Balloon sheaths for gastrointestinal guidance and access: a preliminary phantom study

Abstract

Objective: We 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 methods: The 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.

Results: Both 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).

Conclusion: The 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.

Fig. 1

The new balloon sheath. A. The deflated balloon sheath. (a) the distal angulated part, (b) the balloon part, (c) the straight part, and (d) the proximal handling part. B. The inflated balloon sheath and the three gold markers (arrows) at each end of the balloon and at the tip of the balloon sheath.

Fig. 2

Photograph of the silicone phantom model without stricture and filled with red ink. A. Anteroposterior view. B. Lateral view. The gastroduodenal junction is angled about 90° in a posterior direction to the long axis of the gastric antrum. E = esophagus, F = fundus, A = antrum, D1 = first segment of duodenum, D2 = second segment of duodenum, D3 = third segment of duodenum, D4 = fourth segment of duodenum, J = proximal portion of the jejunum.

Fig. 3

Radiographies of a coil catheter (arrowheads) being advanced over a guide wire (arrows) into the gastroduodenal phantom with stricture in the four groups. A. Group I, without a balloon sheath. B. Group II, through the deflated balloon sheath. C. Group III, through the inflated balloon sheath with the inflated balloon located in the gastric fundus. D. Group IV, through the inflated balloon sheath with the inflated balloon located in the gastric body.