Patent Application
20140088413
This disclosure relates to medical devices and methods, and more particularly to systems and methods for optical fiber sensing for determining applicator geometries during interventional therapy in real-time.
Brachytherapy can be used for the treatment of malignant tumors by employing ionizing radiation. One important challenge with brachytherapy can be to ensure that delivery of radiation dose is performed accurately, according to a pre-procedural plan. This challenge includes, for example, the need to accurately position brachytherapy sources, and to compensate for any deviations from the plan as may arise from positioning errors, target volume deformation such as from tissue swelling or changes in radiation transport properties as from the formation of an edema in a surgical cavity. Existing methods generally rely on imaging information, which can provide snapshots of applicator and/or seed positions in time. Implanted beacons have been used to detect organ movement. These approaches can be considered limited in spatial accuracy and/or timeliness of the detection of changes.
In accordance with the present principles, a system for monitoring changes during therapy includes a first probing segment having an optical fiber sensor disposed therein. The first segment is percutaneously inserted in or near a target area and providing a local reference for one or more treatment devices. A second probing segment has an optical fiber sensor disposed therein. The second segment is generally disposed apart from the first probe and provides a spatial reference point for the first segment. The first and second segments have at least one common position to function as a reference between the first and second probes. A shape determination method is configured to determine a shape of each of the first and second segments based on feedback signals to measure changes in the shapes during a procedure and update a therapy plan in accordance with the changes.
A workstation for monitoring changes during therapy includes a computer including a processor and memory. A shape determination module is stored in the memory and configured to determine shapes of a plurality of flexible probes based on feedback signals. The flexible probes each have an optical fiber sensor disposed therein. The flexible probes are configured to measure changes in the shapes during a procedure to provide reference locations for one or more treatment devices. A therapy plan module is stored in the memory and configured to compare and update a therapy plan based upon the reference locations for the one or more treatment devices. The plurality of probes has at least one common position to function as a reference between the probes. The probes include a first probe for being percutaneously inserted in or near a target area, and a second probe for being generally disposed apart from the first probe and providing a spatial reference point for the first probe.
A method for monitoring changes during therapy includes determining positions and path trajectories of sources for focal energy deposition by introducing at least one flexible probe percutaneously into a body to a location in or close to a region of tissue targeted for the focal energy deposition, the probe including at least one optical fiber sensor; comparing the positions and path trajectories in real time to a therapy plan to quantify deviations from the plan; and providing adaptations of therapy to achieve a therapy goal accounting for the deviations in subsequent activities in the procedure.
These and other objects, features and advantages of the present disclosure will become apparent from the following detailed description of illustrative embodiments thereof, which is to be read in connection with the accompanying drawings.
This disclosure will present in detail the following description of preferred embodiments with reference to the following figures wherein:
In accordance with the present principles, systems and methods are provided to determine, estimate and/or visualize (in real time, during therapy), positions and path trajectories of sources for focal energy deposition. Focal energy deposition may include, e.g., radiation sources for brachytherapy or other therapies, cryotherapy probes, applicators for laser ablation, photodynamic therapy, high-intensity focused ultrasound, or other forms of minimally invasive local ablation, etc. The systems and methods may be employed to relate these determinations and/or estimates in real time to a therapy plan and to intra-procedural imaging or other biophysical monitoring, so as to quantify potential deviations from the plan. This results in triggering and guiding suitable adaptations of therapy, so as to realize the therapy goal in spite of deviations from the original therapy plan.
In one embodiment, a collection of (precisely) known source locations within a tissue anatomy of interest can be combined with known characteristics about source-tissue interaction to calculate a final spatial distribution of dose delivery. For example, this information can be related to clinical outcomes on a patient specific basis, which can be used to create a library/database/atlas for, e.g., future optimization of such procedures, physicians-in-training, clinical outcomes studies, and/or patient-specific atlas/database driven automation of seed placement. The present principles may be employed to overcome a wide range of problems and/or disadvantages, including estimating deviations from planned delivery positions in real time throughout the positioning of brachytherapy sources, and for appropriate compensation. Further, the exemplary systems and methods may also be applicable to other minimally or non-invasive therapy modalities that utilize focal energy deposition, such as cryotherapy, RF ablation, laser ablation, photodynamic therapy, high-intensity focused ultrasound, etc.
The present principles will be generically described with respect to an interventional procedure. The interventional procedure may take many forms. A few non-limiting examples will be explained herein for illustrative purposes. In one embodiment, brachytherapy can be used for the treatment of malignant tumors with ionizing radiation. It is generally considered that there are two main forms of brachytherapy. These include permanent seed implantation and high-dose-rate brachytherapy. Permanent seed implantation, which can also be referred to as low-dose-rate brachytherapy, employs rice kernel-sized metallic seeds containing radioactive isotopes such as 125I or 103Pd. The isotopes are inserted permanently through a needle or catheter into a treatment volume. Usually, needles or catheters are inserted sequentially along different trajectories, and the seeds are delivered into the target tissue at positions along an insertion track of the needle or catheter while the needle or catheter is retracted. The radiation dose can be delivered over a period of weeks to months. High-dose-rate brachytherapy, which involves the placement of multiple catheters within which a radioactive isotope, or a miniaturized x-ray source, can be inserted and moved to defined positions for defined times (“afterloading”) so as to deliver internal radiation therapy in several sessions over the course of, e.g., 2 days. After the treatment course, the catheters can be removed. The catheters can form a parallel bundle, or meridian-like lines along the surface of a balloon applicator.
With both forms of brachytherapy, delivery of a correct radiation dose to the tumor is needed, and the radiation dose received by adjacent tissues should be minimized. Planning with pre-procedural images is often used to tailor the dose distribution to a patient's anatomy. Computed tomography (CT), magnetic resonance (MR) or ultrasound (US) images can be utilized to provide relatively high contrast for many tumor types.
With brachytherapy, compensation for positioning errors, catheter displacement, target volume deformation such as from tissue swelling, or changes in radiation transport properties as from the formation of an edema in a surgical cavity needs to be taken into account. For example, if significant deviations in source positions, target tissue geometry, or target volume content occur, planning that was performed with pre-procedural images will likely no longer be relevant and, as a result, the tumor can be inadequately treated and adjacent tissues can be placed at risk for radiation damage.
In accordance with preferred embodiments, optical shape sensing is employed to assist in tracking components for patient treatment. In particularly useful embodiments, a three-dimensional (3D) shape of a flexible, elongated structure can be tracked in real-time. The fundamental principles underlying optical shape sensing, as implemented, for example, with Fiber Bragg Gratings (FBGs) and with Rayleigh scattering are relied upon to provide detailed spatial information for tools during a procedure. With optical shape sensing, the 3D position of a particular location on a patient can be tracked. This sensing method can also allow for tracking of the 3D shape of a deformable mesh that can be tightly fitted around a patient's body, for example.
Relative to other tracking methods such as electromagnetic (EM) tracking, optical shape sensing can have the advantage of immunity to external fields and to distortions of EM fields that can occur due to the presence of metallic objects (e.g., a common occurrence in clinical practice).
It should be understood that the present invention will be described in terms of medical instruments; however, the teachings of the present invention are much broader and are applicable to any instruments employed in tracking or analyzing complex biological or mechanical systems. In particular, the present principles are applicable to internal tracking procedures of biological systems, procedures in all areas of the body such as the lungs, gastro-intestinal tract, excretory organs, blood vessels, etc. The elements depicted in the FIGS. may be implemented in various combinations of hardware and software and provide functions which may be combined in a single element or multiple elements.
The functions of the various elements shown in the FIGS. can be provided through the use of dedicated hardware as well as hardware capable of executing software in association with appropriate software. When provided by a processor, the functions can be provided by a single dedicated processor, by a single shared processor, or by a plurality of individual processors, some of which can be shared. Moreover, explicit use of the term “processor” or “controller” should not be construed to refer exclusively to hardware capable of executing software, and can implicitly include, without limitation, digital signal processor (“DSP”) hardware, read-only memory (“ROM”) for storing software, random access memory (“RAM”), non-volatile storage, etc.
Moreover, all statements herein reciting principles, aspects, and embodiments of the invention, as well as specific examples thereof, are intended to encompass both structural and functional equivalents thereof. Additionally, it is intended that such equivalents include both currently known equivalents as well as equivalents developed in the future (i.e., any elements developed that perform the same function, regardless of structure). Thus, for example, it will be appreciated by those skilled in the art that the block diagrams presented herein represent conceptual views of illustrative system components and/or circuitry embodying the principles of the invention. Similarly, it will be appreciated that any flow charts, flow diagrams and the like represent various processes which may be substantially represented in computer readable storage media and so executed by a computer or processor, whether or not such computer or processor is explicitly shown.
Furthermore, embodiments of the present invention can take the form of a computer program product accessible from a computer-usable or computer-readable storage medium providing program code for use by or in connection with a computer or any instruction execution system. For the purposes of this description, a computer-usable or computer readable storage medium can be any apparatus that may include, store, communicate, propagate, or transport the program for use by or in connection with the instruction execution system, apparatus, or device. The medium can be an electronic, magnetic, optical, electromagnetic, infrared, or semiconductor system (or apparatus or device) or a propagation medium. Examples of a computer-readable medium include a semiconductor or solid state memory, magnetic tape, a removable computer diskette, a random access memory (RAM), a read-only memory (ROM), a rigid magnetic disk and an optical disk. Current examples of optical disks include compact disk-read only memory (CD-ROM), compact disk-read/write (CD-R/W), DVD and Blu-Ray™
Referring now to the drawings in which like numerals represent the same or similar elements and initially to
An optical console 108 is controlled by and provides data to the computer 106. The optical console 108 delivers light to optical fiber probes 112 and 114 and receives light from the probes 112 and 114. The probes 112 and 114 are flexible, and each encloses an optical fiber shape sensor or sensors. It should be noted that the number of probes may be greater than two or a single probe may be employed. The first probe 112 and second probes 114 may include two segments on separate tethers or may include different sub-sections or segments on a same tether. It should also be understood that each probe 112, 114 may include a plurality of optical fibers, e.g., 2, 3, 4 or more fibers. Optical fiber shape sensing may take many forms and may employ different technologies, such as, e.g., multi core geometry, interferometer, polarization diversity, laser characteristics, etc. Shape sensing is illustratively described in, e.g., Published Patent Application US2011/0109898, to Froggatt et al., incorporated herein by reference.
Referring to
Referring again to
Preferably, there are one or more reference points along a single probe or several such probes for referencing that can characterize a localization/orientation of the patient anatomy near the treatment volume (118). The location of the first flexible probe 112 can therefore be tracked relative to the location of the reference points (due to e.g., probe 114). In the case that a second flexible probe 114 is employed as a reference, the second flexible probe 114 may be mechanically attached or coupled to the first flexible probe 112 on a proximal end, to ensure that errors in the output of the shape determination algorithm 107 are as similar as possible for both probes. The mechanical attachment between the two probes may also be realized with coupling of the second probe 114 to first probe 112 at a mid-segment position along probe 112 so long as the attachment point and associated tracking errors at that point are characterized and accounted for when tracking the second probe 114. The coupling of the probes 112 and 114 may be provided using a sheath 110 or other device to couple the proximal ends of the probes 112 and 114 together. For the case where the segments (probes) are on a same tether (in-line), a common reference point would be a shared connection point between the two segments.
There can be additional markers on the probes 112, 114 at the one or more reference locations along the lengths of the probes 112, 114 (e.g., multiple sheaths 110 or connecting points with, e.g., EM markers 117) that can be tracked with methods other than optical shape sensing. The information from these markers 117 can be incorporated into the shape determination algorithm 107 in real time to improve the accuracy of the shape determination algorithm 107. These exemplary markers 117 may not provide information about the spatial locations of the probe tips themselves but can provide information about the spatial locations of more proximal parts of the probes 112, 114 that could nonetheless present boundary conditions that are useful for the shape determination algorithm 107.
In one embodiment, the patient 122 may be positioned on a table 124 that can be translated with a motion controller 102. The tumor region 118 is an intended radiotherapy target. The system 100 may include a device 113 for delivering radiation, which may include a needle, catheter or other device 113 for implanting seeds or focusing radiation in the tumor 118. The device 113 is connected to the probe 112 so that the locations of therapeutic devices (e.g., radiation seeds) and their placement trajectories are known using the optical fiber sensing feedback from the probe 112. Other radiation delivery or therapy systems 136 may also be employed. One flexible probe 112 (which includes an optical fiber sensor or sensors) extends from the optical console 108 and joins a therapy application catheter (N) 113, and follows the catheter 113 to the tumor region 118.
The second flexible probe 114 which includes another optical fiber sensor is extended from the optical console 108 to a fixed region or surface point (SP) on the surface of the patient 122. In this instance, close to the optical console 108, the two optical fiber sensors of probes 112 and 114 are enclosed within the sheath 110 that is designed to permit minimal torsion, with bending radii that are as large as possible without compromising functionality. Inside the sheath 110, the two optical fiber sensors are either kept at fixed angulations with respect to each other or if they are freely moving relative to one another, the location and orientation of the fibers are tracked or otherwise determined relative to one another and relative to a common reference in a laboratory or environmental coordinate system. The optical console 108 interrogates or polls for measurements from each of the two fiber sensors either serially in a temporally-defined (or time-stamped) rapid interleaved fashion or in parallel with simultaneous readings from both fiber sensors (depending on the configuration of the interrogation platform). This concept can be extended further to more than 2 fibers to enable guidance to multiple treatment sites in parallel.
The data from the optical console 108 can be received by the computer 106, which processes the data with the shape determination algorithm 107. In this way, the computer 106 derives estimates of the 3D shapes of the optical fibers in probes 112 and 114. The shape determination algorithm 107 may include as a boundary condition the fact that the two optical fiber sensors are mechanically constrained or of known position/orientation relative to one another within the sheath 110. The relative position/orientation of the two fiber sensor reference locations can alternately be derived from actual measurements of reference markers and external tracking with a secondary position/orientation measurement device (e.g., 117).
After deriving these determinations and/or estimates, the computer 106 can compare them with determinations, therapy plans and/or estimates from previous time points to determine whether applicator movement has occurred relative to the body of the patient 122, as referenced by the second flexible probe 114.
In one embodiment, the therapy plan module/system 116 may be stored or have a portion stored in memory 109. The therapy plan module/system 116 may be configured to compare planned placements of the one or treatment devices (e.g., seeds, catheters, etc.) with actual placements of the one or treatment devices based on path trajectories determined from the probe 112. The therapy plan module 116 is configured to output subsequent locations for placement of the one or treatment devices based upon achieving overall plan objectives. The therapy plan module 116 may include weighting systems with alternative roadmaps and/or clinical decision trees based on prior history so that evaluations of current feedback can be employed to ensure that the objectives of the treatment plan are met.
If there is no relative movement between the actual measurements and the therapy plan, the 3D shapes of the parts of the sensors that are fixed to the patient 122 (probes 112 and 114) could be expected to move synchronously (i.e., together). Otherwise, they would have asynchronous movement indicating a change. The impact of any detected relative motion is then determined with knowledge of the patient's anatomy obtained with the pre-procedural image database 104 and with information derived from similar prior studies in a database or library linking interventional path characteristics with clinical outcomes. If the relative movement exceeds defined alarm limits, a warning is given and therapy is suspended pending an adaption of the therapy plan according to the changed applicator geometry. The warning may be produced audibly, visually on a display 119 or by any other suitable method including haptic feedback within the probe itself.
Programming, device control, monitoring of functions and/or any other interactions with the computer 106 or workstation 101 may be performed using an interface 128. Display 119 may also permit a user to interact with the workstation 101 and its components and functions, or any other element within the system 100. This is further facilitated by the interface 128 which may include a keyboard, mouse, a joystick, a haptic device, or any other peripheral or control to permit user feedback from and interaction with the workstation 101 or system 100.
In another exemplary embodiment, the flexible probe 112 with the optical fiber sensor can be inserted to reach the tumor region with endovascular access. For example, the probe 112 can be advanced through the patient's vasculature until it is close to the tumor region 118. The probe 112 is then inserted through the vascular wall towards the tumor region 118. This exemplary procedure can likely be performed with fluoroscopic guidance using an imaging system 130 in combination with radio opaque contrast agents, for example. Other imaging techniques may also be employed. More than one flexible probe (112) can be inserted into the tumor region 118. More than one flexible probe (114) can also be placed at an additional point outside the tumor region 118 to monitor a position of the patient 122 or other equipment employed during the procedure.
In one illustrative embodiment, flexible probes 134 (e.g., therapy applicators or other devices) can be tracked and/or imaged independently of the optical console 108. For example, data from these tracking/imaging methods can be used by the shape determination algorithm/procedure 107 to impose additional geometric constraints on the spatial positions of the probes 112, 114, to, e.g., improve the accuracy of the 3D shape estimates and/or delineate physiological structures (both target and normal tissue) in the volume of interest (118). In this way, independent reference points are created using tracking technologies such as EM, imaging (imaging system 130), etc., which permit a check on the position/orientations of the other probes 112, 114 employed in the procedure. Imaging device 130 and therapy system 136 may be connected to the workstation 101. In this way, the imaging system 130 and the therapy system 136 can be controlled by and/or provide feedback to the rest of the system 100.
In another embodiment, a greater number of flexible probes equipped with fiber optic shape sensors may be employed to monitor flexible surfaces and/or volumes. These surfaces or volumes may or may not be a target of interest such as a tumor, but instead may include patient movements, movements of internal organs, movement of a table 124 or other platform, movements of instruments etc. A region may include one or more optical fiber shape sensors that can be used to derive estimates of 2D or 3D changes in applicator and/or tissue geometry that can occur inside and/or outside the tumor region 118. Such an embodiment can be more complex and can likely utilize more than two optical fiber shape sensors (probes 112 or 114). This can likely provide more information about the movement of the therapy applicators relative to target and/or normal tissues, for example. The system 100 can be made modular to easily accommodate a plurality of flexible probes with fiber optic sensors.
Referring to
Similarly, local strain (e.g., positions/movement) of the mass 302 needs to be monitored relative to its local coordinate system 310. In this case, a fiber optic sensor 306 may be placed on the mass 302 to monitor local changes. In addition, positions of the target 304, mass 302 and devices 309 (e.g., radiation sources, seeds, etc.) need to be understood in accordance with a more global coordinate system 314. The devices 309 are positioned by a tracked tool and so their positions are accurately known. Additional information relating the coordinates systems 310 and 312 can be provided by various constraints and boundary conditions. For example, the optical fiber sensors 306 and 308 may share a common position or positions, or are otherwise tracked so that the reference point on one fiber is known relative to the reference point on the other. As described above, this may be achieved by bundling portions of the optical fibers for both sensors 306 and 308 (e.g., in a sheath or the like). In this way, a common reference or constraint is known and a solution to all other points along the optical fiber sensors 306 and 308 can be determined and monitored relative to a common coordinate system 314.
In the case described above for radiation therapy, the monitoring of the target 304 may include changes due to swelling of target areas, due to patient activity, due to movement of equipment, due to error in placement of device 309, etc. Having another reference point or points from sensors 306 provides not only local movements for another position on the patient but also knowledge of the orientation of the mass 302 (e.g., patient on a table or platform, etc.) relative to the other sensor 308. In the example, this can provide guidance for aiming/focusing radiation, placement of radiation seeds, etc.
Referring to
In block 404, feedback signals are collected from the at least one flexible probe and input to a shape determination module to detect changes in the at least one flexible probe such that, in accordance with a therapy plan, the region of tissue targeted for therapy and an intensity of treatment can be altered based on the output of the shape determination module.
In block 406, the positions and path trajectories are compared in real time to a therapy plan to quantify deviations from the plan. In block 408, a second probe may be introduced to provide a reference position for the first probe. The second probe also preferably includes at least one optical fiber sensor. The at least one flexible probe and the second probe may share at least one common position to provide a constraint or condition for correlating coordinate systems in block 410, or each probe may have reference positions that are known relative to one another.
In block 412, adaptations of therapy are provided to achieve a therapy goal based on the collected feedback and plan comparisons. The deviations are accounted for in subsequent activities in the procedure. In block 414, subsequent locations for placement of the one or treatment devices based upon achieving overall plan objectives may be output. Other changes, suggestions or actions may be called for to ensure that the therapy plan goals are achieved. In block 416, an additional tracking device or devices configured to independently track paths of at least one flexible probe may be employed to verify and/or improve position measurements of the at least one flexible probe or otherwise provide solution constraints or conditions for determining positional information for sensor probes. In block 418, the procedure continues until completed, e.g., the plan objectives are met.
In interpreting the appended claims, it should be understood that:
Having described preferred embodiments for systems and methods for optical fiber sensing for determining real time changes in applicator geometry for interventional therapy (which are intended to be illustrative and not limiting), it is noted that modifications and variations can be made by persons skilled in the art in light of the above teachings. It is therefore to be understood that changes may be made in the particular embodiments of the disclosure disclosed which are within the scope of the embodiments disclosed herein as outlined by the appended claims. Having thus described the details and particularity required by the patent laws, what is claimed and desired protected by Letters Patent is set forth in the appended claims.
This application claims priority to commonly assigned U.S. provisional application Ser. No. 61/495,906 filed Jun. 20, 2011 and incorporated herein by reference.
| Filing Document | Filing Date | Country | Kind | 371c Date |
|---|---|---|---|---|
| PCT/IB2012/052816 | 6/5/2012 | WO | 00 | 11/15/2013 |
| Number | Date | Country | |
|---|---|---|---|
| 61495906 | Jun 2011 | US | |
| 61566619 | Dec 2011 | US |
