Radioactive vascular liner

• US 6,261,320 B1
• Filed: 02/19/1999
• Issued: 07/17/2001
• Est. Priority Date: 11/21/1996
• Status: Expired due to Fees

• Current Assignee: Radiance Medical Systems, Inc.
• Original Assignee: Radiance Medical Systems, Inc.
• Inventors: Trauthen, Brett A., Tam, Lisa A.
• Primary Examiner(s): Milano, Michael J.
• Application Number:
  US09/253,177
• Time in Patent Office: 879 Days
• Field of Search: 623/1.15, 623/1.2, 623/1.36, 623/1.39, 623/1.4
• US Class Current: 623/1.15
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 takes precedence
• CPC Class Codes: A61F 2/07 Stent-grafts
• 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 2/95 Instruments specially adapted for placement or removal of stents or stent-grafts
• CPC Class Codes: A61F 2002/075 the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/826 more than one stent being applied sequentially
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2210/0095 radioactive
• CPC Class Codes: A61F 2220/005 using adhesives
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

Disclosed is a radioactive tubular prosthesis formed by rolling a flexible sheet around a longitudinal axis. Preferably, the prosthesis is self expandable under the radially outwardly directed spring bias of the rolled sheet. At least a portion of the sheet is provided with a coating comprising at least one radioisotope.

Claims

1. A radioactive tubular prosthesis, comprising:

a flexible sheet having a first edge and a second edge, the sheet rollable into a tube such that the first edge is disposed on the inside of the tube and the second edge is disposed on the outside of the tube;

a first transition zone near the first edge; and

a second transition zone near the second edge;

wherein the first transition zone has an increasing flexibility in the direction of the first edge, and the second transition zone has an increasing flexibility in the direction of the second edge, wherein the increased flexibility is achieved by having increasingly less sheet material in the first and second transition zones in the direction of the first and second edges respectively, and at least a portion of the sheet has a radioactive coating.

2. A tubular prosthesis as in claim 1, wherein the sheet further comprises an intermediate zone of relatively constant flexibility between the first and second transition zones.

3. A tubular prosthesis as in claim 2, wherein the first transition zone has an axial length of no more than about 20% of the axial length of the sheet.

4. A tubular prosthesis as in claim 1, wherein the first transition zone comprises a series of apertures, said apertures becoming prooressively larger in the direction of the first edge.

5. A tubular prosthesis as in claim 1, wherein the first transition zone comprises a series of apertures, said apertures becoming more numerous in the direction of the first edge.

6. A tubular prosthesis as in claim 1, wherein the first transition zone comprises a series of trapezoidal apertures ninning axially along the length of the first transition zone, said trapezoidal apertures having their shorter parallel side pointing away from the first edge.

7. A tubular prosthesis as in claim 2, wherein the first transition zone is thinnest at the first edge, becoming progressively thicker in the direction of the intermediate zone.

8. A tubular prosthesis as in claim 5, wherein the apertures are sized within the range of from about 2 to 10 microns.

9. A self expandable radioactive tubular prosthesis having a plurality of ports through the side wall thereof, the prosthesis comprising a flexible sheet having a plurality of perforations therein rolled a first number of revolutions about an axis into a first, insertion diameter, the prosthesis radially expandable under its own bias by unrolling to a substantially cylindrical prosthesis having second, implanted diameter having a second, smaller number of revolutions, wherein some of the perforations are inclined at an anile with respect to the axis which is different from the inclination of other of the perforations with respect to the axis, and a sufficient number of perforations through adjacent layers of the sheet align to produce a plurality of ports extending all the way through the side wall of the prosthesis, the sheet provided with zones of differing spring strength so that an inner most revolution of the sheet conforms substantially to the cylinder, and at least a portion of the sheet has a coating comprising at least one radioisotope.

10. A tubular prosthesis, comprising:

a flexible sheet, having a longitudinal axis and at least first, second, and third groups of apertures extending therethrough;

the first group comprising a first plurality of parallel slots inclined at a first angle with respect to the longitudinal axis;

the second group comprising a second plurality of parallel slots inclined at a second angle with respect to the longitudinal axis;

the first, second, and third groups of apertures arranged on the sheet such that when the sheet is wrapped about an axis through at least about three revolutions to form a tubular prosthesis, apertures from the first, second, and third groups align to produce a plurality of ports extending through the side wall of the prosthesis; and

a radioactive coating on at least a portion of the sheet comprising at least one radioisotope.

11. A radioactive intraluminal stent implantable in a body vessel lumen, comprising:

a tubular body having a side wall and an inner lumen with an axial length extending between first and second ends of the tubular body, said tubular body formed of a sheet of bio-compatible material forming said side wall and inner lumen when placed in the vessel lumen in an expanded roll state, said sheet having a sheet length providing said first and second overlapping layers when said sheet is in the expanded roll state and a sheet width corresponding to said axial length; and

first and second perforation zones formed in first and second portions of said sheet displaced from one another along said sheet length, said first perforation zone having a first plurality of elongated perforations extending in parallel with one another in a first direction, and said second perforation zone having a second plurality of elongated perforations extending in parallel with one another in a second direction differing from said first direction; and

at least one transition zone on the sheet having a different spring force than at least one other portion of the sheet, transition zone exposed to the inner lumen; and

a radioactive coating on at least a portion of said sheet, wherein the first and second perforation zones substantially overlap one another when said sheet is rolled up into said tubular body having at least two layers in the vessel lumen and provide openings in said side wall through aligned portions of said elongated perforations.