends through the balloon and the penetration member is advanced out of a distal opening of the catheter shaft located distal of the balloon.

5. The method of claim 1, wherein the balloon catheter is advanced through the lumen of the tubular portion of the support catheter to position the balloon beside the extension segment.

6. The method of claim 1, wherein the extension segment includes a guidewire lumen.

7. The method of claim 6, wherein advancing the support catheter into a subintimal space includes:

advancing the support catheter along a guidewire extending through the guidewire lumen.

8. The method of claim 1, wherein advancing the support catheter into a subintimal space includes:

advancing the support catheter along a guidewire extending through the lumen.

9. The method of claim 8, further comprising:

advancing the balloon catheter through the lumen of the support catheter with the guidewire extending through a lumen of the balloon catheter.

10. The method of claim 1, further comprising:

rotating the support catheter to position the extension segment at a rotational position furthest away from the lumen of the blood vessel.