Radioactive medical device and process

• US 6,010,445 A
• Filed: 11/12/1997
• Issued: 01/04/2000
• Est. Priority Date: 09/11/1997
• Status: Expired due to Fees

• Current Assignee: Implant Sciences Corporation
• Original Assignee: Implant Sciences Corporation
• Inventors: Bunker, Stephen N., Armini, Anthony J.
• Primary Examiner(s): Lacyk, John P.
• Application Number:
  US08/968,982
• Time in Patent Office: 783 Days
• Field of Search: 600/1-8, 606/191, 606/198, 623/1, 623/12
• US Class Current: 600/3
• CPC Class Codes: A61F 2/82 Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents stent-grafts for tubular structures of the body other than blood vessels A61F2/04; stent-grafts for blood vessels A61F2/07; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95; for closing wounds, or holding wounds closed A61B17/04 - A61B17/115; dilators A61M29/00
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61K 41/009 Neutron capture therapy, e.g. using uranium or non-boron material
• CPC Class Codes: A61K 51/1282 Devices used in vivo and carrying the radioactive therapeutic or diagnostic agent, therapeutic or in vivo diagnostic kits, stents
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy
• CPC Class Codes: G21G 1/06 by neutron irradiation
• CPC Class Codes: G21G 4/08 specially adapted for medical application radiation therapy using radioactive sources A61N5/10
• CPC Class Codes: Y10S 977/931 Medical device coating
• CPC Class Codes: Y10S 977/952 Display

Abstract

An implantable medical device according to the systems and methods described herein may include a metal body or stent that does not contain significant quantities of iron or chromium and that is initially formed from a non-radioactive structural material. A non-radioactive activatable additive (the precursor isotope) may be added into or onto the body of the medical device. Neutron activation of the body of the medical device with the incorporated non-radioactive isotope may then be accomplished, and, if the metal body of the medical device contains a significant quantity of nickel, a coating of a high-density material may be applied over the radioactive body of the medical device. In an alternate embodiment, a coating of certain types of high-density material may be applied prior to neutron activation. The coating of high-density material may serve several useful purposes, including containment of undesirable beta particles from spurious long-lived radioactive species, creation of a biologically inert surface, and enhancement of the x-ray radiopacity to improve the visibility of the implantable medical device.

Claims

1. An implantable device comprising:

a body comprising a nickel-containing metal alloy or a combination of metals which includes nickel;

a non-radioactive precursor isotope disposed within or about said body; and

a high-density metal coating disposed over at least a portion of said body containing said non-radioactive precursor isotope.

2. The implantable device of claim 1, wherein the body comprises at least about 8% by weight of nickel.

3. The implantable device of claim 1, wherein said body is substantially free of iron and chromium.

4. The implantable device of claim 1, wherein said alloy comprises nitinol.

5. The implantable device of claim 1, wherein said non-radioactive precursor comprises ¹⁸⁵ Re or ¹⁸⁷ Re.

6. The implantable device of claim 1, wherein said high density coating comprises a metal selected from the group consisting of palladium, platinum, iridium, praseodymium, rhodium, rhenium and gold.

7. The implantable device of claim 1, wherein said high density coating has a thickness sufficient to block beta particle emissions of nickel-63 from the device.

8. The implantable device of claim 7, wherein said high density coating is between approximately 5 micrometers and approximately 20 micrometers thick.

9. The implantable device of claim 1, further comprising an adhesion coating disposed between said body and said non-radioactive precursor isotope.

10. The implantable device of claim 9, wherein said adhesion coating comprises a material selected from the group consisting of:

aluminum, silicon, titanium, vanadium, manganese, copper, nickel, rhodium and combinations thereof.

11. The implantable device of claim 1, wherein said high density metal coating comprises the same metal as the non-radioactive precursor isotope.

12. The implantable device of claim 11, wherein said metal is rhenium.

13. A radioactive implant made by exposing to thermal neutrons a non-radioactive device comprising:

a body comprising a nickel-containing metal alloy or a combination of metals which includes nickel;

a non-radioactive precursor isotope disposed within or about said body; and

a high-density metal coating disposed over at least a portion of said body containing said non-radioactive precursor isotope;

said exposure to thermal neutrons being sufficient to transform at least a portion of the non-radioactive precursor isotope to a radioactive isotope.

14. The radioactive implant of claim 13, wherein said thermal neutron exposure exceeds a dose of about 8×

10¹³ neutrons/cm².

15. The radioactive implant of claim 13, wherein said high density coating has a thickness sufficient to block beta particle emissions of nickel-63 from the device.