POSITIVE ENERGY, LLC (Springfield, MO)

Aspects herein are directed to an anchorable brachytherapy device designed to be permanently implanted in a tumor bed prior to the surgical removal of the tumor. The brachytherapy device could comprise of several hollow tubes that form an ellipsoid or spherical shape. Protrusions or grooves could be created on the outer surface of the tubes to aid in anchoring the brachytherapy device in the tumor bed. In order to provide radiation to the tumor the radioactive seeds and strings can be placed inside the tubes channels.

Radiation therapy, or brachytherapy, is a known modality for treating certain types of tumors such as, for example, breast tumors, brain tumors, lung tumors, sarcomas, and the like and has been shown to result in good tumor control.Brachytherapy may be used by itself or in combination with other therapies such as surgical resection, and/or chemotherapy. The treatment of radiation is traditionally delivered using external beam radiation and/or by delivering radioactive sources to a tumor’s site through, for example a catheter. These treatment options can take up to a few weeks or days and are costly, time-consuming, painful and uncomfortable for patients. For instance, catheter-based partial breast radiation may take five to eight days. The patient must be treated twice a day, six hours apart and the catheter remains within the patient for 2 up to three weeks. The catheter’s tail could protrude from the patient’s body which can cause pain and infection. Catheter-based radiation is expensive and time-consuming. Some patients might choose to undergo more severe however, they may not need the treatmentslike mastectomy, instead of lumpectomy, and adjuvant radiation for breast cancer.

The Summary is designed to provide a range of concepts in a simplified form which are further explained in the detailed description. The Summary does not define the most important features or features of claimed subject matter. It is also not intended to be used to determine the subject matter. The claims define the present invention.

Aspects herein are directed to an implantable and anchorable brachytherapy device. These aspects may also be directed at the possibility of an anchorable, implantable stereotactic mark device. With respect to the implantable and anchorable brachytherapydevice the present invention is a bioabsorbable or biocompatible, three-dimensional (3-D) or two-dimensional (2-D) device that could be, for instance permanently inserted into a tumor bed at the time of the surgical resection the tumor. It does not require removal. As such, the brachytherapy equipment described herein provides a convenient and cost-effective alternative to the traditional catheter-based and/or external beam radiation alternatives. Additionally, since the device is contained within thetumor bed, there are no catheter tails protruding from the patient, which decreases the risk of pain, bleeding, and infection. Further, because the device is anchored within the tumor bed, the risk of device rotation and/or migration is reduced.Additionally, in some instances, filling the void caused by surgical removal of the tumor with one of the devices described herein may be associated with a better cosmetic outcome as described below.

In one particular example the device is comprised of multiple grooves, as well as a number of projections and, in some cases one or more central channels that extend through the device body. Before being placed within the tumor bed, one or more low-doseradioactive sources (e.g. seeds, seeds or strands) are secured within the grooves. The central channels may also be used to secure the radioactive source (e.g. seeds or strands) which are low-dose or high dose. The projections are placed in the surgical area and serve as anchors to the device. They prevent the device from shifting, moving and rotating or being moved during radiation delivery. This, in turn, enables an accurate delivery of radiation to the intended area of the body of the patient.

In another example aspect the device is comprised of several hollow tubes with grooves, projections, or grooves. In one case, the device comprises one continuous hollow tube that is shaped in a helical design with an opening or space at itscenter. The strands or seeds of radioactive material can be placed inside the tube channel prior placing it intraoperatively. The grooves and/or projections can be used to anchor the device when it is placed inside the tumor bed. A second configuration of the device is made up of hollow tubes that have been shaped into a shape such as an ellipsoid, or spherical form with a void in its center. The radioactive seeds or strands can be loaded into one or more of the tubes prior to intra-operative placement. After device placement projections or grooves can be employed to secure the device.

With respect to hollow tube configurations: since each one of these configurations has an empty space in the center, it can be considered a nonspace (or at least spaces-) space-occupying device. This is why it’s beneficial in closed-space locations such as the brain to stop the increase in intracranial pressure. Furthermore, the void in the center of the device might allow for the migration or influx of any blood, secretions, and other fluids that are inflammatory that are produced by the tumor bed therebyminimizing the chance for these fluids to collect between the tumor and the device’s wall which may decrease the effectiveness of radiation therapy.

The brachytherapy devices discussed in this article provide a custom-made efficient, precise, and continuous radiation delivery system that requires minimal physician and patient intervention following the placement. The brachytherapy equipment discussed in this article could help to reduce the risk of adverse effects like radiation damage or infection. In addition, in situations such as after an operation to remove a lump in the breast or a breast lumpectomy, the use of a 3-D brachytherapy device may provide a pleasing cosmetic effect tothe breast.

The device in 3-D or 2-D as described in this document may be utilized as an instrument for stereotactic marking. Stereotactic markers usually include at least one radiopaque marker. Once placed within an area of cancer, the device can be used to direct external beam radiation. In one instance the devices discussed in this article may include both an brachytherapy device as well as a stereotactic marker device. Regarding this aspect, both radioactive seeds/strands and radiopaque markers canbe placed into the grooves of the device and central channels of the device, or in the device tube channels. In addition these devices may be used as just a brachytherapy device or as simply a stereotactic marker device. As such it is possible that the term”brachytherapy device” as defined herein could be a combination of a device used to deliver therapy radiation or that can be used as a stereotactic marker.

Other advantages and new aspects of this invention will be explained in detail. The description will be made accessible to experienced art professionals after a thorough review.

Click here to view the patent on USPTO website.

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