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Singh, Kern, Elliot D.K. Cha, Conor P. Lynch, Kevin C. Jacob, Madhav R. Patel, Michael C. Prabhu, Nisheka N. Vanjani, and Hanna Pawlowski. 2021. “Device Profile of SonoVisionTM Ultrasound System: Efficacy and Safety for Lateral Approach Spinal Surgery.” Journal of Orthopaedic Experience & Innovation Medical Device Innovations (Mar 2020-Jan 2022).
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  • Figure 1. Surgical Approaches of the Lumbar Spine
  • Figure 2. Conventional intraoperative imaging. A) Fluoroscopy; B) Computed Tomography; C) Magnetic Resonance Imaging
  • Figure 3. Sonovision System. A) Sonovision TM B) Beluga1 Probe
  • Figure 4. Real-time overlay of tissue type
  • Figure 5. Intraoperative docking of tubular stabilizer
  • Figure 6. Fluoroscopy confirmation of Beluga1 Probe placement
  • Figure 7. Replacement of SonoVision TM transducer with dilator guide
  • Figure 8. Dilator trajectory paths
  • Figure 9. Porcine nerve dissection
  • Figure 10. A) Detection of nerve by SonoVision ultrasound; B) Confirmation of nerve by dissection
  • Figure 11. Localization of bony surface. A) Detection of bony surface by SonoVision ultrasound; B) Confirmation of bony surface by dissection
  • Figure 12. Evaluation of vasculature and bloodflow by SonoVision Ultrasound in 3 different animal cases

Abstract

Introduction

Minimally invasive spinal surgeries rely heavily on imaging for localization of key anatomical structures. Current established modalities either do not provide adequate visualization of soft-tissue structures or do so in an indirect manner. Real-time integrated soft-tissue imaging will allow surgeons to accurately differentiate nerves, muscle, vasculature, and bone while simultaneously preventing excessive dissection of tissue and risk to patients.

Areas Covered

SonoVision™ is a novel imaging device able to meet the needs of intraoperative anatomical visualization. This review explains the mechanism of the device and summarizes the empirical support for its use. Multiple animal, cadaver, and human studies have been used to compile machine-learning training data and validate the system’s accuracy and usability through actual and simulated surgical scenarios.

Expert Opinion

SonoVision™ represents a significant improvement over current intraoperative imaging technology in terms of accuracy, efficiency, and ease of use. This system provides vital anatomical information that would otherwise be unavailable in an intuitive, real-time format. SonoVision™ may play an important role in improving outcomes in lateral approach spine surgery as well as making minimally invasive techniques more accessible to a wider range of surgeons.

Article Highlights

  • The direct lateral transpsoas approach for lumbar fusion has distinct advantages, but is associated with various complications, many of which are related to inadequate intraoperative imaging.

  • There is a significant unmet need for real-time intraoperative soft-tissue imaging in spine surgery.

  • The SonoVision™ ultrasound system utilizes machine-learning algorithms to provide real-time soft tissue imaging and differentiation for use during spine procedures.

  • Early trials are promising with regard to SonoVision’s™ ability to meet needs for intraoperative soft-tissue imaging in lateral approach spine surgery.

Accepted: August 18, 2021 EDT

Reference Annotations

  • Reference 5.* Mobbs RJ, Phan K, Malham G, Seex K, Rao PJ. Lumbar interbody fusion: techniques, indications and comparison of interbody fusion options including PLIF, TLIf, MI-TLIF, OLIF/ATP, LLIP and ALIF. J Spine Surg. 2015;1(1):2-18. doi:10.3978/j.issn.2414-469X.2015.10.05.

    This article highlights differences between various approaches for lumbar spinal fusions and provides support for the benefits of the lateral approach.

  • Reference 7.** Hijji FY, Narain AS, Bohl DD, Ahn J, Long WW, DiBattista JV, Kudaravalli KT, Singh K. Lateral lumbar interbody fusion: a systematic review of complication rates. Spine J. 2017;17(10):1412-1419. doi:10.1016/j.spinee.2017.04.022.

    This systematic review examined the incidence of various categories of complications associated with lateral lumbar interbody fusion. The authors determined that neurological complications are among the most common complications following LLIF.

  • Reference 9.* Cahill KS, Martinez JL, Wang MY, Vanni S, Levi AD. Motor nerve injuries following the minimally invasive lateral transpsoas approach. J Neurosurg Spine. 2012;17(3):227-231. doi:10.3171/2012.5.SPINE1288.

    This study documents the risk of femoral nerve injury as a result of LLIF procedures particularly at the L4L5 level.

  • Reference 19.** Uribe JS, Vale FL, Dakwar E. Electromyographic monitoring and its anatomical implications in minimally invasive spine surgery. Spine . 2010;35(26 Suppl):S368-S374. doi:10.1097/BRS.0b013e3182027976.

    This article provides background for the use of intraoperative EMG and highlights several key limitations of this modality that may be better addressed by SonoVisionTM.

  • Reference 25.* Chaudhary K, Speights K, McGuire K, White AP. Trans-cranial motor evoked potential detection of femoral nerve injury in trans-psoas lateral lumbar interbody fusion. J Clin Monit Comput. 2015;29(5):549-554. doi:10.1007/s10877-015-9713-8.

    This case series demonstrates some of the potential shortcomings of EMG in terms of identifying iatrogenic neurological deficits and supports the need for more advanced intraoperative imaging to avoid such injuries.