The Fabrication and Integration of a 15 MHz Array Within a Biopsy Needle

It is proposed that integrating ultrasound transducer arrays at the tip of tools such as biopsy needles could enable valuable, real-time image feedback during interventional procedures. High-resolution ultrasound imaging has the potential to aid navigation of interventional tools, and to assist diagnosis or treatment via in-vivo tissue characterisation in the breast, amongst many other applications. In order to produce miniature transducer arrays incorporated within biopsy needle-sized packages (2-5 mm diameter), the challenges in micromachining and handling transducer materials at this scale must be overcome. This paper presents fabrication processes used in the micromachining of a 16 element 15 MHz PIN-PMN-PT piezocrystal-polymer composite array and its integration into an 11 G breast biopsy needle. Particular emphasis is given to the manufacturing of the 1-3 dice-and-fill piezocrystal composite, and establishing electrical interconnects. Characterisation measurements have demonstrated operation of each of the 16 elements within the needle case

In Vivo Characterization of a Wireless Telemetry Module for a Capsule Endoscopy System Utilizing a Conformal Antenna

This paper describes the design, fabrication, packaging, and performance characterization of a conformal helix antenna created on the outside of a 10 mm ×30 mm capsule endoscope designed to operate at a carrier frequency of 433 MHz within human tissue. Wireless data transfer was established between the integrated capsule system and an external receiver. The telemetry system was tested within a tissue phantom and in vivo porcine models. Two different types of transmission modes were tested. The first mode, replicating normal operating conditions, used data packets at a steady power level of 0 dBm, while the capsule was being withdrawn at a steady rate from the small intestine. The second mode, replicating the worst-case clinical scenario of capsule retention within the small bowel, sent data with stepwise increasing power levels of –10, 0, 6, and 10 dBm, with the capsule fixed in position. The temperature of the tissue surrounding the external antenna was monitored at all times using thermistors embedded within the capsule shell to observe potential safety issues. The recorded data showed, for both modes of operation, a low error transmission of 10−3 packet error rate and 10−5 bit error rate and no temperature increase of the tissue according to IEEE standards

Optimization and characterisation of bonding of piezoelectric transducers using anisotropic conductive adhesive

Bonding technology using anisotropic conductive paste shows great promise to achieve the denser integration schemes that are required for the application of high resolution ultrasonic imaging. A design of experiments has been carried out to characterize and optimize a flip-chip bonding technology that utilizes a novel, magnetically aligned anisotropic conductive paste. This optimized process has the potential to implement more reliable and electrically conductive, fine pitch bonding for the production of high density ultrasound transducer arrays in needle devices

Translational trial outcomes for capsule endoscopy test devices

Current clinical standards in the endoscopic diagnosis of gastrointestinal diseases are primarily based on the use of optical systems. Ultrasound has established diagnostic credibility in the form of endoscopic ultrasound (EUS), however it is limited to examination of the upper gastrointestinal tract (oesophagus, stomach and upper (proximal) small bowel). Access to the remainder of the small bowel is currently limited to optical capsule endoscopes and a limited number of other modalities as these capsules are restricted to visual examination of the surface or mucosa of the gut wall. Ultrasound capsule endoscopy has been proposed to integrate microultrasound imaging capabilities into the existing capsule format and extend examination capabilities beyond the mucosa. To establish the ability of high frequency ultrasound to resolve the histological structure of the gastrointestinal tract, ex vivo scans of pig and human tissue were performed. This was done using 25 and 34 MHz single element, physically focused composite transducers mechanically scanned along the tissue. Tethered prototype devices were then developed with 30 MHz physically focused polyvinylidene fluoride (PVDF) single element transducers embedded for use in initial translational trials in the small bowel of porcine subjects. B-scan images from the ex vivo model validation and the in vivo trials are presented

A highly compact packaging concept for ultrasound transducer arrays embedded in neurosurgical needles

State-of-the-art neurosurgery intervention relies heavily on information from tissue imaging taken at a pre-operative stage. However, the data retrieved prior to performing an opening in the patient’s skull may present inconsistencies with respect to the tissue position observed by the surgeon during intervention, due to both the pulsing vasculature and possible displacements of the brain. The consequent uncertainty of the actual tissue position during the insertion of surgical tools has resulted in great interest in real-time guidance techniques. Ultrasound guidance during neurosurgery is a promising method for imaging the tissue while inserting surgical tools, as it may provide high resolution images. Microfabrication techniques have enabled the miniaturisation of ultrasound arrays to fit needle gauges below 2 mm inner diameter. However, the integration of array transducers in surgical needles requires the development of advanced interconnection techniques that can provide an interface between the microscale array elements and the macroscale connectors to the driving electronics. This paper presents progress towards a novel packaging scheme that uses a thin flexible printed circuit board (PCB) wound inside a surgical needle. The flexible PCB is connected to a probe at the tip of the needle by means of magnetically aligned anisotropic conductive paste. This bonding technology offers higher compactness compared to conventional wire bonding, as the individual electrical connections are isolated from one another within the volume of the paste line, and applies a reduced thermal load compared to thermo-compression or eutectic packaging techniques. The reduction in the volume required for the interconnection allows for denser wiring of ultrasound probes within interventional tools. This allows the integration of arrays with higher element counts in confined packages, potentially enabling multi-modality imaging with Raman, OCT, and impediography. Promising experimental results and a prototype needle assembly are presented to demonstrate the viability of the proposed packaging scheme. The progress reported in this work are steps towards the production of fully-functional imaging-enabled needles that can be used as surgical guidance tools

Optimization and characterisation of bonding of piezoelectric transducers using anisotropic conductive adhesive

Bonding technology using anisotropic conductive paste shows great promise to achieve the denser integration schemes that are required for the application of high resolution ultrasonic imaging. A design of experiments has been carried out to characterize and optimize a flip-chip bonding technology that utilizes a novel, magnetically aligned anisotropic conductive paste. This optimized process has the potential to implement more reliable and electrically conductive, fine pitch bonding for the production of high density ultrasound transducer arrays in needle devices

15 MHz single element ultrasound needle transducers for neurosurgical applications

Image-guided surgery is today considered to be of significant importance in neurosurgical applications. However, one of its major shortcomings is its reliance on preoperative image data, which does not account for the intraoperative brain deformations and displacements that occur during surgery. In this work, we propose to tackle this issue with the incorporation of an ultrasound device within a biopsy needle that is commonly used as an interventional tool so as to provide immediate feedback to neurosurgeons during surgical procedures. In order to identify the most appropriate path to access a targeted tissue site, needle single element transducers that look both forwards and sideways have been designed and fabricated. Monolithic PZT plates and micro-moulded 1-3 piezocomposites have been adopted as the active materials for feasibility tests. Impedance analysis and pulse-echo testing have been carried out, demonstrating the functionality of the transducers at frequencies of ~15 MHz. The imaging capabilities of these transducers have been studied by wire phantom scans. Variations in the transducer properties as a result of the use of different active materials are discussed