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(12) Patent Application Publication (10) Pub. No.: US 2009/0156881 A1 Stokes (43) Pub US 20090156881A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0156881 A1 Stokes (43) Pub. Date: Jun. 18, 2009 (54) CONVERGENT WELL IRRADIATING Publication Classification PLAOUE FOR CHOROIDAL MELANOMA (51) Int. Cl. (76) Inventor: John P. Stokes, San Antonio, TX A6M 36/12 (2006.01) (US) A6DF 9/00 (2006.01) (52) U.S. Cl. ............................................................ 6OOf7 Correspondence Address: MEYERTONS, HOOD, KIVLIN, KOWERT & (57) ABSTRACT GOETZEL, P.C. Provided in some embodiments is a device suitable for treat P.O. BOX 398 ing an eye that includes a housing and a plurality offins. The AUSTIN, TX 78767-0398 (US) housing includes a base and a rim coupled to the perimeter of the base. The base and the rim at least partially define a cavity (21) Appl. No.: 12/252,136 in the housing, and the cavity is configured to accept one or more radiation seeds. The plurality of fins at least partially (22) Filed: Oct. 15, 2008 reside within or proximate the cavity of the housing. At least a portion of the fins are configured such that radiation emitted Related U.S. Application Data from one or more radiation seeds positioned in the cavity is (60) Provisional application No. 60/980,079, filed on Oct. substantially directed toward a center portion of the eye dur 15, 2007. ing use. SClera ChOroid Patent Application Publication Jun. 18, 2009 Sheet 1 of 8 US 2009/O156881 A1 C-H > O wis w CN Sa CNwas O C v N. l e CD VN sU O S & U wal w- F S S wis,N ws Patent Application Publication Jun. 18, 2009 Sheet 2 of 8 US 2009/O156881 A1 2O2 M 2O1 N Patent Application Publication Jun. 18, 2009 Sheet 3 of 8 US 2009/O156881 A1 450 415 FIG. 5 M 110 150 1 11 FIG. 6B Patent Application Publication Jun. 18, 2009 Sheet 6 of 8 US 2009/O156881 A1 FIG. 7 i Patent Application Publication Jun. 18, 2009 Sheet 7 of 8 US 2009/O156881 A1 FIG. 9B Patent Application Publication Jun. 18, 2009 Sheet 8 of 8 US 2009/0156881 A1 US 2009/0156881 A1 Jun. 18, 2009 CONVERGENT WELLIRRADATING 0009 Episcleral plaque brachytherapy (EBT) is the most PLAOUE FOR CHOROIDAL MELANOMA frequently used eye-sparing treatment for choroidal mela noma. The goal of EBT is to target radiation to the tumor and PRIORITY OF THE INVENTION spare the eye. If the eye is to be spared, it is important to administer high doses of radiation to the tumor and very little 0001. This application claims priority to U.S. Provisional to the rest of the eye. This is typically accomplished by Patent Application No. 60/980,079 filed on Oct. 15, 2007, Suturing a radioactive ophthalmic plaque to the Surface of the which is herein incorporated by reference. eye at the base of the tumor. The ophthalmic plaque consists ofradiation seeds fixed to one side of a small disc. One side of BACKGROUND OF THE INVENTION the ophthalmic plaque is shielded with a thin layer of gold. Alternatively, the ophthalmic plaque may be shielded by fab 0002 1. Field of the Invention ricating the plaque of a gold alloy. Gold shielding effectively 0003. The present application generally relates to the field blocks radiation emitted from the seeds and prevents exces of radiation oncology. More specifically, the application dis sive irradiation of tissues in the head. The tumor is irradiating closes a device and method for the treatment of ophthalmic for a period typically ranging from 3-7 days, after which the malignancies. In particular, the device and method disclosed ophthalmic plaque is removed. hereincan be utilized to deliver a dose of radiation to a portion 0010. Iodine-125 (I'''), gold-198 (Au), palladium-103 of the eye globe to treat a malignancy of the eye (such as, e.g., ('Pd), and other ophthalmic plaques can be effective in the choroidal melanoma). treatment of medium-sized melanomas. I' is the most com 0004 2. Description of the Related Art monly used isotope because of its good tissue penetration, 0005 Melanoma is a type of cancer that originates within accessibility, adequate shielding of the Source, and thus lesser melanocytes, the cells that form pigment or melanin. While risk to other ocular structures and medical personnel. Meth melanoma is most commonly found on the skin, it can also ods to ensure proper dose homogeneity to the tumor and occur inside the eye as well as on the Surface. The pigmented plaque placement are critical to Successful radiation therapy. areas of eye such as the choroid and iris are most commonly Such methods typically include conformal therapy, which affected; however, melanoma Sometimes occurs on the con seeks to improve dose homogeneity within the tumor while junctiva as well. minimizing the dose to uninvolved structures. Radioactive 0006 Choroidal melanoma is the most common form of sources are typically distributed uniformly over the surface of ocular melanoma. The choroid is a highly pigmented layer an opthalmic plaque and are sometimes offset slightly from that lies just behind the retina. With this type of malignancy, the scleral surface in order to reduce the dose to the sclera the chance of retaining vision in the affected eye is low, but relative to the apex and prescribed therapeutic margin at the the overall prognosis is often good. The primary concern is tumor base. Nevertheless, it is not uncommon for scleral dose the risk of the cancer spreading to another area of the body. to exceed the dose to the apex of intermediate to tall tumors by The risk is proportional to the size of the tumor, proximity to a factor of 4 or more. the optic nerve, visual symptoms, and whether the tumor has 0011. Initial results from the Collaborative Ocular Mela documented growth. Those with a tumor that is greater than 2 noma Study (COMS) have demonstrated comparable 5-year mm thick or is close to the optic nerve have a higher risk of the survival rates for patients with medium-sized tumors treated melanoma spreading or metastasizing. An individual with primarily with I' plaque irradiation (5-year survival–82%; none of the above risk factors (e.g., Small tumor situated away 95% CI, 79%-85%) or enucleation (5-year survival=81%; from the optic nerve, normal vision, and no documented 95% CI, 77%-84%). Among the patients treated with I? growth over time) may have a very low risk of metastasis. brachytherapy, 85% retained their eye for 5 years or more, 0007. The appropriate treatment for choroidal melanoma and 37% had visual acuity better than 20/200 in the irradiated depends largely on the size and location of the melanoma. In eye 5 years after treatment. general, Small tumors that cause no visual symptoms and are 0012 Charged-particle radiation therapy can be per not close to the optic nerve may be carefully observed for formed with a proton beam or helium ions. Some investiga signs of growth or change. The melanoma is measured and tors report better tumor control with helium ion irradiation documented with ultrasound, photography, and dilated eye than with I' episcleral plaque treatment in terms of local examinations. Small tumors are sometimes treated with laser tumor control and eye retention; however, more anterior seg photocoagulation. Medium and large choroidal melanomas ment complications are found. are usually treated either by Surgically applying a radioactive 0013. Other radiation therapy techniques that are occa plaque to the eye (commonly refered to as episcleral plaque sionally employed but not as extensively studied include brachytherapy) or by removing the eye completely (enucle external-beam radiation therapy and gamma knife radiation ation). therapy. Preliminary evidence Suggests that gamma knife 0008 Episcleral plaque therapy (brachytherapy) and Surgery may be a feasible treatment option for medium-sized external-beam, charged-particle radiation therapy offer choroidal melanomas. patients eye-sparing and vision-sparing alternatives to 0014 Structures and tissues within the eye are highly sus enucleation. Both treatment approaches result in relatively ceptible to radiation-induced damage. Although every effort slow regression of uveal melanoma during a period of 6 is made to minimize the amount of radiation that is delivered months to 2 years. Most tumors regress to approximately 50% to healthy eye tissue adjacent to the melanoma, Iodine-125 of their original thickness; only occasionally does a tumor plaque radiotherapy is nevertheless associated with signifi regress to a completely flat scar. Local control is achieved in cant complications that can lead to loss of visual function or a large proportion of treated eyes with either technique. The to Subsequent enulceation. Complications include cataract probability of visual preservation and of eye retention with formation, neovascularization of the iris, radiation maculopa either method is related to tumor size and location. thy, and radiation-induced optic neuropathy. The risk of com US 2009/0156881 A1 Jun. 18, 2009 plications increases with increasing melanoma size. The risk 0025. Enucleation: Considered primarily if there is a dif of radiation maculopathy or radiation neuropathy increases fuse melanoma or if there is extraocular extension; radiation with proximity to the macula or optic nerve, respectively 1. complications or tumor recurrence may eventually make For example, nearly one half of the patients treated with I-125 enucleation necessary. brachytherapy in the medium-size tumor arm of the COMS lost substantial vision by three years (loss of six or more lines SUMMARY OF THE INVENTION from the baseline). 00.15 Modified plaque designs that include partial colli 0026. In some embodiments, a device suitable for treating mation have been used with Success in controlling medium to an eye includes a housing and a plurality offins.
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