Patent Publication Number: US-2023135830-A1

Title: Needle guidance device for brachytherapy and method of use

Description:
RELATED APPLICATIONS 
     This application is a continuation and claims priority under 35 USC 120, 121 to U.S. patent application Ser. No. 16/801,103, filed Feb. 25, 2020 that claims the benefit under 35 USC 119(e) of U.S. Provisional Application No. 62/812,197, filed Feb. 28, 2019, both of which are incorporated herein by reference. 
    
    
     FIELD 
     The disclosure relates generally to a mechanism and method for radiation oncology. 
     BACKGROUND 
     When women are treated for breast cancer (which is the most commonly diagnosed cancer in women), they can opt for a mastectomy (complete removal of the breast tissue) or a breast conservation surgery. Due to the use of widespread screening mammograms, women are diagnosed with localized and early-stage disease so that the breast conservation surgery followed by radiation treatment may be used. The typical radiation treatment is adjuvant breast radiation. While the adjuvant breast radiation results in good survival rates, adjuvant breast radiation treatment typically takes 3.5 to 7 weeks which is too long. In addition, since the adjuvant breast radiation treatment is typically provided using external beam radiation, there is a greater risk of acute skin reactions due to the healthy tissue interaction with the radiation. 
     As a result, accelerated partial breast irradiation may be used which results in a quicker treatment time and less radiation-induced acute skin reactions. One technique used for the accelerated partial breast irradiation is brachytherapy. In one method, radioactive sources are permanently implanted into the breast tissue at the site of the surgery wherein the radioactive sources may be high dose or low dose. 
     Currently 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 103 PD 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 lose dose rate (LDR) radioactive source strands into the treatment site. In this method, the fiducial needle can be challenging to place in the surgical cavity because locating the surgical cavity relies on the user&#39;s ultrasound skills. Also, the fiducial needle can migrate/move once inserted thus changing the depth at which the source strands are deployed. In addition, the system is very cumbersome to use and is not user intuitive. The user manually operates the locking template and stereotactic fixation system by turning knobs to adjust and lock/unlock positions. The position and orientation of the locking template is determined by a treatment planning software. The correct position and orientation of the template are verified by other instruments such as an inclinometer and a ruler. Overall, the system can be difficult to use in a reproducible and precise manner. 
     Thus, it is desirable to provide a needle guidance device that can mark the treatment area with the goal of improving the reproducibility of the procedure and ensuring that the sources are reliably and consistently inserted in an exact position per a patient prescription treatment plan from patient to patient as well as improve the ease-of-use of the device and procedure and it is to this end that the disclosure is directed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG.  1    is a caudal cross section of breast tissue and an example of the needle guidance device used with a fiducial needle; 
         FIG.  2    illustrates a method of using the needle guidance device shown in  FIG.  1   ; 
         FIG.  3    is a caudal cross section of breast tissue and illustrates another example of the needle guidance device used with a brachytherapy fiducial needle fixation system; and 
         FIG.  4    illustrates another method of using the needle guidance device shown in  FIG.  3   . 
     
    
    
     DETAILED DESCRIPTION OF ONE OR MORE EMBODIMENTS 
     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 with an example. It will be appreciated, however, that the device and method has greater utility since the device can be used with other devices besides the template, needles, and radioactive sources and in various different tissues in which it would be desirable to be able to perform brachytherapy using radioactive seeds. Furthermore, although the example below illustrates a fiducial needle being guided into breast tissue, the device also may be used to guide other brachytherapy devices into the tissue. 
       FIG.  1    is a caudal cross section of breast tissue and an example of the needle guidance device  100  used with a fiducial needle to guide one or more fiducial needles  112  to a treatment region  110  within tissue. In the example shown in  FIG.  1   , the tissue is breast tissue  102  shown against a chest wall  104  of a patient that has the treatment region. Once the one or more fiducial needles are fixed into a region of treatment  110 , one or more radioactive seeds or strands of seeds may be placed into the tissue (based on a treatment plan) to irradiate a tumor in the tissue or irradiate a margin from which a tumor has been removed by the radiation released by the one or more radioactive seeds. As noted above, the needle guidance device  100  may be used to guide a needle into various different tissues and is not in any way limited to the example use in breast tissue shown in  FIG.  1   . 
     A needle guidance device  106  may be inserted into and secured in the tissue. The needle guidance device may have a body portion that can attach onto or take in a needle, such as the exemplary fiducial needle  112  shown in  FIG.  1   . Example of the needle guidance device  106  and its body portion may include, for example, a hollow tube, such as a catheter or cannula, through which a needle can be inserted (as shown in the example in  FIG.  1   ), a guidewire that can be used with a hollow needle, a balloon catheter, through which a needle can be inserted and/or a balloon on a guidewire. The needle guidance device  106  may have an anchoring feature  108  that secures the device  106  into the tissue, but is easily removable. Examples of the anchoring feature  108  may include, for example, holes for suturing the device  106  into the tissue as shown in the example in  FIG.  1   , one or more hooks can be deployed into the tissue as in the example embodiment shown in  FIG.  3   , a screw-like tip (tip has threads) can be used to secure the device  106  into tissue and/or a balloon can be inflated inside the cavity to secure the device  106 . 
     The device  106  may be manufactured out of a polymer-based material, stainless steel, stainless steel alloys, bioabsorbable materials or any other suitable material. The device  106  may have a feature  114  that allows the device  106  to be placed percutaneously into the cavity (for example, formed when a tumor has been surgically removed) in the treatment region  110 . The feature  114  may be, for example, a sharpened tip (such as shown in the examples in  FIGS.  1  and  3   ) to facilitate easy penetration into tissue or an accessory component such as a trochar can be used to place the device  106  into the tissue. The device  106  or at least one portion of the device  106  may be visible under one or more imaging modalities (e.g., fluoroscopy, magnetic resonance imaging, computerized tomography, ultrasound, etc.). For example, the entire body of the device  106  may be visible, features on or inside the device (i.e., beads, bands, markers, imaging agent) may be visible, balloon can be inflated for visibility and/or an accessory component that is visible under medical imaging can be placed inside the device wherein the accessory component may have features for depth measurements. 
     The device  106  may also have an interface feature  116  at an end of the body portion at each end of the body portion that includes the anchoring feature so that the device  106  can accept and interface with one or more brachytherapy devices, including a needle. For example, an end of the device  106  may have a flared opening to ease the insertion of a fiducial device, such as a needle and/or may have a cap can be attached to the end of the device, on the skin surface, with an accessible opening for a fiducial device, such as a needle, to enter the device as shown in the example in  FIG.  1   . The device  106  may contain electronic components, such as sensors, that can communicate or interact with software. For example, the location of the device  106  can be identified with software and the treatment plan can be adjusted according to the location of the device  106 . In addition, the device  106  can be used with an ultrasound imaging system to provide real-time location of the insertion and guidance at the time the device is implanted which provides visualization of the surrounding tissue on a screen. In the example in  FIG.  1   , the interface feature  116  anchors the needle guidance device  106  on each end of the treatment site, although the needle guidance device  106  may also be anchored only on one side of the treatment site. In addition to the alternatives set forth above for the anchoring feature, the interface feature  116  also may be, for example, a button, sutures, both button and suture, or some other type of anchoring feature. 
       FIG.  2    illustrates a method  200  of using the needle guidance device shown in  FIG.  1   . In one example, the needle guidance device is used to place one or more brachytherapy seeds into a treatment region which is a lumpectomy cavity in breast tissue from which a tumor was surgically removed previously. In a brachytherapy procedure in which one or more radioactive seeds are placed into the treatment region, one or more fiducial needles are first fixated into the treatment region through a brachytherapy template and then needles with the one or more radioactive seeds are inserted through the template (fixated by at least one fiducial needle) to place the one or more radioactive seeds precisely into the treatment region based on a treatment plan. The installed one or more radioactive seeds release radiation that irradiates the tissue in the treatment region. In one embodiment, the one or more radioactive seeds kill tumor cells in the lumpectomy region that remain after surgery to remove a tumor. 
     In the method, the needle guidance device  106 , in the form of a cannula in one embodiment, is placed at the time of lumpectomy in the treatment region that is the lumpectomy cavity ( 202 ). The needle guidance device  106  may be secured in the lumpectomy cavity with sutures ( 204 ) to prevent migration. When the patient is confirmed to receive permanent breast seed implantation, a CT-visible marker is placed inside the device for treatment planning. The CT-visible marker has bands spaced  1  cm apart for depth measurements. Treatment planning (using treatment planning software) is done using the device as a reference point ( 206 ). During the treatment planning, the need guidance device is imaged and the treatment planning software ( 207 ) is used to plan one or more characteristics of the insertion of a brachytherapy needle, such as placement, angle and/or depth of insertion) prior to the procedure. The CT-visible marker is removed after the plan. 
     On the day of the radioactive seed implantation (that may be the same day/same time as the treatment planning or at a different time), a template grid of the brachytherapy fiducial needle fixation system (an example of which is described in U.S. Pat. No. 8,764,619 that is incorporated herein by reference) is set up. A fiducial needle may then be placed through the grid and inside the needle guidance device  106  ( 208 ) without the need for ultrasound guidance since the implanted needle guidance device  106  precisely guides the needles. The radioactive seeds may then be implanted per the treatment plan ( 210 ). Ultrasound guidance can be used for verification of the final placement of the radioactive seeds. The needle guidance device  106 , the fiducial needles and other components then may be removed after the completion of the procedure ( 212 ). 
     In an alternative method, when the patient is confirmed to receive permanent breast seed implantation, the needle guidance device  106  may be placed percutaneously with a trochar. The device is visible under CT and ultrasound imaging. In this embodiment, the needle guidance device  106  may be secured in the lumpectomy cavity with an inflated balloon. Treatment planning is done using the device as a reference point. On the day of the implantation, the fiducial needle uses the guidewire component of the device as a track into the cavity without ultrasound guidance. Ultrasound guidance can be used for verification of the final placement. The device is removed after the completion of the procedure. 
       FIG.  3    is a caudal cross section of breast tissue and illustrates another example of the needle guidance device  106  used with a brachytherapy fiducial needle fixation system. In this embodiment, many of the elements in  FIG.  1    are the same and are labeled as such and will not be further described for this embodiment. In this embodiment, the needle guidance device  106  may have one or more deployable hooks  302  that may be the anchor device used to anchor the installed needle guidance device  106  at the treatment region  110 . In operation, the hook(s) may be withdrawn into a distal end of the needle guidance device  106  during installation and then be deployed as shown in  FIG.  3    once the needle guidance device  106  is placed adjacent/in the treatment region  110 . Each hook may be spring biased so that it deploys once released. The hooks  302  may also use the same spring mechanism or a different spring mechanism to retreat the hooks for removal of the device. The needle guidance device  106  may also have a brachytherapy needle template guide  304  that is attached to the needle guidance device  106  as shown. The needle template guide  304  is a template through which fiducial needles and/or radioactive seed/source needles are guided into the treatment site in order to place one or more radioactive seeds/sources into/adjacent the treatment site. 
       FIG.  4    illustrates another method  400  of using the needle guidance device shown in  FIG.  3   . In one example, the needle guidance device is used to place one or more brachytherapy seeds into a treatment region which is a lumpectomy cavity in breast tissue from which a tumor was surgically removed previously. In the method, the needle guidance device  106 , in the form of a cannula in one embodiment, is placed at the time of lumpectomy in the treatment region that is the lumpectomy cavity ( 402 ). The needle guidance device  106  may be secured in the lumpectomy cavity using the deployed hooks ( 404 ) to prevent migration. When the patient is confirmed to receive permanent breast seed implantation, a CT-visible marker is placed inside the device for treatment planning. The CT-visible marker has bands spaced 1 cm apart for depth measurements. Treatment planning (with known treatment planning software) is done using the device as a reference point ( 406 ). During the treatment planning, the need guidance device is imaged and the treatment planning software ( 407 ) is used to plan one or more characteristics of the insertion of a brachytherapy needle, such as placement, angle and/or depth of insertion) prior to the procedure. The CT-visible marker may be removed after the plan. 
     On the day of the radioactive seed implantation (that may be the same day/same time as the treatment planning or at a different time), a template grid of the brachytherapy fiducial needle fixation system (an example of which is described in U.S. Pat. No. 8,764,619 that is incorporated herein by reference) is set up and placed into position ( 408 ). Then, a fiducial needle may be placed through the grid and inside the needle guidance device  106  ( 410 ) and secured without the need for ultrasound guidance since the implanted needle guidance device  106  precisely guides the needles. The radioactive seeds may then be implanted per the treatment plan ( 412 ). Ultrasound guidance can be used for verification of the final placement of the radioactive seeds. The needle guidance device  106 , the fiducial needles and other components then may be removed after the completion of the procedure ( 412 ). 
     In an alternative embodiment, the needle guidance device  106  may be a catheter that is open at both ends (unlike the embodiment shown in  FIG.  1   ) that is inserted inside the body with a trocar which is the element that penetrates the tissue. Once the device  106  is inserted percutaneously inside the body, the trocar is removed. The device  106  may be anchored in place with a button at the skin surface. A brachytherapy needle is inserted inside the device for the placement of one or more radioactive seeds inside the body. The brachytherapy needle is removed and a fiducial needle is inserted inside so that it can be fixated with a brachytherapy needle template grid. The other brachytherapy needles can be inserted with the brachytherapy needle template grid. 
     The foregoing description, for purpose of explanation, has been described 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 an/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, the scope of which is defined by the appended claims