Balloon Sheaths for Gastrointestinal Guidance and Access: A Preliminary Phantom Study

Abstract

ObjectiveWe wanted to evaluate the feasibility and usefulness of a newly designed balloon sheath for gastrointestinal guidance and access by conducting a phantom study.Materials and MethodsThe newly designed balloon sheath consisted of an introducer sheath and a supporting balloon. A coil catheter was advanced over a guide wire into two gastroduodenal phantoms (one was with stricture and one was without stricture); group I was without a balloon sheath, group ll was with a deflated balloon sheath, and groups III and IV were with an inflated balloon and with the balloon in the fundus and body, respectively. Each test was performed for 2 minutes and it was repeated 10 times in each group by two researchers, and the positions reached by the catheter tip were recorded.ResultsBoth researchers had better performances with both phantoms in order of group IV, III, II and I. In group IV, both researchers advanced the catheter tip through the fourth duodenal segment in both the phantoms. In group I, however, the catheter tip never reached the third duodenal segment in both the phantoms by both the researchers. The numeric values for the four study groups were significantly different for both the phantoms (p < 0.001). A significant difference was also found between group III and IV for both phantoms (p < 0.001).ConclusionThe balloon sheath seems to be feasible for clinical use, and it has good clinical potential for gastrointestinal guidance and access, particularly when the inflated balloon is placed in the gastric body.

Usefulness of a Guiding Sheath for Fluoroscopic Stent Placement in Patients with Malignant Gastroduodenal Obstruction

“…The use of those wires was not considered as an alternative in this study due to the increased risk of ulceration and minor bleeding in the gastroduodenal tract due to the wires being pushed hard against very tight strictures (12). Endoscopic assistance has also often been performed to overcome this technical problem during the procedure (5, 7).…”

“…Many authors have experienced difficulties in negotiating a guidewire (GW) and a stent delivery system (SDS) through strictures, especially due to GW buckling or the SDS forming a loop in the dilated stomach and gastroduodenal tract (3, 4). In order to facilitate GW and SDS introductions, the use of alternative methods such as the percutaneous approach and endoscopic guidance have been considered (5). Of these methods, endoscopy has often been referred in order to help movement of a GW through the working channel of the endoscope, eliminating the possibility that the GW becomes trapped in the gastroduodenal tract (6, 7).…”

“…Of these methods, endoscopy has often been referred in order to help movement of a GW through the working channel of the endoscope, eliminating the possibility that the GW becomes trapped in the gastroduodenal tract (6, 7). However, this method has some limitations, in particular the discomfort caused by the endoscopy and an inability of the currently available large diameter SDSs, which are designed for covered stents, to pass via the working channel (5, 8).…”

Stomach Simulator for Analysis and Validation of Surgical Endoluminal Robots

“…However, it is difficult to obtain quantitative and reproducible data due to individual differences of the animal organs and difficulty to control their motions. Regarding the stomach for which some of the endoluminal surgical devices are being developed, the available stomach models are limited to plastic models for medical education, silicone models [7,8] that replicate the gastric anatomy but do not provide any simulation of the stomach physiologic activity, or electromechanical models that simulate the gastric activity but do not have a realistic shape [14].…”

Modelling and manufacturing of 3D-printed, patient-specific, and anthropomorphic gastric phantoms: a pilot study

“…In addition, the gastrointestinal phantom used to investigate IGB performance must be fabricated with durable and flexible materials for enabling the simulation of gastric motility. In previous studies including gastric simulators, in vivo and in vitro experiments were performed by replicating the gastric internal tract 9,[11][12][13] . However, in-vivo tests such as animal experiments are difficult to reproduce due to poor repeatability 9,11 .…”