Radiopaque stent markers

• US 6,334,871 B1
• Filed: 09/03/1996
• Issued: 01/01/2002
• Est. Priority Date: 03/13/1996
• Status: Expired due to Term

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Medtronic Incorporated (Medtronic Plc)
• Inventors: Beyar, Mordechay, Loshakove, Amir, Dor, Ofer, Globerman, Oren, Beyar, Rafael
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US08/697,989
• Time in Patent Office: 1,946 Days
• Field of Search: 623/11, 623/1, 623/12, 623/1.34, 623/1.1, 623/1.15
• US Class Current: 623/1.34
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• 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 2002/91583 by a bridge, whereby at least one of its ends is connected along the length of a strut between two consecutive apices within a band
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Stents which are inserted into a body lumen preferably are made of materials which are not radiopaque enough, such as stainless steel 316L. X-ray visualization of a stent enables an accurate positioning of the stent and also a follow-up of its functioning within the patient'"'"'s body. The radiopaque markers described here are rivets made of a material which is more radiopaque than the stent substance so the location of the stent can be identified. Preferably the stents are heat treated so that atoms from the stent material migrate into the marker material and vice versa.

Claims

1. A method for increasing the radiopacity of an implantable medical device produced from a material selected from the group comprising stainless steel 316L, nitinol, a cobalt-chromium alloy, and other materials of similar radiopacity, which comprises the steps of

(a) forming openings in at least the distal edges or ends of the device,

(b) inserting a different marker material with greater radiopacity than the rest of the device selected from the group comprising gold, gold alloys, tantalum, tantalum alloys, platinum, platinum alloys and other materials of similar radiopacity, into said openings to form a rivet in each opening, and

(c) heating the device from step (b) for a sufficient temperature and for a sufficient time to cause atoms from the device to migrate into the marker material and atoms from the marker material to migrate into the device.

2. The method of claim 1, wherein the heating in step (c) is under vacuum.

3. The method of claim 2, wherein the heating is at from about 10⁻

4 to 10<sup>−

6</sup> torr.

4. The method of claim 1, wherein the heating in step (c) is from about 700°

C. to 1200°

C. and for from about 1 minute to 2 hours.

5. An implantable medical device produced from a material selected from the group comprising stainless steel 316L, nitinol, a cobalt-chromium alloy, and other materials of similar radiopacity, with increased radiopacity, which comprises

openings formed in at least the distal edges or ends of the device and

a different marker material with greater radiopacity than the rest of the device of the device selected from the group comprising gold, gold alloys, tantalum, tantalum alloys, platinum, platinum alloys and other materials of similar radiopacity, compressed into said openings to form a rivet in each opening,

wherein atoms from the device have migrated into the marker material and atoms from the marker material have migrated into the device.

6. The device of claim 5, wherein the atoms have migrated from 10 to 1000 Å

.

7. The device of claim 5, which is a stent.

8. The device of claim 5, wherein there are at least two openings with a rivet in each opening.

9. The device of claim 5, wherein each opening is round and the rivet in each opening does not protrude from the outer surface of the stent.

10. The device of claim 5, wherein the respective edges of the opening are beveled.

11. The device of claim 5 further comprising a composite cover layer on the surface of the rivet, the composite cover layer comprising atoms from the device and atoms from the marker material.

12. In an implantable medical device, the improvement wherein the ends or edges of the device have openings and the openings contain markers comprised of material more radiopaque than the material of the device, wherein the devices have been heat treated so that atoms from the device migrate into the marker material and atoms from the marker material migrate into the device material.

13. A product prepared according to a process comprising the steps of:

a) forming an implantable medical device produced from a material selected from the group comprising stainless steel 316L, nitinol, a cobalt-chromium alloy, and other materials of similar radiopacity;

b) forming openings in at least the distal edges or ends of the device;

c) inserting a different marker material with greater radiopacity then the rest of the device selected from the group comprising gold, gold alloys, tantalum, tantalum alloys, platinum, platinum alloys and other materials of similar radiopacity, into said openings to form a rivet in each opening; and

d) heating the device from step c) for a sufficient time to cause atoms from the device to migrate into the marker material and atoms from the marker material to migrate into the device.

14. A method for increasing the radiopacity of an implantable medical device produced from a material selected from the group comprising stainless steel 316L, nitinol, a cobalt-chromium alloy, and other materials of similar radiopacity, which comprises the steps of

(a) forming openings in at least the distal edges or ends of the device,

(b) inserting a different marker material with greater radiopacity than the rest of the device selected from the group comprising gold, gold alloys, tantalum, tantalum alloys, platinum, platinum alloys and other materials of similar radiopacity, into said openings to form a rivet in each opening, and

(c) heating the device under vacuum from about 700°

C. to 1200°

C. and for from about 1 minute to 2 hours.

15. The method of claim 14, wherein the heating is at from about 10⁻

4 to 10<sup>−

6</sup> torr.

16. The method of claim 14, wherein the heating is from about 1050°

C. to 1100°

C.

17. The method of claim 14 wherein the heating is for from about 2 minutes to about 30 minutes.