Method and devices for preventing restenosis after angioplasty

• US 5,213,561 A
• Filed: 03/19/1992
• Issued: 05/25/1993
• Est. Priority Date: 09/06/1990
• Status: Expired due to Term

• Current Assignee: Joseph S. Weinstein, Martin H. Frank Jr
• Original Assignee: Joseph S. Weinstein, Martin H. Frank
• Inventors: Martin, H. Frank, Weinstein, Joseph S.
• Primary Examiner(s): Rosenbaum, C. Fred
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US07/855,445
• Time in Patent Office: 432 Days
• Field of Search: 606/108, 606/155, 606/191, 606/192, 606/194, 606/195, 606/198, 604/95, 128/898, 128/657, 128/770, 600/3, 600/7, 600/8
• US Class Current: 600/7
• CPC Class Codes: A61B 2017/22068 Centering
• CPC Class Codes: A61M 2025/1047 having centering means, e.g. balloons having an appropriate shape
• CPC Class Codes: A61M 25/104 used for angioplasty
• CPC Class Codes: A61N 2005/1004 having expandable radiation sources
• CPC Class Codes: A61N 5/1002 Intraluminal radiation therapy

Abstract

The incidence of restenosis after angioplasty is reduced by exposing the potentially stenotic site to radiation from a source within the same vascular structure in which the site is located. The radioactive source can be mounted at the distal end of a guidewire, or in a balloon catheter, or on a balloon expansible stent, and is inserted through the vascular structure to the site to be exposed.

Claims

1. A device for reducing the incidence of restenosis at a site within a vascular structure following percutaneous transluminal coronary or peripheral angioplasty of said site, comprising,

an elongated flexible member which is insertable longitudinally through vascular structure,

an intravascular radioactive source mounted at a distal end of said flexible member,

said source being positionable at an intravascular angioplasty site within said vascular structure for radiating said site by inserting said flexible member longitudinally through said structure,

radiation shielding means on said flexible member for selectively shielding and exposing said radioactive source,

said shielding means being a retractable sleeve around said radioactive source, said sleeve being selectively movable relative to said source to expose said source when said source has been positioned at said site, thereby to radiate said site,

said flexible member, source and shielding means having dimensions sufficiently small that said device is insertable longitudinally through said vascular structure.

2. The device of claim 1 wherein said flexible member is a guidewire,

said sleeve and radioactive source being mounted on and movable with said guidewire for withdrawal from said vascular structure.

3. The device of claim 1 wherein said flexible member is a guidewire.

4. The device of claim 3 wherein said guidewire comprises an outer sleeve around an inner wire.

5. The device of claim 4 wherein said radioactive source is mounted to a distal end of said inner wire.

6. The device of claim 1 wherein said radioactive source is Cobalt 60.

12. The device of claim 1 further including a shiftable sleeve around said tube, said sleeve having a shield for selectively exposing said source.

7. A device for reducing the incidence of restenosis at a site within a vascular structure following percutaneous transluminal coronary or peripheral angioplasty of said site, comprising,

an elongated flexible member which is insertable longitudinally through vascular structure,

an intravascular radioactive source mounted at a distal end of said flexible member,

said source being positionable at an intravascular angioplasty site within said vascular structure for radiating said site by inserting said flexible member longitudinally through said structure,

radiation shielding means on said flexible member for selectively shielding and exposing said radioactive source,

said shielding means being a retractable sleeve around said radioactive source, said sleeve being in the form of a coil having a radiation shielding coating, said sleeve being selectively axially shiftable relative to said source to expose said source when said source has been positioned at said site, thereby to radiate said site.

8. The device of claim 7 wherein said coating is a lead coating on a wire coil.

9. A device for reducing the incidence of restenosis at a site within a vascular structure following percutaneous transluminal coronary of peripheral angioplasty of said site, comprising,

an elongated flexible member which is insertable longitudinally through vascular structure,

an intravascular radioactive source mounted at a distal end of said flexible member,

said source being positionable at an intravascular angioplasty site within said vascular structure for radiating said site by inserting said flexible member longitudinally through said structure,

radiation shielding means on said flexible member for selectively shielding and exposing said radioactive source,

said shielding means being a retractable sleeve around said radioactive source, said sleeve being selectively movable relative to said source to expose said source when said source has been positioned at said site, thereby to radiate said site,

said flexible member being guidewire which extends axially through a balloon catheter.

10. A device for reducing the incidence of restenosis at a site within a vascular structure following percutaneous transluminal coronary or peripheral angioplasty of said site, comprising,

an elongated flexible member which is insertable longitudinally through vascular structure,

an intravascular radioactive source mounted at a distal end of said flexible member,

said source being positionable at an intravascular angioplasty site within said vascular structure for radiating said site by inserting said flexible member longitudinally through said structure,

radiation shielding means on said flexible member for selectively shielding and exposing said radioactive source,

said shielding means being a retractable sleeve around said radioactive source, said sleeve being selectively movable relative to said source to expose said source when said source has been positioned at said site, thereby to radiate said site,

said flexible member being a guidewire which comprises an outer sleeve around an inner wire, said sleeve comprising a wire coil.

11. A device for reducing the incidence of restenosis at a site within a vascular structure following percutaneous transluminal coronary or peripheral angioplasty of said site, comprising,

an elongated flexible member which is insertable longitudinally through vascular structure, said flexible member being a plastic tube of a catheter having a balloon at one end thereof,

an intravascular radioactive source mounted at a distal end of said flexible member,

said source being positionable at an intravascular angioplasty site within said vascular structure for radiating said site by inserting said flexible member longitudinally through said structure, said radioactive source being mounted to the distal end of said tube, inside said balloon.

radiation shielding means on said flexible member for selectively shielding and exposing said radioactive source,

said shielding means being a retractable sleeve around said radioactive source, said sleeve being selectively movable relative to said source to expose said source when said source has been positioned at said site, thereby to radiate said site.