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|||||||||||||III USOO5302369A United States Patent (19) (11) Patent Number: 5,302,369 Day Et Al |||||||||||||III USOO5302369A United States Patent (19) (11) Patent Number: 5,302,369 Day et al. (45) Date of Patent: k Apr.p 12, 1994 (54) MERSHERES FOR RADIATION OTHER PUBLICATIONS RAPY Makishima et al., "Elastic Moduli and Refractive Indi (75) Inventors: Delbert E. Day, Rolla; Gary J. ces of Aluminosilicate Glasses Containing Y2O3, La2O3, Ehrhardt, Columbia, both of Mo. and TiO2'; Journal of the American Ceramic Society; 73) Assignee: The Curators of the University of vol. 61, pp. 247-249; May-Jun. 1978. Missouri, Columbia, Mo. Loehman, "Preparation and Properties of Yttri (*) Notice: The portion of the term of this patent um-Silicon-Aluinum Oxynitride Glasses"; Journal of subsequent to Dec. 6, 2005 has been the American Ceramic Society; vol. 62, pp. 491-494; disclaimed. Sep.-Oct. 1979. Makishima, et al., “Alkaline Durability of High Elastic R21 Appl.pp No.:O 751,721 Modulus Alumino-Silicatey s Glasses Containing Y2O3, (22 Filed: Aug. 29, 1991 La2O3 and TiO2'; Journal of Non-Crystalline Solids 38 & 39, pp. 661-666 (1980). Related U.S. Application Data Bonder, et al., "Phase Equilibria in the System Y2O (63) Stylist Ser. No. 280,005, FS, 59. al 3-Al2O3-SiO2'; I. V. Grebenschikov Institute of Sili Oe W1c is a contation o er. O. is aws's cate Chemistry, Academy of Sciences, USSR, trans Nov. 19, 1984, Pat. No. 4,789,501. lated from Izvestiya Akademii Nauk USSR, Seriya 51 int. Cl. ....................... A61K 43/00; A61N 5/00; Khimicheskaya, No. 7, pp. 1325-1326, Jul. 1964. CO3C 3/095; CO3C 3/097 52 U.S. Cl. ................................... 424/1.29; 252/645; (List continued on next page.) 501/64; 501/63; 501/33; 600/3 Primary Examiner-Robert L. Stoll - 58 Field of Search ................. 424/1.1; 428/406, 402; Assistant Examiner-John M. Covert 501/153, 55, 64, 68,33, 63,69; 128/657; 600/3; Attorney, Agent, or Firm-Senniger, Powers, Leavitt & 252/645 Roedel (56) References Cited 57) ABSTRACT U.S.S. PATPATENT D OCUMENTS Microspheres for radiation--- therapy of a mammal which- 3,334,050 8/1967 Grotenhuis ...................... 252/301; have a non-radioactive isotope which emits beta or : (39. 3. t al. .. E. gamma radiation of therapeutic intensity upon being 4,247,406a l/1981 WidderaPei. etT. al.. .. 424/1.1 irradiated. The microspheres also containA. elementst 4,314,909 2/982 Beail et al 252/629 which do not become radioactive upon irradiation. The 4,350,675 9/1982 Drake ............ 424/1.1 chemical durability of the microspheres is such that 4,362,659 12/1982 Macedeo et al. ... 252/644 they do not release a significant amount of radiation 4,403,615 9/1983 Hoehner ............ ... 28/692 emitting radioisotope into the mammal's system upon 4.406,697 9/1983 Parak et al. ... 252/644 administration. Microspheres containing phosphorus or 4,464,294 8/1984. Thielew ................ ... 252A629 yttrium; and carbon, nitrogen, fluorine, sodium, magne : (7. Mahipal "E. sium, aluminum, silicon, potassium, Vanadium, manga 4,772.5i 5/1988 Woodea. 428/325 nese, gallium, niobium, iodine and/or lead. FOREIGN PATENT DOCUMENTS 48556 8/1975 U.S.S.R. .............................. SO/33 20 Claims, 5 Drawing Sheets sevgeavey/var-ea --9aa/waaaaya/ra 42e a 77//77 aw Wrreza agaas (as -) vs. 44.44a/M3 77a fall - - - - - - - - - - - - - - all or - - - - - - - - - - * aaaafaa 1 a r 4a a 4e 64 aa vaar (za /42 (44 via 2. aaaaaa-3 ?aia, Ayolas 5,302,369 Page 2 OTHER PUBLICATIONS State Scientific-Research and Design Institute of the Sedykh, et al., "Refractive Indices in the System Rare Metals Industry-Dedykh et al., Refractive Indi Y203-SiO2-Al2O3" in the Vitrification Region; State cies in the System Y2O3-SiO2-Al2O3 in the Vitrification Scientific-Research and Design Institute of the Rare Region. Translated from Izvestiya Akademi Nauk Metals Industry, Translated from Izvestiya Akademii, USSR, Neorganicheskie Materially, vol. 11, No. 6, pp. Nauk USSR, Neorganicheskie Materially, vol. 11, No. 1153-1154 Jun. 1975. 6, pp. 1153-1154, Jun., 1975. The American Surgeon-Nolan et al., Intravascular TR Mosk, Khim-Tekhnol, 76, 48-57, Beirit et al., “Ef. Particulate Radioisotope Therapy, Mar. 1969, vol. 34 fect of Phosphorus Pentoxide On Glasses" (Russian) No. 3 pp. 181-188. 1973. The American Surgeon-Grady et al., Intra-Arterial TR Mosk, Khim-Tekhnol 76, 44-47 Zhurba et al., “Ef Radioisotopes To Treat Cancer, Oct. 1960 vol. 26 pp. fect of Titanium Dioxide On Systems', (Russian) 1973. 678-684. I. V. Grenbenschikov Institute of Silicate Chemistry, Int. J. Appl. Rafiat. Isot-Zielinski et al., Synthesis and Academy of Sciences, USSR-Bonder et al., Phase Quality Control Testing of 32P Labeled Ion Exchange Equilibria In The System Y2O3-Al2O3-SiO2, Jul. 1964, Resin Microspheres for Radiation Therapy of Hepatic pp. 1325-1326. Neoplasms, vol. 34, No. 9, pp. 1343-1350, 1983. U.S. Patent Apr. 12, 1994 Sheet 1 of 5 5,302,369 F G P 5/42 U.S. Patent Apr. 12, 1994 Sheet 2 of 5 5,302,369 F. G. 2 C/A767-3 O 476-/o O- O 6.42.É.4/476-24-0 4/26-24 e/476-/7 /4 22 32 22 77% (22-3) U.S. Patent Apr. 12, 1994 Sheet 3 of 5 5,302,369 F. G. 3 24 74) 44 N 3.4 O -1 4/M-2a -/4 O VN /.4 () u-8 4/, geas 24 - Q Y tyN N O.3 O 4/47a-24 SN 22 Q Š O a 44a/a/2/714/47/7 4. / Q 77474 (244-3) U.S. Patent Apr. 12, 1994 Sheet 4 of 5 5,302,369 S2/72,7%72,zz^///>&#77 †7'9)|— AM/22222 dé --, -o 72/127/v24/27cs U.S. Patent Apr. 12, 1994 Sheet 5 of 5 5,302,369 F. G. 5 A472a aa Za1aa Zaaaaa,7a 24 aeos-22-7-77e/27 g4/74a aZaz/42. 244 A.2c/as /44 .S.s 420 /4) 49 42 /44 /46 266 77A-7a, Ayoz/e6 5,302,369 1 2 In still another application, microspheres have been MICROSPHERES FOR RADIATION THERAPY prepared comprising a ceramic material and having a radioactive isotope incorporated into the ceramic mate This is a continuation application of application Ser. rial. While the release of radioactive isotopes from a No. 280,005, filed Dec. 5, 1988, now abandoned, which radioactive coating into other parts of the human body was a continuation application of application Ser. No. may be eliminated by incorporating the radioisotopes 673,123, filed Nov. 19, 1984, now U.S. Pat. No. into ceramic spheres, the latter product form is never theless not without its disadvantages. Processing of 4,789,501. these ceramic microspheres is complicated because BACKGROUND OF THE INVENTION 10 potentially volatile radioactivity must be added to ce The present invention relates generally to micro ramic melts and the microspheres must be produced and spheres useful in the treatment of cancerous and tumor sized while radioactive, with concomitant hazards of bearing tissue and more particularly to novel glass mi exposure to personnel and danger of radioactive con crospheres useful in this treatment. tamination of facilities. In the treatment of patients with certain kinds of 15 Consequently, a need has remained for a microsphere cancer, methods are known in which radioactive parti which is useful in the treatment of cancer or tumor cles are introduced intravascularly in order to trap the bearing tissue, but which will not release a radioactive radioactive particle at a particular site for its radiation coating or isotope into remote parts of the body of the effect. According to this technique, a small quantity of patient after administration, will not require any techni the radioactive particles are injected into the patient 20 cians to handle any radioactive materials during the and a diffuse, homogeneous field of radiation within a formation and spheroidization of the microsphere and selected region of the body is achieved by permanent which have a density which will permit the micro lodgement of the particles in the capillary bed of the spheres to be suspended in a fluid suitable for injection proposed area, typically the location of a tumor. In into a human. early applications of this technique, yttrium oxide pow 25 der was suspended in a viscous medium prior to admin SUMMARY OF THE INVENTION istration. Yttrium was selected for the technique be Among the several objects of the invention, therefore cause of its suitable characteristics: it emits nearly 100 may be noted the provision of a novel microsphere for percent beta radiation. See, e.g., Nolan, et al., Intravas use in radiation therapy; the provision of such a micro cular Particulate Radioisotope Therapy". The American 30 sphere wherein the radioactive isotope is uniformly Surgeon 35: 181-188 (1969) and Grady, et. al., Intra-Ar distributed throughout the microsphere material; the terial Radioisotopes to Treat Cancer", American Sur provision of such a microsphere wherein there is no geon 26: 678-684 (1960). This method is not totally significant release of the radioactive isotope from the satisfactory, however. Two disadvantages of yttrium microsphere into the body of the patient; the provision oxide powder are its high density (5.01 gm/cm) and 35 of such a microsphere in which the microsphere is com irregular particle shape. The high density of pure yt pletely non-radioactive until irradiated for use in ther trium oxide powder makes it difficult to keep the parti apy; the provision of such a microsphere which con cles in suspension in the liquids used to inject them into tains a stable element or isotope that can be activated to the body, and accelerates their tendency to settle in the 40 a beta or gamma radiation emitting isotope by neutron blood stream prior to reaching the desired tumor.
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