Medicated porous metal prosthesis and a method of making the same

• US 7,699,890 B2
• Filed: 01/28/2004
• Issued: 04/20/2010
• Est. Priority Date: 04/15/1997
• Status: Expired due to Fees

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Yan, John Y.
• Primary Examiner(s): Woo; Julian W
• Application Number:
  US10/767,296
• Publication Number:
  US 20040186553A1
• Time in Patent Office: 2,274 Days
• Field of Search: 623/1.15, 623/1.4, 623/1.39, 623 142- 148, 623/3.13, 623/1.19, 424/422, 424/423, 424/489, 424/490, 604/175, 606/191
• US Class Current: 623/1.44
• 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 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2002/91533 characterised by the phase between adjacent bands
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/416 Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/45 Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/602 Type of release, e.g. controlled, sustained, slow
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 31/148 Materials at least partially resorbable by the body
• CPC Class Codes: A61L 31/16 Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: Y10T 29/49982 Coating
• CPC Class Codes: Y10T 428/12153 Interconnected void structure [e.g., permeable, etc.]
• CPC Class Codes: Y10T 428/12479 Porous [e.g., foamed, spongy, cracked, etc.]

Abstract

A porous prosthesis for delivering a medication to the site of implantation, and a method of making the same, is disclosed.

Claims

1. A stent comprising a strut element,

wherein the strut element includes a solid metallic inner core having an inner side and an opposed, outer side, an outer layer disposed on the outer side, the outer layer being a first porous layer of metallic material formed by particles, filaments or fibers sintered to the inner core, and an inner layer disposed on the inner side, the inner layer being a second porous layer of metallic material formed by particles, filaments or fibers sintered to the inner core,

wherein the strut is formed from a metallic sheet such that the solid core causes a therapeutic agent impregnated in the second porous layer to flow only in a radially inward direction after the stent has been implanted in a vessel, and

wherein the stent is configured for being radially expanded by a balloon and for providing support to a body vessel after the stent has been radially expanded by the balloon.

2. The stent of claim 1, wherein the stent is a coiled stent including a head portion, at least two slots and tail portions receivable in the slots.

3. The stent of claim 1, wherein the sintered particles, filaments or fibers forming the outer and inner layers are made from the same metallic material.

4. The stent of claim 1, wherein the pores of the porous layers hold the therapeutic agent that is released after the stent has reached an implant site.

5. The stent of claim 1, wherein one or more therapeutic agents are impregnated within one or both of the first porous layer of metallic material and second porous layer of metallic material.

6. A stent comprising:

a metallic sheet having opposed ends and forming a cylinder, the sheet including a solid metallic core and porous metallic layers formed by particles, filaments or fibers sintered to opposite sides of the core, wherein one or more therapeutic agents are impregnated within the porous metallic layers, wherein the stent is configured for being radially expanded by a balloon and for providing support to a body vessel after the stent has been radially expanded by the balloon, and wherein the porous layers include a first porous layer facing radially outward, a second porous layer facing radially inward, the solid core is disposed between and separating the first porous layer from the second porous layer and configured such that a first agent contained in the first layer only permeates radially outward and a second agent contained in the second layer only permeates radially inward.

7. The stent of claim 6, wherein the stent is a coiled stent including a head portion, at least two slots and tail portions receivable in the slots.