Curvilinear catheter implantation in HDR prostate brachytherapy: feasibility study.

BACKGROUND: High-dose-rate (HDR) brachytherapy (BT) has been acknowledged as a widely utilized treatment for patients with intermediate- and high-risk prostate cancer, despite its side effects such as edema, incontinence, and impotence. Nevertheless, the treatment is consistently limited by the potential danger of excessive irradiation to organs-at-risk (OARs) like the urethra, bladder, and rectum. PURPOSE: This study aims to introduce curvilinear catheter implantation in the prostate gland for HDR treatment. The objective is to improve the radiation dose distribution by offering access channels conformal to the prostate anatomy. This approach seeks to minimize toxicity to nearby OARs while utilizing a reduced number of needles, potentially leading to improved clinical outcomes. METHODS: Curvilinear catheters were first pre-planned for an anonymized patient using Oncentra treatment planning system (TPS) and hybrid inverse planning optimization (HIPO) algorithm. The trajectories of the catheters were then analyzed using MATLAB to extract their radius of curvature. Tendon-driven active needles were then used to implant curvilinear catheters inside an anthropomorphic phantom. RESULTS: Proposed curvilinear catheter implantation resulted in significant improvement in terms of dosimetric constraints to the OARs and coverage to the prostate. Tendon-driven active needles were shown to be capable of realizing the required pre-planned curvatures inside prostate. It was shown that the active needle can realize a desired radius of curvature and a desired trajectory with an average accuracy of 9.1 ± 8.6  and 1.27 ± 0.50 mm in air and inside a tissue-mimicking phantom, respectively. CONCLUSION: This work demonstrates the feasibility of using tendon-driven active curvilinear catheter implantation in prostate to improve the outcomes of HDR-BT via improved radiation dose distribution to the prostate and reduced toxicity to the OARs.

A mechanics-based model for a tendon-driven active needle navigating inside a multiple-layer tissue.

Percutaneous minimally invasive procedures such brachytherapy and biopsy require a flexible active needle for precise movement inside tissue and accurate placement at target positions for higher success rates for diagnosis and treatment, respectively. In a previous work, we presented a tendon-driven active needle to navigate inside tissue. This work presents a new model to predict the deflection of the tendon-driven needle while steering in a multiple-layer soft tissue. A multi-layer phantom tissue with different localized stiffness was developed for needle insertion tests followed by indentation tests to identify its mechanical properties. Using a robot that inserts and actively bends the tendon-driven needle inside the soft tissue while simultaneously tracking the needle through ultrasound imaging, various experiments were conducted for model validation. The proposed model was verified by comparing the simulation results to the empirical data. The results demonstrated the accuracy of the model in predicting the tendon-driven needle deflection in multiple-layer (different stiffness) soft tissue.

Teleoperated and Automated Control of a Robotic Tool for Targeted Prostate Biopsy.

This work presents a robotic tool with bidirectional manipulation and control capabilities for targeted prostate biopsy interventions. Targeted prostate biopsy is an effective image-guided technique that results in detection of significant cancer with fewer cores and lower number of unnecessary biopsies compared to systematic biopsy. The robotic tool comprises of a compliant flexure section fabricated on a nitinol tube that enables bidirectional bending via actuation of two internal tendons, and a biopsy mechanism for extraction of tissue samples. The kinematic and static models of the compliant flexure section, as well as teleoperated and automated control of the robotic tool are presented and validated with experiments. It was shown that the controller can force the tip of the robotic tool to follow sinusoidal set-point positions with reasonable accuracy in air and inside a phantom tissue. Finally, the capability of the robotic tool to bend, reach targeted positions inside a phantom tissue, and extract a biopsy sample is evaluated.

Kinematics modelling and dynamics analysis of an SMA-actuated active flexible needle for feedback-controlled manipulation in phantom.

Percutaneous needle-based procedures such as prostate brachytherapy demands for accurate placement of the needle tip at target locations. Recently, robotic needle insertion systems have been made available to help physicians in needle guidance and control inside tissue. It is often challenging to obtain an accurate and real-time position of the needle tip in clinical practice using medical imaging techniques. However, this information is vital for closed-loop control of the needles inside tissue. This work presents an SMA-actuated active flexible needle that is controlled inside a phantom without a need for a position sensor or a medical imaging device. The needle tip position feedback is found using shape sensing capabilities of the embedded SMA-wire actuators and a force sensor at the needle base. Three models were characterized and used to estimate needle tip position in real time. The control scheme was then tested on the active flexible needle to track a desired triangular trajectory in a phantom. It was shown that the control scheme presented in this work was able to manipulate the needle in this path with a reasonable accuracy.

HDR Brachytherapy Planning using Active Needles - Preliminary Investigation on Dose Planning.

In this study we present a new approach to plan a high-dose-rate (HDR) prostate brachytherapy (BT) using active needles recently developed by our group. The active needles realize bi-directional bending inside the tissue, and thereby more compliant with the patient's anatomy compared with conventional straight needles. A computational method is presented to first generate a needle arrangement configuration based on the patient's prostate anatomy. The needle arrangement is generated to cover the prostate volume, providing accessible channels for the radiation source during a HDR BT. The needle arrangement configuration avoids healthy organs and prevents needle collision inside the body. Then a treatment plan is proposed to ensure sufficient prescribed dosage to the whole prostate gland. The method is applied to a prostate model reconstructed from an anonymized patient to show the feasibility of this method. Finally, the active needle's capability to generate the required bending is shown. We have shown that our method is able to automatically generate needle arrangement configuration using active needles, and plan for a treatment that meets the dose objectives while using fewer needles (about 20% of conventional straight needles) than the conventional HDR BT performed by straight needles.

Modeling and Operator Control of a Robotic Tool for Bidirectional Manipulation in Targeted Prostate Biopsy.

This work introduces design, manipulation, and operator control of a bidirectional robotic tool for minimally invasive targeted prostate biopsy. The robotic tool is purposed to be used as a compliant flexure section of active biopsy needles. The design of the robotic tool comprises of a flexure section fabricated on a nitinol tube that enables bidirectional bending via actuation of two internal tendons. The statics of the flexure section is presented and validated with experimental data. Finally, the capability of the robotic tool to reach targeted positions inside prostate gland is evaluated.

Integrating robot-assisted ultrasound tracking and 3D needle shape prediction for real-time tracking of the needle tip in needle steering procedures.

BACKGROUND: Needle insertions have been used in several minimally invasive procedures for diagnostic and therapeutic purposes. Real-time position of the needle tip is an important information in needle steering systems. METHODS: This work introduces a robot-assisted ultrasound tracking (R-AUST) system integrated with a needle shape prediction method to provide 3D position of the needle tip. The tracking system is evaluated in phantom and ex vivo beef liver tissues. RESULTS: An average error of 0.60 mm was found for needle insertion tests inside the phantom tissue. The R-AUST integrated with shape prediction in the beef liver tissue was able to track the needle tip with an average and maximum error of 0.37 and 0.67 mm, respectively. The average error reported in this work is within the mean allowable needle placement error (<2.7 mm) in targeted procedures. CONCLUSIONS: Integration of R-AUST tracking method with needle shape prediction results in a reasonably accurate real-time tracking suitable for ultrasound-guided needle insertions.

Steering a Tendon-Driven Needle in High-Dose-Rate Prostate Brachytherapy for Patients with Pubic Arch Interference.

High-dose-rate brachytherapy (HDR BT) is a radiation therapy that places radioactive sources at cancerous tissue using needles. HDR BT offers better dose conformality and sparing of clinical structures, lower operator dependency, and fewer acute irritative symptoms compared to the other form of BT (low-dose-rate (LDR)). However, use of HDR BT is limited for patients with pubic arch interference, where the transperineal path to the prostate is blocked. This study aims to introduce a tendon-driven needle that can bend inside tissue to reach desired positions inside prostate. Initial experiments in a phantom tissue showed the feasibility of the needle to get around the pubic arch for placement at hard-to-reach target positions.

Compact 3D-Printed Active Flexible Needle for Percutaneous Procedures.

Needle-based intervention has been a popular procedure for diagnosis and treatment of many types of cancer. However, poor needle placement and tumor visualization have been among the challenges resulting in poor clinical outcomes. There has been a lot of progress in medical imaging technology, but the structure of surgical needles has remained unchanged. This work presents a wire-driven 3D steerable, 3D-printed active needle for improved guidance inside the tissue toward the target. The needle is manipulated by 3 embedded tendons via a programmed motorized control unit. Feasibility tests in a tissue phantom showed an average 3D needle angular deflection of about 11°. This amount of angular deflection is expected to assist prostate brachytherapy via a curvilinear approach.

Simulation and experimental studies in needle-tissue interactions.

This work aims to introduce a new needle insertion simulation to predict the deflection of a bevel-tip needle inside soft tissue. The development of such a model, which predicts the steering behavior of the needle during needle-tissue interactions, could improve the performance of many percutaneous needle-based procedures such as brachytherapy and thermal ablation, by means of the virtual path planning and training systems of the needle toward the target and thus reducing possible incidents of complications in clinical practices. The Arbitrary-Lagrangian-Eulerian (ALE) formulation in LS-DYNA software was used to model the solid-fluid interactions between the needle and tissue. Since both large deformation and fracture of the continuum need to be considered in this model, applying ALE method for fluid analysis was considered a suitable approach. A 150 mm long needle was used to bend within the tissue due to the interacting forces on its asymmetric bevel tip. Three experimental cases of needle steering in a soft phantom were performed to validate the simulation. An error measurement of less than 10 % was found between the predicted deflection by the simulations and the one observed in experiments, validating our approach with reasonable accuracy. The effect of the needle diameter and its bevel tip angle on the final shape of the needle was investigated using this model. To maneuver around the anatomical obstacles of the human body and reach the target location, thin sharp needles are recommended, as they would create a smaller radius of curvature. The insertion model presented in this work is intended to be used as a base structure for path planning and training purposes for future studies.

Design optimization study of a shape memory alloy active needle for biomedical applications.

Majority of cancer interventions today are performed percutaneously using needle-based procedures, i.e. through the skin and soft tissue. The difficulty in most of these procedures is to attain a precise navigation through tissue reaching target locations. To overcome this challenge, active needles have been proposed recently where actuation forces from shape memory alloys (SMAs) are utilized to assist the maneuverability and accuracy of surgical needles. In the first part of this study, actuation capability of SMA wires was studied. The complex response of SMAs was investigated via a MATLAB implementation of the Brinson model and verified via experimental tests. The isothermal stress-strain curves of SMAs were simulated and defined as a material model in finite element analysis (FEA). The FEA was validated experimentally with developed prototypes. In the second part of this study, the active needle design was optimized using genetic algorithm aiming its maximum flexibility. Design parameters influencing the steerability include the needle's diameter, wire diameter, pre-strain and its offset from the needle. A simplified model was presented to decrease the computation time in iterative analyses. Integration of the SMA characteristics with the automated optimization schemes described in this study led to an improved design of the active needle.

A model to predict deflection of bevel-tipped active needle advancing in soft tissue.

Active needles are recently being developed to improve steerability and placement accuracy for various medical applications. These active needles can bend during insertion by actuators attached to their bodies. The bending of active needles enables them to be steered away from the critical organs on the way to target and accurately reach target locations previously unachievable with conventional rigid needles. These active needles combined with an asymmetric bevel-tip can further improve their steerability. To optimize the design and to develop accurate path planning and control algorithms, there is a need to develop a tissue-needle interaction model. This work presents an energy-based model that predicts needle deflection of active bevel-tipped needles when inserted into the tissue. This current model was based on an existing energy-based model for bevel-tipped needles, to which work of actuation was included in calculating the system energy. The developed model was validated with needle insertion experiments with a phantom material. The model predicts needle deflection reasonably for higher diameter needles (11.6% error), whereas largest error was observed for the smallest needle diameter (24.7% error).

Polyacrylamide phantom for self-actuating needle-tissue interaction studies.

This study presents a polyacrylamide gel as a phantom material for needle insertion studies specifically developed for self-actuating needles to enhance the precise placement of needles in prostate. Bending of these self-actuating needles within tissue is achieved by Nitinol actuators attached to the needle body; however these actuators usually involve heating that can thermally damage the tissue surrounding the needles. Therefore, to develop and access feasibility of these needles, a polyacrylamide gel has been developed that mimics the thermal damage and mechanical properties of prostate tissue. Mechanical properties of the polyacrylamide gel was controlled by varying the concentrations of acrylamide monomer and N,N-methylene-bisacrylamide (BIS) cross-linker, and thermal sensitivity was achieved by adding bovine serum albumin (BSA) protein. Two polyacrylamide gels with different concentrations were developed to mimic the elastic modulus of the tissue. The two phantoms showed different rupture toughness and different deflection of bevel-tip needle. To study the thermal damage, a Nitinol wire was embedded in the phantom and resistively heated. The measured opaque zone (0.40mm) formed around the wire was close to the estimated damage zone (0.43mm) determined using the cumulative equivalent minutes at 43°C.