Multilayer composite tubular structure and method of making

• US 5,858,556 A
• Filed: 01/21/1997
• Issued: 01/12/1999
• Est. Priority Date: 01/21/1997
• Status: Expired due to Term

• Current Assignee: Texas Stent Technologies, Inc.
• Original Assignee: UTI Corporation (Integer Holdings Corporation Inc)
• Inventors: Farina, Jeffrey M., Thomas, John G., Kelly, Jeffrey C., Gadda, Joseph P., Eckert, John K.
• Primary Examiner(s): Zimmerman, John J.
• Application Number:
  US08/784,622
• Time in Patent Office: 721 Days
• Field of Search: 428/586, 428/685, 428/660, 428/661, 428/662, 428/670, 428/672, 148/521, 606/194, 606/195, 623/1, 623/12, 138/143, 228/194, 228/195, 228/193, 228/127
• US Class Current: 428/586
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• 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 2240/001 Designing or manufacturing processes
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers
• CPC Class Codes: A61F 2310/00017 Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: B32B 15/01 all layers being exclusively metallic making layered metal workpieces by pressure cladding B23K20/22; making coatings with a metallic material characterised by its composition C23C30/00
• CPC Class Codes: C21D 2251/02 Clad material
• CPC Class Codes: C21D 8/105 of ferrous alloys
• CPC Class Codes: Y10T 428/12292 Workpiece with longitudinal passageway or stopweld material [e.g., for tubular stock, etc.]
• CPC Class Codes: Y10T 428/12819 Group VB metal-base component
• CPC Class Codes: Y10T 428/12875 Platinum group metal-base component
• CPC Class Codes: Y10T 428/12889 Au-base component
• CPC Class Codes: Y10T 428/12979 Containing more than 10% nonferrous elements [e.g., high alloy, stainless]

Abstract

A multilayer composite tubular structure for use as a stent in surgical procedures has an outer layer of biocompatible material, a middle layer of radiopaque material, and an inner layer of biocompatible material. The layers are metallurgically bonded, to form a composite stent which is ductile and permits large deformation without delamination between the biocompatible and radiopaque layers. The composite structure formed is visible on a fluoroscope, yet does not obstruct the details of the stent itself, or of the anatomical features surrounding the stent.

A process of forming a multilayer composite tubular structure is also disclosed. A tube formed from radiopaque material is coaxially surrounded by a tube of biocompatible material. The tubes are simultaneously reduced, such as by tube drawing, swaging, or deep drawing, until a composite structure of a desirable diameter and wall thickness is formed. The tubes are then heat treated to cause diffusion bonding of the biocompatible and radiopaque layers.

Claims

1. A multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) an outer layer comprising a biocompatible material;

(b) a middle layer comprising a radiopaque material metallurgically bonded to the outer layer; and

(c) an inner layer comprising a biocompatible material metallurgically bonded to the middle layer.

2. The multilayer composite tubular structure according to claim 1, wherein the outer layer is stainless steel.

3. The multilayer composite tubular structure according to claim 1, wherein the inner layer is stainless steel.

4. The multilayer composite tubular structure according to claim 1, wherein the middle layer is selected from the group consisting of tantalum, gold, gold alloy, platinum, and platinum alloy.

5. The multilayer composite tubular structure according to claim 1, wherein the thickness of the radiopaque layer is selected to produce a luminosity on a fluoroscope.

6. A multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) an outer tube of biocompatible material;

(b) an inner tube of biocompatible material, the inner tube having a layer of radiopaque material deposited on the outer surface thereof, the radiopaque layer being metallurgically bonded to the outer tube.

7. The multilayer composite tubular structure according to claim 6, wherein the radiopaque material is deposited on the outer surface of the inner tube through a process selected from the group consisting of vapor deposition, electroplating, and spraying.

8. The multilayer composite tubular structure according to claim 6, wherein the outer tube is formed from stainless steel.

9. The multilayer composite tubular structure according to claim 6, wherein the inner tube is formed from stainless steel.

10. The multilayer composite tubular structure according to claim 6, wherein the radiopaque layer is selected from the group consisting of tantalum, gold, gold alloy, platinum, and platinum alloy.

11. The multilayer composite tubular structure according to claim 6, wherein the thickness of the radiopaque layer is selected to produce a luminosity on a fluoroscope.

12. A multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) an outer tube of biocompatible material, the outer tube having a layer of radiopaque material deposited on the inner surface thereof;

(b) an inner tube of biocompatible material, the radiopaque layer being metallurgically bonded to the inner tube.

13. The multilayer composite tubular structure according to claim 12, wherein the radiopaque material is deposited on the inner surface of the outer tube through selected from the group consisting of vapor deposition, electroplating, and spraying.

14. The multilayer composite tubular structure according to claim 12, wherein the outer tube is formed from stainless steel.

15. The multilayer composite tubular structure according to claim 12, wherein the inner tube is formed from stainless steel.

16. The multilayer composite tubular structure according to claim 12, wherein the radiopaque layer selected from the group consisting of tantalum, gold, gold alloy, platinum, and platinum alloy.

17. The multilayer composite tubular structure according to claim 12, wherein the thickness of the radiopaque layer is selected to produce a luminosity on a fluoroscope.

18. A multilayer composite tubular structure for use as a stent in surgical procedures, comprising a layer of radiopaque metallic material and a layer of biocompatible metallic material, each layer being metallurgically bonded to a suitable metallic interleaf between the radiopaque material and the biocompatible material.

19. The multilayer composite tubular structure according to claim 18, wherein the metallic interleaf is formed from gold.

20. The multilayer composite tubular structure according to claim 18, wherein the thickness of the radiopaque layer is selected to produce a luminosity on a fluoroscope.

21. The process of forming a multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) surrounding a tube of radiopaque material coaxially with a tube of biocompatible material;

(b) reducing the tubes simultaneously to a desired diameter and thereby producing a residual clamping stress between the tubes;

(c) heat treating the tubes to cause diffusion bonding of the tubes so that the composite tube formed is ductile and will permit deformation without delamination between the radiopaque and biocompatible materials.

22. The process of forming a multilayer composite tubular structure according to claim 21, wherein the layers are reduced by one of the steps of tube drawing and swaging.

23. The process of forming a multilayer composite tubular structure according to claim 21, wherein the residual clamping stress is at least 50 p.s.i.

24. The process of forming a multilayer composite tubular structure according to claim 21, wherein heat is applied in step (c) at a temperature of at least 1550°

F.

25. The process of forming a multilayer composite tubular structure according to claim 21, wherein heat is applied in step (c) at a temperature not greater than 1850°

F.

26. The process of forming a multilayer composite tubular structure according to claim 21, wherein heat is applied in step (c) for between 6 and 15 minutes.

27. The process of forming a multilayer composite tubular structure according to claim 21, wherein heat is applied in step (c) in the temperature range from about 1550°

F. to about 1850°

F. for between 6 to 15 minutes.

28. A process of forming a multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) depositing a radiopaque layer onto the outer surface of a first tube, the first tube formed from biocompatible material;

(b) coaxially surrounding the first tube with a second tube formed from biocompatible material;

(c) reducing the tubes simultaneously to a desired diameter and thereby producing a residual clamping stress between the tubes;

(d) heat treating the tubes to cause diffusion bonding of the radiopaque layer to the outer tube, to form a composite tube which is ductile and will permit deformation without delamination between the radiopaque and biocompatible materials.

29. The process of forming a multilayer composite tubular structure according to claim 28, wherein the radiopaque material is deposited on the outer surface of the first tube through a process selected from the group consisting of vapor deposition, electroplating, and spraying.

30. The process of forming a multilayer composite tubular structure according to claim 28, wherein the tubes are reduced by one of the steps of tube drawing and swaging.

31. The process of forming a multilayer composite tubular structure according to claim 28, wherein the residual clamping stress is at least 50 p.s.i.

32. The process of forming a multilayer composite tubular structure according to claim 28, wherein heat is applied in step (d) at a temperature of at least 1550°

F.

33. The process of forming a multilayer composite tubular structure according to claim 28, wherein heat is applied in step (d) at a temperature not greater than 1850°

F.

34. The process of forming a multilayer composite tubular structure according to claim 28, wherein heat is applied in step (d) for between 6 and 15 minutes.

35. The process of forming a multilayer composite tubular structure according to claim 28, wherein heat is applied in step (d) in the temperature range from about 1550°

F. to about 1850°

F. for between 6 to 15 minutes.

36. A process for forming a multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) depositing a radiopaque layer onto the inner surface of a first tube of biocompatible material;

(b) placing the first tube coaxially around a second tube of biocompatible material;

(c) reducing the tubes simultaneously to a desired diameter and thereby producing a residual clamping stress between the tubes;

(d) heat treating the tubes to cause diffusion bonding of the radiopaque layer and the inner surface of the outer tube, wherein the composite tube formed is ductile and will permit deformation without delamination between the radiopaque and biocompatible materials.

37. The process of forming a multilayer composite tubular structure according to claim 36, wherein the radiopaque material is deposited on the inner surface of the first tube through a process selected from the group consisting of vapor deposition, electroplating, and spraying.

38. The process of forming a multilayer composite tubular structure according to claim 36, wherein the tubes are reduced by one of the steps of tube drawing and swaging.

39. The process of forming a multilayer composite tubular structure according to claim 36, wherein the residual clamping stress is at least 50 p.s.i.

40. The process of forming a multilayer composite tubular structure according to claim 36, wherein heat is applied in step (d) at a temperature of at least 1550°

F.

41. The process of forming a multilayer composite tubular structure according to claim 36, wherein heat is applied in step (d) at a temperature not greater than 1850°

F.

42. The process of forming a multilayer composite tubular structure according to claim 36, wherein heat is applied in step (d) for between 6 and 15 minutes.

43. The process of forming a multilayer composite tubular structure according to claim 36, wherein heat is applied in step (d) in the temperature range from about 1550°

F. to about 1850°

F. for between 6 to 15 minutes.

44. A process of forming a multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) surrounding a tube of radiopaque material coaxially with a tube of biocompatible material;

(b) placing a metallic interleaf between the radiopaque and biocompatible tubes;

(c) reducing the tubes simultaneously to a desired diameter and thereby producing a residual clamping stress between the tubes;

(d) heat treating the tubes to cause diffusion bonding of the radiopaque layer and the biocompatible layer so that the composite tube formed is ductile and will permit deformation without delamination.

45. The process of forming a multilayer composite tubular structure according to claim 44, wherein the layers are reduced by one of the steps of tube drawing and swaging.

46. The process of forming a multilayer composite tubular structure according to claim 44, wherein the residual clamping stress is at least 50 p.s.i.

47. The process of forming a multilayer composite tubular structure according to claim 44, wherein heat is applied in step (d) at a temperature of a least 1550°

F.

48. The process of forming a multilayer composite tubular structure according to claim 44, wherein heat applied is applied in step (d) at a temperature not greater than 1850°

F.

49. The process of forming a multilayer composite tubular structure according to claim 44, wherein heat is applied in step (d) for between 6 and 15 minutes.

50. The process of forming a multilayer composite tubular structure according to claim 44, wherein heat is applied in step (d) in the temperature range from about 1550°

F. to about 1850°

F. for between 6 to 15 minutes.

51. A process for forming a multilayer composite tubular structure for use as a stent in surgical procedures, comprising:

(a) placing a strip having a layer of radiopaque material and a layer of biocompatible material over a die;

(b) reducing the strip by deep drawing the strip through a series of dies, thereby producing a clamping stress between the layers and forming a tube of desired wall thickness having a closed end;

(c) removing the closed end of the tube once the desired wall thickness has been achieved; and

(d) heat treating the tube to cause diffusion bonding of the radiopaque layer and the biocompatible layers so that the composite tube formed is ductile and will permit deformation without delamination between the radiopaque and biocompatible layers.

52. The process of forming a multilayer composite tubular structure according to claim 51, wherein the residual clamping stress is at least 50 p.s.i.

53. The process of forming a multilayer composite tubular structure according to claim 51, wherein heat is applied in step (d) at a temperature of at least 1550°

F.

54. The process of forming a multilayer composite tubular structure according to claim 51, wherein heat is applied in step (d) at a temperature not greater than 1850°

F.

55. The process of forming a multilayer composite tubular structure according to claim 51, wherein heat is applied in step (d) for between 6 and 15 minutes.

56. The process of forming a multilayer composite tubular structure according to claim 51, wherein heat is applied in step (d) in the temperature range from about 1550°

F. to about 1850°

F. for between 6 to 15 minutes.

57. A process of delivering a multilayer composite metallic tubular structure for use as a surgical stent to an anatomical site, comprising:

(a) providing a metallic tubular structure having metallurgically bonded metal biocompatible and radiopaque layers;

(b) deploying the structure to an anatomical site;

(c) expanding the structure with a balloon using a pressure not greater than 3.5 atmospheres until the walls of the structure contact tissue at the anatomical site; and

(d) imbedding the structure into said tissue at the anatomical site by further expanding the structure with a balloon using a pressure not greater than 7.5 atmospheres.