Radiant energy – Radiation controlling means – Shielded receptacles for radioactive sources
Reexamination Certificate
2001-11-02
2003-10-28
Lee, John R. (Department: 2881)
Radiant energy
Radiation controlling means
Shielded receptacles for radioactive sources
C600S003000, C600S007000
Reexamination Certificate
active
06639237
ABSTRACT:
BACKGROUND
1. Technical Field
This invention relates to medical devices, and more particularly to medical devices useful for brachytherapy procedures.
2. Background Information
Brachytherapy is a form of cancer treatment in which radiation sources are placed inside a patient's body to irradiate a tumor. In brachytherapy, a surgeon usually implants several radioactive seeds in or around a tumor, thus providing a higher radiation dose to the tumor than would be possible with external beam radiation therapy. Careful placement of the radioactive seeds allows localized and precise irradiation of the tumor. Because the radiation dose diminishes rapidly outside the radioactive seed, the radiation dose to surrounding healthy tissues is minimized.
Radioactive seeds typically are tiny (generally about 0.8 mm by 4.5 mm), roughly cylindrical objects containing very small amounts of radioactive material. In one widely practiced brachytherapy procedure, the radioactive seeds are implanted permanently inside the patient's body. The half-life of the radioactive material is generally short, and the radioactivity in the seeds decays after about three to six months to the point that there is little detectable radiation. Two radioactive isotopes commonly used for permanent implants are iodine-125, often used to treat slower growing tumors, and palladium-103, which is preferred when a tumor is fast growing. Other radioactive materials have been used in implants as well.
Many forms of cancer respond to brachytherapy, including several forms of prostate cancer. Brachytherapy is generally less invasive than surgery, usually results in fewer side effects than surgery or external beam radiation, allows for a shorter recovery time, and reduces the impact on the patient's quality of life.
SUMMARY
The invention relates to brachytherapy devices, methods for making brachytherapy devices, and methods for using brachytherapy devices. Specifically, the invention provides staging-sterilization devices and insert devices. Staging-sterilization devices can have a staging area with a loading area that can be used to secure a seed holder such that a practitioner can load the seed holder with radioactive seeds. The loading area can be configured to secure the seed holder in five of six degrees of freedom. For example, the loading area can be configured to restrict or prevent side to side as well as up-down movements of the seed holder. In addition, the loading area can be configured such that a secured seed holder can be removed from the loading area by pivoting the seed holder around its transverse axis through its base followed by a translation along its longitudinal axis. The pivoting movement can have an angular range from zero to ten degrees with an angle of five to ten degrees being needed to allow removal of the seed holder via the translation. Such a configuration can allow the practitioner to load a seed holder with confidence that any accidental pressures applied to the seed holder will not dislodge the seed holder. Thus, the loading areas provided herein can prevent accidental movements of a seed holder. Preventing accidental movements of a seed holder protects practitioners from unnecessary exposure to radioactivity.
The staging-sterilization devices provided herein also can have a staging area configured such that any radioactive seeds dropped over the staging area collect in a trough. This allows the practitioner to locate dropped radioactive seeds quickly. Locating a dropped radioactive seed in a trough can prevent practitioners from having to search a large area such as the floor. In addition, having dropped radioactive seeds collect in a trough can prevent exposure to radioactivity that may otherwise occur if the dropped radioactive seed rolls outside the shielded work station.
In addition, the staging-sterilization devices provided herein can be used to store, transfer, and sterilize other brachytherapy components such as seed holders, radioactive seeds, and transfer devices. Such staging-sterilization devices can have at least one well and a lid such that radioactive material can be placed in the well and shielded when the lid is closed. Staging-sterilization devices can protect practitioners from unnecessary exposure to radiation and can provide a convenient vessel for organizing brachytherapy components. In addition, the staging-sterilization devices provided herein can be configured such that the components within the staging-sterilization device heat and cool quickly. In other words, staging-sterilization devices can be configured to maximize heat exchange, minimizing the amount of time needed to wait after sterilizing brachytherapy components.
The invention provides brachytherapy devices such as insert devices that can be configured to hold multiple seed holders. For example, an insert device can have seven seed holder pockets such that seven seed holders can be vertically placed into a single insert device. Insert devices can be configured to maximize heat exchange such that seed holders placed in the insert device heat and cool quickly, minimizing the amount of time between sterilization and surgical implantation of radioactive seeds.
The staging-sterilization devices and insert devices provided herein can be designed such that the insert device fits within an insert receiving well of the staging-sterilization device. In addition, the staging-sterilization devices and insert devices provided herein can be designed such that movement of the insert device and any seed holder within the insert device is restricted while within the staging-sterilization device with its lid closed. Restricting movement of the insert device and seed holders within the insert device can prevent damage to the seed holders and can prevent radioactive seeds from being dislodged from seed holders if, for example, the staging-sterilization device is accidentally dropped.
In general, the invention features a brachytherapy device containing (a) a body containing a top surface, a bottom surface, and a staging area surface, wherein the top surface contains an insert receiving well capable of holding an insert device, and wherein the staging area surface slopes away from the top surface and toward the bottom surface; and (b) a lid attached to the body, wherein the lid is capable of opening to expose the insert receiving well and is capable of closing over the top surface to cover the insert receiving well. The body can contain a vent that creates a line of sight through the body. Such a vent can extend from the top surface to the bottom surface. The body can contain a vent that does not create a line of sight through the body. Such a vent can extend from the insert receiving well to the bottom surface. The top surface can be substantially parallel with a flat surface when the bottom surface rests on the flat surface. The top surface can contain multiple insert receiving wells. The top surface can contain a transfer device well capable of holding a transfer device. The top surface can contain multiple transfer device wells. A portion of the top surface can be raised. The insert receiving well can be cylindrically shaped. The bottom of the insert receiving well can contain a pin capable of aligning the insert device. The pin can be conically shaped. The bottom of the insert receiving well can contain multiple pins capable of aligning the insert device. The bottom surface can contain a hollow bottom. At least a portion of the hollow bottom can be positioned underneath the staging area surface. The angle of the staging area with respect to a flat surface can be less than 60 degrees when the bottom surface rests on the flat surface. The angle is of the staging area with respect to a flat surface can be between 80 and 10 degrees when the bottom surface rests on the flat surface. The angle of the staging area with respect to a flat surface can be between 60 and 30 degrees when the bottom surface rests on the flat surface. The staging area surface can contain a loading area having one or more seed holder supports ca
Barber Jerry
Crouther Ronald
Femrite Dennis
Henderson Scott
Pedersen Laust
Fish & Richardson P.C. P.A.
Johnston Phillip A
Lee John R.
Mentor Corporation
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