Surgery – Diagnostic testing – Sensitivity to impact
Reexamination Certificate
1998-10-01
2001-07-03
Gilbert, Samuel G. (Department: 3736)
Surgery
Diagnostic testing
Sensitivity to impact
Reexamination Certificate
active
06254552
ABSTRACT:
FIELD OF THE INVENTION
This invention relates generally to intra-coronary radiation devices containing Ce-144 or Ru-106 and methods of using and making the same.
BACKGROUND OF THE INVENTION
The effectiveness of radiation in preventing restenosis following angioplasty was demonstrated in a 1995-1996 study conducted by Paul Teirstein of Scripps Clinic in which sources prepared from Ir-192 were used in patients previously receiving balloon angioplasty and stent implantation (Teirstein et al.,
N. Engl. J. Med.,
336:1697-1703 (1997)). The study showed that in patients receiving the radioactive source treatment, the restenosis rate dropped to 16.7% in the radiation treated group versus 53.6% of the patients in the “placebo” group not receiving radiation.
One of the problems with the current intra-coronary radiation devices (ICRD) is the exposure of the source to the medical personnel. For example, currently after administration of the Ir-192 source, the operators and physicians have to leave the treatment room to avoid getting an excessive dose.
Sr-90 and P-32 are among the other ICRD sources currently in clinical trials. Both of these sources has serious limitations. Sr-90 is problematic due to its high toxicity in the event of source and catheter rupture in the patient. P-32 may have a less than optimum beta energy to provide the proper dose profile, at least in larger calcified plaque occluded arteries.
It is desirable to develop an ICRD which can provide a 4:1 dose at 1 mm and 4 mm respectively in the artery, have a sufficiently long half-life to allow multiple patient use at minimum cost, and have minimum radiation exposure to the medical personnel.
SUMMARY OF THE INVENTION
Accordingly, one object of the present invention is to provide a novel intra-coronary radiation device.
It is another object of the present invention is to provide a method for treating arterial disease, which comprises administering to a host in need of such treatment a therapeutically effective intra-coronary radiation device.
It is another object of the present invention to provide a method of preparing an intra-coronary radiation device.
These and other objects, which will become apparent during the following detailed description, have been achieved by the inventors', discovery that an intra-coronary radiation device containing either Ce-144 or Ru-106 should be an economical and safe means of treating arterial disease.
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Furukawa et al., JP 62254773, (Chemical Abstracts, No. 109, XP002095177, 1988).
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Lewis Robert E.
Singh Prahlad R.
Tercho Gerald P.
Walsh Paul R.
Dolan Peter L.
E.I. Du Pont de Nemours and Company
Gilbert Samuel G.
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