Implantable expandable medical devices having regions of differential mechanical properties and methods of making same
View Patent ↗An implantable expandable medical device in which selected regions of the device are in a martensite phase and selected regions are in an austenite phase. The martensitic regions exhibit pseudoplastic behavior in vivo and may be deformed without recovery under in vivo body conditions. In contrast the austenitic regions exhibit superelastic behavior in vivo and will recover their pre-programmed configuration upon deformation or release of an applied strain.
1. A method of making a geometrically expansible, implantable stent comprising the steps of:
forming a stent having a plurality of circumferential ring members having first hinge members, a plurality of interconnecting members each comprising a first portion, a second portion, and a second hinge member disposed between the first and second portions, wherein the interconnecting members are configured to connect adjacent pairs of circumferential ring members, the plurality of circumferential ring members, the first hinge members and the plurality of interconnecting members having an austenitic phase in vivo, and wherein both the first and second portions of each interconnecting member are oblique to the second hinge member at a point immediately adjacent to a junction between the second hinge member and either the first or second portions; and
selectively altering the mechanical properties of at least some of the second hinge members to form a martensitic region in the second hinge members to behave pseudoplastically under in vivo conditions, while maintaining the austenitic phase in vivo in the first and second portions, wherein the second hinge members are substantially non-collinear with other regions of the interconnecting members when the second hinge members behave pseudoplastically under in vivo conditions.
2. The method of claim 1 , wherein the step of selectively altering the mechanical properties of the second hinge members further comprises selectively heat treating the second hinge members to form the martensitic region.
3. The method of claim 2 , wherein the step of selectively heat treating the second hinge members further comprises applying focal thermal energy to the second hinge members to form the martensitic region.
4. The method of claim 1 , wherein the step of selectively altering the mechanical properties of the second hinge members further comprises selectively altering the bulk chemical composition of the second hinge members during formation of the stent to form the martensitic region.
5. The method of claim 1 , wherein the step of forming the stent further comprises the step of vacuum depositing titanium to form the martensitic region of the second hinge members.
6. The method of claim 1 , wherein the step of forming the stent further comprises forming each of the circumferential ring members with a plurality of generally linear members interconnected by the first hinge members.
7. The method of claim 6 , further comprising forming the first hinge members in a substantially austenite phase.
8. The method of claim 6 , wherein the step of forming the stent comprises vacuum deposition.
9. The method of claim 8 , further comprising selectively altering the mechanical properties of the plurality of interconnecting members to include a martensite-austenite phase gradient.
10. The method of claim 9 , wherein the step of forming the stent further comprises forming the plurality of interconnecting members in a sufficiently austenite phase to behave pseudoelastically in vivo.
11. The method of claim 1 , further comprising selectively altering the mechanical properties of the plurality of interconnecting members to include a martensite-austenite phase gradient.
12. The method of claim 1 , wherein the step of forming the stent further comprises forming the plurality of interconnecting members in a sufficiently austenite phase to behave pseudoelastically in vivo.
13. The method of claim 1 , further comprising forming the first hinge members in a substantially austenite phase.
14. A method of making a geometrically expansible, implantable stentt comprising the steps of:
forming a stent having a plurality of circumferential ring members, each having a plurality of generally linear members interconnected by a plurality of first hinge members;
forming a plurality of interconnecting members each having at least one second hinge member disposed between non-hinge regions, wherein the interconnecting members interconnect adjacent pairs of the circumferential ring members; and
selectively altering the mechanical properties of at least some of the second hinge members to form a martensitic region, while the non-hinge regions of the interconnecting members are generally austenitic, wherein the second hinge members are substantially non-collinear with the non-hinge regions of the interconnecting members when the stent is in an expanded state;
wherein the step of selectively altering the mechanical properties of the second hinge members further comprises selectively altering the bulk chemical composition of the second hinge members during formation of the interconnecting members to form the martensitic region.
15. The method of claim 14 , wherein the step of forming the plurality of interconnecting members each having at least one second hinge member further comprises the step of vacuum depositing titanium to form the martensitic region.
16. The method of claim 14 , further comprising selectively altering the mechanical properties of the plurality of interconnecting members to include a martensite-austenite phase gradient.
17. The method of claim 14 , wherein the step of forming the plurality of interconnecting members further comprises forming the plurality of interconnecting members in a sufficiently austenite phase to behave pseudoelastically in vivo.
18. The method of claim 14 , further comprising forming the first hinge members in a substantially austenite phase.
19. A method of making a geometrically expansible, implantable stent comprising the steps of:
forming a stent having a plurality of circumferential ring members by vacuum deposition, each circumferential ring member having a plurality of generally linear members interconnected by a plurality of first hinge members;
forming a plurality of interconnecting members each comprising a first portion, a second portion, and a second hinge member disposed between the first and second portions by vacuum deposition, wherein the interconnecting members interconnect adjacent pairs of the circumferential ring members, and the second hinge members are substantially non-collinear with the first and second portions of the interconnecting members along a longitudinal axis of the stent; and
configuring the second hinge members to be sufficiently martensitic to behave pseudoplastically in vivo by selectively altering the bulk chemical composition of the second hinge members during formation of the interconnecting members, while the first and second portions are generally austenitic.
20. The method of claim 19 , further comprising forming the first hinge members in a substantially austenite phase.