Simplifying medical additive manufacturing: making the surgeon the designer

Additive Manufacturing, a technology which has been in existence since three decades, is now successfully being transitioned from a research setting to finding technologically and financially viable end-user applications. A key sector in which Additive Manufacturing is being used is the medical devices and healthcare sector. Drivers in this sector include the ability to create customized, patient specific devices and implants with quick turnaround time in a cost-effective manner. Doctors and surgeons are important change agents and innovators in the creation of new healthcare devices as well as surgical methods. Often times, they may find it necessary at first to build devices and plan surgeries which are not even being thought of or acted upon by the major healthcare companies. In this sense, they perform the roles of designers, creating new ideas and improving on them until they can be implemented and adopted by others. However, the scope for performing this creative activity is often limited in their workplaces, with resource, time and financial impediments often being present. Additive Manufacturing can be helpful to speed up the iterative process of designing such medical devices or planning surgeries as well as help convince people outside of the surgery room of the feasibility and business case for such innovations. This paper proposes to introduce a framework of design, processes and tools which will enable non-engineers (specifically surgeons) to create custom-built products. It is hoped that this paper will motivate more surgeons and non-engineers to get involved in the process of designing for additive manufacturing.

Online mining abnormal period patterns from multiple medical sensor data streams

With the advanced technology of medical devices and sensors, an abundance of medical data streams are available. However, data analysis techniques are very limited, especially for processing massive multiple physiological streams that may only be understood by medical experts. The state-of-the-art techniques only allow multiple medical devices to independently monitor different physiological parameters for the patient's status, thus they signal too many false alarms, creating unnecessary noise, especially in the Intensive Care Unit (ICU). An effective solution which has been recently studied is to integrate information from multiple physiologic parameters to reduce alarms. But it is a challenge to detect abnormalities from high frequently changed physiological streams data, since abnormalities occur gradually due to the complex situation of patients. An analysis of ICU physiological data streams shows that many vital physiological parameters are changed periodically (such as heart rate, arterial pressure, and respiratory impedance) and thus abnormalities are generally abnormal period patterns. In this paper, we develop a Mining Abnormal Period Patterns from Multiple Physiological Streams (MAPPMPS) method to detect and rank abnormalities in medical sensor streams. The efficiency and effectiveness of the MAPPMPS method is demonstrated by a real-world massive database of multiple physiological streams sampled in ICU, comprising 250 patients' streams (each stream involving over 1.3 million data points) with a total size of 28 GB data.

Survey commentaries and analysis on Singapore biotechnology venture capital, intellectual and property regulatory law

The article presents survey commentaries and analysis on biotechnology venture capital, intellectual and property regulatory law in Singapore as of April 2006. The survey revealed that the financial sector and venture capitalists lack the ability to evaluate and understand biotechnology. Some major concerns for stakeholders are the lack of experience in the litigation of cases by Singaporean law firms and the lack of strategic management of portfolios for biomedical and pharmaceutical companies and the government. Stakeholders cited the need for Singaporean laws to be amended to accommodate developments in medical devices, herbal medicine, some biological areas and pre-clinical and clinical trials.

Conducting polymer enzyme alloys : electromaterials exhibiting direct electron transfer

Glucose oxidase (GOx) is an important enzyme with great potential application for enzymatic sensing of glucose, in implantable biofuel cells for powering of medical devices in vivo and for large-scale biofuel cells for distributed energy generation. For these applications, immobilisation of GOx and direct transfer of electrons from the enzyme to an electrode material is required. This paper describes synthesis of conducting polymer (CP) structures in which GOx has been entrained such that direct electron transfer is possible between GOx and the CP. CP/enzyme composites prepared by other means show no evidence of such “wiring”. These materials therefore show promise for mediator-less electronic connection of GOx into easily produced electrodes for biosensing or biofuel cell applications.

Design and properties of a new hybrid stent-graft device

This PhD work explored a novel bio-inspired approach for designing artificial blood vessel implants known as stent-grafts. The design was inspired from body design of a caterpillar. This design concept induced natural flexibility and expandability property in the new stent-graft, which is considered critical in deciding long-term health of treated patients.

Human passive motions and a user-friendly energy harvesting system

Energy harvesting for wireless sensors and consumer electronic devices can significantly improve reliability and environmental sustainability of the devices. This is achieved by eliminating the dependency of these devices on rechargeable batteries, using clean and/or renewable energy sources. Energy harvesting from various energy sources is widely discussed among researchers and entrepreneurs, including harvesting energy from microscale phenomena. This topic is receiving increasing attention due to the rising numbers of low-power consumer electronic devices and wireless sensors, but also the increasing demand for more convenient and available devices. This article presents a feasibility study for an energy harvesting system based on a human's breathing motion. The system is based on a modified pants belt that is integrated with an array of piezoelectric films and a harvesting circuit. The proposed energy harvester generates electricity from reciprocal abdominal motions of the human subject. In comparison with existing breathing-based energy harvesters, the proposed system allows for safe and convenient energy harvesting with no influence on the natural movement of the lungs. Stomach pressure analysis and measurement, as well as the design and simulations of the proposed harvester, are presented. © 2013 The Author(s).

Biocompatible ionic liquid-biopolymer electrolyte-enabled thin and compact magnesium-air batteries.

With the surge of interest in miniaturized implanted medical devices (IMDs), implantable power sources with small dimensions and biocompatibility are in high demand. Implanted battery/supercapacitor devices are commonly packaged within a case that occupies a large volume, making miniaturization difficult. In this study, we demonstrate a polymer electrolyte-enabled biocompatible magnesium-air battery device with a total thickness of approximately 300 μm. It consists of a biocompatible polypyrrole-para(toluene sulfonic acid) cathode and a bioresorbable magnesium alloy anode. The biocompatible electrolyte used is made of choline nitrate (ionic liquid) embedded in a biopolymer, chitosan. This polymer electrolyte is mechanically robust and offers a high ionic conductivity of 8.9 × 10(-3) S cm(-1). The assembled battery delivers a maximum volumetric power density of 3.9 W L(-1), which is sufficient to drive some types of IMDs, such as cardiac pacemakers or biomonitoring systems. This miniaturized, biocompatible magnesium-air battery may pave the way to a future generation of implantable power sources.

Toward a skin-material interface with vacuum-integrated capped macroporous scaffolds

Avulsion, epidermal marsupialization, and infection cause failure at the skin-material interface. A robust interface would permit implantable robotics, prosthetics, and other medical devices; reconstruction of surgical defects, and long-term access to blood vessels and body cavities. Torus-shaped cap-scaffold structures were designed to work in conjunction with negative pressure to address the three causes of failure. Six wounds were made on the backs of each of four 3-month old pigs. Four unmodified (no caps) scaffolds were implanted along with 20 cap-scaffolds. Collagen type 4 was attached to 21 implants. Negative pressure then was applied. Structures were explanted and assessed histologically at day 7 and day 28. At day 28, there was close tissue apposition to scaffolds, without detectable reactions from defensive or interfering cells. Three cap-scaffolds explanted at day 28 showed likely attachment of epidermis to the cap or cap-scaffold junction, without deeper marsupialization. The combination of toric-shaped cap-scaffolds with negative pressure appears to be an intrinsically biocompatible system, enabling a robust skin-material interface. © 2016 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater, 2016.

The effect of treatment time on the ionic liquid surface film formation: promising surface coating for Mg alloy AZ31

Mg alloys are attractive materials for medical devices. The main limitation is that they are prone to corrosion. A low toxicity surface coating that enables uniform, controlled corrosion at a desired rate (this usually means it must offer barrier functions for a limited time period) is desirable. Phosphate-based ionic liquids (ILs) are known to induce a coating that can reduce the corrosion rate of Mg alloys, Furthermore, some ILs are known to be biocompatible and therefore, controlling the corrosion behaviour of an Mg alloy and its surface biocompatibility can be achieved through adding an appropriate low toxic IL surface layer to the substrate. In this study, we have evaluated the cytotoxicity of three phosphate-based ILs to primary human coronary artery endothelial cells. Among them, tributyl(methyl)-phosphonium diphenylphosphate (P1,4,4,4dpp) shows the lowest cytotoxicity. Therefore, further work was aimed at developing an appropriate treatment method to produce a homogeneous and passive surface coating based on P1,4,4,4dpp IL, with the focus on investigating the effect of treatment time. The results showed that that the formation of IL coating on AZ31 has proceeded progressively, and treatment time plays an important role. An IL treatment at 100 °C with an extended treatment time of 5 h significantly enhanced corrosion resistance of the AZ31 alloy in simulated body fluid. Additionally, the corrosion morphology was uniform and there was no evidence of "localized pitting corrosion" observed. Such a performance makes this ionic liquid coating as a potential surface coating biodegradable Mg-based implants.

Oxygen delivery to patients after cardiac surgery : a medical record audit

OBJECTIVE: To describe how intensive care nurses manage the administration of supplemental oxygen to patients during the first 24 hours after cardiac surgery.
METHODS: A retrospective audit was conducted of the medical records of 245 adult patients who underwent cardiac surgery between 1 January 2005 and 31 May 2008 in an Australian metropolitan hospital. Physiological data (oxygen saturation measured by pulse oximetry and respiratory rate) and intensive care unit management data (oxygen delivery device, oxygen flow rate and duration of mechanical ventilation) were collected at hourly intervals over the first 24 hours of ICU care.
RESULTS: Of the 245 patients whose records were audited, 185 were male; mean age was 70 years (SD, 10), and mean APACHE II score was 17.5 (SD, 5.14). Almost half the patients (122, 49.8%) were extubated within 8 hours of ICU admission. The most common oxygen delivery device used immediately after extubation was the simple face mask (214 patients, 87%). Following extubation, patients received supplemental oxygen via, on average, two different delivery devices (range, 1-3), and had the delivery device changed an average of 1.38 times (range, 0-6) during the 24 hours studied. Twenty-two patients (9%) received non-invasive ventilation or high-flow oxygen therapy, and 16 (7%) experienced one or more episode of hypoxaemia during mechanical ventilation. A total of 148 patients (60%) experienced one or more episodes of low oxygenation or abnormal respiratory rate during the first 24 hours of ICU care despite receiving supplemental oxygen.
CONCLUSION: These findings suggest that the ICU environment does not protect cardiac surgical patients from suboptimal oxygen delivery, and highlights the need for strategies to prompt the early initiation of interventions aimed at optimising blood oxygen levels in cardiac surgical patients in the ICU.

Individually tailored client-focused reports for ubiquitous devices : an experimental analysis

We describe results of a test of a method for tailoring communications based on the recipient’s preferred information processing style and dominant motivational attitude. Results indicate that the greater the match between the style of the report and the individual’s attributes, the more informed the reader feels about the subject of the report. This research has been conducted as part of a study into methods to design patient-centred medical using diabetic patients as an exemplar of chronic disease. The long term aim is to use reports personalised to the recipient to better inform patients about their disease and strengthen their motivation to follow the treatment plan.