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Axially rigid steerable needle with compliant active tip control.

ABSTRACT: Steerable instruments allow for precise access to deeply-seated targets while sparing sensitive tissues and avoiding anatomical structures. In this study we present a novel omnidirectional steerable instrument for prostate high-dose-rate (HDR) brachytherapy (BT). The instrument utilizes a needle with internal compliant mechanism, which enables distal tip steering through proximal instrument bending while retaining high axial and flexural rigidity. Finite element analysis evaluated the design and the prototype was validated in experiments involving tissue simulants and ex-vivo bovine tissue. Ultrasound (US) images were used to provide visualization and shape-reconstruction of the instrument during the insertions. In the experiments lateral tip steering up to 20 mm was found. Manually controlled active needle tip steering in inhomogeneous tissue simulants and ex-vivo tissue resulted in mean targeting errors of 1.4 mm and 2 mm in 3D position, respectively. The experiments show that steering response of the instrument is history-independent. The results indicate that the endpoint accuracy of the steerable instrument is similar to that of the conventional rigid HDR BT needle while adding the ability to steer along curved paths. Due to the design of the steerable needle sufficient axial and flexural rigidity is preserved to enable puncturing and path control within various heterogeneous tissues. The developed instrument has the potential to overcome problems currently unavoidable with conventional instruments, such as pubic arch interference in HDR BT, without major changes to the clinical workflow.

SUBMITTER: de Vries M

PROVIDER: S-EPMC8675730 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Ultrasound is an essential tool for guidance of many minimally-invasive surgical and interventional procedures, where accurate placement of the interventional device is critical to avoid adverse events. Needle insertion procedures for anaesthesia, fetal medicine and tumour biopsy are commonly ultrasound-guided, and misplacement of the needle may lead to complications such as nerve damage, organ injury or pregnancy loss. Clear visibility of the needle tip is therefore critical, but visibility is often precluded by tissue heterogeneities or specular reflections from the needle shaft. This paper presents the in vitro and ex vivo accuracy of a new, real-time, ultrasound needle tip tracking system for guidance of fetal interventions. A fibre-optic, Fabry-Pérot interferometer hydrophone is integrated into an intraoperative needle and used to localise the needle tip within a handheld ultrasound field. While previous, related work has been based on research ultrasound systems with bespoke transmission sequences, the new system-developed under the ISO 13485 Medical Devices quality standard-operates as an adjunct to a commercial ultrasound imaging system and therefore provides the image quality expected in the clinic, superimposing a cross-hair onto the ultrasound image at the needle tip position. Tracking accuracy was determined by translating the needle tip to 356 known positions in the ultrasound field of view in a tank of water, and by comparison to manual labelling of the the position of the needle in B-mode US images during an insertion into an ex vivo phantom. In water, the mean distance between tracked and true positions was 0.7 ± 0.4 mm with a mean repeatability of 0.3 ± 0.2 mm. In the tissue phantom, the mean distance between tracked and labelled positions was 1.1 ± 0.7 mm. Tracking performance was found to be independent of needle angle. The study demonstrates the performance and clinical compatibility of ultrasound needle tracking, an essential step towards a first-in-human study.

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Axially rigid steerable needle with compliant active tip control.

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