Effects of post-curing duration on the mechanical properties of complex 3D printed geometrical parts.

This study aims to assess the efficacy of post-curing guidance supplied by 3D printing resin manufacturers. Current guidance applies generically to all geometries with the caveat that post-curing should be extended for 'large' or 'complex' geometries but specific guidance is not provided. Two vat-polymerisation 3D printers (Form3B, Figure 4 Standalone) were used to print test models in 6 biocompatible resins (Pro Black, Med White, Med Amber, Biomed Black, Biomed White, Biomed Amber). The test model is of a complex geometry whilst also housing ISO 527 test specimens in concentric layers. Two separate intervals of curing were applied (100%, 500% stated guidance) creating different curing treatments of the specimens throughout the model. Post processed test models were disassembled and pull testing performed on each of the specimens to assess the mechanical properties. The analysis showed that extending the curing duration had significant effects on the mechanical properties of some materials but not all. The layers of the model had a significant effect except for elongation at break for the Med Amber material. This research demonstrates that generic post-curing guidance regarding UV exposures is not sufficient to achieve homogenous material strength properties for complex geometries. Large variations in mechanical properties throughout the models suggest some material was not fully-cured. This raises a query if such materials as originally marketed as biocompatible are fully cured and therefore safe to use for medical applications involving complex geometries.

Design and initial testing of a novel disposable oscillating positive expiratory pressure device.

BACKGROUND: Oscillating positive expiratory pressure (OPEP) devices play a key role in airway clearance, particularly in patients with cystic fibrosis. These devices, however, have the potential to become reservoirs for pathogenic organisms and require daily, or even more frequent, cleaning. This places a large burden on patients and their carers. AIMS: The objective of this work was to develop a disposable OPEP device, with comparable mechanical performance to commercial devices, that negates the need for cleaning after use thus reducing microbiological risks. METHODS: 3D printing was used to iterate and develop a prototype disposable device (The University of Limerick OPEP, abbreviated to the UL-OPEP) that was compared with a selection of commercially available devices for mean pressure and oscillation amplitude (cmH2O), as well as oscillation frequency (Hz). All devices were tested using a healthy volunteer at a target expiratory flow of ~ 20 L/min. The target therapeutic range was 10-20 cmH2O at a flow rate of 10-20 L/min as is reported widely in the literature. RESULTS: The prototype disposable device achieved a mean pressure of 14.82 cmH2O at a mean flow rate of 18.82 L/min, and generated an oscillation frequency of 26 Hz with an amplitude of 1.28 cmH2O. These characteristics compare favourably with existing, more complex, reusable OPEP devices. CONCLUSIONS: The UL-OPEP device is a small, disposable OPEP device, that generates pressure and oscillation amplitudes for clinically effective airway clearance. The device negates the need for cleaning and disinfecting, removing the risk of devices acting as a potential reservoir for pathogenic organisms while maintaining mucus-clearing benefits.

Assessment and selection of filler compounds for radiopaque PolyJet multi-material 3D printing for use in clinical settings.

The aim of this research was to assess a selection of radiopaque filler compounds for increasing radiopacity in a resin suitable for Polyjet multi-material 3D printing. A radiopaque resin has potential applications in medicine to produce patient-specific anatomical models with realistic radiological properties, training aids, and skin contacting components such as surgical or procedural guides that require visibility under fluoroscopy. The desirable filler would have a high level of radiopacity under ionising imaging modalities, such as X-ray, CT, fluoroscopy or angiography. Nine potential filler compounds were selected based on atomic number and handling risk: barium sulphate, bismuth oxide, zirconium oxide, strontium oxide, strontium fluoride, strontium carbonate, iodine, niobium oxide and tantalum oxide. The fillers were evaluated using selected criteria. A weighted material selection matrix was developed to prioritise and select a filler for future 3D printing on a multi-material 3D printer. Zirconium oxide was the highest scoring filler compound in the material selection matrix, scoring 4.4 out of a maximum of 5. MED610TM resin doped with zirconium oxide was shown to be UV curable, and when cured is non-toxic, environmentally friendly, and has the ability to display antimicrobial properties. In terms of radiopacity, a sample with thickness 1.5 mm of MED610™ resin doped with 20 wt.% zirconium oxide produced X-ray radiopacity equivalent to 3 mm of aluminium. Zirconium oxide was selected using the material selection matrix. This radiopaque resin can be used to produce anatomical models with accurate radiological properties, training aids or skin contacting devices that require visibility under ionising imaging modalities. The 3D printing validation run successfully demonstrated that the material selection matrix prioritised a filler suitable for radiopaque multi-material 3D printing.

Warmed contrast media temperature loss in traditional manifold systems during angiographic procedures.

BACKGROUND: Extrinsic warming of contrast media (CM) to 37 °C before angiographic procedures is performed to improve bolus kinetics and avoid potential adverse effects. Extrinsically warmed CM readily loses temperature after removal from the warming cabinet, but the extent of its cooling has not been previously investigated. PURPOSE: To assess temperature loss of extrinsically warmed CM in tubing of traditional angiographic manifolds during simulated angiography. MATERIAL AND METHODS: In total, 35 scheduled diagnostic angiographic procedures were observed in a hospital setting. Relevant time points of CM use during the procedures were recorded. The shortest, median, and longest procedures were then simulated in the experimental laboratory to measure CM temperatures at specific times at three locations along the tubing system. RESULTS: The angiographic procedures lasted 7.0-26.6 min (median = 11.7 min), with the total duration dependent primarily on the time from contrast being removed from the warming cabinet to the commencement of imaging. During the simulated procedures, consistent patterns of temperature loss were observed. By the last simulated angiographic run, injected CM temperature decreased by 7.4-16.4 °C, depending on procedure length. Most of the heat loss occurred in the tubing between the CM bottle and coronary control syringe. CONCLUSION: During angiographic procedures, prewarmed CM loses its temperature rapidly with the duration of exposure to ambient room temperature. If no additional measures are employed to maintain its temperature outside of the warming cabinet, extrinsic warming has limited impact on injected CM temperature.

An initial evaluation of the safety of a disposable oscillating positive expiratory pressure device in patients with chronic obstructive pulmonary disease: a sort-term pilot study.

BACKGROUND: Handheld oscillating positive expiratory pressure (OPEP) devices have been a mainstay of treatment for patients with hypersecretory conditions such as cystic fibrosis (CF) and chronic obstructive pulmonary disease (COPD) since the 1970s. Current devices are reusable and require regular cleaning and disinfection to prevent harbouring potentially pathogenic organisms. Adherence to cleaning regimens for respiratory devices is often poor and in response to this, a prototype disposable OPEP device-the 'UL-OPEP' (University of Limerick-Oscillating Positive Expiratory Pressure device)-was developed to mitigate the risk of contamination by pathogens. The device was previously evaluated successfully in a group of paediatric CF patients. The aim of the current study was to initially evaluate the safety of the prototype in patients with COPD over a period of 1 month to ensure no adverse events, negative impacts on lung function, exercise tolerance, or quality of life. Data on user experience of the device were also collected during post-study follow-up. METHODS: A sample of 50 volunteer participants were recruited from pulmonary rehabilitation clinics within the local hospital network. The patients were clinically stable, productive, and not current or previous users of OPEP devices. Participants were invited to use a prototype disposable OPEP device daily for a period of 1 month. Pre- and post-study lung function was assessed with standard spirometry, and exercise tolerance with the 6-min-walk-test (6MWT). Quality of life was assessed using the St. George's Respiratory Questionnaire (SGRQ), and user experience of the prototype device evaluated using a post-study questionnaire. RESULTS: 24 Participants completed the study: 9 were female. Overall median age was 67.5 years, range 53-85 years. Lung function, 6-min walk test, and SGRQ scores showed no significant change post-study. User feedback was positive overall. CONCLUSIONS: The results indicate that the UL-OPEP is safe to use in patients with COPD. No adverse events were recorded during the study or in the follow-up period of 2 weeks. The device did not negatively impact patients' lung function, exercise tolerance, or quality of life during short term use (1 month), and usability feedback received was generally positive. Larger, longer duration studies will be required to evaluate efficacy. Registration The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

A short-term evaluation of a prototype disposable Oscillating Positive Expiratory Pressure (OPEP) device in a cohort of children with cystic fibrosis.

BACKGROUND: Oscillating Positive Expiratory Pressure (OPEP) devices are important adjuncts to airway clearance therapy in patients with cystic fibrosis (CF). Current devices are typically reusable and require daily, or often more frequent, cleaning to prevent risk of infection by acting as reservoirs of potentially pathogenic organisms. In response, a daily disposable OPEP device, the UL-OPEP, was developed to mitigate the risk of contamination and eliminate the burdensome need for cleaning devices. METHODS: A convenience sample of 36 participants, all current OPEP device users, was recruited from a paediatric CF service. For one month, participants replaced their current OPEP device with a novel daily disposable device. Assessment included pre- and post-intervention lung function by spirometry, as well as Lung Clearance Index. Quality of life was assessed using the Cystic Fibrosis Questionnaire - Revised, while user experience was evaluated with a post-study survey. RESULTS: 31 participants completed the study: 18 males; median age 10 years, range 4-16 years. Lung function (mean difference ± SD, %FEV1 = 1.69 ± 11.93; %FVC = 0.58 ± 10.04; FEV1: FVC = 0.01 ± 0.09), LCI (mean difference ± SD, 0.08 ± 1.13), six-minute walk test, and CFQ-R were unchanged post-intervention. Participant-reported experiences of the device were predominantly positive. CONCLUSIONS: The disposable OPEP device maintained patients' lung function during short term use (≤ 1 month), and was the subject of positive feedback regarding functionality while reducing the risk of airway contamination associated with ineffective cleaning. REGISTRATION: The study was approved as a Clinical Investigation by the Irish Health Products Regulatory Authority (CRN-2209025-CI0085).

Relationship Between Interface Pressures and Pneumatic Cuff Inflation Pressure at Different Assessment Sites of the Lower Limb to Aid Soft Exoskeleton Design.

OBJECTIVE: The aim was to develop a means of predicting interface pressure from cuff inflation pressure during circumferential compression at the lower limb, in order to inform the design of soft exoskeletons. BACKGROUND: Excessive mechanical loading of tissues can cause discomfort and soft tissue injury. Most ergonomic studies on exoskeletons are of interface pressure, but soft exoskeletons apply circumferential pressures similar to tourniquet cuffs by way of cuff inflation pressure. This study details the relationship between interface and cuff inflation pressures for pneumatic tourniquet cuffs. METHOD: Pneumatic cuffs of different widths were inflated to target pressures on (A) a rigid cylinder, (B) the dominant thigh and calf, and (C) knee of healthy participants standing still. Interface pressures were measured under the cuffs using a pressure-sensing mat. Average interface pressures were then compared to cuff inflation pressures. The influence of cuff width, cuff inflation pressure, and participants' anthropometric data on pressure transmission was assessed. RESULTS: A strong linear relationship between cuff inflation pressures and interface pressures was observed. Interface pressures were generally higher than cuff inflation pressures. The efficiency of pressure transmission to the lower limb depended on assessment site, adipose tissue thickness, cuff size, cuff inflation pressure, and possibly limb circumference. Regression equations were developed to predict interface pressures at the thigh, calf, and knee. CONCLUSION: Interface pressures under pneumatic cuffs are influenced by the cuff size, cuff inflation pressure, and tissue compressibility. Predicted interface pressure from cuff inflation pressure and vice versa can be used to aid the design of soft exoskeletons.

Three-Dimensional Printed Devices for Health Care in Response to the Coronavirus Disease 2019: Lessons Learned to Date.

During the first surge of the coronavirus disease 2019 (COVID-19) there was a tremendous global response from three-dimensional (3D) printing communities and individuals to support local health care systems and staff. The responses involved a range of 3D printer users from amateur makers to conglomerate manufacturers creating personal protective equipment (PPE) and other supplies of which there were shortages. These new supply chains resulted from the democratization of 3D printing, open source file sharing, mass production of desktop machines, and the relatively cheap cost of 3D printers. The democratized state of 3D printing facilitated an altruistic movement of makers with ranging experience, to work alongside traditional manufacturers to make medical supplies. With the critical nature of the shortages and the sharp increase in COVID-19 infections, many standards and regulations were bypassed, and good manufacturing processes disregarded, in cases. The outcomes from this article is a set of six lessons learned from the authors perspective regarding the use of 3D printing during the initial phase of the COVID-19 pandemic. We note challenges experienced around volume manufacturing, infection control requirements of produced parts and the cleanability of devices, mechanical strength considerations, good manufacturing practices, product and intellectual property (IP) liability, and the role of involving clinical stakeholders.

Three-Dimensional Printing of Medical Devices Used Directly to Treat Patients: A Systematic Review.

Until recently, three-dimensional (3D) printing/additive manufacturing has not been used extensively to create medical devices intended for actual clinical use, primarily on patient safety and regulatory grounds. However, in recent years there have been advances in materials, printers, and experience, leading to increased clinical use. The aim of this study was to perform a structured systematic review of 3D-printed medical devices used directly in patient treatment. A search of 13 databases was performed to identify studies of 3D-printed medical devices, detailing fabrication technology and materials employed, clinical application, and clinical outcome. One hundred and ten papers describing one hundred and forty medical devices were identified and analyzed. A considerable increase was identified in the use of 3D printing to produce medical devices directly for clinical use in the past 3 years. This is dominated by printing of patient-specific implants and surgical guides for use in orthopedics and orthopedic oncology, but there is a trend of increased use across other clinical specialties. The prevailing material/3D-printing technology used were titanium alloy/electron beam melting for implants, and polyamide/selective laser sintering or polylactic acid/fused deposition modeling for surgical guides and instruments. A detailed analysis across medical applications by technology and materials is provided, as well as a commentary regarding regulatory aspects. In general, there is growing familiarity with, and acceptance of, 3D printing in clinical use.

Circumferential tissue compression at the lower limb during walking, and its effect on discomfort, pain and tissue oxygenation: Application to soft exoskeleton design.

Soft exoskeletons apply compressive forces at the limbs via connection cuffs to actuate movement or stabilise joints. To avoid excessive mechanical loading, the interface with the wearer's body needs to be carefully designed. The purpose of this study was to establish the magnitude of circumferential compression at the lower limb during walking that causes discomfort/pain. It was hypothesized that the thresholds differ from those during standing. A cohort of 21 healthy participants were tested using two sizes of pneumatic cuffs, inflated at the thigh and calf in a tonic or phasic manner. The results showed lower inflation pressures triggering discomfort/pain at the thigh, with tonic compression, and wider pneumatic cuffs. The thresholds were lower during walking than standing still. Deep tissue oxygenation increased during phasic compression and decreased during tonic compression. According to the findings, circumferential compression by soft exoskeletons is preferably applied at anatomical sites with smaller volumes of soft tissue, using narrow connection cuffs and inflation pressures below 14 kPa.

The effect of simulated circumferential soft exoskeleton compression at the knee on discomfort and pain.

There is a lack of data and guidance on soft exoskeleton pressure contact with the body. The purpose of this research was to study the relationship between circumferential loading at the knee and discomfort/pain, to inform the design of soft exoskeletons/exosuits. The development of discomfort and pain was studied during standing and walking with circumferential compression using a pneumatic cuff. Our results show higher tolerance for intermittent than continuous compression during standing. Discomfort was triggered at pressures ranging from 13.7 kPa (continuous compression) to 30.4 kPa (intermittent compression), and pain at 52.9 kPa (continuous compression) to 60.6 kPa (intermittent compression). During walking, cyclic compression caused an increase in discomfort with time. Higher cuff inflation pressures caused an earlier onset and higher end intensities of discomfort than lower pressures. Cyclic cuff inflation of 10 kPa and 20 kPa was reasonably well tolerated. Practitioner summary Soft exoskeleton compression of the knee was simulated during static and dynamic compression cycles. The results can be used to understand how users tolerate pressure at the knee, and also to understand the levels at which discomfort and pain are experienced. Abbreviations: BMI: body mass index; DDT: discomfort detection threshold; EndVAS: end of experiment rating on visual analog discomfort scale; PDT: pain detection threshold; SD: standard deviation; SE: standard error; TSP: temporal summation of pain; VAS: visual analogue scale.

Discomfort/Pain and Tissue Oxygenation at the Lower Limb During Circumferential Compression: Application to Soft Exoskeleton Design.

OBJECTIVE: To establish the relationship between circumferential compression on the lower limb during simulated ramp and staircase profile loading, and the resultant relationship with discomfort/pain and tissue oxygenation. BACKGROUND: Excessive mechanical loading by exoskeletons on the body can lead to pressure-related soft tissue injury. Potential tissue damage is associated with objective oxygen deprivation and accompanied by subjective perception of pain and discomfort. METHOD: Three widths of pneumatic cuffs were inflated at the dominant thigh and calf of healthy participants using two inflation patterns (ramp and staircase), using a computer-controlled pneumatic rig. Participants rated discomfort on an electronic visual analog scale and deep tissue oxygenation was monitored using near infrared spectroscopy. RESULTS: Circumferential compression with pneumatic cuffs triggered discomfort and pain at lower pressures at the thigh, with wider cuffs, and with a ramp inflation pattern. Staircase profile compression caused an increase in deep tissue oxygenation, whereas the ramp profile compression decreased it. CONCLUSION: Discomfort and pain during circumferential compression at the lower limb is related to the width of pneumatic cuffs, the inflation pattern, and the volume of soft tissue at the assessment site. The occurrence of pain is also possibly related to the decrease in deep tissue oxygenation during compression. APPLICATION: Our findings can be used to inform safe and comfortable design of soft exoskeletons to avoid discomfort and possible soft tissue injury.

A Radiopaque Nanoparticle-Based Ink Using PolyJet 3D Printing for Medical Applications.

The aim of this study was to develop a 3D printable radiopaque ink and successfully print a finished artifact. Radiopaque 3D printing would be hugely beneficial to improve the visibility of medical devices and implants, as well as allowing more realistic phantoms and calibration aids to be produced. Most 3D printing technologies are polymer based. Polymers are naturally radiolucent, allowing X-rays to pass through, showing up as faint dark gray regions on X-ray detectors, as for soft tissues. During this study, a 3D printable ultraviolet (UV) curable resin containing zirconium oxide (ZrO2) nanoparticles was developed. 5 wt.% ZrO2 was dispersed in a base resin using a high-shear mixer. Particles remained in suspension for 6-8 h at room temperature, allowing time for 3D printing. A model of a hand including radiopaque bones and a test block demonstrating a range of internal radiopaque features were successfully 3D printed. Radiopacity was demonstrated in the 3D-printed models, and there was good dispersion of ZrO2 within the resin matrix. The impregnated resin remained UV curable and viscosity was not compromised. In this study, 3D-printed radiopaque features demonstrated clear radiopacity under X-ray and microcomputed tomography imaging.

Oscillating Positive Expiratory Pressure Therapy May Be Performed Poorly by Children With Cystic Fibrosis.

BACKGROUND: Oscillating positive expiratory pressure devices aid removal of excess secretions and reduce gas trapping in patients with hypersecretory pulmonary diseases, for example, cystic fibrosis. Oscillating positive expiratory pressure works when the patient exhales actively against a fixed resistor, which generates mean intrapulmonary pressures of 10-20 cm H2O with rapid fluctuations of at least 1 cm H2O from the mean. In this study, we evaluated the performance of oscillating positive expiratory pressure therapy by pediatric subjects with cystic fibrosis to determine adherence to target therapeutic pressures. METHODS: Twenty-one pediatric subjects were recruited. Each had a history of using an oscillating positive expiratory pressure device twice daily and had received standardized training and instructions from the same specialist physiotherapist. Performance was evaluated by using a flow and pressure sensor placed in-line between the participant's mouth and the device. The participants performed expirations as per their normal routine. RESULTS: None of the participants achieved target therapeutic pressure ranges during expiration. The mean ± SD pressure generated was 16.2 ± 6.8 cm H2O, whereas mean ± SD flow was 31.3 ± 8.9 L/min. The mean ± SD expiration length was 2.5 ± 1.4 s. CONCLUSIONS: Despite standardized instruction, the results demonstrated considerable variation among the participants and overall poor technique during use. Outcomes of this study indicated that airway clearance effects of oscillating positive expiratory pressure were compromised due to poor technique.

Shrinking the Supply Chain for Implantable Coronary Stent Devices.

Stenting treatments for the management of disease in the heart, arterial and venous systems, biliary ducts, urethras, ureters, oesophageal tract and prostate have made enormous technical advances since their introduction into clinical use. The progression from metallic to polymer based bio-absorbable stents, coupled with the advances in additive manufacturing techniques, present a unique opportunity to completely re-envision the design, manufacture, and supply chain of stents. This paper looks at current stenting trends and proposes a future where the stent supply chain is condensed from ~150 days to ~20 min. The Cardiologist therefore has the opportunity to become a designer, manufacturer and user with patients receiving custom stents specific to their unique pathology that will be generated, delivered and deployed in the Cath-lab. The paper will outline this potentially revolutionary development and consider the technical challenges that will need to be overcome in order to achieve these ambitious goals. A high level overview of the generating eluting stents in situ program-GENESIS-is outlined including some early experimental work.