Cold-molding process for loading a stent onto a stent delivery system

• US 20050143752A1
• Filed: 02/23/2005
• Published: 06/30/2005
• Est. Priority Date: 09/19/2001
• Status: Active Grant

• Current Assignee: Abbott Laboratories Limited (Abbott Laboratories Incorporated)
• Original Assignee: Abbott Laboratories Vascular Enterprises Limited
• Inventors: Schwager, Michael, Frei, Martin, Ha, Suk-Woo
• Granted Patent: US 9,295,570 B2
• Time in Patent Office: Days
• US Class Current: 606/108
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/9522 Means for mounting a stent or stent-graft onto or into a placement instrument
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2002/9583 Means for holding the stent on the balloon, e.g. using protrusions, adhesives or an outer sleeve
• CPC Class Codes: A61F 2310/00011 Metals or alloys
• CPC Class Codes: A61M 2025/1004 Balloons with folds, e.g. folded or multifolded
• CPC Class Codes: Y10T 29/49927 Hollow body is axially joined cup or tube

Abstract

A method of making a stent delivery system is provided in which a delivery catheter has a balloon that extends non-uniformly into interstices of a stent. In accordance with the method a balloon/stent/crimping tube assembly is placed in a crimping tool, the balloon is inflated, and the crimping tool is actuated to compress the stent on the outside of the balloon without application of heat or chemicals, thereby causing creases of the balloon to extend non-uniformly into the interstices of the stent. Optionally, pillows may be formed in the balloon to prevent longitudinal movement of the stent with respect to the balloon during intravascular delivery. One or more secondary crimpings also may be performed to achieve a smoother delivery profile.

Claims

1. A stent delivery system having a contracted delivery configuration and an expanded deployed configuration, the stent delivery system comprising:

a stent; and

a delivery catheter having an inflatable balloon, the stent disposed about the balloon, wherein the balloon comprises creases that extend non-uniformly within interstices of the stent in the contracted delivery configuration.

2. The stent delivery system of claim 1, wherein the inflatable balloon further comprises pillows disposed proximally and distally of the stent in the contracted delivery configuration.

3. The stent delivery system of claim 1, wherein the delivery catheter further comprises markers.

4. The stent delivery system of claim 3, wherein the markers are radiopaque.

5. The stent delivery system of claim 1, wherein the stent comprises an external coating.

6. The stent delivery system of claim 5, wherein the coating is configured to retard restenosis or thrombus formation around the stent.

7. The stent delivery system of claim 5, wherein the coating is configured to deliver therapeutic agents into a patient'"'"'s blood stream or vessel wall when implanted within the patient'"'"'s vasculature.

8. A method of fabricating a stent delivery system comprising:

providing apparatus comprising a stent and a delivery catheter having an inflatable balloon;

disposing the stent about the inflatable balloon;

placing the balloon and stent within a crimping tool;

inflating the balloon;

deflating the balloon; and

actuating the crimping tool to compress the stent on the outside of the balloon at a substantially constant temperature, thereby securing non-uniform creases of the balloon within the interstices of the stent and forming the stent delivery system.

9. A method for stenting at a target site within a patient'"'"'s vessel, the method comprising:

providing a stent delivery system comprising a stent and a delivery catheter with an inflatable balloon, the stent disposed about the inflatable balloon, wherein the balloon has creases that extend non-uniformly within interstices of the stent;

percutaneously delivering the stent delivery system to the target site within the patient'"'"'s vessel in a contracted delivery configuration; and

expanding the stent delivery system to an expanded deployed configuration, wherein the balloon is inflated, the interstices of the stent open, removing the creases of the balloon from the interstices, and the stent engages the target site.

10. The method of claim 9 further comprising:

deflating the balloon; and

removing the delivery catheter from the patient'"'"'s vessel.