Endovascular stent and delivery system

• US 5,100,429 A
• Filed: 10/20/1989
• Issued: 03/31/1992
• Est. Priority Date: 04/28/1989
• Status: Expired due to Fees

• Current Assignee: Medtronic Ave Incorporated (Medtronic Plc)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: Sinofsky, Edward L., McNamara, Edward I., Boseck, Gary L.
• Primary Examiner(s): Pellegrino, Stephen C.
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US07/424,660
• Time in Patent Office: 893 Days
• Field of Search: 604/96, 604/104, 128/DIG. 8, 606/191, 606/194, 606/195, 606/7, 606/8, 606/13-15, 623/1, 623/12
• US Class Current: 623/1.21
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 2017/005 hardenable using external energy source, e.g. laser, ultrasound
• CPC Class Codes: A61B 2017/00513 Tissue soldering
• CPC Class Codes: A61B 2017/00517 using laser
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/958 Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61M 2025/1013 with concentrically mounted balloons, e.g. being independently inflatable
• CPC Class Codes: Y10S 128/08 Collagen

Abstract

An uncured or partially cured, collagen-based material is delivered to a selected site in a blood vessel and is crosslinked in the blood vessel by laser energy or other suitable energy to form an endovascular stent. The collagen-based material can be delivered to the blood vessel as a coating on an inflatable balloon mounted on the distal end of a catheter. The collagen-based material can also be delivered to the blood vessel in liquid form and forced through a porous balloon to form a tubular configuration. The collagen-based material is preferably crosslinked by laser radiation carried through an optical fiber to a diffusing tip located within the balloon. In another embodiment, an endovascular stent is formed by rolling a flexible sheet of biologically-compatible material onto an outside surface of an inflatable balloon. A crosslinkable collagen-based adhesive is used to adhere overlapping portions of the sheet together in the blood vessel and can be used to attach the stent to an inside surface of the blood vessel. The collagen-based adhesive is crosslinked in the blood vessel by application of laser energy or other suitable energy. A photodegradable adhesive can be used on an inside surface of the stent to releasably attach the stent to the inflatable balloon.

Claims

1. A method for treating a selected region of a blood vessel, comprising the steps of:

applying a crosslinkable adhesive material to one side of a flexible sheet of biologically-compatible material;

rolling the sheet of biologically-compatible material so that portions of the sheet overlap to form a generally tubular body, said tubular body having said crosslinkable adhesive material between overlapping portions of the sheet;

delivering the tubular body to the selected region of the blood vessel; and

applying energy to the tubular body at the selected region of the blood vessel so as to crosslink the adhesive material and cause overlapping portions of the sheet to adhere together to thereby form a stent in the blood vessel.

2. A method as defined in claim 1 wherein the step of applying a crosslinkable adhesive material includes applying a crosslinkable collagen-based material.

3. A method as defined in claim 1 wherein the step of rolling the sheet of biologically-compatible material includes rolling the sheet onto an outer surface of an inflatable balloon located at or near the distal end of a catheter.

4. A method as defined in claim 3 wherein the step of delivering the tubular body includes advancing the catheter through the blood vessel until the balloon is positioned at the selected region.

5. A method as defined in claim 4 further including the step of inflating the balloon to thereby increase the diameter of the tubular body and urge the tubular body into contact with an inside surface of the blood vessel.

6. A method as defined in claim 1 wherein the step of applying energy includes applying light energy to the tubular body.

7. A method as defined in claim 1 wherein the step of applying energy includes applying diffused laser energy to the tubular body.

8. A method as defined in claim 3 further including the step of applying a photodegradable adhesive to the other side of the sheet of biologically-compatible material prior to the step of rolling the sheet onto an inflatable balloon so that said tubular body is adhered to said inflatable balloon by said photodegradable adhesive.

9. A method as defined in claim 8 wherein the step of applying energy to the tubular body includes applying energy i a first wavelength range selected to degrade said photodegradable adhesive and release said tubular body from said inflatable balloon in the selected region of the blood vessel.

10. A method as defined in claim 9 wherein said photodegradable adhesive includes a fluorescent material that is stimulated by energy in said first wavelength range to emit energy in a second wavelength range required for crosslinking of said crosslinkable adhesive material so that said photodegradable adhesive is degraded by energy in said first wavelength range and said crosslinkable adhesive material is crosslinked by energy emitted by said fluorescent material.

11. A method as define din claim 2 wherein said collagen-based material comprises a collagen containing riboflavin and the step of applying energy includes applying energy int he visible or near-ultraviolet wavelength range.

12. A method as defined in claim 8 wherein said photodegradable adhesive comprises a polyamide.

13. A method as defined in claim 8 wherein said photodegradable adhesive comprises nitrocellulose.

14. A method as defined in claim 10 wherein said fluorescent material comprises a laser dye.

15. A method as defined in claim 1 wherein said sheet has a continuous surface.

16. A method as defined in claim 1 wherein said sheet is patterned with a plurality of openings.

17. A method as defined in claim 1 wherein said crosslinkable adhesive material is applied to an outside surface of said tubular body and wherein the step of applying energy to the tubular body causes the tubular body to be attached to the blood vessel.

18. A combination of a stent and an apparatus for placing a stent in a selected region of a blood vessel, comprising:

a flexible, elongated tube having an inflatable balloon at or near its distal end;

a generally tubular body comprising a sheet of biologically-compatible material rolled onto said balloon so that portions of the sheet overlap, said tubular body having a crosslinkable adhesive material between overlapping portions of the sheet, said tubular body being releaseably adhered to the outside surface of said balloon;

means for inflating said balloon to thereby urge said tubular body into contact with an inside surface of said blood vessel; and

means for applying energy to the tubular body at the selected region of the blood vessel with said balloon inflated so as to crosslink the crosslinkable adhesive material and cause overlapping portions of the sheet to adhere together to thereby form a stent.

19. Apparatus as defined in claim 18 wherein said biologically-compatible material comprises polylactic acid.

20. Apparatus as defined in claim 18 wherein said crosslinkable adhesive material comprises a collagen-based material.

21. Apparatus as defined in claim 20 wherein said collagen-based material comprises a collagen containing riboflavin.

22. Apparatus as defined in claim 18 wherein said means for applying energy includes mean for applying light energy.

23. Apparatus as defined in claim 18 wherein said means for applying energy includes means for applying diffused laser energy.

24. Apparatus as defined in claim 18 wherein said tubular body is releaseably adhered to said balloon with a photodegradable adhesive.

25. Apparatus as defined in claim 24 wherein said photodegradable adhesive comprises a polyamide.

26. Apparatus as defined in claim 24 wherein said photodegradable adhesive comprises nitrocellulose.

27. Apparatus as defined in claim 24 wherein said photodegradable adhesive includes a fluorescent material that is stimulated by energy in a first wavelength range selected to degrade said photodegradable adhesive and release said stent, said fluorescent material emitting energy in a second wavelength range required for crosslinking of said crosslinkable adhesive material when stimulated by energy in said first wavelength range.

28. Apparatus as defined in claim 18 wherein said tubular body has said crosslinkable adhesive material on an outside surface thereof and said means for applying energy to the tubular body causes the tubular body to be attached to the blood vessel.

29. Apparatus as defined in claim 18 wherein said sheet has a continuous surface.

30. Apparatus as defined in claim 18 wherein said sheet is patterned with a plurality of openings.

31. An endovascular stent in a selected region of a blood vessel comprising a tubular body formed as a rolled sheet of biologically-compatible material wherein portions of the sheet overlap, said tubular body having a crosslinked adhesive material between overlapping portions of the sheet.

32. An endovascular stent as defined in claim 31 wherein said biologically-compatible material comprises a polymer.

33. An endovascular stent as defined in claim 31 wherein said biologically compatible material comprises polylactic acid.

34. An endovascular stent as defined in claim 31 wherein said crosslinked adhesive material comprises a collagen-based material.

35. An endovascular stent as defined in claim 34 wherein said collagen-based material comprises a collagen containing riboflavin.

36. An endovascular stent as defined in claim 31 further including a photodegradable adhesive on an inside surface of said tubular body.

37. An endovascular stent as defined in claim 36 wherein said photodegradable material comprises a polyamide.

38. An endovascular stent as defined in claim 36 wherein said photodegradable material comprises nitrocellulose.

39. An endovascular stent as defined in claim 36 wherein said photodegradable adhesive includes a fluorescent material that is stimulated by energy in a first wavelength range selected to degrade said photodegradable adhesive and release said stent, said fluorescent material emitting energy in a second wavelength range required for crosslinking of said crosslinkable adhesive material when stimulated by energy in said first wavelength range.

40. An endovascular stent as defined in claim 31 wherein said tubular body has said crosslinked adhesive material on an outside surface thereof.

41. An endovascular stent as defined in claim 31 wherein said sheet has a continuous surface.

42. An endovascular stent as defined in claim 31 wherein said sheet is patterned with a plurality of openings.

43. An endovascular stent as defined in claim 42 wherein said tubular configuration comprises a plurality of interconnected rings.

44. An endovascular stent as defined in claim 43 wherein interconnected rings have different widths to provide variable flexibility along the length of the stent.