Method for retaining a vascular stent on a catheter
First Claim
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1. A method of mounting a stent on a catheter, comprising:
- positioning the stent on a balloon of the catheter;
applying a radially compressive force on an outer surface of the stent, thereby decreasing the outer diameter of the stent on the balloon;
pressurizing the balloon in a range from 10 psi to 300 psi and heating the balloon in a range from 70°
F. to 250°
F. while restricting radial expansion of the outer surface of the stent during a first period of time whereby balloon material protrudes into gaps between stent struts;
performing a process on the stent and balloon wherein the balloon protrusions withdraw from the gaps; and
pressurizing the balloon in a range from 10 psi to 300 psi and heating the balloon in a range from 70°
F. to 250°
F. while restricting radial expansion of the outer surface of the stent during a second period of time whereby balloon material protrudes into the gaps.
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Abstract
A method of securely mounting a stent on a balloon of a catheter. The method generally includes crimping a stent on a balloon of a catheter at least one time, and positioning the balloon with the stent thereon within a polished bore of a mold formed at least in part of a metallic material. The balloon is pressurized and heated within the mold, or within a sheath, in two stages as the stent is restrained from radially expanding. The method may include crimping the stent onto the balloon one or two times during processing. The method increases retention of the stent on the balloon catheter following sterilization.
249 Citations
28 Claims
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1. A method of mounting a stent on a catheter, comprising:
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positioning the stent on a balloon of the catheter; applying a radially compressive force on an outer surface of the stent, thereby decreasing the outer diameter of the stent on the balloon; pressurizing the balloon in a range from 10 psi to 300 psi and heating the balloon in a range from 70°
F. to 250°
F. while restricting radial expansion of the outer surface of the stent during a first period of time whereby balloon material protrudes into gaps between stent struts;performing a process on the stent and balloon wherein the balloon protrusions withdraw from the gaps; and pressurizing the balloon in a range from 10 psi to 300 psi and heating the balloon in a range from 70°
F. to 250°
F. while restricting radial expansion of the outer surface of the stent during a second period of time whereby balloon material protrudes into the gaps. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method of mounting a stent on a balloon catheter, comprising:
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positioning a stent on a balloon catheter, the balloon catheter having an elongated shaft with an inflation lumen and a guidewire lumen and an inflatable balloon on a distal shaft section with an interior in fluid communication with the inflation lumen, and the stent having an open-walled body of stent struts with gaps between adjacent stent struts; applying at least one radially compressive force on an outer surface of the stent and thereby decreasing the outer diameter of the stent on the balloon catheter; heating the balloon in a range from 70°
F. to 250°
F. and introducing inflation media into the interior of the balloon in a pressure range from 10 psi to 300 psi for a first period of time to radially expand the balloon with the stent restrained from radially expanding, wherein the balloon forms protrusions that expand into the stent gaps to embed the stent in an outer surface of the balloon;performing a process on the stent and balloon wherein the balloon protrusions withdraw from the gaps; removing the inflation media from the balloon interior; and heating the balloon in a range from 70°
F. to 250°
F. and introducing inflation media into the interior of the balloon in a range from 70°
F. to 250°
F. for a second period of time to radially expand the balloon with the stent restrained from radially expanding, wherein the balloon forms protrusions that expand into the stent gaps to embed the stent in an outer surface of the balloon. - View Dependent Claims (18, 19, 20, 21, 22, 23, 24)
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25. A method of increasing retention of an intravascular device on a balloon catheter, comprising:
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crimping the intravascular device onto a balloon of the balloon catheter; a first stage of heating the balloon in a range from 70°
F. to 250°
F. and pressurizing the balloon in a range from 10 psi to 300 psi;performing a process on the stent and balloon that partially dislodges the stent from the balloon; and a second stage of heating the balloon in a range from 70°
F. to 250°
F. and pressurizing the balloon in a range from 10 psi to 300 psi. - View Dependent Claims (26, 27, 28)
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Specification