Medical devices configured from deep drawn nickel-titanium alloys and nickel-titanium clad alloys and method of making the same
First Claim
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1. A medical device, comprising:
- a structural element having a particular medical device geometry formed from nickel-titanium alloy and being collapsible to be placed in a delivery position and self-expandable from the delivery position to a deployed position, where the nickel-titanium alloy has been processed in a deep drawing process which forms hollow-shaped structural element and cold works the nickel-titanium alloy so that it remains in a martensitic phase only regardless of stress that may be applied to the structural element to maintain the structural element in the delivery position, the hollow-shaped structural element being formed into the desired medical device geometry which includes a hollow structure.
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Abstract
Nickel-titanium alloys that have been deep drawn in a cold working process have linear pseudoelastic behavior without a phase transformation or onset of stress-induced martensite. A medical device made from a structural element which has been deep drawn and subsequently formed into a desired medical device geometry will experience such linear pseudoelastic behavior.
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Citations
20 Claims
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1. A medical device, comprising:
a structural element having a particular medical device geometry formed from nickel-titanium alloy and being collapsible to be placed in a delivery position and self-expandable from the delivery position to a deployed position, where the nickel-titanium alloy has been processed in a deep drawing process which forms hollow-shaped structural element and cold works the nickel-titanium alloy so that it remains in a martensitic phase only regardless of stress that may be applied to the structural element to maintain the structural element in the delivery position, the hollow-shaped structural element being formed into the desired medical device geometry which includes a hollow structure. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A method for manufacturing a medical device for use in a body lumen, comprising:
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providing nickel-titanium stock;
deep drawing the nickel-titanium alloy stock into a structure element having a hollow shape; and
forming the structural element into a desired medical device geometry which includes a hollow structure, the structural element being capable of assuming a first position when a stress is applied to it and movable to a second position when the stress is removed. - View Dependent Claims (13, 14, 15)
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16. A self-expanding medical device, comprising:
a structural element having a particular medical device geometry formed from a nickel-titanium alloy and being collapsible to be placed in a delivery position and self-expandable from the delivery position to a deployed position, wherein the nickel-titanium alloy has been processed in a deep drawing process which forms hollow-shaped structural element and cold works the nickel-titanium alloy and heat treated so that the alloy remains in a martensitic phase only regardless of stress that may be applied to the structural element to maintain the structural element in the delivery position, the hollow-shaped structural element being formed into the desired medical device geometry which includes a hollow structure. - View Dependent Claims (17, 18, 19, 20)
Specification