Method of uniform crimping and expansion of medical devices
A medical device-includes a scaffold crimped to a catheter having an expansion balloon. The scaffold is crimped to the balloon by a process that includes one or more balloon pressurization steps. The balloon pressurization steps are selected to enhance scaffold retention to the balloon, maintain a relatively uniform arrangement of balloon folds about the inner surface of the crimped scaffold so that the scaffold expands in a uniform manner when the balloon is inflated, and to avoid any possible over-stretching of balloon material.
1. A method for crimping, comprising:
using a crimping device comprising jaws forming an iris, and crimping a polymeric scaffold to a balloon, the scaffold having an outer diameter and prior to crimping the scaffold has a pre-crimp outer diameter, the crimping including:
heating the scaffold to an elevated temperature;
performing a first crimping of the scaffold to the balloon while a first pressure is maintained in the balloon, the first crimping including reducing the scaffold outer diameter from the pre-crimp outer diameter to between 45% to 55% of the pre-crimp outer diameter;
deflating the balloon while the outer diameter is between 45% to 55% of the pre-crimp outer diameter; and
while the balloon is deflated,
performing a second crimping including reducing the scaffold outer diameter from the between 45% to 55% of the pre-crimp outer diameter to a final outer diameter,
performing a final dwell, and
removing the scaffold from the crimping device.
2. The method of claim 1 , wherein the scaffold comprises a polymer having a lower-end of a glass transition temperature (TG) and during the first and second crimping the scaffold temperature is between TG and 15 degrees less than TG.
3. The method of claim 1 , wherein the scaffold comprises poly (L-lactide) (PLLA) and during the first and second crimping the scaffold temperature is between 40 Deg. C. and 55 Deg. C.
4. The method of claim 1 , wherein the final outer diameter is between 30% to 35% of the pre-crimp outer diameter.
5. A method for crimping, comprising;
using an inflated balloon;
using a stent or scaffold having an outer diameter, wherein prior to crimping the stent or scaffold has a pre-crimp outer diameter; and
using a crimping device comprising jaws forming an iris,
performing a first crimping of the stent or scaffold to the inflated balloon including reducing the outer diameter from the pre-crimp outer diameter to between 40% to 60% of the pre-crimp outer diameter, wherein a balloon pressure is maintained throughout the first crimping;
while the stent or scaffold has the outer diameter between 40% to 60% of the pre-crimp outer diameter, decreasing the pressure of the inflated balloon from a first pressure to a second pressure and maintaining the second pressure for a dwell period, followed by deflating the balloon; and
while the balloon is deflated,
performing a second crimping including reducing the stent or scaffold outer diameter from the between 40% to 60% of the pre-crimp outer diameter to a final outer diameter,
performing a final dwell while the stent or scaffold has the final outer diameter, and
removing the stent or scaffold from the crimping.
6. The method of claim 5 , wherein the first and second crimping is performed on a stent made from a metal, metal alloy, bio-erodible metal or metal alloy.
7. The method of claim 5 , wherein an inner diameter of the stent or scaffold prior to crimping is between about 109-116% of a diameter of the inflated balloon.
8. The method of claim 5 , wherein the scaffold comprises a polymer having a lower-end of a glass transition temperature (TG) and during the first and second crimping the scaffold temperature is between TG and 15 degrees less than TG.
9. The method of claim 5 , wherein the scaffold comprises poly (L-lactide) (PLLA) and during the first and second crimping the scaffold temperature is between 40 Deg. C. and 55 Deg. C.
10. The method of claim 5 , wherein the final outer diameter is between 30% to 35% of the pre-crimp outer diameter.
11. The method of claim 5 , wherein the first crimping further includes the steps of:
while the balloon is inflated, performing steps (a), (b) and (c):
(a) removing the stent or scaffold from the crimping device when the stent or scaffold has an outer diameter intermediate of the pre-crimp outer diameter and the between 40% to 60% of the pre-crimp outer diameter,
(b) inspecting the stent or scaffold while the stent or scaffold is removed from the crimping device, and
(c) returning the stent or scaffold to the crimping device.
12. The method of claim 5 , wherein while the stent or scaffold has the outer diameter between 40% to 60% of the pre-crimp outer diameter, the balloon is deflated by opening a valve supplying a pressure to the balloon prior to the start of the second crimping.
13. The method of claim 1 , wherein the first crimping further includes the steps of:
while maintaining the first pressure, performing steps (a), (b) and (c):
(a) removing the scaffold from the crimping device when the scaffold has an outer diameter intermediate of the pre-crimp outer diameter and the between 45% to 55% of the pre-crimp diameter,
(b) inspecting the scaffold while the stent or scaffold is removed from the crimping device, and
(c) returning the scaffold to the crimping device.
14. The method of claim 1 , wherein while the scaffold has the outer diameter between 45% to 55% of the pre-crimp outer diameter, the balloon is deflated by opening a valve supplying a pressure to the balloon.