Implant having high fatigue resistance, delivery system, and method of use
First Claim
1. An implant and delivery system comprising an implant comprising a nickel titanium alloy tube having a first end and a second end, said tube having an Austenite finish temperature suitable for use in a patient, said tube is shape set to a first substantially longitudinal configuration, and said tube having a kink radius of less than 0.195 inches;
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Accused Products
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.
21 Citations
21 Claims
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1. An implant and delivery system comprising an implant comprising a nickel titanium alloy tube having a first end and a second end, said tube having an Austenite finish temperature suitable for use in a patient, said tube is shape set to a first substantially longitudinal configuration, and said tube having a kink radius of less than 0.195 inches;
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a catheter for delivering the implant to a delivery site, the catheter constraining the implant until release of the implant from the catheter at which occurrence, the implant self expands to an enlarged condition thereof.
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2. A surgical system comprising:
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a catheter; and an implant disposed within the catheter in a collapsed condition to be delivered by the catheter to a delivery site and being releasable from the catheter to expand to an enlarged condition, the implant comprising a nickel titanium alloy tube having a first end and a second end, said tube having an Austenite finish temperature suitable for use as a stent in a patient, said tube is shape set to a first substantially longitudinal configuration, and said tube having a kink radius of no greater than 0.195 inches, the implant being 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 selected to dissolve nickel rich precipitates in the implant; (b) after (a), with the implant remaining on the mandrel, annealing the implant within a second temperature range that is lower than the first temperature range; and
selected to set the Austenite finish temperature of the implant. - View Dependent Claims (3, 4, 5, 6)
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7. An implant and delivery system, comprising:
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a stent implant comprising a nickel titanium alloy tube having a first end and a second end, said tube having an Austenite finish temperature suitable for use in a patient, said tube is shape set to a first substantially longitudinal configuration, and said tube having a kink radius of less than 0.195 inches, the implant being dimensioned and adapted to transition from a constrained condition to an expanded condition, the implant being 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 selected to dissolve nickel rich precipitates in the implant; (b) after (a), with the implant remaining on the mandrel, annealing the implant within a second temperature range lower than the first temperature range and selected to set the Austenite finish temperature; and a catheter for delivering the implant to a delivery site, the catheter dimensioned to maintain the implant in the constrained condition, whereby upon release of the implant from the catheter, the implant moves to the expanded condition thereof. - View Dependent Claims (8, 9, 10, 11, 12, 13, 14, 15, 16, 17)
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18. An implant and delivery system, comprising:
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an implant member suitable for use as a stent in a patient, said implant member including a nickel titanium alloy tube having a first end and a second end, said tube having an Austenite finish temperature suitable for use as a stent in a patient, and having a kink radius of less than 0.195 inches; wherein said tube is shape set to a first substantially longitudinal configuration, and wherein said tube has an ultimate tensile strength between 1.032 MPa and 1134 MPa; and a catheter for delivering the implant memter member to a delivery site, wherein the implant is retained on the catheter in a collapsed state, wherein the implant memter is selectively releasable from the catheter, wherein when the implant member is released from the catheter, the implant member is expandable to an enlarged state to abut an inner wall of a body lumen. - View Dependent Claims (19, 20, 21)
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Specification