Crimping method for bioresorbable stents
The present patent application relates to a method of crimping a tubular stent having a stent lumen onto an inflatable balloon of a stent delivery catheter.
1. A method of crimping a bioresorbable polymeric tubular stent having a stent lumen onto an inflatable balloon of a stent delivery catheter, the stent having a multiplicity of stent struts evenly distributed around the stent lumen and a multiplicity of interstices between the stent struts, and the stent having a deployed diameter and a crimped diameter that is smaller than the deployed diameter, the bioresorbable polymer having a glass transition temperature (Tg), the inflatable balloon having a wall material arranged into a multiplicity of folds and evenly distributed around the stent lumen, and the method comprising in the following order:
(a) inserting the inflatable balloon of the stent delivery catheter into the stent lumen of the tubular stent with the inflatable balloon at a deflated diameter and with the tubular stent at approximately the deployed diameter;
(b) heating the tubular stent to a temperature at or above the glass transition temperature of the bioresorbable polymer;
(c) inflating the inflatable balloon of the stent delivery catheter to an inflated diameter within the stent lumen of the tubular stent with an inflation pressure between 0.1 to 5 bars;
(d) crimping the tubular stent from the deployed diameter to the crimped diameter while maintaining the inflation pressure within the inflatable balloon of the stent delivery catheter;
(e) cooling the tubular stent to a temperature below the glass transition temperature while maintaining the inflation pressure within the inflatable balloon of the stent delivery catheter; and
(f) deflating the inflatable balloon of the stent delivery catheter while maintaining the tubular stent at the crimped diameter.
2. The method of claim 1 , wherein the tubular stent comprises a poly (lactic acid) polymer.
3. The method of claim 1 , further comprising after the crimping step and prior to the deflating step, increasing the inflation pressure of the inflatable balloon of the stent delivery catheter within the stent lumen of the tubular stent to an inflation pressure of approximately 3.0 to 7.0 bars while maintaining the tubular stent at the crimped diameter.
4. The method of claim 1 , further comprising prior to inserting the inflatable balloon of the stent delivery catheter into the stent lumen of the tubular stent, inserting the tubular stent into a crimping machine at approximately the deployed diameter and precrimping the tubular stent to a precrimped diameter that is slightly smaller than the deployed diameter.
5. The method of claim 4 , further comprising after the deflating step, removing the tubular stent and the inflatable balloon of the stent delivery catheter from the crimping machine.
6. The method of claim 1 , wherein the tubular stent is formed from a bioresorbable polymer having a glass transition temperature and wherein the method further comprises:
prior to inserting the inflatable balloon of the stent delivery catheter into the stent lumen of the tubular stent, inserting the tubular stent into a crimping machine at approximately the deployed diameter and precrimping the tubular stent to a precrimped diameter that is slightly smaller than the deployed diameter;
prior to the crimping step, heating the tubular stent to a temperature at or above the glass transition temperature;
prior to the crimping step, inflating the inflatable balloon of the stent delivery catheter within the stent lumen of the tubular stent with an inflation pressure of approximately 0.2 to 2.0 bars and maintaining this inflation pressure during the crimping step;
after the crimping step and prior to the deflating step, increasing the inflation pressure of the inflatable balloon of the stent delivery catheter within the stent lumen of the tubular stent to an inflation pressure of approximately 3.0 to 7.0 bars while maintaining the tubular stent at the crimped diameter and cooling the tubular stent to a temperature below the glass transition temperature; and
after the deflating step, removing the tubular stent and the inflatable balloon of the stent delivery catheter from the crimping machine.
7. The method of claim 6 , wherein the tubular stent comprises a poly (lactic acid) polymer.