Method for loading a medical device into a delivery system

1. A process for loading a medical device into a delivery system prior to insertion into a body lumen, the process comprising:

applying a force to a medical device comprising a shape memory material to obtain a delivery configuration of the medical device, the medical device being at a first temperature within an R-phase temperature range of the shape memory material during the applying;

removing the force from the medical device; and

after removing the force, loading the medical device into a delivery system.

2. The process according to claim 1 , further comprising cooling the medical device in the delivery configuration to a second temperature below the first temperature prior to removing the force from the medical device.

3. The process according to claim 2 , wherein the second temperature is at or below a martensite finish temperature of the shape memory material.

4. The process according to claim 2 , wherein the medical device recovers at least a portion of the delivery configuration upon recooling to the second temperature following removal of the force.

5. The process according to claim 1 , wherein the medical device substantially maintains the delivery configuration for a time of at least about 5 seconds following removal of the force.

6. The process according to claim 1 , wherein the loading is carried out in an environment maintained at a temperature of less than an austenite start temperature of the shape memory material.

7. The process according to claim 1 , further comprising warming the medical device from an initial temperature to the first temperature in the R-phase temperature range.

8. The process according to claim 7 , wherein the R-phase temperature range extends from an R′-phase start temperature to below an austenite start temperature of the shape memory material.

9. The process according to claim 8 , wherein the initial temperature is at or below a martensite finish temperature of the shape memory material.

10. The process according to claim 1 , further comprising cooling the medical device from a starting temperature to the first temperature in the R-phase temperature range.

11. The process according to claim 10 , wherein the R-phase temperature range extends from an R-phase start temperature to above a martensite start temperature of the shape memory alloy.

12. The process according to claim 11 , wherein the starting temperature is at or above an austenite finish temperature of the shape memory material.

13. The process according to claim 1 , wherein the medical device is a self-expanding stent,

wherein the force is a compressive radial force,

wherein the delivery configuration is a compressed configuration, and

wherein the delivery system is a tube, and

further comprising warming the stent from an initial temperature at or below a martensite finish temperature to the first temperature within the R-phase temperature range, and

further comprising cooling the stent in the compressed configuration to a second temperature at or below a martensite finish temperature of the shape memory alloy prior to removing the compressive radial force from the stent.

14. The process according to claim 1 , further comprising, after loading the medical device into the delivery system, inserting the medical device into a body lumen.

15. A process for loading a medical device into a delivery system, the process comprising:

applying a force to a medical device comprising a shape memory material to obtain a delivery configuration of the medical device, the medical device being at a first temperature within an R-phase temperature range of the shape memory material during the applying;

cooling the medical device in the delivery configuration to a second temperature at or below a martensite finish temperature of the shape memory material;

removing the force from the medical device following the cooling;

loading the medical device into a delivery system, wherein the medical device substantially maintains the delivery configuration during loading.

16. The process according to claim 15 , further comprising warming the medical device from an initial temperature to the first temperature in the R-phase temperature range.

17. The process according to claim 16 , wherein the R-phase temperature range extends from an R′-phase start temperature to below an austenite start temperature of the shape memory material.

18. The process according to claim 15 , further comprising cooling the medical device from a starting temperature to the first temperature in the R-phase temperature range.

19. The process according to claim 18 , wherein the R-phase temperature range extends from an R-phase start temperature to above a martensite start temperature of the shape memory alloy.

20. A process for a loading a stent into a delivery system, the process comprising:

cooling a stent comprising a shape memory material from a temperature at or above an austenite finish temperature of the shape memory material to an initial temperature at or below a martensite finish temperature of the shape memory material;

warming the stent from the initial temperature to a first temperature at or above an R′-phase start temperature and below an austenite start temperature of the shape memory material;

applying a force to the stent to obtain a compressed configuration of the stent, the stent being at the first temperature during the applying;

cooling the stent in the compressed configuration to a second temperature at or below the martensite finish temperature;

removing the force from the stent after the cooling in the compressed configuration; and

loading the stent into a delivery system after removing the force, wherein the stent substantially maintains the compressed configuration during loading.

21. The process according to claim 20 , wherein loading the stent into the delivery system comprises a force of less than about 1 N.