Combination self-expandable, balloon-expandable endoluminal device

• US 6,890,350 B1
• Filed: 10/31/2000
• Issued: 05/10/2005
• Est. Priority Date: 07/28/1999
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed, Inc. (Boston Scientific Corporation)
• Original Assignee: Scimed Life Systems Incorporated (Boston Scientific Corporation)
• Inventors: Walak, Steven E.
• Primary Examiner(s): McDermott, Corrine
• Assistant Examiner(s): Matthews, William H
• Application Number:
  US09/702,226
• Time in Patent Office: 1,652 Days
• Field of Search: 623/1.15, 623/1.18, 623/1.2, 623/1.44, 623/1.45, 623/1.46, 623/1.11
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/01 Filters implantable into blood vessels
• CPC Class Codes: A61F 2/90 characterised by a net-like or mesh-like structure
• 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 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/91541 Adjacent bands are arranged out of phase
• CPC Class Codes: A61F 2002/91558 connected peak to peak
• CPC Class Codes: A61F 2210/0019 operated at only one temperature whilst inside or touching the human body, e.g. constrained in a non-operative shape during surgery, another temperature only occurring before the operation
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/0054 V-shaped
• CPC Class Codes: A61F 2250/0018 differing in elasticity, stiffness or compressibility
• CPC Class Codes: A61F 2250/0048 differing in mechanical expandability, e.g. in mechanical, self- or balloon expandability
• CPC Class Codes: A61L 31/18 Materials at least partially X-ray or laser opaque

Abstract

An endoluminal device, such as a stent or a vena cava filter, comprising at least one superelastic section and at least one plastically deformable section. The superelastic section may comprise, for example, a superelastic grade of nitinol, whereas the plastically deformable section may comprise, for example, gold, platinum, tantalum, titanium, stainless steel, tungsten, a nickel alloy, a cobalt ally, a titanium alloy, or a combination thereof. Each plastically deformable section may merely comprise a constrained portion of the superelastic section comprising a plastically deformable material, such as gold. The device enables deployment by a method comprising introducing the device into a body lumen with the device radially constrained in a first configuration having a first diameter; allowing the device to self-expand into a second configuration having a second diameter less than or equal to a fully-self-expanded diameter; and then optionally “fine-tuning” the device by forcibly expanding the device into a third configuration having a third diameter in a range between the second diameter and less than or equal to a fully-forcibly-expanded diameter. The superelastic and plastically deformable sections may be tubular sections placed end-to-end, such that the plastically deformable section can be conformed to fit a tapered section of a lumen.

Claims

1. An endoluminal device comprising:

a framework having a central longitudinal axis, the framework forming a wall having a plurality of cells, the wall having a constant thickness, the cells extending through the thickness of the wall, the framework comprising a first section having a thickness and a second section having a thickness, the first section consisting of a superelastic material, the second section comprising a combination of a first portion of superelastic material and a second portion of plastically deformable material, the second portion being a constant distance from said central longitudinal axis along the length of the second section, the thickness of the first section being equal to the thickness of the second section.

2. The device of claim 1, wherein the portion of plastically deformable material has a greater x-ray visibility than the first section.

3. The device of claim 1, wherein each said superelastic section comprises a precision-cut sheet or a longitudinally severed precision-cut tube.

4. The device of claim 1, wherein the plastically deformable portion constrains the superelastic portion of the second section

5. The device of claim 4, wherein said combination is selected from a group consisting of:

plastically deformable material plated onto said superelastic material, a plastically deformable hypotube overlaid onto said superelastic material, ion implantation of said plastically deformable material into said superelastic material, and a composite comprising said deformable material and said superelastic material.

6. The device of claim 4, wherein the combination further comprises a third portion of superelastic material, wherein the second portion of plastically deformable material is sandwiched between the first and third portions of the superelastic material.

7. The device of claim 4, wherein the plastically deformable material is gold.

8. The device of claim 1 having a first constrained diameter, a second fully-self-expanded diameter, and a third fully-forcibly-expanded diameter, wherein said third diameter is greater than said second diameter and said second diameter is greater than said first diameter.

9. The device of claim 1, wherein said superelastic material comprises nitinol and said plastically deformable material is selected from the group consisting of:

gold, platinum, tantalum, titanium, stainless steel, tungsten, palladium, a nickel alloy, a titanium alloy, a cobalt alloy, and a combination thereof.

10. The device of claim 1, wherein the device is selected from the group consisting of:

a stent and a vena cava filter.

11. The device of claim 1, wherein said at least one superelastic section comprises a first tubular section and said at least one plastically deformable section comprises a second tubular section.

12. The device of claim 11, wherein the first tubular section consists essentially of a superelastic material alone and the second tubular section consists essentially of plastically deformable material alone.

13. An endoluminal device comprising:

a framework cut from a tube having a central longitudinal axis, the framework comprising a first section having a thickness and a second section having a thickness, the first section consisting of a superelastic material, the second section comprising a combination of a first portion of superelastic material and a second portion of plastically deformable material, the second portion being a constant distance from said central longitudinal axis along the length of the second section, the thickness of the first section being equal to the thickness of the second section.

14. The device of claim 13, wherein the second portion has a greater x-ray visibility than the first section.

15. The device of claim 13, wherein the plastically deformable portion constrains the superelastic portion of the second section.

16. The device of claim 15, wherein said combination is selected from a group consisting of:

plastically deformable material plated onto said superelastic material, a plastically deformable hypotube overlaid onto said superelastic material, ion implantation of said plastically deformable material into said superelastic material, and a composite comprising said deformable material and said superelastic material.

17. The device of claim 15, wherein the combination further comprises a third portion of superelastic material, wherein the second portion of plastically deformable material is sandwiched between the first and third portions of the superelastic material.

18. The device of claim 15, wherein the plastically deformable material is gold.

19. The device of claim 13, having a first constrained diameter, a second fully-self-expanded diameter, and a third fully-forcibly-expanded diameter, wherein said third diameter is greater than said second diameter and said second diameter is greater than said first diameter.

20. The device of claim 13, wherein said superelastic material comprises nitinol and said plastically deformable material is selected from the group consisting of:

gold, platinum, tantalum, titanium, stainless steel, tungsten, palladium, a nickel alloy, a titanium alloy, a cobalt alloy, and a combination thereof.

21. The device of claim 13, wherein the device is selected from the group consisting of:

a stent and a vena cava filter.

22. An endoluminal device comprising:

a framework having a central longitudinal axis, the framework forming an apertured wall, the apertured wall having a constant thickness, the apertures extending through the thickness of the wall, the framework comprising a first section having a thickness and a second section having a thickness, the first section consisting of a superelastic material, the second section comprising a combination of a first portion of superelastic material and a second portion of plastically deformable material, the second portion and being a constant distance from said central longitudinal axis along the length of the second section, the thickness of the first section being equal to the thickness of the second section.