A miniature surgical drill using ultrasonic/sonic frequency vibration

A study is presented of a miniature ultrasonic surgical drill designed for bone biopsy, based on an ultrasonic/sonic drill which converts high frequency to low frequency vibrations through a freely vibrating mass between an ultrasonic transducer-horn and a drill bit. For conventional surgical drilling using a rotary drill or an ultrasonic drill, considerable power is required to penetrate into bone and the efficiency is low. However, for ultrasonic/sonic drilling, sufficient acoustic energy is accumulated and then released through each impact to achieve precise drilling with a lower power requirement. The ultrasonic/sonic drill was originally invented for rock drilling in low gravity environments. In this study it is incorporated in a miniature ultrasonic surgical drill and the effective impulse delivered to the bone is used to evaluate the drilling performance. To develop a miniature surgical device based on maximising the effective impulse, optimisation of the ultrasonic horn and free-mass is first demonstrated. The shape and dimensions of the ultrasonic horn and free-mass are determined through FEA, which focuses on maximising the post-collision velocity of the free-mass. Then, the entire dynamic stack constituting the surgical drill device is modelled as a mass-spring-damper system to analyse the dynamic behaviour. The numerical model is validated through experiments, using a prototype drill, which record the velocity of the free-mass and the drilling force. The results of the numerical models and experiments indicate this miniature ultrasonic surgical drill can deliver sufficient impulse to penetrate bone and form the basis of an ultrasonically activated bone biopsy device

Understanding nonlinear vibration behaviours in high-power ultrasonic surgical devices

Ultrasonic surgical devices are increasingly used in oral, craniofacial and maxillofacial surgery to cut mineralized tissue, offering the surgeon high accuracy with minimal risk to nerve and vessel tissue. Power ultrasonic devices operate in resonance, requiring their length to be a half-wavelength or multiple-half-wavelength. For bone surgery, devices based on a half-wavelength have seen considerable success, but longer multiple-half-wavelength endoscopic devices have recently been proposed to widen the range of surgeries. To provide context for these developments, some examples of surgical procedures and the associated designs of ultrasonic cutting tips are presented. However, multiple-half-wavelength components, typical of endoscopic devices, have greater potential to exhibit nonlinear dynamic behaviours that have a highly detrimental effect on device performance. Through experimental characterization of the dynamic behaviour of endoscopic devices, it is demonstrated how geometrical features influence nonlinear dynamic responses. Period doubling, a known route to chaotic behaviour, is shown to be significantly influenced by the cutting tip shape, whereas the cutting tip has only a limited effect on Duffing-like responses, particularly the shape of the hysteresis curve, which is important for device stability. These findings underpin design, aiming to pave the way for a new generation of ultrasonic endoscopic surgical devices

Design of a slender tuned ultrasonic needle for bone penetration

This paper reports on an ultrasonic bone biopsy needle, particularly focusing on design guidelines applicable for any slender tuned ultrasonic device component. Ultrasonic surgical devices are routinely used to cut a range of biological tissues, such as bone. However the realisation of an ultrasonic bone biopsy needle is particularly challenging. This is due to the requirement to generate sufficient vibrational amplitude capable of penetrating mineralised tissue, while avoiding flexural vibrational responses, which are known to reduce the performance and reliability of slender ultrasonic devices. This investigation uses finite element analysis (FEA) to predict the vibrational behaviour of a resonant needle which has dimensions that match closely to an 8Gx4inch bone marrow biopsy needle. Features of the needle, including changes in material and repeated changes in diameter, have been included and systematically altered to demonstrate that the location of and geometry of these features can significantly affect the resonant frequency of bending and torsional modes of vibration while having a limited effect on the frequency and shape of the tuned longitudinal mode. Experimental modal analysis was used to identify the modal parameters of the selected needle design, validating the FEA model predictions of the longitudinal mode and the close flexural modes. This verifies that modal coupling can be avoided by judicious small geometry modifications. Finally, the tuned needle assembly was driven under typical operational excitation conditions to demonstrate that an ultrasonic biopsy needle can be designed to operate in a purely longitudinal motion

Ultrasonic needles for bone biopsy

Bone biopsy is an invasive clinical procedure where a bone sample is recovered for analysis during the diagnosis of a medical condition. When the architecture of the bone tissue is required to be preserved, a core-needle biopsy is taken. Although this procedure is performed while the patient is under local anaesthesia, the patient can still experience significant discomfort. Additionally, large haematoma can be induced in the soft tissue surrounding the biopsy site due to the large axial and rotational forces which are applied through the needle to penetrate bone. It is well documented that power ultrasonic surgical devices offer advantages of low cutting force, high accuracy and preservation of soft tissues. This paper reports a study of the design, analysis and test of two novel power ultrasonic needles for bone biopsy that operate using different configurations to penetrate bone. The first utilises micrometric vibrations generated at the distil tip of a full-wavelength resonant ultrasonic device, while the second utilises an ultrasonic-sonic approach where vibrational energy generated by a resonant ultrasonic horn is transferred to a needle via the chaotic motion of a free-mass. It is shown that the dynamic behaviour of the devices identified through experimental techniques closely match the behaviour calculated through numerical and FEA methods, demonstrating that they are effective design tools for these devices. Both devices were able to recover trabecular bone from the metaphysis of an ovine femur, and the biopsy samples were found to be comparable to a sample extracted using a conventional biopsy needle. Furthermore, the resonant needle device was also able to extract a cortical bone sample from the central diaphysis, which is the strongest part of the bone, and the biopsy was found to be superior to the sample recovered by a conventional bone biopsy needle

Ultrasonic Biopsy Needle Based on the Class IV Flextensional Configuration

This study builds on previous research by the authors, where the design of a miniaturized class IV transducer configuration and adaption for including an end-effector for use in biopsy are investigated. Device design has focused on the generation of displacement uniformity across the output surface of the transducer. This has the aim of maximizing device reliability and minimizing nonlinear responses that could adversely affect the performance of devices incorporating endeffectors. The devices investigated in this study, designed using finite element analysis, have been experimentally characterized to identify their impedance and resonant characteristics

An ultrasonic orthopaedic surgical device based on a cymbal transducer

AbstractAn ultrasonic orthopaedic surgical device is presented, where the ultrasonic actuation relies on a modification of the classical cymbal transducer. All current devices consist of a Langevin ultrasonic transducer with a tuned cutting blade attached, where resonance is required to provide sufficient vibrational amplitude to cut bone. However, this requirement restricts the geometry and offers little opportunity to propose miniaturised devices or complex blades. The class V flextensional cymbal transducer is proposed here as the basis for a new design, where the cymbal delivers the required vibrational amplitude, and the design of the attached cutting insert can be tailored for the required cut. Consequently, the device can be optimised to deliver an accurate and precise cutting capability. A prototype device is presented, based on the cymbal configuration and designed to operate at 25.5kHz with a displacement amplitude of 30μm at 300V. Measurements of vibrational and impedance responses elucidate the mechanical and electrical characteristics of the device. Subsequent cutting tests on rat femur demonstrate device performance consistent with a commercial Langevin-based ultrasonic device and show that cutting is achieved using less electrical power and a lower piezoceramic volume. Histological analysis exhibits a higher proportion of live cells in the region around the cut site for the cymbal device than for a powered sagittal or a manual saw, demonstrating the potential for the ultrasonic device to result in faster healing

Optimization of TAM16, a Benzofuran That Inhibits the Thioesterase Activity of Pks13; Evaluation toward a Preclinical Candidate for a Novel Antituberculosis Clinical Target

[Image: see text] With increasing drug resistance in tuberculosis (TB) patient populations, there is an urgent need for new drugs. Ideally, new agents should work through novel targets so that they are unencumbered by preexisting clinical resistance to current treatments. Benzofuran 1 was identified as a potential lead for TB inhibiting a novel target, the thioesterase domain of Pks13. Although, having promising activity against Mycobacterium tuberculosis, its main liability was inhibition of the hERG cardiac ion channel. This article describes the optimization of the series toward a preclinical candidate. Despite improvements in the hERG liability in vitro, when new compounds were assessed in ex vivo cardiotoxicity models, they still induced cardiac irregularities. Further series development was stopped because of concerns around an insufficient safety window. However, the demonstration of in vivo activity for multiple series members further validates Pks13 as an attractive novel target for antitubercular drugs and supports development of alternative chemotypes

Effects of antiplatelet therapy on stroke risk by brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases: subgroup analyses of the RESTART randomised, open-label trial

Background Findings from the RESTART trial suggest that starting antiplatelet therapy might reduce the risk of recurrent symptomatic intracerebral haemorrhage compared with avoiding antiplatelet therapy. Brain imaging features of intracerebral haemorrhage and cerebral small vessel diseases (such as cerebral microbleeds) are associated with greater risks of recurrent intracerebral haemorrhage. We did subgroup analyses of the RESTART trial to explore whether these brain imaging features modify the effects of antiplatelet therapy

Effects of antiplatelet therapy after stroke due to intracerebral haemorrhage (RESTART): a randomised, open-label trial

Background: Antiplatelet therapy reduces the risk of major vascular events for people with occlusive vascular disease, although it might increase the risk of intracranial haemorrhage. Patients surviving the commonest subtype of intracranial haemorrhage, intracerebral haemorrhage, are at risk of both haemorrhagic and occlusive vascular events, but whether antiplatelet therapy can be used safely is unclear. We aimed to estimate the relative and absolute effects of antiplatelet therapy on recurrent intracerebral haemorrhage and whether this risk might exceed any reduction of occlusive vascular events. Methods: The REstart or STop Antithrombotics Randomised Trial (RESTART) was a prospective, randomised, open-label, blinded endpoint, parallel-group trial at 122 hospitals in the UK. We recruited adults (≥18 years) who were taking antithrombotic (antiplatelet or anticoagulant) therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage, discontinued antithrombotic therapy, and survived for 24 h. Computerised randomisation incorporating minimisation allocated participants (1:1) to start or avoid antiplatelet therapy. We followed participants for the primary outcome (recurrent symptomatic intracerebral haemorrhage) for up to 5 years. We analysed data from all randomised participants using Cox proportional hazards regression, adjusted for minimisation covariates. This trial is registered with ISRCTN (number ISRCTN71907627). Findings: Between May 22, 2013, and May 31, 2018, 537 participants were recruited a median of 76 days (IQR 29–146) after intracerebral haemorrhage onset: 268 were assigned to start and 269 (one withdrew) to avoid antiplatelet therapy. Participants were followed for a median of 2·0 years (IQR [1·0– 3·0]; completeness 99·3%). 12 (4%) of 268 participants allocated to antiplatelet therapy had recurrence of intracerebral haemorrhage compared with 23 (9%) of 268 participants allocated to avoid antiplatelet therapy (adjusted hazard ratio 0·51 [95% CI 0·25–1·03]; p=0·060). 18 (7%) participants allocated to antiplatelet therapy experienced major haemorrhagic events compared with 25 (9%) participants allocated to avoid antiplatelet therapy (0·71 [0·39–1·30]; p=0·27), and 39 [15%] participants allocated to antiplatelet therapy had major occlusive vascular events compared with 38 [14%] allocated to avoid antiplatelet therapy (1·02 [0·65–1·60]; p=0·92). Interpretation: These results exclude all but a very modest increase in the risk of recurrent intracerebral haemorrhage with antiplatelet therapy for patients on antithrombotic therapy for the prevention of occlusive vascular disease when they developed intracerebral haemorrhage. The risk of recurrent intracerebral haemorrhage is probably too small to exceed the established benefits of antiplatelet therapy for secondary prevention