The disclosure relates generally to a mechanism and method for radiation oncology.
When women are treated for breast cancer, the most commonly diagnosed cancer in women, they can opt for mastectomy (complete removal of the breast tissue) or breast conservation therapy (BCT) which is comprised of lumpectomy plus radiotherapy. Due to the widespread use of screening mammography, women are diagnosed with localized and early-stage disease so that BCT may be used. The typical radiation treatment is adjuvant breast radiation. While adjuvant breast radiation results in excellent survival rates, this regimen typically takes 3.5 to 7 weeks and is burdensome to women and the overall healthcare system. In addition, since the adjuvant breast radiation treatment is typically provided using external beam radiation, there is a greater risk of acute and late toxicity due to unnecessary healthy tissue interaction with the radiation.
As a result, accelerated partial breast irradiation (APBI) may be used which results in a quicker treatment time and less radiation-induced acute and late toxicity. One technique used for the APBI is brachytherapy. In one method, radioactive sources are temporarily or permanently implanted into the breast tissue at the site of the surgery wherein the radioactive sources may be high dose-rate or low dose-rate.
There are a handful of ways to insert radioactive sources into breast tissue. One is by a free hand method, another uses a compressive template device to temporary hold insertion catheters and the last uses a locking template system and non-fixated fiducial needle. These methods are limited in that they do not ensure the sources are placed in the desired location as prescribed by the treatment plan 100% of the time. The lack of ability to place the radioactive sources in the desired location means that the remaining tumor margin is not receiving the appropriate radiation and healthy tissue is receiving unwanted radiation.
In the high dose-rate brachytherapy area, a clinician would place hollow catheters into the breast to facilitate the insertion of a temporary radioactive source per a treatment plan which are then removed once the treatment is completed. The placement of these catheters may be by either free hand directly into the breast or by free hand though compressive template systems used to stereo-tactically immobilize the breast. Both Varian Medical Systems and Nucletron offer commercially available template immobilization products.
In the low dose-rate brachytherapy area, one method for permanent breast radioactive seed implantation is described in detail in “First Report of a Permanent Breast 103PD Seed Implant As Adjuvant Radiation Treatment for Early-Stage Breast Cancer”, Dr. Jean-Philippe Pignol et al., International Journal of Radiation Oncology Biological Physics, Vol. 64, No. 1, pp. 176-181 (2006) which is incorporated herein by reference. This method uses a non-fixated fiducial needle, locking template and stereotactic fixation to insert low dose rate (LDR) radioactive source strands into the treatment site under image guidance. In this method, the stereotactic fixation device uses a rail clamp to mount to a fixed frame of reference. For certain imaging modalities, the stereotactic fixation device does not meet the technical specifications of the imaging modality. For instance, a CT system does not have rails and certain materials can cause imaging artifacts. Thus, the system, a brachytherapy device, is limited for use in environments with tables that have side rails (such as an operating room) and with certain types of image guidance.
Thus, it is desirable to provide a device that can provide a fixed frame of reference for the system with the goal of expanding the use of the system in other environments and imaging modalities. It is to this end that the disclosure is directed.
It is noted that the following disclosure is particularly applicable to radioactive source implantation into breast tissue and it is in this context that the disclosure will be described. It will be appreciated, however, that the device and method have greater utility since the device can be used with other devices besides the template, needles, and radioactive sources and in various different tissues.
The disclosure described allows the fixation of a brachytherapy device and can be implemented using the various devices and mechanisms described below. In one embodiment, the fixation device may be used for a breast brachytherapy treatment and it is in this context that the disclosure is provided, but it is understood that the fixation support device may be used for other treatments.
The fixation support device disclosed below is a portable device that is capable of stabilizing and fixating one or more medical modalities, such as one or more breast brachytherapy devices, with an attachment mechanism at a position on or near a treatment surface wherein the fixation support device is compatible with image guidance that may be used during the treatment. The fixation support device can have attachment mechanisms such as a rail clamp, pin, tightening knob, etc.
Each of the above embodiments of the fixation support device may be a portable device that is capable of stabilizing and fixating one or more breast brachytherapy devices with an attachment mechanism at a position on or near a treatment surface, compatible with image guidance. The breast brachytherapy devices may be a brachytherapy template and armature and can have attachment mechanisms such as a rail clamp, pin, tightening knob, etc.
The portable device with one or more rails comprises one or a combination of the following: a main body that can be placed on top or near a treatment surface (e.g., a procedure table, CT table, Mill table, chair, etc . . . ); one or more wheels that can move the device wherein the one or more wheels can retract, the one or more wheels can lock in position, the one or more wheels are removable; and the device has one or more adjustable bases to lift the wheels away from the floor. The portable device may have one or more stabilizing mechanisms that can quickly and securely immobilize the device on a fixed frame of reference and One or more handles that can be used to move the device.
The device has the means to fixate one or more brachytherapy devices. Examples include but are not limited to: one or more bars that can be used to secure a brachytherapy device with a clamp; one or more clamps to secure a brachytherapy device; and a receiving feature to secure a brachytherapy device, such as a pin and slot mechanism to secure a brachytherapy device.
The device has the means to stabilize on a fixed or moving frame of reference (e.g., treatment surface—procedure table, CT table, MRI table, chair, etc . . . ). Examples may include but are not limited to: one side of the device has sufficient friction with the fixed frame of reference so that it is immobilized when a weight is placed on it; one or more clamps are used to fixate the device on the top, side, or bottom of the surface; one or more wheels on the body can retract or can be removed or can be lifted off the floor with an adjustable base, such that device is immobile; one or more protrusions are used to fixate the device on the surface; and/or one or more receiving features on the body that allows the use of the device with other brachytherapy fixation devices, such as an indexing bar.
The device has the means to be used in real-time or intermittently with imaging modalities such as CT, MRI, fluoroscopy, ultrasound, PET, and/or other novel medical imaging technology. Examples may include but are not limited to: the device may be manufactured out of a polymer-based material, stainless steel, stainless steel alloys, or any other suitable material. For example, polyethene and carbon fiber are compatible with CT and MRI; the device has indexing or reference features that can be used with the imaging modality.
The device may have a mechanism to move the rail along multiple axes. Examples include but are not limited to: a receiving feature for a rail so that the position of the rail can be adjusted and locked on the device; rack and pinion movement in a mechanical or hydraulic or pneumatic or power-assisted manner—the rail moves linearly or along one plane at a time; leadscrew-driven movement in a mechanical or hydraulic or pneumatic or power-assisted manner—the rail moves linearly or along one plane at a time; and/or motorized or robotic arm—the rail moves linearly and/or rotationally.
The foregoing description, for purpose of explanation, has been with reference to specific embodiments. However, the illustrative discussions above are not intended to be exhaustive or to limit the disclosure to the precise forms disclosed. Many modifications and variations are possible in view of the above teachings. The embodiments were chosen and described in order to best explain the principles of the disclosure and its practical applications, to thereby enable others skilled in the art to best utilize the disclosure and various embodiments with various modifications as are suited to the particular use contemplated.
The system and method disclosed herein may be implemented via one or more components, systems, servers, appliances, other subcomponents, or distributed between such elements. When implemented as a system, such systems may include and/or involve, inter alia, components such as software modules, general-purpose CPU, RAM, etc. found in general-purpose computers. In implementations where the innovations reside on a server, such a server may include or involve components such as CPU, RAM, etc., such as those found in general-purpose computers.
Additionally, the system and method herein may be achieved via implementations with disparate or entirely different software, hardware and/or firmware components, beyond that set forth above. With regard to such other components (e.g., software, processing components, etc.) and/or computer-readable media associated with or embodying the present inventions, for example, aspects of the innovations herein may be implemented consistent with numerous general purpose or special purpose computing systems or configurations. Various exemplary computing systems, environments, and/or configurations that may be suitable for use with the innovations herein may include, but are not limited to: software or other components within or embodied on personal computers, servers or server computing devices such as routing/connectivity components, hand-held or laptop devices, multiprocessor systems, microprocessor-based systems, set top boxes, consumer electronic devices, network PCs, other existing computer platforms, distributed computing environments that include one or more of the above systems or devices, etc.
In some instances, aspects of the system and method may be achieved via or performed by logic and/or logic instructions including program modules, executed in association with such components or circuitry, for example. In general, program modules may include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular instructions herein. The inventions may also be practiced in the context of distributed software, computer, or circuit settings where circuitry is connected via communication buses, circuitry or links. In distributed settings, control/instructions may occur from both local and remote computer storage media including memory storage devices.
The software, circuitry and components herein may also include and/or utilize one or more type of computer readable media. Computer readable media can be any available media that is resident on, associable with, or can be accessed by such circuits and/or computing components. By way of example, and not limitation, computer readable media may comprise computer storage media and communication media. Computer storage media includes volatile and nonvolatile, removable and non-removable media implemented in any method or technology for storage of information such as computer readable instructions, data structures, program modules or other data. Computer storage media includes, but is not limited to, RAM, ROM, EEPROM, flash memory or other memory technology, CD-ROM, digital versatile disks (DVD) or other optical storage, magnetic tape, magnetic disk storage or other magnetic storage devices, or any other medium which can be used to store the desired information and can accessed by computing component. Communication media may comprise computer readable instructions, data structures, program modules and/or other components. Further, communication media may include wired media such as a wired network or direct-wired connection, however no media of any such type herein includes transitory media. Combinations of the any of the above are also included within the scope of computer readable media.
In the present description, the terms component, module, device, etc. may refer to any type of logical or functional software elements, circuits, blocks and/or processes that may be implemented in a variety of ways. For example, the functions of various circuits and/or blocks can be combined with one another into any other number of modules. Each module may even be implemented as a software program stored on a tangible memory (e.g., random access memory, read only memory, CD-ROM memory, hard disk drive, etc.) to be read by a central processing unit to implement the functions of the innovations herein. Or, the modules can comprise programming instructions transmitted to a general-purpose computer or to processing/graphics hardware via a transmission carrier wave. Also, the modules can be implemented as hardware logic circuitry implementing the functions encompassed by the innovations herein. Finally, the modules can be implemented using special purpose instructions (SIMD instructions), field programmable logic arrays or any mix thereof which provides the desired level performance and cost.
As disclosed herein, features consistent with the disclosure may be implemented via computer-hardware, software, and/or firmware. For example, the systems and methods disclosed herein may be embodied in various forms including, for example, a data processor, such as a computer that also includes a database, digital electronic circuitry, firmware, software, or in combinations of them. Further, while some of the disclosed implementations describe specific hardware components, systems and methods consistent with the innovations herein may be implemented with any combination of hardware, software and/or firmware. Moreover, the above-noted features and other aspects and principles of the innovations herein may be implemented in various environments. Such environments and related applications may be specially constructed for performing the various routines, processes and/or operations according to the invention or they may include a general-purpose computer or computing platform selectively activated or reconfigured by code to provide the necessary functionality. The processes disclosed herein are not inherently related to any particular computer, network, architecture, environment, or other apparatus, and may be implemented by a suitable combination of hardware, software, and/or firmware. For example, various general-purpose machines may be used with programs written in accordance with teachings of the invention, or it may be more convenient to construct a specialized apparatus or system to perform the required methods and techniques.
Aspects of the method and system described herein, such as the logic, may also be implemented as functionality programmed into any of a variety of circuitry, including programmable logic devices (“PLDs”), such as field programmable gate arrays (“FPGAs”), programmable array logic (“PAL”) devices, electrically programmable logic and memory devices and standard cell-based devices, as well as application specific integrated circuits. Some other possibilities for implementing aspects include: memory devices, microcontrollers with memory (such as EEPROM), embedded microprocessors, firmware, software, etc. Furthermore, aspects may be embodied in microprocessors having software-based circuit emulation, discrete logic (sequential and combinatorial), custom devices, fuzzy (neural) logic, quantum devices, and hybrids of any of the above device types. The underlying device technologies may be provided in a variety of component types, e.g., metal-oxide semiconductor field-effect transistor (“MOSFET”) technologies like complementary metal-oxide semiconductor (“CMOS”), bipolar technologies like emitter-coupled logic (“ECL”), polymer technologies (e.g., silicon-conjugated polymer and metal-conjugated polymer-metal structures), mixed analog and digital, and so on.
It should also be noted that the various logic and/or functions disclosed herein may be enabled using any number of combinations of hardware, firmware, and/or as data and/or instructions embodied in various machine-readable or computer-readable media, in terms of their behavioral, register transfer, logic component, and/or other characteristics. Computer-readable media in which such formatted data and/or instructions may be embodied include, but are not limited to, non-volatile storage media in various forms (e.g., optical, magnetic or semiconductor storage media) though again does not include transitory media. Unless the context clearly requires otherwise, throughout the description, the words “comprise,” “comprising,” and the like are to be construed in an inclusive sense as opposed to an exclusive or exhaustive sense; that is to say, in a sense of “including, but not limited to.” Words using the singular or plural number also include the plural or singular number respectively. Additionally, the words “herein,” “hereunder,” “above,” “below,” and words of similar import refer to this application as a whole and not to any particular portions of this application. When the word “or” is used in reference to a list of two or more items, that word covers all of the following interpretations of the word: any of the items in the list, all of the items in the list and any combination of the items in the list.
Although certain presently preferred implementations of the invention have been specifically described herein, it will be apparent to those skilled in the art to which the invention pertains that variations and modifications of the various implementations shown and described herein may be made without departing from the spirit and scope of the invention. Accordingly, it is intended that the invention be limited only to the extent required by the applicable rules of law.
While the foregoing has been with reference to a particular embodiment of the disclosure, it will be appreciated by those skilled in the art that changes in this embodiment may be made without departing from the principles and spirit of the disclosure.
This application is a continuation of PCT/US2021/036474 filed Jun. 8, 2021 that in turn claims priority under 35 USC 119(e) and claims the benefit of U.S. Provisional Application No. 63/036,266, filed Jun. 8, 2020 and U.S. Provisional Application No. 63/088,280, filed Oct. 6, 2020, all of which are both incorporated herein by reference.
Number | Date | Country | |
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63036266 | Jun 2020 | US | |
63088280 | Oct 2020 | US |
Number | Date | Country | |
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Parent | PCT/US2021/036474 | Jun 2021 | US |
Child | 18075995 | US |