Steerable guide catheters and methods for their use

• US 8,939,960 B2
• Filed: 07/22/2008
• Issued: 01/27/2015
• Est. Priority Date: 12/17/2004
• Status: Active Grant

• Current Assignee: BioCardia, Inc
• Original Assignee: BioCardia, Inc
• Inventors: Rosenman, Daniel, Kayser, Daniel, Keleher, Michael, Fravala, Nick, Cook, Richard, Tale, Mark, Arko, Frank, Stertzer, Simon, Altman, Peter A.
• Primary Examiner(s): Desanto, Matthew F
• Application Number:
  US12/177,338
• Publication Number:
  US 20080287918A1
• Time in Patent Office: 2,380 Days
• Field of Search: 604523-529, 604/95.04, 604/95.05
• US Class Current: 604/528
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• 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 2025/09133 having specific material compositions or coatings; Materials with specific mechanical behaviours, e.g. stiffness, strength to transmit torque
• CPC Class Codes: A61M 2210/12 Blood circulatory system
• 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 25/0051 made from fenestrated or weakened tubing layer
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 25/0136 Handles therefor
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0141 having flexible regions as a result of using materials with different mechanical properties
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/0152 with pre-shaped mechanisms, e.g. pre-shaped stylets or pre-shaped outer tubes

Abstract

Methods for easy, atraumatic access to areas of the vasculature that are otherwise difficult to access, using steerable guide catheters constructed with components that are selected to provide optimal navigability, torque transfer, and push ability for a variety of typical percutaneous access routes. The catheter wall thickness in the deflecting segment of the guide catheter is about 1 French (⅓ mm) or less, and includes a slotted deflection tube, and this construction allows a very tight turning radius which in turn enables guide catheter access to regions of the vasculature that are otherwise inaccessible.

Claims

1. A guide catheter having a deflectable segment at the distal end thereof, said deflectable segment having a wall thickness of less than about ⅓

mm with a distal end that can be curved in a tight radius of less than about 1 to 3 cm while maintaining an open lumen wherein the deflectable segment comprises a catheter inner tube comprising a polymer-embedded coil, a resilient tube having a plurality of transverse slots therein providing for biased deflection of said resilient tube, said resilient tube disposed over the catheter inner tube, and a catheter outer tube disposed over the resilient tube.

2. The guide catheter of claim 1, wherein the resilient tube is slotted to provide a bend of 180°

and a bend radius of less than about 1 to 3 cm.

3. The guide catheter of claim 1, wherein the resilient tube is slotted to provide a bend of 135°

and a bend radius of less than about 1 to 3 cm.

4. The guide catheter of claim 1, wherein the resilient tube is slotted to provide a bend of 90°

and a bend radius of less than about 1 cm.

5. The guide catheter of claim 1, wherein the resilient tube is slotted to provide a bend of 90°

and a bend radius of less than about 1.25 inches (3 to 4 cm).

6. The guide catheter of claim 1, wherein the resilient tube is slotted to provide a bend of 75°

and a bend radius of less than about 1 cm.

7. A guide catheter having a distal end and a proximal end, comprising an outer catheter shaft and an inner catheter shaft with a first deflectable segment at the distal end of the guide catheter, a main body comprising proximal portions of the outer catheter shaft and inner catheter shaft extending proximally from the deflecting segment to a handle having a pull wire actuator, and a pullwire extending from the deflectable segment to the pull wire actuator, wherein:

the deflectable segment comprises a PTFE liner surrounded by a wire coil impregnated with pebax with a hardness of 35D, coaxially disposed within a slotted nitinol deflection tube, coaxially disposed within an outer catheter tube comprising a pebax tube of hardness 35D, said deflectable segment having a total wall thickness of about ⅓

mm; and

the deflectable segment is about 2 to 4 cm long, and the slotted nitinol deflection tube is configured to provide a bend arc of about 90° and

a bend radius of about 1 cm; and

the main body portion of the inner catheter shaft comprises a PTFE liner surrounded by a flat ribbon braid embedded in pebax having a hardness of 50D for a second segment of about 5 cm length immediately proximal to the deflecting segment, a hardness of about 63D for a third segment of about 12.5 cm immediately proximal to the second segment, and a hardness of about 72D for the length of the inner catheter tube proximal to this second segment; and

the main body portion of the outer catheter shaft comprises a metal braided tube surrounded a Pebax outer jacket having a hardness of 50D for a second segment of about 5 cm length immediately proximal to the deflecting segment, a hardness of about 63D for a third segment of about 12.5 cm immediately proximal to the second segment, and a hardness of about 72D for the length of the inner catheter tube proximal to this second segment.

8. A steerable guide catheter for percutaneously accessing the carotid artery of a human patient comprising:

a guide catheter having a distal end and a proximal end, comprising an outer catheter shaft of diameter of less than 2.75 mm (8.25 French) and an inner catheter shaft of internal diameter greater than 2.08 mm (6.25 French) with a deflectable segment at the distal end of the guide catheter,

a catheter shaft extending proximally from the deflecting segment to a handle having an actuator for applying tension along a longitudinal element to the deflection segment, and said longitudinal element extending from the deflectable segment to the actuator to provide a bend arc of at least 90°

between the deflectable segment and the catheter shaft;

wherein the deflecting segment comprises the inner catheter shaft comprising a polymer-embedded coil, a slotted metal deflection tube, and the outer catheter shaft.

9. A steerable guide catheter for percutaneously accessing the renal artery of a human patient comprising:

a guide catheter having a distal end and a proximal end, comprising an outer catheter shaft of diameter of less than 2.75 mm (8.25 French) and an inner catheter shaft of internal diameter greater than 2.08 mm (6.25 French) with a deflectable segment at the distal end of the guide catheter,

a catheter shaft extending proximally from the deflecting segment to a handle having an actuator for applying tension along a longitudinal element to the deflection segment, said longitudinal element extending from the deflectable segment to the actuator to provide a bend arc of at least 135°

between the deflectable segment and the catheter shaft;

wherein the deflecting segment comprises the inner catheter shaft comprising a polymer-embedded coil, a slotted metal deflection tube, and the outer catheter shaft.