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Sensors (Basel, Switzerland) Sep 2023This article presents a prototype of a new, non-invasive, cuffless, self-calibrating blood pressure measuring device equipped with a pneumatic pressure sensor. The...
This article presents a prototype of a new, non-invasive, cuffless, self-calibrating blood pressure measuring device equipped with a pneumatic pressure sensor. The developed sensor has a double function: it measures the waveform of blood pressure and calibrates the device. The device was used to conduct proof-of-concept measurements on 10 volunteers. The main novelty of the device is the pneumatic pressure sensor, which works on the principle of a pneumatic nozzle flapper amplifier with negative feedback. The developed device does not require a cuff and can be used on arteries where cuff placement would be impossible (e.g., on the carotid artery). The obtained results showed that the systolic and diastolic pressure measurement errors of the proposed device did not exceed ±6.6% and ±8.1%, respectively.
Topics: Humans; Calibration; Blood Pressure; Blood Pressure Determination; Amplifiers, Electronic; Arteries
PubMed: 37766043
DOI: 10.3390/s23187985 -
Revista Brasileira de Enfermagem 2023to evaluate the outcomes of Interval Copper Intrauterine Device (IUD) insertion performed by certified midwives and obstetric nurse practitioners at a Peri-Hospital...
OBJECTIVES
to evaluate the outcomes of Interval Copper Intrauterine Device (IUD) insertion performed by certified midwives and obstetric nurse practitioners at a Peri-Hospital Birth Center.
METHODS
a cross-sectional study was conducted involving 75 women who underwent IUD insertion between January 2018 and February 2020. Data collection was carried out using medical records and telephone interviews.
RESULTS
no instances of uterine perforation were observed. Expulsion rates of the devices were 1.3% within 30 to 45 days of use and 5.3% within the first year of use. The follow-up removal rate was 4.0%. The average pain score reported was 4.2 (SD = 3.3). Among those who continued using the device, 93.1% expressed satisfaction.
CONCLUSIONS
the findings demonstrate that IUD insertion by certified midwives and obstetric nurse practitioners is a safe procedure, yielding outcomes comparable to those reported in the existing literature.
Topics: Pregnancy; Female; Humans; Intrauterine Devices; Cross-Sectional Studies; Midwifery; Intrauterine Devices, Copper
PubMed: 38018608
DOI: 10.1590/0034-7167-2022-0286 -
JACC. Clinical Electrophysiology Sep 2023Permanent pacemakers (PPMs) may be necessary in up to 10% of patients after heart transplantation (HT).
BACKGROUND
Permanent pacemakers (PPMs) may be necessary in up to 10% of patients after heart transplantation (HT).
OBJECTIVES
The purpose of this study was to evaluate long-term outcomes and clinical courses of heart transplant recipients who received PPM.
METHODS
All patients who required PPM after bicaval HT at Columbia University between January 2005 and December 2021 were included. Cases were compared to matched heart transplant recipients by age, sex, and year of transplantation. Patient and device characteristics including complications and device interrogations were reviewed. Outcomes of re-transplantation or graft failure/death were compared between groups.
RESULTS
Of 1,082 heart transplant recipients, 41 (3.8%) received PPMs. The median time from transplantation to PPM was 118 days (IQR: 18-920 days). The most common indications were sinus node dysfunction (60%, n = 25) and atrioventricular (AV) nodal disease (41.5%, n = 17). Post-implantation complications included pocket hematoma (n = 3), lead under-sensing (n = 2), and pocket infection requiring explant (n = 1). Rates of death and re-transplantation at 10 years post-HT were similar between groups. In multivariable analysis, after adjustment for mechanical circulatory support, pretransplantation amiodarone use, donor ischemic time and age, only older donor age was associated with increased risk of PPM implantation (P = 0.03). There was a significant decrease in PPM placement after 2018 (1.2% vs 4.4%, P = 0.02), largely driven by a decline in early PPM placement. There were no differences in mortality or need for re-transplantation between groups.
CONCLUSIONS
PPMs are implanted after HT for sinus and atrioventricular node dysfunctions with low incidence of device-related complications. Our study shows a decrease in PPM implantation after 2018, likely attributable to expectant management in the early postoperative period.
Topics: Humans; Heart Transplantation; Amiodarone; Cardiac Conduction System Disease; Hematoma; Pacemaker, Artificial
PubMed: 37480861
DOI: 10.1016/j.jacep.2023.05.020 -
Biosensors May 2024The demand for easy-to-use, affordable, accessible, and reliable technology is increasing in biological, chemical, and medical research. Microfluidic devices have the... (Review)
Review
The demand for easy-to-use, affordable, accessible, and reliable technology is increasing in biological, chemical, and medical research. Microfluidic devices have the potential to meet these standards by offering cost-effective, highly sensitive, and highly specific diagnostic tests with rapid performance and minimal sample volumes. Traditional microfluidic device fabrication methods, such as photolithography and soft lithography, are time-consuming and require specialized equipment and expertise, making them costly and less accessible to researchers and clinicians and limiting the applicability and potential of microfluidic devices. To address this, researchers have turned to using new low-cost materials, such as double-sided tape for microfluidic device fabrication, which offers simple and low-cost processes. The innovation of low-cost and easy-to-make microfluidic devices improves the potential for more devices to be transitioned from laboratories to commercialized products found in stores, offices, and homes. This review serves as a comprehensive summary of the growing interest in and use of double-sided tape-based microfluidic devices in the last 20 years. It discusses the advantages of using double-sided tape, the fabrication techniques used to create and bond microfluidic devices, and the limitations of this approach in certain applications.
Topics: Microfluidics; Lab-On-A-Chip Devices; Cost-Benefit Analysis; Microfluidic Analytical Techniques; Equipment Design; Humans
PubMed: 38785723
DOI: 10.3390/bios14050249 -
Skin Research and Technology : Official... Nov 2023An excessive proliferation of fibroblasts and collagen synthesis after an injury may lead to a benign fibrous tumor, known as keloid, which does not regress...
INTRODUCTION
An excessive proliferation of fibroblasts and collagen synthesis after an injury may lead to a benign fibrous tumor, known as keloid, which does not regress spontaneously. Earlobes are a very frequent site of onset, since after a trauma (i.e., piercing) keloids may develop either on the helix and on the anterior or posterior lobe, from a few months up to several years after the injury.
OBJECTIVES
To report the effectiveness of a combined protocol of CO2 laser + Dye laser + a portable Blue LED Light medical device for Photobiomodulation Therapy (EmoLED®).
METHODS
Fifty-two patients with a total of 56 ear keloids have been treated in the same session with a single CO2 laser procedure + a pulsed Dye laser procedure with an adjunctive EmoLED® procedure for 3 up to 6 min. A monthly follow-up has been performed with an adjunctive EmoLED® session in case of signs of inflammation.
RESULTS
Among 56 treated keloids, 89.3% of them (50/56) did not recur during a follow-up period (from 6 up to 24 months, mean 16.3 months) while six keloids recurred (6/56, 10.7%) with mild thickening of the scar, thus requiring further treatments.
CONCLUSIONS
Even if an excellent outcome obtained by the synergistic effect of combined laser treatments has already been described (i.e., CO2 laser + Dye Laser), the present study showed the adjuvant procedure with EmoLED® can reduce significantly the risk of keloids recurrences.
Topics: Humans; Keloid; Inflammation; Lasers, Gas; Recurrence; Light; Treatment Outcome
PubMed: 38009040
DOI: 10.1111/srt.13506 -
Scientific Reports Sep 2023The development of wearable bioelectronic systems is a promising approach for optimal delivery of therapeutic treatments. These systems can provide continuous delivery...
The development of wearable bioelectronic systems is a promising approach for optimal delivery of therapeutic treatments. These systems can provide continuous delivery of ions, charged biomolecules, and an electric field for various medical applications. However, rapid prototyping of wearable bioelectronic systems for controlled delivery of specific treatments with a scalable fabrication process is challenging. We present a wearable bioelectronic system comprised of a polydimethylsiloxane (PDMS) device cast in customizable 3D printed molds and a printed circuit board (PCB), which employs commercially available engineering components and tools throughout design and fabrication. The system, featuring solution-filled reservoirs, embedded electrodes, and hydrogel-filled capillary tubing, is assembled modularly. The PDMS and PCB both contain matching through-holes designed to hold metallic contact posts coated with silver epoxy, allowing for mechanical and electrical integration. This assembly scheme allows us to interchange subsystem components, such as various PCB designs and reservoir solutions. We present three PCB designs: a wired version and two battery-powered versions with and without onboard memory. The wired design uses an external voltage controller for device actuation. The battery-powered PCB design uses a microcontroller unit to enable pre-programmed applied voltages and deep sleep mode to prolong battery run time. Finally, the battery-powered PCB with onboard memory is developed to record delivered currents, which enables us to verify treatment dose delivered. To demonstrate the functionality of the platform, the devices are used to deliver H[Formula: see text] in vivo using mouse models and fluoxetine ex vivo using a simulated wound environment. Immunohistochemistry staining shows an improvement of 35.86% in the M1/M2 ratio of H[Formula: see text]-treated wounds compared with control wounds, indicating the potential of the platform to improve wound healing.
Topics: Animals; Mice; Wound Healing; Capillary Tubing; Dimethylpolysiloxanes; Disease Models, Animal
PubMed: 37679425
DOI: 10.1038/s41598-023-41572-w -
PloS One 2023Autoinjectors have become popular modern injectable medical devices used as drug delivery systems. Due to their ease, capability and reliability compared to other...
Autoinjectors have become popular modern injectable medical devices used as drug delivery systems. Due to their ease, capability and reliability compared to other conventional injectable medical devices, the market and manufacturing demand for autoinjector devices are increasing rapidly and expected to reach a market of $37.5 billion globally by 2025. Although autoinjectors can offset healthcare treatment costs through self-administered medication, they can be expensive for consumers, which limit their accessibility. This study describes the design and manufacture of a spring-driven and 3-D printed autoinjector to overcome this economic accessibility challenge. The digitally replicable device is released as open-source hardware to enable low-cost distributed manufacturing. The bill of materials and assembly instructions are detailed, and the effectiveness of the autoinjector is tested against the current standard (ISO 11608-1:2022) for needle-based injection systems. The safety and dosing accuracy was tested by measuring the weight of 100% ethyl alcohol expelled from six BD Insulin syringes with varying capacities or needle lengths. A one-way analysis assessed the variability between the dose delivery efficiency of 1mL, 0.5mL, and 0.3mL syringes. Testing indicated that the entire dose was delivered over 97.5% of the time for 1mL and 0.5mL syringes, but the autoinjector's loaded spring force and size exceeded structural limitations of 0.3mL or smaller syringes. Components can be manufactured in about twelve hours using an open-source desktop RepRap-class fused filament 3-D printer. The construction requires two compression springs and 3-D printed parts. The total material cost of CAD$6.83 is less than a tenth of comparable commercial autoinjectors, which makes this approach promising. The autoinjector, however, is a class two medical device and must be approved by regulators. Future work is needed to make distributed manufacturing of such medical devices feasible and reliable to support individuals burdened by healthcare costs.
Topics: Humans; Reproducibility of Results; Pharmaceutical Preparations; Syringes; Needles; Drug Delivery Systems
PubMed: 37450496
DOI: 10.1371/journal.pone.0288696 -
Farmacia Hospitalaria : Organo Oficial... 2024The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous... (Review)
Review
OBJECTIVE
The off-label use in clinical practice of non-approved syringes for intravitreal drug administration has resulted in the detection of silicone oil drops in the vitreous of some patients. This situation derives from the lack of approved syringes for intraocular use in the Spanish market. The aim of this work is to review the use of syringes for intraocular administration, as well as to search for alternatives that meet the legal requirements for these unmet needs.
METHOD
A systematic review was performed following the PRISMA 2020 guidelines by searching PubMed with the descriptors: (silicone) AND (syringes) AND ((intraocular) OR (intravitreal)) and filtering all existing publications from January 2006 to December 2023, including all those articles dealing with silicone oil release in intravitreal injections and analysing the possible consequences.
RESULTS
Sixty-eight results were found, 23 of which were excluded because they did not deal with the subject under study, leaving a total of 45 articles for the systematic review. These were classified according to the conclusions obtained in 4 groups: the adverse reactions produced by silicone; the administration technique; the physicochemical aspects of silicone release; and the characteristics of the medical device. After reviewing the current manufacturers and technical data sheets of commercialised syringes, the existing syringes for this use have been collected, finding 2 that will probably be commercialised in Spain at the beginning of 2024: Zero Residual™ 0.2 ml SiO-free and VitreJect® Ophthalmic.
CONCLUSIONS
From the results obtained, it can be interpreted that the use of syringes and needles with silicone for intravitreal use is a concern for health professionals due to the implications and consequences that may arise in patients, the most important being adverse reactions, so it is necessary to have silicone-free syringes on the market that are specific for intraocular use. Safety and legality in the use of intraocular syringes and needles is essential to guarantee ocular integrity and patient health.
Topics: Syringes; Humans; Silicone Oils; Intravitreal Injections; Off-Label Use; Spain
PubMed: 38705829
DOI: 10.1016/j.farma.2024.04.011 -
International Wound Journal Sep 2023The aim of this review study is to investigate the nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers (MDRPUs). An... (Review)
Review
The aim of this review study is to investigate the nurses' knowledge and related factors towards the prevention of medical device-related pressure ulcers (MDRPUs). An extensive search was conducted in international electronic databases such as PubMed, Web of Science, and Scopus, and Persian databases, such as Iranmedex and the Scientific Information Database from December 1, 2022. During this search, keywords extracted from Medical Subject Headings, such as "Prevention knowledge," "Nurse," "Pressure ulcer," "Equipment and Supplies," and "Intensive Care Units" were used. The quality of the present studies in this review was evaluated based on the appraisal tool for cross-sectional studies (AXIS tool). A total of 1847 nurses participated in this review from five studies, and the majority of them (82.94%) were female. The mean age of the participants was 31.40 (SD = 5.97). The mean score of MDRPUs prevention knowledge in nurses based on PU2014 scale and researcher-made questionnaires were 16.50 (SD = 3.74) out of 31 and 65.49 (SD = 6.33) out of 100, respectively. The knowledge of nurses is influenced by factors such as age, sex, level of education, work experience, technical titles, type of hospital, level of hospital, and type of ward. Various factors had a significant positive relationship with nurses' MDRPUs prevention knowledge, which includes level of education, work experience, previous training on MDRPU, having a wound care certificate, an online search about MDRPU, and attitude and practise towards MDRPU prevention. At the same time, nurses' knowledge about the prevention of MDRPUs had a significant negative relationship with the time interval since last participating in MDRPU training or workshop. Overall, the level of MDRPUs prevention knowledge among nurses was insufficient to moderate. Therefore, it is suggested to provide facilities for nurses to receive the necessary training.
Topics: Humans; Male; Female; Pressure Ulcer; Cross-Sectional Studies; Clinical Competence; Attitude of Health Personnel; Hospitals; Surveys and Questionnaires; Health Knowledge, Attitudes, Practice; Nurses
PubMed: 36792930
DOI: 10.1111/iwj.14122 -
BMJ Open Dec 2023The clinical assessment of Parkinson's disease (PD) symptoms can present reliability issues and, with visits typically spaced apart 6 months, can hardly capture their...
INTRODUCTION
The clinical assessment of Parkinson's disease (PD) symptoms can present reliability issues and, with visits typically spaced apart 6 months, can hardly capture their frequent variability. Smartphones and smartwatches along with signal processing and machine learning can facilitate frequent, remote, reliable and objective assessments of PD from patients' homes.
AIM
To investigate the feasibility, compliance and user experience of passively and actively measuring symptoms from home environments using data from sensors embedded in smartphones and a wrist-wearable device.
METHODS AND ANALYSIS
In an ongoing clinical feasibility study, participants with a confirmed PD diagnosis are being recruited. Participants perform activity tests, including Timed Up and Go (TUG), tremor, finger tapping, drawing and vocalisation, once a week for 2 months using the Mobistudy smartphone app in their homes. Concurrently, participants wear the GENEActiv wrist device for 28 days to measure actigraphy continuously. In addition to using sensors, participants complete the Beck's Depression Inventory, Non-Motor Symptoms Questionnaire (NMSQuest) and Parkinson's Disease Questionnaire (PDQ-8) questionnaires at baseline, at 1 month and at the end of the study. Sleep disorders are assessed through the Parkinson's Disease Sleep Scale-2 questionnaire (weekly) and a custom sleep quality daily questionnaire. User experience questionnaires, Technology Acceptance Model and User Version of the Mobile Application Rating Scale, are delivered at 1 month. Clinical assessment (Movement Disorder Society-Unified Parkinson Disease Rating Scale (MDS-UPDRS)) is performed at enrollment and the 2-month follow-up visit. During visits, a TUG test is performed using the smartphone and the G-Walk motion sensor as reference device. Signal processing and machine learning techniques will be employed to analyse the data collected from Mobistudy app and the GENEActiv and correlate them with the MDS-UPDRS. Compliance and user aspects will be informing the long-term feasibility.
ETHICS AND DISSEMINATION
The study received ethical approval by the Swedish Ethical Review Authority (Etikprövningsmyndigheten), with application number 2022-02885-01. Results will be reported in peer-reviewed journals and conferences. Results will be shared with the study participants.
Topics: Humans; Parkinson Disease; Pilot Projects; Reproducibility of Results; Machine Learning; Wearable Electronic Devices
PubMed: 38154904
DOI: 10.1136/bmjopen-2023-077766