Systems and methods for image-guided boiling histotripsy tissue intervention - Patents.com

Abstract

One embodiment is directed to a minimally invasive system for treating a target tissue structure of a patient, comprising: an electro-mechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electro-mechanical support assembly; and a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system, wherein the computing system is configured to operate the electro-mechanical support assembly to control a position of the transducer assembly relative to the patient such that a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of the target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront being configured to generate one or more vapor bubbles within the target tissue structure, and to controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated.

Description

[Technical field]

[0001] This application claims the benefit of U.S. Provisional Patent Application No. 63 / 290,647, filed December 16, 2022, U.S. Provisional Patent Application No. 63 / 308,051, filed February 8, 2021, and U.S. Provisional Patent Application No. 63 / 356,988, filed June 29, 2022, each of which is incorporated by reference in its entirety herein.

[0002] The present invention relates generally to systems and methods for the modification of tissue structure for the treatment of pathological conditions and the promotion of non-pathological functions through the use of boiling histotripsy. [Brief description of the drawings]

[0003] [Figure 1A] 1 illustrates various aspects of spinal anatomy. [Figure 1B] 1 illustrates various aspects of spinal anatomy. [Figure 1C] 1 illustrates various aspects of spinal anatomy. [Figure 2A] 1 illustrates various aspects of spinal anatomy that have a herniation problem. [Figure 2B] 1 illustrates various aspects of spinal anatomy that have a herniation problem. [Diagram 3] 1 illustrates aspects of a conventional approach to spinal intervention. [Figure 4A] 1 illustrates aspects of a conventional approach to spinal intervention. [Figure 4B] 1 illustrates aspects of a conventional approach to spinal intervention. [Diagram 5] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 6A] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 6B] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 6C] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 6D] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 6E] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 7] 1 illustrates an embodiment of a histotripsy-based approach for spinal intervention utilizing one or more ultrasound transducers. [Figure 8A] 1 illustrates various aspects of hardware configurations that may be utilized in conjunction with an ultrasound-based histotripsy intervention. [Figure 8B] 1 illustrates various aspects of hardware configurations that may be utilized in conjunction with an ultrasound-based histotripsy intervention. [Figure 9A] 1 illustrates various aspects of hardware configurations that may be utilized in conjunction with an ultrasound-based histotripsy intervention. [Figure 9B] 1 illustrates various aspects of hardware configurations that may be utilized in conjunction with an ultrasound-based histotripsy intervention. [Figure 9C] 1 illustrates various aspects of hardware configurations that may be utilized in conjunction with an ultrasound-based histotripsy intervention. [Figure 10A] Illustrate various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature electro-mechanical or robotic positioning and / or orientation systems. [Figure 10B] Illustrate various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature electro-mechanical or robotic positioning and / or orientation systems. [Figure 10C]Illustrate various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature electro-mechanical or robotic positioning and / or orientation systems. [Figure 10D] Illustrate various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature electro-mechanical or robotic positioning and / or orientation systems. [Figure 11] Illustrate various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature electro-mechanical or robotic positioning and / or orientation systems. [Figure 12A] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 12B] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 13] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 14A] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 14B] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 15] Illustrated are various aspects of configurations that may be utilized in an ultrasound-based histotripsy intervention, which may also feature an electro-mechanical or robotic positioning and / or orientation system, as well as one or more alternative imaging modalities. [Figure 16A]Illustrated are various aspects of configurations that may be utilized to vibrate or sweep the field of view or imaging of a device such as an ultrasound transducer, as well as the integration of such configurations into an interventional system. [Figure 16B] Illustrated are various aspects of configurations that may be utilized to vibrate or sweep the field of view or imaging of a device such as an ultrasound transducer, as well as the integration of such configurations into an interventional system. [Figure 17A] Illustrated are various aspects of configurations that may be utilized to vibrate or sweep the field of view or imaging of a device such as an ultrasound transducer, as well as the integration of such configurations into an interventional system. [Figure 17B] Illustrated are various aspects of configurations that may be utilized to vibrate or sweep the field of view or imaging of a device such as an ultrasound transducer, as well as the integration of such configurations into an interventional system. [Figure 18] Illustrated are various aspects of configurations that may be utilized to vibrate or sweep the field of view or imaging of a device such as an ultrasound transducer, as well as the integration of such configurations into an interventional system. [Figure 19] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 20] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 21] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 22] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 23] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 24] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Diagram 25] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 26] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 27A] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 27B] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 28] Illustrated are various aspects of configurations that may be utilized in ultrasound-based histotripsy interventions, which may also feature one or more devices that assist in determining and / or tracking the positions of various components relative to one another. [Figure 29A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a cyst within a patient. [Figure 29B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a cyst within a patient. [Diagram 30]1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a cyst within a patient. [Figure 31A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a facet joint and / or ligamentum flavum within a patient. [Figure 31B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a facet joint and / or ligamentum flavum within a patient. [Figure 31C] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a facet joint and / or ligamentum flavum within a patient. [Diagram 32] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a facet joint and / or ligamentum flavum within a patient. [Diagram 33] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a facet joint and / or ligamentum flavum within a patient. [Figure 34A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention related to an epidural tumor within a patient. [Figure 34B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention related to an epidural tumor within a patient. [Diagram 35] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention related to an epidural tumor within a patient. [Figure 36A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding metastatic spinal tumors in a patient. [Figure 36B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding metastatic spinal tumors in a patient. [Figure 37] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding metastatic spinal tumors in a patient. [Figure 38A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a spinal sarcoma in a patient. [Figure 38B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a spinal sarcoma in a patient. [Figure 39] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding a spinal sarcoma in a patient. [Figure 40A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding spinal myeloma in a patient. [Figure 40B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding spinal myeloma in a patient. [Diagram 41] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention regarding spinal myeloma in a patient. [Figure 42A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 42B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 42C] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Diagram 43] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Diagram 44] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 45A]1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 45B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 45C] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 45D] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 46] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions involving joints and associated tissue structures within a patient. [Figure 47A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical intervention for targeting lymphoma lesions within a patient. [Figure 47B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical intervention for targeting lymphoma lesions within a patient. [Figure 48] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical intervention for targeting lymphoma lesions within a patient. [Figure 49A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a gland within a patient, such as the prostate. [Figure 49B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a gland within a patient, such as the prostate. [Figure 49C] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a gland within a patient, such as the prostate. [Figure 49D] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a gland within a patient, such as the prostate. [Figure 50] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in a medical intervention involving a gland within a patient, such as the prostate. [Figure 51A] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions relating to uterus-related tissue structures within a patient, such as uterine fibroids or endometrial lesions. [Figure 51B] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions relating to uterus-related tissue structures within a patient, such as uterine fibroids or endometrial lesions. [Figure 51C] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions relating to uterus-related tissue structures within a patient, such as uterine fibroids or endometrial lesions. [Figure 52] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions relating to uterus-related tissue structures within a patient, such as uterine fibroids or endometrial lesions. [Diagram 53] 1 illustrates various aspects of a configuration for utilizing ultrasound-based histotripsy in medical interventions relating to uterus-related tissue structures within a patient, such as uterine fibroids or endometrial lesions. [Figure 54A] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 54B] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 55] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 56A] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 56B] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 57] Illustrated are various aspects of configurations for utilizing ultrasound-based histotripsy in medical interventions relating to aspects of a patient's cardiovascular system, such as plaque, blood clots, and / or embolism. [Figure 58A] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 58B] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 59A] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 59B] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 59C] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 60] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 61] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 62A] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 62B] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 63] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 64]1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 65] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 66] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 67A] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 67B] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 68] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 69] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Figure 70] 1 illustrates various aspects of a system, or portions thereof, for utilizing or facilitating an ultrasound-based histotripsy intervention. [Background technology]

[0004] The incidence of structural problems in human tissue is high and correlates with significant pain, disability, and costly interventions, typically using techniques such as open surgery. For example, it is estimated that approximately 40 percent of people over the age of 40 have at least one type of degenerative disc disease ("DDD") associated with the spine. With reference to FIG. 1A, a spine (20) of a patient (18) is shown. FIG. 1B illustrates aspects of the lower spine, such as the spinal cord (2), a series of vertebrae (4), and facet joints (6), with aspects of the vertebral structures in contact with spinal nerve (8) structures and intervertebral discs (10). With reference to FIG. 1C, some patients experience pain and / or instability that may be associated, for example, with a herniated condition, which may generally result in abnormal contact between a portion of the nucleus pulposus (14) and / or annulus fibrosus (16) of the intervertebral disc (10) and nearby portions of the nerves (8) associated with the patient's spine. 2A and 2B illustrate such a herniation scenario in which a herniated portion (22) of the nucleus pulposus (14) extends outward from the border of the annulus fibrosus (16) toward the associated nerve (8). Referring to FIG. 3, to address such a condition, spinal surgery may be performed to correct, reduce, or eliminate the abnormal contact between these structures. FIG. 3 illustrates the distal ends of two surgical tools (24, 26), such as a cutting grasper and an aspiration needle, that are utilized to remove at least a portion of the herniation (22) through an invasive surgical procedure. Conventionally, such spinal surgery is typically preceded by imaging of the associated tissues using modalities such as magnetic resonance, computed tomography, biplane radiography, fluoroscopy, ultrasound, and / or camera devices to understand the scenario preoperatively. One or more of such imaging modalities may also be utilized intraoperatively to assist the interventionalist in optimizing the treatment paradigm. For example, FIG. 4A illustrates a modern spinal surgery operating room setup (28), and FIG. 4B illustrates a mode of surgical intervention on the spine (20) of a patient (18).With the patient (18) in a prone position on the operating table, an incision may be made in the patient's back to provide access to the target tissue structure, while various anatomical structures and interventional tools are positioned and oriented to engage the target tissue structure, and one or more imaging modalities may be utilized to assist in understanding the position and orientation of these tools, for example, when removing a portion of nucleus pulposus tissue beyond the normal boundaries of the annulus fibrosus and in contact with a nearby nerve. In other interventional variations, it may be useful to implant various metallic and / or non-metallic materials or structures (30) to assist in providing additional structural support for the target region of the spine as a result of such tissue removal intervention. As discussed above, such interventions are generally invasive. Such interventions also require significant resources, time, and costs, which may be in short supply in the various healthcare delivery systems at issue. There is a need for systems, methods, devices, and configurations to address the need for efficient and minimally invasive tissue structure interventions to address challenges such as degenerative disc disease of the spine. More generally, there is a need for minimally invasive and efficient systems, methods, devices, and arrangements for performing precision diagnostic imaging to aid in understanding the location and orientation of target tissue structures and interventional tools in pre-operative, post-operative, and intra-operative scenarios. Additionally, there is a need for minimally invasive and efficient systems, methods, devices, and arrangements for facilitating controlled navigation of various instruments relative to target tissue structures, and for modifying and / or removing the target tissue structures or portions thereof. Summary of the Invention

[0005] One embodiment is directed to a minimally invasive system for treating a target tissue structure of a patient, the minimally invasive system comprising: an electromechanical support assembly having a proximal portion and a distal portion; a HIFU treatment transducer array coupled to the distal portion of the electromechanical support assembly and operably coupled to a computing system; the computing system configured to operate the electromechanical support assembly to control a position of the transducer assembly relative to the patient such that a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of the target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The electromechanical support assembly may comprise a plurality of elongated portions coupled by one or more movable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine a position of the one or more movable joints. The electromechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electromechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The system may further comprise one or more motors operably coupled to the electromechanical support assembly and configured to apply loads to the electromechanical support assembly to maintain or change a position or attitude of the electromechanical support assembly. The electromechanical support assembly may comprise a robotic arm. The computing system may further be configured to operate the electromechanical support assembly to control the attitude of the transducer assembly relative to the patient.The electromechanical support assembly may be controlled by the computer in response to inputs provided by an operator. The inputs provided by the operator may be manual electromechanical support assembly movement commands. The inputs provided by the operator may be commands for the electromechanical support assembly to follow a defined sequence of movements. The electromechanical support assembly may be automatically controlled by the computer in response to predefined inputs provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electromechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electromechanical support assembly may be operably coupled to the computing system using a wired connection configuration. The system may further comprise an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electromechanical support assembly. The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel interposed between the delivery interface and the patient and configured to further assist in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds.The computing system may be configured to generate a pulsating wavefront for a pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a peak negative pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0006] Another embodiment is a minimally invasive system for treating a target tissue structure of a patient, comprising: an electro-mechanical support assembly having a proximal portion and a distal portion; a source of pre-operative image data relating to the target tissue structure of the patient; a computing system operably coupled to the electro-mechanical support assembly and the source of pre-operative image data; and a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system, wherein the computing system calculates positioning of the HIFU treatment transducer assembly and the patient relative to pre-operative image data from the source of pre-operative image data such that the pre-operative image data can be utilized to assist in positioning the HIFU treatment transducer relative to anatomical features of the patient. The present invention is directed to a minimally invasive system, the system being configured to operate the electro-mechanical support assembly to control the position of the HIFU treatment transducer assembly relative to the patient by aligning the landmark, the computing system being further configured to align the treatment focal point of the HIFU treatment transducer array to treat at least a portion of the target tissue structure of the patient and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The pre-operative image data may be selected from the group consisting of radiography data, fluoroscopy data, ultrasound imaging data, MRI data, and CT data. The system may further comprise a source of intra-operative data regarding the target tissue structure of the patient, the intra-operative data also being co-registered with the pre-operative image data such that both the pre-operative image data and the intra-operative image data may be utilized to assist in positioning the HIFU treatment transducer relative to the anatomical features of the patient. The computing system may be configured to operate a neural network to assist in aligning the coordinate systems of the HIFU treatment transducer assembly and the patient to pre-operative image data from a source of pre-operative image data.The computing system may be configured to operate a neural network to assist in the alignment of the HIFU treatment transducer assembly and the patient coordinate system to the pre-operative image data and intra-operative data. The electro-mechanical support assembly may comprise a plurality of elongated portions coupled by one or more movable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine the position of the one or more movable joints. The electro-mechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electro-mechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The system may further comprise one or more motors operably coupled to the electro-mechanical support assembly and configured to apply a load to the electro-mechanical support assembly to maintain or change a position or attitude of the electro-mechanical support assembly. The electro-mechanical support assembly may comprise a robotic arm. The computing system may further be configured to operate the electro-mechanical support assembly to control the attitude of the transducer assembly relative to the patient. The electro-mechanical support assembly may be controlled by the computer in response to inputs provided by an operator. The inputs provided by the operator may be manual electro-mechanical support assembly movement commands. The inputs provided by the operator may be commands for the electro-mechanical support assembly to follow a defined series of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to predefined inputs provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration.The electromechanical support assembly may be operatively coupled to the computing system using a wired connection configuration. The system may further comprise an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electromechanical support assembly. The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a peak negative pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles. The system may further comprise one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the electro-mechanical support structure relative to the patient.The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor. The system may further comprise one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the HIFU treatment transducer array relative to the patient. The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor. The system may further comprise one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the patient. The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor.

[0007] Another embodiment is directed to a system for positioning an instrument for a minimally invasive intervention on a patient, comprising: an elongate guide member having a proximal end, a distal end, and a guide lumen defined therethrough, the distal end being configured to be positioned adjacent a target intervention site in the patient, and an imaging transducer configured to be interfaced to the patient, the imaging transducer defining an imaging field of view that can be displayed on an operably coupled display device, the imaging transducer being movably coupled to the elongate guide member such that the distal end of the elongate guide member can be maintained within the field of view of the imaging transducer and such that the field of view of the imaging transducer can be repositioned when the elongate guide member is repositioned relative to the patient. The imaging transducer may be rotatably coupled to the elongate guide member. The rotatable coupling may comprise a drive motor configured to generate a vibrational motion of at least a portion of the imaging transducer such that a field of view of the imaging transducer is swept in a selected pattern to capture the distal end of the elongated guide member along with aspects of the patient adjacent the distal end of the elongated guide member. The elongated guide member may be an instrument selected from the group consisting of a cannula, a needle, and a catheter. The elongated guide member may be a needle configured to aspirate a portion of tissue that may have been previously lysed at the target intervention location. The system may further comprise a HIFU therapy transducer array operably coupled to the computing system, the computing system configured to position a treatment focal point of the HIFU therapy transducer array in alignment to treat at least a portion of the target intervention site of the patient, and operate the HIFU therapy transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed at the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles within the target intervention site, and to controllably generate cavitation of one of the more vapor bubbles such that a controllably lysed portion of the patient's tissue at the target intervention site is generated.The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel inserted between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves can be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves can be configured to have a peak negative pressure received at the treatment focal point of between about 10 MPa and about 15 MPa. The controllably lysed portion can be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0008] Another embodiment is a minimally invasive system for treating a target tissue structure in a patient, comprising: an electro-mechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electro-mechanical support assembly; a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; and an elongated guide member movably coupled to the HIFU treatment transducer array and having a proximal end, a distal end, and a guide lumen defined therethrough, the distal end being configured to be positioned adjacent the target tissue structure in the patient; The present invention is directed to a minimally invasive system configured to operate an electro-mechanical support assembly to control a position of the transducer assembly relative to a patient such that a treatment focal point of the transducer array is aligned to treat at least a portion of a target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles within the target tissue structure and to controllably generate cavitation of one of more of the vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated, and an elongated guide member configured to be utilized to remove the controllably dissolved portion.

[0009] The elongated guide member may be movably coupled to the treatment focal point of the HIFU treatment transducer array such that a distal portion of the elongated guide member may be inserted along a predetermined axis selected to be aligned with the location of the treatment focal point and the controllably dissolved portion. The elongated guide member may be an instrument selected from the group consisting of a cannula, a needle, and a catheter. The elongated guide member may be a needle configured to aspirate the controllably dissolved portion. The electromechanical support assembly may comprise a plurality of elongated portions coupled by one or more moveable joints. The one or more moveable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine the position of the one or more moveable joints. The electromechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electromechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of a joint load sensor, a joint torque sensor, a strain gauge, and a deflection gauge. The system may further comprise one or more motors operably coupled to the electromechanical support assembly and configured to apply a load to the electromechanical support assembly to maintain or change a position or attitude of the electromechanical support assembly. The electromechanical support assembly may comprise a robotic arm. The computing system may further be configured to operate the electromechanical support assembly to control the attitude of the transducer assembly relative to the patient. The electromechanical support assembly may be controlled by the computer in response to inputs provided by an operator. The inputs provided by the operator may be manual electromechanical support assembly movement commands. The inputs provided by the operator may be commands for the electromechanical support assembly to follow a defined sequence of movements. The electromechanical support assembly may be automatically controlled by the computer in response to predefined inputs provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration.The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration. The system may further comprise an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 Watts to about 4,000 Watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0010] Another embodiment is directed to a minimally invasive system for treating a target tissue structure of a patient, comprising: an electromechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electromechanical support assembly; and a HIFU treatment transducer array coupled to the distal portion of the electromechanical support assembly and operably coupled to the computing system, the computing system configured to operate the electromechanical support assembly to control a position of the transducer assembly relative to the patient such that an interface load between the transducer assembly and the patient is controlled and such that a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of the target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The electromechanical support assembly may comprise a plurality of elongated portions coupled by one or more moveable joints. The one or more mobile joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine the position of the one or more mobile joints. The electro-mechanical support assembly may include one or more sensors configured to sense one or more loads in the electro-mechanical support assembly associated with an interface load between the HIFU treatment transducer array and the patient. The computing system may be configured to maintain the interface load below a predetermined maximum value. The computing system may be configured to maintain the interface load above a predetermined minimum value and below a predetermined maximum value during a treatment period for the patient.The computing system may be configured to maintain a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during a treatment period of the patient, while also maintaining an interface load above a predetermined minimum value and below a predetermined maximum value. The computing system may be configured to facilitate repositioning of the HIFU treatment transducer relative to the patient, while also maintaining a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during a treatment period of the patient, while also maintaining an interface load above a predetermined minimum value and below a predetermined maximum value. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The system may further comprise one or more motors operably coupled to the electro-mechanical support assembly and configured to apply a load to the electro-mechanical support assembly to maintain or change a position or orientation of the electro-mechanical support assembly. The electro-mechanical support assembly may comprise a robotic arm. The computing system may be further configured to operate the electro-mechanical support assembly to control the orientation of the transducer assembly relative to the patient. The electro-mechanical support assembly may be controlled by the computer in response to inputs provided by an operator. The inputs provided by the operator may be manual electro-mechanical support assembly movement commands. The inputs provided by the operator may be commands for the electro-mechanical support assembly to follow a defined series of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to predefined inputs provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration.The system may further comprise an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0011] Another embodiment is a robotic medical intervention system for treating a target tissue structure of a patient, comprising a robotic system base, a computing system operably coupled to the robotic system base, a plurality of robotic arms, each having a proximal end and a distal end, the proximal end being movably coupled to the robotic system base, a plurality of interventional end effectors, each interventional end effector coupled to a distal end of one of the plurality of robotic arm distal ends, at least one of the interventional end effectors comprising a HIFU treatment transducer array, and a computing system operably coupled to the robotic system base. The present invention is directed to a robotic medical intervention system, the robotic medical intervention system being configured to operate one of a plurality of robotic arms to control a position of the transducer assembly relative to a patient such that a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of a target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The computing system may be further configured to operate one of the plurality of robotic arms to control a position of the transducer assembly relative to the patient such that an interface load between the transducer assembly and the patient is controlled. At least one of the plurality of robotic arms may comprise a plurality of elongated portions joined by one or more movable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine a position of the one or more movable joints. The multiple robotic arms may include one or more sensors configured to sense one or more loads associated with an interface load between the HIFU treatment transducer array and the patient.The computing system may be configured to maintain the interface load below a predetermined maximum value. The computing system may be configured to maintain the interface load above a predetermined minimum value and below a predetermined maximum value during the patient's treatment. The computing system may be configured to maintain a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during the patient's treatment, while also maintaining the interface load above a predetermined minimum value and below a predetermined maximum value. The computing system may be configured to facilitate repositioning of the HIFU treatment transducer relative to the patient, while also maintaining a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during the patient's treatment, and also maintaining the interface load above a predetermined minimum value and below a predetermined maximum value. The one or more sensors are selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The computing system may be further configured to operate at least one of the plurality of robotic arms to control the orientation of the transducer assembly relative to the patient. The position of the HIFU treatment transducer may be controlled by the computer in response to input provided by an operator. The input provided by the operator may be a manual HIFU therapy transducer movement command. The input provided by the operator may be a command for the HIFU therapy transducer to follow a set of predefined movements. The position of the HIFU therapy transducer may be automatically controlled by the computer in response to the predefined input provided by the operator. The HIFU therapy transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU therapy transducer array may be operably coupled to the computing system using a wired connection configuration. The multiple robotic arms may be operably coupled to the computing system using a wireless connection configuration. The multiple robotic arms may be operably coupled to the computing system using a wired connection configuration.The system may further comprise an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of at least one of the robotic arms. The system may further comprise a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The system may further comprise a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0012] Another embodiment is directed to a minimally invasive method for treating a target tissue structure of a patient, the minimally invasive method including: providing an electro-mechanical support assembly having a proximal portion and a distal portion, a computing system operably coupled to the electro-mechanical support assembly, and a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system, and utilizing the computing system to operate the electro-mechanical support assembly to control a position of the transducer assembly relative to the patient such that a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of the target tissue structure of the patient, and to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure, and to controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The electro-mechanical support assembly may comprise a plurality of elongated portions coupled by one or more moveable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide an input to the computing system to determine a position of the one or more movable joints. The electromechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electromechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The method may further include providing one or more motors operably coupled to the electromechanical support assembly and configured to apply a load to the electromechanical support assembly to maintain or change a position or attitude of the electromechanical support assembly. The electromechanical support assembly may comprise a robotic arm.The computing system may further be configured to operate the electro-mechanical support assembly to control the orientation of the transducer assembly relative to the patient. The electro-mechanical support assembly may be controlled by the computer in response to input provided by an operator. The input provided by the operator may be a manual electro-mechanical support assembly movement command. The input provided by the operator may be a command for the electro-mechanical support assembly to follow a defined sequence of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to a predefined input provided by the operator. The HIFU therapy transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU therapy transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration. The method may further include providing an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU therapy transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts.The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0013] Another embodiment is a minimally invasive method for treating a target tissue structure of a patient, comprising providing an electro-mechanical support assembly having a proximal portion and a distal portion, a source of pre-operative image data relating to the target tissue structure of the patient, a computing system operably coupled to the electro-mechanical support assembly and the source of pre-operative image data, and a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system, and registering coordinate systems of the HIFU treatment transducer assembly and the patient relative to pre-operative image data from the source of pre-operative image data such that the pre-operative image data may be utilized to assist in positioning the HIFU treatment transducer relative to anatomical features of the patient. The present invention is directed to a minimally invasive method, comprising: utilizing a computing system to operate an electro-mechanical support assembly to control a position of an IFU therapy transducer assembly; and utilizing a computing device system to operate the HIFU therapy transducer array such that a treatment focal point of the HIFU therapy transducer array is aligned to treat at least a portion of a target tissue structure of a patient, and the HIFU therapy transducer array controllably generates a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure, and to controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The pre-operative image data may be selected from the group consisting of radiography data, fluoroscopy data, ultrasound imaging data, MRI data, and CT data. The method may further include providing a source of intra-operative data regarding the target tissue structure of the patient, the intra-operative data also being co-registered with the pre-operative image data such that both the pre-operative image data and the intra-operative image data may be utilized to assist in positioning the HIFU therapy transducer relative to an anatomical feature of the patient.The computing system may be configured to operate a neural network to assist in aligning the HIFU treatment transducer assembly and the patient's coordinate system to pre-operative image data from a source of pre-operative image data. The computing system may be configured to operate a neural network to assist in aligning the HIFU treatment transducer assembly and the patient's coordinate system to the pre-operative image data and the intra-operative data. The electro-mechanical support assembly may comprise a plurality of elongated portions coupled by one or more movable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine a position of the one or more movable joints. The electro-mechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electro-mechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The method may further include providing one or more motors operably coupled to the electro-mechanical support assembly and configured to apply a load to the electro-mechanical support assembly to maintain or change a position or attitude of the electro-mechanical support assembly. The electro-mechanical support assembly may comprise a robotic arm. The computing system may further be configured to operate the electro-mechanical support assembly to control the orientation of the transducer assembly relative to the patient. The electro-mechanical support assembly may be controlled by the computer in response to input provided by an operator. The input provided by the operator may be a manual electro-mechanical support assembly movement command. The input provided by the operator may be a command for the electro-mechanical support assembly to follow a defined sequence of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to a predefined input provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration.The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration. The method may further include providing an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of a treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 Watts to about 4,000 Watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.The method may include providing one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the electro-mechanical support structure relative to the patient. The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor. The method may further include providing one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the HIFU treatment transducer array relative to the patient. The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor. The method may further include providing one or more sensors operably coupled to the computing system and configured to provide data to the computing system to enable three-dimensional tracking of the patient. The one or more sensors may be selected from the group consisting of a joint position sensor, an image capture device, an electromagnetic tracking sensor, a LIDAR device, an IMU, and an extension sensor.

[0014] Another embodiment is directed to a method for positioning an instrument for a minimally invasive intervention on a patient, the method including providing an elongate guide member having a proximal end, a distal end, and a guide lumen defined therethrough, the distal end being configured to be positioned adjacent a target intervention site in the patient, and providing an imaging transducer configured to be interfaced to the patient, the imaging transducer defining an imaging field of view that can be displayed on an operably coupled display device, the imaging transducer being movably coupled to the elongate guide member such that the distal end of the elongate guide member can be maintained within the field of view of the imaging transducer and such that the field of view of the imaging transducer can be repositioned when the elongate guide member is repositioned relative to the patient. The imaging transducer may be rotatably coupled to the elongate guide member. The rotatable coupling may comprise a drive motor configured to generate an oscillatory motion of at least a portion of the imaging transducer such that a field of view of the imaging transducer is swept in a selected pattern to capture the distal end of the elongated guide member along with aspects of the patient adjacent the distal end of the elongated guide member. The elongated guide member may be an instrument selected from the group consisting of a cannula, a needle, and a catheter. The elongated guide member may be a needle configured to aspirate a portion of tissue that may have been previously lysed at the target intervention location. The method may further include providing a HIFU therapy transducer array operably coupled to a computing system, the computing system configured to position a treatment focal point of the HIFU therapy transducer array in alignment to treat at least a portion of the target intervention site of the patient, and operate the HIFU therapy transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed at the treatment focal point, the pulsating wavefront configured to generate one or more vapor bubbles within the target intervention site, and to controllably generate cavitation of one of the more vapor bubbles such that a controllably lysed portion of the patient's tissue at the target intervention site is generated.The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves can be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves can be configured to have a peak negative pressure received at the treatment focal point of between about 10 MPa and about 15 MPa. The controllably lysed portion can be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0015] Another embodiment is a minimally invasive method for treating a target tissue structure in a patient, comprising providing an electro-mechanical support assembly having a proximal portion and a distal portion; providing a computing system operably coupled to the electro-mechanical support assembly; providing a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; providing an elongated guide member movably coupled to the HIFU treatment transducer array and having a proximal end, a distal end, and a guide lumen defined therethrough, the distal end being configured to be positioned adjacent the target tissue structure in the patient; and providing an elongated guide member movably coupled to the HIFU treatment transducer array and having a proximal end, a distal end, and a guide lumen defined therethrough, the distal end being configured to be positioned adjacent the target tissue structure in the patient. and utilizing a computing device system to operate an electro-mechanical support assembly to control a position of the transducer assembly relative to the patient such that a therapeutic focal point of the array is aligned to treat at least a portion of a target tissue structure of the patient and to operate the HIFU therapy transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the therapeutic focal point, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated, and an elongated tissue structure is configured to be utilized to remove the controllably dissolved portion. The elongated guide member may be movably coupled to the therapeutic focal point of the HIFU therapy transducer array such that a distal portion of the elongated guide member may be inserted along a predetermined axis selected to be aligned with the position of the therapeutic focal point and the controllably dissolved portion. The elongated guide member may be an instrument selected from the group consisting of a cannula, a needle, and a catheter. The elongated guide member may be a needle configured to aspirate the controllably dissolved portion. The electro-mechanical support assembly may include a number of elongated sections joined by one or more moveable joints.The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine the position of the one or more movable joints. The electromechanical support assembly may comprise one or more sensors configured to sense one or more loads in the electromechanical support assembly associated with a physical interface between the HIFU treatment transducer array and the patient. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The method may further include providing one or more motors operably coupled to the electromechanical support assembly and configured to apply loads to the electromechanical support assembly to maintain or change a position or attitude of the electromechanical support assembly. The electromechanical support assembly may comprise a robotic arm. The computing system may further be configured to operate the electromechanical support assembly to control the attitude of the transducer assembly relative to the patient. The electromechanical support assembly may be controlled by the computer in response to input provided by an operator. The input provided by the operator may be a manual electromechanical support assembly movement command. The input provided by the operator may be a command for the electromechanical support assembly to follow a defined sequence of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to predetermined inputs provided by an operator. The HIFU therapy transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU therapy transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration. The method may further include providing an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU therapy transducer array.The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate a pulsating wavefront for a pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a peak negative pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0016] Another embodiment is directed to a minimally invasive method for treating a target tissue structure of a patient, comprising: providing an electro-mechanical support assembly having a proximal portion and a distal portion; providing a computing system operably coupled to the electro-mechanical support assembly; providing a HIFU treatment transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; utilizing the computing system to operate the electro-mechanical support assembly to control a position of the transducer assembly relative to the patient such that an interface load between the transducer assembly and the patient is controlled and a treatment focal point of the HIFU treatment transducer array is aligned to treat at least a portion of the target tissue structure of the patient; utilizing the computing system to operate the HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the treatment focal point, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure and controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The electro-mechanical support assembly may comprise a plurality of elongated portions coupled by one or more moveable joints. The one or more mobile joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine the position of the one or more mobile joints. The electro-mechanical support assembly may include one or more sensors configured to sense one or more loads in the electro-mechanical support assembly associated with an interface load between the HIFU treatment transducer array and the patient. The computing system may be configured to maintain the interface load below a predetermined maximum value. The computing system may be configured to maintain the interface load above a predetermined minimum value and below a predetermined maximum value during a treatment period for the patient.The computing system may be configured to maintain a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during a treatment period of the patient, while also maintaining an interface load above a predetermined minimum value and below a predetermined maximum value. The computing system may be configured to facilitate repositioning of the HIFU treatment transducer relative to the patient, while also maintaining a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during a treatment period of the patient, while also maintaining an interface load above a predetermined minimum value and below a predetermined maximum value. The one or more sensors may be selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The method may further include providing one or more motors operably coupled to the electro-mechanical support assembly and configured to apply a load to the electro-mechanical support assembly to maintain or change a position or orientation of the electro-mechanical support assembly. The electro-mechanical support assembly may comprise a robotic arm. The computing system may be further configured to operate the electro-mechanical support assembly to control the orientation of the transducer assembly relative to the patient. The electro-mechanical support assembly may be controlled by the computer in response to inputs provided by an operator. The inputs provided by the operator may be manual electro-mechanical support assembly movement commands. The inputs provided by the operator may be commands for the electro-mechanical support assembly to follow a defined series of movements. The electro-mechanical support assembly may be automatically controlled by the computer in response to predefined inputs provided by the operator. The HIFU treatment transducer array may be operably coupled to the computing system using a wireless connection configuration. The HIFU treatment transducer array may be operably coupled to the computing system using a wired connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wireless connection configuration. The electro-mechanical support assembly may be operably coupled to the computing system using a wired connection configuration.The method may further include providing an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of the electro-mechanical support assembly. The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles.

[0017] Another embodiment is a method of robotic medical intervention for treating a target tissue structure of a patient, comprising providing a robotic system base; a computing system operably coupled to the robotic system base; a plurality of robotic arms, each having a proximal end and a distal end, the proximal end being movably coupled to the robotic system base; and a plurality of intervention end effectors, each coupled to a distal end of one of the plurality of robotic arm distal ends, at least one of the intervention end effectors comprising a HIFU treatment transducer array; and controlling the treatment of the HIFU treatment transducer array. and utilizing a computing device system to operate one of a plurality of robotic arms to control a position of a transducer assembly relative to a patient such that a therapeutic focus is aligned to treat at least a portion of a target tissue structure of the patient and to operate a HIFU treatment transducer array to controllably generate a pulsating wavefront of ultrasonic radiation directed to the therapeutic focus, the pulsating wavefront being configured to generate one or more vapor bubbles in the target tissue structure and to controllably generate cavitation of one of the more vapor bubbles such that a controllably dissolved portion of the target tissue structure is generated. The computing system may further be configured to operate one of the plurality of robotic arms to control a position of the transducer assembly relative to the patient such that an interface load between the transducer assembly and the patient is controlled. At least one of the plurality of robotic arms may comprise a plurality of elongated portions coupled by one or more movable joints. The one or more movable joints may be coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system to determine a position of the one or more movable joints. The multiple robotic arms may include one or more sensors configured to sense one or more loads associated with an interface load between the HIFU treatment transducer array and the patient.The computing system may be configured to maintain the interface load below a predetermined maximum value. The computing system may be configured to maintain the interface load above a predetermined minimum value and below a predetermined maximum value during a patient treatment period. The computing system may be configured to maintain a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto during a patient treatment period, while also maintaining the interface load above a predetermined minimum value and below a predetermined maximum value. The computing system may be configured to facilitate repositioning of the HIFU treatment transducer relative to the patient during a patient treatment period, while also maintaining a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto, and also maintaining the interface load above a predetermined minimum value and below a predetermined maximum value. The one or more sensors are selected from the group consisting of joint load sensors, joint torque sensors, strain gauges, and deflection gauges. The computing system may be further configured to operate at least one of the plurality of robotic arms to control the orientation of the transducer assembly relative to the patient. The position of the HIFU treatment transducer may be controlled by the computer in response to input provided by an operator. The input provided by the operator can be a manual HIFU therapy transducer movement command. The input provided by the operator can be a command for the HIFU therapy transducer to follow a predetermined set of movements. The position of the HIFU therapy transducer can be automatically controlled by the computer in response to the predetermined input provided by the operator. The HIFU therapy transducer array can be operably coupled to the computing system using a wireless connection configuration. The HIFU therapy transducer array can be operably coupled to the computing system using a wired connection configuration. The multiple robotic arms can be operably coupled to the computing system using a wireless connection configuration. The multiple robotic arms can be operably coupled to the computing system using a wired connection configuration.The method may further include providing an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of the treatment focal point of the HIFU treatment transducer array. The HIFU treatment transducer array and the imaging ultrasound transducer may both be coupled to a distal portion of at least one of the robotic arms. The method may further include providing a delivery interface positioned between the HIFU treatment transducer array and the patient and configured to provide an efficient medium for conducting sound energy between the HIFU treatment transducer array and the patient. The method may further include providing a layer of acoustic gel interposed between the delivery interface and the patient and configured to further aid in efficient transmission between the HIFU treatment transducer array and the patient. The treatment focal point may have a maximum dimension of about 5 millimeters. The treatment focal point may have a maximum dimension of about 100 microns. The HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. The HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. The pulsating wavefront may include a plurality of waves formed into pulses, the pulses having a pulse duration of about 1 millisecond to about 30 milliseconds. The computing system may be configured to generate the pulsating wavefront for the pulse duration and then pause for about 0.1 seconds to about 1 second before commencing another pulse. The waves may be configured to have a pressure amplitude received at the treatment focal point of greater than about 60 MPa. The waves may be configured to have a negative peak pressure received at the treatment focal point of about 10 MPa to about 15 MPa. The controllably lysed portion may be generated, at least in part, by an acoustic fountain reaction associated with cavitation of one or more vapor bubbles. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0018] Recent advances in transducer technology and configurations have led to an evolving set of techniques for the use of high intensity focused ultrasound, or "HIFU," in various clinical scenarios. Although delivery of energy to one or more target tissue structures in a conventional HIFU configuration is attractive for minimally invasive intervention scenarios where an attempt may be made to minimize access via a conventional percutaneous surgical wound, it is associated with potentially undesirable temperature rise at sites local to the focal point of the associated HIFU transducer assembly, as well as other side effects, and as a result, certain indications may not be well suited for conventional HIFU intervention. More recently, boiling histotripsy ("boiling histotripsy, BH") HIFU techniques and configurations have been developed that may be utilized to avoid certain side effects of conventional HIFU. Various aspects of BH are described, for example, in U.S. Patent Nos. 8,876,740, 9,700,742, and 9,498,651, each of which is incorporated herein by reference in its entirety. In various embodiments, a so-called boiling histotripsy configuration has been developed in which a relatively low pressure wavefront is directed at one or more nucleated vapor bubbles, causing controlled cavitation and resulting controlled lysis of cells and / or tissue within the treatment focal volume (54). Referring previously to Figures 6C and 6D, a train of pulses (72) from a BH transducer assembly, such as those described in the above-mentioned incorporated references, may be utilized to direct (74) ultrasonic energy through the skin (48) to the target tissue structure (56) to produce highly focused and controlled atomization, emulsification, and / or destruction of tissue at a relatively discrete focal point or volume (54) by using gas bubbles / boiling (76) and associated cavitation, which may result in what has been described as a localized "acoustic fountain" (80) type reactive configuration at the focal point or volume (54).6E, an elongated instrument (84), such as an aspiration needle, may be utilized to remove the locally atomized, emulsified, and / or disrupted tissue portion (82) as desired, preferably using image guidance from modalities such as radiography, fluoroscopy, and / or imaging ultrasound to assist in positioning a distal portion of such elongated instrument (84) at a location of a focal point or volume (54) within the target tissue structure (56). In various embodiments, a computing system may be operatively coupled to a HIFU treatment transducer or transducer array (such as, for example, element 67 of assembly 44) and configured to operate such transducer array to controllably generate a pulsed wavefront of ultrasonic radiation directed at a selected treatment focal point (54). The pulsating wavefront may be configured to generate or nucleate one or more vapor bubbles by heating tissue in the region of the treatment focal point (54) to approximately 100 degrees Celsius within a few milliseconds. The continuous energy from the wavefront in pulses, such as those shown in FIG. 6C, may be configured to controllably generate cavitation of one or more vapor bubbles such that a controllably lysed portion of the target tissue structure is generated, which may then be removed, such as by aspiration. Referring again to FIG. 6C, each pulse may be in the range of 1-10 milliseconds long, or in some embodiments 1-30 milliseconds long, and then a pause in the pulse train (such as about 0.1 seconds to 1 second, thereby resulting in a "duty cycle" of about 2% or less) may be implemented by the controller or computer, followed by another pulse of the wavefront until the desired cavitation occurs at the treatment focal point (54). In various embodiments, the treatment focal point (54) may have a maximum dimension of about 5 millimeters, and in other embodiments, the treatment focal point (54) may be configured to be as small as 100 microns. In various embodiments, the HIFU treatment transducer array may have an output frequency of about 1 MHz to about 3 MHz. In various embodiments, the HIFU treatment transducer array may have an output power of about 300 watts to about 4,000 watts. Suitable transducers may include, for example, piezoelectric materials selected to vibrate and generate waves and wavefronts with desired characteristics.Waves having each wavefront of the pulse may be configured to have a pressure amplitude received at the treatment focal point (54) greater than about 60 MPa, but importantly, may have a relatively low range of negative peak pressures of about 10 MPa to about 15 MPa. With reference to Figures 5, 6A, and 6B, a function generator (32), an amplifier (34), a computer, computing system, or controller device (36), and a power source (38) may be operatively coupled (42) to the HIFU transducer array (44) and configured to deliver a pulsating BH HIFU configuration, such as that shown in Figure 6C or those described in the above-mentioned incorporated references, to discrete focal points or volumes (54) within a target tissue structure (56) by using a delivery interface (52) preferably comprising an efficient medium for conducting acoustic energy between the transducer array and the target tissue interface (such as water, which may be deionized and / or degassed), and a layer of acoustic gel (50) to aid in transmission efficiency. The system configurations of Figures 5, 6A, and 6B illustrate that the computing system may be operatively coupled to various components, such as the electromechanical support assembly configuration (such as element 146), interventional and imaging ultrasound transducers, and related components (such as elements 44, 60, 67, 66, 70, etc.), via wired or wireless interfaces (e.g., via IEEE 802.11 wireless connections or mobile wireless connections), to control and monitor such components; in other embodiments featuring other interconnected electronic components, such as sensors (such as IMUs, optical tracking sensors, joint encoders, image capture devices, electromagnetic tracking sensors, LIDAR sensors, and strain or extension sensors, all of which are discussed in more detail below), storage devices (such as for making certain pre-operative or intra-operative information available, as described herein), and the like, such components may be similarly operatively coupled to the computing system. Additionally, the computing system may be programmable and / or controllable by inputs, predetermined variables, and predetermined paths.In scenarios where pockets of gas or air are located in the path between the transducer array (44) and the target tissue structure, additional efficient media material (such as water, which again may be deionized and / or degassed) may be injected or placed in such path to improve transmission efficiency between the transducer array (44) and the target tissue structure. In a relatively basic embodiment as illustrated in FIG. 5, the HIFU transducer array (44) may be held in place by a movable mounting structure (46) and guidance may be assisted through the use of conventional ultrasound imaging, such as through a system such as that available from Siemens under the trade name Sequoia®, which may incorporate an ultrasound imaging head (60) including one or more ultrasound transducers operably coupled to an ultrasound imaging controller (70), such as a computer system. The ultrasound imaging head (60) may be configured to be held in place by a movable mounting structure (58) and configured to provide ultrasound image data associated with one or more "slices" associated with an associated field of view (64) of tissue scanned by the ultrasound imaging head (70).

[0019] With reference to Fig. 6B, another embodiment is illustrated with an ultrasound system (66) coupled to a HIFU transducer array (44) and operably coupled (68) to an imaging ultrasound transducer (67) configured to provide a field of view (65) that is at least partially pre-aligned with the treatment focal point (54) of the HIFU transducer array (44). Fig. 6A illustrates an embodiment that features imaging ultrasound integrated into the transducer array (44) structure as well as separate ultrasound imaging (70, 60, 62) for additional image-based confirmation of interventional activity in the target tissue structure (56). With reference to Fig. 7, methods and configurations are illustrated in which aspects of the system configurations described above may be utilized. A patient may undergo pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) for a particular patient scenario (90), such as a herniated disc in the patient's spine. Once it is determined (92) that a structural intervention is indicated, such as modification of a portion of an intervertebral tissue structure (such as modification and / or removal of a portion of an intervertebral annulus fibrosus or nucleus pulposus that extends beyond normal anatomical margins toward neural structures), the medical team may prepare for the intervention. The patient may be positioned on an intervention platform (such as a hospital bed) in proximity to a suitable imaging modality (such as ultrasound, radiography, MRI, fluoroscopy, etc.) and a controllable HIFU transducer that may be operably coupled to a control system configured to perform boiling histotripsy at a selected focal point utilizing a selected sequence of pulses from the HIFU transducer (94). The HIFU system may be utilized to perform boiling histotripsy pulse sequencing and focal point sequencing following image confirmation (such as via ultrasound imaging) to break down portions of the target tissue structure (HIFU settings and sequencing may be specifically tailored according to the characteristics of the target tissue structure) (96).The degraded portions of the target tissue structure may be left in place to be addressed by the patient's physiological and healing processes, or alternatively, at least a portion of these degraded portions of the target tissue structure may be removed, such as via image-guided controlled aspiration using, for example, ultrasound confirmation of the suction instrument site relative to the degraded portions of the target tissue structure (98).

[0020] 8A-28, additional aspects of other embodiments are illustrated with reference to minimally invasive spinal herniorrhaphy interventions. For example, in various embodiments, it may be desirable to utilize an electromechanical system, such as an electromechanical or robotic manipulator or arm, to assist in positioning the HIFU transducer head (44) relative to the patient (18) and the target tissue structures. Image guidance, as well as global stabilization of certain relevant structures relative to one another, may be utilized to assist in accurate relative positioning and orientation of the manipulator with respect to the patient (e.g., it may be useful to globally prevent a hospital bed holding a patient from moving across the operating room floor during a procedure). 8A and 8B, a hospital or surgical bed (102) may be configured to have a controllably braked wheel assembly (104) that may be configured to have not only conventional braking (such as by depression of a brake interface member 108 by an operator's foot to engage a brake member 122 against the wheels 120) to prevent further rolling motion of the wheels (120), but also braking and / or temporary locking (such as via a remotely actuated solenoid 110 configured to push a fixed shaft 112 into a fixed socket 114 fixedly coupled to the lower wheel frame 118 (and retract upon a release command)) at a roll axis of rotation between the foot (106) and the lower wheel frame (118) portion of the bed (102). In one embodiment, the roll axis of the four wheel assemblies (104) of the surgical bed may be controllably locked at its roll axis, for example, by pressing a button. Similarly, the illustrated manual wheel brakes (122) may be configured to be electromechanically actuated, such as via a solenoid. Thus, referring to Figure 9A, a patient (18) on a surgical bed (102) can be positioned adjacent to an intervention cart (126) and the two can be locked in place relative to each other and to the operating room (28). Figure 9B shows a view looking down from the ceiling of the operating room (28) toward the patient (18), illustrating the bed (102) and intervention cart (126) braked into position relative to each other.The embodiment of Fig. 9B also illustrates several removable coupling locks (136) configured to releasably latch the two platforms (126, 102) relative to one another for additional stability. Fig. 9B illustrates a portion of a spine (20) of a patient (18), which may be under the skin of the patient (18) in a closed position (i.e., without a traditional surgical wound approach), with a herniated portion (22) of an intervertebral disc (10) shown as a target for a boil histotripsy intervention. The coordinate systems of the operating room (130), the intervention platform (132), and the surgical bed (134) are illustrated as a reminder that in certain interventional configurations, it may be important to maintain an understanding of the position and orientation of these coordinate systems (130, 132, 134) relative to one another. Referring to FIG. 9C, optical tracking fiducials (140, 142, 144) may be coupled to the operating room (130), interventional platform (132), and surgical bed (134) as shown, to assist in tracking any position and / or orientation changes of these structures relative to one another via a precision multi-camera based optical tracking system (138), such as a system available from Northern Digital, Inc.

[0021] 10A-10D, an electromechanical manipulator or electromechanical support assembly (146), such as a robotic arm (e.g., robotic arms available from manufacturers such as Barrett Technology, Inc. (Newton, Massachusetts) or Kuka AG (Augsburg, Germany)), may comprise a variety of elongated segments, motors or actuators, and joints (e.g., may be operatively coupled to joint encoders to facilitate determination of joint angles or positions), and may be utilized to precisely reposition and reorient the BH HIFU transducer head (44) relative to the anatomy of the patient (18) for precision intervention. The manipulator assembly (146) may comprise a stabilizing base (160) that may be fixedly coupled to the interventional platform (126). A series of controllable joints (154, 156, 158) positioned between substantially rigid elongated linkage structures (148, 150, 152, 160) may be utilized operatively coupled to a computing system to controllably position and orient the transducer head (44) relative to the patient (18), for example, such repositioning and reorienting may be performed manually as shown in FIG. 10A, but is preferably performed in conjunction with a constantly updated determination of the positions and orientations of the manipulator (146), transducer head (44), platform (102, 126), and associated related structures, such as the anatomy of the patient (18). An initial calibration, kinematic relationships, and knowledge of the joint positions of the manipulator (146) may be utilized to obtain a basic understanding of the position and orientation of the manipulator (146). With reference to Figures 10B and 10C, one or more tracking fiducials (162) may also be coupled directly to the transducer head (44) or other structures associated with the manipulator (146) to assist in obtaining further determinations of the position and orientation of various structures before, during, and after providing energy for boil tissue lysis through the transducer head (44).Referring to Figure 10D, a configuration similar to that of Figure 10C is illustrated, except that an elongated interventional instrument (86), such as an aspiration needle, infusion needle, or cannula, is movably coupled to the transducer head (44), such as by a set of miniature linear bearing clamps (100, 101), such that the elongated instrument (86) may be advanced / retracted (88) along an axis predicted for the transducer head pose, such as an axis that places a distal portion of the elongated instrument (86) at the focal point of the transducer head (44) upon full insertion (88) of the elongated instrument. Accordingly, referring to Figure 11, methods and configurations are illustrated in which aspects of the system configurations described above may be utilized. The patient may undergo pre-intervention analysis and planning (MRI, CT, fluoroscopy, radiography, ultrasound imaging, functional analysis, etc.) of the patient and the target tissue structures of interest (170). The resulting image information is registered (i.e., so that the coordinate systems are positioned and oriented in anatomical alignment with each other and with associated instrumentation related to the procedure in a global coordinate system) based on the anatomical geometry and details of the images (which may be accomplished at least in part by an image processing computer configuration), so that the image information from two or more sources may be utilized geometrically together as a volume or grouping of registered image data related to tissue structures of interest within the patient (172). In various embodiments, both the pre-operative and intra-operative image data may be registered to the coordinate system of the HIFU treatment transducer to enable image-based navigation of the transducer within the image data. Intervention preparation may be performed to fix the operating table and intervention platform with respect to the global coordinate system of the operating room and with respect to each other. The patient may be positioned on the operating table in a posture and access selected to facilitate the proposed intervention and associated imaging (174).

[0022] Tracking (such as tracking of the intervention platform and operating table relative to the global coordinate system of the operating room, tracking of the intervention transducer head relative to the global coordinate system and / or relative to the intervention platform) may be initiated, as well as any tracking redundancy (inverse kinematics via the manipulator, deflection sensors (such as conductive or optical strain or deflection gauges) that may be incorporated in various components, inertial measurement units (IMUs), which may comprise accelerometers, gyros, etc.) that may be incorporated in various components (e.g., IMUs may be coupled to each key segment of an electromechanical manipulator to help determine and confirm movements, accelerations, repositioning, reorientation), electromagnetic tracking (such as magnetic flux-based position and / or orientation tracking sensors and systems, such as sensors and systems available from Polhemus of Israel or Ascension Systems of Vermont), time-of-flight sensing (such as Hokuyo Automatic USA of Indian Trail, North Carolina, USA ... In one embodiment, a camera or “computer vision” based tracking or pose determination technique (which may use an operatively coupled camera, such as a camera that may be characterized as part of an optical tracking system) (embodiments may include configurations referred to as simultaneous localization and mapping, or “SLAM” configurations and techniques) may be initiated (176).

[0023] Referring again to FIG. 11 and the configuration described above, with the interventional transducer head (44) aligned to the global coordinate system, imaging of the target anatomical structure may commence, such as by utilizing ultrasound imaging transducer capabilities that may be integrated into the interventional ultrasound head (44) (as shown in FIGS. 6A and 6B), to capture appropriate information for alignment to the preoperative volume of aligned image data (178). Such a combination of intraoperative imaging and aligned data set and interventional head (44) provides an improved level of interventional control, as the system may be configured to assist the operator in precisely directing the BH HIFU focus to the target tissue structure of interest based on the updated relative position and orientation determined by the aligned system and updated information from all relevant sensing configurations. Thus, the interventional team may perform boil histotripsy intervention (180) using the interventional transducer head aligned to the relevant patient anatomical structure via continuous real-time or near real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of electromechanical manipulators.

[0024] 12A-12B, another embodiment may incorporate separate real-time or near real-time imaging to assist with image-guided intervention. An ultrasound imaging system (60), similar to the system described with reference to FIGS. 5 and 6A, may be integrated to provide additional information regarding the target tissue structure and intervention site, and may be positioned / oriented and repositioned / oriented as needed by manual operation or via electromechanical techniques (such as via an electromechanical manipulator, such as an additional robotic arm, not shown). With reference to FIG. 12B, a tracking fiducial (164) may be coupled to the ultrasound imaging head (60) to assist in registering images generated from this subsystem with other registered images related to the intervention.

[0025] Thus, with reference to FIG. 13, a configuration similar to that of FIG. 11 is illustrated, except that after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178), the interventional team may perform the boil histotripsy intervention (182) using the interventional transducer head registered to the anatomical structures via continuous real-time imaging that remains registered to the known pre-operative and intra-operative image data, such as through the use of an electromechanical manipulator, while also utilizing an alternative real-time or near real-time imaging configuration (such as an additional ultrasound imaging configuration that may be separate from the interventional transducer head) for confirmation.

[0026] 14A and 14B, additional real-time or near real-time image information may additionally or alternatively be provided using radiography and / or fluoroscopy techniques, which may use, for example, a system known as a "C-arm," which features a radiography source (190) coupled to a sensor (192) using a "C-arm" structure (188), which may be movably and controllably coupled to a C-arm base structure (186), which may be configured to be wheeled and locked in a fixed position (104). To aid in the alignment of images generated from the radiography of a scenario, aspects of the C-arm assembly may be tracked relative to other structures and coordinate systems, such as via one or more optical tracking fiducials (168, 166), which may be coupled to the associated structures. Other inputs related to the C-arm assembly may also be utilized in tracking associated structures and aligning images, such as knowledge of the kinematics and geometry of the C-arm structure, as well as an understanding of the joint positions with respect to the position or orientation of various components (such as the roll axis of the C-arm relative to the base 186).

[0027] Thus, in a manner somewhat similar to the configuration of FIG. 13 , after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178), the interventional team can perform the boil histotripsy intervention using the interventional transducer head registered to the anatomical structures via continuous real-time imaging that remains registered to known pre-operative and intra-operative image data, such as through the use of electromechanical manipulators, while also utilizing alternative real-time or near real-time imaging configurations for confirmation (such as additional imaging configurations that may include x-ray and / or fluoroscopy and that may be separate from the interventional transducer head) (184).

[0028] 16A and 16B, an electromechanical subsystem may be utilized to controllably oscillate or cycle the orientation of the ultrasound imaging transducer in a controllable manner such that an associated housing may be fixedly coupled or held in place while the imaging ultrasound transducer (196) is cycled through a "volume" of tissue in the form of various distinct "slices" of ultrasound data that may be assembled, inspected, and registered to other data and structures. Referring to FIG. 16A, a main housing (200) may be rotatably coupled to a housing (198) for the ultrasound imaging transducer (196). The drive motor (202) may be fixedly mounted to the main housing (200) and configured to rotate a shaft (210) coupled to a lead or ball screw (206) configured to precisely interface with a sprocket (208), which in turn may be operatively coupled (such as via a drive belt 212) to a pulley (209) coupled to controllably reorient the transducer housing (198), thereby controllably reorienting the ultrasound imaging transducer (196), in a periodic manner (214) that may be defined and selected, for example, by an operator, to provide near real-time image data for a selected group of ultrasound image "slices," or a "volume" image assembled from such slices (the imaging ultrasound transducer 196 and drive motor 222 may be operatively coupled to a controller or computer (216) and an interconnected power source (218), for example, via wire leads 220, 222, etc.). Such a configuration may be considered, for example, a "scanning ultrasound imaging" or "scanning volumetric ultrasound imaging" configuration.

[0029] 17A and 17B, a scanning ultrasound imaging configuration 192 is shown integrated into an operational configuration. The embodiment of FIG. 17B illustrates that the scanning ultrasound imaging configuration 192 may be coupled to a tracking fiducial 224, such as an optical tracking fiducial, so that image data obtained therefrom may be aligned with other data and structures associated with the interventional setup.

[0030] Thus, with reference to FIG. 18, after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178) in a manner somewhat similar to the configuration of FIG. 13, the interventional team may perform the boil histotripsy intervention (226) using the interventional transducer head registered to the anatomical structures via continuous real-time imaging that remains registered to the known pre-operative and intra-operative image data, such as through the use of electromechanical manipulators, while also utilizing an alternative real-time or near real-time imaging configuration (such as a scanning volumetric ultrasound imaging configuration that may be separate from the interventional transducer head) for confirmation.

[0031] 19 , additional image capture devices such as cameras (228, 230, 232), which may be configured to operate in the visible and / or infrared spectrum for image capture, for example, may be coupled to various aspects of the intervention configuration to provide the system and operator with additional information such as unobstructed views, close-up views for automated computer vision based analysis of repositioning and / or reorienting certain structures relative to one another, for error analysis, optical calibration, thermal mapping and detection, etc. For example, these image capture devices (228, 230, 232) may be utilized to aid in pose (i.e., image-based determination of position and / or orientation) determination / confirmation relative to associated coordinate frames and structures, as well as in conjunction with SLAM-based techniques for mapping, tracking, and pose determination / confirmation.

[0032] Thus, with reference to FIG. 20, after the interventional transducer head (44) and other relevant structures and image data have been aligned and read for the intervention (178) in a manner somewhat similar to the configuration of FIG. 13, the interventional team may perform the boil histotripsy intervention (234) using the interventional transducer head aligned to the anatomical structures via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of electromechanical manipulators, while also utilizing an alternative real-time or near real-time imaging configuration (such as image data from one or more image capture devices that may be operatively coupled to various aspects of the interventional system) for confirmation.

[0033] With reference to FIG. 21 , electromagnetic flux-based position and / or orientation sensors and associated systems (such as the sensors and systems available from Polhemus or Ascension, as described above) may be utilized to track the positions of various structures and elements relative to one another (i.e., without the use of optical tracking techniques and optical tracking-based fiducials), such as the relative positions and / or orientations of the interventional transducer head (44), surgical bed (102), intervention cart (238), and operating room (236) relative to one another.

[0034] Thus, with reference to FIG. 22, in a manner somewhat similar to the configuration of FIG. 13, after the interventional transducer head (44) and other relevant structures and image data have been aligned and read for the intervention (178), the interventional team may perform the boil histotripsy intervention using the interventional transducer head aligned to the anatomical structures via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of electromechanical manipulators, while also utilizing an alternative real-time or near real-time imaging configuration (such as image data from one or more image capture devices that may be operatively coupled to various aspects of the interventional system) for confirmation.

[0035] 23, time-of-flight or point cloud sensors such as LIDAR sensors may be integrated into the target system as shown in the embodiment of FIG 23, where electromagnetic flux-based tracking may involve data from one or more LIDAR sensors (246, 248) that may be positioned, oriented, and configured to assist in tracking, control, and identification of various structures relative to one another. For example, a LIDAR sensor (246) may be fixedly coupled to the operating room (128) to provide updated point cloud data related to general movement of structures and anatomical structures relevant to the intervention, which may be aligned and fed to the control system, and another LIDAR sensor (248) may be configured to provide aligned and updated point cloud data related to closer-in movement of the interventional transducer head (44), the patient (18), and the electromechanical manipulator components (146) relative to one another.

[0036] Thus, with reference to FIG. 24, in a manner somewhat similar to the configuration of FIG. 13, after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178), the interventional team may perform the boil histotripsy intervention (250) using the interventional transducer head registered to the anatomical structures via continuous real-time imaging, such as through the use of electromechanical manipulators and electromagnetic tracking such as LIDAR and / or time-of-flight sensing, which remains registered to the known pre-operative and intra-operative image data.

[0037] With reference to Figures 25 and 27A-27B, in certain embodiments it may be useful to have precision electromechanical manipulation of two or more interventional assemblies or instruments. Figure 25 illustrates an embodiment with a separate electromechanical manipulator assembly (252, similar to the first manipulator assembly 146, the second manipulator assembly 252 as in Figures 27A-27B, or the third manipulator assembly 262, which may be an articulated robotic arm, such as the articulated robotic arms available from Barrett or Kuka as described above) coupled to an interventional instrument (256), such as an aspiration needle, cannula, or catheter. As described above, in certain embodiments it may be desirable to controllably remove material, such as by aspiration, after boiling histotripsy, preferably under image guidance. Using known geometric and kinematic relationships, joint positions relative to the manipulator assemblies (252 and / or 262 in the embodiment of Figs. 27A-27B), and data from tracking sensors that may be interconnected (the embodiment of Figs. 25 and 27A illustrates an electromagnetic tracking device 254 coupled to the distal end of the second manipulator 252 and an electromagnetic tracking device 268 coupled to the distal end of the third manipulator 262 in Figs. 27A and 27B). The close-up of Fig. 27B also shows IMU devices (278, 280, 282, 284) that may be coupled to various structures to assist in determining changes in position and / or orientation, control system input and validation, collision sensing, etc.

[0038] Thus, referring to FIG. 26, in a manner somewhat similar to the configuration of FIG. 13, after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178), the interventional team may perform a boil histotripsy intervention (258) using two electromechanical manipulators and the interventional transducer head registered to the anatomical structures via continuous real-time imaging that remains registered to the known pre-operative and intra-operative image data, such as through the use of electromagnetic tracking and / or time-of-flight sensing, such as LIDAR. A third manipulator assembly (262) in FIG. 27B may be utilized to deliver and deliver further interventional instruments, such as a cannula, aspiration needle, injection needle (e.g., to help achieve high-precision injection of medications, such as for pain or infection management, under image guidance using coordinate system / image data registration), or an imaging probe. FIG. 27B also shows additional image capture devices (274, 276) and a LIDAR sensor (266) positioned to capture point clouds, images, and generally information related to the intervention. The additional intervention cart (260) may also be equipped with a specialized braking / stabilizing wheel assembly (104) and may be tracked, for example, by using an electromagnetic flux-based position and / or attitude sensor (272) that may be coupled thereto.

[0039] Referring to FIG. 28, in a manner somewhat similar to the configuration of FIG. 13, after the interventional transducer head (44) and other relevant structures and image data have been registered and read for the intervention (178), the interventional team may perform the boil histotripsy intervention using the interventional transducer head registered to the anatomical structures via continuous real-time imaging, such as through the use of three electromechanical manipulators and electromagnetic tracking such as LIDAR and / or time-of-flight sensing, which remains registered to the known pre-operative and intra-operative image data (286).

[0040] Although the foregoing embodiments have been discussed for illustrative purposes generally in the context of spinal intervention for herniated discs, the above-described systems are broadly applicable. Figures 29A-57 illustrate additional treatment paradigms and embodiments in which such systems, methods, and configurations may be employed.

[0041] With reference to Figure 29A, removal of a spinal cyst (288) within the spine (20) of a patient (18) using traditional surgical approaches can be highly invasive. As shown in Figure 29B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such cysts, followed by potential image-guided aspiration and / or injection.

[0042] 30, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of the cyst in the patient may be performed (290), after which aspects of the image information may be registered relative to each other based on the anatomical geometry and image details to generate registered image data related to the tissue structure of interest in the patient (292). Intervention preparation may be performed to fix the operating table and the intervention platform relative to the global coordinate system and relative to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (294). Tracking (intervention platform and operating table relative to the global coordinate system of the room, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (296). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the cyst (298). The interventional team may perform a boil histotripsy intervention of at least a portion of the cyst (300) using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators.

[0043] With reference to Figure 31A, hypertrophy or other abnormalities in the geometry of the ligamentum flavum (302) or facet joints (304) within the spine (20) of a patient (18) can pose significant problems and can be very invasive using traditional surgical approaches. As shown in Figure 31B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the target facet joint (304) articular and / or connective tissue structures, followed by potential image-guided aspiration and / or injection. As shown in FIG. 31C, the interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the targeted portion of the ligamentum flavum (302) connective tissue structure, after which potential image-guided aspiration and / or injection can occur.

[0044] 32, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of one or more facet joints in a patient may be performed (306), after which aspects of the image information may be registered relative to each other based on the anatomical geometry and image details to generate registered image data related to tissue structures of interest in the patient (308). Intervention preparation may be performed to fix the operating table and the intervention platform relative to the global coordinate system and relative to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (310). Tracking (intervention platform and operating table relative to the global coordinate system of the surgery, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (312). With the interventional transducer head aligned with respect to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of one or more facet joints (314). The interventional team may perform a boil histotripsy intervention of at least a portion of the one or more facet joints using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (316).

[0045] Image-guided ultrasound emission from a target structure may also be utilized to perform one or more nerve block or denervation procedures, such as a medial branch block, in the vicinity of a facet joint of the spine.

[0046] 33, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the ligamentum flavum in the patient may be performed (318), after which aspects of the image information may be registered relative to each other based on the anatomical geometry and image details to generate registered image data related to the tissue structures of interest in the patient (320). Intervention preparation may be performed to fix the operating table and the intervention platform relative to the global coordinate system and relative to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (322). Tracking (intervention platform and operating table relative to the global coordinate system of the room, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (324). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the ligamentum flavum (326). The interventional team may perform a boil histotripsy intervention of at least a portion of the ligamentum flavum using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (328).

[0047] With reference to Figure 34A, epidural tumors (330) within the spinal column (20) of a patient (18) can pose significant problems and can be very invasive using traditional surgical approaches. As shown in Figure 34B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the epidural tumor (330), followed by potential image-guided aspiration and / or injection.

[0048] 35, pre-intervention analysis and planning (MRI, X-ray, ultrasound, functional analysis, etc.) of aspects of the epidural tumor in the patient may be performed (332), after which aspects of the image information may be registered with each other based on anatomical geometry and image details to generate registered image data related to tissue structures of interest in the patient (334). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (336). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (338). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the epidural tumor (340). The interventional team may perform a boil histotripsy intervention of at least a portion of the epidural tumor using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (342).

[0049] With reference to Figure 36A, metastatic spinal tumors (344) within the spine (20) of a patient (18) can pose significant problems and can be very invasive using traditional surgical approaches. As shown in Figure 36B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the metastatic spinal tumor (344), followed by potential image-guided aspiration and / or injection.

[0050] 37, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of metastatic spinal tumors in a patient may be performed (352), after which aspects of image information may be registered with each other based on anatomical geometry and image details to generate registered image data related to tissue structures of interest in the patient (354). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (356). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (358). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the metastatic spinal tumor (360). The interventional team may perform a boil histotripsy intervention of at least a portion of the metastatic spinal tumor using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (362).

[0051] With reference to Figure 38A, spine-associated sarcomas (346) in the spine (20) of a patient (18) can pose significant problems and can be very invasive using traditional surgical approaches. As shown in Figure 38B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the spine-associated sarcomas (346), followed by potential image-guided aspiration and / or injection.

[0052] Referring to FIG. 39, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the sarcoma in the patient may be performed (366), followed by registration of aspects of the image information relative to one another based on the anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (368). Intervention preparation may be performed to fix the operating table and the intervention platform relative to the global coordinate system and relative to one another, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (370). Tracking (intervention platform and operating table relative to the global coordinate system of the room, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (372). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the target sarcoma (374). The interventional team may perform a boil histotripsy intervention of at least a portion of the target sarcoma using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (376).

[0053] With reference to Figure 40A, one or more spine-associated myelomas (348) in the spine (20) of a patient (18) may pose significant problems and may be highly invasive using traditional surgical approaches. As shown in Figure 40B, an interventional BH HIFU transducer head (44) may be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the one or more spine-associated myelomas (348), followed by potential image-guided aspiration and / or injection.

[0054] Referring to FIG. 39, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of at least one aspect of myeloma in a patient may be performed (380), after which aspects of image information are registered with respect to each other based on anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (382). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to a global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (384). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (386). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the targeted myeloma (388). The interventional team may perform a boil histotripsy intervention of at least a portion of the targeted myeloma using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (390).

[0055] Referring to FIG. 41, a registered interventional configuration is illustrated in which pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) can be performed for myeloma of the spine in a patient (380). Registration of aspects of image information relative to each other can be performed based on the anatomical shape and details of the images, and a volume of registered image data related to tissue structures of interest in the patient can be generated (382). Intervention preparation can be performed to fix the operating table and the intervention platform relative to the global coordinate system and relative to each other. Positioning of the patient on the operating table can be performed in a posture and access selected to facilitate imaging and intervention (384). Tracking (intervention platform and operating table relative to the global coordinate system of the room, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) can be initiated, as well as any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) can be initiated (386). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the target myeloma (388). A boil histotripsy intervention may be performed on at least a portion of the target myeloma using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (390).

[0056] 42A, various structures of a knee (402) of a patient (18) are shown, including the femur (396), patella (392), anterior cruciate ligament (404), femoral articular cartilage (398), meniscus (400), and tibia (394). Damage to various structures of the knee, such as the anterior cruciate ligament ("ACL") or meniscus, or other ligaments, tendons, or structures, can cause significant problems and may be very invasive using traditional surgical approaches. As shown in Figures 42B and 42C, the interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of structures, such as worn or damaged portions (406, 408, respectively) of the ACL (404) or meniscus (400), followed by potential image-guided aspiration and / or injection.

[0057] With reference to FIG. 43, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of at least one damaged ligament or tendon in the patient may be performed (412), followed by registration of aspects of image information relative to each other based on anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (414). Intervention preparation may be performed to fix the operating table and the intervention platform relative to a global coordinate system and relative to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (416). Tracking (intervention platform and operating table relative to the global coordinate system of the room, intervention transducer head relative to the global coordinate system and / or to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (418). With the interventional transducer head aligned with respect to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the pre-operative volume of aligned image data associated with the site of the target ligament or tendon (420). The interventional team may perform a boil histotripsy intervention of at least a portion of the target ligament or tendon using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (422).

[0058] Referring to FIG. 44, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the patient's meniscus or a portion thereof may be performed (426), after which aspects of the image information are registered with respect to each other based on the anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (428). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (430). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (432). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to a pre-operative volume of aligned image data associated with the site of the target meniscus or portion thereof (434).The interventional team may perform a boil histotripsy intervention of at least a portion of the target meniscus or portion thereof using the interventional transducer head as aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electro-mechanical manipulators (436).

[0059] Referring to FIG. 45A, various structures of the hip joint of a patient (18) are shown, including the femur (396), femoral head (442), pelvis (440), acetabulum (448), hip labrum (444), and damaged portion of the hip labrum (446). Damage to various structures of the hip joint, such as the hip labrum (444), can cause significant problems and utilizing traditional surgical approaches can be very invasive. As shown in FIG. 45B, FIG. 45C, and FIG. 45D, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize such aspects of the structure, such as the worn or damaged portion (446) of the target hip labrum (444) or portion thereof, followed by potential image-guided aspiration and / or injection, leaving a reduced injury (450) at the target site.

[0060] Referring to FIG. 46, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of at least one aspect of the damaged hip labrum in the patient may be performed (452), and then aspects of the image information may be registered with respect to each other based on the anatomical geometry and image details. Registered image data related to the tissue structures of interest in the patient may be generated (454). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (456). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (458). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the pre-operative volume of aligned image data associated with the site of the target hip labrum (460). The interventional team may perform a boil histotripsy intervention of at least a portion of the target hip labrum using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electro-mechanical manipulators (462).

[0061] Referring to Fig. 47A, various aspects of a lymph node (466) containing at least two lesions of cancerous lymphoma cells (468, 469) are shown. Traditional surgical approaches to address such cancerous lesions can be highly invasive. As shown in Fig. 47B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize the lymphoma cell lesions, followed by potential image-guided aspiration and / or injection.

[0062] Referring to FIG. 48, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of at least one aspect of a lymphoma cell lesion in a patient may be performed (472), after which aspects of the image information are registered with respect to each other based on the anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (474). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to a global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (476). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (478). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure can begin to capture appropriate information for alignment to the preoperative volume of aligned image data associated with the site of the target lymphoma (480). The interventional team can perform a boil histotripsy intervention of at least a portion of the target lymphoma using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known preoperative and intraoperative image data, such as through the use of one or more electromechanical manipulators (482).

[0063] Referring to Figure 49A, a male human bladder (484), prostate (486), and urethra (488) are shown. Traditional surgical approaches to remove part or all of the prostate, such as by direct open surgery or transurethral radical prostatectomy (or "TURP"), are highly invasive and can have varying levels of effectiveness and complications. As shown in Figures 49B-49D, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize (490, 491) part or all of the prostate (486), followed by potential image-guided aspiration and / or injection.

[0064] With reference to FIG. 50, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the prostate in a patient may be performed (502), and then aspects of image information may be registered with each other based on anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (504). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to a global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (506). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (508). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to a pre-operative volume of aligned image data associated with the target prostate or portion thereof (510). The interventional team may perform a boil histotripsy intervention of at least a portion of the target prostate or portion thereof using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (512).

[0065] Referring to FIG. 51A, a female human uterus (514) and fallopian tubes (516, 517) are shown with a group of fibroids (518, 520, 522, 524) located at various positions and tissue depths relative to the involved uterus (514). Traditional surgical approaches to remove some or all of the fibroids, such as by direct open surgery, can be highly invasive and have varying levels of effectiveness and complications. As shown in FIG. 51B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize some or all of the targeted fibroids (518, 520, 522, 524) or portions thereof, followed by potential image-guided aspiration and / or injection.

[0066] With reference to FIG. 52, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the fibroid tumor in the patient may be performed (534), after which aspects of the image information are registered with respect to each other based on the anatomical geometry and image details. Registered image data related to the tissue structures of interest in the patient may be generated (536). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (538). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (540). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to a pre-operative volume of aligned image data associated with the site of the target fibroid or portion thereof (542).The interventional team may perform a boil histotripsy intervention of at least a portion of the target fibroid or portion thereof using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (544).

[0067] Referring to FIG. 51C, a female human uterus (514) and fallopian tubes (516, 517) are shown with a group of endometrial lesions (526, 528, 530, 532) located in various positions and connections relative to the involved uterus (514) and fallopian tubes (517). Traditional surgical approaches to remove some or all of the endometrial lesions (such as by direct open surgery) can be highly invasive and can have varying levels of effectiveness and complications. As shown in FIG. 51C, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize some or all of the targeted endometrial lesions (526, 528, 530, 532) or portions thereof, followed by potential image-guided aspiration and / or injection.

[0068] Referring to FIG. 53, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of endometrial lesions in a patient may be performed (552), after which aspects of image information are registered with respect to each other based on anatomical geometry and image details. Registered image data related to tissue structures of interest in the patient may be generated (554). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to a global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (556). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (558). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to a pre-operative volume of aligned image data associated with the site of the target endometrial lesion or portion thereof (560). The interventional team may perform a boil histotripsy intervention of at least a portion of the target endometrial lesion or portion thereof using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (562).

[0069] Referring to Fig. 54A, in the depicted scenario, a blood vessel (566), such as a human artery, is shown with a vessel wall (572) defining a blood flow path (568) that is partially blocked by a formed plaque structure (570). Conventional surgical approaches to remove part or all of such plaque structures, for example via direct open vessel surgery, can be highly invasive and can have varying levels of effectiveness and complications. As shown in Fig. 54B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize part or all of the targeted plaque structure or a portion thereof, followed by potential image-guided aspiration and / or injection. Referring to FIG. 54B, an intravascular device (574) such as a catheter, which may feature a foldable screen portion (576) and be configured with a defined lumen for providing vacuum / suction and / or suction (such as vacuum / suction that can be used to capture clots during neurovascular and other interventions), may be used to assist in capturing plaque material that can be removed by the BH HIFU intervention.

[0070] With reference to FIG. 55, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the plaque structure in the patient may be performed (578), after which aspects of the image information are registered with respect to each other based on the anatomical geometry and image details. Registered image data related to the tissue structure of interest in the patient may be generated (580). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (582). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) as well as any tracking redundancy (inverse kinematics, deflection sensors, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (584). With the interventional transducer head aligned with respect to the global coordinate system, imaging of the target anatomical structure may begin to capture appropriate information for alignment to the pre-operative volume of aligned image data associated with the site of the target plaque or portion thereof (586). The interventional team may perform a boil histotripsy intervention of at least a portion of the target plaque or portion thereof using the interventional transducer head aligned to the anatomical structure via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (588).

[0071] Referring to Fig. 56A, a blood vessel (567), such as a human peripheral vein, is shown with a vessel wall (573) that defines a blood flow path (568), which in the depicted scenario is partially blocked by a formed clot or embolic structure or mass (590). Conventional surgical approaches to remove a portion or all of such a clot or embolic structure or mass, for example via direct vessel cut-down surgery, can be highly invasive and can have varying levels of effectiveness and complications. As shown in Fig. 56B, an interventional BH HIFU transducer head (44) can be positioned and / or oriented with image-guided precision, such as via an image-guided electromechanical manipulator (146), to emulsify and / or atomize a portion or all of the targeted clot or embolic structure or portion thereof, followed by potential image-guided aspiration and / or injection. Referring to FIG. 56B, an intravascular device (574) such as a catheter, which may feature a foldable screen portion (576) and be configured with a defined lumen for providing vacuum / suction and / or suction (such as vacuum / suction that can be used to capture clots during neurovascular and other interventions), may be used to assist in capturing plaque material that can be removed by the BH HIFU intervention.

[0072] 57, a pre-intervention analysis and planning (MRI, X-ray, ultrasound imaging, functional analysis, etc.) of aspects of the clot or embolism in the patient may be performed (602), after which aspects of the image information are registered with respect to each other based on the anatomical geometry and image details. Registered image data related to the tissue structures of interest in the patient may be generated (604). Intervention preparation may be performed to fix the operating table and the intervention platform with respect to the global coordinate system and with respect to each other, and to position the patient on the operating table with a posture and access selected to facilitate imaging and intervention (606). Tracking (intervention platform and operating table with respect to the global coordinate system of the room, intervention transducer head with respect to the global coordinate system and / or with respect to the intervention platform, etc.) and any tracking redundancy (inverse kinematics, deflection sensor, IMU, electromagnetic tracking, time-of-flight sensing, camera-based SLAM, etc.) may be initiated (608). With the interventional transducer head aligned to the global coordinate system, imaging of the target anatomy may begin to capture appropriate information for alignment to a pre-operative volume of aligned image data associated with the site of the targeted clot or embolism or portion thereof (610). The interventional team may perform a boil histotripsy intervention of at least a portion of the targeted clot or embolism or portion thereof using the interventional transducer head aligned to the anatomy via continuous real-time imaging that remains aligned to the known pre-operative and intra-operative image data, such as through the use of one or more electromechanical manipulators (612).

[0073] Referring back to FIG. 10D, in various embodiments, an additional instrument (86), such as a cannula or needle, may be inserted (88) or retracted along a known orientation relative to the transducer (44) to assist in various aspects of a medical procedure, such as controlled and image-guided injection and / or aspiration. Referring to FIG. 58A and FIG. 58B, partial orthogonal views of related embodiments are shown. Referring to FIG. 58A, the transducer (44) may be operatively coupled to an arm or mounting structure, such as a robotic manipulator (146), such that the interface (52) is positioned and oriented to facilitate ultrasound emission at the focal point (54), while a distal portion of the additional instrument (86) is directed toward the same focal point (54). A movable housing (616) for the additional instrument (86) may be configured to be controllably reoriented (618) relative to the interface (52) housing, thereby controllably reorienting (618) the additional instrument (86) relative to the transducer (44), such as via an electromechanical subsystem controllable by an operator. The electromechanical subsystem may also be configured to control the precision insertion / retraction (88) of the additional instrument (86). Referring to FIG. 58B, a variation similar to that of FIG. 58A is illustrated that also features a secondary additional instrument (624), which may be controllably insertable and retractable (such as by electromechanical actuation) relative to the interface (52) housing, and may comprise an elongated instrument such as a needle or cannula that may be utilized to physically address a remote focal point (54) for applied ultrasound radiation, as shown in FIG. 58B. The elongated instrument (624) may also be utilized to aid in precision delivery of the therapeutic and / or imaging radiation toward the focal point (54) and may include a waveguide or refractive device configured to aid in the delivery and / or focusing of the delivered radiation, such as ultrasound radiation. The instrumentation utilized with the present system may be coated with or comprise a material selected to be luminescent or reflective to the associated applied ultrasound radiation, and may be configured to emit radiation, such as light or other radiation of various wavelengths, to aid in identification and visualization during image-guided procedures.

[0074] In various embodiments, low intensity pulsed ultrasound (sometimes referred to as "LIPUS") may be transmitted from a transducer and utilized to aid in the precisely directed stimulation and / or healing of collagen or other soft tissues, or calcified tissues, such as at a fracture site. Such LIPUS configurations may also be utilized for cosmetic purposes, such as image-guided non-invasive reshaping of one or more tissue structures, such as correcting or adjusting the shape of disfiguring tissue structures. Image-guided ultrasound emission from a target configuration may also be utilized to monitor the curing of an implantable compound (such as an implantable compound including a thermosetting resin, which may undergo a molecular "crosslinking" process in "curing" that irreversibly changes from being at least a portion of a viscous liquid to a more rigid and highly crosslinked polymeric solid) that may be injected into a newly formed cavity. Such deformation may be configured to detect sound velocity and attenuation. Sound velocity and attenuation are highly sensitive to changes in the viscoelastic properties of the cured resin, since velocity is related to the resin storage modulus and density, while attenuation is related to energy dissipation and scattering in the cured resin. Imaging-guided ultrasound emission from the target structure may also be utilized to generate additional localized micromotion to enhance or promote stiffening or tissue healing.

[0075] 59A-61, various configurations related to load control by the transducer head (44) are shown. Referring to FIG. 59A, an embodiment similar to that of FIG. 10A is illustrated with a robotic manipulator (146) assembly coupled to the transducer head (44) that may be positioned adjacent to the patient (18) for diagnostic and / or interventional purposes. The manipulator assembly (146) may be configured to assist in determining the loads applied to the patient (18) by the transducer head (44). For example, in one embodiment, joint encoders and kinematic relationships at the joints (e.g., 154, 156, 158) may be utilized with so-called "inverse kinematics" techniques in conjunction with an interconnected computing system to estimate the loads applied to the patient (18) by the manipulator (146) and the interconnected transducer head (44). The joints (e.g., 154, 156, 158) may also be fitted with load sensors, such as optical based load sensors, or torque sensors, such as those available from ATI Industrial Automation (a Novanta Company). Additionally, the various lengths of the assembly may be fitted with elongated sensors (636, 638, 640, 642, 644, 646), such as strain gauges, which may be based on configurations such as configurations using lead wire elongation detection, or optical fiber elongation detection (as in the case of a fiber Bragg deflection sensing fiber configuration). Multiple configurations selected from configurations including inverse kinematics, joint encoders, strain gauges, joint torque or load sensing, and / or current monitoring may be used to have sensing redundancy and may be used in Kalman filter type configurations where uncorrelated errors of redundant sensing systems may be advantageous. Referring to FIG. 59B, such sensors may be connected to a computing system, which may also be operatively coupled to a motor controller subsystem of the robotic manipulator (146), such as via a wired lead (652, or as shown in FIG. 59C, via a wireless connection, such as between two or more wireless transceivers 656, 658).60, both the robotic manipulator and the load sensing arrangement may be powered on, operably coupled to a computing system, calibrated, and ready (660). The interventional transducer head may be coupled to the robotic manipulator and configured to engage a patient tissue structure, such as a skin surface, during a procedure, while the load sensing arrangement is configured to determine a load applied to such tissue structure by the robotic manipulator (662). The computing system may be configured to operate the robotic manipulator to prevent the determined load from exceeding a predetermined load threshold, for example, by preventing further movement in one or more vectors that may be determined by the computing system to be associated with increased load upon further positive movement by the robotic manipulator (664).For example, in one embodiment the computing system may be configured to maintain an interface load between the HIFU transducer and a portion of the patient's tissue below a predetermined maximum load, in another embodiment the computing system may be configured to maintain an interface load above a predetermined minimum and below a predetermined maximum during the patient's treatment period, in another embodiment the computing system is configured to maintain a relative orientation between the HIFU treatment transducer and an adjacent portion of the patient's body immediately adjacent thereto (such as an electro-mechanical support assembly may be configured to dynamically adjust the position and / or orientation of the HIFU treatment transducer to follow the orientation of a target tissue surface in contact with the patient, in other words an automatic terrain or surface following configuration). configuration), while also maintaining the interface load above a predetermined minimum and below a predetermined maximum during the patient's treatment period; in another embodiment, the computing system may be configured to facilitate repositioning of the HIFU treatment transducer relative to the patient during the patient's treatment period, while also maintaining the relative orientation between the HIFU treatment transducer and its immediately adjacent adjacent portion of the patient's body, and also maintaining the interface load above a predetermined minimum and below a predetermined maximum (in other words, automatic terrain or surface following configuration under interface load control), so that the transducer can be moved manually in response to a predetermined command or manual command, such as an operator interface operatively coupled to the computing system, or automatically moved in a direction orthogonal to the contact vector relative to the coupled tissue while maintaining the orientation and load at the contact vector (e.g., the transducer can be moved manually or automatically in the X-axis or Y-axis direction while the system maintains the contact, load, and orientation in the Z-axis direction).

[0076] 61, both the robotic manipulator and the load sensing arrangement may be powered on, operably coupled to a computing system, calibrated, and ready (660). The interventional transducer head may be coupled to the robotic manipulator and configured to engage a patient tissue structure, such as a skin surface, during a procedure, while the load sensing arrangement is configured to determine a load applied to such tissue structure by the robotic manipulator (662). The computing system may be configured to operate the robotic manipulator to adjust a position and / or orientation of the interventional transducer to maintain an interface load between the interventional transducer and the engaged patient tissue structure within a predetermined load profile (e.g., minimum applied load to maximum applied load) (666).

[0077] 62A-63, the transducer (196) may be manual (such as the interconnected hand 686 of FIG. 62B) or electromechanical (such as an interconnected motor / drive configuration similar to the configuration shown in FIG. 16A and 16B above in FIG. 62A). The mounting bracket (682) may be configured to couple the elongated guide member (676) to the housing (198) of the transducer (196) such that a lumen (678) defined through the elongated guide member (676) may terminate at the distal end (680) of the elongated guide member (676) at a location configured to be within the field of view of the transducer (196). In other words, the transducer, along with a needle or other member inserted through the elongated guide member (676), may be utilized to visualize, such as via ultrasound imaging, a tissue structure or site of interest at or adjacent to the tissue structure or site of interest. Such visualization may be enhanced via electromechanical, such as manual or cyclical, motion of the transducer (196) to capture additional "slices" of image data related to the site of interest. For example, with reference to FIG. 63, the imaging transducer may be powered up and ready to engage a patient for an intervention using precision placement of an elongated member, such as a cannula or needle (690). The imaging transducer may be coupled to an elongated guide member defining a guide lumen configured to receive fluids, gases, and / or elongated instruments related to the planned intervention (692). The elongated guide member may include a distal portion configured to terminate within the field of view of the imaging transducer such that a display operably coupled to the imaging transducer may be utilized to visualize both the elongated guide member distal portion and the target intervention site to confirm and observe the relative positioning and orientation of the elongated guide member distal portion and the target intervention site during the intervention (694).The elongated guidance member and imaging transducer may be configured to facilitate low frequency vibration or repetitive movement (e.g., manual or electromechanical) of the imaging transducer relative to the patient to facilitate monitoring of a volume of the patient's tissue over time, for example, to facilitate precise vectoring of the imaging transducer at the target intervention site prior to insertion of the elongated guidance member or other related elongated instrument toward the target intervention site and into the patient's tissue (696).

[0078] With reference to FIG. 64, for example, just as repeated expert manual identification (i.e., labeling for supervised learning techniques) of specific anatomical landmarks of the spine under ultrasound imaging along with optimization of scan parameters (702) may be utilized in training to help the system become increasingly proficient in automatically identifying tissue structures and their landmarks in a given patient scenario without constant expert supervision, supervised learning techniques may be utilized to train a convolutional neural network (710, “convolutional neural network, CNN”) to assist in recognizing anatomical landmarks from image data, such as ultrasound image data. Such documentation / labeling of ultrasound scan parameters for specific anatomical landmarks of the ultrasound spine and other tissue structures (704) for images may be utilized to train the CNN (710). Additionally, data from actual results may be labeled (712) to assist in further training the CNN (710). To help scale training beyond these fairly manual means of having expert labeled data for supervised learning configurations, one or more synthetic data environments can be created and utilized to generate synthetic images from various viewpoints with various known / labeled landmarks (706), and this synthetic labeled data can be utilized to train a CNN as shown in FIG. 64 (708).

[0079] With reference to Figures 65 and 66, a variety of off-the-shelf robotic manipulator (146) configurations, such as those available from Universal Robotics A / S (716) or Kuka Robotics Corporation (718), can be utilized to couple with the present transducer head configuration (44).

[0080] With reference to Fig. 67A, the transducer head (44) and the interconnected robotic manipulator (146) may be coupled to a portion (such as arm 722) of a surgical robotic system, such as the system sold under the trade name DaVinci® by Intuitive Surgical, Corporation, and configured to be utilized separately or in conjunction with one or more of the other instruments (734, 732) that comprise such a system. As shown in Fig. 67A, the surgical robotic system may include a central base from which a number of articulated robotic arms (such as by electromechanical movable joints, position, orientation, and load sensing and control configurations as described above) may extend, each of which may be coupled to a surgical and / or interventional instrument or end effector, or an interventional HIFU configuration. Such configurations may thus be utilized to perform therapeutic and / or diagnostic procedures as described above with reference to the various system configurations. For example, referring to FIG. 67B, an elongated instrument member or shaft (734) coupled to a distal end effector (732) may be at least partially inserted into a patient, such as through a port access type surgical access point (728), to facilitate intervention of a target tissue structure (730), while coordinated positioning and / or orientation of the manipulator (146) and the interconnected transducer head (44) positioned relative to a surface of the patient (such as the skin 726) may be utilized to visualize the target tissue structure and interventional tool (732, 734) during operation. For example, referring to FIG. 68, a patient may be positioned for a diagnostic and / or interventional procedure (752). A robotic system may be positioned adjacent to the patient with a range of motion to reach the tissue structure of interest (754). Surgical access may be formed (756), such as through a percutaneous surgical port type access, for a first interventional tool that may be coupled to a first arm of the robotic system.A diagnostic and / or interventional transducer head may be coupled to a second arm of the robotic system and positioned and / or oriented to contact a patient's tissue surface, such as a skin surface, to provide coupling for the transducer head to assist in imaging and / or intervention on the target tissue structure (758). The three-dimensional position and orientation of the first interventional instrument and the transducer head may be determined through the robotic system to which they are both coupled (760). The robotic system may be utilized to perform an intervention on the target tissue structure while simultaneously utilizing the first interventional instrument and the transducer head (762).

[0081] 69 and 70, one or more sensors may be configured to assist in aligning the transducer head (44) with respect to a three-dimensional surface profile of a patient adjacent the transducer head (44). Referring to FIG. 69, a manipulator assembly (146) is shown for positioning the transducer head (44) with respect to a surface of a patient, such as the patient's skin (726). A bracket or interconnect member (742) may be configured to fixedly mount the LIDAR sensor (246) such that a point cloud is generated within a capture volume (740) that captures not only points related to three-dimensional positions on a posterior surface (736) of the transducer head (44), but also three-dimensional positions of points along the surface (i.e., surface profile) of the patient (726), particularly points (738) along an area surrounding or immediately adjacent the transducer head (44), which may have a known orientation for a diagnostic or interventional capability of the transducer head (44). Such an arrangement, or other related arrangements described above that may be configured to track the position and / or orientation of the transducer head (44) in space relative to points along the surface of the patient, may be utilized during imaging and / or intervention. For example, with reference to FIG. 70, a patient may be positioned in an operating room and prepared for a diagnostic and / or interventional procedure (766). The diagnostic and / or interventional transducer head may be coupled to a robotic manipulator and monitored (e.g., via robotic system inverse kinematics and / or one or more sensing subsystems configured to assist in determining the position and / or orientation of the transducer head) such that the position and orientation of the transducer head within a coordinate system (such as the global coordinate system of the operating room) may be estimated (768).A sensing device, such as a LIDAR sensor, may be configured to assist in determining a surface profile of the patient's external anatomical structure (i.e., the patient's skin surface, etc.) adjacent a contact area between the transducer head and the patient's external anatomical structure (e.g., in one embodiment, the LIDAR sensor may be coupled to the robotic manipulator and configured to capture a point cloud sufficient to determine a relative pose alignment between the transducer head and the patient's external anatomical structure adjacent a contact area between the transducer head and the external anatomical structure) (770). An associated control system may be operatively coupled to the robotic manipulator and may be configured to provide feedback to an operator regarding the alignment of the transducer head to the external anatomical structure contact area and / or automatically pose the transducer relative to the contact area using a predetermined or desired pose or set of poses (772).

[0082] Various exemplary embodiments of the present invention are described herein. These examples are referred to in a non-limiting sense. The examples are provided to illustrate the more broadly applicable aspects of the present invention. Various modifications may be made to the described invention, and equivalents may be substituted, without departing from the true spirit and scope of the invention. In addition, many modifications may be made to adapt a particular situation, material, composition, process, process acts or steps to the objective, spirit or scope of the present invention. Moreover, those skilled in the art will recognize that each of the individual variations described and exemplified herein have individual components and features that may be readily separated or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. All such modifications are intended to be within the scope of the claims associated with this disclosure.

[0083] Any of the devices described for performing the subject diagnostic or interventional procedures may be provided in packaged combinations for use in performing such interventions. These supply "kits" may further include instructions for use and may be packaged in sterile trays or containers such as those commonly used for such purposes.

[0084] The present invention includes methods that may be implemented using the subject devices. The methods may include the act of providing such a suitable device. Such provision may be implemented by an end user. In other words, the act of "providing" merely requires the end user to obtain, access, approach, locate, set up, activate, power on, or otherwise operate to provide the device required in the method. The methods recited herein may be carried out in any order of the recited events, and the recited order of events, that is logically possible.

[0085] Exemplary aspects of the invention are described above, along with details regarding material selection and manufacturing. As for other details of the invention, these may be appreciated in conjunction with the patents and publications referenced above, and are generally known or may be appreciated by those skilled in the art. The same may be true with respect to additional acts typically or logically taken with respect to method-based aspects of the invention.

[0086] In addition, although the present invention has been described with reference to several embodiments that optionally incorporate various features, the present invention should not be limited to the embodiments described or shown as contemplated for each variation of the present invention. Various modifications may be made to the described invention, and equivalents (whether described herein or not included for some brevity) may be substituted, without departing from the true spirit and scope of the present invention. In addition, when a range of values ​​is provided, it is understood that all intervening values ​​between the upper and lower limits of the range, and any other stated or intervening values ​​within the stated range, are encompassed by the present invention.

[0087] It is also contemplated that any optional feature of the described invention variations may be described and claimed independently or in combination with any one or more of the features described herein. Reference to a single item includes the possibility of a plurality of the same items. More specifically, as used in this specification and the claims associated therewith, the singular forms "a," "an," "said," and "the" include plural referents unless expressly stated otherwise. In other words, the use of articles permits "at least one" of the subject items in the above description as well as in the claims associated with this disclosure. It is further noted that such claims may be drafted to exclude any optional element. As such, this statement is intended to serve as a prerequisite for the use of exclusive language such as "solely," "only," and the like in connection with the recitation of claim elements or the use of "negative" limitations.

[0088] Without using such exclusive terms, the term "comprising" in claims relating to this disclosure shall be construed as allowing for the inclusion of any additional elements, regardless of whether a given number of elements are recited in such claim or whether the addition of features can be considered as changing the nature of the elements recited in such claim. Except as specifically defined herein, all technical and scientific terms used herein should be given the broadest possible and commonly understood meaning while maintaining the validity of the claims.

[0089] The scope of the present invention is not intended to be limited to the examples and / or subject matter described herein, but rather is limited only by the scope of the language of the claims associated with this disclosure.

Claims

1. 1. A minimally invasive system for treating a target tissue structure in a patient, comprising: an electromechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electro-mechanical support assembly; a HIFU therapy transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; the computing system, operating the electro-mechanical support assembly to control a position or orientation of the HIFU therapy transducer array relative to the patient such that a treatment focal point of the HIFU therapy transducer array is aligned to treat at least a portion of the target tissue structure of the patient; manipulating the electro-mechanical support assembly to further adjust at least one of a position or an orientation of the HIFU therapy transducer array to maintain an interface load between the HIFU therapy transducer array and the target tissue structure within a predetermined load range; 10. A minimally invasive system configured to operate the HIFU therapy transducer array to generate a pulsating wavefront comprising a plurality of pressure waves directed at the treatment focal point, whereby the pulsating wavefront generates one or more vapor bubbles within the target tissue structure, and cavitation of the one or more vapor bubbles generates a lysed portion of the target tissue structure.

2. The system of claim 1 , wherein the electro-mechanical support assembly comprises a plurality of elongated sections joined by one or more movable joints.

3. 3. The system of claim 2, wherein one or more movable joints are coupled to one or more encoders operably coupled to the computing system and configured to provide input to the computing system for determining a position of the one or more movable joints.

4. 10. The system of claim 1, wherein said electromechanical support assembly comprises one or more sensors configured to sense one or more loads within said electromechanical support assembly associated with a physical interface between said HIFU therapy transducer array and said patient.

5. The system of claim 4 , wherein the one or more sensors include at least one of a joint load sensor, a joint torque sensor, a strain gauge, and a deflection gauge.

6. 10. The system of claim 1, further comprising one or more motors operably coupled to the electro-mechanical support assembly and configured to apply a load to the electro-mechanical support assembly to maintain or change a position or attitude of the electro-mechanical support assembly.

7. The system of claim 6 , wherein the electromechanical support assembly comprises a robotic arm.

8. The system of claim 1 , wherein the electromechanical support assembly is controlled by a computer in response to inputs provided by an operator.

9. The system of claim 8 , wherein the input provided by the operator is a manual electro-mechanical support assembly movement command.

10. The system of claim 8 , wherein the input provided by the operator is a command for the electro-mechanical support assembly to follow a predetermined set of movements.

11. The system of claim 1 , wherein the electromechanical support assembly is automatically controlled in response to predetermined inputs provided by an operator.

12. 10. The system of claim 1, wherein said HIFU therapy transducer array is operably coupled to said computing system using at least one of a wireless connection configuration and a wired connection configuration.

13. 10. The system of claim 1, further comprising an imaging ultrasound transducer having an ultrasound imaging field of view aligned to capture at least a portion of said treatment focal point of said HIFU treatment transducer array.

14. The system of claim 13 , wherein the HIFU therapy transducer array and the imaging ultrasound transducer are both coupled to the distal portion of the electro-mechanical support assembly.

15. 10. The system of claim 1, further comprising a delivery interface positioned between said HIFU therapy transducer array and said patient and configured to provide a medium for conducting ultrasound energy between said HIFU therapy transducer array and said patient.

16. 16. The system of claim 15, further comprising a layer of acoustic gel interposed between said delivery interface and said patient and configured to further assist in efficient transmission between said HIFU therapy transducer array and said patient.

17. 1. A minimally invasive system for treating a target tissue structure in a patient, comprising: an electromechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electro-mechanical support assembly; a HIFU therapy transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; an elongate instrument having a distal end configured to be positioned within the patient; The computing system includes: operating the electro-mechanical support assembly to control a position or orientation of the HIFU therapy transducer array relative to the patient such that a treatment focal point of the HIFU therapy transducer array is aligned to treat at least a portion of the target tissue structure of the patient; configured to operate the electromechanical support assembly to generate a pulsating wavefront including a plurality of pressure waves projected toward the treatment focal point; 10. A minimally invasive system, wherein the elongated instrument is configured to assist in transmitting or focusing the plurality of pressure waves, such that the pulsating wavefront reaches the target tissue structure, generates one or more vapor bubbles within the target tissue structure, and cavitation of the one or more vapor bubbles generates a lysed portion of the target tissue structure.

18. The system described in claim 17, wherein the elongated instrument includes at least one of a waveguide or a refractive device.

19. 1. A minimally invasive system for treating a target tissue structure in a patient, comprising: an electromechanical support assembly having a proximal portion and a distal portion; a computing system operably coupled to the electro-mechanical support assembly; a HIFU therapy transducer array coupled to the distal portion of the electro-mechanical support assembly and operably coupled to the computing system; an elongate instrument having a distal end configured to be positioned within the patient, the elongate instrument configured to physically manipulate the target tissue structure; The computing system includes: operating the electro-mechanical support assembly to control a position or orientation of the HIFU therapy transducer array relative to the patient such that a treatment focal point of the HIFU therapy transducer array is aligned to treat at least a portion of the target tissue structure of the patient; generating a pulsating wavefront comprising a plurality of pressure waves directed at a treatment focal point, operating the HIFU therapy transducer array such that the pulsating wavefront generates one or more vapor bubbles within the target tissue structure, and cavitation of the one or more vapor bubbles generates a lysed portion of the target tissue structure; operating the HIFU therapy transducer array to further control movement of the elongate instrument and position the distal end of the elongate instrument at or near the target tissue structure; A minimally invasive system configured to operate the elongate instrument to physically manipulate at least a portion of the target tissue structure.

20. 20. The system of claim 19, wherein the elongate instrument comprises one or more of a cannula, a needle, a catheter, or an imaging probe.

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