Anastomosis Device Research Articles

Mechanical Viability and Functionality Assessment of a New Sutureless Endoluminal Microvascular Device: A Preliminary In Vivo Rabbit Study.

Our group has developed a new nitinol endoluminal self-expandable device for microvascular anastomosis. It attaches to each vessel ending with opposite directed microspikes and reaches complete expansion at body temperature, using the nitinol shape memory capacity. The main purpose of this first in vivo trial is to evaluate the mechanical viability of the device and its immediate and early functionality. A recuperation study with seven New Zealand White rabbits was designed. A 1.96 mm outer diameter prototype of the new device was placed on the right femoral artery of each rabbit. Each anastomosis was reassessed on the seventh postoperative day to reevaluate the device function. The average anastomosis time with the new device was 18 min and 45 seg (±0.3 seg). It could be easily placed in all the cases with an average of 1.14 (1) complementary stitches needed to achieve a sealed anastomosis. Patency test was positive for all the cases on the immediate assessment. On the 1 week revision surgery, patency test was negative for the seven rabbits due to blood clot formation inside the device. The new device that we have developed is simple to use and shows correct immediate functionality. On the early assessment, the presence of a foreign body in the endoluminal space caused blood clot formation. We speculate that a heparin eluting version of the device could avoid thrombosis formation. We consider that the results obtained can be valuable for other endoluminal sutureless devices.

Mechanism of action and selection of endoscopic bariatric therapies for treatment of obesity.

Endoscopic bariatric therapies (EBTs) are minimally invasive and safe procedures with favorable weight loss outcomes in obesity treatment. We aimed to present the weight loss mechanism of action of EBTs and an individualized selection method for patients with obesity. We searched PubMed, Medline, Scopus, Embase, and Google Scholar databases for studies on the topic from databases inception to July 1, 2023, written in English. We focused on EBTs potential mechanism of action to induce weight loss. We also present an expert opinion on a novel selection of EBTs based on their mechanism of action. EBTs can result in weight loss through variable mechanisms of action. They can induce earlier satiation, delay gastric emptying, restrict the accommodative response of the stomach, decrease caloric absorption, and alter the secretion of gastrointestinal hormones. Selecting EBTs may be guided through their mechanism of action by which patients with abnormal satiation may benefit more from tissue apposition devices and aspiration therapy while patients with fast gastric emptying may be better candidates for intragastric devices, endoscopic anastomosis devices, and duodenal mucosal resurfacing. Consequently, the selection of EBTs should be guided by the mechanism of action which is specific to each type of therapy.

AI-driven automatic compression system for colorectal anastomosis.

Although circular staplers offer technical advancements over traditional hand-sewn techniques, their use remains challenging for unskilled users, necessitating substantial time and experience for mastery. In particular, it is challenging to apply a consistent pressure of an appropriate magnitude. We developed an automated circular anastomosis device using artificial intelligence (AI) to solve this problem. Automation through AI reduces experiential factors during the anastomosis process. We defined damage occurring during the anastomosis process, noting that a greater depth of damage indicated a more severe injury. For automated anastomosis, data at a tissue strain of 40% were used for the AI model, as this strain level showed optimal performance based on the accuracy and cost matrix. We compared the outcomes of automated anastomosis using a trained AI with those of unskilled users. The results were validated using the Shapiro-Wilk test and t tests. Compression damage was verified on collagen sheets. The AI-driven automatic compression system resulted in less damage compared to unskilled users. In particular, a more significant difference in damage was observed in poor-condition collagen than in good-condition collagen. Damage to the collagen under poor conditions was 54.8% when handled by unskilled users, while the AI-driven automatic compression system resulted in 38.9% damage. This study confirmed that novices' use of AI for automated anastomosis reduces the risk of damage, especially for tissues in poor condition.

Systemic assessment of manual circular stapler versus powered circular stapler for anastomosis in rectal cancer: A multicenter prospective cohort study.

e15614 Background: Mechanical anastomosis offers several advantages over traditional hand-sutured anastomosis. However, complications such as anastomotic leaks, strictures, and bleeding persist due to factors like interactions between staples and tissue. Powered circular anastomosis is an effective method to address these issues. Currently, there are no domestic studies on the application of powered-anastomosis technology in colorectal anastomosis. Methods: The study adopted a multicenter, randomized, parallel-controlled, non-inferiority study design, with a 1:1 random allocation ratio. The study involved 187 patients with rectal cancer who underwent Dixon surgery using IntoCare™ disposable powered circular stapler (ICS), and 195 patients who received similar process with manual circular stapler (MCS). The efficacy of stapler was evaluated by anastomosis success rate, anastomosis-related adverse events, anastomosis device performance assessment, operation time, anastomosis time, and postoperative recovery. Safety evaluation indicators included adverse events, vital signs, and laboratory tests. Results: Baseline demographic characteristics showed no notable disparities between two groups (Table 1). A high proportion of patients, 99.47% in the MCS group and 99.49% in the ICS group, successfully completed anastomosis. In the MCS group, the average anastomosis duration was clocked at 2.84 minutes (min) (±2.3), with a median time of 2.0 min (ranging from 1.0 to 22.0 min). In contrast, the ICS group exhibited a slightly quicker average anastomosis duration of 2.40 min (±1.7), and a comparable median time of 2.0 min (but with a narrower range from 1.0 to 15.0 min). Adverse events did not differ significantly between two groups. Conclusions: The results uncovered the powered stapler could considerably reduce stapling time while maintaining a safety profile. Notably, the incidence of patients with anastomotic leakage one month post-surgery, and anastomotic stricture six months post-surgery in the powered stapler group, was lower than those in the manual stapler group. This suggests that the anastomosis created by the powered stapler is more stable and promotes more effective postoperative anastomotic healing. Clinical trial information: NCT05879172 . [Table: see text]

Outcomes of 881 Consecutive Coronary Artery Bypass Graft Patients Using Heartstring Device.

One of the strategies to prevent stroke after coronary artery bypass grafting (CABG) may be the use of a device for proximal anastomosis without partial clamp of the ascending aorta. We retrospectively investigated early and late outcomes in consecutive 881 patients undergoing isolated CABG using Heartstring for proximal anastomosis from January 2008 to December 2022, to reveal the validity to use it. All patients underwent preoperative imaging workups to evaluate neurovascular atherosclerosis. The mean age of the patients was 68.9 years, 20% were female and 13% had previous history of stroke. CABG was on-pump beating heart (52.2%) or off-pump (47.8%) with a mean number of distal anastomoses of 3.38 ± 0.93, using 1.62 ± 0.53 Heartstring devices under different aortic manipulations. In-hospital mortality was 2.0% and perioperative stroke rate was 0.9%, none of them died during hospital stay. During the follow-up period of 70 ± 47 months, the overall actuarial survival rates were 86 and 66%, and major adverse cardiac and cerebrovascular events (MACCEs)-free rates were 86 and 70% at 5 and 10 years, respectively. On multivariable analysis, risk factors for late death included male, previous history of stroke, postoperative sternomediastinitis, late new-onset stroke, and MACCEs, but did not include the perioperative stroke. Low stroke rate, as low as 0.9%, after CABG using Heartstring for proximal anastomosis, although under a variety of aortic manipulations, may contribute to the improved long-term prognosis.

Assessing the influence of parameters on tissue welding in small bowel end-to-end anastomosis in vitro and in vivo.

The use of high-frequency electric welding technology for intestinal end-to-end anastomosis holds significant promise. Past studies have focused on in vitro, and the safety and efficacy of this technology is uncertain, severely limiting the clinical application of this technology. This study investigates the impact of compression pressure, energy dosage, and duration on anastomotic quality using a homemade anastomosis device in both in vitro and in vivo settings. Two hundred eighty intestines and 5 experimental pigs were used for in vitro and in vivo experiments, respectively. The in vitro experiments were conducted to study the effects of initial pressure (50-400kpa), voltage (40-60V), and time (10-20s) on burst pressure, breaking strength, thermal damage, and histopathological microstructure of the anastomosis. Optimal parameters were then inlaid into a homemade anastomosis and used for in vivo experiments to study the postoperative porcine survival rate and the pathological structure of the tissues at the anastomosis and the characteristics of the collagen fibers. The anastomotic strength was highest when the compression pressure was 250kPa, the voltage was 60V, and the time was 15s. The degree of thermal damage to the surrounding tissues was the lowest. The experimental pigs had no adverse reactions after the operation, and the survival rate was 100%. 30days after the operation, the surgical site healed well, and the tissues at the anastomosis changed from immediate adhesions to permanent connections. High-frequency electric welding technology has a certain degree of safety and effectiveness. It has the potential to replace the stapler anastomosis in future and become the next generation of new anastomosis device.

Myocardial Revascularisation in Calcified Aorta in CKD Patient with Help of ENCLOSEII Device, A Bail Out Situation

In this case, a 56 years dialysis dependent patient presented with complaints of angina at rest for 2 weeks after which she was thoroughly evaluated and was diagnosed with coronary artery disease with calcified aorta along with calcification of other vessels also, following which she was planned for CABG surgery. The unclampable ascending aorta (UAA) is a condition increasingly encountered during CABG procedures[1]. Aging of the population and the increase in patients on dialysis have led to an increasing frequency of “porcelain aorta”[2]. The use of the no-touch technique is associated with a high perioperative risk but a superior possibility of complete revascularisation, whereas the adoption of the no-pump strategy ensures a smoother postoperative course at the expense of a higher incidence of ischemia recurrence[3]. Enclose-II anastomosis assist device was originally developed as an ancillary device for proximal anastomosis in off-pump coronary artery bypass grafting (OPCABG), to assist anastomosis for the vascular grafts without clamping the ascending aorta[3]

Off-pump coronary artery bypass grafting with clampless aortic anastomosis devices: Aortic sealing devices versus automated anastomosis punching

ObjectivesClampless aortic anastomosis devices aim to lower stroke risk in off-pump coronary artery bypass grafting. Two main strategies for clampless anastomosis devices emerged with automated anastomosis punching and aortic sealing devices, prompting the question of perioperative outcome differences. MethodsAll consecutive patients undergoing elective off-pump coronary artery bypass grafting with a clampless aortic anastomosis device between September 2014 and December 2021 in 2 centers were retrospectively included. Cohorts were divided by the use of an automated anastomosis punching device or an aortic sealing device to achieve proximal anastomosis on the ascending aorta. To reach group comparability propensity score matching was performed. The primary end point was defined as a composite of all-cause mortality, stroke and rethoracotomy. Secondary end points were perioperative outcome parameters. ResultsA total of 3703 patients were enrolled of whom 575 and 3128 were included in the automated anastomosis punching and the aortic sealing device group, respectively. By propensity score matching a total of 1150 patients were included with 575 in each group. The primary composite endpoint showed no significant difference with 6.3% versus 5.9% events (odds ratio, 0.9; 95% confidence interval, 0.58-1.53, P = .81). All-cause mortality (P = .36), stroke (P = .81), and rethoracotomy (P = .89) also exhibit no disparity. Operation time was significantly longer in the aortic sealing device cohort with 220.0 ± 50.8 minutes and 204.6 ± 53.8 minutes (P < .01). ConclusionsClampless aortic anastomosis strategies aortic sealing device and automated anastomosis punching did not differ in perioperative outcome parameters, whereas the implementation of aortic sealing devices were associated with a prolonged operation time without inducing any inferior clinical outcome.

The coupling device for venous anastomosis: a retrospective comparative study.

The coupling device for venous anastomosis: a retrospective comparative study.

Side-to-side magnetic duodeno-ileostomy in adults with severe obesity with or without type 2 diabetes: early outcomes with prior or concurrent sleeve gastrectomy

BackgroundConventional metabolic/bariatric surgical anastomoses with sutures/staples may cause severe adverse events (AEs). ObjectivesThe study aim was to evaluate the feasibility, safety, and effectiveness of primary and revisional side-to-side duodeno-ileostomy (DI) bipartition using a novel magnetic compression anastomosis device (Magnet Anastomosis System [MS]). SettingMulticenter: private practices and university hospitals. MethodsIn patients with body mass index ([BMI, kg/m2] ≥35.0 to ≤50.0 with/without type 2 diabetes [T2D] glycosylated hemoglobin [HbA1C > 6.5 %]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating magnet fusion and gradual DI (MagDI). The MagDI-after-SG group had undergone prior sleeve gastrectomy (SG); the MagDI + SG group underwent concurrent SG. AEs were graded by Clavien-Dindo Classification (CDC). ResultsBetween November 22, 2021 and May 30, 2023, 43 patients (88.0% female, mean age 43.7 ± 1.3 years) underwent the study procedures. The MS met feasibility criteria of magnet device placement, creation of patent anastomoses confirmed radiologically, and magnet passage in 100.0% of patients. There were 64 AEs, most were CDC grade I and II, significantly fewer in the MagDI-after-SG group (P < .001). No device-related AEs including anastomotic leakage, bleeding, obstruction, infection, or death. The MagDI-after-SG group experienced 6-month mean weight loss of 8.0 ± 2.5 kg (P < .01), 17.4 ± 5.0% excess weight loss (EWL). The MagDI + SG group had significantly greater weight loss (34.2 ± 1.6 kg, P < .001), 66.2 ± 3.4% EWL. All patients with T2D improved. ConclusionsIn early results of a multicenter study, the incisionless, sutureless Magnet System formed patent, complication-free anastomoses in side-to-side DI with prior or concurrent SG.

(Invited) ultrasensitive Low Cost Flexible Sensors and Bioinspired Sutureless Anastomosis Devices

I will present our efforts for investigating flexible electronic sensors for potential health monitoring applications and bioinspired sutureless anastomosis devices for easier, faster, and safer surgery.Highly sensitive flexible tactile sensors are of continuing interest for various applications including human–machine interface systems, internet of things, and wearable health monitoring devices. Current technologies for high sensitivity piezoresistive sensors tend to rely on costly materials and/or fabrication methods, limiting accessibility and scalability. Here, we report a facile sacrificial casting–etching method to synthesize nanoporous carbon nanotube/polymer composites for ultra-sensitive and low-cost piezoresistive pressure sensors. Our synthesis method overcomes the limitations of the traditional solution-dip-coating method for adhering nanoscale conductive materials to the nanoscale porous surface. Importantly, we show ultra-high sensitivity with a strain gauge factor over 300, which is ∼50 times higher than that of traditional CNT-based piezoresistive sensors. For practical tactile sensing applications, we demonstrate that the sensors can detect both gentle pressures (1 Pa–1 kPa) and low pressures (1 kPa–25 kPa) with a fraction of the cost. Our nanoporous polymer composite could contribute to expanding the scope of using nanocomposite sensors for medical applications from its easy tunability for sensing diverse range of tactile signals.Anastomosis, the surgical connection of adjacent tubular organs is a foundational surgical skill for many surgical procedures. The current standard of anastomosis is manually suturing two tubular structures together around an opening with fine sutures. However, it requires several years of surgical training, a long time (60 to 90 minutes per anastomosis) for procedure, and, at times, specialized equipment, facility and staffs. Thus, it is an expensive (up to $35,000 per procedure).Moreover, even in the hands of skilled surgeons, the anastomosis can be complicated by leakage or thrombosis. To address current challenges, we investigated a sutureless anastomosis device inspired by rose prickles. I will present our approach to design, fabricate, and test devices. Our device showed the failure force comparable to that of the handsewn suture (4.9 N) and no leakage up to 45 mL/min flow rate, well above the physiologic blood flow rate. Compared with handsewn anastomosis, the device resulted in minimum deformation of the anastomotic site. From in-vivo non-survival porcine studies, the device showed successful anastomosis (< 5 min per anastomosis) with no leaking for both arterial and venous anastomoses. We envision our findings can contribute to enabling easier, faster, and safer anastomosis, and making anastomotic techniques more accessible to a broad range of clinicians, researchers, and patients across the world.

Magnetic compression anastomosis for reconstruction of digestive tract after total gastrectomy in beagle model.

Magnetic compression anastomosis (MCA) is a simple procedure contributing to a reliable anastomosis. However, digestive-tract reconstruction after total gastrectomy using MCA has not yet been reported. To investigate the feasibility of MCA for simultaneous esophagojejunostomy and jejunojejunostomy after total gastrectomy using beagle dogs. Sixteen beagles were randomly divided into an MCA group (study group, n = 8) and a manual-suture anastomosis group (control group, n = 8). Two different magnetic anastomosis devices were used in the study group for esophagojejunal and jejunojejunal anastomoses. Both devices included a pair of circular daughter and parent magnets each. The time of esophagojejunostomy and jejunojejunostomy, postoperative complications, and survival rate of the two groups were compared. The dogs were sacrificed one month after the operation and their anastomotic specimens were obtained. Healing was observed by the naked eye and a light microscope. Digestive-tract reconstruction after total gastrectomy was successfully completed in both groups (survival rate = 100%). In the study group, esophagojejunal and jejunojejunal anastomoses took 6.13 ± 0.58 and 4.06 ± 0.42 min, respectively, significantly lower than those in the control group (15.63 ± 1.53 min, P < 0.001 and 10.31 ± 1.07 min, P < 0.001, respectively). Complications such as bleeding, anastomotic leakage, and anastomotic stenosis were not observed. In the study group, the magnets did not interfere with each other. Discharge time of the jejunojejunal magnetic anastomosis device was 10.75 ± 1.28 d, while that of the esophagojejunal magnetic anastomosis device was 12.25 ± 1.49 d. Residual silk was found in the control group. The study group showed a greater smoothness of the anastomosis than that of the control group. All layers of anastomosis healed well in both groups. MCA is a safe and feasible procedure for digestive-tract reconstruction after total gastrectomy in this animal model.

A Novel Sutureless Anastomotic Device in a Swine Model: A Proof of Concept Study

IntroductionVascular reconstruction requires technical expertise and is often time consuming. As a novel alternative to traditional hand-sewn vascular anastomoses, the VasoLock (VL), is a nonabsorbable, sutureless anastomosis device with traction anchors designed to hold free artery ends together. These anchors do not penetrate the vessel wall but adhere by leveraging the elasticity of the vessels to fasten blood vessels together. This pilot study assesses the performance and patency of this novel device in a porcine model of femoral artery injury. MethodsFemale swine (n = 7) underwent femoral artery exposure for a total of 10 VL implanted. Study animals underwent hemodilution to a target hematocrit of 15% and ROTEM was used to assess coagulopathy, followed by an arterial injury via transection. The VL was inserted without any sutures. Flow-probe monitors were positioned proximal and distal to the device and flow rates were measured continuously for a total of 90 min. Flow was analyzed and presented as a ratio of distal to proximal flow with the slope of this ratio across time subsequently determined. Angiographic assessment was completed to evaluate for patency and technical complications after 90 min of implant. ResultsThe average animal weight was 44.1 ± 3.2 kg. The average mean arterial pressure at the time of implant was 51.2 ± 7.8 mmHg, median heart rate was 77.4 (IQR = 77.25-157.4) beats per minute, and average temperature was 36.1 ± 1.5°C. The baseline hematocrit was 13.5 ± 3.0%, average pH was 7.20 ± 0.1, average clotting time was 154.1 ± 58.7 s and average clot formation time was 103.4 ± 10.9 s all demonstrating the acidotic, hypothermic, and coagulopathic state of the swine at the time of insertion. During the 90-min observation period, the average flow gradient identified across the VL was 0.99 ± 0.24, indicating no significant change in flow across the VL. The average slope of the gradients was 0.0005 (P = 0.22), suggesting the ratio of proximal and distal flow did not change over the 90 min. Following 90 min of dwell time, all VL were patent without technical complication. Angiographic assessment at 90 min demonstrated no evidence of dissection, device migration, arterial extravasation, or thromboembolism with any of the 10 devices. ConclusionsThis pilot study demonstrated technical feasibility of the novel VL device over a 90-min observation period. All VL were patent and no negative events or complications were identified. This technology demonstrated significant promise in a coagulopathic state: additional investigation, involving long-term survival, is warranted for further validation.

Side-to-side magnet anastomosis system duodeno-ileostomy with sleeve gastrectomy: early multi-center results

IntroductionGastrointestinal anastomoses with classical sutures and/or metal staples have resulted in significant bleeding and leak rates. This multi-site study evaluated the feasibility, safety, and preliminary effectiveness of a novel linear magnetic compression anastomosis device, the Magnet System (MS), to form a side-to-side duodeno-ileostomy (DI) diversion for weight loss and type 2 diabetes (T2D) resolution.MethodsIn patients with class II and III obesity (body mass index [BMI, kg/m2] ≥ 35.0– ≤ 50.0 with/without T2D [HbA1C > 6.5%]), two linear MS magnets were delivered endoscopically to the duodenum and ileum with laparoscopic assistance and aligned, initiating DI; sleeve gastrectomy (SG) was added. There were no bowel incisions or retained sutures/staples. Fused magnets were expelled naturally. Adverse events (AEs) were graded by Clavien-Dindo Classification (CDC).ResultsBetween November 22, 2021 and July 18, 2022, 24 patients (83.3% female, mean ± SEM weight 121.9 ± 3.3 kg, BMI 44.4 ± 0.8) in three centers underwent magnetic DI. Magnets were expelled at a median 48.5 days. Respective mean BMI, total weight loss, and excess weight loss at 6 months (n = 24): 32.0 ± 0.8, 28.1 ± 1.0%, and 66.2 ± 3.4%; at 12 months (n = 5), 29.3 ± 1.5, 34.0 ± 1.4%, and 80.2 ± 6.6%. Group mean respective mean HbA1C and glucose levels dropped to 1.1 ± 0.4% and 24.8 ± 6.6 mg/dL (6 months); 2.0 ± 1.1% and 53.8 ± 6.3 mg/dL (12 months). There were 0 device-related AEs, 3 procedure-related serious AEs. No anastomotic bleeding, leakage, stricture, or mortality.ConclusionIn a multi-center study, side-to-side Magnet System duodeno-ileostomy with SG in adults with class III obesity appeared feasible, safe, and effective for weight loss and T2D resolution in the short term.

Primary Laparoscopic Repair of Iatrogenic Rectal Perforation during Total Laparoscopic Hysterectomy Using an Endoscopic Automatic Anastomotic Device: A Case Report and Literature Review

Background: Rectal injuries are the most severe complications of gynecologic surgeries, especially total laparoscopic hysterectomy. In several cases, an ileostomy is performed as a lifesaving procedure. Recently, studies have suggested that primary repair should be attempted for all cases of intraperitoneal rectal injuries. To the best of our knowledge, previous case reports have not discussed the specific repair of a rectal injury involving all layers. Case: We report a case of rectal perforation during total laparoscopic hysterectomy and bilateral salpingo-oophorectomy that was laparoscopically repaired using an automatic anastomosis device. Conclusions: A rectal injury may be repaired laparoscopically if the bowel is adequately prepared preoperatively and a skilled surgeon is present.

Esophageal Magnetic Anastomosis Device (EMAD) to Simplify and Improve Outcome of Thoracoscopic Repair for Esophageal Atresia with Tracheoesophageal Fistula: A Proof of Concept Study

BackgroundWe designed a new Esophageal Magnetic Anastomosis Device (EMAD) for thoracoscopic repair of esophageal atresia (EA) with tracheoesophageal fistula (TEF) without the need of handheld suturing or additional gastrostomy. MethodsSynthetic EA-TEF model: Spherical and tubular shaped rubber balloons and a term infant sized plastic doll were used. Medical students (n = 10) and surgical trainees (n = 10) were asked to perform thoracoscopic repair of an “EA” with a hand sutured anastomosis (HA) and with the EMAD. Euthanized animal model: The esophagus in 5 piglets (3–4 kg) was dissected and a thoracoscopic esophageal magnetic anastomosis (EMA) was performed. Bursting pressure (BP) and pulling force (PF): HA and EMA were created on ex vivo New Zealand white rabbit (2.5–3 kg) esophagi (n = 25 in each test series). BP and PF were measured and compared against each other. ResultsMedical students were unable to complete HA, but were successful with the EMAD in 11.1 ± 2.78 min. Surgical trainees completed EMA in 4.6 ± 2.06 min vs. HA 30.8 ± 4.29 min (p<0.001). The BP following a HA (14.1 ± 3.32 cmH2O) was close to the physiological intraluminal pressure reported in a neonatal esophagus (around 20 cmH2O), whereas the BP with the EMAD was extremely high (>90 cmH2O) (p<0.001). The PF of an EMA (1.8 ± 0.30 N) was closer to the safety limits of anastomotic tension reported in the literature (i.e. 0.75 N) compared with the HA (3.6 ± 0.43 N) (p<0.0001). ConclusionThe EMAD could simplify, shorten, and potentially improve the outcome of thoracoscopic repair for EA with TEF in the future. A high BS and a relative low PF following EMAD application may lower the risk of postoperative complications such as esophageal leakage and stricture formation.

Electromagnetic tool for the endoscopic creation of colon anastomoses—development and feasibility assessment of a novel anastomosis compression implant approach

BackgroundColorectal anastomoses are among the most commonly performed interventions in abdominal surgery, while associated patient trauma is still high. Most recent trends of endoscopic anastomosis devices integrate magnetic components to overcome the challenges of minimally invasive surgery. However, the mutual attraction between magnetic implant halves may increase the risk of inadvertently pinching healthy structures. Thus, we present a novel anastomosis device to improve system controllability and flexibility.MethodsA magnetic implant and an applicator with electromagnetic control units were developed. The interaction of magnetic implants with the electromagnets bears particular challenges with respect to the force-related dimensioning. Here, attraction forces must be overcome by the electromagnet actuation to detach the implant, while the attraction force between the implant halves must be sufficient to ensure a stable connection. Thus, respective forces were measured and the detachment process was reproducibly investigated. Patient hazards, associated with resistance-related heating of the coils were investigated.ResultsAnastomosis formation was reproducibly successful for an implant, with an attraction force of 1.53 pm 0.3 N, resulting in a compression pressure of 0.0048 frac{N}{{mathrm{mm}}^{2}}. The implant was reproducibly detachable from the applicator at the anastomosis site. Coils heated up to a maximum temperature of {T}_{mathrm{max}}=41.6 pm 0.1^circ mathrm{C}. Furthermore, we were able to establish a neat reconnection of intestinal bowel endings using our implant.DiscussionAs we achieved nearly equal compression forces with our implant as other magnetic anastomosis systems did (Magnamosis™: 1.48 N), we concluded that our approach provides sufficient holding strength to counteract the forces acting immediately postoperatively, which would eventually lead to an undesired slipping of the implant halves during the healing phase. Based on heat transfer investigations, preventive design specifications were derived, revealing that the wall thickness of a polymeric isolation is determined rather by stability considerations, than by heat shielding requirements.

Design and pre-clinical evaluation of a folding magnetic anastomosis device for minimally invasive surgery

Objective: This work presents the results of Benchtop tests and pre-clinical study of a novel design for a foldable magnetic anastomosis device. The device can be deployed through an endoscope device channel and fold into a ring larger than the deployment port. This new design enables the target application in JJ-anastomosis creation. Material and methods: The folding anastomosis device is constructed from a chain of permanent magnets suspended in a suture weaving inspired by the contact-aided compliant mechanisms. The device was deployed through an endoscope in Benchtop experiments and its expected coupling force was measured in a pull test. A set of experiments was executed during the pre-clinical study, where the device was deployed in the abdomen, to estimate the reliability of deployment and the plausibility of the use in jejuno-jejunal (JJ)- and gastrojejunal (GJ)-anastomosis creation. Results: The presented folding anastomosis device was shown to deploy through an endoscope device channel and a catheter with an inner diameter of 3.2 mm. After deployment the device folds reliably into a ring with an outer diameter of 7–8 mm. The folded device was shown to exhibit a coupling force comparable to similar cases of JJ-anastomosis creation. It is concluded that the presented design of a folding magnetic ring is suitable for select cases of magnetic compression anastomosis where the device is either delivered through a catheter to fold into an anastomosis ring larger than the deployment port or through an endoscopes device channel to allow for convenient visual confirmation of the device during placement.

A COMPARATIVE STUDY OF STAPLERS VERSUS HAND SEWN ANASTOMOSIS IN INTESTINAL SURGERIES

INTRODUCTION: Intestinal anastomosis is a surgical procedure to establish communication between two separated portions of the intestine. This procedure restores intestinal continuity after removal of a pathological condition affecting the bowel. Intestinal anastomosis can be performed by a hand-sewn technique using absorbable or non-absorbable sutures, mechanical stapling devices. Sutured anastomosis (hand-sewn technique) is the commonly used method. The newer stapling devices for intestinal anastomosis has provided an alternative option to perform rapid anastomosis.1 Various studies have contradictory results in terms of duration of procedure, post operative recovery and anastomotic leak. There are insufcient evidence to demonstrate superiority of either technique and more studies are needed to demonstrate the superiority of either technique. AIM MATERIAL AND METHODS:: To study and compare the effectiveness of staplers vs hand sewn anastomosis in Intestinal surgeries. A comparative observational study Consists of patients presenting with need of bowel resection and anastomosis inclusion criteria at Apollo Hospital Gandhinagar, Gujarat. The patients who are admitted for elective as well as emergency resection &amp; anastomosis of small and large intestines for various illnesses are selected after thorough clinical examination and investigations to conrm the diagnosis co- morbid conditions. Details were recorded in the proforma prepared. : 62.5% complications in comorbid subjects and 37.5% complications in non comorbid subjects.RESULTS The mean of anastomotic time for hand sewn group was 27.8 minutes whereas for the stapler group it was 9.0 minutes mins .With respect to return of bowel sounds, mean time was 46.32 hours in the hand sewn group and 35 hours in the stapler group Mean day of hospitalization was 8.16 days in hand sewn and 7.8 days in stapler technique. mean time taken for resumption of oral feeds the was 66.96 hours in hand sewn group and was 59.52 hours in stapler group .hand sewn group had total ve complications(20%), whereas stapler group had three complications(12%) Both the groups did not have any mortality. The mean cost of hand sewn anastomosis is 717.4 Rs which is signicantly less than mean cost of stapled anastomosis which is 33,754 Rs. : Stapler anastomosis signicantly reduces operative time and time taken for return of normal bowel sounds.CONCLUSION Because of the shortened total operating time in the stapled anastomosis .There is increased risk of overall complications in patients having co- morbidities in both hand sewn and stapled anastomosis. Mechanical staplers are far more costly than suture materials. Stapling technique can be used safely and effectively

The novel application of an emerging device for salvage of primary repair in high-risk complex esophageal atresia

IntroductionPreservation of native esophagus is a tenet of esophageal atresia (EA) repair. However, techniques for delayed primary anastomosis are severely limited for surgically and medically complex patients at high-risk for operative repair. We report our initial experience with the novel application of the Connect-EA, an esophageal magnetic compression anastomosis device, for salvage of primary repair in 2 high-risk complex EA patients. Compassionate use was approved by the FDA and treating institutions. Operative TechniqueTwo approaches using the Connect-EA are described – a totally endoscopic approach and a novel hybrid operative approach. To our knowledge, this is the first successful use of a hybrid operative approach with an esophageal magnetic compression device. OutcomesSalvage of delayed primary anastomosis was successful in both patients. The totally endoscopic approach significantly reduced operative time and avoided repeat high-risk operation. The hybrid operative approach salvaged delayed primary anastomosis and avoided cervical esophagostomy. ConclusionThe Connect-EA is a novel intervention to achieve delayed primary esophageal repair in complex EA patients with high-risk tissue characteristics and multi-system comorbidities that limit operative repair. We propose a clinical algorithm for use of the totally endoscopic approach and hybrid operative approach for use of the Connect-EA in high-risk complex EA patients.