Bioabsorbable marker having radiopaque constituents

• US 6,174,330 B1
• Filed: 08/01/1997
• Issued: 01/16/2001
• Est. Priority Date: 08/01/1997
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Schneider Electric SE
• Inventors: Stinson, Jonathan S.
• Primary Examiner(s): Prebilic, Paul B.
• Application Number:
  US08/904,951
• Time in Patent Office: 1,264 Days
• Field of Search: 623/1, 623/2, 623/12, 623/1.15, 623/1.34, 623/23.7, 623/23.71, 606/191, 606/198
• US Class Current: 623/1.34
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/1214 Coils or wires
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/86 Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/30062 (bio)absorbable, biodegradable, bioerodable, (bio)resorbable, resorptive
• CPC Class Codes: A61F 2002/3008 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2210/0004 bioabsorbable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61L 27/50 Materials characterised by their function or physical properties , e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
• CPC Class Codes: A61L 27/58 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers

Abstract

A temporary bioabsorbable-radiopaque marker for use on an implantable endoprosthesis. The bioabsorbable-radiopaque marker is adapted to be disposed on or adjacent an implantable endoprosthesis in a body lumen for a predetermined amount of time until the bioabsorbable and radiopaque materials are absorbed or dispersed in the body. The bioabsorbable material may include polylactide and the radiopaque material may include bismuth trioxide and barium sulfate. The weight percent of the radiopaque material in the bioabsorbable material may range from about 1% to about 80%. The radiopaque material may have a linear attenuation coefficient of from about 10 cm⁻¹ at 50 KeV to about 120 cm⁻¹ at 50 KeV.

Claims

1. An endoprosthesis and radiopaque marker assembly comprising:

an expandable endoprosthesis made of a substantially radiolucent material; and

at least one elongated radiopaque marker at least partially functionally cooperative together with the expandable endoprosthesis, the at least one elongated radiopaque marker comprising bioabsorbable material and radiopaque material and having a proximal end, a distal end, and a thickness, the radiopaque material including metallic particles of a size less than about 10 microns and having a linear attenuation coefficient ranging from about 5.46 cm<sup>−

1</sup> at 50 KeV to about 149.08 cm<sup>−

1</sup> at 50 KeV, the weight percentage of the metallic particles in the at least one elongated radiopaque marker ranging from about 1% to about 80%.

2. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the expandable endoprosthesis further includes a plurality of elongated filaments and wherein the at least one elongated radiopaque marker is disposed between at least two elongated filaments.

3. The endoprosthesis and radiopaque marker assembly of claim 2 wherein the at least one elongated radiopaque marker and one or more of the plurality of elongated filaments are at least partially braided to form a structure.

4. The endoprosthesis and radiopaque marker assembly of claim 2 wherein the plurality of elongated filaments are bioabsorbable.

5. The endoprosthesis and radiopaque marker assembly of claim 2 wherein the plurality of elongated filaments include a polymer or copolymer.

6. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the bioabsorbable material includes at least one of poly-L-lactide, poly-D-lactide, polyglycolide, polydioxanone, polycaprolactone, polygluconate, polylactic acid-polyethylene oxide copolymers, modified cellulose, collagen, poly(hydroxybutyrate), polyanhydride, polyphosphoester, poly(amino acids), and combinations thereof.

7. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the at least one elongated radiopaque marker has an average thickness of from about 20 microns to about 500 microns.

8. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the radiopaque material includes at least one of tantalum, bismuth, iridium, platinum, gold and combinations thereof.

9. The endoprosthesis and radiopaque marker assembly of claim 1 wherein one of the bioabsorbable material or radiopaque material is coated or compounded with the other.

10. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the at least one elongated radiopaque marker substantially degrades in less than about 3 years.

11. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the at least one elongated radiopaque marker includes at least one of a hollow, cavity, and porous portion and the radiopaque material is disposed therein.

12. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the at least one elongated radiopaque marker has radiopacity for at least one week after being disposed in the body lumen.

13. The endoprosthesis and radiopaque marker assembly of claim 2 wherein the endoprosthesis has a tubular structure.

14. The endoprosthesis and radiopaque marker assembly of claim 1 wherein the weight percentage of the metallic particles ranges from about 15% to about 60%.

15. An endoprosthesis and radiopaque marker assembly comprising:

An expandable endoprosthesis made of an at least partially radiolucent material and including a plurality of elongated filaments; and

at least one elongated radiopaque marker disposed between at least two of the elongated filaments at least partially functionally cooperative together with the endoprosthesis, the at least one elongated radiopaque marker comprising bioabsorbable material and radiopaque material and having a proximal end, a distal end, and a thickness, the radiopaque material having a linear attenuation coefficient ranging from about 5.46 cm<sup>−

1</sup> at 50 KeV to about 151.53 cm<sup>−

1</sup> at 50 KeV and a weight percentage of the radiopaque material in the at least one elongated radiopaque marker ranging from about 1% to about 80%.

16. The endoprosthesis and radiopaque marker assembly of claim 15 wherein the at least one elongated radiopaque marker and one or more of the plurality of elongated filaments are at least partially braided to form a structure.

17. The endoprosthesis and radiopaque marker assembly of claim 15 wherein the plurality of elongated filaments are bioabsorbable.

18. The endoprosthesis and radiopaque marker assembly of claim 17 wherein the bioabsorbable material is metabolized through or excreted from the body and the radiopaque material is excreted from or stored in the body.

19. The endoprosthesis and radiopaque marker assembly of claim 15 wherein the radiopaque material has a linear attenuation coefficient ranging from about 5.46 cm⁻

1 at 50 KeV to about 149.08<sup>−

1</sup> at 50 KeV.