Compositions, devices and kits for selective internal radiation therapy
Inventors
Amato, Antonino • Paganelli, Giovanni
Assignees
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Publication Number
US-11141526-B2
Publication Date
2021-10-12
Expiration Date
Abstract
Systems, kits and methods for preparing an injection system and/or treating target lesions with a selective internal radiation therapy which includes a double-barrel syringe loaded with a two-component tissue glue and radioisotope loaded microspheres. The microspheres are loaded into the syringe based on the size of the target location and are administered with a needle or dual-lumen catheter. Dosing regimens for treating breast cancer lesions or surgical beds up to 130 mm in diameter and hepatocellular carcinoma lesions up to 50 mm are included.
Core Innovation
The invention relates to selective internal radiation therapy for breast cancer using a dual chamber syringe and two-component tissue glue with 90Y. A method is provided that determines an average tumor size of a breast cancer lesion, and selects both a 90Y syringe activity level and a 90Y treatment activity level based on the average tumor size. The selected 90Y treatment activity level is defined by specific activity ranges corresponding to tumor radius ranges.
The method includes loading a dual chamber syringe such that the first chamber is pre-loaded with bovine serum albumin and the second chamber is pre-loaded with glutaraldehyde. After loading, the selected 90Y treatment activity level is injected at a treatment site of the breast cancer lesion using the dual chamber syringe.
The partial content also describes development of a dual-lumen catheter design for matching flow rates of glue components and kit-like elements for radiation-protective handling, including syringes and radioprotective containers. Further dependent limitations are directed to loading ratio, radio-protective containers, and confirming residual activity after injection.
Claims Coverage
The document includes one independent claim that covers a breast cancer treatment method integrating tumor-size based 90Y activity selection with loading and injection using a dual chamber syringe containing bovine serum albumin and glutaraldehyde. The inventive features are centered on the defined radius-to-activity mapping, the dual chamber loading, and the injection at the lesion treatment site.
Tumor-size based 90Y activity selection by radius ranges
Determining an average tumor size of a breast cancer lesion; selecting a 90Y syringe activity level and a 90Y treatment activity level using the average tumor size, wherein the 90Y treatment activity level is defined by specific activity ranges for tumor radius ranges.
Dual chamber syringe loaded with bovine serum albumin and glutaraldehyde
Loading a dual chamber syringe with the selected 90Y syringe activity level, wherein the dual chamber syringe comprises a first chamber pre-loaded with bovine serum albumin and a second chamber pre-loaded with glutaraldehyde.
Injection at the breast cancer lesion treatment site using the dual chamber syringe
Injecting the selected 90Y treatment activity level at a treatment site of the breast cancer lesion using the dual chamber syringe.
Dual chamber loading ratio
Loading the dual chamber syringe comprises loading the 90Y syringe activity level into the first and second chambers in a 1:4 ratio.
Radio-protective containers formed by PMMA cylinders
The first and second radio-protective containers comprise PMMA cylinders.
Residual activity confirmation after injection
Further comprises confirming a residual activity level of the dual chamber syringe after injecting the treatment site.
Overall, the claim coverage centers on matching 90Y treatment activity to determined average tumor size using radius-defined activity ranges, delivering the selected activity using a dual chamber syringe with bovine serum albumin and glutaraldehyde pre-loaded, and injecting at the lesion treatment site. The refinements specify dual chamber loading ratio, PMMA-based radio-protective containers, and confirmation of residual activity after injection.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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