Implant having high fatigue resistance, delivery system, and method of use
AssigneeCovidien LP
InventorsJianlu Ma, Joe Tatalovich, Lixiao Wang, Xiaoling Zhao, Dan Ranum
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Abstract
According to one aspect of the present invention, a fatigue resistant stent comprises a flexible tubular structure having an inside diameter, an outside diameter, and a sidewall therebetween and having apertures extending through the sidewall. According to other aspects of the invention, processes for making a fatigue resistant stent are disclosed. According to further aspects of the invention, delivery systems for a fatigue resistant stent and methods of use are provided.
Claims36
A method of shape setting an implant comprising a nickel titanium alloy, the method comprising:
- (a) restraining the implant on a mandrel having a first diameter and annealing the implant within a first temperature range;
- (b) after (a), restraining the implant on a mandrel having a second diameter and annealing the implant within a second temperature range that is higher than the first temperature range;
- and
- (c) after (b), annealing the implant within a third temperature range that is lower than the second temperature range and while the implant is restrained on a mandrel;
- and
- wherein the second diameter is larger than said first diameter.
A tubular implant, comprising a nickel titanium alloy, and having a bend-rotate fatigue life of at least 1 million cycles to failure, wherein the cycles to failure is the number of full rotations made by the implant before the implant breaks.
An implant comprising a nickel titanium alloy that is shape set by a process comprising:
- (a) restraining the implant on a mandrel having a first diameter and annealing the implant within a first temperature range;
- (b) after (a), restraining the implant on a mandrel having a second diameter and annealing the implant within a second temperature range that is higher than the first temperature range;
- and
- (c) after (b), annealing the implant within a third temperature range that is lower than the second temperature range and while the implant is restrained on a mandrel;
- and
- wherein the second diameter is larger than said first diameter.
A delivery device comprising:
- a catheter for delivering an implant to a delivery site;
- and
- an implant comprising a nickel titanium alloy that is shape set by a process comprising:
- (a) restraining the implant on a mandrel having a first diameter and annealing the implant within a first temperature range;
- (b) after (a), restraining the implant on a mandrel having a second diameter and annealing the implant within a second temperature range that is higher than the first temperature range;
- and
- (c) after (b), annealing the implant within a third temperature range that is lower than the second temperature range and while the implant is restrained on a mandrel;
- and
- wherein the second diameter is larger than said first diameter.
An implant, comprising a nickel titanium alloy, and having a kink radius of no greater than 0.195 inches, wherein the kink radius is half the distance between the implant unkinked ends held parallel to each other when the implant is kinked by bending.
Dependencies are inferred from the claim text.