下腹部を対象とした極細針によるCTガイド下高正確度穿刺プランニング

早大学位記番号:新8149早稲田大

SMART IMAGE-GUIDED NEEDLE INSERTION FOR TISSUE BIOPSY

M.S

Dissolving microneedles for cutaneous drug and vaccine delivery

Currently, biopharmaceuticals including vaccines, proteins, and DNA are delivered almost exclusively through the parenteral route using hypodermic needles. However, injection by hypodermic needles generates pain and causes bleeding. Disposal of these needles also produces biohazardous sharp waste. An alternative delivery tool called microneedles may solve these issues. Microneedles are micron-size needles that deliver drugs or biopharmaceuticals into skin by creating tiny channels in the skin. This thesis focuses on dissolving microneedles in which the needle tips dissolve and release the encapsulated drug or vaccine upon insertion. The project aimed to (i) design and optimize dissolving microneedles for efficient drug and vaccine delivery to the skin, (ii) maintain vaccine stability over long-term storage, and (iii) immunize animals using vaccine encapsulated microneedles. The results showed that influenza vaccine encapsulated in microneedles was more thermally stable than unprocessed vaccine solution over prolonged periods of storage time. In addition, mice immunized with microneedles containing influenza vaccine offered full protection against lethal influenza virus infection. As a result, we envision the newly developed dissolving microneedle system can be a safe, patient compliant, easy to-use and self-administered method for rapid drug and vaccine delivery to the skin.Ph.D.Committee Chair: Prausnitz, Mark; Committee Member: Compans, Richard; Committee Member: Milam, Valeria; Committee Member: Murthy, Niren; Committee Member: Weniger, Bruc

Intracortical Neural Probes with Post-Implant Self-Deployed Electrodes for Improved Chronic Stability.

This thesis presents a new class of implantable intracortical neural probe with small recording electrodes that deploy away from a larger main shank after insertion. This concept is hypothesized to enhance the performance of the electrodes in chronic applications. Today, electrodes that can be implanted into the brain for months or years, are an irreplaceable tool for brain machine interfaces and neuroscience studies. However, these chronically implanted neural probes suffer from continuous loss of signal quality, limiting their utility. Histological studies found a sheath of scar tissue with decreased neural density forming around probe shanks as part of an ongoing chronic inflammation. This was hypothesized to contribute to the deterioration of recorded signals. The neural probes developed in this thesis are designed to deploy electrodes outside this sheath such that they interface with healthier neurons. To achieve this, an actuation mechanism based on starch-hydrogel coated microsprings was integrated into the shank of neural probes. Recording electrodes were positioned at the tip of micrometer fine and flexible needles that were attached to the springs. Before insertion, the hydrogel dehydrates, retracting the springs. After insertion, the gel rehydrates, releasing the springs, which then deploy the electrodes. The actuation mechanism functions in a one-time release fashion, triggered by contact with biological fluids at body temperature. The deployment of the electrodes occurred over the course of two hours and can be divided into three stages: For the first 20 s, the electrodes did not deploy. Within the first three minutes they deployed by roughly 100 µm (0.5 µm/s). Tor the following two hours they deployed an additional 20 µm (0.17 µm/min). The employed design supported six deploying electrodes, each at the end of a 5 µm wide and thick, and 100 µm long needle. These were attached to a shank with 290 µm width, 12 µm thickness and 3 mm length. The shanks could be inserted into the cortex of rats through an opening in the pia without breaking. The acquired waveforms indicate that some of the deployed electrodes were able to record neural action potentials.PhDElectrical EngineeringUniversity of Michigan, Horace H. Rackham School of Graduate Studieshttp://deepblue.lib.umich.edu/bitstream/2027.42/113317/1/egertd_1.pd

Design and evaluation of a computed tomography (CT)-compatible needle insertion device using an electromagnetic tracking system and CT images

Purpose Percutaneous needle insertion procedures are commonly used for diagnostic and therapeutic purposes. Although current technology allows accurate localization of lesions, they cannot yet be precisely targeted. Lung cancer is the most common cause of cancer-related death, and early detection reduces the mortality rate. Therefore, suspicious lesions are tested for diagnosis by performing needle biopsy. Methods In this paper, we have presented a novel computed tomography (CT)-compatible needle insertion device (NID). The NID is used to steer a flexible needle (ϕ0.55mm ϕ0.55mm) with a bevel at the tip in biological tissue. CT images and an electromagnetic (EM) tracking system are used in two separate scenarios to track the needle tip in three-dimensional space during the procedure. Our system uses a control algorithm to steer the needle through a combination of insertion and minimal number of rotations. Results Noise analysis of CT images has demonstrated the compatibility of the device. The results for three experimental cases (case 1: open-loop control, case 2: closed-loop control using EM tracking system and case 3: closed-loop control using CT images) are presented. Each experimental case is performed five times, and average targeting errors are 2.86±1.14 2.86±1.14, 1.11±0.14 1.11±0.14 and 1.94 0.63mm 1.94±0.63mm for case 1, case 2 and case 3, respectively. Conclusions The achieved results show that our device is CT-compatible and it is able to steer a bevel-tipped needle toward a target. We are able to use intermittent CT images and EM tracking data to control the needle path in a closed-loop manner. These results are promising and suggest that it is possible to accurately target the lesions in real clinical procedures in the future

Optical Fiber-Based Needle Shape Sensing in Real Tissue: Single Core vs. Multicore Approaches

Flexible needle insertion procedures are common for minimally-invasive surgeries for diagnosing and treating prostate cancer. Bevel-tip needles provide physicians the capability to steer the needle during long insertions to avoid vital anatomical structures in the patient and reduce post-operative patient discomfort. To provide needle placement feedback to the physician, sensors are embedded into needles for determining the real-time 3D shape of the needle during operation without needing to visualize the needle intra-operatively. Through expansive research in fiber optics, a plethora of bio-compatible, MRI-compatible, optical shape-sensors have been developed to provide real-time shape feedback, such as single-core and multicore fiber Bragg gratings. In this paper, we directly compare single-core fiber-based and multicore fiber-based needle shape-sensing through identically constructed, four-active area sensorized bevel-tip needles inserted into phantom and \exvivo tissue on the same experimental platform. In this work, we found that for shape-sensing in phantom tissue, the two needles performed identically with a $p$-value of $0.164 > 0.05$, but in \exvivo real tissue, the single-core fiber sensorized needle significantly outperformed the multicore fiber configuration with a $p$-value of $0.0005 < 0.05$. This paper also presents the experimental platform and method for directly comparing these optical shape sensors for the needle shape-sensing task, as well as provides direction, insight and required considerations for future work in constructively optimizing sensorized needles

A Novel Bio-Inspired Insertion Method for Application to Next Generation Percutaneous Surgical Tools

The use of minimally invasive techniques can dramatically improve patient outcome from neurosurgery, with less risk, faster recovery, and better cost effectiveness when compared to conventional surgical intervention. To achieve this, innovative surgical techniques and new surgical instruments have been developed. Nevertheless, the simplest and most common interventional technique for brain surgery is needle insertion for either diagnostic or therapeutic purposes. The work presented in this thesis shows a new approach to needle insertion into soft tissue, focussing on soft tissue-needle interaction by exploiting microtextured topography and the unique mechanism of a reciprocating motion inspired by the ovipositor of certain parasitic wasps. This thesis starts by developing a brain-like phantom which I was shown to have mechanical properties similar to those of neurological tissue during needle insertion. Secondly, a proof-of-concept of the bio-inspired insertion method was undertaken. Based on this finding, the novel method of a multi-part probe able to penetrate a soft substrate by reciprocal motion of each segment is derived. The advantages of the new insertion method were investigated and compared with a conventional needle insertion in terms of needle-tissue interaction. The soft tissue deformation and damage were also measured by exploiting the method of particle image velocimetry. Finally, the thesis proposes the possible clinical application of a biologically-inspired surface topography for deep brain electrode implantation. As an adjunct to this work, the reciprocal insertion method described here fuelled the research into a novel flexible soft tissue probe for percutaneous intervention, which is able to steer along curvilinear trajectories within a compliant medium. Aspects of this multi-disciplinary research effort on steerable robotic surgery are presented, followed by a discussion of the implications of these findings within the context of future work

Robotics-Assisted Needle Steering for Percutaneous Interventions: Modeling and Experiments

Needle insertion and guidance plays an important role in medical procedures such as brachytherapy and biopsy. Flexible needles have the potential to facilitate precise targeting and avoid collisions during medical interventions while reducing trauma to the patient and post-puncture issues. Nevertheless, error introduced during guidance degrades the effectiveness of the planned therapy or diagnosis. Although steering using flexible bevel-tip needles provides great mobility and dexterity, a major barrier is the complexity of needle-tissue interaction that does not lend itself to intuitive control. To overcome this problem, a robotic system can be employed to perform trajectory planning and tracking by manipulation of the needle base. This research project focuses on a control-theoretic approach and draws on the rich literature from control and systems theory to model needle-tissue interaction and needle flexion and then design a robotics-based strategy for needle insertion/steering. The resulting solutions will directly benefit a wide range of needle-based interventions. The outcome of this computer-assisted approach will not only enable us to perform efficient preoperative trajectory planning, but will also provide more insight into needle-tissue interaction that will be helpful in developing advanced intraoperative algorithms for needle steering. Experimental validation of the proposed methodologies was carried out on a state of-the-art 5-DOF robotic system designed and constructed in-house primarily for prostate brachytherapy. The system is equipped with a Nano43 6-DOF force/torque sensor (ATI Industrial Automation) to measure forces and torques acting on the needle shaft. In our setup, an Aurora electromagnetic tracker (Northern Digital Inc.) is the sensing device used for measuring needle deflection. A multi-threaded application for control, sensor readings, data logging and communication over the ethernet was developed using Microsoft Visual C 2005, MATLAB 2007 and the QuaRC Toolbox (Quanser Inc.). Various artificial phantoms were developed so as to create a realistic medium in terms of elasticity and insertion force ranges; however, they simulated a uniform environment without exhibiting complexities of organic tissues. Experiments were also conducted on beef liver and fresh chicken breast, beef, and ham, to investigate the behavior of a variety biological tissues

Realistic tool-tissue interaction models for surgical simulation and planning

Surgical simulators present a safe and potentially effective method for surgical training, and can also be used in pre- and intra-operative surgical planning. Realistic modeling of medical interventions involving tool-tissue interactions has been considered to be a key requirement in the development of high-fidelity simulators and planners. The soft-tissue constitutive laws, organ geometry and boundary conditions imposed by the connective tissues surrounding the organ, and the shape of the surgical tool interacting with the organ are some of the factors that govern the accuracy of medical intervention planning.\ud \ud This thesis is divided into three parts. First, we compare the accuracy of linear and nonlinear constitutive laws for tissue. An important consequence of nonlinear models is the Poynting effect, in which shearing of tissue results in normal force; this effect is not seen in a linear elastic model. The magnitude of the normal force for myocardial tissue is shown to be larger than the human contact force discrimination threshold. Further, in order to investigate and quantify the role of the Poynting effect on material discrimination, we perform a multidimensional scaling study. Second, we consider the effects of organ geometry and boundary constraints in needle path planning. Using medical images and tissue mechanical properties, we develop a model of the prostate and surrounding organs. We show that, for needle procedures such as biopsy or brachytherapy, organ geometry and boundary constraints have more impact on target motion than tissue material parameters. Finally, we investigate the effects surgical tool shape on the accuracy of medical intervention planning. We consider the specific case of robotic needle steering, in which asymmetry of a bevel-tip needle results in the needle naturally bending when it is inserted into soft tissue. We present an analytical and finite element (FE) model for the loads developed at the bevel tip during needle-tissue interaction. The analytical model explains trends observed in the experiments. We incorporated physical parameters (rupture toughness and nonlinear material elasticity) into the FE model that included both contact and cohesive zone models to simulate tissue cleavage. The model shows that the tip forces are sensitive to the rupture toughness. In order to model the mechanics of deflection of the needle, we use an energy-based formulation that incorporates tissue-specific parameters such as rupture toughness, nonlinear material elasticity, and interaction stiffness, and needle geometric and material properties. Simulation results follow similar trends (deflection and radius of curvature) to those observed in macroscopic experimental studies of a robot-driven needle interacting with gels