Project description:ObjectiveTo evaluate the effectiveness and safety of an intrauterine vacuum-induced hemorrhage-control device for postpartum hemorrhage treatment.MethodsA multicenter, prospective, single-arm treatment study of a novel intrauterine device that uses low-level vacuum to induce uterine myometrial contraction to achieve control of abnormal postpartum uterine bleeding and postpartum hemorrhage was undertaken at 12 centers in the United States. The primary effectiveness endpoint was the proportion of participants in whom use of the intrauterine vacuum-induced hemorrhage-control device controlled abnormal bleeding without requiring escalating interventions. The primary safety endpoint was the incidence, severity, and seriousness of device-related adverse events. Secondary outcomes included time to bleeding control, rate of transfusion, and device usability scored by each investigator using the device.ResultsOf 107 participants enrolled with primary postpartum hemorrhage or abnormal postpartum uterine bleeding, 106 received any study treatment with the device connected to vacuum, and successful treatment was observed in 94% (100/106, 95% CI 88-98%) of these participants. In those 100 participants, definitive control of abnormal bleeding was reported in a median of 3 minutes (interquartile range 2.0-5.0) after connection to vacuum. Eight adverse events deemed possibly related to the device or procedure were reported, all of which were outlined as risks in the study and all of which resolved with treatment without serious clinical sequelae. Transfusion of 1-3 units of red blood cells was required in 35 participants, and five participants required 4 or more units of red blood cells. The majority of investigators reported the intrauterine vacuum-induced hemorrhage-control device as easy to use (98%) and would recommend it (97%).ConclusionIntrauterine vacuum-induced hemorrhage control may provide a new rapid and effective treatment option for abnormal postpartum uterine bleeding or postpartum hemorrhage, with the potential to prevent severe maternal morbidity and mortality.Funding sourceAlydia Health, Inc.Clinical trial registrationClinicalTrials.gov, NCT02883673.
Project description:Postpartum hemorrhage (PPH) is a leading cause of maternal morbi-mortality. Although obstetric risk factors are well described, the impact of predelivery hematologic and hemostatic biomarkers remains incompletely understood. In this systematic review, we aimed to summarize the available literature on the association between predelivery hemostatic biomarkers and PPH/severe PPH. Searching MEDLINE, EMBASE, and CENTRAL databases from inception to October 2022, we included observational studies on unselected pregnant women without bleeding disorder reporting on PPH and on predelivery hemostatic biomarkers. Two review authors independently performed title, abstract and full-text screening, upon which quantitative syntheses of studies reporting on the same hemostatic biomarker were conducted, calculating the mean difference (MD) between women with PPH/severe PPH and controls. A search on 18 October 2022 yielded 81 articles fitting our inclusion criteria. The heterogeneity between studies was considerable. With regard to PPH, the estimated average MD in the investigated biomarkers (platelets, fibrinogen, hemoglobin, Ddimer, activated partial thromboplastin time, and prothrombin time) were not statistically significant. Women who developed severe PPH had lower predelivery platelets than controls (MD = -26.0 109/L; 95% confidence interval, -35.8 to -16.1), whereas differences in predelivery fibrinogen concentration (MD = -0.31 g/L; 95% confidence interval, -0.75 to 0.13) and levels of factor XIII or hemoglobin were not statistically significant in women with and without severe PPH. Predelivery platelet counts were, on average, lower in women with severe PPH compared with controls, suggesting the potential usefulness of this biomarker for predicting severe PPH. This trial was registered at the International Prospective Register of Systematic Reviews as CRD42022368075.
Project description:A simple modified suction drainage device made from Gibbon catheter and intravenous fluid glass bottle is described. It is cheaper than the suction drains available in the market and useful to general surgeons in peripheral hospitals.
Project description:During total joint replacement, high concentrations of mesenchymal stromal cells (MSCs) are released at the implantation site. They can be found in cell-tissue composites (CTC) that are regularly removed by surgical suction. A surgical vacuum suction handle was filled with bone substitute granules, acting as a filter allowing us to harvest CTC. The purpose of this study was to investigate the osteopromotive potential of CTC trapped in the bone substitute filter material during surgical suction. In the course of 10 elective total hip and knee replacement surgeries, β-tricalcium-phosphate (TCP) and cancellous allograft (Allo) were enriched with CTC by vacuum suction. Mononuclear cells (MNC) were isolated from the CTC and investigated towards cell proliferation and colony forming unit (CFU) formation. Furthermore, MSC surface markers, trilineage differentiation potential and the presence of defined cytokines were examined. Comparable amounts of MNC and CFUs were detected in both CTCs and characterized as MSC‱ of MNC with 9.8 ± 10.7‱ for the TCP and 12.8 ± 10.2‱ for the Allo (p = 0.550). CTCs in both filter materials contain cytokines for stimulation of cell proliferation and differentiation (EGF, PDGF-AA, angiogenin, osteopontin). CTC trapped in synthetic (TCP) and natural (Allo) bone substitute filters during surgical suction in the course of a joint replacement procedure include relevant numbers of MSCs and cytokines qualified for bone regeneration.
Project description:Background Development of the flexible CO2 fiber has presented new opportunities for the use of precision laser cutting in cranial procedures. The efficacy of the CO2 scalpel is further enhanced by combining it with a fluid removal suction capability. Objectives We report our experience with a novel CO2 laser-suction device. Methods The novel laser-suction device was designed in conjunction with OmniGuide Inc. (Cambridge, Massachusetts, USA). We performed a case review of its use in firm tumors that were resistant to resection by bipolar, suction, and ultrasonic aspirator. Results The laser-suction device was applied in three tumors where resection with ultrasonic aspiration failed. Tumor resection using the laser-suction device was successful in all three cases. There were no complications related to the laser-suction device. There were no instances of intraoperative device malfunction. Discussion The CO2 laser combined with suction is a useful instrument for resection of firm tumors that prove to be resistant to ultrasonic aspiration. We also find it to be useful in settings where precise tissue incisions are desired with minimal manipulation. In our experience, the surgical efficiency of the CO2 laser is improved by the laser-suction device. This device allows the surgeon to utilize a suction device and laser in a single hand and enables concurrent use of bipolar electrocautery without repeated instrument changes.
Project description:Postpartum hemorrhage (PPH) is defined as blood loss of ≥ 500-1000 ml within 24 h after delivery. Yet, assessment of blood loss is imprecise. The present study aimed to profile the hemoglobin (Hb) drop after vaginal delivery with versus without PPH. This was a secondary analysis of a prospective cohort study of women who delivered vaginally. Women were included if complete blood counts (CBC) before and after delivery were taken until stabilization (N = 419). Women were categorized into the PPH group and controls, for whom post-delivery CBCs were performed due to indications unrelated to bleeding. The PPH patients were then classified as either overt or occult PPH (symptoms related to hypovolemia without overt bleeding) subgroups. The primary endpoint was mean Hb drop after delivery. One hundred and ten (26%) and 158 (38%) women presented with overt PPH or occult PPH, respectively; 151 (36%) women were included in the control group. Mean Hb decrease from baseline was 3.0 ± 1.6, 2.0 ± 1.4 and 0.9 ± 1.0 g/dl, respectively (p < 0.0001). In all groups, maximal rate of Hb decline was in the first 6-12 h postpartum and plateaued after 24-48 h. At 48 h post-delivery, 95% and 86% of women who had dropped to Hb ≤ 9.5 and < 7 g/dl, respectively, reached those thresholds. Taken together, an Hb decrease ≥ 2 g/dl was consistent with PPH diagnosis and should be followed for at least 48 h after delivery.
Project description:Blood loss by hemorrhaging wounds accounts for over one-third of ∼5 million trauma fatalities worldwide every year. If not controlled in a timely manner, exsanguination can take lives within a few minutes. Developing new biomaterials that are easy to use by non-expert patients and promote rapid blood coagulation is an unmet medical need. Here, biocompatible, and biodegradable microneedle arrays (MNAs) based on gelatin methacryloyl (GelMA) biomaterial hybridized with silicate nanoplatelets (SNs) are developed for hemorrhage control. The SNs render the MNAs hemostatic, while the needle-shaped structure increases the contact area with blood, synergistically accelerating the clotting time from 11.5 min to 1.3 min in vitro. The engineered MNAs reduce bleeding by ∼92% compared with the untreated injury group in a rat liver bleeding model. SN-containing MNAs outperform the hemostatic effect of needle-free patches and a commercial hemostat in vivo via combining micro- and nanoengineered features. Furthermore, the tissue adhesive properties and mechanical interlocking support the suitability of MNAs for wound closure applications. These hemostatic MNAs may enable rapid hemorrhage control, particularly for patients in developing countries or remote areas with limited or no immediate access to hospitals.
Project description:Hemorrhage is the leading cause of preventable death in combat trauma and the secondary cause of death in civilian trauma. A significant number of deaths due to hemorrhage occur before and in the first hour after hospital arrival. A literature search was performed through PubMed, Scopus, and Institute of Scientific Information databases for English language articles using terms relating to hemostatic agents, prehospital, battlefield or combat dressings, and prehospital hemostatic resuscitation, followed by cross-reference searching. Abstracts were screened to determine relevance and whether appropriate further review of the original articles was warranted. Based on these findings, this paper provides a review of a variety of hemostatic agents ranging from clinically approved products for human use to newly developed concepts with great potential for use in prehospital settings. These hemostatic agents can be administered either systemically or locally to stop bleeding through different mechanisms of action. Comparisons of current hemostatic products and further directions for prehospital hemorrhage control are also discussed.
Project description:In this study, we aim to develop a narrow-diameter and long-bore device for minimally invasive surgery that achieves the simultaneous cutting and suction of body tissue such as the diseased part of an organ. In this paper, we propose a screw made of a thin metal plate, and we developed a prototype device using this screw. For smooth operation, the suction performance must be superior to the cutting performance. Therefore, we performed experiments and evaluated the suction performance of the developed device assuming the crushed tissue pieces correspond to a highly viscous fluid. From the results, we confirmed that the suction volume is almost proportional to the rotation speed of the screw in the low speed range, and the device has an upper limit of suction volume at a certain rotation speed. Considering practical use, its proportional speed range is suitable for the device controllability of cutting and suction volume, and the size of the device tip needs to be 1 mm or more. Based on these conditions, we are planning to examine the shape of the cutting edge for realizing efficient cutting and suction and we will complete the device.
Project description:In this paper, a simple syringe‑assisted pumping method is introduced. The proposed fluidic micropumping system can be used instead of a conventional pumping system which tends to be large, bulky, and expensive. The micropump was designed separately from the microfluidic channels and directly bonded to the outlet of the microfluidic device. The pump components were composed of a dead‑end channel which was surrounded by a microchamber. A syringe was then connected to the pump structure by a short tube, and the syringe plunger was manually pulled out to generate low pressure inside the microchamber. Once the sample was loaded in the inlet, air inside the channel diffused into the microchamber through the PDMS (polydimethylsiloxane) wall, acting as a dragging force and pulling the sample toward the outlet. A constant flow with a rate that ranged from 0.8 nl · s - 1 to 7.5 nl · s - 1 was achieved as a function of the geometry of the pump, i.e., the PDMS wall thickness and the diffusion area. As a proof-of-concept, microfluidic mixing was demonstrated without backflow. This method enables pumping for point-of-care testing (POCT) with greater flexibility in hand-held PDMS microfluidic devices.