Physical vapor deposition of radiopaque markings on a graft

• US 6,649,030 B1
• Filed: 08/31/2000
• Issued: 11/18/2003
• Est. Priority Date: 08/31/2000
• Status: Expired due to Fees

• Current Assignee: Lifeshield Sciences LLC (Acacia Research Corporation)
• Original Assignee: EndoVascular Technologies Incorporated (Boston Scientific Corporation)
• Inventors: Tesar, Aleta A
• Primary Examiner(s): MCDONALD, RODNEY GLENN
• Application Number:
  US09/652,945
• Time in Patent Office: 1,174 Days
• Field of Search: 204/192.14, 204/192.15, 427/2.1, 427/2.24, 427/2.25, 427/468, 427/250, 427/251
• US Class Current: 204/192.14
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/0095 Packages or dispensers for prostheses or other implants for intraocular lenses A61F2/1691; for dental surgery A61C19/02
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2002/065 Y-shaped blood vessels
• CPC Class Codes: A61F 2250/0097 Visible markings, e.g. indicia
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: C23C 14/205 by cathodic sputtering

Abstract

Physical vapor deposition of radiopaque markings onto a graft is described. A graft is placed into a chamber, and a radiopaque material is vaporized and then deposited onto the graft. The chamber is kept at a temperature below the damage threshold of the graft material. A template optionally placed on the graft may define the design of the deposited radiopaque markings. The deposited radiopaque markings of the present invention may have any design and may comprise any radiopaque material.

Claims

1. A method comprising:

providing a deposition chamber containing a source of a radiopaque metal;

introducing a graft comprising a polymeric material having a damage threshold into the chamber in contact with a conductive base plate;

evacuating the chamber;

vaporizing the radiopaque metal from the source to form a vaporized metal within the evacuated chamber;

depositing the vaporized metal onto the graft to form a radiopaque marking that is visible under a fluoroscope while maintaining a temperature that is not greater than the damage threshold; and

conducting heat from the graft into the conductive base plate.

2. The method as described in claim 1, wherein depositing comprises depositing an initial layer of the vaporized metal having a thickness that is at least 0.1 μ

m at an average initial rate in a range of about 0.1 nm to about 0.3 nm per second and then increasing the rate of deposition of the vaporized metal onto the graft.

3. The method as described in claim 1:

wherein introducing the graft into the chamber comprises introducing the graft into the chamber such that a first portion of the graft that is facing the source is shielded in order to reduce exposure to ultraviolet radiation generated at the source;

wherein depositing comprises depositing sputtered metal on a second portion of the graft that is not facing the source;

the method further comprising, after depositing the sputtered metal on the second portion, rotating the graft so that the first portion of the graft is not facing the source; and

wherein depositing further comprises depositing sputtered metal on the first portion of the graft after it has been rotated so that it is not facing the source.

4. The method as described in claim 1, wherein the graft comprises a tubular shaped portion and wherein said introducing includes positioning the graft relative to the source so that an opening faces the source.

5. The method as described in claim 1, wherein said introducing the graft into the chamber in contact with the conductive base plate comprises slipping the graft over the conductive base plate.

6. The method as described in claim 1:

wherein the graft comprises a tubular shaped portion;

wherein the conductive base plate has a cylindrical shaped portion that generally conforms to the tubular shaped portion of the graft; and

wherein introducing the graft into the chamber in contact with the conductive base plate comprises slipping the tubular shaped portion of the graft over the cylindrically shaped portion of the base plate.

7. The method as described in claim 1:

wherein the graft has a bifurcation and the conductive base plate has a conforming bifurcation; and

wherein introducing the graft into the chamber in contact with the conductive base plate comprises slipping the bifurcation of the graft over the conforming bifurcation of the conductive base plate.

8. The method as described in claim 1, wherein depositing the vaporized metal onto the graft to form the radiopaque marking comprises depositing a metal that is selected from the group consisting of platinum, iridium, tungsten, gold, and any combination thereof onto the graft at a deposition rate that is in a range of about 0.1 nm to about 5 nm per second to form a radiopaque marking having a thickness in a range of about 0.5 μ

m to about 1 mm.

9. The method as described in claim 1, wherein depositing the vaporized metal onto the graft to form the radiopaque marking comprises depositing platinum onto the graft to form a radiopaque marking having a thickness in a range of about 1 μ

m to about 10 μ

m.

10. The method as described in claim 1, further comprising moving the graft through the vaporized metal while depositing the vaporized metal onto the graft.

11. The method as described in claim 1:

further comprising placing a template having a design formed therethrough in a position relative to the graft prior to evacuating the chamber; and

wherein depositing comprises depositing the vaporized metal through the design in the template onto the graft.

12. The method as described in claim 1:

wherein the graft comprises a bifurcated graft having a main body and a bifurcation that defines a first leg and a second leg;

further comprising placing a template having a design formed therethrough in a position relative to the graft prior to evacuating the chamber; and

wherein depositing comprises depositing the vaporized metal through the design in the template onto the graft to deposit a differentiating marking on the first leg of the graft to allow the first leg to be differentiated from the second leg of the graft.

13. The method as described in claim 1, wherein the graft comprises a polyethylene terephthalate and the chamber is kept at a temperature that is not greater than about 150°

C.

14. The method as described in claim 1, wherein the conductive base plate comprises a material that is selected from the group consisting of stainless steel and aluminum.

15. The method as described in claim 1, wherein the graft is maintained at the temperature that is not greater than the damage threshold.

16. The method as described in claim 1, wherein the chamber is maintained at the temperature that is not greater than the damage threshold.

17. The method as described in claim 1, wherein depositing comprises depositing a portion of the vaporized metal at an initial rate of deposition and then depositing another portion at an increased rate of deposition.

18. The method as described in claim 1, wherein introducing comprises positioning the graft off-axis from the source.

19. The method as described in claim 1, wherein depositing comprises depositing vaporized platinum onto the graft to form the radiopaque marking having a thickness that is greater than 1 μ

m.

20. The method as described in claim 1, further comprising placing a template having a design therethrough in a position relative to the graft.

21. The method as described in claim 20, wherein the template comprises a conductive metal template, wherein said placing the template comprises placing the conductive metal template into contact with the graft, and wherein the method further comprises conducting heat from the graft into the template.

22. The method as described in claim 20, wherein placing the template in a position relative to the graft comprises fitting a tubular portion of the template over a tubular portion of the graft.

23. The method as described in claim 1, wherein depositing comprises forming a leg identification marking.

24. The method as described in claim 1, wherein depositing comprises forming an opening identification marking.

25. The method as described in claim 12, wherein the differentiating marking comprises a letter that is selected from the group consisting of a letter R and a letter L.

26. A method comprising:

providing a deposition chamber containing a source of a radiopaque metal and a conductive cylindrically shaped base plate;

placing a tubular shaped graft comprising a polymeric textile having a damage threshold into the chamber in contact with the cylindrically shaped base plate by slipping the tubular graft over the cylindrically shaped base plate;

placing a template having a design therethrough in a position relative to the graft;

evacuating the chamber;

vaporizing the radiopaque metal from the source to form a vaporized metal within the evacuated chamber;

depositing the vaporized metal through the design in the template onto the graft to form a radiopaque marking which is visible under a fluoroscope, wherein depositing includes depositing at an average deposition rate in a range of about 0.1 nm per second to about 5 nm per second, to form a radiopaque marking having a thickness in a range of about 0.5 μ

m to about 1 mm, while maintaining a temperature that is not greater than the damage threshold; and

conducting heat from the graft into the conductive base plate.

27. The method as described in claim 26, wherein depositing comprises depositing an initial layer of the vaporized metal having a thickness that is at least 0.1 μ

m at an average initial rate in a range of about 0.1 nm to about 0.3 nm per second and then increasing the rate of deposition of the vaporized metal onto the graft.

28. The method as described in claim 26:

wherein introducing the graft into the chamber comprises introducing the graft into the chamber such that a first portion of the graft that is facing the source is shielded in order to reduce exposure to ultraviolet radiaiation generated at the source;

wherein depositing comprises depositing sputtered metal on a second portion of the graft that is not facing the source;

the method further comprising, after depositing the sputtered metal on the second portion, rotating the graft so that the first portion of the graft is not facing the source; and

wherein depositing further comprises depositing sputtered metal on the first portion of the graft after it has been rotated so that it is not facing the source.

29. The method as described in claim 26, wherein the graft comprises a tubular shaped portion that is positioned relative to the source so that an opening faces the source.

30. The method as described in claim 26:

wherein placing the template in the position relative to the graft comprises placing a conductive template into contact with the graft; and

further comprising conducting heat from the graft into the conductive template.

31. The method as described in claim 26:

wherein the polymeric material comprises a polyethylene terephthalate and the damage threshold is about 150°

C.; and

wherein the radiopaque metal comprises platinum deposited while maintaining the temperature not greater than about 150°

C. as a layer having a thickness in a range about 1 μ

m to about 10 μ

m.

32. The method as described in claim 26, further comprising moving the graft through the vaporized metal while depositing the vaporized metal onto the graft.

33. The method as described in claim 26:

wherein the graft has a bifurcation and the conductive base plate has a conforming bifurcation; and

wherein introducing the graft into the chamber in contact with the conductive base plate comprises slipping the bifurcation of the graft over the conforming bifurcation of the conductive base plate.

34. The method as described in claim 26:

wherein the graft comprises a bifurcated graft having a main body and bifurcation that defines a first leg and a second leg; and

further comprising placing a template having a design formed therethrough in a position relative to the graft prior to evacuating the chamber; and

wherein depositing comprises depositing the vaporized metal through the design in the template onto the graft including;

depositing a differentiating marking on the first leg of the graft to allow the first leg to be differentiated from the second leg of the graft,

depositing a first opening identification mark at an opening of the first leg to allow the opening of the first leg to be identified,

depositing a second opening identification mark at an opening of a main body to allow the opening of the main body to be identified, and

depositing a bifurcation identification mark at the bifurcation to allow the bifurcation to be identified.