Stent, method for processing stent, and method of stenting a patient

Abstract

The subject invention pertains instruments for use in nuclear spin tomography comprising a metal alloy comprising aluminum, vanadium, and titanium. In a specific embodiment, the subject invention relates to cardiovascular stents which can exhibit a low incidence of artifacts and are viewable in a nuclear spin tomography unit. The subject invention also pertains to a method for processing instruments for use in nuclear spin tomography. Spin processing can comprise application of a wet chemical etching solution. In a specific embodiment, the wet chemical etching solution can comprise three parts hydrochloric acid and two parts saltpeter acid.

Description

DESCRIPTION

This invention relates to the use of a material in claim 1 and a process in claims 3 and 5. In today's stent technology it is desirable to use cardiovascular stents that are able to adequately prop open the vessel, that can be accurately positioned and that, and this is new—can be viewed with nuclear spin tomography. Traditional stents are made of stainless steel and show distinct image distortions, so called artifacts. These artifacts occur when materials with high magnetic susceptibility are used.

A goal of the invention is to show means by which the occurrence of artifacts in combination with the stents and nuclear spin tomography can be avoided.

The solution is recapitulated in claims 1 through 5.

An alloy of 3 percent aluminum by weight and 2.5 percent vanadium by weight, with the remainder being titanium, known as material TIA13V2.5 or material No. 3.7194 or 253.7195 (ASTM Grade 9), shows especially few image artifacts and has sufficient hardness to be suitable for interventional instruments used in nuclear spin tomography.

The above named alloy according to ASTM Grade 9 is harder than an alloy according to ASTM Grade 5 or ISO 3.765 or 3.7165. This would have the following components: 90% titanium, 6% aluminum, and 4% vanadium. The material is more flexible than the so-called ASTM grade 9 material and is therefore more suitable for expanding a stent with the help of a balloon catheter.

Materials that are made to be artifact free but created with tools containing magnetizing components after processing show an increase in screen artifacts which rubbed off the tools. A reduction of surface magnetism can be achieved through dipping in etching solutions which etches the materials the tools are made of. The rub-off from the tools is eliminated by the wet chemical etching solution. Such an etching solution that removes the iron impurities consists for example of 3 parts hydrochloric acid and 2 parts saltpeter acid and can be further reduced with additional parts water in the etching process.

Stents manufactured in the manner here described can be ideally observed in nuclear spin tomography units in magnetic flux density >1.0 Testa. It was possible, for example with an unexpanded stent having a diameter of 1 mm, that was balloon expanded to a diameter of 4 mm, to clearly see all the stent struts, the so-called strats. It was also possible to get a good look inside the expanded stent. So-called in-stent-restenose in the interior of the stent can be seen when a stent has been treated in this manner.

Claims

1-5. (canceled)

6. A method for control of in-stent-restenosis, comprising: positioning a stent in a vessel, wherein the stent comprises TIA13V2.5; and viewing in-stent-restenosis within an inner lumen of the stent with nuclear spin tomography, wherein the TIA13V2.5 exhibits a low incidence of artifacts in nuclear spin tomography, wherein viewing in-stent-restenosis within the inner lumen of the stent with nuclear spin tomography is useful for control of in-stent-restenosis.

7. The method according to claim 6, wherein the stent consists essentially entirely of TIA13V2.5.

8. The method according to claim 6, wherein TIA13V2.5 has the following composition by weight: up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.

9. The method according to claim 7, wherein TIA13V2.5 has the following composition by weight: up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.

10. A method for control of in-stent-restenosis, comprising: positioning a stent in a vessel, wherein the stent comprises TIA16V4; and viewing in-stent-restenosis within an inner lumen of the stent with nuclear spin tomography, wherein the TIA16V4 exhibits a low incidence of artifacts in nuclear spin tomography, wherein viewing in-stent-restenosis within the inner lumen of the stent with nuclear spin tomography is useful for control of in-stent-restenosis.

11. The method according to claim 10, wherein the stent is expandable with a balloon catheter.

12. The method according to claim 10, wherein the stent consists essentially entirely of TIA16V4.

13. The method according to claim 10, wherein the TIA16V4 has the following composition by weight: up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.

14. The method according to claim 12, wherein the TIA16V4 has the following composition by weight: up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.

15. A method of stenting a patient, comprising: stenting a patient with a stent, wherein the stent comprises: TIA13V2.5, wherein the TIA13V2.5 exhibits a low incidence of artifacts in nuclear spin tomography.

16. The method according to claim 15, wherein the stent consists essentially entirely of TIA13V2.5.

17. The method according to claim 15, wherein TIA13V2.5 has the following composition by weight: up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; less than 0.015% H2; and the balance Ti.

18. The method according to claim 16, wherein TIA13V2.5 has the following composition by weight: up to 0.08% C; up to 0.03% N2; up to 0.15% O2; 2.0% to 3.0% V; 2.5% to 3.5% Al; up to 0.25% Fe; up to 0.015% H2; and the balance Ti.

19. A method of stenting a patient, comprising: stenting a patient with a stent, wherein the stent comprises TIA16V4, wherein the TIA16V4 exhibits a low incidence of artifacts in nuclear spin tomography.

20. The method according to claim 19, wherein the stent is expandable with a balloon catheter.

21. The method according to claim 19, wherein the stent consists essentially entirely of TIA16V4.

22. The method according to claim 19, wherein the TIA16V4 has the following composition by weight: up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.

23. The method according to claim 21, wherein the TIA16V4 has the following composition by weight: up to 0.08% C; up to 0.05% N2; up to 0.2% O2; 3.5% to 4.5% V; 5.5% to 6.75% Al; up to 0.4% Fe; up to 0.015% H2; and the balance Ti.

24. A method of stenting a patient, comprising: stenting a patient with a stent processed with tools containing magnetizing components, wherein prior to stenting the patient exposing the surface of the stent processed with tools containing magnetizing components to an etching solution that etches the magnetizing components, wherein exposing the surface of the stent processed with tools containing magnetizing components reduces surface magnetism of the stent, wherein reducing surface magnetism of the stent reduces the occurrence of artifacts from the stent in nuclear spin tomography.

25. The method according to claim 24, wherein the etching solution etches iron impurities.

26. The method according to claim 25, wherein the etching solution comprises: 3 parts hydrochloric acid; and 2 parts saltpeter acid.

27. The method according to claim 26, wherein the etching solution further comprises water.