Stent for angioplasty and a production process therefor

• US 6,645,243 B2
• Filed: 01/08/1998
• Issued: 11/11/2003
• Est. Priority Date: 01/09/1997
• Status: Expired due to Term

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Vallana, Franco, Curcio, Maria, Rolando, Giovanni, Chinaglia, Benito
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): STEWART, ALVIN J
• Application Number:
  US09/004,376
• Publication Number:
  US 20030135254A1
• Time in Patent Office: 2,133 Days
• Field of Search: 623/1.1, 623/1.15, 623/1.34, 623/1.42, 623/1.44, 623/1.45, 623/1.46, 600/3
• US Class Current: 623/1.46
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2002/91516 the meander having a change in frequency along the band
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

The stent for angioplasty has a body in the form of a generally tubular casing capable of being dilated in use from a radially-contracted position to a radially-expanded position. The body includes a support structure made from a first material capable of withstanding this dilation without losing its structural integrity. A structure made from a second material which has been rendered radioactive following the exposure of the stent itself to a neutron flux is associated with at least a portion of the carrying structure.

Claims

1. A method for inhibiting restenosis in a lumen of a vessel comprising:

providing a stent formed from a first material, the stent having a body in the form of a substantially tubular casing capable of being dilated in use from a radially-contracted position to a radially-expanded position;

coating the stent with a second material capable of being made radioactive;

exposing the coated stent to a neutron flux so that the second material becomes radioactive;

determining an optimal radiation level for inhibiting restenosis in the lumen of the vessel;

implanting the exposed coated stent in the lumen of the vessel at a predetermined time after the exposing step, the predetermined time being selected such that the level of radioactivity of the second material has decayed to the optimal radiation level.

2. The method according to claim 1, wherein the coating step is done by one of galvanic techniques and sputtering.

3. The method according to claim 1, wherein the coating step is done by means of coextrusion.

4. The method according to claim 3, wherein the coextrusion forms a core of the second material within the first material.

5. The method according to claim 4, wherein the core has a diameter ranging from about 10 to about 100 micrometers.

6. The method according to claim 1, wherein the step of coating the stent with the second material is done by one of welding, mounting and inclusion.

7. The method according to claim 1, wherein the step of coating comprises coating a continuous layer of the second material on the stent.

8. The method according to claim 7, wherein the continuous layer is selected from iridium, tantalum, and mixtures thereof.

9. The method according to claim 7, wherein the continuous layer has a thickness between 0.4 and 1 micrometers.

10. The method according to claim 1 wherein the level of radioactivity is a result of beta radiation.

11. The method according to claim 1 wherein the second material is iridium 191.

12. The method according to claim 1 wherein the second material is tantalum 181.