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Method and devices for preventing restenosis after angioplasty
| Details |
Inventors: Weinstein, Joseph S.; Martin, H. Frank;
Assignee:
Primary Examiner: Rosenbaum; C. Fred
Assistant Examiner: Lewis; Wm.
Attorney, Agent or Firm: Wood, Herron & Evans
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. |
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DETAILED DESCRIPTION OF THE INVENTION FIG.
1 of the drawings shows a balloon catheter guidewire 1 which can be inserted through the center of a balloon catheter for steering the catheter through vascular structure to a site where an angioplasty is to be performed.
The guidewire 1 has an outer sleeve 3 around an inner or center wire 5.
The guidewire structure 1 is sized to fit within a balloon catheter tube to allow guidance or steering of the balloon catheter by manipulation of guidewire 1.
The outer sleeve 3 of the guidewire is preferably a tightly wound wire spiral or coil of stainless steel, with an inside diameter large enough so that it can be slid or shifted longitudinally with respect to the inner wire 5.
The distal end 7 of inner wire 5 is the portion of the guidewire 1 which is to be positioned for radiation treatment of the site of the angioplasty.
The distal end 7 has a radioactive material 9 such as Cobalt-60 which provides an intravascular radiation source, that is, it can be inserted through the vascular structure and will irradiate the site from within, as distinguished from an external radiation source.
Outer sleeve 3 has an end portion 11 at its distal end which is made of or coated with a radiation shielding substance for shielding the radioactive source 9.
In a preferred embodiment, the shielding section is lead or lead coated steel.
The remaining portion 13 of the outer sleeve 3, extending from shielding section 11 to the other end of guidewire 1 (opposite from distal end 7) can be of a non-shielding substance such as stainless steel wire.
By way of example, the guidewire may for example be 150 cm.
long with an 0.
010" inner wire, having a 30 mm.
long radioactive end 9, and a sleeve 3 of 0.
018" diameter having a lead coating 11 which is 30 cm.
long.
Except for the radioactive source 9 and retractable shielding 11 at the tip, guidewire 1 may be generally conventional.
As already noted, the outer sleeve 3 of the guidewire 1 is slidable over the inner wire 5, at least for a distance sufficient to cover and uncover radioactive material 9, so that the shielding section 11 of the outer sleeve can be moved away from the radioactive material 9 to expose the angioplasty site to radiation
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