A thermal treatment system including a heat applying element for generating thermal doses for ablating a target mass in a patient, a controller for controlling thermal dose properties of the heat applying element, an imager for providing preliminary images of the target mass and thermal images during the treatment, and a planner for automatically constructing a treatment plan, comprising a series of treatment sites that are each represented by a set of thermal dose properties. The planner automatically constructs the treatment plan based on input information including one or more of a volume of the target mass, a distance from a skin surface of the patient to the target mass, a set of default thermal dose prediction properties, a set of user specified thermal dose prediction properties, physical properties of the heat applying elements, and images provided by the imager. The default thermal dose prediction properties are preferably based on a type of clinical application and include at least one of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site, cooling time between thermal doses, and electrical properties for the heat applying element. The user specified thermal dose prediction properties preferably include at least one or more of overrides for any default thermal dose prediction properties, treatment site grid density; and thermal dose prediction properties not specified as default thermal dose prediction properties from the group comprised of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site cooling time between thermal doses, and electrical properties for the heat applying element.
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0. 24. A thermal treatment system, comprising:
a heat applying element for delivering thermal doses to ablate a target mass in a patient;
a controller for controlling thermal dose properties of the heat applying element;
an imager for providing preliminary images of the target mass; and
a planner for automatically constructing a treatment plan, the treatment plan comprising a series of treatment sites that are each represented by a set of thermal dose properties,
wherein the planner automatically constructs the treatment plan based on input information including thermal dose prediction properties comprising at least one of
a set of default thermal dose prediction properties, or
a set of user specified thermal dose prediction properties.
0. 37. A method of treating a target tissue mass in a patient using a focused ultrasound system, the system comprising a transducer for delivering thermal doses of ultrasound energy to the target tissue mass, an imager for providing images of the target mass, a controller for controlling the transducer, and a planner for constructing a treatment plan, the method comprising
obtaining preliminary images of the target tissue mass; and
based on the preliminary images, constructing a treatment plan for ablating the target mass, the treatment plan comprising a series of treatment sites in the target mass that are to each receive a thermal dose of ultrasound energy from the transducer, each treatment site represented by a set of thermal dose properties to be used by the controller to control the delivery of ultrasound energy by the transducer.
0. 48. A method for treating a target tissue mass in a patient using a thermal energy treatment system, the system comprising a heat applying element for delivering thermal doses used to ablate the target mass, a controller for controlling thermal dose properties of the heat applying element, an imager for providing images of the target mass, and a planner for constructing a treatment plan, the method comprising:
receiving input information including preliminary images of the target mass; and
based on the input information, automatically constructing a treatment plan for ablating the target mass, the treatment plan comprising a series of treatment sites in the target mass that are to each receive a thermal dose from the heat applying element, each treatment site represented by a set of thermal dose properties to be used by the controller to control the delivery of the thermal doses.
1. A thermal treatment system, comprising:
a heat applying element for generating a delivering thermal dose doses used to ablate a target mass in a patient;
a controller for controlling thermal dose properties of the heat applying element;
an imager for providing preliminary images of the target mass; and
a planner for automatically constructing a treatment plan, the treatment plan comprising a series of treatment sites that are each represented by a set of thermal dose properties;
wherein the planner automatically constructs the treatment plan based on input information including one or more of:
a volume of the target mass,
a distance from a skin surface of the patient to the target mass,
a set of default thermal dose prediction properties,
a set of user specified thermal dose prediction properties,
physical properties of the heat applying elements, and
images provided by the imager.
14. A focused ultrasound system, comprising:
a transducer for generating delivering successive delivered thermal doses of ultrasound energy that results in thermal doses to ablate for ablating a target mass in a patient;
a controller for controlling thermal dose properties of the transducer;
an imager for providing preliminary images of the target mass, and for providing thermal images illustrating an actual thermal dose distribution in the patient resulting from a delivered thermal dose of ultrasound energy to the target mass; and
a planner configured for automatically constructing a treatment plan using the preliminary images, the treatment plan comprising a series of predicted thermal doses to treatment sites represented by a set of thermal dose properties used by a controller to control the transducer of the target mass;
wherein the planner further constructs a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan;
wherein after a thermal dose is delivered to each treatment site in the treatment plan, the actual thermal dose distribution is compared to the predicted thermal dose distribution to determine remaining untreated locations within the target mass.
0. 61. A method of treating a target tissue mass in a patient using a focused ultrasound system, the system comprising a transducer for delivering thermal doses of ultrasound energy to the target tissue mass, an imager for providing images of the target mass, a controller for controlling the transducer, and a planner for constructing a treatment plan, the method comprising
obtaining preliminary images of the target tissue mass;
based on the preliminary images, automatically constructing, with the planner, a treatment plan for ablating the target mass, the treatment plan comprising a series of treatment sites in the target mass that are to each receive a thermal dose of ultrasound energy from the transducer, each treatment site represented by a set of thermal dose properties to be used by the controller to control the delivery of ultrasound energy by the transducer;
constructing a predicted thermal dose distribution illustrating the predicted thermal dose contours of the treatment sites in the treatment plan; and
delivering thermal doses of ultrasound energy to the treatment sites according to the treatment plan,
wherein the imager provides thermal images illustrating an actual thermal dose distribution in the target tissue mass resulting from a thermal dose delivered to a treatment site, and
wherein after a thermal dose is delivered to each treatment site, the actual thermal dose distribution is compared to the predicted thermal dose distribution to determine remaining untreated locations within the target mass.
2. The treatment system of
3. The treatment system of
thermal dose threshold,
thermal dose prediction algorithm,
maximum allowed energy for each thermal dose,
thermal dose duration for each treatment site,
cooling time between thermal doses, and
electrical properties for the heat applying element.
4. The treatment system of
overrides for any default thermal dose prediction properties,
treatment site grid density, and
thermal dose prediction properties not specified as default thermal dose prediction properties selected from the group comprised consisting of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site cooling time between thermal doses, and electrical properties for the heat applying element.
5. The treatment system of
6. The treatment system of
7. The treatment system of
8. The treatment system of
9. The treatment system of
11. The treatment system of
13. The treatment system of
ultrasound energy,
laser light energy,
RF energy,
microwave energy, and
electrical energy.
15. The focused ultrasound system of
16. The focused ultrasound system of
17. The focused ultrasound system of
18. The focused ultrasound system of
19. The focused ultrasound system of
20. The focused ultrasonic system of
21. The focused ultrasonic system of
22. The focused ultrasound system of claim 20 21, wherein the sensitive regions comprise bones, gas, and other sensitive tissues.
0. 23. The focused ultrasound system of claim 14, wherein based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution for a given treatment site, the planner adjusts the treatment plan to include delivery of an additional thermal dose to the same or substantially the same treatment site.
0. 25. The treatment system of claim 24, wherein the thermal dose properties translate, at least in part, to electrical and mechanical properties of the heat applying element.
0. 26. The treatment system of claim 24, wherein the default thermal dose prediction properties are based on a type of clinical application and include at least one of:
thermal dose threshold,
thermal dose prediction algorithm,
maximum allowed energy for each thermal dose,
thermal dose duration for each treatment site,
cooling time between thermal doses, and
electrical properties for the heat applying element.
0. 27. The treatment system of claim 24, wherein the user specified thermal dose prediction properties include at least one of:
overrides for any default thermal dose prediction properties,
treatment site grid density, and
thermal dose prediction properties not specified as default thermal dose prediction properties and selected from the group consisting of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site cooling time between thermal doses, and electrical properties for the heat applying element.
0. 28. The treatment system of claim 24, wherein the treatment plan ensures that the entire target mass is covered by a series of thermal doses so as to obtain a composite thermal dose sufficient to ablate the entire target mass.
0. 29. The treatment system of claim 24, wherein the thermal dose properties are automatically optimized using physiological properties as the optimization criterion.
0. 30. The treatment system of claim 24, wherein the planner limits the thermal dose at each treatment site in order to prevent carbonization or evaporation.
0. 31. The treatment system of claim 24, wherein the planner constructs a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan.
0. 32. The treatment system of claim 24, further comprising a user interface for entering user specified thermal dose prediction properties and for editing the treatment plan once the treatment plan is constructed.
0. 33. The treatment system of claim 24, wherein the treatment plan is constructed in three dimensions.
0. 34. The treatment system of claim 24, wherein the imager provides thermal images illustrating an actual thermal dose distribution resulting from a respective thermal dose delivery at each treatment site.
0. 35. The treatment system of claim 24, wherein the heat applying element applies one of the following:
ultrasound energy,
laser light energy,
RF energy,
microwave energy, and
electrical energy.
0. 36. The treatment system of claim 24, wherein the input information further includes a volume of the target tissue mass.
0. 38. The method of claim 37, further comprising constructing a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan.
0. 39. The method of claim 37, further comprising delivering thermal doses of ultrasound energy to one or more of the treatment sites.
0. 40. The method of claim 37, wherein the imager provides thermal images illustrating an actual thermal dose distribution in the target tissue mass resulting from a thermal dose of ultrasound energy to a treatment site, the method further comprising
constructing a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan,
delivering thermal doses of ultrasound energy to the treatment sites according to the treatment plan, and
after a thermal dose is delivered to a treatment site in the treatment plan, comparing the actual thermal dose distribution to the predicted thermal dose distribution for the treatment site.
0. 41. The method of claim 40, further comprising, based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution, selectively changing the treatment plan by one or more of adding treatment sites, removing treatment sites, and modifying treatment sites, to ensure complete ablation of the target mass.
0. 42. The method of claim 40, further comprising, based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution, delivering an additional thermal dose of ultrasound energy to the same or substantially the same treatment site.
0. 43. The method of claim 37, further comprising manually adjusting the treatment plan.
0. 44. The method of claim 37, further comprising:
identifying in images used to construct the treatment plan outlines of regions within the patient that are sensitive to the application of ultrasound, and
constructing the treatment plan so as to avoid exposure of the sensitive regions to ultrasound energy delivered by the transducer.
0. 45. The method of claim 37, wherein the thermal dose properties translate, at least in part, to electrical and mechanical properties of the transducer.
0. 46. The method of claim 37, wherein the treatment plan ensures that the entire target mass is covered by a series of thermal doses of ultrasound energy so as to obtain a composite thermal dose sufficient to ablate the entire target mass.
0. 47. The method of claim 37, further comprising optimizing the thermal dose properties based on physiological properties as optimization criterion.
0. 49. The method of claim 48, further comprising automatically constructing a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan.
0. 50. The method of claim 48, further comprising delivering thermal doses from the heat applying element to one or more of the treatment sites.
0. 51. The method of claim 48, wherein the imager provides thermal images illustrating an actual thermal dose distribution in the target tissue mass resulting from a thermal dose delivered to a treatment site, the method further comprising
constructing a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan,
delivering thermal doses to the treatment sites according to the treatment plan, and
after a thermal dose is delivered to a treatment site in the treatment plan, comparing the actual thermal dose distribution to the predicted thermal dose distribution for the treatment site.
0. 52. The method of claim 51, further comprising, based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution, changing the treatment plan by one or more of adding treatment sites, removing treatment sites, and modifying treatment sites, to ensure complete ablation of the target mass.
0. 53. The method of claim 51, further comprising, based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution, leaving the treatment plan unchanged in order to ensure complete ablation of the target mass.
0. 54. The method of claim 51, further comprising, based on the comparison of the actual thermal dose distribution to the predicted thermal dose distribution, delivering an additional thermal dose to the same or substantially the same treatment site.
0. 55. The method of claim 48, further comprising manually adjusting the treatment plan.
0. 56. The method of claim 48, wherein the thermal dose properties translate, at least in part, to electrical and mechanical properties of the heat applying element.
0. 57. The method of claim 48, wherein the treatment plan ensures that the entire target mass is covered by a series of thermal doses so as to obtain a composite thermal dose sufficient to ablate the entire target mass.
0. 58. The method of claim 48, further comprising optimizing the thermal dose properties based on physiological properties as optimization criterion.
0. 59. The method of claim 48, wherein the input information further includes one or more of the group consisting of:
a volume of the target mass,
default thermal dose prediction properties, and
user specified thermal dose prediction properties.
0. 60. The method of claim 53, wherein the heat applying element applies one of the following:
ultrasound energy,
laser light energy,
RF energy,
microwave energy, and
electrical energy.
0. 62. The method of claim 61, wherein the comparison of the actual thermal dose distribution to the predicted thermal dose distribution is used to determine changes to the treatment plan for treating the remaining untreated locations.
0. 63. The method of claim 61, wherein the planner automatically evaluates the treatment plan based on the remaining untreated locations and, in order to ensure complete ablation of the target mass, either changes the treatment plan by one or more of adding treatment sites, removing treatment sites, and modifying existing treatment sites, or leaves the treatment plan unchanged.
0. 64. The method of claim 61, further comprising manually adjusting the treatment plan based on the remaining untreated locations.
0. 65. The method of claim 61, wherein the preliminary images and the thermal images represent three-dimensional data.
0. 66. The method of claim 61, wherein the predicted thermal dose distribution and actual thermal dose distribution represent three-dimensional data.
0. 67. The method of claim 61, wherein the imager further provides outlines of regions within the patient that are sensitive to ultrasound, and wherein the planner uses the outlines in constructing the treatment plan so as to avoid exposing the sensitive regions to ultrasound.
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This application is a reissue of U.S. patent application Ser. No. 09/724,670, filed Nov. 28, 2000, issued as U.S. Pat. No. 6,618,620.
The present invention relates generally to thermal treatment systems, and more particularly to a method and apparatus for controlling thermal dosing in a thermal treatment system.
Thermal energy, such as generated by high intensity focused ultrasonic waves (acoustic waves with a frequency greater than about 20 kilohertz), may be used to therapeutically treat internal tissue regions within a patient. For example, ultrasonic waves may be used to ablate tumors, thereby obviating the need for invasive surgery. For this purpose, piezoelectric transducers driven by electric signals to produce ultrasonic energy have been suggested that may be placed external to the patient but in close proximity to the tissue to be ablated. The transducer is geometrically shaped and positioned such that the ultrasonic energy is focused at a “focal zone” corresponding to a target tissue region within the patient, heating the target tissue region until the tissue is coagulated. The transducer may be sequentially focused and activated at a number of focal zones in close proximity to one another. This series of “sonications” is used to cause coagulation necrosis of an entire tissue structure, such as a tumor, of a desired size and shape.
In such focused ultrasound systems, the transducer is preferably geometrically shaped and positioned so that the ultrasonic energy is focused at a “focal zone” corresponding to the target tissue region, heating the region until the tissue is necrosed. The transducer may be sequentially focused and activated at a number of focal zones in close proximity to one another. For example, this series of “sonications” may be used to cause coagulation necrosis of an entire tissue structure, such as a tumor, of a desired size and shape.
By way of illustration,
As illustrated in
More advanced techniques for obtaining specific focal distances and shapes are disclosed in U.S. patent application Ser. No. 09/626,176, filed Jul. 27, 2000, entitled “Systems and Methods for Controlling Distribution of Acoustic Energy Around a Focal Point Using a Focused Ultrasound System;” U.S. patent application Ser. No. 09/556,095, filed Apr. 21, 2000, entitled “Systems and Methods for Reducing Secondary Hot Spots in a Phased Array Focused Ultrasound System;” and U.S. patent application Ser. No. 09/557,078, filed Apr. 21, 2000, entitled “Systems and Methods for Creating Longer Necrosed Volumes Using a Phased Array Focused Ultrasound System.” The foregoing (commonly assigned) patent applications, along with U.S. Pat. No. 4,865,042, are all hereby incorporated by reference for all they teach and disclose.
It is significant to implementing these focal positioning and shaping techniques to provide a transducer control system that allows the phase of each transducer element to be independently controlled. To provide for precise positioning and dynamic movement and reshaping of the focal zone, it is desirable to be able to alter the phase and/or amplitude of the individual elements relatively fast, e.g., in the μ second range, to allow switching between focal points or modes of operation. As taught in the above-incorporated U.S. patent application Ser. No. 09/556,095, it is also desirable to be able to rapidly change the drive signal frequency of one or more elements.
Further, in a MRI-guided focused ultrasound system, it is desirable to be able to drive the ultrasound transducer array without creating electrical harmonics, noise, or fields that interfere with the ultra-sensitive receiver signals that create the images. A system for individually controlling and dynamically changing the phase and amplitude of each transducer element drive signal in phased array focused ultrasound transducer in a manner which does not interfere with the imaging system is taught in commonly assigned U.S. patent application Ser. No. [not-yet-assigned; Lyon & Lyon Attorney Docket No. 254/189, entitled “Systems and Methods for Controlling a Phased Array Focussed Ultrasound System,”], which was filed on the same date herewith and which is hereby incorporated by reference for all it teaches and discloses.
Notably, after the delivery of a thermal dose, e.g., ultrasound sonication, a cooling period is required to avoid harmful and painful heat build up in healthy tissue adjacent a target tissue structure. This cooling period may be significantly longer than the thermal dosing period. Since a large number of sonications may be required in order to fully ablate the target tissue site, the overall time required can be significant. If the procedure is MRI-guided, this means that the patient must remain motionless in a MRI machine for a significant period of time, which can be very stressful. At the same time, it may be critical that the entire target tissue structure be ablated (such as, e.g., in the case of a malignant cancer tumor), and that the procedure not take any short cuts just in the name of patient comfort.
Accordingly, it would be desirable to provide systems and methods for treating a tissue region using thermal energy, such as focused ultrasound energy, wherein the thermal dosing is applied in a more efficient and effective manner.
In accordance with a first aspect of the invention, a thermal treatment system is provided, the system including a heat applying element for generating a thermal dose used to ablate a target mass in a patient, a controller for controlling thermal dose properties of the heat applying element, an imager for providing preliminary images of the target mass and thermal images during the treatment, and a planner for automatically constructing a treatment plan, comprising a series of treatment sites that are each represented by a set of thermal dose properties. By way of non-limiting example only, the heat applying element may apply any of ultrasound energy, laser light energy, radio frequency (RF) energy, microwave energy, or electrical energy.
In a preferred embodiment, the planner automatically constructs the treatment plan based on input information including one or more of a volume of the target mass, a distance from a skin surface of the patient to the target mass, a set of default thermal dose prediction properties, a set of user specified thermal dose prediction properties, physical properties of the heat applying elements, and images provided by the imager. The default thermal dose prediction properties are preferably based on a type of clinical application and include at least one of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site, cooling time between thermal doses, and electrical properties for the heat applying element. The user specified thermal dose prediction properties preferably include at least one or more of overrides for any default thermal dose prediction properties, treatment site grid density; and thermal dose prediction properties not specified as default thermal dose prediction properties from the group comprised of thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site cooling time between thermal doses, and electrical properties for the heat applying element.
Preferably, the treatment plan ensures that the entire target mass is covered by a series of thermal doses so as to obtain a composite thermal dose sufficient to ablate the entire target mass, and the thermal dose properties are automatically optimized using physiological properties as the optimization criterion. Preferably, the planner limits the thermal dose at each treatment site in order to prevent evaporation or carbonization.
In a preferred embodiment, the planner constructs a predicted thermal dose distribution in three dimensions, illustrating the predicted thermal dose threshold contours of each treatment site in the treatment plan. A User Interface (UI) may also be provided for entering user specified thermal dose prediction properties and for editing the treatment plan once the treatment plan is constructed. A feedback imager for providing thermal images may also be provided, wherein the thermal images illustrate the actual thermal dose distribution resulting at each treatment site. In one embodiment, the imager acts as the feedback imager.
In accordance with another aspect of the invention, a focused ultrasound system is provided, including a transducer for generating ultrasound energy that results in thermal doses used to ablate a target mass in a patient, a controller for controlling thermal dose properties of the transducer, an imager for providing preliminary images of the target, and for providing thermal images illustrating an actual thermal dose distribution in the patient, and a planner for automatically constructing a treatment plan using the preliminary images, the treatment plan comprising a series of treatment sites represented by a set of thermal dose properties used by the controller to control the transducer.
The planner preferably constructs a predicted thermal dose distribution illustrating the predicted thermal dose contours of each treatment site in the treatment plan, wherein after a thermal dose is delivered to a treatment site in the treatment plan, the actual thermal dose distribution is compared to the predicted thermal dose distribution to determine remaining untreated locations within the target mass. The planner preferably automatically evaluates the treatment plan based on the remaining untreated locations and will update the treatment plan to ensure complete ablation of the target mass is achieved by adding treatment sites, removing treatment sites, modifying existing treatment sites, or leaving the treatment plan unchanged. In some embodiments, a user can manually adjust the treatment plan based on the remaining untreated locations.
Preferably, the imager provides outlines of sensitive regions within the patient where ultrasonic waves are not allowed to pass, wherein the processor uses the outlines in constructing the treatment plan so as to avoid exposing the sensitive regions to ultrasound.
In accordance with still another aspect of the invention, a method of controlling thermal dosing in a thermal treatment system is provided, which includes selecting an appropriate clinical application protocol, the selected application protocol having associated with it certain default thermal dosing properties; retrieving relevant magnetic resonant images for thermal dose planning; tracing a target mass on the images; entering user specified thermal dosing properties and selectively modifying the default thermal dosing properties; and automatically constructing a treatment plan representing thermal doses to be applied to treatment sites, the treatment plan based on the default thermal dosing properties and the user specified thermal dosing properties.
In preferred implementations, tracing the target mass can be done manually or automatically, and may include evaluating the target mass to ensure that obstacles including bones, gas, or other sensitive tissue will not interfere with the thermal doses and repositioning a patient or a heat applying element in order to bypass any such obstacles. Preferably, the treatment plan ensures that a target mass receives a composite thermal dose sufficient to ablate the target mass, wherein automatically constructing the treatment plan includes predicting and displaying a predicted thermal dose distribution. Preferably, automatically constructing the treatment plan further includes calculating limits for each thermal dose to be applied to each treatment site in order to prevent evaporation or carbonation.
In a preferred implementation, the treatment plan may be manually edited, including at least one of adding treatment sites, deleting treatment sites, changing the location of treatment sites, changing thermal dosing properties, and reconstructing the entire treatment plan with new thermal dosing properties.
In one implementation, the method includes applying a low energy thermal dose at a predetermined spot within the target mass in order to verify proper registration, and evaluating said predetermined spot and adjusting and/or re-verifying if necessary. In a following step, the low energy thermal dose could be extended to a full dose sonication that will be evaluated to assess the thermal dosing parameters as a scaling factor for the full treatment.
Other aspects and features of the invention will become apparent hereinafter.
The drawings illustrate both the design and utility of preferred embodiments of the invention, in which similar elements in different embodiments are referred to by the same reference numbers for purposes of ease in illustration, and wherein:
The invention will now be illustrated by examples that use an ultrasound transducer as the means of delivering energy to a target mass. It will be apparent to those skilled in the art, however, that other energy delivery vehicles can be used. For example, the invention is equally applicable to systems that use laser light energy, radio frequency (RF) energy, microwave energy, or electrical energy converted to heat, as in an ohmic heating coil or contact. Therefore, the following preferred embodiments should not be considered to limit the invention to an ultrasound system.
Ultrasound is a vibrational energy that is propagated as a mechanical wave through a target medium. In system 100, transducer 102 generates the mechanical wave by converting an electronic drive signal into mechanical motion. The frequency of the mechanical wave, and therefore ultrasound beam 112, is equal to the frequency of the drive signal. The ultrasound frequency spectrum begins at 20 Khz and typical implementations of system 100 employ frequencies in the range from 0.5 to 10 Mhz. Transducer 102 also converts the electronic drive signal power into acoustic power in ultrasound beam 112. Ultrasound beam 112 raises the temperature of target mass 104 by transferring this power as heat to target mass 104. Ultrasound beam 112 is focused on the target mass 104 in order to raise the temperature of the target mass tissue to a point where the tissue is destroyed. The heat distribution within the tissue is controlled by the intensity distribution in the focal spot of beam 112, the intensity distribution, in turn, is shaped by the interaction of the beam with the tissue and the frequency, duration, and power of beam 112, which are directly related to the frequency, duration, and power of the electronic drive signal.
As seen in
Two proportionalities illustrate this point: (1) d is proportional to k1(v/f)(R/2a); and (2) l is proportional to k2(v/f) (R/2a)2. In (1), d represents the diameter of the focal spot of beam 112. R represents the radius of curvature, and 2a represents the diameter, respectively, of transducer 102. Therefore, the physical parameters associated with transducer 102 are important parameters, as well. In (2), l represents the axial length of the focus of beam 112. Different cross sections can be targeted by changing the frequency f, which will vary the focal length l. In both (1) and (2), v is the speed of sound in body tissue and is approximately 1540 m/s.
As can be seen, the same parameters that play an important role in determining the focal length l, also play an important role in determining the focal spot diameter d. Because the focal spot will typically be many times smaller than transducer 102, the acoustic intensity will be many times higher in the focal spot as compared to the intensity at the transducer. In some implementations, the focal spot intensity can be hundreds or even thousands of times higher than the transducer intensity. The frequency f also effects the intensity distribution within energy zone 206: The higher the frequency, the tighter the distribution, which is beneficial in terms of not heating near field 204.
The duration of a sonication determines how much heat will actually be transferred to the target mass tissue at the focal spot. For a given signal power and focal spot diameter, a longer duration results in more heat transfer and, therefore, a higher temperature. Thermal conduction and blood flow, however, make the actual temperature distribution within the tissue unpredictable for longer sonication duration. As a result, typical implementations use duration of only a few seconds. In focused ultrasound systems, care must also be taken not to raise the temperature at the focal point too high. A temperature of 100° C. will cause water in the tissue to boil forming gas in the path of beam 112. The gas blocks the propagation of beam 112, which significantly impacts the performance of system 100.
Controller 106 controls the mechanical and electrical properties of transducer 102. For example, controller 106 controls electrical properties such as the frequency, duration, and amplitude of the electronic drive signal and mechanical properties such as the position of transducer 102. By controlling the position of transducer 102, the position of the focal spot within target mass 116 can be controlled. In one embodiment, controller 106 controls the x-position, z-position, the pitch, and the roll of transducer 102. A preferred mechanical positioning system for controlling the physical position of the transducer is taught in commonly assigned U.S. patent application Ser. No. 09/628,964, entitled “Mechanical Positioner for MRI Guided Ultrasound Therapy System,” which is hereby incorporated by reference for all it teaches and discloses.
In one implementation, electromechanical drives under the control of controller 106 are used to control these positional aspects. It will be apparent to those skilled in the art that other implementations may employ other means to position transducer 102 including hydraulics, gears, motors, servos, etc. Additionally, it must be remembered that controlling the electrical properties, mainly frequency f and phase of transducer 102 controls the position of the focal spot along the y-axis of transducer 102 and the dimensions of the focal volume. Controller 106 uses properties provided by planner 108 to control the mechanical and electrical properties of transducer 102.
Planner 108 automatically constructs a treatment plan, which consists of a series of treatment site represented by thermal dose properties. The purpose of the treatment plan is to ensure complete ablation of target mass 104 by planning a series of sonications that will apply a series of thermal doses at various points within target mass 104, resulting in a composite thermal dose sufficient to ablate the entire mass.
For example, the plan will include the frequency, duration, and power of the sonication and the position and mode of the focal spot for each treatment site in series of treatment sites. The mode of the focal spot refers to the fact that the focal spot can be of varying dimensions. Typically, there will be a range of focal modes from small to large with several intermediate modes in between. The actual size of the focal spot will vary, however, as a function of the focal distance (l), the frequency and focal spot dispersion mode. Therefore, planner 108 must take the mode and focal spot size variation into account when planning the position of the focal spot for a treatment site. The treatment plan is then passed to controller 106 in the relevant format to allow controller 106 to perform its tasks.
In order to construct the treatment plan, planner 108 uses input from User Interface (UI) 110 and imager 114. For example, in one implementation, a user specifies the clinical application protocol, i.e., breast, pelvis, eye, prostate, etc., via UI 110. Selection of the clinical application protocol may control at least some of the default thermal dose prediction properties such as thermal dose threshold, thermal dose prediction algorithm, maximum allowed energy for each thermal dose, thermal dose duration for each treatment site, cooling time between thermal doses, and electrical properties for the heat applying element.
In other implementations, some or all of these properties are input through UI 110 as user specified thermal dose prediction properties. Other properties that may be input as user specified thermal dose prediction properties are the sonication grid density (how much the sonications should overlap) and the physical parameters of transducer 102. The latter two properties may also be defined as default parameters in certain implementations.
Additionally, a user may edit any of the default parameters via UI 110. In one implementation, UI 110 comprises a Graphical User Interface (GUI): A user employs a mouse or touch screen to navigate through menus or choices as displayed on a display device in order to make the appropriate selections and supply the required information.
To further aid planner 108 in constructing the treatment plan, imager 114 supplies images of target mass 104 that can be used to determine volume, position, and distance from skin surface 202. In a typical implementation, imager 114 is a Magnetic Resonance Imaging (MRI) device and, in one implementation, the images provided are three-dimensional images of target mass 104. Once planner 108 receives the input from UI 110 and the images from imager 114, planner 108 automatically constructs the treatment plan.
As illustrated in
In one implementation, the treatment plan is a three-dimensional treatment plan.
Planner 108 will also predict the lesion size in the cross-sectional layer and will provide the maximal allowed energy in each layer, taking into account the maximum allowed temperature rise. The energy or power will be normalized among different layers, such that the maximal temperature at the focus remains approximately constant throughout the treatment zone 206.
Constructing the three-dimensional treatment plan begins in step 402 with obtaining diagnostic quality images of the target mass. For example, the diagnostic quality images may be the preliminary images supplied by an imager such as imager 114. In step 404, planner 108 uses the diagnostic images to define the treatment region. Then, in step 406, a line y=[ynear:yfar] is defined such that (y) cuts through target zone 206 perpendicular to transducer along the transducer axis from the nearest point within target mass 104 (ynear) to the furthest point (yfar). Line (y) will be the axis along which the treatment layers will be defined.
Once (y) is defined planner 108 will perform a dose prediction in step 408 using the maximal power required for small and large spot sizes at (yfar). In step 410, planner 108 determines if the resulting maximal temperature exceeds the allowed limit. It should be noted that properties such as the maximal power and the maximal temperature limit may be supplied as default thermal dose prediction properties or may be supplied as user supplied thermal dose prediction properties. If the resulting maximal temperature does exceed the allowable limit, the power is scaled down linearly in step 412 until the temperature elevation is within the allowable limit.
The small and large focal modes may correspond to modes 0 and 4, respectively, with additional modes 1, 2 and 3 falling between modes 0 and 4. Therefore, in step 414, planner 108 predicts the maximal power for the intermediate modes 1, 2 and 3, from the scaled max powers at modes 0 and 4. Thus, in step 416, if there are further modes, planner 108 reverts to step 408 and predicts the maximal power for these modes. If it is the last mode for (yfar) then planner 108 uses the same scaled max power, as in step 418, to find the corresponding maximal powers for each focal mode at (ynear). Then in step 420, planner 108 finds the maximal temperature elevation and lesion size for the appropriate mode and the required maximal power at a point (yl), such that ynear<yl<yfar. Preferably, (yl) is close to (ynear). For example, in one implementation, yl=ynear+25 mm. If the temperature elevation at (yl) exceeds the allowable limit as determined in step 422, then in step 424 the power is scaled down until the temperature elevation is within the limit, and then planner 108 determines the resulting lesion size at (yl).
Using an overlap criterion with respect to the (ynear) boundary, which may be provided via a sonication grid density, the first treatment is placed. The treatment will actually be a three-dimensional layer or slice. Then, in step 428, using an inter-layer overlap criterion, an auxiliary treatment slice is placed on top of the previous treatment layer using the same height for the second slice as for the first slice. In step 430, planner 108 determines if more layers are needed to reach (yfar). If more layers are needed, then the process reverts to step 418, and (yl) replaces (ynear) (step 432) in the algorithm.
Once the last treatment layer is reached, planner 108 will determine if the layer extends beyond the target limit (yfar). If the layer does extend too far, then the overlap criterion should be used with the outer limit (yfar) as a boundary instead of the previous layer. Using (yfar) in the overlap criterion may cause overdose but will not damage healthy tissue outside target mass 104.
In one implementation, the thermal dose properties are automatically optimized using physiological parameters as the optimization criterion in one implementation mechanical tissue parameters like compressibility, stiffens and scatter are used.
Referring to
As illustrated in
The online feedback imager 502 provides real-time temperature sensitive magnetic resonance images of target mass 104 after some or all of the sonications. The planner 108 uses the images from the feedback imager 502 to construct an actual thermal dose distribution 600 comparing the actual composite thermal dose to the predicted composite thermal dose as illustrated in
In one implementation, the images provided by feedback imager 502 and the updated thermal dose distributions 600 represent three-dimensional data. Planner 108 uses thermal dose distribution 600 to automatically adjust the treatment plan, in real-time, after each sonication or uses the thermal dose distribution 600 in some of the points to adjust for the neighboring points. Planner 108 can adjust the treatment plan by adding treatment sites, removing treatment sites, or continuing to the next treatment site. Additionally, the thermal dose properties of some or all remaining treatment sites may automatically be adjusted by planner 108 based on real-time feedback from feedback imager 502.
As mentioned, planner 108 reformulates the treatment plan automatically after each thermal dose or after some of the sonication points, thus ensuring that target mass 104 is completely ablated in an efficient and effective manner. In addition, the feedback provided by online feedback imager 502 might be used to manually adjust the treatment plan or to override the changes made by planner 108. It should be noted that in one example embodiment, imager 114 also functions as feedback imager 502.
A preferred method of controlling thermal dosing in a thermal treatment system (e.g., systems 100 and 500) is illustrated in
In step 708, the user may enter additional thermal dose prediction properties or modify any default thermal dose prediction properties already selected. For example, these additional properties may be entered via UI 110. Then in step 710, a treatment plan is automatically constructed based on the properties obtained in the previous steps. The purpose of the treatment plan is to ensure a proper composite thermal dose sufficient to ablate the target mass by applying a series of thermal doses to a series of treatment sites, automatically accounting for variations in the focal spot sizes and in the thermal dose actually delivered to the treatment site.
The treatment plan may, for example, be automatically constructed by a planning means such as planner 108. In one embodiment, automatically constructing the treatment plan includes constructing an expected thermal dose distribution showing the predicted thermal dose at each treatment site. This thermal dose distribution may represent a three-dimensional distribution, and, in such an implementation, constructing the treatment plan may follow the steps illustrated in
In step 712, the treatment plan is edited by manual input. For example, UI 110 may be used to edit the treatment plan. In one embodiment, editing the plan may include adding treatment sites, deleting treatment sites, changing the location of some or all of the treatment sites, changing other thermal dose properties for some or all treatment sites, or reconstructing the entire plan. As illustrated by step 720, if the plan is edited, then the process reverts to step 708 and continues from there. Once the plan is set, then verification step 714 is performed. Verification is required to ensure that treatment system 100 is properly registered with regard to the position of the focal spot relative to patient 116 and target mass 104. In one embodiment, verification comprises performing a low energy thermal dose at a predefined spot within said target mass in order to verify proper registration. In a following step, the verification could be repeated at full energy level to calibrate the dosing parameters. As illustrated by step 722, re-verification may be required depending on the result of step 714. In this case, the process reverts back to step 714 and verification is performed again. On the other hand, mechanical properties, such as position, relating to transducer 102 may need to be changed (step 720) and, therefore, the process reverts to step 708.
Once the verification is complete, the treatment plan is implemented in step 716. In one embodiment, this step comprises capturing temperature sensitive image sequences of the target mass as each step of the plan is being implemented. These images will illustrate the actual thermal dose distribution resulting from each successive thermal dose. An online feedback imager 502 may, for example, provide the temperature sensitive images that are used to construct the actual thermal dose distribution. In step 718, the actual thermal dose distribution is compared with the predicted thermal dose distribution in order to determine how closely the actual treatments are tracking the treatment plan. Then in step 724, it is determined if the treatment can proceed to the next step (repeat step 716), or if changes must be made to the treatment plan. (step 720). The changes may be accomplished manually or automatically and may comprise adding treatment sites, deleting treatment sites, repeating treatment sites, or modifying specific thermal dose properties for some or all of the treatment sites.
There are several methods that are used to change or update the treatment plan. For example, at the end of each thermal dose, there may be regions within the target layer that are not covered by accumulated dose contours. These untreated areas are separated into individual regions. Each of these regions is then sent through the process, beginning with step 708, resulting in an updated treatment plan constructed to treat the remaining regions. The process will repeat until there are no more untreated regions.
In order to accomplish the tracking of untreated regions, each treatment region may be maintained as a two-dimensional linked list of pixel ranges sorted by (y) and then (x) coordinates as illustrated in
Once a thermal dose is applied, the area of the target mass that is destroyed (the treated region) is represented in the same fashion as the untreated region shown in
Subtraction of the run-lengths representing untreated region and the treated-region follows the following rules:
For run-length segments [a,b] and [c,d],
[a,b] − [c,d] =
c > b or d < a
[a,b]
(1)
c <= a and d >= b
0
(2)
c > a and d >= b
[a, c − 1]
(3)
c <= a and d < b
[d + 1, b]
(4)
c > a and d < b
[a, c − 1] and [d + 1, b]
(5)
The subtraction, therefore, of two regions involves traversing the lines in each region and subtracting a line in the first data structure from its corresponding line in the second data structure.
The above rules will be further explained by means of an example in which region 808 illustrated in
(Step 1) Top Row:
[1,2] − [1,2] = 0
Rule (2)
[7,7] − [1,2] = [7,7], [7,7] − [6,11] = 0
Rules (1), (2)
[11,11] − [1,2] = [11,11], [11,11] − [6,11] = 0
Rules (1), (2)
(Step 2) Second Row:
[1,3] − [2,3] = [1,1], [1,1] − [7,7] = [1,1], [1,1] −
Rules (3), (1), (1)
[11,11] = [1,1]
[7,11] − [2,3] = [7,11], [7,11] − [7,7] = [7,11], [7,11] −
Rules (1), (1), (3)
[11,11] = [7,10]
(Step 3) Third Row:
[1,11] − [1,11] = 0
Rule (2)
(Step 4) Lower Row:
[1,10] − [4,9] = [1,3] and [10,10]
Rule (5)
In performing the subtraction, each segment 806d and 806e in row 1 of data structure 810 is subtracted from each segment 806a, 806b, and 806c in row 1 of data structure 804. Thus, as can be seen for the top row under Step 1 above, segment 806d is subtracted from segment 806a using Rule (2). The application of Rule (2) results in a run-length segment that contains no pixels, i.e., a range of 0. Intuitively, it can be seen that segment 806d is the same as segment 806a and that subtraction of the two should result in 0, as it does under Rule (2). Next, segment 806d is subtracted from segment 806b, using Rule (1). Intuitively, because the pixel range described by segment 806d does not overlap the range described by segment 806b, subtracting 806d from 806b should have no effect. Indeed, application of rule (1) has no effect on segment 806b.
Now, however, segment 806e must be subtracted from segment 806b. As can be seen, segment 806e overlaps segment 806b entirely. Therefore, application of rule (2), which is the appropriate rule for these two segments, results in 0. In other words, if region 802 is a target mass, and region 808 defines an expected thermal dose, then the dose represented by segment 806e will completely ablate the portion of the target mass represented by segment 806b. The same result occurs for the subtraction of segments 806e and 806d from segment 806c. The subtraction then continues for each row as illustrated by steps 2, 3, and 4 above. The resulting region is illustrated in
An alternative method for updating the treatment plan involves eliminating steps 710 and 712 in
Referring back to
Thus, on a most detailed and narrow aspect, the invention provides methods for constructing a three-dimensional thermal dose treatment plan, including:
Although many aspects and features of the present invention have been described and illustrated in the above description and drawings of the preferred embodiments, it is understood that numerous changes and modifications can be made by those skilled in the art without departing from the invention concepts disclosed herein.
The invention, therefore, is not to be restricted, except by the following claims and their equivalents.
Freundlich, David, Vitek, Shuki, Vortman, Jacob, Yagel, Roni, Brenner, Naama
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