Catheter systems and methods for crossing vascular occlusions

• US 8,702,679 B2
• Filed: 06/10/2004
• Issued: 04/22/2014
• Est. Priority Date: 06/10/2003
• Status: Active Grant

• Current Assignee: Cardinal Health Switzerland 515 GmbH (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Deckman, Robert K., Thai, Erik, Aguilar, Amiel R., Clark, Benjamin J., Salinas, Sergio, Francis, Daniel E., Sparks, Kurt D.
• Primary Examiner(s): Flick, Jason
• Assistant Examiner(s): CHANDER, DIVA KAKAR
• Application Number:
  US10/865,231
• Publication Number:
  US 20050021002A1
• Time in Patent Office: 3,603 Days
• Field of Search: 604/527, 604/107
• US Class Current: 604/523
• CPC Class Codes: A61B 2017/22042 Details of the tip of the guide wire
• CPC Class Codes: A61B 2017/22094 for crossing total occlusions, i.e. piercing
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/0687 having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths
• CPC Class Codes: A61M 25/0045 multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes

Abstract

Interventional catheter-based systems and methods are described herein for use in generating an initial pathway through vascular occlusions. The catheter systems generally include two elements. A first element is a Blunt Dissection Catheter including a manually actuated assembly located at the distal tip of the Blunt Dissection Catheter that performs blunt dissection in the vascular occlusion to produce a dissection track, or small pathway through the occlusion. The second element is a Sheath Catheter that serves as a conduit within which the Blunt Dissection Catheter is freely advanced, retracted and rotated. The first and second elements are used in some combination to cross vascular occlusions in both the coronary and peripheral vasculature.

Claims

1. A catheter system comprising:

a catheter shaft including a braided tubular member having an inner surface and an outer surface, the braided tubular member comprising braided filaments formed into a mesh;

at least one inner polymer layer having an inner surface and an outer surface and formed from a lubricious polymer coupled to the inner surface of the braided tubular member, the outer surface of the at least one inner polymer layer being configured with microscopic interstices;

at least one outer polymer laminate layer coupled to the outer surface of the braided tubular member, wherein the polymer materials of the outer polymer laminate layer are interspersed through the braided tubular member and connect into interstices of the outer surface of the inner polymer layer, the thickness of the outer polymer laminate layer being configured to cover the braided tubular member thereby forming a smooth uninterrupted surface;

at least one lumen in the catheter shaft, wherein the inner polymer layer and the outer polymer laminate layer are bonded together between cross-over points of the braided structure and form bridges that connect into the microscopic interstices of the inner polymeric layer thereby forming a unified structure; and

a sheath introducer including a member having a proximal and a distal end and forming a single lumen configured to track over a guide wire, wherein the member is configured to be inserted into the catheter shaft, wherein a distal region of the member extends beyond a distal end of the catheter shaft when the member is fully inserted.

2. The system of claim 1, wherein the sheath introducer further comprises at least one hub on the proximal end, the hub configured to lock into a hub on a proximal end of the catheter shaft when the sheath introducer is fully inserted into the catheter shaft.

3. The system of claim 1, wherein the sheath introducer further comprises a fluoroscopic marker system in a distal region of the member.