A Novel Device to Prevent Stone Fragment Migration During Percutaneous Lithotripsy: Results from an In Vitro Kidney Model

2016 ◽  
Vol 30 (11) ◽  
pp. 1239-1243 ◽  
Author(s):  
Jodi A. Antonelli ◽  
Heather Beardsley ◽  
Stephen Faddegon ◽  
Monica S.C. Morgan ◽  
Jeffrey C. Gahan ◽  
...  
Keyword(s):  
Stone Fragment ◽  
Novel Device ◽  
Percutaneous Lithotripsy

First Prize: A Novel Device to Prevent Stone Fragment Migration During Percutaneous Lithotripsy

2014 ◽  
Vol 28 (12) ◽  
pp. 1395-1398 ◽  
Author(s):  
Justin I. Friedlander ◽  
Jodi A. Antonelli ◽  
Heather Beardsley ◽  
Stephen Faddegon ◽  
Monica S.C. Morgan ◽  
...  
Keyword(s):  
Stone Fragment ◽  
Novel Device ◽  
Percutaneous Lithotripsy

PD37-03 PERCSAC: A NOVEL DEVICE TO PREVENT STONE FRAGMENT MIGRATION DURING PERCUTANEOUS LITHOTRIPSY

2014 ◽  
Vol 191 (4S) ◽  
Author(s):  
Jodi Antonelli ◽  
Justin Friedlander ◽  
Jeffrey Gahan ◽  
Heather Beardsley ◽  
Margaret Pearle ◽  
...  
Keyword(s):  
Stone Fragment ◽  
Novel Device ◽  
Percutaneous Lithotripsy

scholarly journals Tissue stress from laparoscopic grasper use and bowel injury in humans: establishing intraoperative force boundaries

2021 ◽  
Vol 3 (1) ◽  
pp. e000084
Author(s):  
Amanda Farah Khan ◽  
Matthew Kenneth MacDonald ◽  
Catherine Streutker ◽  
Corwyn Rowsell ◽  
James Drake ◽  
...  
Keyword(s):  
Small Bowel ◽  
Tissue Injury ◽  
Ex Vivo ◽  
Gastrointestinal Surgery ◽  
Convenience Sample ◽  
Thickness Change ◽  
Novel Device ◽  
Significant Difference ◽  
Laparoscopic Grasper

ObjectivesWe aim to determine what threshold of compressive stress small bowel and colon tissues display evidence of significant tissue trauma during laparoscopic surgery.DesignThis study included 10 small bowel and 10 colon samples from patients undergoing routine gastrointestinal surgery. Each sample was compressed with pressures ranging from 100 kPa to 600 kPa. Two pathologists who were blinded to all study conditions, performed a histological analysis of the tissues. Experimentation: November 2018–February 2019. Analysis: March 2019–May 2020.SettingAn inner-city trauma and ambulatory hospital with a 40-bed inpatient general surgery unit with a diverse patient population.ParticipantsPatients were eligible if their surgery procured healthy tissue margins for experimentation (a convenience sample). 26 patient samples were procured; 6 samples were unusable. 10 colon and 10 small bowel samples were tested for a total of 120 experimental cases. No patients withdrew their consent.InterventionsA novel device was created to induce compressive “grasps” to simulate those of a laparoscopic grasper. Experimentation was performed ex-vivo, in-vitro. Grasp conditions of 0–600 kPa for a duration of 10 s were used.ResultsSmall bowel (10), M:F was 7:3, average age was 54.3 years. Colon (10), M:F was 1:1, average age was 65.2 years. All 20 patients experienced a significant difference (p<0.05) in serosal thickness post-compression at both 500 and 600 kPa for both tissue types. A logistic regression analysis with a sensitivity of 100% and a specificity of 84.6% on a test set of data predicts a safety threshold of 329–330 kPa.ConclusionsA threshold was discovered that corresponded to both significant serosal thickness change and a positive histological trauma score rating. This “force limit” could be used in novel sensorized laparoscopic tools to avoid intraoperative tissue injury.

An in Vitro Model of Neural Trauma: Device Characterization and Calcium Response to Mechanical Stretch

2001 ◽  
Vol 123 (3) ◽  
pp. 247-255 ◽  
Author(s):  
Donna M. Geddes ◽  
Robert S. Cargill
Keyword(s):  
Strain Rate ◽  
In Vitro Model ◽  
Mechanical Stretch ◽  
Neural Cells ◽  
Novel Device ◽  
Loop Feedback ◽  
Closed Loop Feedback ◽  
Cellular Tolerance ◽  
Vitro Model

An in vitro model for neural trauma was characterized and validated. The model is based on a novel device that is capable of applying high strain rate, homogeneous, and equibiaxial deformation to neural cells in culture. The deformation waveform is fully arbitrary and controlled via closed-loop feedback. Intracellular calcium [Ca2+]i alterations were recorded in real time throughout the imposed strain with an epifluorescent microscopy system. Peak change in [Ca2+]i, recovery of [Ca2+]i, and percent responding NG108-15 cells were shown to be dependent on strain rate (1−1 to 10−1) and magnitude (0.1 to 0.3 Green’s Strain). These measures were also shown to depend significantly on the interaction between strain rate and magnitude. This model for neural trauma is a robust system that can be used to investigate the cellular tolerance and response to traumatic brain injury.

scholarly journals A Biomechanical Evaluation of a Next-Generation Integrated and Modular ACDF Device Possessing Full-Plate, Half-Plate, and No-Profile Fixation Iterations

2019 ◽  
Vol 9 (8) ◽  
pp. 826-833
Author(s):  
Ripul Panchal ◽  
Anup Gandhi ◽  
Chris Ferry ◽  
Sam Farmer ◽  
Jeremy Hansmann ◽  
...  
Keyword(s):  
Plate Fixation ◽  
Testing Machine ◽  
Axial Rotation ◽  
Biomechanical Study ◽  
The Novel ◽  
Novel Device ◽  
Plate Group ◽  
Flexion Extension ◽  
Group 2

Study Design: In vitro biomechanical study. Objectives: The objective of this in vitro biomechanical range-of-motion (ROM) study was to evaluate spinal segmental stability following fixation with a novel anterior cervical discectomy and fusion (ACDF) device (“novel device”) that possesses integrated and modular no-profile, half-plate, and full-plate fixation capabilities. Methods: Human cadaveric (n = 18, C3-T1) specimens were divided into 3 groups (n = 6/group). Each group would receive one novel device iteration. Specimen terminal ends were potted. Each specimen was first tested in an intact state, followed by anterior discectomy (C5/C6) and iterative instrumentation. Testing order: (1) novel device (group 1, no-profile; group 2, half-plate; group 3, full-plate); (2) novel device (all groups) with lateral mass screws (LMS); (3) traditional ACDF plate + cage; (4) traditional ACDF plate + cage + LMS. A 2 N·m moment was applied in flexion/extension (FE), lateral bending (LB), and axial rotation (AR) via a kinematic testing machine. Segmental ROM was tracked and normalized to intact conditions. Comparative statistical analyses were performed. Results: Key findings: (1) the novel half- and full-plate constructs provided comparable reduction in FE and LB ROM to that of traditional plated ACDF ( P ≥ .05); (2) the novel full-plate construct significantly exceeded all other anterior-only constructs ( P ≤ .05) in AR ROM reduction; and (3) the novel half-plate construct significantly exceeded the no-profile construct in FE ( P < .05). Conclusions: The novel ACDF device may be a versatile alternative to traditional no-profile and independent plating techniques, as it provides comparable ROM reduction in all principle motion directions, across all device iterations.

scholarly journals Preclinical Assessment of a Novel Conformable Foam-Based Left Atrial Appendage Closure Device

2021 ◽  
Vol 2021 ◽  
pp. 1-8
Author(s):  
Robert J. Sommer ◽  
Ronald Lamport ◽  
David Melanson ◽  
Carol Devellian ◽  
Andy Levine ◽  
...  
Keyword(s):  
Atrial Fibrillation ◽  
Left Atrial ◽  
Left Atrial Appendage ◽  
Canine Model ◽  
Atrial Appendage ◽  
Closure Device ◽  
Left Atrial Appendage Closure ◽  
Novel Device ◽  
In Vitro Assessment

Background. Left atrial appendage (LAA) occlusion has been established as an alternative to systemic anticoagulation for stroke prevention in patients with atrial fibrillation; however, limitations of current devices have slowed adoption. We present preclinical evaluations of a novel device, the Conformal Left Atrial Appendage Seal (CLAAS). Methods. An in vitro assessment of conformability was conducted to evaluate the two CLAAS devices (regular 27 mm and large 35 mm) and a Watchman 2.5 (27 mm). Devices were placed within silicone tubes and compressed in a vise submerged in a water bath at 37°C. Changes in device diameter and visual seal were noted. Acute ( n = 1 ) and chronic 60-day ( n = 6 ) canine studies with gross and histologic assessment were performed. Results. Conformability bench tests demonstrated that the regular CLAAS implant was able to seal oval orifices from 20 × 30   mm to 15 × 33   mm and the large from 30 × 35   mm to 20 × 40   mm . As the CLAAS implant was compressed in the minor diameter, it increased in the major diameter, thereby filling the oval space, whereas the Watchman 2.5 showed gaps and maintained its round configuration when compressed in one direction. Seven devices were successfully implanted in the canine model with complete seal without thrombus. Histologic examination showed complete neointima covering with minimal inflammation at 60 days. Conclusions. Preclinical testing demonstrated the conformability of the CLAAS implant and its ability to seal the LAA. Clinical studies are ongoing to characterize the utility of the CLAAS implant in the treatment of patients with atrial fibrillation.

FRI0389 TOWARDS ONE-STAGE ARTICULAR CARTILAGE REPAIR USING DEVICE BASED ARTHROSCOPIC MECHANICAL RELEASE OF SYNOVIAL MESENCHYMAL STEM CELLS WITH CHONDROGENESIS AUGMENTATION WITH AUTOLOGOUS PLATELET CONCENTRATE WITHOUT CELL CULTURE EXPANSION

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 792-793
Author(s):  
A. Altaie ◽  
E. Jones ◽  
O. Wall ◽  
D. Mcgonagle
Keyword(s):  
Flow Cytometry ◽  
Synovial Fluid ◽  
Cartilage Repair ◽  
Ex Vivo ◽  
Synovial Cells ◽  
The Novel ◽  
Novel Device ◽  
Chondrogenic Potential ◽  
Before And After

Background:Synovial fluid contains resident mesenchymal stem cells (SF-MSCs) that are derived from the synovial membrane and may interact with superficial cartilage injury sites. We previously reported on a novel methodology for increasing the number of MSCs in the knee joints using synovial brushing combined with platelet lysate (PL) as a chondrogenic inducer [1, 2].Objectives:The purpose of this study was to evaluate autologous and allogenic PL as a chondrogenic inducer and the chondrogenic potential of the mobilised MSCs without further ex vivo expansion. The desired goal of the study was to provide in vitro proof of concept of direct chondrogensis without resort to MSC expansion protocols, since adequate MSCs towards repair could be mechanically procured in a minimally invasive fashion.Methods:SF-MSCs were derived from the joint cavity of patients undergoing arthroscopy procedures. For the mechanical release of MSCs ‘before’ and ‘after’ brushing the synovium with the novel device (Figure 1A), samples of irrigation fluid were collected and MSC numbers were evaluated by CFU-F assay and flow cytometry for stromal and immune populations. Standard chondrogenic assay was performed on uncultured and cultured expanded synovial MSCs. Pellet cultures were maintained in complete chondrogenic media (CCM), DMEM+50% autologous filtared platelet concentrate (fPC), 50% Stemulate (allogeneic human PL; Cook Regentec, Indianapolis, IN), or expansion media (control). Chondrogenesis was assessed by Glycosaminoglycan (GAG) andToluidine bluestaining. Autologous blood was processed through a gravity-based filtration system, HemaTrate®(HT; Cook Regentec, Indianapolis, IN), to produce a PC.Figure 1.Flow cytometry analysis of stromal and immune populations before’ and ‘after’ mechanically release of synovial with the novel device (CD90highCD45Lowin red circle) (A). Uncultured synovial cells after 21 days exposure to complete chondrogenic media Toulid Blue staining (B) Gags level (C) n=3.Results:Mechanically mobilized SF-MSC numbers increased as measured by CFU-F assay and flow cytometry for CD90HighCD45Lowcells (p<0.001), and CD14+HLA-DR+CD206+CD86+M2 macrophages also increased (p<0.05). The HT system significantly concentrated platelets and WBCs by 6- (p<0.0001) and 1.8-folds (p<0.001), respectively. Device-mobilized SF-MSC proliferation significantly increased after 6 days in DMEM + 10% PC (p<0.001) and correlated with PC platelet number (p<0.005). Autologous PC increased GAG levels compared to control (p<0.0001), and there was no significant difference compared to allogenic PL (p>0.5). Uncultured synovial cells produced significantly more GAG when cultured in CCM or DMEM + 50% autologous PC compared to control (p<0.0001). The GAG levels of uncultured synovial cells positively correlated with CFU-F (p<0.005). Chondrogenic potential of uncultured synovial cells that were mechanically mobilized with initial irrigation exhibited an increase (1.5-fold) in GAG levels (p<0.001) figure 1-B and also positively correlated with CFU-F (p<0.005).Conclusion:Synovial MSCs can be mechanically released in sufficient number to undergo in vitro chondrogenic induction with significant chondrogenic activity without the need for ex vivo culture expansion. In vitro, autologous PC can be used as chondrogenic inducer for uncultured SF-MSCs. The data presented here supports one stage arthroscopy procedures for cartilage repairReferences:[1]T.G. Baboolal, S.C. Mastbergen, E. Jones, S.J. Calder, F.P. Lafeber, D. McGonagle, Synovial fluid hyaluronan mediates MSC attachment to cartilage, a potential novel mechanism contributing to cartilage repair in osteoarthritis using knee joint distraction, Annals of the rheumatic diseases 75(5) (2016) 908-15.[2]A. Altaie, T.G. Baboolal, O. Wall, E. Jones, D. McGonagle, Platelet lysate enhances synovial fluid multipotential stromal cells functions: Implications for therapeutic use, Cytotherapy 20(3) (2018) 375-384.Disclosure of Interests:Ala Altaie: None declared, Elena Jones: None declared, Owen Wall: None declared, Dennis McGonagle Grant/research support from: Janssen Research & Development, LLC

scholarly journals Use of a novel suction cervical retractor for intrauterine device insertion: a pilot feasibility trial

2018 ◽  
Vol 45 (1) ◽  
pp. 47-53
Author(s):  
David K Turok ◽  
Rebecca G Simmons ◽  
Benjamin Cappiello ◽  
Lori M Gawron ◽  
Jane Saviers-Steiger ◽  
...  
Keyword(s):  
Ex Vivo ◽  
Intrauterine Device ◽  
Feasibility Trial ◽  
Novel Device ◽  
Pain Scores ◽  
Single Tooth ◽  
Lower Pain ◽  
Stage 1 ◽  
And Control

IntroductionThe Bioceptive suction cervical retractor (SCR) is a novel device that can replace the standard single-tooth tenaculum to place traction on the cervix. A feasibility trial was conducted on the device for intrauterine device (IUD) placement.MethodsOur three-stage feasibility process began with Stage 1, where the device was tested on in-vitro and ex-vivo samples. In Stage 2, 10 women received their IUD using the device. In Stage 3, a feasibility trial, we randomly assigned 25 consenting women to receive their IUD using either the Bioceptive SCR or the standard single-tooth tenaculum. In Stages 2 and 3, we collected pain scores using an electronically adapted 100-point visual analogue scale (VAS) at eight timepoints during and after the insertion procedure, as well as satisfaction and acceptability measures. The primary outcome was the pain score after attaching the SCR or tenaculum (VAS 3). Wilcoxon rank sum tests compared pain scores between devices.ResultsIn Stage 2, pain scores with the SCR were lower than historical controls with the single-tooth tenaculum. In Stage 3, the median VAS 3 pain scores were 31 and 57 for the intervention and control groups, respectively. The differences in pain scores were not statistically significant but the trend was to lower pain scores with the intervention. Reported patient satisfaction with the SCR device was 80% in Stage 2% and 90% in Stage 3.ConclusionsThe Bioceptive SCR has potential as an atraumatic alternative to standard cervical retractor devices for gynaecological procedures. These findings can guide point estimates for future clinical studies.Trial registrationNCT02283463.

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