Device Insertion Research Articles

Benchtop impaction device replicates cadaveric loading conditions of the transforaminal lumbar interbody fusion (TLIF) procedure

Background contextLumbar spine disc pathologies often necessitate removal of the intervertebral disc and implantation of a lumbar interbody fusion (LIF) device. Herein, the objective was to measure use condition forces while simulating intra-operative loading conditions of transforaminal lumbar interbody fusion (TLIF) procedures. MethodsIn this work, we developed a transferable method to measure impact forces in a cadaveric intra-operative setting and designed a drop weight benchtop device equipped with force and displacement sensors to replicate cadaveric impact conditions, including number of strikes required for interbody device insertion, peak force, initial slope of the impact waveform, impact duration, and area under the force-time curve (impulse). Following cadaveric testing, a benchtop biomechanical study varying interbody device height, drop height, and drop weight was performed to evaluate the utility of the benchtop device to replicate impact loading conditions which occurred in the cadaveric model. ResultsSeveral benchtop test groups replicated the cadaver group in number of strikes required for device insertion. The average cadaveric peak force, 13.03 kN, was replicated by three benchtop groups: 12 mm device height, 60 cm drop height, 0.75 lb drop weight; 12 mm device height, 60 cm drop height, 1.0 lb drop weight; and 14 mm device height, 60 cm drop height, 0.50 lb drop weight. The initial slope of the impact waveform was replicated best by 12 mm devices. Both the impact duration and impulse were lower in all benchtop groups than in cadaver testing. ConclusionsThis work validated the outfitting of an impact force sensor onto an interbody device insertion instrument as a reproducible, quantifiable method for collecting impact loading data in a cadaveric model. This benchtop device and methodology will aid in testing interbody devices relative to anticipated use conditions, enhance interbody device designs, and accelerate surgical technique refinement.

The Impact of Implementing the Vortex Approach on Airway Management Performance in Stressed Medical Students: A Randomized Controlled Simulation Study.

BACKGROUND The ability to manage airways in emergencies is paramount, especially for less experienced medical students. Although the Vortex Approach, a useful scheme to support decision-making during airway management, promises structured guidance, there's limited research on its benefits among students. Our study aimed to evaluate student proficiency in a simulated difficult airway scenario and assess the advantages of the Vortex Approach. MATERIAL AND METHODS Medical students initially practiced on low-fidelity mannequins. Subsequently, they were divided into Vortex (n=48) and control groups (n=48). The Vortex group received specialized training. Both groups encountered a simulated scenario focusing on proper ventilation and supraglottic device insertion when traditional intubation failed. Performance was assessed using the airway management outcome score (AMOS). RESULTS The Vortex-trained group demonstrated superior capabilities. Fewer participants exceeded 3 lifeline interventions (4.2% vs 16.7%, P=0.046). The Vortex group consistently optimized subsequent attempts (31.3% vs 10.4%, P=0.01) and reduced prolonged apnea episodes (47.9% vs 81.3%, P=0.0009). Their AMOS scores were notably higher (56.3% vs 27.1%, AMOS=2, P=0.002), reflecting better patient outcomes (41.7% vs 10.4%, P=0.0005). CONCLUSIONS There is a marked need to enhance airway management skills among senior medical students. The Vortex Approach, even after brief exposure, yields significant skill improvements, underscoring its potential as a pivotal component in medical training. Integrating it into the curriculum could bridge the evident skill gap, optimizing future patient care.

Postpartum intrauterine device (PPIUD) insertion: A single centre follow-up telephone survey assessing clinical outcomes and client perception

Introduction: Closely spaced pregnancies result in adverse maternal perinatal and infant outcomes. Postpartum Family Planning (PPFP) enables women to achieve healthy intervals between births, potentially averting maternal deaths and reducing child mortality. The PPIUD enables women to leave the birth facility with a safe, effective, long-acting, reversible method already in place.The aim of the study was to study clinical outcomes and client perceptions on follow-up after insertion of PPIUD from 2014 to 2019 at the Teaching Hospital, Mahamodara (THM), Galle, Sri Lanka.Results: A total of 46,815 deliveries were reported in the facility during the study period, and 470 (3.4%) PPIUD insertions were carried out. Only 67/470 (14.3%) women who had PPIUD responded to the survey. The median (IQR) duration of PPIUD in situ was 63 (39 - 76) months, and it was positively correlated with the satisfaction score (Spearman’s rho 0.29, p=0.02). Out of all, 58 (86.6%) women recommended PPIUD to a friend as a PPFP method. Median (IQR) satisfaction score for the PPIUD was 9.5 (5.5 - 9.5), and most women (65.7%) were satisfied with PPIUD. However, 19.4% of women responded as ‘Neutral’ to the questionnaire. There were no uterine perforations or ectopic pregnancies.Conclusions: The study shows that PPIUD is a good option as an effective contraceptive method before leaving the birth facility.

Low-speed instrumented drill press for bone screw insertion

Screw insertion torque is a widely used/effective method for quantifying fixation strength in orthopedic implant research for different screw geometries, implantation sites, and loads. This work reports the construction of an open-source instrumented benchtop screw insertion device for a total cost of $7545 ($492 + $7053 for equipped sensors), as well as validation of the device and an example use-application. The insertion device is capable of recording the axial load, rotational speed, and applied torque throughout the screw insertion process at 10 samples per second, as demonstrated in the validation test. For this combination of bone analog (20 PCF Sawbones©), screw, and loading, the resolution of the torque sensor was 25% of the maximum measured torque; a different model torque sensor would be required to meet ASTM F543-17, which specifies a resolution of 10% of the maximum torque. This system is optimized for fastener insertion at speeds of 120 rpm or less and axial loading up to 50 N.

Real-World Utilization of an Intrauterine, Vacuum-Induced, Hemorrhage-Control Device.

To assess the real-world effectiveness and safety of a U.S. Food and Drug Administration (FDA)-cleared intrauterine vacuum-induced-hemorrhage control device for postpartum hemorrhage (PPH) management. Sixteen centers in the United States participated in this observational, postmarket registry medical record review (October 2020 through March 2022). The primary effectiveness outcome was treatment success , defined as bleeding control after insertion with no treatment escalation or bleeding recurrence. Additional outcomes included blood loss, time to device insertion, indwelling time, bleeding recurrence, and time to bleeding control. Treatment success and severe maternal morbidity measures (transfusion of 4 or more units of red blood cell, intensive care unit admission, and hysterectomy) were evaluated by blood loss before insertion. To assess safety, serious adverse events (SAEs) and adverse device effects were collected. All outcomes were summarized by mode of delivery; treatment success was summarized by bleeding cause (all causes, any atony, isolated atony, nonatony). In total, 800 individuals (530 vaginal births, 270 cesarean births) were treated with the device; 94.3% had uterine atony (alone or in combination with other causes). Median total blood loss at device insertion was 1,050 mL in vaginal births and 1,600 mL in cesarean births. Across all bleeding causes, the treatment success rate was 92.5% for vaginal births and was 83.7% for cesarean births (95.8% [n=307] and 88.2% [n=220], respectively, in isolated atony). Median indwelling time was 3.1 hours and 4.6 hours, respectively. In vaginal births, 14 SAEs were reported among 13 individuals (2.5%). In cesarean births, 22 SAEs were reported among 21 individuals (7.8%). Three (0.4%) SAEs were deemed possibly related to the device or procedure. No uterine perforations or deaths were reported. For both vaginal and cesarean births in real-world settings, rapid and effective bleeding control was achieved with an FDA-cleared intrauterine vacuum-induced hemorrhage-control device. The safety profile was consistent with that observed in the registrational trial (NCT02883673), and SAEs or adverse device effects were of the nature and severity expected in the setting of PPH. This device is an important new tool for managing a life-threatening condition, and timely utilization may help to improve obstetric hemorrhage outcomes. ClinicalTrials.gov , NCT04995887.

EFFICACY AND SAFETY OF INTRA CAESAREAN IUCD

The objective of this study was to evaluate the effectiveness and complications of post-partum intrauterine contraceptive device (PPIUCD) insertion during cesarean delivery. The study was conducted at Nishtar Medical Hospital from June to December 2022. A total of 150 women were included in the study. In the first phase, medical eligibility for the intervention was assessed, while in the second phase, WHO Medical Eligibility Criteria were evaluated. The IUCD was manually inserted after delivery with its string towards the cervix. The patients were followed up at 2 and 6 months. After 6 months, 9 (6%) cases reported abdominal pain, 22 (15%) had menorrhagia, and 23 (15.3%) had missed threads with the IUCD in place. None of the patients reported pregnancy or perforation of the uterus. After 6 months, 133 (88.6%) patients continued to use this method of contraception, while 9(6%) were lost to follow-up, 4 (2.6%) had the device removed due to complications, and 4 (2.6%) had spontaneous expulsion. The study concluded that PPIUCD is a safe and effective long-term contraceptive method. Clinicians should evaluate patients' eligibility for PPIUCD and counsel women on adopting this method.

Risk Factors for Glaucoma Diagnosis and Surgical Intervention following Pediatric Cataract Surgery in the IRIS® Registry

To compare demographic and clinical factors associated with glaucoma following cataract surgery (GFCS) and glaucoma surgery rates between infants, toddlers, and older children using a large, ophthalmic registry. Retrospective cohort study. Patients in the IRIS®Registry (Intelligent Research in Sight) who underwent cataract surgery at ≤ 17 years old and between January 1, 2013 and December 31,2020. Glaucoma diagnosis and procedural codes were extracted from the electronic health records of practices participating in the IRIS Registry. Children with glaucoma diagnosis or surgery before cataract removal were excluded. The Kaplan-Meier estimator was used to determine the cumulative probability of GFCS diagnosis and glaucoma surgery after cataract surgery. Multivariable Cox regression was used to identify factors associated with GFCS and glaucoma surgery. Cumulative probability of glaucoma diagnosis and surgical intervention within 5 years after cataract surgery. The study included 6658 children (median age, 10.0 years; 46.2% female). The 5-year cumulative probability of GFCS was 7.1% (95% confidence interval [CI], 6.1%-8.1%) and glaucoma surgery was 2.6% (95% CI, 1.9%-3.2%). The 5-year cumulative probability of GFCS for children aged < 1 year was 22.3% (95% CI, 15.7%-28.4%). Risk factors for GFCS included aphakia (hazard ratio [HR], 2.63; 95% CI, 1.96-3.57), unilateral cataract (HR, 1.48; 95% CI, 1.12-1.96), and Black race (HR, 1.61; 95% CI, 1.12-2.32). The most common surgery was glaucoma drainage device insertion (32.6%), followed by angle surgery (23.3%), cyclophotocoagulation (15.1%), and trabeculectomy (5.8%). Glaucoma following cataract surgery diagnosis in children in the IRIS Registry was associated with young age, aphakia, unilateral cataract, and Black race. Glaucoma drainage device surgery was the preferred surgical treatment, consistent with the World Glaucoma Association 2013 consensus recommendations for GFCS management. Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

PECS II block for cardiac implantable electronic device insertion: A pilot study.

Some truncal blocks could provide adequate surgical anesthesia and postoperative analgesia in cardiac implantable electronic devices (CIED) insertion. The aim of this study was to evaluate the feasibility of the pectoral nerves (PECS) II block for CIED insertion. PECS II blocks were performed on the left side using the ultrasound-guided single injection technique in all patients. The primary outcome for feasibility was the percentage of the cases completed without intraoperative additional local anesthesia. Secondary outcomes were the amount of intraoperative additional local anesthetic, intraoperative opioid requirement, postoperative pain scores, first requirement for postoperative analgesia, postoperative analgesic consumption, patient satisfaction, and block-related complications. Of the total 30 patients, 19 (63.3%) required intraoperative additional local anesthetic. The median (IQR [range]) volume of the additional local anesthetic used was 7 (4-10 [2.5-12]) mL. Two patients needed additional IV analgesics in the first 24h postoperatively. No statistically significant differences were determined between the patients requiring and not requiring intraoperative additional local anesthetic in respect of age, gender, duration of surgery, block performance time, and hospital stay. A total of 26 (86.6%) patients reported a high level of satisfaction with the procedure. PECS II block for cardiac electronic implantable device insertion provides effective postoperative analgesia for at least 24h. Although PECS II block alone could not provide complete surgical anesthesia in the majority of the patients, when combined with supplementary local anesthetic, contributes to a smooth intraoperative course for patients.

Comparison of Baska Mask Versus I-Gel in Short Gynaecological Laparoscopic Surgeries Under General Anaesthesia in Adult Female: A Randomized Interventional Study

Background: Various newer generations of Supraglottic Airway Devices (SAD) with improved designs and performance are available for use by anaesthesiologist. We conducted the present study to compare 3rd generation SAD Baska Mask with 2nd generation SAD I-gel with the aim of comparing their clinical performance in terms of insertion parameters and oropharyngeal leak pressure in short laparoscopic gynaecological surgeries in adult females.&#x0D; Methods: 80 adult female patients were randomly allocated to either Baska Mask (n=40) or I-gel (n=40) groups. Insertion characteristics that included number of attempts, mean insertion time and manipulation frequency were recorded and compared. Oropharyngeal leak pressure was measured just after insertion of device and after 5 min of creating pneumoperitoneum in both devices and were compared.&#x0D; Results: Baska Mask insertion was successfully achieved in first attempt in 38/40 patients in Baska group vs 35/40 patients in I-gel group. Mean oropharyngeal leak pressure (OLP) in Baska Mask versus I-gel just after insertion was (29.24±4.20cm H20 vs 26.33±2.51cm H2O, P=0.003) whereas it was (29.42±2.70 vs 26.18±2.54 cm H2O) after 5 min of creating pneumoperitoneum. Both groups were comparable in terms of removal characteristics and postoperative laryngopharyngeal airway morbidities.&#x0D; Conclusion: Baska Mask provided more effective ventilation in terms of greater oropharyngeal leak pressure as compared to I-gel. However Baska Mask was more difficult to insert and the incidence of postoperative laryngopharyngeal morbidity was higher in case of Baska Mask.

Knowledge, Attitude, and Practice of Brazilian Physicians about Immediate Postpartum and Postabortion Intrauterine Device Insertion.

To assess the knowledge, attitude, and practice of Brazilian physicians about immediate postpartum and postabortion intrauterine device insertion. Cross-sectional online survey involving physicians on duty in public Brazilian hospitals. Participants answered an anonymous questionnaire with close-ended questions to assess their knowledge, attitude, and experience on the immediate postpartum and postabortion insertion of copper intrauterine devices. One hundred twenty-seven physicians working in 23 hospitals in the 5 geographic regions of Brazil completed the questionnaire. Most were female (68.5%) and worked in teaching hospitals (95.3%). The mean (standard deviation) knowledge score (0-10 scale) was 5.3 (1.3); only 27.6% of the participants had overall scores ≥ 7.0. Most physicians (73.2%) would insert a postpartum intrauterine device in themselves/family members. About 42% of respondents stated that they had not received any training on postpartum or postabortion intrauterine device insertion. In the past 12 months, 19.7%, 22.8%, and 53.5% of respondents stated they had not inserted any intrauterine device during a cesarean section, immediately after a vaginal delivery, or after an abortion, respectively. Most study participants have a positive attitude toward the insertion of intrauterine devices in the immediate postpartum period, but they have limited knowledge about the use of this contraceptive method. A large percentage of respondents did not have previous training on postpartum and postabortion intrauterine device insertion and had not performed any such insertions in the last 12 months. Strategies are needed to improve the knowledge, training, and experience of Brazilian physicians on immediate postpartum and postabortion intrauterine device insertion.

The Insertion of Intrauterine Devices in the Immediate Postpartum Period Remains an Important Missed Opportunity to Prevent Unplanned Pregnancies in Brazil.

The Insertion of Intrauterine Devices in the Immediate Postpartum Period Remains an Important Missed Opportunity to Prevent Unplanned Pregnancies in Brazil.

Temporal bone phantom for decoupled cochlear implant electrode insertion force measurement

Abstract In research on cochlear implants, preclinical testing of newly developed electrode arrays and surgical tools is an essential procedure, which requires the availability of a suitable testing environment. For this purpose, human temporal bone specimens are most realistic, but their availability is limited and additional parameters such as insertion forces are hardly measurable. Therefore, the aim of this study was to develop a temporal bone phantom with realistic anatomical structures for intracochlear force measurement. The temporal bone was segmented from CBCT data of a human cadaver head. The segmented model was 3D printed with an additional artificial skin layer to enable the simulated use of surgical instruments such as a self-retaining retractor. A mechanically decoupled artificial cochlear model was realistically positioned within the temporal bone and was furthermore attached to a force sensor. The usability of the phantom was evaluated by performing automated EA insertions using an automated hydraulic insertion device. The experiments showed that the insertion forces within the cochlea could be measured without interferences from surrounding structures. Moreover, the artificial skin provided a rigid interface for the insertion tool. The new phantom is a realistic testing and training platform for cochlear implant electrode insertions with the advantage of measureable insertion forces.

How to Prepare for Advancement to Central Venous Access Device Insertion Beyond Peripherally Inserted Central Catheters: Socially Relevant

How to Prepare for Advancement to Central Venous Access Device Insertion Beyond Peripherally Inserted Central Catheters: Socially Relevant

Glycosaminoglycans: Roles in wound healing, formation of corneal constructs and synthetic corneas

Maintaining the clarity of the cornea is essential for vision, and is achieved through an exquisite array of collagen fibrils and proteoglycans in the corneal stroma. Alterations in the identity and modifications of the glycosaminoglycans (GAGs) are seen both throughout the normal wound healing process and in pathological conditions resulting in corneal opacity. Understanding these changes has been essential for the development of corneal prostheses and corneal reconstruction. The goal of this review article is to summarize and consolidate research in the alterations seen in glycosaminoglycans in injured and hypoxic states, address the role of proteins that can regulate glycosaminoglycans in the corneal wound healing process, and apply these findings to the context of corneal restoration through reconstruction or the insertion of synthetic devices.

Statement of Retraction [Different analgesics prior to intrauterine device insertion: is there any evidence of efficacy?

Statement of Retraction [Different analgesics prior to intrauterine device insertion: is there any evidence of efficacy?

Double Skin Façade Mechanical Systems as Ad-vanced Building Technologies

The double-wall façades (or “double skin façades”) are deter-mined as building mechanical and engineered systems realized by the cavity between the inner curtain and the outer screen, for thermal and acoustic insulation, for ventilation and for the inser-tion of functional devices (such as sunscreens) and, also, plant ducts. The cavity between the two enclosures constitutes a venti-lated cavity that can be used according to certain modes of func-tioning (passive or active type) aimed at controlling external cli-matic and environmental stresses in order to regulate the condi-tions of the interior spaces. The double envelope system is real-ized as an apparatus of mediation and reaction towards envi-ronmental loads, according to the needs of well-being and reduc-tion of energy consumption. In general, the system offers the functioning in the form of a passive solar system, assuming the use and accumulation of solar radiation for the regulation of indoor thermal comfort conditions, and the functioning for the capture and input of air flows. The calibration of solar radiation is integrated with the use of shading devices in order to achieve diffuse lighting conditions in interior spaces. In addition, the application of the double glass surface reduces thermal losses from the interior spaces by reducing the speed of the airflow in contact with the inner curtain, increasing thermal insulation. The system foresees that the ventilated cavity performs various inte-grated functions (for the definition of complex mechanisms of dynamic interaction with the external climatic conditions), both permanent (e.g. for the increase of thermal inertia and acoustic insulation relative to the internal curtain) and temporary (e.g. for the cooling of the same spaces during periods of high tempera-ture).

Sustained Delivery of the Antiviral Protein Griffithsin and Its Adhesion to a Biological Surface by a Silk Fibroin Scaffold.

The protein Griffithsin (Grft) is a lectin that tightly binds to high-mannose glycosylation sites on viral surfaces. This property allows Grft to potently inhibit many viruses, including HIV-1. The major route of HIV infection is through sexual activity, so an important tool for reducing the risk of infection would be a film that could be inserted vaginally or rectally to inhibit transmission of the virus. We have previously shown that silk fibroin can encapsulate, stabilize, and release various antiviral proteins, including Grft. However, for broad utility as a prevention method, it would be useful for an insertable film to adhere to the mucosal surface so that it remains for several days or weeks to provide longer-term protection from infection. We show here that silk fibroin can be formulated with adhesive properties using the nontoxic polymer hydroxypropyl methylcellulose (HPMC) and glycerol, and that the resulting silk scaffold can both adhere to biological surfaces and release Grft over the course of at least one week. This work advances the possible use of silk fibroin as an anti-viral insertable device to prevent infection by sexually transmitted viruses, including HIV-1.

Management of Vasoplegic Shock in Left Ventricular Assist Device Insertion Procedures.

Management of Vasoplegic Shock in Left Ventricular Assist Device Insertion Procedures.

Risks of Uterine Perforation and Expulsion Associated With Intrauterine Devices.

The APEX-IUD (Association of Perforation and Expulsion of Intrauterine Devices) study evaluated the association of postpartum timing of intrauterine device (IUD) insertion, breastfeeding, heavy menstrual bleeding, and IUD type (levonorgestrel-releasing vs copper) with risks of uterine perforation and IUD expulsion in usual clinical practice. We summarize the clinically important findings to inform counseling and shared decision making. APEX-IUD was a real-world (using U.S. health care data) retrospective cohort study of individuals aged 50 years and younger with IUD insertions between 2001 and 2018 and with electronic health record data. Cumulative incidences of uterine perforation and IUD expulsion were calculated. Adjusted hazard ratios (aHRs) and 95% CIs were estimated from proportional hazards models with control of confounding. Among the study population of 326,658, absolute risk of uterine perforation was low overall (cumulative incidence, 0.21% [95% CI 0.19-0.23%] at 1 year and 0.61% [95% CI 0.56-0.66% at 5 years]) but was elevated for IUDs inserted during time intervals within 1 year postpartum, particularly among those between 4 days and 6 weeks postpartum (aHR 6.71, 95% CI 4.80-9.38), relative to nonpostpartum insertions. Among postpartum insertions, IUD expulsion risk was greatest for insertions in the immediate postpartum period (0-3 days after delivery) compared with nonpostpartum (aHR 5.34, 95% CI 4.47-6.39). Postpartum individuals who were breastfeeding had a slightly elevated risk of perforation and lowered risk of expulsion than those not breastfeeding. Among nonpostpartum individuals, those with a heavy menstrual bleeding diagnosis were at greater risk of expulsion than those without (aHR 2.84, 95% CI 2.66-3.03); heavy menstrual bleeding also was associated with a slightly elevated perforation risk. There was a slightly elevated perforation risk and slightly lower expulsion risk associated with levonorgestrel-releasing IUDs compared with copper IUDs. Absolute risk of adverse outcomes with IUD insertion is low. Clinicians should be aware of the differences in risks of uterine perforation and expulsion associated with IUD insertion during specific postpartum time periods and with a heavy menstrual bleeding diagnosis. This information should be incorporated into counseling and decision making for patients considering IUD insertion. Bayer AG. EU PAS register, EUPAS33461.

Statement of Retraction [Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial

Statement of Retraction [Self-administrated vaginal 2% lidocaine in-situ gel for pain relief during copper intrauterine device insertion in women with previous caesarean delivery only: a randomised, double-blind placebo-controlled trial