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.2020 Dec:108:106210.
doi: 10.1016/j.ultras.2020.106210. Epub 2020 Jun 20.

Minimally invasive therapeutic ultrasound: Ultrasound-guided ultrasound ablation in neuro-oncology

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Minimally invasive therapeutic ultrasound: Ultrasound-guided ultrasound ablation in neuro-oncology

Micah Belzberg et al. Ultrasonics.2020 Dec.

Abstract

Introduction: To improve patient outcomes (eg, reducing blood loss and infection), practitioners have gravitated toward noninvasive and minimally invasive surgeries (MIS), which demand specialized toolkits. Focused ultrasound, for example, facilitates thermal ablation from a distance, thereby reducing injury to surrounding tissue. Focused ultrasound can often be performed noninvasively; however, it is more difficult to carry out in neuro-oncological tumors, as ultrasound is dramatically attenuated while propagating through the skull. This shortcoming has prompted exploration of MIS options for intracranial placement of focused ultrasound probes, such as within the BrainPath™ (NICO Corporation, Indianapolis, IN). Herein, we present the design, development, and in vitro testing of an image-guided, focused ultrasound prototype designed for use in MIS procedures. This probe can ablate neuro-oncological lesions despite its small size.

Materials & methods: Preliminary prototypes were iteratively designed, built, and tested. The final prototype consisted of three 8-mm-diameter therapeutic elements guided by an imaging probe. Probe functionality was validated on a series of tissue-mimicking phantoms.

Results: Lesions were created in tissue-mimicking phantoms with average dimensions of 2.5 × 1.2 × 6.5 mm and 3.4 × 3.25 × 9.36 mm after 10- and 30-second sonification, respectively. 30 s sonification with 118 W power at 50% duty cycle generated a peak temperature of 68 °C. Each ablation was visualized in real time by the built-in imaging probe.

Conclusion: We developed and validated an ultrasound-guided focused ultrasound probe for use in MIS procedures. The dimensional constraints of the prototype were designed to reflect those of BrainPath trocars, which are MIS tools used to create atraumatic access to deep-seated brain pathologies.

Keywords: Ablation; Acoustic probes; Engineering design; Focused ultrasound; Minimally invasive surgery; Neurosurgery; Oncology; Therapeutic ultrasound; Transducer design; Ultrasound.

Copyright © 2020 Elsevier B.V. All rights reserved.

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Conflict of interest statement

Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: Kyle Morrison, Francisco Chavez, and Kah Timothy Xiong are employees of Sonic Concepts, Inc. They developed the reported customized transducer under contract from Johns Hopkins University. Dr. Henry Brem is a consultant serving as Medical Advisory Board Chairman for InSightec, a company active in the space of ultrasound for neurosurgical applications. He is also member of the board of directors for Galen Robotics. Dr. Nao J Gamo is the founder and CEO of Neurosonics Medical, Inc. Dr. Stephen Restaino is the Director of Engineering at Maryland Development Center, a startup studio supporting local medical device innovations.

Figures

Fig. 1.
Fig. 1.
The BrainPath™ is a minimally invasive neurosurgical toolkit that can accommodate neuroendoscopic devices. (A&B) The BrainPath™ trocar is inserted into brain tissue to create atraumatic surgical access to deep-seated lesions. (C&D) The ultrasound-guided focused ultrasound alpha prototype probe described in this study is shown in relation to the BrainPath™ dimensions.A and B contain original images presented with permission from NICO Corporation.
Fig. 2.
Fig. 2.
Probe designs and prototyping details. (A) Two late-stage designs of the custom probe containing a 12 × 12-mm imaging transducer adjacent to a therapeutic component. Design I is a 1-piece, 9 × 32mm, cylindrically curved rectangular aperture with 45 mm RoC. Design II contains 3 circular therapeutic elements measuring 8 mm in diameter, arrayed along a 9 × 32mm, cylindrically curved rectangular aperture with 45 mm RoC. The therapeutic array fits within a casing 12 mm in diameter, which widened to 15 mm to accommodate the built-in imaging array. (B) A commercial imaging probe (Sonic Concepts IP-105, center frequency: 5 MHz) which was integrated into our custom ultrasound-guided probe; (C) functional prototype of the custom probe (Design I) housed in a stainless steel casing; (D) 8-mm-diameter circular therapeutic elements (Design II); (E) complete prototype of Design II, containing both the imaging and therapeutic components.
Fig. 3.
Fig. 3.
Experimental setup. (i) ultrasound-guided focused ultrasound prototype, (ii) tissue-mimicking phantom, (iii) acoustic absorber, (iv) Vantage 64 LE system, (v) pre-amplifier, (vi) matching network, (vii) screen for real-time monitoring of ablation, and (viii) stepper motor to raise solid water tissue-mimicking phantoms with each sonification.
Fig. 4.
Fig. 4.
Validation of the prototype. (A) Device aligned with the 3D-printed holder. (B) The prototype generated lesions in tissue-mimicking phantoms secured within the 3D-printed holder.
Fig. 5.
Fig. 5.
Results of 10- and 30-second ablation of solid water samples. The maximum linear dimension of each lesion created was measured using a slide micrometer under microscope.
Fig. 6.
Fig. 6.
10 s sonification of solid water phantom as visualized by the built-in imaging probe: (A) pre ablation, (B) post ablation, and (C) the difference between. The red circle outlines the lesion.
See this image and copyright information in PMC

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