Stent Design Allowing Extended Release of Drug and/or Enhanced Adhesion of Polymer to OD Surface

• US 20090076591A1
• Filed: 09/19/2007
• Published: 03/19/2009
• Est. Priority Date: 09/19/2007
• Status: Abandoned Application

• Current Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Original Assignee: Boston Scientific Scimed (Boston Scientific Corporation)
• Inventors: Knapp, David M., Bhave, Aparna, Kokate, Jaykeep Y., Heidner, Matt, Lindquist, Jeffrey S., Chen, John J., Gregorich, Daniel, Kveen, Graig L., Weber, Jan, Arcand, Benjamin, Girton, Timothy S., Eidenschink, Tracee, Miller, Matthew J., Harrison, Kent D., Anand, Umang, Kuehling, Michael, Rizq, Raed, Edelman, Peter
• Application Number:
  US11/857,736
• Publication Number:
  US 20090076591A1
• Time in Patent Office: Days
• US Class Current: 623/1.160
• 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 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0066 stapled
• CPC Class Codes: A61F 2220/0083 using hook and loop-type fasteners
• 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

Abstract

The invention is directed to mechanisms and methods that reduce the delamination of a therapeutic agent from a stent. The mechanisms include holes (channels, wells, and other hole configurations), protrusions, sintered metal cores, clamps/staples, pins, and stainless steel shields.

Claims

1. A stent, the stent comprising a plurality of members, at least one of the plurality of members comprising a first mechanism to reduce delamination of a substance and a second mechanism to reduce delamination of a substance, the first mechanism being different than the second mechanism, wherein the first mechanism to reduce delamination of a substance is selected from at least one member of the group consisting of holes, protrusions, stainless steel shields, clamps, pins, porous material, surface texture or roughness, and any combination thereof, and the second mechanism to reduce delamination of a substance is selected from at least one member of the group consisting of holes, protrusions, stainless steel shields, clamps, pins, porous material, surface texture or roughness, and any combination thereof.

2. The stent of claim 1, the substance selected from at least one member of the group consisting of non-genetic therapeutic agents, genetic therapeutic agents, cellular material, polymer agent and any combination thereof

3. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body the first member defining the at least one channel, the at least one channel comprising a first channel in the at least one surface of the first member, the first channel comprising an opening in the at least one surface of the body of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the at least one surface of the body of the first member to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being at least one hole, the body of the first member further defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface of the first member, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member, the at least one hole further comprising a second hole, the second hole at a second oblique angle to the at least one surface of the first member, the first hole and the second hole forming a passageway, the passageway having a configuration selected from at least one member of the group consisting of V-shaped, U-shaped, Y-shaped, y-shaped, X-shaped, L-shaped, T-shaped, irregular shaped and any combination thereof.

4. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body of the first member defining the at least one channel, the at least one channel comprising a first channel in the at least one surface of the first member, the first channel comprising an opening in the at least one surface of the body of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the at least one surface of the body of the first member to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof.

5. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body of the first member defining the at least one channel, the at least one channel comprising a first channel in the at least one surface of the first member, the first channel comprising an opening in the at least one surface of the body of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the at least one surface of the body of the first member to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being at least one shield, the at least one surface of the first member having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body of the first member, the transverse portion at an oblique angle to the body of the first member.

6. The stent of claim 1, the at least one of the plurality of members comprising a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body of the first member defining the at least one channel, the at least one channel comprising a first channel in the at least one surface, the first channel comprising an opening in the at least one surface of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the at least one surface of the body to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp comprising a first clamp, the first clamp having a body comprising a width, a first region and a second region, the width of the body of the first clamp greater than the width of the body of the first member, the first clamp further having a first arm and a second arm, the first arm engaged to the body of the first clamp at the first region, the second arm engaged to the body of the first clamp at the second region, the first and second arms extending at an oblique angle to the body of the first clamp, the first arm, the second arm and the body of the first clamp engaging the first clamp to the body of the first member.

7. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body of the first member defining the at least one channel, the first channel comprising an opening in the at least one surface of the body of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the at least one surface of the body of the first member to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being at least one pin, the at least one pin comprising a first pin, the first pin comprising a shaft and a head, the first member defining at least one hole, the at least one hole comprising a first hole, the first hole having a complementary shape to the shaft of the first pin so that the shaft can be inserted into the first hole.

8. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the at least one hole being a channel, the body of the first member defining the at least one channel, the at least one channel comprising a first channel in the at least one surface of the first member, the first channel comprising an opening in the at least one surface of the first member, a first side, a second side, a third side, a fourth side and a bottom surface, the distance from the first surface of the body of the first member to the bottom surface of the first channel determining a first depth, the first depth less than the thickness of the body of the first member, the distance from the first side to the third side determining a first width, the first width less than the width of the body of the first member, the distance from the second side to the fourth side determining a first length, the first length less than the length of the body of the first member;

the second mechanism being a porous material, at least a portion of the body of the first member comprising the porous material.

9. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the body of the first member defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface of the first member, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member.

the second mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof.

10. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the body of the first member defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member;

the second mechanism being at least one shield, the at least one surface having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body, the transverse portion at an oblique angle to the body of the first member.

11. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the body of the first member defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member;

the second mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp having a body comprising a width, a first region and a second region, the width of the body of the at least one clamp greater than the width of the body of the first member, the at least one clamp further having a first arm and a second arm, the first arm engaged to the body of the at least one clamp at the first region, the second arm engaged to the body of the at least one clamp at the second region, the first and second arms extending at an oblique angle to the body of the clamp, the first arm, the second arm and the body of the at least one clamp engaging the at least one clamp to the body of the first member.

12. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the body of the first member defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member;

the second mechanism being at least one pin, the at least one pin comprising a shaft and a head, the body of the first member defining at least one hole, the at least one hole having a complementary shape to the shaft of the at least one pin so that the shaft can be inserted into the at least one hole.

13. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one hole, the body of the first member defining the at least one hole, the at least one hole comprising a first hole, the first hole at a first oblique angle to the at least one surface, the first hole having a first depth, the first depth at most equal to the thickness of the body of the first member;

the second mechanism being a porous material, the first member comprising a first portion, the first portion of the body of the first member comprising the porous material.

14. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof,

the second mechanism being at least one shield, the at least one surface of the first member having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body of the first member, the transverse portion at an oblique angle to the body of the first member.

15. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof,

the second mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp having a body comprising a width, a first region and a second region, the width of the body of the at least one clamp greater than the width of the body of the first member, the at least one clamp further having a first arm and a second arm, the first arm engaged to the body of the clamp at the first region, the second arm engaged to the body of the clamp at the second region, the first and second arms extending at an oblique angle to the body of the clamp, the first arm, the second arm and the body of the at least one clamp engaging the at least one clamp to the body of the first member.

16. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof,

the second mechanism being at least one pin, the at least one pin comprising a shaft and a head, the body of the first member defining at least one hole, the at least one hole having a complementary shape to the shaft of the at least one pin so that the shaft can be inserted into the at least one hole.

17. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one protrusion, the at least one surface of the first member having the at least one protrusion, the at least one protrusion comprising a body, the body of the at least one protrusion having a configuration selected from at least one member of the group consisting of substantially round, substantially oval, substantially square, substantially rectangular, substantially triangular, substantially octagonal, substantially polygon, a plurality of peaks and valleys, and any combination thereof,

the second mechanism being a porous material, the first member comprising a first portion, the first portion of the body of the first member comprising the porous material.

18. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one shield, the at least one surface of the first member having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body of the first member, the transverse portion at an oblique angle to the body of the first member;

the second mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp having a body comprising a width, a first region and a second region, the width of the body of the at least one clamp greater than the width of the body of the first member, the at least one clamp further having a first arm and a second arm, the first arm engaged to the body of the at least one clamp at the first region, the second arm engaged to the body of the at least one clamp at the second region, the first and second arms extending at an oblique angle to the body of the at least one clamp, the first arm, the second arm and the body of the at least one clamp engaging the at least one clamp to the body of the first member.

19. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one shield, the at least one surface of the first member having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body of the first member, the transverse portion at an oblique angle to the body of the first member;

the second mechanism being at least one pin, the at least one pin comprising a shaft and a head, the body of the first member defining at least one hole, the at least one hole having a complementary shape to the shaft of the at least one pin so that the shaft can be inserted into the at least one hole.

20. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one shield, the at least one surface of the first member having the at least one shield, the at least one shield having an exterior surface and comprising a transverse portion and an elongated portion, the elongated portion parallel to the body of the first member, the transverse portion at an oblique angle to the body of the first member;

the second mechanism being a porous material, the first member comprising a first portion, the first portion of the body of the first member comprising the porous material.

21. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp having a body comprising a width, a first region and a second region, the width of the body of the at least one clamp greater than the width of the body of the first member, the at least one clamp further having a first arm and a second arm, the first arm engaged to the body of the at least one clamp at the first region, the second arm engaged to the body of the at least one clamp at the second region, the first and second arms extending at an oblique angle to the body of the at least one clamp, the first arm, the second arm and the body of the at least one clamp engaging the at least one clamp to the body of the first member;

the second mechanism being at least one pin, the at least one pin comprising a shaft and a head, the body of the first member defining at least one hole, the at least one hole having a complementary shape to the shaft of the at least one pin so that the shaft can be inserted into the at least one hole.

22. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one clamp, the body of the first member having the at least one clamp engaged thereto, the at least one clamp having a body comprising a width, a first region and a second region, the width of the body of the at least one clamp greater than the width of the body, the at least one clamp further having a first arm and a second arm, the first arm engaged to the body of the at least one clamp at the first region, the second arm engaged to the body of the at least one clamp at the second region, the first and second arms extending at an oblique angle to the body of the at least one clamp, the first arm, the second arm and the body of the at least one clamp engaging the at least one clamp to the body of the first member;

the second mechanism being a porous material, the first member comprising a first portion, the first portion of the body of the first member comprising the porous material.

23. The stent of claim 1, the at least one of the plurality of members being a first member, the first member having a body, the body having at least one surface, a length, a width and a thickness;

the first mechanism being at least one pin, the at least one pin comprising a shaft and a head, the body of the first member defining at least one hole, the at least one hole having a complementary shape to the shaft of the at least one pin so that the shaft can be inserted into the at least one hole;

the second mechanism being a porous material, the first member comprising a first portion, the first portion of the body of the first member comprising the porous material.