Anastomosis Device Research Articles

Novel stapling device for open and thoracoscopic esophageal anastomosis in congenital esophageal atresia

Esophageal atresia, with or without trachea-esophageal fistula, are relatively common congenital anomalies. The surgical correction requires placement of anastomotic sutures, which are considered technically demanding, relatively imprecise and are associated with a steep learning curve. The need for a mechanical device for anastomosis has been stressed, as conventional stapling devices have their own limitations in this regard. We propose a unique anastomotic device that can be used in open and thoracoscopic repairs. This device is based on the principle that ideal healing requires adequate approximation and minimal tension. We try to achieve this by placing staples circumferentially, with the body of the staple being parallel to the long axis of the esophagus.This novel technique has many advantages. The tedious part of anastomosis can be done easily, quickly and safely. Adequate approximation would minimize scarring and stricture, and there will be no purse-string effect, and hence no impedance to the growth of neonatal esophagus. Such a device would be very helpful, and it needs to be manufactured, tested and modified to tackle unforeseen hurdles.

Meta-analysis on the use of the Heartstring anastomotic device to prevent stroke in patients undergoing off-pump coronary artery bypass grafting

Postoperative stroke is the Achilles' heel of coronary artery bypass surgery compared with percutaneous coronary intervention. In this meta-analysis, we sought to determine the efficacy of the Heartstring proximal anastomotic device to reduce the risk of postoperative stroke after off-pump coronary artery bypass grafting (OPCAB). Studies on the Heartstring device were identified by searching PubMed, Cochrane Library and Scopus up to November 2010. The results were expressed as pooled proportions (%) with 95% confidence interval (95% CI). Heterogeneity across the studies was evaluated by the I(2) test and a random effects model was used. Eighteen articles were pertinent with this issue and we were able to retrieve data on the Heartstring anastomotic device in OPCAB from eight studies. Three studies were prospective and routine epi-aortic ultrasound was used in three studies. A total of 819 patients were enrolled in these eight studies and six of them suffered stroke postoperatively. Cumulative analysis showed a pooled rate of immediate postoperative stroke after OPCAB with the use of Heartstring of 1.9% (95% CI 0.8-4.5, I(2)=23%). Sensitivity analysis including the only three studies evaluating patients with diseased ascending aorta as detected at epi-aortic ultrasound showed that a pooled rate of stroke was 3.2% (95% CI 0.8-11.9, I(2)=0%). Six studies reported on immediate postoperative mortality and the pooled mortality rate was 1.9% (95% CI 0.1-3.4). The results of this meta-analysis suggest that the risk of stroke after OPCAB may not be markedly reduced by the use of Heartstring device. On the other hand, a rather low rate of stroke was observed among patients with diseased ascending aorta indicating its potential value in these patients. Most of studies included in this meta-analysis were of poor methodological quality, and properly conducted prospective studies are needed to get more conclusive results on the safety and efficacy of Heartstring anastomosis device.

Improvement of neurological outcome in coronary surgery using an automated proximal anastomosis device

Improvement of neurological outcome in coronary surgery using an automated proximal anastomosis device

Novel Suture-Less Vascular Anastomotic Device (BYFix) in Femoro-Popliteal Surgery, Early Clinical Experience

Objectives: To evaluate the early experience of using the BYFix-innovative anastomotic device for creating suture-less vascular anastomosis in major and peripheral arteries surgery. Design: Uncontrolled prospective study. Materials: The BYFix anastomotic device for suture-less vascular anastomosis with surgical tools and standard vascular grafts. Methods: 7 patients, age 63.6 ± 9.2 years, with peripheral vascular occlusion above the knee scheduled for surgical repair were operared. They underwent the surgical procedure using the BYFix anastomotic device for creating proximal anastomosis and the conventional manual suturing for creating the distal anastomosis of the implantable vascular graft. Results: The anastomoses by using BYFix anastomotic device were successfully created in all patients. The duration of anastomosis creation was significantly shorter by using BYFix device, compared to conventional manual suturing, 5:10 ± 1:50 minutes compared to 33 ± 17:40 minutes respectively. No adverse events related to BYFix anastomotic device were observed, during the surgical procedure or recovery period. One year follow up revealed no complications related to BYFix anastomotic device. Conclusions: The BYFix anastomotic device enables the creation of efficient vascular anastomosis in peripheral vascular occlusions. It shortens the time needed for creating vascular anastomosis and thus reducing the operation time and might reduce distal complications related to the vascular procedure. Further clinical trials are needed to establish the results.

UP-1.76: Capio RP suturing device for vesico-urethral anastomosis improves urinary continence and post-surgical strictures rates after radical retropubic prostatectomy

UP-1.76: Capio RP suturing device for vesico-urethral anastomosis improves urinary continence and post-surgical strictures rates after radical retropubic prostatectomy

Endoscopic magnetic gastroenteric anastomosis for palliation of malignant gastric outlet obstruction: a prospective multicenter study

Palliation of malignant gastric outlet obstruction remains challenging. Although there are 2 established treatment options, ie, surgical gastrojejunostomy and endoscopic duodenal stent insertion, there is an ongoing search for a technique that would combine the safety and rapid effect of duodenal stent placement with the long-term efficacy and low reintervention rate of a surgical gastrojejunostomy. To investigate the safety and success rate of endoscopic creation of a gastroenteric anastomosis formed by magnetic compression and stent placement. Prospective, multicenter cohort study. Four referral centers. The expected number of patients with symptomatic malignant gastric outlet obstruction to be included at the participating hospitals during a year was 40. Because of a serious adverse device event, the study was terminated after inclusion of 18 patients. Creation of an endoscopic gastroenteric anastomosis by using the Cook Magnetic Anastomosis Device with transanastomotic deployment of a self-expandable stent. Primary endpoints were safety and success rate associated with the creation of an endoscopic gastrojejunostomy by using a magnetic anastomotic device with transanastomotic deployment of a self-expandable stent. Because of a serious adverse event, the study was terminated prematurely. A success rate of 66.7% (12 of 18 patients) was achieved; 1 serious adverse event (stent perforation) occurred leading to the death of the patient. Three patients (25%) experienced an adverse device effect (stent migration). Small sample size, lack of a control group. Endoscopic creation of a gastroenteric anastomosis by magnetic compression is feasible and safe; however, the necessity of a stent led to serious morbidity and even mortality in this study. The current system can therefore not be recommended for clinical use.

The Use of Enclose(®)II Anastomosis Assist Device for the Proximal Coronary Branch Anastomosis to Vascular Graft.

We used the Enclose(®)II anastomosis assist device (Novare Surgical Systems, Inc., CA, USA), which was originally developed as an ancillary device for proximal anastomosis in off-pump coronary artery bypass grafting (OPCAB), to assist anastomosis for the vascular grafts without clamping those conduits in two cases. In these cases, it was difficult to clump vascular graft partially, because vascular graft was short. So we used Enclose(®)II anastomosis assist device for these cases. The advantage of this method is that the Enclose(®)II anastomosis assist device facilitates the anastomosis of arterial side branches to the artificial graft (1) by eliminating the use of partial clamp on the artificial conduits and (2) by providing a plane surface for easy handling for suture.

Side-to-Side Anastomosis without Vessel Clamp : A Practical Method for Arterio-Venous Fistula

The radial artery to cephalic vein fistula (radial AVF, Brescia-Cimino, radiocephalic) is the basic technique in arteriovenous fistula construc tion before hemodialysis and the side to side anastomosis is commonly used between these vessels. The vessel clamps in bulldog and approximater types are special and crucial devices for anastomosis. When any vascular clamp is not available, we perform side to side anastomosis with a needleholder or an ordinary forceps in arteriovenous fistula operation. This method is easy, practical, and inexpensive, and may successfully be used in this operation.

Inverted graft insertion technique for apicoaortic bypass

The proximal anastomosis of the apicoarotic bypass is technically demanding. We describe our novel surgical technique to reinforce the proximal anastomosis of the apicoaortic bypass. After moving circular muscle of the left ventricle (LV) under ventricular fibrillation, an inverted tube graft is inserted into LV through the opening of the apex. Then, end-to-end anastomosis is made with horizontal mattress sutures passing from the inside of the inverted tube graft through the entire thickness of LV muscle and a running suture of the edge of LV muscle and graft. As the tube graft is pulled out from the LV, the anastomosis is completed. This technique permits simple and reliable suture placement without the need for any special device for the proximal anastomosis of the apicoaortic bypass.

Novel implant for transcervical sterilization

Compared to laparoscopic surgery for interval tubal sterilization, the transcervical approach is an effective method of female sterilization which obviates the requirement of general anesthesia and surgical incision. However, current methods of transcervical sterilization are unable to provide an instant occlusion. This paper focuses on the design, development and testing of a novel implant (James E., Coleman, Christy Cummins, 2009. Anastomosis Devices and Method. US Patent 20090105733A1) to achieve instant permanent female sterilization via the transcervical approach. The implant is designed to be deployed under hysteroscopic visualization into the ostium of the fallopian tube and relies on instant mechanical occlusion. The implant includes two sets of wings that penetrate into the ostium and uterine muscle tissue and trap the tissue in between thus plugging the entrance of the fallopian tube. In order to design the shape of implant wings and to investigate the mechanical behavior of the implant, a three-dimensional (3D) model was developed and Finite Element Method (FEM) was used for simulations. The implant was validated by a number of successful deployments in bench testing, animal tissue and explanted human uteri. During the deployments in animal tissue and explanted uteri, it was observed that the two sets of wings completely trapped the tissue in between and the hydraulic pressure testing of the explanted uteri using saline solution and methylene blue proved the instant occlusion of the fallopian tubes. Initial results suggest that this novel implant provides a safe and effective method of female sterilization. Further development work is ongoing in preparation for "first-in-man" clinical trials.

Expandable device type III for easy and reliable approximation of dissection layers in sutureless aortic anastomosis. Ex vivo experimental study☆

In past years, we developed expandable devices (type I and II) for sutureless aortic anastomosis. We have now further modified the device (type III) incorporating a second expandable ring, external to the main one, which can be operated contrariwise in such a way that the aortic wall (i.e. the dissection layers) is compressed between the two expandable rings, providing full control on both the layers compression pressure and the anastomosis final diameter. The device was evaluated in ex vivo experimental models of swine aortic arch fresh samples; air-tight sealing at increasing endovascular pressures was also evaluated and compared with sealing achieved by standard suturing. Ex vivo data suggest that the present version of the device can be used easily and quickly also in elliptical, asymmetric 'oblique' anastomosis as when concavity arch is involved. Perfect air-tight sealing of the anastomosis was verified at endovascular pressures up to 150 mmHg, while standard suture cannot withstand even minimal endovascular air pressure. Compared to the previous versions, the present device is less bulky and softer, can be used also for concavity arch resection and provides full and standardizable control on dissection layers stable and sealed approximation.

Complete Ileal Neobladder Intracorporeal Construction With Standard Sutured Technique and Novel Technology

We compared the surgical efficacy and efficiency of a completely suture based procedure with a novel entero-urethral anastomosis device and an EndoGIA stapler to create an ileal neobladder. Two groups of 7 pigs each were survived for 8 weeks. In group 1 the neobladder was constructed using a U-shaped segment of ileum sealed with the stapler. The entero-urethral anastomosis was created with a novel sutureless anastomosis device. All other procedures were completed with standard intracorporeal suturing techniques. In group 2 animals completely intracorporeal sutured technique was used. Total procedure, and enteroenteric, ileal neobladder, uretero-enteric and entero-urethral anastomosis times were recorded. Cystograms done immediately postoperatively, at 2 weeks and at sacrifice to evaluate the newly constructed system were rated from 0-no leakage to 3-severe leakage. In group 1 vs 2 the overall procedure, and enteroenteric, ileal neobladder, uretero-enteric and entero-urethral anastomoses were completed in 285.3, 32.3, 58.8, 54.2 and 5.5 vs 350.1, 29.9, 139.1, 58.0 and 46.3 minutes, respectively. In groups 1 and 2 the average postoperative cystogram rating was 0.83 and 1.6, respectively (p = 0.63). At 2 weeks and at sacrifice cystograms showed no extravasation in either group. The overall surgical procedure, pouch creation and entero-urethral anastomosis were statistically briefer in group 1 (p = 0.036, 0.01 and 0.039, respectively). Average survival in groups 1 and 2 was 30 (range 4 to 56) and 41 days (range 1 to 56), respectively (p = 0.36). All animals had voiding complications within 1 week after ureteral and urethral catheters were removed. One neobladder ruptured in group 1. Combining stapled ileal neobladder construction and the entero-urethral anastomosis device significantly decreases operative time, pouch creation and urethral anastomoses.

The Use of Enclose®II Anastomosis Assist Device for the Proximal Coronary Branch Anastomosis to Vascular Graft

The Use of Enclose®II Anastomosis Assist Device for the Proximal Coronary Branch Anastomosis to Vascular Graft

Hemodynamic Performance of a Sutureless Anastomosis Device (the Graft Connector): A Numerical Study

Sutureless anastomosis devices have been developed to facilitate arterial bypass surgery on the beating heart. However, these devices can significantly alter the hemodynamics at the end-to-side anastomosis and in the host artery, leading to the formation of thrombus or/and intimal hyperplasia (IH). In this study, a numerical analysis was performed on the hemodynamic performance of the Graft Connector (GC), a sutureless anastomosis device, under pulsatile flow conditions. The results showed that blood flow was severely disturbed in the GC model with the formation of vortices and flow stagnation at the bed and the toe, and distal to each of the stent struts, which led to low wall shear stresses and high oscillating shear indices in these regions. This may cause severe IH in the host artery and compromise the performance of the device. Based on the numerical study, suggestions were proposed for the design of the GC to improve its performance.

Laparoscopic Total Intracorporeal Correction of Choledochal Cyst in Pediatric Population

The laparoscopic correction of the choledochal cyst is an attractive treatment option. However, even the skilled surgeons do not prefer the intracorporeal jejunojejunal anastomosis due to the technical difficulties. In this article, we present the feasibility of laparoscopic total intracorporeal correction of the choledochal cyst, including the retrocolic Roux-en-Y hepaticojejunostomy and jejunojejunostomy. A prospective review of 6 cases of consecutive laparoscopic surgery for choledochal cyst in the pediatric population from March 2007 to April 2008 was performed. All patients underwent laparoscopic excision of a choledochal cyst and total intracorporeal Roux-en-Y reconstructions. The intracoporeal jejunojejunostomy was made by introducing an endoscopic gastrointestinal anastomosis device (Endo-GIA; US Surgical, Norwalk, CT) through the umbilical port with hand-sewn reinforcement. We evaluated the patient's age at the time of operation, time taken for total operation, time taken for jejunojejunostomy, and intra- and postoperative events. All 6 cases were girls (age ranging from 4 months to 7 years). All had type I choledochal cyst. Five ports were utilized: one telescopic port at the umbilicus, one left subcostal port for liver retraction, two operating ports on the right flank and left side of the umbilicus, and one right-lower quadrant port for the assistant. The mean time for total operation was 275 + or - 58 minutes (range, 210-360). Total intracoroporeal jejunojejunostomy took 38 + or - 10 minutes (range, 25-55). All patients were symptom free during the median follow up of 3.5 months. In the pediatric population with choledochal cyst, total intracorporeal Roux-en-Y hepaticojejunostomy and jejunojejunostomy during laparoscopic surgery is feasible without the need for exteriorization of the bowel.

A New Device for Performing the Bladder Urethral Anastomosis during the Laparoscopic Radical Prostatectomy

Background: A good quality urethra-vesical anastomosis is the key for lowering the incidence of the urethral strictures. In the same time this anastomosis requires the most delicate and time consuming steps of the laparoscopic procedure. We designed and manufactured a device that allows performing the anastomosis starting from the urethra with separate stitches. Material and Method: The new technique inserts the suture needle through the urethra and allows the surgeon to perform extracorporeal knotting. The urethral anastomosis device was designed by the first author and we have a patent pending for it. We evaluated the characteristics of the vesico urethral anastomosis in 3 groups of 7 patients in which we performed it by the usual laparoscopic fashion (the first group 7 patients we used separate stitches, the second group 7 patients with continuous running sutures) and the third group using our urethral suturing device. We followed the parameters: duration of the anastomosis, number of stitches, urine leak time, and cooptation of mucosa rate. Result: The time of the anastomosis is decreased from 34 to 21 minutes by using the urethral suturing device. We were able to use more stitches when we used the urethral suturing device but the urine leak time was not significantly changed. The cooptation of mucosa was performed in all the stitches where we used the urethral suturing device. Conclusion: Using the urethral suturing device the difficulty of the urethral suturing during the vesico ureteral anastomosis is decreased. In this new manner we encountered a significant decreased anastomosis time. We postulate a lower incidence of the urethral strictures considering a better cooptation of the mucosa in the anastomosis using the urethral suturing device.

Intermediate-Term Patency of Saphenous Vein Graft With a Clampless Hand-Sewn Proximal Anastomosis Device After Off-pump Coronary Bypass Grafting

To avoid complications related to aortic manipulation, devices were developed to perform clampless anastomosis. However, there are few studies concerning the late patency of the graft. The aims of this study were to investigate the patency rate of saphenous vein (SV) graft after off-pump coronary artery bypass grafting (OPCAB) and to evaluate the influence of a clampless hand-sewn proximal anastomosis on late graft patency. Patients (n = 232) were enrolled who underwent OPCAB with SV grafts from 2004 to 2007 and had follow-up angiography. For proximal anastomoses, a clampless device was used in 73 (group A; HEARTSTRING [Guidant Corporation, Santa Clara, CA] in 54, Enclose II [Novare Surgical Systems, Inc, Cupertino, CA] in 19), and partial clamping was used in 159 (group B). The proximal anastomosis procedure was modified according to the results of epiaortic ultrasonography. Coronary angiography was performed early (11.8 +/- 10.4 days) and one-year postoperatively (n = 180, 371.5 +/- 102.6 days). There were no significant differences in patient characteristics between the two groups except for a higher reoperation rate in group A. The overall SV patency rate at the early and one-year postoperative angiography was 95.7% and 83.0%, respectively. The patency rates were similar between the two groups (early: 97.3% vs 98.1%, p = 0.729; 1 year: 87.0% vs 81.3%, p = 0.316). There was also no significant difference in the target vessel revascularization rate during follow-up (6.8% vs 10.1%, p = 0.623). Intermediate-term angiographic follow-up demonstrate an acceptable SV patency rate after OPCAB. The SV patency rate with a clampless device for proximal anastomosis is comparable with that with partial clamping during the first postoperative year.

Endoscopic Magnetic Anastomosis Device for Palliation of Malignant Gastric Outlet Obstruction: Short Term Results of a Prospective Multicenter Study

Endoscopic Magnetic Anastomosis Device for Palliation of Malignant Gastric Outlet Obstruction: Short Term Results of a Prospective Multicenter Study

A hinged metalloplastic anastomotic device: a novel method for choledochoduodenostomy

In biliary obstruction, the creation of a large-diameter permanent fistula between the bile duct and the duodenum would be attractive. To invent, prototype, and test a new method of forming a biliary duodenal anastomosis. Survival and nonsurvival porcine model. An animal laboratory with general anesthesia. A novel hybrid metalloplastic 7F anastomosis device that consisted of a central ferrous metallic tube sandwiched between 2 tapered flexible plastic end pieces was used. The device was hinged on either side of the metal insert so that a magnetic force could form an anastomosis and then the plastic components of the device could deform to fall through the compression anastomosis. These devices were inserted into the bile duct of the pigs over a 0.035-inch guidewire with a pusher tube. Cylindrical-shaped magnets were then positioned over the intraduodenal bile duct so that they exerted compressive ischemic force on the duodenum and bile duct above the papilla. Choledochoduodenal anastomoses created were inspected at subsequent endoscopy and postmortem for patency and size. Seven anastomosis devices were placed in the bile duct of pigs (weight 22-54 kg). All 4 survival animals were well and eating as soon as they were awake. Anastomoses were successfully accomplished in all survival animals. The supra-ampullary opening into the bile duct ranged from 5 to 10 mm. The small number of animals. A new method for achieving larger-diameter biliary drainage was developed. Four animals were euthanized after 2 to 7 days. Our best anastomosis resulted from 2 magnets left in the animals for 4 days.

Magnamosis: magnetic compression anastomosis with comparison to suture and staple techniques

Purpose An ideal anastomosis between hollow viscera should be easily performed, strong, and operator independent. We hypothesized that transluminal attraction between magnets in the intestine could be harnessed to create an intestinal compression anastomosis (magnamosis) with these characteristics. We further hypothesized that variation of attraction force and geometry of compression would affect the quality of the intestinal anastomosis. Methods We designed a self-orienting device composed of 2 neodymium-iron-boron magnets affixed to polytetrafluoroethylene moldings. Two topologies were evaluated: one designed with ‘uniform’ compression and the other with ‘gradient’ compression. Sixteen young adult pigs ( Sus scrofa) underwent laparotomy with creation of a magnetic side-to-side anastomosis: 8 with the uniform device and 8 with the gradient device. Each also had a stapled anastomosis, and 5 had an additional hand-sutured anastomosis. Animals were euthanized at 1, 2, and 3 weeks after operation, then anastomoses were compared on the basis of gross appearance, histology, functional radiography, and mechanical integrity. Results All magnetic devices formed patent anastomoses without leak. One stapled anastomosis resulted in a contained leak. Mechanical integrity of magnetic anastomoses was not statistically significantly different from staple or suture counterparts, and there was a trend toward greater strength with magnetic anastomoses. Comparison between device types revealed the gradient device trended toward greater strength and earlier patency (67% vs 33% at 1 week). There was no evidence of stenosis, and histologic examination demonstrated tissue remodeling with mucosal and serosal apposition across the magnamoses. Conclusions The magnetic compression anastomosis (magnamosis) device is a safe and effective means of sutureless full-thickness intestinal anastomosis with serosal apposition in a pig model. Gradient compression is superior to uniform compression. This technique is compatible with endoscopic and natural orifice approaches.