University of Washington

Mirabilis Medica, Inc.

Other

Shahram Vaezy

Roy W Martin

Lawrence A Crum

Stephen J Carter

Victor Y Fujimoto

Jessica Foley

Peter John Kaczkowski

James W Little

George W Keilman

George Woodrow Keilman

Andrew Hollis Proctor

Donald E Moore

Arthur H Chan

W Scott Helton

Michael Gaps

Vesna Zderic

Michael J Connolly

Alexander Lebedev

Michael William Lau

John I Clark

Siddhartha Sikdar

Michael P H Lau

Ravi A Managuli

Jinfei Yu

Nelson Teng

Misty Noble

Adrian Prokop

Robert Held

Thuc Nghi Nguyen

Ravi Managuli

A water pillow for coupling acoustic energy into tissue. The pillow is configured to conform to a transducer to facilitate coupling of ultrasound energy. The pillow includes a pouch that accommodates the transducer to enable a snug fit between the pillow and the transducer. The pillow includes a liquid inlet and outlet to facilitate liquid circulation for cooling, is biocompatible, has a low attenuation, is conformal to the shape of the transducer, facilitates use of an adjustable pressure to achieve various standoffs, includes an integral pouch to facilitate an interference fit to the transducer, facilitates water circulation for cooling, is sterilizable, and is disposable. Either the surface of the pillow adapted to conform to a tissue interface, or the surface of the pillow adapted to conform to the transducer, or both, can include pores configured to weep liquid to facilitate acoustic coupling of the pillow with the transducer and/or tissue.

Acoustic coupler using an independent water pillow with circulation for cooling a transducer

An ultrasound therapy probe including a thin-profile therapy head for implementing therapeutic procedures in confined spaces. The thin-profile is achieved by incorporating a cooling fluid channel about a periphery of at least a portion of the housing. A therapy transducer is disposed in an inner volume of the housing, and fluid circulated through the peripheral cooling channel can be used to remove heat generated by the therapy transducer, without requiring bulky external cooling devices, such as balloons. The housing can include an acoustic lens portion, to enable the housing to be used with flat transducers and can also be configured to be used with concave transducers, and so that an acoustic lens is not required. Electrical connections can be made with conductors that extend through an elongate hollow handle.

Thin-profile therapeutic ultrasound applicators

A plurality of concepts related to HIFU therapy are disclosed, including a technique to spatially track and display the relative positions of a HIFU focal point and an imaging plane from an ultrasound imager, so that a clinician can ensure that the HIFU focus remains in the image plane during HIFU therapy, thereby facilitating image guided HIFU therapy. Also disclosed are a plurality of transvaginal probes that include a HIFU transducer optimized for the treatment of uterine fibroids. In one embodiment, the probe includes a piezoceramic crystal bonded to an aluminum lens, to achieve a HIFU transducer having a focal length of about 4 cm. In another embodiment, the probe includes a generally spoon-shaped transducer including a plurality of individual emitter elements. Still another concept disclosed herein is a method for evaluating a quality of a coupling between a liquid-filled volume encompassing a HIFU transducer and a tissue interface.

Methods for using high intensity focused ultrasound and associated systems and devices

A probe having a high intensity focused ultrasound (HIFU) transducer is positioned in a female patient. The HIFU transducer is deployed within the vagina of the patient outside of the cervix and uterine cavity and is configured to direct HIFU energy to a treatment site within the uterus of the patient. An imaging component positioned relative to the patient images a portion of the patient's uterus that includes the treatment site to help guide the delivery of the HIFU energy to the treatment site. A liquid medium may be infused into the uterine cavity of the patient where it is maintained during imaging and delivery of the HIFU therapy. The HIFU transducer produces a thermal heating of tissue at a focus within the treatment site to initiate necrosis of the tissue. The location of the focus is controlled in accordance with an image obtained by the imaging component.

Methods and apparatus for the treatment of menometrorrhagia, endometrial pathology, and cervical neoplasia using high intensity focused ultrasound energy

A method for using high intensity focused ultrasound (HIFU) to treat neurological structures to achieve a desired therapeutic effect. Depending on the dosage of HIFU applied, it can have a reversible or irreversible effect on neural structures. For example, a relatively high dose of HIFU can be used to permanently block nerve function, to provide a non-invasive alternative to severing a nerve to treat severe spasticity. Relatively lower doses of HIFU can be used to reversibly block nerve function, to alleviate pain, to achieve an anesthetic effect, or to achieve a cosmetic effect. Where sensory nerves are not necessary for voluntary function, but are involved in pain associated with tumors or bone cancer, HIFU can be used to non-invasively destroy such sensory nerves to alleviate pain without drugs. Preferably, ultrasound imaging synchronized to the HIFU therapy is used to provide real-time ultrasound image guided HIFU therapy of neural structures.

Image guided high intensity focused ultrasound treatment of nerves

Ultrasound guided high intensity focused ultrasound treatment of nerves

An apparatus for delivering HIFU energy may include a probe with a plurality of leaves that provide a bowl-shaped HIFU therapy transducer. In once case, pins may slide within grooves in the leaves to deploy the leaves. In another case, spines may be configured to slide in a channel defined in each leaf. In other cases, a spring or a shape memory alloy may be used to deploy the leaves. In another implementation, a probe may be fitted with a flexible material that couples the HIFU therapy transducer to the probe and allows the transducer to be drawn to the side of the probe for insertion. In another implementation, a probe may have one or more inflatable bladders that form the HIFU therapy transducer. In yet another implementation, a probe may have an imaging component and a HIFU therapy transducer disposed thereon that rotate, as a unit, about a hinge.

Apparatus for delivering high intensity focused ultrasound energy to a treatment site internal to a patient's body

Method and probe for using high intensity focused ultrasound

A noninvasive technique that can be used to deny blood flow to a particular region of tissue, without the inherent risks associated with invasive procedures such as surgery and minimally-invasive procedures such as embolization. Blood flow in selected portions of the vasculature can be occluded by selectively treating specific portions of the vasculature with high intensity focused ultrasound (HIFU). The occlusion denies undesired tissue the nutrients and oxygen provided by blood flow, causing necrosis in the undesired tissue. An imaging technology (such as magnetic resonance imaging, magnetic resonance angiography, ultrasound imaging, Doppler based ultrasound imaging, or computed tomographic angiography) is used to identify the undesired tissue, and the vascular structures associated with the undesired tissue. A portion of the vasculature providing blood flow to the undesired tissue is selected, and HIFU is administered to the selected portion of the vasculature to occlude blood flow through that portion of the vasculature.

Treatment of unwanted tissue by the selective destruction of vasculature providing nutrients to the tissue

Ultrasound contrast agents are used to enhance imaging and facilitate HIFU therapy in four different ways. A contrast agent is used: (1) before therapy to locate specific vascular structures for treatment; (2) to determine the focal point of a HIFU therapy transducer while the HIFU therapy transducer is operated at a relatively low power level, so that non-target tissue is not damaged as the HIFU is transducer is properly focused at the target location; (3) to provide a positive feedback mechanism by causing cavitation that generates heat, reducing the level of HIFU energy administered for therapy compared to that required when a contrast agent is not used; and, (4) to shield non-target tissue from damage, by blocking the HIFU energy. Various combinations of these techniques can also be employed in a single therapeutic implementation.

Use of contrast agents to increase the effectiveness of high intensity focused ultrasound therapy

Disclosed herein is a method for obtaining a composite interference-free ultrasound image when non-imaging ultrasound waves would otherwise interfere with ultrasound imaging. A conventional ultrasound imaging system is used to collect frames of ultrasound image data in the presence of non-imaging ultrasound waves, such as high-intensity focused ultrasound (HIFU). The frames are directed to a processor that analyzes the frames to identify portions of the frame that are interference-free. Interference-free portions of a plurality of different ultrasound image frames are combined to generate a single composite interference-free ultrasound image that is displayed to a user. In this approach, a frequency of the non-imaging ultrasound waves is offset relative to a frequency of the ultrasound imaging waves, such that the interference introduced by the non-imaging ultrasound waves appears in a different portion of the frames.

Interference-free ultrasound imaging during HIFU therapy, using software tools

A frame ensures that the alignment between a high intensity focused ultrasound (HIFU) transducer designed for vaginal use and a commercially available ultrasound image probe is maintained, so that the HIFU focus remains in the image plane during HIFU therapy. A water-filled membrane placed between the HIFU transducer and the treatment site provides acoustic coupling. The coupling is evaluated to determine whether any air bubbles exist at the coupling interface, which might degrade the therapy provided by the HIFU transducer. HIFU lesions on tissue appear as hyperechoic spots on the ultrasound image in real time during application of HIFU therapy. Ergonomic testing in humans has demonstrated clear visualization of the HIFU transducer relative to the uterus and showed the potential for the HIFU transducer to treat fibroids from the cervix to the fundus through the width of the uterus.

Image guided high intensity focused ultrasound device for therapy in obstetrics and gynecology

A method for using high intensity focused ultrasound (HIFU) to treat neurological structures to achieve a desired therapeutic affect. Depending on the dosage of HIFU applied, it can have a reversible or irreversible effect on neural structures. For example, a relatively high dose of HIFU can be used to permanently block nerve function, to provide a non-invasive alternative to severing a nerve to treat severe spasticity. Relatively lower doses of HIFU can be used to reversible a block nerve function, to alleviate pain, to achieve an anesthetic effect, or to achieve a cosmetic effect. Where sensory nerves are not necessary for voluntary function, but are involved in pain associated with tumors or bone cancer, HIFU can be used to non-invasively destroy such sensory nerves to alleviate pain without drugs. Preferably, ultrasound imaging synchronized to the HIFU therapy is used to provide real-time ultrasound image guided HIFU therapy of neural structures.

The present invention employs hydrogels as acoustic couplings for clinical applications of ultrasound imaging and therapy, but is particularly applicable to high intensity focused ultrasound (HIFU) based therapy. While other materials can be used, it has been determined that polyacrylamide is sufficiently robust and transmissive to withstand the high temperatures encountered in HIFU therapy. One embodiment of a hydrogel coupling is configured in shape and size (length) to ensure that a focal region of an ultrasound transducer is disposed proximate the target area when the distal tip of the transducer is in contact with tissue. These couplings can be shaped to correspond to the beam focus characteristics of specific transducers. Water can be applied to hydrate the tip of the hydrogel coupling during use, and medication absorbed into the hydrogel material can be applied to the tissue in contact with the distal surface of the hydrogel.

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Seattle, WA, United States of America

Shahram Vaezy