Systems and methods for open loop ultrasound therapy

Abstract

A method for delivering ultrasound therapy using open loop control, comprising: inserting a distal tip of a therapeutic ultrasound applicator into a urethra of a patient, the distal tip comprising an ultrasound transducer; acquiring an ultrasound image of the patient's urethra and prostate using an ultrasound imaging probe; using the ultrasound image to align the distal tip of the therapeutic ultrasound applicator with the patient's prostate; delivering therapeutic ultrasound energy to the patient's prostate with the ultrasound transducer according to a treatment plan, the treatment plan comprising a predetermined limited angular range for therapeutic ultrasound energy, the predetermined limited angular range avoiding the patient's rectum, neurovascular bundles, wherein the therapeutic ultrasound is delivered without temperature feedback data.

Description

[0001] Cross-references to related applications

[0002] This application claims priority to U.S. Provisional Application No. 63 / 882,662, filed August 5, 2019, entitled "Open-Loop Ultrasound Therapy," the entire contents of which are incorporated herein by reference. Technical Field

[0003] In summary, this application relates to ultrasound therapy for medical conditions. Background Technology

[0004] Existing ultrasound therapy systems, such as focused ultrasound therapy and surgical systems, require or benefit from guidance, which can be provided by ultrasound, magnetic resonance imaging (MRI), or other methods. Guidance helps the operator (human or machine) control the application of focused ultrasound spatially and / or temporally to direct therapeutic thermal energy to the desired (e.g., diseased) target or area of ​​interest.

[0005] MRI-guided procedures are an expensive undertaking, requiring the patient and MRI-compatible treatment equipment to be placed in a specialized environment for monitoring the treatment using MR thermography. Specialized MRI radiologists are needed to operate and monitor the MRI-guided thermotherapy facilities and procedures. Furthermore, because MRI-guided procedures require patient immobilization (to avoid motion artifacts and interference), general anesthesia may be necessary, which is another complex and costly procedure. Such operations are not portable and are unavailable at sites lacking MRI facilities.

[0006] Some surgeries can be performed without the need for high-precision real-time imaging (such as MRI imaging), and there is a need for lower-cost and more readily available solutions in hyperthermia (such as ultrasound hyperthermia). Summary of the Invention

[0007] The exemplary embodiments described herein possess novel features, wherein no single novel feature is essential or solely responsible for its desired properties. The following description and accompanying drawings illustrate certain illustrative embodiments of this disclosure, indicating several exemplary ways in which various principles of this disclosure can be implemented. However, the illustrative examples do not exhaustively cover the many possible embodiments of this disclosure. Some advantageous features will now be summarized without limiting the scope of the claims. Other objects, advantages, and novel features of this disclosure will be set forth in conjunction with the accompanying drawings, which are intended to illustrate and not limit the invention.

[0008] One aspect of the present disclosure relates to a method for delivering ultrasound therapy using open-loop control. The method includes inserting a distal tip of a therapeutic ultrasound applicator into a urethra of a patient, the distal tip including an ultrasound transducer; acquiring ultrasound images of the urethra and prostate of the patient using an ultrasound imaging probe; aligning the distal tip of the therapeutic ultrasound applicator with the prostate of the patient using the ultrasound images; delivering therapeutic ultrasound energy to the prostate of the patient with the ultrasound transducer according to a treatment plan, the treatment plan including a predetermined limited angular range for the therapeutic ultrasound energy, the predetermined limited angular range avoiding the rectum, neurovascular bundles, and internal organs other than the prostate of the patient. The therapeutic ultrasound is delivered without temperature feedback data.

[0009] In one or more embodiments, the method further includes registering the ultrasound images with a reference location on the therapeutic ultrasound applicator to provide registered ultrasound images. In one or more embodiments, the reference location includes a fiducial marker. In one or more embodiments, the method further includes defining the treatment plan in a computer using the registered ultrasound images. In one or more embodiments, defining the treatment plan includes setting a predetermined limited radial range for the therapeutic ultrasound energy, the predetermined limited radial range avoiding an area immediately outside the prostate of the patient. In one or more embodiments, defining the treatment plan includes setting a predetermined limited axial range for the therapeutic ultrasound energy between a base and an apex of the prostate of the patient.

[0010] In one or more embodiments, the predetermined limited angular range corresponds to an anterior direction of the patient. In one or more embodiments, the predetermined limited angular range is 0° to 280°. In one or more embodiments, the predetermined limited angular range is 0° to 240°, and 240° corresponds to a transition region of the prostate.

[0011] In one or more embodiments, the method further includes mechanically coupling the therapeutic ultrasound applicator to an ultrasound applicator positioning system. In one or more embodiments, the method further includes automatically aligning the distal tip of the therapeutic ultrasound applicator with the prostate of the patient using the ultrasound applicator positioning system. In one or more embodiments, the method further includes rotating the therapeutic ultrasound applicator using the ultrasound applicator positioning system within the predetermined limited angular range while the therapeutic ultrasound energy is being delivered.

[0012] In one or more embodiments, the method further comprises displaying the ultrasound image on a display in electrical communication with the ultrasound imaging probe. In one or more embodiments, the distal tip of the therapeutic ultrasound applicator comprises a plurality of ultrasound transducers disposed around at least a portion of a circumference of the distal tip, and the method further comprises simultaneously delivering therapeutic ultrasound energy to the patient's prostate in a plurality of angular directions using the ultrasound transducers. In one or more embodiments, the method further comprises rotating the therapeutic ultrasound applicator so that the ultrasound transducers collectively sweep through the predetermined limited angular range while delivering the therapeutic ultrasound energy to the patient's prostate in a plurality of angular directions.

[0013] In one or more embodiments, the therapeutic ultrasound is delivered without MRI temperature measurement feedback data. In one or more embodiments, the ultrasound imaging probe is integrated into the therapeutic ultrasound applicator.

[0014] Another aspect of the present disclosure relates to a system for open loop ultrasound therapy delivery. The system comprises: a therapeutic ultrasound applicator having a distal tip comprising ultrasound transducers; an ultrasound imaging probe that acquires ultrasound images of the patient's urethra and prostate; an ultrasound applicator positioning system mechanically coupled to the therapeutic ultrasound applicator; a microprocessor-based UA positioning system controller in electrical communication with the ultrasound applicator positioning system, the UA positioning system controller configured to adjust the position and orientation of the ultrasound transducers to deliver therapeutic ultrasound energy to the patient's prostate according to a treatment plan; and a microprocessor-based computer in electrical communication with the therapeutic ultrasound applicator, the ultrasound imaging probe, and the UA positioning system controller, the computer having non-volatile memory storing computer readable instructions that, when executed by the microprocessor, cause the computer to: receive one or more inputs corresponding to the treatment plan, the treatment plan comprising a predetermined limited angular range for therapeutic ultrasound energy, the predetermined limited angular range avoiding the patient's rectum, neurovascular bundles, and internal organs other than the patient's prostate; and generate control signals that cause the UA positioning system controller to rotate the ultrasound transducers through the predetermined limited angular range while simultaneously delivering therapeutic ultrasound energy from the ultrasound transducers through the predetermined limited angular range. The therapeutic ultrasound is delivered without temperature feedback data.

[0015] In one or more embodiments, the computer readable instructions further cause the computer to automatically register the ultrasound image with a reference location on the therapeutic ultrasound applicator. In one or more embodiments, the reference location comprises a fiducial marker.

[0016] In one or more embodiments, the treatment plan includes a predetermined limited radial range of the therapeutic ultrasound energy that avoids an area immediately outside the patient's prostate. In one or more embodiments, the treatment plan includes a predetermined limited axial range of the therapeutic ultrasound energy between a base and an apex of the patient's prostate. In one or more embodiments, the predetermined limited angular range corresponds to an anterior direction of the patient. In one or more embodiments, the predetermined limited angular range is 0° to 280°. In one or more embodiments, the predetermined limited angular range is 0° to 240°, and 0° and 240° correspond to transition regions of the prostate.

[0017] In one or more embodiments, the computer readable instructions further cause the computer to send a display output signal to a computer display to display the ultrasound image. In one or more embodiments, the UA positioning system controller is further configured to automatically align a distal tip of the therapeutic ultrasound applicator with the prostate using the ultrasound image. In one or more embodiments, the ultrasound imaging probe is integrated into the therapeutic ultrasound applicator. In one or more embodiments, the computer readable instructions further cause the computer to determine a position of the therapeutic ultrasound applicator relative to the patient's prostate. BRIEF DESCRIPTION OF DRAWINGS

[0018] For a more complete understanding of the nature and advantages of this concept, reference should be made to the following detailed description and to the accompanying drawings.

[0019] Figure 1 is a block diagram of an open loop ultrasound treatment system according to one or more embodiments.

[0020] Figure 2 is a side view of an example ultrasound applicator according to an embodiment.

[0021] Figure 3 is a flowchart of a method for open loop ultrasound treatment according to one or more embodiments.

[0022] Figure 4 is a cross-sectional view of an example ultrasound applicator in a prostate according to an embodiment. DETAILED DESCRIPTION

[0023] An open loop ultrasound treatment system is used to deliver ultrasound energy to a target region without the MRI feedback information that is typically available in existing closed loop ultrasound treatment systems. In particular, in conjunction with ultrasound thermotherapy of a diseased tissue region, such as a diseased prostate, the system and method can be used to provide conformal ultrasound treatment from an ultrasound applicator inserted into a patient. One application is the treatment of benign prostatic hyperplasia (BPH, also known as prostate enlargement), but other applications and target tissues are possible. Here, an elongated ultrasound applicator can be inserted into the urethra of a patient and positioned generally in place to deliver therapeutic ultrasound energy at or within the diseased region. The ultrasound applicator includes a plurality of elements, each element providing a directional ultrasound beam, where the direction of the ultrasound beam is adjustable by rotating the applicator. In addition, cooling of non-diseased, particularly critical or sensitive, tissue in the vicinity of the target region can also be implemented in certain aspects. For example, a rectal cooling device designed and operated to remove heat from the rectal wall and its vicinity can be used in conjunction with the treatment described above. In other aspects, ultrasound imaging of the region at or near the treatment site can be used in one or more embodiments.

[0024] The open loop ultrasound treatment system includes an ultrasound applicator that is inserted transurethrally into the prostate of a patient. A computer-controlled ultrasound applicator positioning system can then be used to fine tune the position of the ultrasound applicator to align the ultrasound transducers on the insertion end of the ultrasound applicator with the prostate. For example, an ultrasound imaging probe, such as a transrectal ultrasound probe and / or a transcapsular ultrasound probe, can generate ultrasound image data of the prostate and urethra, and a user can use this ultrasound image data (e.g., depicted on a computer display) to guide or inform the user or system on how and where to apply and place the ultrasound transducers on the insertion end of the ultrasound applicator to align it with the prostate. In one embodiment, the ultrasound applicator includes ultrasound fiducial markers so that the position of the ultrasound applicator can be explicitly inferred from ultrasound images obtained from an ultrasound probe. In another embodiment, an ultrasound probe element is directly integrated into the ultrasound applicator and used to image tissue surrounding the ultrasound applicator to determine its position relative to the prostate.

[0025] In addition, a user can use the ultrasound image data displayed on a computer screen to create a treatment plan for ablation of the prostate. The treatment plan can include parameters defining a treatment region in the prostate. The parameters can include an axial component, a radial component, and an angular range component. The radial and angular range components are defined in a plane that is orthogonal to the axis of the axial component. Alternatively, the treatment plan can be an arbitrary region around the urethra. The treatment plan is created so that the ultrasound applicator generally directs ultrasound energy forward, away from the rectum, nerve bundles, and internal organs other than the rectum, to improve patient safety.

[0026] The computer controls the ultrasound applicator to perform sonic penetration and ablation of a treatment zone in the prostate according to a treatment plan. The control is achieved by modulating the acoustic power and ultrasound frequency emitted by each ultrasound element on the applicator, and continuously rotating the ultrasound applicator at an adjustable speed. Other parameters can also be controlled, such as the drive frequency of the ultrasound transducers. During the course of the treatment, the computer can display ultrasound images (e.g., sagittal) acquired by an ultrasound imaging probe, which can be integrated into the ultrasound applicator. The computer can also display a progress indicator showing the percentage of the treatment zone that has been irradiated by the sonic waves.

[0027] Figure 1 is a block diagram of an open-loop ultrasound therapy system 10 according to one or more embodiments. The system 10 includes an ultrasound applicator (UA) 100, a UA positioning system 110, an ultrasound imaging probe 120, and a system cart 130. The system cart 130 includes a computer 132, a computer display 134, system electronics 140, and a fluid circulation system 150. The system cart 130 can include wheels or casters to facilitate portability.

[0028] An example of the UA 100 is described in U.S. Patent No. 9,707,413, issued July 18, 2017, entitled “Controllable Rotating Ultrasound Therapy Applicator,” which is incorporated by reference herein. An example of the UA positioning system 110 is disclosed in U.S. Patent Application No. 16 / 248,246, filed January 15, 2019, entitled “Therapeutic Applicator Positioning System With Passive and Active Positioning,” which is incorporated by reference herein.

[0029] The computer 132 includes a hardware-based microprocessor, a memory operably coupled to the microprocessor, network ports, I / O ports, a graphics processor, and other components. The memory includes non-volatile memory storing computer-readable instructions (e.g., software) that are executable by the microprocessor to perform one or more operations, functions, and / or tasks.

[0030] The system electronics 140 includes an RF power controller 142 that generates a drive signal for powering the UA 100 at a desired frequency and amplitude (power). The drive signal is sent to the UA 100 via one or more radio frequency cables 105. An example of an RF power control unit is disclosed in U.S. Patent No. 9,931,523, issued April 3, 2018, entitled “RF Power Controller for Ultrasound Therapy System,” which is incorporated herein by reference. The UA 100 can be used to perform ultrasound therapy on a target region of a patient 160, who can be in a supine position on a patient support 170. In one example, the target region corresponds to a tumor, and the ultrasound therapy includes using ultrasound energy to generate enough energy to ablate the tumor.

[0031] The system electronics 140 also includes a UA positioning system controller 144 that generates optional motion control signals for the UA positioning system 110 to align the UA 100 with the prostate. The motion control signals can be based at least in part on image data output from the ultrasound imaging probe 120. The ultrasound imaging probe 120 can be a transrectal ultrasound (TRUS) probe, a transvaginal ultrasound probe, a probe integrated into the UA, or other ultrasound imaging probe. Data representing ultrasound images is sent from the ultrasound imaging probe 120 to the computer 132, which can optionally render and display the ultrasound images on the display 134.

[0032] The fluid circulation system 150 recirculates cooling fluid (e.g., water) to the UA 100. The fluid circulation system 150 includes a fluid circulation pump and a cooling unit (e.g., a chiller, a heat exchanger, etc.) to circulate the cooling fluid between (a) the UA 100 (for cooling the UA 100 during operation) and (b) the cooling unit (where the heated cooling fluid is cooled to a predetermined temperature setpoint, such as room temperature or other temperature). The fluid circulation pump can be a peristaltic pump or another pump. The tube set 108 can fluidly couple the UA 100 and the fluid circulation system 150. In some embodiments, the fluid circulation system 150 includes a degasser that removes air bubbles from the cooling fluid.

[0033] The computer 132 is in electrical communication with the system electronics 140 and the fluid circulation system 150 (e.g., via wired and / or wireless connections). Through the electrical connections, the computer 132 can send control signals to any of the system electronics 140 or the fluid circulation system 150, and can receive data or other information from any of the system electronics 140 or the fluid circulation system 150. For example, the computer 132 can send RF power control signals to the RF controller 142, which cause the RF controller 142 to generate a drive signal having a frequency and amplitude for powering the UA 100 according to a treatment plan. Further, the computer 132 can send UA position control signals that cause the UA position controller 144 to adjust the UA positioning system 110 to set the position, orientation, and / or rotation of the UA 100 (e.g., according to a treatment plan). Further, the computer 132 can send fluid circulation control signals to the fluid circulation system 150 to set a temperature setpoint for the cooling fluid and / or to set a speed of the fluid circulation pump.

[0034] The computer 132 can also receive feedback data or other information from the system electronics 140 and / or the fluid circulation system 150. For example, the RF controller 142 can send the actual RF power of the drive signal to the computer 132, and the computer 132 can make any adjustments to the RF power control signals as needed. Similarly, the UA position controller 144 can send the actual position, orientation, and / or rotation of the UA positioning system 110 to the computer 132, and the computer 132 can make any adjustments to the UA position control signals as needed. Further, the fluid circulation system 150 can send the actual temperature of the cooling fluid and / or the actual speed of the fluid circulation pump to the computer 132, and the computer 132 can make any adjustments to the fluid circulation control signals as needed. The computer 132 can also be in electrical communication with other devices or instruments that can independently monitor these components and provide independent feedback data. For example, an RF detector can monitor the drive signal generated by the RF controller 142 and provide feedback data to the RF controller 142 and / or the computer 132. Similarly, a thermocouple can monitor the temperature of the cooling fluid and provide feedback data to the chiller and / or the computer 132.

[0035] The computer 132 also receives ultrasound image data from the ultrasound imaging probe 120, which the computer 132 can use as feedback data to adjust the UA position control signal. The computer 132 can also use the ultrasound image data to align the distal tip of the UA 100 with the prostate (e.g., auto-align) and to register one or more reference locations on the UA 100 with the ultrasound image (e.g., auto-register). For example, the UA 100 can include one or more fiducial markers that are opaque to ultrasound and thus visible in the ultrasound image. Further, the shaft of the UA 100 can include two or more fiducial markers that are disposed along a reference line that is parallel to the longitudinal axis of the shaft. The computer 132 can determine the reference line by detecting the relative positions of the fiducial markers using the ultrasound image, and can infer other aspects of the UA 100 based on their relationship to the reference line. The memory of the computer 132 can have information about the relationship between the fiducial markers and other parts of the UA 100, such as the distance between the fiducial markers and other parts of the UA 100.

[0036] Alternatively, the ultrasound imaging probe 120 and the UA 100 can be integrated together as a single unit. In this embodiment, the ultrasound imaging probe 120 can acquire images of the surrounding tissue and / or anatomy. Software running on the computer 132 can determine the relative position of the integrated UA / imaging probe with respect to the prostate based on these images (e.g., through image recognition, machine learning, and / or other techniques) to enable image registration and prostate alignment.

[0037] Figure 2 is a side view of an example ultrasound applicator 20 according to an embodiment. The ultrasound applicator 20 includes a shaft 210 that connects a handle 220 to a distal tip 230. One or more ultrasound transducers are disposed on the distal tip 230. The proximal end 240 of the ultrasound applicator 20 includes electrical connections for receiving drive signals from an ultrasound controller (e.g., the RF power controller 142). Further, the proximal end includes inlet and outlet fluid couplings that can be fluidically coupled to a fluid circulation system (e.g., the fluid circulation system 150) to circulate cooling fluid within the ultrasound applicator 20. The ultrasound applicator 20 can be the same as or different from the UA 100. In some embodiments, the ultrasound applicator 20 includes one or more ultrasound imaging elements 250 that acquire images of the surrounding tissue and / or anatomy to determine the relative position of the ultrasound applicator 20 with respect to the prostate.

[0038] Figure 3 is a flowchart 30 of a method for open loop ultrasound therapy according to one or more embodiments. The system 10 can be used to perform one or more steps of the flowchart 30. The method is performed using an open loop process control without using temperature feedback data (e.g., MRI thermometry data).

[0039] In step 300, the patient lies on (e.g., in a supine position) a surgical bed (e.g., patient support 170) or other work surface. The patient (e.g., patient 160) can be sedated prior to the start of the procedure. In step 310, a clinician or technician inserts the distal tip of the UA 100 transurethrally into the patient’s prostate. The distal tip of the UA 100 includes one or more ultrasound transducers that can generate therapeutic ultrasound energy. In step 220, the UA 100 is mechanically coupled to (e.g., mounted on) the UA positioning system 110. In some embodiments, step 320 can occur prior to step 310.

[0040] In step 330, the ultrasound imaging probe 120 is used to acquire ultrasound images of the prostate, urethra, and surrounding anatomy. The acquired ultrasound images can include multiplanar ultrasound images (e.g., multiple cross-sectional ultrasound images) or three-dimensional ultrasound images. Ultrasound image data representing the acquired ultrasound images is sent from the ultrasound imaging probe 120 to the computer 132. The computer 132 can optionally display the ultrasound images on the computer display 134. As noted above, the ultrasound imaging probe 120 and the UA 100 can be integrated together as a single unit.

[0041] In step 340, the clinical operator remotely controls the UA 100 (e.g., by controlling the UA positioning system 110) to align the distal tip of the UA 100 with the prostate. The alignment can be based on the ultrasound images acquired and displayed in step 330, which can be used for visual feedback by the clinical operator. Alternatively, the computer 132 can use the ultrasound images to automatically align the distal tip of the UA 100 with the prostate by sending appropriate UA position control signals to the UA position controller 144. The computer 132 can use image recognition or machine learning to determine whether the distal tip of the UA 100 and the prostate are aligned and generate UA position control signals to align the distal tip of the UA 100 and the prostate. Alternatively, when the imaging probe 120 is integrated into the UA 100, the computer 132 can use the images acquired by the imaging probe 120 to determine how far to move the UA 100 to achieve registration with the prostate. Steps 330 and 340 can be performed simultaneously.

[0042] In step 350, the computer 132 registers the image of the prostate with one or more reference locations (e.g., reference frame) on the UA 100, such as one or more fiducial markers. For example, the fiducial markers can be located at a certain predetermined distance from the distal tip of the UA 100. The computer 132 can automatically locate the fiducial markers, or the fiducial markers can be manually identified using the computer 132. Alternatively, the computer 132 can register the image with respect to the UA 100 including the imaging probe 120.

[0043] Using the registered images, at step 360, a clinical operator uses the computer 132 to define a treatment plan for the ultrasound treatment. The treatment plan can include defining radial, axial, and angular range coordinates for the ultrasound treatment (e.g., ablation) of the target zone. The radial and / or angular range coordinates can vary as a function of the axial position. In some embodiments, the angular range can include an angular range of 0° to about 280°, including up to about 240°, which can correspond to the transition region of the prostate (e.g., as shown in Figure 4 The axial position can cover a region extending from the base of the prostate to a point proximate the apex of the prostate. The radial coordinates are preferably configured to avoid regions beyond the capsule of the prostate. Typically, the coordinates of the target zone are selected to avoid anatomically sensitive regions, such as the neurovascular bundle of the patient, rectum, and internal organs other than the prostate. For example, the angular range coordinates can correspond to the anterior of the patient and / or the anterior and lateral of the patient to avoid the neurovascular bundle of the patient, rectum, and internal organs other than the prostate.

[0044] Figure 4 is a cross-sectional view of an example ultrasound applicator 400 in a prostate 410 according to an embodiment. The treatment plan defines a treatment zone 420 such that the angular range coordinates avoid the neurovascular bundle 430 and rectum 440 of the patient, which are typically posterior relative to the ultrasound applicator 400. For example, the angular range coordinates can include 0° (e.g., left side in Figure 4 ) to 180° (e.g., right side in Figure 4 ). Alternatively, the angular range coordinates can include 0° to 240°, where the 0° radial line 422 intersects the left transition region 412 and the 240° radial line 424 intersects the right transition region 414. Typically, the angular range coordinates correspond to the lateral and / or anterior direction of the patient relative to the ultrasound applicator 400. The angular range coordinates can also avoid internal organs other than the prostate. The ultrasound applicator 400 can be the same as or different from the ultrasound applicator 20 and UA 100.

[0045] Returning to Figure 3 , at step 370, the UA 100 delivers ultrasound energy according to the treatment plan using open loop control that does not include temperature feedback data. The ablation generally occurs anterior and / or lateral relative to the UA 100, away from anatomically sensitive regions, such as the neurovascular bundle and rectum of the patient (e.g., as shown in Figure 4The ultrasound energy is delivered in an open loop manner (e.g., without temperature feedback such as MRI temperature feedback), with the power level and rotation rate of the UA 100 controlled by software running in the computer 132. The UA 100 can be rotated by the UA positioning system 110. In alternative embodiments, the UA 100 can include multiple transducers arranged around at least a portion of the circumference of the distal end of the UA 100. The transducers can be operated to direct ultrasound energy in multiple angular directions, which can reduce treatment time compared to rotating the UA 100 over the entire angular range of the target zone.

[0046] In step 380, the computer 132 optionally displays the ultrasound image on the display 134. The ultrasound image (e.g., a sagittal plane image) can be displayed using ultrasound image data collected by the ultrasound imaging probe 120. The computer 132 can also display a progress indicator that displays the percentage of completion of the procedure. In some embodiments, the computer 132 can overlay the treatment zone on the ultrasound image. Additional images or other images can also be displayed. Step 380 can occur concurrently with any of steps 330, 340, 350, 360, and / or 370.

[0047] In one aspect, the present systems and methods allow for cost-effective and clinically adequate treatment of some conditions, such as prostate enlargement, using ultrasound energy directed by one or more ultrasound transducers in a suitable probe, where the procedure is controlled in an open loop manner without the need for MRI imaging. In some embodiments, the ultrasound transducers can include an ultrasound transducer array that can be controlled (e.g., phase controlled) to focus ultrasound and / or electronically steer the ultrasound. In one or more examples, multi-planar images can be employed to inform the method, system, or clinical operator of details of the treatment delivery. The treatment can include a plan involving radial and / or axial spatial extent for the treatment.

[0048] In particular, and in some aspects, the ultrasound treatment applicator can be inserted in conjunction with a transrectal ultrasound imaging probe for treatment applicator positioning and monitoring into the male urethra. In other aspects, the present invention provides continuous or substantially continuous treatment in conjunction with an open loop treatment algorithm and treatment plan, including appropriate treatment parameters, which in turn can include a rotation rate of the treatment applicator about its axis, a power level of one or more ultrasound energy sources, and the like.

[0049] The auxiliary features of the present invention can also include a controlled cooling water circulation in the treatment device or location for controlling or reducing unwanted heat buildup therein. A sterile fluid such as water can be circulated in the device or location through a set of tubes using a peristaltic pump or other fluid driver. In some embodiments, it is possible implementation to use a rectal cooling device to cool the transurethral applicator and / or cool the tissue.

[0050] Another advantage of the systems and methods disclosed herein is that the cost of the procedure is reduced. This is a result of the reduced treatment time and the ability to perform the procedure without the use of an MRI system.

[0051] The present invention should not be considered limited to the particular examples described above. Various modifications, equivalent processes, as well as many of the structures and devices essentially associated with the present invention, will be apparent to those of ordinary skill in the art upon reading the present disclosure. The examples described above are intended to be illustrative of the present invention and in no way limit the scope of the present invention. The scope of the present invention is limited only by the claims.

[0052] In this respect, various inventive concepts can be embodied as a non-transitory computer readable storage medium (or multiple non-transitory computer readable storage media) (e.g., a computer memory, including a volatile or persistent digital storage unit, a circuit configuration in a field-programmable gate array (FPGA) or other semiconductor device, or other tangible computer storage medium) encoded with one or more programs that, when executed on one or more computers or other processors, perform methods consistent with the various embodiments described above. When implemented in software (e.g., as an application or “app”), the software code can be executed on any suitable processor or collection of processors, whether provided in a single computer or distributed among multiple computers.

[0053] Moreover, it is to be understood that a computer can be embodied in any of a number of forms, such as a rack-mounted computer, a desktop computer, a laptop computer, or a tablet computer. Additionally, a computer can be embedded in a device not generally regarded as a computer, but which has the appropriate processing capabilities, including a PDA, a smart phone or any other suitable portable or fixed electronic device.

[0054] Further, a computer can have one or more input and / or output devices. These devices can be used, among other things, to present user interfaces and / or to accept user input. Examples of output devices that can be used to provide user interfaces include printers or display screens for visual presentation of output and speakers or other sound generating devices for audible presentation of output. Examples of input devices that can be used for a user to

[0055] Further, a computer can have one or more input and / or output devices. These devices can be used, among other things, to present user interfaces and / or to accept user input. Examples of output devices that can be used to provide user interfaces include printers or display screens for visual presentation of output and speakers or other sound generating devices for audible presentation of output. Examples of input devices that can be used for a user to

[0056] One or more non-transitory computer readable media can be transportable, such that the one or more programs stored therein can be loaded into one or more different computers or other processors to implement various aspects of the above-described one or more aspects as described in connection with the above. In some embodiments, computer readable media can be non-transitory.

[0057] The terms "program," "app," and "software" are used herein in a generic sense to refer to any type of computer code or set of computer-executable instructions that can be employed to program a computer or other processor to implement various aspects as described above. Additionally, it should be appreciated that according to one aspect, one or more computer programs that when executed perform some or all of the methods of the present application need not reside on a single computer or processor, but can be distributed in a modular fashion

[0058] Computer-executable instructions can be in many forms, such as program modules, executed by one or more computers or other devices. Generally, program modules include routines, programs, objects, components, data structures, etc. that perform particular tasks or implement particular abstract data types. Typically the functionality of the program modules can be combined or distributed as desired in various embodiments.

[0059] Also, data structures can be stored in computer-readable media in any suitable form. For simplicity of illustration, data structures can be shown to have fields that are related through location in the data structure. Such relationships can likewise be achieved by assigning storage for the fields with locations in a computer-readable medium that link the fields to data entities through the computer-readable medium. However, any suitable mechanism can be used to establish a relationship between information in fields of a data structure, including through the use of pointers, tags or other mechanisms that establish relationship between data elements.

[0060] Accordingly, the present disclosure and claims include the new and novel improvements to existing methods and techniques to achieve the useful results described above, which were previously unknown and unimplemented. Users of the present methods and systems will derive tangible benefit from the functionality now made possible due to the specific modifications described herein, and the effects in the system and their output to the user. It is contemplated that significant improvements in operation can be realized using the technical components described herein when implementing the claimed application.

[0061] Moreover, as described, some aspects can be embodied as one or more methods. The acts performed as part of the methods can be ordered in any suitable way unless otherwise specified. Accordingly, embodiments in which acts are performed in an order different than illustrated can be constructed, and such embodiments are also considered to be within the scope of the present disclosure.

Claims

1. A system for open loop ultrasound therapy delivery, comprising: a therapeutic ultrasound applicator having a distal tip comprising a plurality of ultrasound transducers disposed around at least a portion of a circumference of the distal tip; an ultrasound imaging probe that acquires ultrasound images of a urethra and a prostate of a patient; an ultrasound applicator positioning system mechanically coupled to the therapeutic ultrasound applicator; a microprocessor-based ultrasound applicator positioning system controller in electrical communication with the ultrasound applicator positioning system, the ultrasound applicator positioning system controller configured to adjust a position and orientation of the plurality of ultrasound transducers within the urethra of the patient to deliver therapeutic ultrasound energy to the prostate of the patient in accordance with a treatment plan; and a microprocessor-based computer in electrical communication with the therapeutic ultrasound applicator, the ultrasound imaging probe, and the ultrasound applicator positioning system controller, the computer having a non-volatile memory storing computer readable instructions that, when executed by the microprocessor, cause the computer to: receive one or more inputs corresponding to the treatment plan, the treatment plan including a predetermined limited angular range for the therapeutic ultrasound energy, the predetermined limited angular range avoiding a rectum, neurovascular bundles, and internal organs other than the prostate of the patient; and generate control signals that cause the ultrasound applicator positioning system controller to rotate the therapeutic ultrasound applicator such that the plurality of ultrasound transducers combine to sweep through the predetermined limited angular range while delivering the therapeutic ultrasound energy from the plurality of ultrasound transducers to the prostate of the patient in a plurality of angular directions within the predetermined limited angular range, wherein the therapeutic ultrasound is delivered without temperature feedback data.

2. The system of claim 1, wherein, the computer readable instructions further cause the computer to automatically register the ultrasound images with a reference location on the therapeutic ultrasound applicator.

3. The system of claim 2, wherein, the reference location comprises a fiducial marker.

4. The system of claim 1, wherein, the treatment plan includes a predetermined limited radial range for the therapeutic ultrasound energy, the predetermined limited radial range avoiding an area immediately outside of the prostate of the patient.

5. The system of claim 4, wherein, the treatment plan includes a predetermined limited axial range for the therapeutic ultrasound energy between a base and an apex of the prostate of the patient.

6. The system of claim 1, wherein, the predetermined limited angular range corresponds to an anterior direction of the patient.

7. The system of claim 1, wherein, the predetermined limited angular range is 0° to 280°.

8. The system of claim 7, wherein: the predetermined limited angular range is 0° to 240°, and 0° and 240° correspond to transitional regions of the prostate.

9. The system of claim 1, wherein, the computer readable instructions further cause the computer to send display output signals to a computer display to display the ultrasound images.

10. The system of claim 1, wherein, the ultrasound applicator positioning system controller is further configured to automatically align the distal tip of the therapeutic ultrasound applicator with the prostate using the ultrasound images.

11. The system of claim 1, wherein, the ultrasound imaging probe is integrated into the therapeutic ultrasound applicator.

12. The system of claim 11, wherein, The computer readable instructions also cause the computer to determine a position of the therapeutic ultrasound applicator relative to the prostate of the patient.

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