Retraction Device Research Articles

A Survey on the Use of Retraction Devices and Techniques among Dental Practitioners in Bulgaria

A Survey on the Use of Retraction Devices and Techniques among Dental Practitioners in Bulgaria

Table-mounted Versus Self-retaining Retraction: An Assessment of Postoperative Dysphagia Following Anterior Cervical Spine Surgery.

Retrospective study. To determine whether there are significant differences in postoperative dysphagia when using table-mounted versus self-retaining retractor tools. Retraction of prevertebral structures during anterior cervical spine surgery (ACSS) is commonly associated with postoperative dysphagia or dysphonia. Retractors commonly used include nonfixed self-retaining retraction devices or fixed table-mounted retractor arms. However, there is a paucity of literature regarding differences in dysphagia between retractor types. Patients who underwent ACSS and adhered to a minimum of 6-month follow-up were retrospectively evaluated. Patient-reported outcomes (PROs) were compared between table-mounted and self-retaining retractor groups at the preoperative and final postoperative time points, including the SWAL-QOL survey for dysphagia. Categorical dysphagia was assessed using previously defined values for the minimum clinically important difference (MCID). Overall, 117 and 75 patients received self-retaining or table-mounted retraction. Average follow-up was significantly longer in the self-retaining cohort (14.8±15.0mo) than in the table-mounted group (9.4±7.8, P=0.005). No differences were detected in swallowing function (P=0.918) or operative time (P=0.436), although 3-level procedures were significantly shortened with table-mounted retraction (P=0.005). Multivariate analysis trended toward worse swallow function with increased operative levels (P=0.072) and increased retraction time (P=0.054), although the retractor used did not predict swallowing function (P=0.759). However, categorical rates of postoperative dysphagia were lower with table-mounted retraction (13.3% vs. 27.4%, P=0.033). There was no significant difference observed in long-term swallowing dysfunction between patients who underwent ACSS with self-retaining and table-mounted retractors, although the rate of dysphagia was lower with table-mounted retraction. In addition, the greater number of operated levels per case in the table-mounted group at a similar time suggests improved efficiency.

Panniculus Retractor Use for Visualization of Fetal Anatomy: A Randomized Controlled Trial.

To evaluate whether use of a panniculus retractor device for pregnant patients with body mass index (BMI) 40 or higher and a panniculus improves the completion rate of the fetal anatomic examination. This was a randomized trial in which eligible patients with BMI 40 or higher and a panniculus were randomized to undergo their detailed fetal anatomic examination with a panniculus retractor device in place compared with usual care. The primary outcome was the completion rate of 16 prespecified views from the anatomic examination. Secondary outcomes included completion rate of all 64 views from our institution's detailed anatomic examination, duration of examination, major fetal anomaly detection rate, depth from the skin to amniotic cavity before and after retractor placement, patient and ultrasonographer satisfaction, and prespecified adverse events. We assumed a baseline completion rate of 23% for the primary outcome and targeted a twofold improvement with 80% power and two-sided α of 0.05, which resulted in a sample size of 132 participants. The goal enrollment was increased to 150 participants to account for potential dropout. Statistical tests included the Student's t test, χ 2 , and relative risks (RRs) as appropriate. From March to July of 2023, 150 participants completed the study: 74 in the retractor group and 76 in the usual care group. Baseline characteristics were similar between groups except for panniculus grade. The completion rate of 16 prespecified views was 25.7% (19/74) in the retractor group and 31.6% (24/76) in the control group (RR 0.81, 95% CI, 0.49-1.35). There were no significant differences between groups for any of the secondary outcomes. Patient satisfaction and ultrasonographer satisfaction were similar between groups. Use of a panniculus retractor device during the fetal anatomic examination for patients with BMI 40 or higher and a panniculus was well tolerated by patients and ultrasonographers but did not improve the completion rate of 16 prespecified fetal anatomic views. ClinicalTrials.gov , NCT05764408.

Comparative analysis of tubular retractors and hook retractors in oblique lumbar interbody fusion at the initial stage of the learning curve

PurposeOblique lumbar interbody fusion (OLIF) still has a steep learning curve that many spinal surgeons who want to develop are hesitant. The purpose of this study is to provide reference for beginners through the comparative analysis of the application of two kinds of retraction devices in the early stage of learning curve.MethodWe prospectively included the first 60 patients with lumbar degenerative diseases treated with OLIF by a surgeon in our department. According to the application of different retraction devices during the operation, the patients were divided into hook retractor group and tubular retractor group. The clinical effects and complications of the two groups were compared.ResultThe average age of hook retractor group was 62 years old, the average age of tubular retractor group was 65 years old. There was no significant difference in age, sex, operative segment, follow-up time and blood loss between the two groups. The operation time in hook retractor group was less than that in tubular retractor group. The incidence of complications in hook retractor group (11.8%) was significantly lower than that in tubular retractor group (38.5%).ConclusionThe tubular retractor group has a higher risk of neurovascular injury in the initial stage of learning, as well as the risk of vertebral fracture. In contrast, the hook retractor group has the advantages of simple method, high fault tolerance and relatively low incidence of complications. Therefore, we believe that the application of hook retractor in the early stage of OLIF learning curve is easier to increase the operator’s confidence and make OLIF more acceptable.

Minimally invasive techniques in quest of Holy Grail of surgical management of enlarged prostates: a narrative review.

Past decade has seen a renewed interest in minimally invasive surgical techniques (MISTs) for management of enlarged prostate. This narrative review aims to explore newer MIST for benign prostatic hyperplasia (BPH) which are not yet integrated into established societal guidelines. We conducted a literature search across PubMed, Google Scholar, and FDA ClinicalTrials.gov databases on June 1st, 2023, to identify studies published within the past decade exploring various MISTs for BPH. Additionally, we gathered insights from abstracts presented in meetings of professional associations and corporate websites. We broadly classified these procedures into three distinct categories: energy-based, balloon dilation, and implant/stent treatments. We collected detail information about the device, procedure details, its inclusion and exclusion criteria, and outcome. Our review reveals that newer energy-based MISTs include Transperineal Laser Ablation, Transurethral Ultrasound Ablation, and High-Intensity Focused Ultrasound. In the sphere of balloon dilation, Transurethral Columnar Balloon Dilation and the Optilume BPH Catheter System were gaining momentum. The noteworthy implants/stents that are on horizon include Butterfly Prostatic Retraction Device, Urocross Expander System, Zenflow Spring System, and ProVee Urethral Expander System. The exploration of various MISTs reflects ongoing efforts to enhance patient care and address limitations of existing treatments. This review provides a bird-eye view and valuable insights for urologists and researchers seeking to navigate the dynamic landscape of MISTs in the quest for effective and minimally invasive solutions for enlarged prostates.

Bone-inspired (GNEC/HAPAAm) hydrogel with fatigue-resistance for use in underwater robots and highly piezoresistive sensors

A novel bone-inspired fatigue-resistant hydrogel with excellent mechanical and piezoresistive properties was developed, and it exhibited great potential as a load and strain sensor for underwater robotics and daily monitoring. The hydrogel was created by using the high edge density and aspect ratio of graphene nanosheet-embedded carbon (GNEC) nanomaterials to form a three-dimensional conductive network and prevent the expansion of microcracks in the hydrogel system. Multiscale progressive enhancement of the organic hydrogels (micrometer scale) was realized with inorganic graphene nanosheets (nanometer scale). The graphene nanocrystals inside the GNEC film exhibited good electron transport properties, and the increased distances between the graphene nanocrystals inside the GNEC film caused by external forces increased the resistance, so the hydrogel was highly sensitive and suitable for connection to a loop for sensing applications. The hydrogels obtained in this work exhibited excellent mechanical properties, such as tensile properties (strain up to 1685%) and strengths (stresses up to 171 kPa), that make them suitable for use as elastic retraction devices in robotics and provide high sensitivities (150 ms) for daily human monitoring.

Comparative analysis of tensile strength between three types of retraction cords.

Gingival retraction is the withdrawal of the marginal gingiva away from the tooth. This procedure creates a space between the prepared tooth and the gingival tissues to catch more fine details of the impression material. The most common retraction device used in clinical practice is the retraction cord.

Navigational water resistance analysis and optimization of the gondola of unmanned boat retractable device

Combining the characteristics of the existing transfer slideway and double-point hanging type two retractable devices, this paper proposes a multiple-point hoisting, fast transfer, and retractable device. According to the viscous flow theory, one-way fluid-structure interaction simulation is used for the gondola structure of the unmanned boat retractable device. Considering the influencing factors of the width of the gondola, the void ratio, the shape and distribution of the void, and the deployment angle of the guardrail, the navigation water resistance of each model is compared and analyzed, and the optimal design of the gondola device is discussed. The results show that the increase of the top width and the decrease of the front-end void ratio will lead to an increase in the water resistance of the gondola; under the same porosity, the rectangular shape performs better than the circular shape, and the smaller interval between the rectangles is more conducive to reducing the water resistance of the gondola; the increase in the angle of the side door guardrail of the gondola will lead to an increase in the navigation water resistance; the final optimized design of the gondola device meets the strength requirements under extreme conditions of high sailing speed.

Oral Sequelae after Head and Neck Radiotherapy: RCT Comparing 3D-Printed Tissue Retraction Devices with Conventional Dental Splints.

To evaluate oral sequelae after head and neck radiotherapy (RT) when using two different types of intraoral appliances. Thermoplastic dental splints (active control) protect against backscattered radiation from dental structures. Semi-individualized, 3D-printed tissue retraction devices (TRDs, study group) additionally spare healthy tissue from irradiation. A total of 29 patients with head and neck cancer were enrolled in a randomized controlled pilot trial and allocated to receive TRDs (n = 15) or conventional splints (n = 14). Saliva quality and quantity (Saliva-Check, GC), taste perception (Taste strips, Burghart-Messtechnik), and oral disability (JFLS-8, OHIP-14, maximum mouth opening) were recorded before and 3 months after RT start. Radiotherapy target volume, modality, total dose, fractionation, and imaging guidance were case-dependent. To evaluate intra-group developments between baseline and follow-up, nonparametric Wilcoxon tests were performed. Mann-Whitney-U tests were applied for inter-group comparisons. At follow-up, taste perception was unimpaired (median difference in the total score; TRDs: 0, control: 0). No significant changes were found regarding oral disability. Saliva quantity (stimulated flow) was significantly reduced with conventional splints (median -4 mL, p = 0.016), while it decreased insignificantly with TRDs (median -2 mL, p = 0.07). Follow-up was attended by 9/15 study group participants (control 13/14). Inter-group comparisons showed no significant differences but a tendency towards a better outcome for disability and saliva quality in the intervention group. Due to the small cohort size and the heterogeneity of the sample, the results must be interpreted with reservation. Further research must confirm the positive trends of TRD application. Negative side-effects of TRD application seem improbable.

Endoscopic submucosal dissection of a gigantic gastric polyp aided by a novel retraction device and complicated by upper esophageal sphincter laceration during retrieval

Video 1Endoscopic submucosal dissection of a sizeable gastric polyp with a short and broad stalk assisted by a novel traction device.

Characterization of the histological response to the Butterfly Prostatic Retraction Device in patients with benign prostatic hyperplasia.

The Butterfly Prostatic Retraction Device ("Butterfly") is a permanent nitinol implant for benign prostatic hyperplasia. This study examines the chronic response of prostate tissue to the Butterfly in histological specimens from patients in the Butterfly pilot clinical study. Retrospective qualitative and semi-quantitative review of histological specimens of seven (7) patients who participated in the Butterfly pilot clinical study. Patients had at least 1-month implantation with the Butterfly prior to implant removal and TURP. Tissue samples were graded by two pathologists. Four out of six patients had IPSS decreased from baseline. All seven patients' samples had signs of chronic inflammation; one demonstrated acute inflammation and one demonstrated fibrosis. In three cases, intraglandular calcification was identified. There was no ischemic necrosis induced by the implant, and no encrustation, urethral edema, or cellular atypia was noted. The Butterfly demonstrated an overall favorable safety profile in terms of tissue response. This study demonstrates that there is no significant tissue reaction in the prostatic urethra due to presence of Butterfly device.

The Butterfly: A Novel Minimally Invasive Transurethral Retraction Device for Benign Hypertrophy of the Prostate

Introduction: The Butterfly Prostatic Retraction device is a novel transurethral implant designed to dilate the prostatic urethra and treat lower urinary tract symptoms. We assessed its safety, efficacy and impact on urinary flow, ejaculation, and quality of life. Materials and Methods: We included 64 men, treated for benign prostate hyperplasia for at least 1 year. All patients had Qmax≤ 13 mL/s and IPSS >12. Insertion of the device was performed via cystoscopy. Follow-up visits were performed at 2 weeks, 1, 3, 6, and 12 months and included uroflowmetry, IPSS, QoL, and sexual function questionnaires. Cystoscopy was performed on 3 and 12 months. Results: Patients age was 50–83 years. 28 patients completed a 1-year follow-up with an intact device. Mean Qmax improved by 2 mL/s (25%), IPSS median drop was 10 points (40%), and QoL score was 1.5 points (38%). Sexually active patients reported antegrade ejaculation. On cystoscopy, gradual coverage of the devices with urethral mucosa was observed. In 1 patient, the device was repositioned. In 19 patients, the device was removed. 12 patients returned to alpha-blocker therapy and 7 patients underwent TURP. One patient developed a bulbar urethral stricture. Conclusions: We demonstrated feasibility and good tolerability of the Butterfly device.

Study of single-level lumbar degenerative diseases treated by unilateral wiltse access with unilateral nail rod fixation assisted by a new automatic retraction device

ObjectiveTo evaluate the clinical efficacy of unilateral wiltse transforaminal lumbar interbody fusion (TLIF) combined with unilateral nail bar system fixation for single-level lumbar degenerative diseases with the assistance of a new automatic retraction device in a retrospective comparative study.MethodsA total of 46 patients with single-level lumbar degenerative diseases from September 2019 to December 2021 were retrospectively analyzed. Bilateral nail bar fixation with bullet-type fusion cage (ctrl group, 24 patients) and unilateral nail bar fixation on the affected side with kidney-like fusion cage (study group, 22 patients) were performed in TLIF via wiltse intermuscular approach assisted by a new automatic retraction device. The differences in intraoperative blood loss, operative time, intraoperative fluoroscopy time, postoperative drainage, bed rest, VAS score, ODI score, JOA score, serological creatine kinase (CK), the proportion of multifidus atrophy, modified Pfirrmann classification and intervertebral space height of the upper intervertebral disc were compared between the two groups based on clinical and imaging data.ResultsIntraoperative bleeding, operative time, and postoperative drainage were significantly lower in study group than ctrl group, and there were no significant differences in bed rest time and intraoperative fluoroscopy time between them. In addition, there was no statistical difference in CK between the study group and the ctrl group at 24 and 48 h postoperatively. Moreover, no statistically significant difference was found in VAS score of low back pain, VAS score of lower limb pain, ODI index, modified Pfirrmann classification of the upper intervertebral disc and intervertebral space height of the upper intervertebral disc between two groups. The atrophy ratio of multifidus muscle was significantly lower in the study group.ConclusionThe new automatic retraction device assisted unilateral TLIF surgery with wiltse approach combined with unilateral nail bar fixation is a simple, effective and easy to master surgical method for single-level lumbar degenerative diseases.

Transcatheter Closure of Atrial Septal Defect with Carag Bioresorbable Septal Occluder™: First-in-Child Experience with 12-MonthFollow-Up.

Nowadays, transcatheter device closure of an atrial septal defect (ASD) is a standard approach in children. Potential early and long-term side effects or complications related to the metal framework of the devices are a known issue. A bioresorbable device such as the Carag Bioresorbable Septal Occluder™ (CBSO) could resolve such complications. Material and Results. The Carag Bioresorbable Septal Occluder™ (CBSO; Carag AG, Baar, Switzerland) is a self-centering double disk, repositionable, and retractable device with a bioresorbable framework (polylactic-co-glycolic acid), which is almost completely resorbed by 18-24 months postimplantation. This manuscript reports the four first-in-child ASD device closures using a CBSO. The patients' age was median (IQ1-IQ3), 4.5 years (4-7.25). Weight was 21.3 kg (17.6-32.7). We demonstrated procedural feasibility and safety. Effective defect closure with the device was 100%. Echocardiographic measurements of the thickness of the interatrial septum did not show any relevant increase over a 12-monthfollow-up period. There were no residual defects found after the procedure or later during the resorption process. The patients showed no evidence of any local or systemic inflammatory reaction. The CBSO device system could offer a new treatment option for transcatheter ASD device closure in the pediatric and adult fields. In our first-in-child experience, it was effectively and safely implanted. During the first 12 months of follow-up, no complications occurred.

8718 Novel Use of Viscera Retainer for Safer Resection of Posterior Fibroids during Laparoscopic Myomectomy

<h3>Study Objective</h3> To demonstrate a novel use of an abdominal viscera retainer for improving safe access to the posterior aspect of the uterus during laparoscopic myomectomy. <h3>Design</h3> Surgical film. <h3>Setting</h3> N/A. <h3>Patients or Participants</h3> Patient with a large 7 × 7cm subserosal and intramural fibroid at the posterior aspect of the uterine body and fundus. <h3>Interventions</h3> A viscera retainer is a device widely used by surgeons to retain omentum and protect underlying bowel during fascial closure of laparotomy cases. The device has been used to improve speed of closure while significantly reducing the risk of unintended needle punctures. During this laparoscopic myomectomy case, we used an umbilical port for the camera, left and right lower quadrant ports, and a midline suprapubic mini-laparotomy incision using a mini GelPoint. We used a medium sized viscera retainer, measuring approximately 6 × 9 inches. The retainer is able to be easily rolled for placement in the pelvis through the mini GelPoint. Once in the abdomen, the retainer can be positioned into the posterior cul-de-sac overtop of any underlying bowel. The weighted center spine helps to keep the device in place and prevents bowel from inadvertently moving into the surgical field. <h3>Measurements and Main Results</h3> The viscera retainer was able to be used as an intra-abdominal retraction device and physical protective barrier for the bowel during laparoscopic myomectomy, specifically during enucleation of the fibroid and suturing of the hysterotomy. <h3>Conclusion</h3> This unique use of a device typically reserved for laparotomy improved surgeon's access to the posterior aspect of the uterus for dissection and enucleation of posterior fibroids during laparoscopic myomectomy.

Initial Multicenter Experience of Traction Wire Endoscopic Submucosal Dissection

Background and AimsEndoscopic submucosal dissection (ESD) is a technically challenging and time-consuming procedure. A major limitation of ESD is the lack of a “second hand” to provide traction. We have developed a novel retraction device, a traction wire (TW), for ESD. This study was conducted to assess the efficacy, safety, and efficiency of TW-ESD. MethodsWe initially evaluated TW-ESD in a randomized live pig study. After the device was approved for clinical use, we used it in patients undergoing ESD at 8 academic centers in the United States and Japan. Data on demographics, procedural performance, histopathology, and clinical follow-up were collected and analyzed retrospectively. ResultsPorcine study: In total, 12 ESDs were performed in random order in 3 live pigs. ESDs performed with TW had significantly shorter submucosal dissection time (7.0 ± 1.9 minutes vs 18.3 ± 3.4 minutes; P < 0.001) and shorter total ESD time (21.5 ± 4.1 minutes vs 29.5 ± 7.7 minutes; P= 0.049). TW was successfully deployed in all 103 study patients. The median device deployment time was 2 minutes (2, 3.0), and the median procedure time was 100.5 (65.50, 175.75) minutes. En-bloc and R0 resection rates were 98.1% (101/103) and 90.29% (93/103), respectively. The median ease of deployment and retrieval of the device on a 100-mm visual analog scale was 100 (80, 100). The median degree to which the device improved ease of procedure was 90 (77.5, 100). No adverse events related to the TW were seen. ConclusionThe TW device was safe and efficient to use in ESD.

Design of water surface collection robot based on deep sea cage culture

At present, the collection of floating garbage such as dead fish in deep and far sea cage culture waters mainly depends on manpower, which is not only difficult and inefficient, but also has great potential safety hazards. In order to solve the above problems, a water surface collection robot based on marine cage culture is designed and developed. The dead fish on the water surface are collected through the joint action of propeller and forearm drainage and retraction device. At the same time, the relevant performance indexes of the designed water surface collection robot are verified by making the prototype and water surface collection experiments, which meets the needs of simple and efficient collection and cleaning of dead fish in deep and open sea cage culture, so as to provide a reference basis for the practical application of the collection robot.

Realizing pure shear mode of dielectric elastomers by tuning biaxial prestress of a deformation controller

In this article, we propose a method to realize the pure shear deformation mode of dielectric elastomer (DE) membranes by tuning two in-plane prestresses. With utilization of carbon grease electrodes, VHB 4905 membranes are prestretched and attached into a retractable device, forming a pure-shear deformation controller. Experimental results demonstrate that, accurate pure shear deformation mode of DEs can be realized by tuning the mechanical loads in the two directions of the deformation controller. Furthermore, large deformation in the direction of free state can be achieved without electromechanical instabilities. The designed deformation controller accurately realizes the specific pure shear deformation mode of DEs and can be utilized to help design the practical soft actuators.

Comparison of the Pretzelflex Retractor and Nathanson Retractor in Laparoscopic Sleeve Gastrectomy Surgery.

Retraction of the left lobe of the liver is an important step in most bariatric surgical procedures. The left lobe of the liver may be enlarged, and laceration, hematoma, or necrosis may develop in the liver due to retraction. In this study, the results of use of the Nathanson retractor (NR) and PretzelFlex retractor (PFR) in the patients undergoing laparoscopic sleeve gastrectomy (LSG) were compared. The patients who underwent LSG were divided into three groups based on the type of liver retraction device used. Group 1: NR was used fixed during the operation; Group 2: PF retractor was used; Group 3: NR were used only for fundus dissection and when necessary. All groups were evaluated in terms of demographic characteristics, liver function tests, and developing complications. The study was conducted with a total of 120 consecutive patients. Operation time in the second group was found to be significantly lower than the other two groups (p = 0.009; p = 0.001; p < 0.01). The duration of retractor use in the first group was significantly higher than the other two groups (p = 0.001; p = 0.001; p < 0.01). While aspartate aminotransferase (AST) values were found to be high in Group 1, alanine aminotransferase (ALT) values were found to be high in Groups 1 and 3. PFR has shorter operating and retraction times. It causes less measurable liver damage. Although the NR will be used, intermittent use causes less damage to the liver as in PFR.

P0045 - The Butterfly: A novel minimally invasive transurethral retraction device for BPH

P0045 - The Butterfly: A novel minimally invasive transurethral retraction device for BPH