title: Resonant ultrasonic bone penetrating needles
Creators: name: Cleary, Rebecca Shirley
Publisher: name: University of Glasgow
Year: 2020
Subjects: subject: Bone biopsy.

description: Bone biopsy is an invasive clinical procedure where a bone sample is recovered for analysis during the diagnosis of a medical condition. The procedure is performed while the patient is under either local or general anaesthesia as the patient can experience significant discomfort and possibly large haematoma due to the large axial and rotational forces 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 thesis details a study of the design, analysis and evaluation of a class of novel power ultrasonic needles for bone penetration, particularly biopsy. Micrometric vibrations generated at the distal tip of a full-wavelength resonant ultrasonic device are used to penetrate the bone. Both ultrasonic longitudinal (L) and longitudinal-torsional (L-T) coupled vibration have proven successful in several applications including ultrasonic surgical devices. Interest in ultrasonic bone cutting has grown since it was first introduced commercially as Piezosurgery in the 1990s. More recent studies have focused on precision cutting of bone, reducing the risk of damage to surrounding delicate tissues in comparison with manual and other powered instruments. Finite element analysis (FEA) is used to design full wavelength ultrasonic needle devices, where the geometry of the device is systematically modified to deter modal coupling by monitoring the frequency spacing between the longitudinal mode of interest and the neighbouring parasitic modes. FEA is further exploited to predict the achievable torsional displacement in a composite mode device tuned to vibrate in a longitudinal-torsional motion through degeneration of the longitudinal motion. While the L-mode device requires the operator to apply a slow backward and forward rotation and a small forward force, to maintain a forward motion and avoid imprinting, a L-T motion at the tip device could avoid this, simplifying the procedure, increasing precision and resulting in a cylindrical, less damaged hole surface. The dynamic behaviours predicted by FEA are validated through experimental modal analysis (EMA) demonstrating the effectiveness of FEA for the design of these devices. EMA is performed by exciting the ultrasonic needle device with a low power random excitation over a predetermined frequency range and measuring the vibration response using a 3D laser Doppler vibrometer (LDV) across a grid of points on the surface of the device. Harmonic analysis was used to investigate the behaviour of the devices at high excitation levels to capture the inherent nonlinearity of the tuned device. The response is captured using bi-directional frequency sweeps across the tuned mode of interest at increasing excitation levels. Ultrasonic surgical instruments typically require to be driven at high excitation levels to generate sufficient vibration amplitude to cut or aspirate tissue or seal vessels. The nonlinearities of the instrument and load presented by the target tissue result in resonance frequency shift, variation in the electric impedance and instability in the vibrational response which can negatively affect the efficacy of the instrument. A resonance tracking system was developed to monitor the voltage and current and adjust the frequency in real time to compensate for the frequency shift. Additional functionality was incorporated to allow modifications to the excitation signal shape and to enable power modulation techniques to be tested in a study of their effects on the rate of progression of the device in its target tissue. Prototype ultrasonic needle devices were evaluated in penetration tests conducted in bone mimic materials and animal bones. The devices recovered trabecular bone from the metaphysis of an ovine femur, and the biopsy samples were architecturally comparable to samples extracted using a trephine biopsy needle. The resonant needle device extracted a cortical bone sample from the central diaphysis, which is the strongest part of the bone, and the biopsy was of superior quality to the sample recovered by a trephine bone biopsy needle. The biopsy sample extracted by the resonant needle was architecturally uniform and cylindrical with an absence of chipping on the surface, suggesting that the biopsy was extracted with precision and control. To penetrate with the L mode device, the operator had to apply a slow backward and forward rotation and the small forward force, to maintain a forward motion. The rotation had to avoid imprinting of the needle tip in the bone, which otherwise resulted in the device stalling. However the L-T mode device, realised by incorporating helical cuts along the axial length, could penetrate the same animal bone sample only requiring the small forward force, hence simplifying the procedure for the operator. The L-T device also provided increased precision, resulting in a cylindrical, less damaged hole surface. Finally, a case study related to skull-based surgery is presented. The petrous apex is a pyramidal shaped structure at the anterior superior portion of the temporal bone and can be the location of tumours, cysts and lesions requiring diagnostic investigation. The petrous apex is challenging to access due to its medial location in the skull base and closeness to important neurovascular structures. An extended surgical approach removes the subject but is associated with morbidity and hence a minimally invasive procedure to access this site to retrieve a biopsy provides a valuable test case for the ultrasonic needle. Guided by the expertise and experience of an ear, nose and throat surgeon, the ultrasonic needle devices were modified and demonstrated in lab-based studies as a new technology for this bone penetration procedure.