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Self-Expanding Anchors for Stabilizing Percutaneously Implanted Microdevices in Biological Tissues.

ABSTRACT: Percutaneously implanted miniaturized devices such as fiducial markers, miniaturized sensors, and drug delivery devices have an important and expanding role in diagnosing and treating a variety of diseases. However, there is a need to develop and evaluate anchoring methods to ensure that these microdevices remain secure without dislodgement, as even minimal migration within tissues could result in loss of microdevice functionality or clinical complications. Here we describe two anchoring methods made from biocompatible materials: (1) a self-expanding nitinol mesh anchor and (2) self-expanding hydrogel particles contained within pliable netting. We integrate these anchors into existing drug-screening microdevices and experimentally measure forces required to dislodge them from varying tissues. We report similar dislodgement forces of 738 ± 37, 707 ± 40, 688 ± 29, and 520 ± 28 mN for nitinol-anchored microdevices, and 735 ± 98, 702 ± 46, 457 ± 47, and 459 ± 39 mN for hydrogel-anchored microdevices in liver, kidney, fat, and muscle tissues, respectively-significantly higher compared with 13 ± 2, 15 ± 3, 15 ± 2, and 15 ± 3 mN for non-anchored microdevices (p < 0.001 in all tissues). The anchoring methods increased resistance to dislodgement by a factor of 30-50× in all tissues, did not increase the required needle gauge for insertion, and were compatible with percutaneous implantation and removal. These results indicate that anchoring significantly improves microdevice stability and should reduce migration risk in a variety of biological tissues.

SUBMITTER: Bhagavatula S

PROVIDER: S-EPMC8067345 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:The purpose of this study was to evaluate the stability of complex markers implanted into lung tumors throughout a course of stereotactic body radiotherapy (SBRT). Fifteen patients referred for lung SBRT were prospectively included. Radio-opaque markers were implanted percutaneously, guided by computed tomography (CT). Deep inspiration breath-hold CT scans (BHCT) were acquired at planning and on three treatment days. The treatment days' BHCTs were registered to the planning BHCT. Intraobserver uncertainty in both tumor and marker registration was determined. Deviations in the difference between tumor and marker-based image registrations of the BHCT scans during treatment quantified the marker stability. Marker position deviation relative to tumor position of less than 2 mm in all three dimensions was considered acceptable for treatment delivery precision. Intra observer uncertainties for image registration in the left-right (LR), anterior-posterior (AP), craniocaudal (CC) directions and three-dimensional vector (3D) were 0.9 mm, 0.9 mm, 1.0 mm, and 1.1 mm (SD) for tumor registration and 0.3 mm, 0.5 mm, 0.7 mm, and 0.7 mm (SD) for marker registration. Mean 3D differences for tumor registrations on all days were significantly larger than for 3D marker registrations (p = 0.007). Overall median differences between tumor and marker position were 0.0 mm (range -2.9 to 2.6 mm) in LR, 0.0 mm (-1.8 to 1.5 mm) in AP, and -0.2 mm (-2.6 to 2.8 mm) in CC directions. Four patients had deviations exceeding 2 mm in one or more registrations throughout the SBRT course. This is the first study to evaluate stability of complex markers implanted percutaneously into lung tumors for image guidance in SBRT. We conclude that the observed stability of marker position within the tumor indicates that complex markers can be used as surrogates for tumor position during a short course of SBRT as long as the uncertainties related to their position within the tumor are incorporated into the planning target volume.

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Self-Expanding Anchors for Stabilizing Percutaneously Implanted Microdevices in Biological Tissues.

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