Device for conveying radioactive agents on angioplasty stents, respective method and kit

• US 20030009076A1
• Filed: 09/06/2002
• Published: 01/09/2003
• Est. Priority Date: 11/23/1999
• Status: Active Grant

• Current Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Original Assignee: Sorin Biomedica Cardio Srl (LivaNova Plc)
• Inventors: Curcio, Maria, Rolando, Giovanni, Chinaglia, Benito, Vallana, Franco
• Granted Patent: US 6,585,632 B2
• Time in Patent Office: Days
• US Class Current: 600/3
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/92 Stents in the form of a rolled-up sheet expanding after insertion into the vessel , e.g. with a spiral shape in cross-section
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2250/0039 differing in diameter
• CPC Class Codes: A61K 51/1272 Sponges
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

A device, method, and kit for conveying a radioactive agent to a site of stenosis. The device includes a body portion to be disposed about the surface of a stent. The device comprises a radioactive agent. The device is capable of expanding, thus following the deployment movement of the stent, and is used to counter restenosis.

Claims

1. A method of delivering a radioactive agent to a stenotic site comprising:

providing a stent having a longitudinal axis, an inner surface and an outer surface, the stent being capable of being dilated from a radially-contracted position to a radially-expanded position;

providing a device comprising a body portion having first and second ends, a longitudinal axis and an inner surface and an outer surface, the body portion configured to be disposed such that one of the inner and outer surfaces of the body portion is adjacent one of the inner and outer surfaces of the stent and configured to be dilated upon delivery of the stent at the stenotic site, the body portion comprising a material adapted to convey an effective amount of the radioactive agent to the stenotic site, the amount of radioactive agent conveyed by the body portion being dependent on the density of the material comprising the body portion, the material having a first density along a first section of the body portion and a second density along a second section of the body portion, the first density being different from the second density, such that the amount of radioactive agent conveyed by the first section is different than the amount of radioactive agent conveyed by the second section;

advancing the stent and the device through a patient'"'"'s vasculature to the site of stenosis; and

dilating the stent and the device at the site of stenosis such that a surface of the body portion of the device is positioned adjacent a surface of the stent.

2. The method of claim 1 wherein the radioactive agent is yttrium 90.

3. The method of claim 1 wherein the step of providing the stent further comprises providing the stent comprising a sheet formed into a tubular structure.

4. The method of claim 1 wherein the step of providing the stent further comprises providing the stent formed from a tubular blank.

5. The method of claim 1 wherein, in the step of providing the device, the first section comprises a tubular coil with a sinusoidal shape having a first frequency and the second section comprises a tubular coil with a sinusoidal shape having a second frequency, the first frequency being different from the second frequency

6. The method of claim 1 wherein, in the step of providing the device, the first section comprises a wire having a first cross-section and forming a tubular coil with a sinusoidal shape, and the second section comprises a wire having a second cross-section and forming a tubular coil with a sinusoidal shape, the first cross-section being different from the second cross-section.

7. The method of claim 1 wherein, in the step of providing the device, the first section comprises a matrix containing the radioactive agent and the second section comprises a matrix containing the radioactive agent, and wherein the density of the radioactive agent in the first section is different than the density of the radioactive agent in the second section.

15. The kit of claim 1 wherein the first section of the body portion comprises a matrix containing the radioactive agent and the second section of the body portion comprises a matrix containing the radioactive agent, and wherein the density of the radioactive agent in the first section is different than the density of the radioactive agent in the second section.

8. A kit for conveying a radioactive agent onto a stent having a longitudinal axis and an inner surface and an outer surface, the stent being capable of being dilated from a radially-contracted position to a radially-expanded position, the kit comprising:

a body portion having first and second ends, a longitudinal axis and an inner surface and an outer surface, the body portion configured to be disposed such that one of the inner and outer surfaces of the body portion is adjacent one of the inner and outer surfaces of the stent and configured to be dilated upon delivery of the stent at the stenotic site, the body portion comprising a material adapted to convey an effective amount of the radioactive agent to the stenotic site, the amount of radioactive agent conveyed by the body portion being dependent on the density of the material comprising the body portion, the material having a first density along a first section of the body portion and a second density along a second section of the body portion, the first density being different from the second density, such that the amount of radioactive agent conveyed by the first section is different than the amount of radioactive agent conveyed by the second section; and

a container configured to house the device.

9. The kit of claim 8 further comprising the stent.

10. The kit of claim 8 further comprising a catheter adapted to deliver the stent and the device to the site of restenosis.

11. The kit of claim 10 wherein the inner surface of the device is configured to be disposed over the outer surface of the stent.

12. The kit of claim 8 wherein the radioactive agent is yttrium 90.

13. The kit of claim 8 wherein the first section of the body portion comprises a tubular coil with a sinusoidal shape having a first frequency and the second section of the body portion comprises a tubular coil with a sinusoidal shape having a second frequency, the first frequency being different from the second frequency.

14. The kit of claim 8 wherein the first section of the body portion comprises a wire having a first cross-section and forming a tubular coil with a sinusoidal shape, and the second section of the body portion comprises a wire having a second cross-section and forming a tubular coil with a sinusoidal shape, the first cross-section being different from the second cross-section.

17. The method of claim 16 wherein the radioactive agent is yttrium 90.

18. The method of claim 16 wherein the step of providing the stent further comprises providing the stent comprising a sheet formed into a tubular structure.

19. The method of claim 16 wherein the step of providing the stent further comprises providing the stent formed from a tubular blank.

20. The method of claim 16 wherein, in the step of providing the device, the first section of the body portion comprises a tubular coil with a sinusoidal shape having a first frequency and the second section of the body portion comprises a tubular coil with a sinusoidal shape having a second frequency, the first frequency being greater than the second frequency.

21. The method of claim 16 wherein, in the step of providing the device, the first section of the body portion comprises a wire having a first cross-section and forming a tubular coil with a sinusoidal shape, and the second section of the body portion comprises a wire having a second cross-section and forming a tubular coil with a sinusoidal shape, the first cross-section being greater than the second cross-section.

16. A method of delivering a radioactive agent to a stenotic site comprising:

providing a stent having a longitudinal axis, an inner surface and an outer surface, the stent being capable of being dilated from a radially-contracted position to a radially-expanded position;

providing a device comprising a body portion having first and second ends, a longitudinal axis and an inner surface and an outer surface, the body portion configured to be disposed such that one of the inner and outer surfaces of the body portion is adjacent one of the inner and outer surfaces of the stent when the stent is in the deployed position within the vessel, the body portion having a first section having a first density of radioactive agent for imparting a first level of local radioactivity and a second section having a second density of radioactive agent for imparting a second level of local radioactivity, the first level of radioactivity being greater than the second level of radioactivity;

advancing the stent and the device through a patient'"'"'s vasculature to the site of stenosis; and

dilating the stent and the device at the site of stenosis such that a surface of the body portion of the device is positioned adjacent a surface of the stent.

22. A kit for conveying a radioactive agent onto a stent having a longitudinal axis and an inner surface and an outer surface, the stent being capable of being dilated from a radially-contracted position to a radially-expanded position, the kit comprising:

a body portion having first and second ends, a longitudinal axis and an inner surface and an outer surface, the body portion configured to be disposed such that one of the inner and outer surfaces of the body portion is adjacent one of the inner and outer surfaces of the stent when the stent is in the deployed position within the vessel, the body portion having a first section having a first density of radioactive agent for imparting a first level of local radioactivity and a second section having a second density of radioactive agent for imparting a second level of local radioactivity, the first level of radioactivity being greater than the second level of radioactivity; and

a container configured to house the device.

23. The kit of claim 22 further comprising the stent.

24. The kit of claim 22 further comprising a catheter adapted to deliver the stent and the device to the site of restenosis.

25. The kit of claim 24 wherein the inner surface of the device is configured to be disposed over the outer surface of the stent.

26. The kit of claim 22 wherein the radioactive agent is yttrium 90.

27. The kit of claim 22 wherein the first section of the body portion comprises a tubular coil with a sinusoidal shape having a first frequency and the second section of the body portion comprises a tubular coil with a sinusoidal shape having a second frequency, the first frequency being greater than the second frequency.

28. The kit of claim 22 wherein the first section of the body portion comprises a wire having a first cross-section and forming a tubular coil with a sinusoidal shape, and the second section of the body portion comprises a wire having a second cross-section and forming a tubular coil with a sinusoidal shape, the first cross-section being greater than the second cross-section.