Method and apparatus for the endoluminal delivery of intravascular devices

• US 9,119,738 B2
• Filed: 06/28/2011
• Issued: 09/01/2015
• Est. Priority Date: 06/28/2010
• Status: Active Grant

• Current Assignee: Colibri Heart Valve, LLC
• Original Assignee: Colibri Heart Valve, LLC
• Inventors: Fish, R. David
• Primary Examiner(s): MCEVOY, THOMAS M
• Application Number:
  US13/171,400
• Publication Number:
  US 20120078343A1
• Time in Patent Office: 1,526 Days
• Field of Search: 623/1.11, 623/1.12, 623/2.11, 604/101.01, 604/101.05
• US Class Current: 1/1
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2/962 having an outer sleeve
• CPC Class Codes: A61M 2025/0058 having an electroactive polymer material, e.g. for steering purposes, for control of flexibility, for locking, for opening or closing
• CPC Class Codes: A61M 2025/0175 having telescopic features, interengaging nestable members movable in relations to one another
• CPC Class Codes: A61M 2025/1081 having sheaths or the like for covering the balloon but not forming a permanent part of the balloon, e.g. retractable, dissolvable or tearable sheaths
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable

Abstract

A dual-balloon delivery catheter system includes a carrier segment that is a lead/carrier balloon or mandrel at a distal portion of a catheter. The carrier segment is sequentially arrayed with a more proximally positioned delivery segment, wherein the delivery segment is a delivery balloon or mandrel. The first carrier segment expands the stent-valve a sufficient amount to receive the delivery segment after the carrier segment is moved away from the sent-valve. The delivery segment is then positioned at the target site and the stent-valve is then deployed.

Claims

1. A system for treating a native heart valve in a patient using endoluminal delivery through vasculature of a patient to a native heart valve seat, the system comprising:

a stent-valve;

an outer delivery sheath including a distal section, wherein at least a portion of the outer delivery sheath is sized for insertion into the vasculature of the patient, wherein at least a portion of the distal section of the outer delivery sheath is expandable and comprises a plurality of piezo-ceramic elements configured to expand the distal section of the outer delivery sheath upon electrically activating the plurality of piezo-ceramic elements;

a carrier segment located at a distal portion of a catheter shaft, the carrier segment having an outer surface sized to temporarily hold the stent-valve in the distal section of the outer delivery sheath, wherein at least a portion of the catheter shaft is located within and coaxial to the outer delivery sheath; and

a delivery segment located coaxially to the outer delivery sheath, the delivery segment having an outer surface sized to radially fit within the stent-valve after detaching the stent-valve from the carrier segment when the stent-valve resides within the distal section of the outer delivery sheath, wherein the delivery segment is configured to deploy the stent-valve at the location of the native heart valve seat.

2. The system of claim 1, wherein the distal section includes at least one of an internal projection and a narrowed area extending radially inward from an interior surface of the distal section.

3. The system of claim 1, wherein a portion of an internal surface of the outer delivery sheath further comprises a guide for retaining at least a portion of a longitudinally extending element configured to selectively manipulate at least a part of the outer delivery sheath or a structure coaxial to the outer delivery sheath.

4. The system of claim 1, wherein a portion of an internal surface of the outer delivery sheath further comprises a guide, the guide comprising at least one of:

(a) a lumen; and

(b) a grommet;

wherein the guide retains at least one control line for selective retention of the stent-valve.

5. The system of claim 1, wherein the carrier segment is situated upon the catheter shaft, and wherein the delivery segment is associated with a delivery segment shaft that is coaxial to the catheter shaft and axially moveable relative to the catheter shaft.

6. The system of claim 1, wherein the carrier segment is an expandable balloon having an expanded diameter smaller than an expanded diameter for the delivery segment.

7. The system of claim 1, wherein the delivery segment is an expandable balloon having an expanded diameter larger than an expanded diameter for the carrier segment.

8. The system of claim 1, wherein at least one of the carrier segment and the delivery segment is a mandrel.

9. The system of claim 1, wherein the mandrel is expandable by mechanical or electromechanical means.

10. The system of claim 1, wherein the delivery segment is located axially proximal to the carrier segment.

11. The system of claim 1, wherein the delivery segment includes a magnet to aid in capture and retention of the stent-valve on the delivery segment.