Retrievable drug delivery stent

• US 5,882,335 A
• Filed: 02/29/1996
• Issued: 03/16/1999
• Est. Priority Date: 09/12/1994
• Status: Expired due to Term

• Current Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Original Assignee: Cordis Corporation (Cardinal Health, Inc.)
• Inventors: Rowland, Stephen M., Hennemann, Willard W. III, Leone, James E.
• Primary Examiner(s): STRIGHT, RONALD K
• Application Number:
  US08/608,850
• Time in Patent Office: 1,111 Days
• Field of Search: 606/191, 606/192, 606/193, 606/194, 606/195, 606/198, 606/108, 623/1, 623/11, 623/12, 623/66, 604/19, 604/54, 604/8, 604/96, 604/93, 604/104, 604/890.1, 604/891.1, 604/264, 604/280, 604/281, 604/282, 604/283, 604/95, 604/9, 604/10, 604/175
• US Class Current: 604/103.02
• CPC Class Codes: A61F 2/88 the wire-like elements formed as helical or spiral coils forming a net-like or mesh-like structure A61F2/90
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/958 Inflatable balloons for placing stents or stent-grafts
• 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 drug delivery stent assembly includes a hollow tubular wire stent which extends in a path defining a generally cylindrical envelope and which has side walls facing outwardly of the cylindrical envelope with holes therein for delivery of liquid to a site in a vessel where the stent is placed. The method for delivering a liquid solution to the interior wall surface of a vessel using the hollow tubular wire stent comprises: placing the stent on a balloon of a balloon on a wire guidewire or on a balloon catheter; inserting the stent on the balloon assembly at a desired site in a vessel; causing the balloon to expand the stent to a larger cylindrical shape; supplying liquid with a liquid supply source to the stent prior to or after placement of the stent so that liquid can be delivered from the outer holes in the stent to the site of placement of the stent in a vessel; disengaging the liquid supply source from the stent prior to or after placement of the stent in a vessel; and allowing the liquid solution to leak from the stent through the outwardly facing holes in the stent.

Claims

1. A retrievable drug delivery stent assembly comprising balloon catheter means having a balloon for supporting and deploying a stent supported on the balloon;

a hollow tubular wire stent which is removably mounted on the surface of the balloon, which extends in a path defining a generally cylindrical envelope and which has side walls facing outwardly of the cylindrical envelope with holes therein for delivery of liquid to a site of placement in a vessel where the stent is placed;

a distal end of said stent being closed;

a proximal end of said stent being open; and

a liquid delivery tubing being coupled by detachable coupling means to said proximal end of said stent.

2. The stent assembly of claim 1 further including a delivery sheath surrounding the stent and balloon assembly, at least during introduction of said stent assembly into a vessel.

3. The stent assembly of claim 2 wherein said sheath has a large proximal open end for receiving said stent assembly and a substantially closed distal end with an opening for a coiled spring wire tip to extend therethrough.

4. The stent assembly of claim 1 wherein said holes in said hollow tubular wire stent are made with a laser and are small enough to prevent rapid leakage of liquid from said stent, but large enough to allow slow leakage of the liquid solution from the stent over a period of several days to a week.

5. The stent assembly of claim 1 wherein said hollow tubular wire stent extends in an undulating helical path to form the cylindrical envelope.

6. The stent assembly of claim 1 wherein said hollow tubular wire stent extends back and forth in a circular fashion and axially forwardly to the distal end of the stent to form a continuous stent defining the cylindrical envelope with the ends of circular portions being connected by loops to next adjacent circular portions.

7. The stent assembly of claim 1 wherein said hollow tubular wire stent extends in a helical or coiled spring path to form a coiled spring type stent defining therein the cylindrical envelope.

8. The stent assembly of claim 1 wherein said stent is made of stainless steel.

9. The stent assembly of claim 1 wherein said stent is made of tantalum.

10. The stent assembly of claim 1 having at least two holes in the side walls of the stent facing inwardly of the cylindrical envelope near at least one end of a delivery sheath surrounding said stent and the balloon.

11. The stent assembly of claim 1 wherein said hollow tubular wire has an outer diameter of 0.008 inches±

0.002 inches and an inner diameter of 0.005 inches±

0.002 inches.

12. The stent assembly of claim 1 wherein said coupling means is made of a dissovable material whereby a body compatible solvent can be introduced into said stent after a predetermined period of time to dissolve said coupling means for facilitating removal of said liquid delivery tubing from said stent with said stent remaining in place in a vessel.

13. The stent assembly of claim 1 wherein said detachable coupling means includes a plug.

14. A retrievable drag delivery stent assembly comprising balloon catheter means having a balloon for supporting and deploying a stent supported on the balloon;

a hollow tubular wire stent which is removably mounted on the surface of the balloon, which extends in a path defining a generally cylindrical envelope and which has side walls facing outwardly of the cylindrical envelope with holes therein for delivery of liquid to a site of placement in a vessel where the stent is placed;

a distal end of said stent being closed;

a proximal end of said stent being open;

a liquid delivery tubing being coupled by coupling means to said proximal end of said stent;

a delivery sheath surrounding said stent and said balloon catheter means; and

,

said sheath having a large proximal open end for receiving said stent assembly and a substantially closed distal end with an opening therein for a wire tip to extend therethrough.