Intraluminar perforated radially expandable drug delivery prosthesis and a method for the production thereof

• US 8,267,991 B2
• Filed: 03/01/2010
• Issued: 09/18/2012
• Est. Priority Date: 03/06/2000
• Status: Expired due to Term

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: De Scheerder, Ivan, Sohier, Jurgen, van der Leden, Natasja, Van Humbeeck, Jan
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US12/714,954
• Publication Number:
  US 20100152836A1
• Time in Patent Office: 932 Days
• Field of Search: 623/1.15, 623/1.16, 623 138- 146, 623/1.13
• US Class Current: 623/1.42
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• 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 2230/0013 Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2250/0068 the pharmaceutical product being in a reservoir
• CPC Class Codes: A61L 2300/00 Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
• CPC Class Codes: A61L 2400/18 Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
• CPC Class Codes: A61L 31/022 Metals or alloys
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: Y10T 29/49996 Successive distinct removal operations

Abstract

A radially expandable prosthesis for implantation in a lumen comprises a tubular wall having an inner surface and an outer surface. The tubular wall is provided with cuts to form solid struts which have a thickness and which enables the prosthesis to expand. The solid struts have reservoirs made therethrough in the form of perforating holes for containing a therapeutic agent. The perforating holes each have an inner opening and an outer opening of substantially the same size. The prosthesis, including said perforating holes, has a smooth electrochemically polished surface.

Claims

1. A radially expandable prosthesis comprising:

a tubular wall comprising a plurality of adjacent filaments, each filament having a plurality of adjacent segments, two adjacent segments defining a segment pair, segments of segment pairs having connected ends and unconnected ends, the connected ends connected to one another via a curved section, the curved section comprising a proximal turn or a distal turn, each segment having an inflection point along its length, wherein the segments of the segment pairs are separated from one another, in a circumferential direction, by a greater distance at their connected ends than at their unconnected ends;

a plurality of axial elements joining the adjacent filaments, each axial element consisting of a single continuous curve;

a plurality of reservoirs disposed within the adjacent filaments; and

a titanium nitride coating disposed on the tubular wall, wherein the titanium nitride coating has a thickness between 1 to 10 μ

m.

2. The prosthesis of claim 1, wherein the titanium nitride coating is porous.

3. The prosthesis of claim 1, wherein the reservoirs are holes extending through the entire thickness of the adjacent filaments.

4. The prosthesis of claim 1, wherein a plurality of reservoirs are disposed only within the adjacent filaments and there are no reservoirs in the connectors.

5. The prosthesis of claim 1, wherein each filament has an outer surface, an inner surface, and a thickness therebetween, and each reservoir comprises an opening in an outer surface of the strut that extends through only a portion of the thickness of the filament.

6. A radially expandable prosthesis comprising:

a tubular wall having an outer surface, an inner surface, and a thickness therebetween, the tubular wall comprising a plurality of interconnected serpentine bands including first bands and second bands, each band comprising adjacent segments, two adjacent segments defining a segment pair, segments of segment pairs having connected ends and unconnected ends, the connected ends connected to one another via a curved section, the curved section comprising a proximal turn or a distal turn, each segment having an inflection point along its length, wherein the segments of the segment pairs are separated from one another, in a circumferential direction, by a greater distance at their connected ends than at their unconnected ends;

the bands connected one to another via a plurality of connectors, each connector consisting of a single continuous curve having a first end and a second end, wherein the first end is circumferentially aligned with the second end along a common longitude;

the first bands being immediately adjacent to two second bands, the second bands being immediately adjacent to two first bands, each first band being out of phase with each second band;

the connectors extending between distal valleys and proximal peaks of immediately adjacent bands;

every third distal valley of each of the first and second serpentine bands having one of the connectors attached thereto;

the serpentine bands comprising a plurality of reservoirs;

wherein the prosthesis has an electrochemically polished surface.

7. The prosthesis of claim 6, wherein the reservoirs are holes extending from the outer surface of the tubular wall, the reservoirs having a depth of at least 30% of the thickness of the tubular wall.

8. The prosthesis of claim 7, wherein the reservoirs have a depth of 50% of the thickness of the tubular wall.

9. The prosthesis of claim 7, wherein the reservoirs have a depth of 60% of the thickness of the tubular wall.

10. The prosthesis of claim 7, wherein the reservoirs extend through the entire thickness of the tubular wall.

11. The prosthesis of claim 6, wherein the reservoirs are filled with a therapeutic agent.

12. The prosthesis of claim 11, wherein at least one of the outer surface and the inner surface of the tubular wall is coated with a therapeutic agent.

13. The prosthesis of claim 6 further comprising a titanium nitride coating, wherein the titanium nitride coating has a thickness between 0.1 to 500 μ

m.

14. The prosthesis of claim 6, wherein the single continuous curve of each of the connectors has a connector peak.

15. The prosthesis of claim 14, wherein each of the connector peaks has the same orientation.

16. The prosthesis of claim 6, wherein a plurality of reservoirs are disposed only within the serpentine bands and there are no reservoirs in the connectors.

17. The prosthesis of claim 6, wherein the connectors connect one distal valley of the first band to a confronting proximal valley of the second band.