What Is a Double Balloon Endoscope

The double-balloon endoscope is an endoscope that is used in a novel insertion method developed to ensure smooth insertion into the distal small intestine. Its principle came to my mind in 1997. I was involved in community health care after graduating from Jichi Medical University and was not familiar with endoscopic expertise, such as enteroscopy, until I went back to my alma mater 11 years after graduation. My thoughts resulted in a novel idea. In community health care settings, the lack of advice from instructors often required ingenuity to solve problems. Over the 10 years following graduation, I developed critical thinking skills instead of being content with the status quo.

To be honest, I thought enteroscopy was an awful examination when I first witnessed an enteroscopic examination. During push enteroscopy, a long endoscope was inserted through the mouth while the patient complained of discomfort. On the fluoroscopic monitor, I found the endoscope forming a loop, stretching the intestine, but advancing little. Efforts to advance the endoscope farther made it form a larger loop with the tip stalled, which caused more discomfort to the patient. Despite the prolonged examination, the endoscope tip reached only 50 cm distal to the ligament of Treitz, and the examination was discontinued with no elucidation of pathologic conditions.

The examination left a deep impression on me, and I wondered why the endoscope had not advanced despite such an effort. A few days later, while driving, I was still wondering and suddenly realized that stretching the intestine prevents insertion. It was well known at the time that straightening the intestinal tract helped insertion of a colonoscope, and a semirigid overtube was used to prevent the straightened intestine from forming a loop again. Such an overtube was also used with a push enteroscope, but it was very difficult to straighten an intricately curved small intestine. Thus, my new idea was not to straighten the intestine but to use a balloon-attached flexible overtube to prevent stretching the curved intestine. Furthermore, another balloon was attached to the endoscope tip to prevent the deeply inserted endoscope from slipping out while advancing the overtube — and a prototype of the double-balloon endoscope was thus developed.

The double-balloon endoscope is often described as a type of "measuring worm" and the procedure as achieving "with balloon support, shortening the intestine and endoscope insertion." Each description is close to but not exactly the same as my concept. The primary objective is to prevent stretching the intestine. The intestine is shortened only to make the best use of the working length of the endoscope and facilitate its insertion. Accordingly, I believed from the beginning that this approach would be useful in colonoscopy as well, especially in patients with adhesions, which make insertion of a colonoscope difficult.

I asked endoscope manufacturers for their cooperation as soon as the principle of insertion occurred to me, but they turned me down. They had convincing reasons, and it could not be helped. However, it was good not to abandon my idea. They told me that the principle was merely an armchair theory and unlikely to be substantiated in the clinical setting; moreover, the endoscope, if practicable, would be unprofitable from the viewpoint of the enteroscope market.

Because endoscope manufacturers declined to cooperate, I had no choice but to do it myself. A balloon was attached to the tip of a plastic tube purchased at a hardware store and this concoction was used in combination with an endoscope. Because of the lack of an air route for the balloon at the endoscope tip, it was attached in a retrograde direction so the air route came out the forceps channel (Fig. 1.1). I could not test the initial prototype clinically and asked Dr. Yukihiro Sato, one of my fellows, for cooperation. He willingly agreed to be a study volunteer. The first trial was conducted with a prototype overtube that had an outer diameter of 14 mm. The volunteer was given pharyngeal anesthesia only, without sedation, and the procedure was not tolerated because the vomiting reflex manifested before the tube reached the small intestine, failing to test the principle. Next, we took turns being the operator and the study volunteer, and the procedure was tested on me. I was unable to tolerate the examination either and gave it up.

I therefore concluded that the safety and usefulness should be demonstrated in animal studies before clinical application, so I tested the procedure in dogs. The procedure was then approved by our institutional ethics committee and used in the clinical setting.

The first three patients were examined with an upper endoscope that had an outer diameter of 7.7 mm and a working length of 103 cm together with a balloon-attached overtube with an outer diameter of 12 mm and a length of 75 cm. The fourth patient was examined with an enteroscope with a working length of 200 cm in combination with a 140-cm overtube. All examinations were successful; and total enteroscopy was completed with the endoscope tip advanced into the large intestine in the fourth patient. The results were reported at scientific meetings in Japan and other countries and published in Gastrointestinal Endoscopy [1].

A few questions remained concerning the clinical safety and effectiveness of this method. One was whether the balloon would grip the less robust small intestine safely and adequately without patient discomfort; thus, an endoscope was inserted with the supporting point as a fulcrum. I believed that appropriate selection of balloon materials, pressure that ensured a wide margin of safety, and a soft balloon with lower pressure and a larger contact area would provide a satisfactory grip. The luminal diameter of the small intestine varies among individuals, and the diameter differs between the jejunum and the ileum. Moreover, some regions are dilated in response to stenosis; and conditions are, of course, totally different in the large intestine. With these factors taken into consideration, inflation of the balloon was specified in terms of inflation pressure, not air content. This approach allowed a balloon to grip intestinal tracts that have different luminal diameters with the same intensity. To demonstrate the safety and determine the optimal pressure, the following experiment was performed in the small intestine of dogs.

Laparotomy was performed under general anesthesia. A silicon or latex balloon attached to the tip of a rod, with a diameter of 10 mm and an approximate length of 15 cm, was

Endoscopy Overtube
Fig. 1.1. Prototype double-balloon endoscope equipped with a handmade balloon-attached overtube

inserted from an incision made in the jejunum to investigate the relation between inflation pressure and resistance to withdrawal.

1. The relation between inflation pressure and grip was measured with two types of balloon (Table 1.1; grip 1 and grip 2 represent two measurements).

2. Withdrawal of the latex balloon with an inflation pressure of 100 mm Hg produced no gross mucosal damage.

These results suggested that a soft latex balloon with an inflation pressure of 40-100 mm Hg was suitable for enteroscopy, and the minimum required pressure was determined to be 45 mm Hg.

Table 1.1. Relation between inflation pressure and grip measured with two types of balloon

Balloon pressure (mm Hg)

Latex balloon (made from condoms)

0 10 20 30 40 50 60 70 80 90 100 120 140 160

0 0 20 30 70 80 120 200 200 220 100 180 210 500

Silicon balloon

0 10 20 30 40 50 60 70 80 90 100 120 140 160 180 200 240

Another concern was friction between the overtube and the endoscope. Controlling an endoscope through a long overtube requires eliminating any influence of friction, thereby allowing the endoscope to slide smoothly, even through a curved overtube. The handmade overtube was therefore equipped with a lubricant inlet around one-third the distance from the tip of the overtube so olive oil could be applied during the examination. Currently, the overtube distributed by Fujinon has a convenient internal and external hydrophilic coating by which water injection alone ensures smooth sliding.

Initially, a syringe was used to inflate and deflate a balloon while the internal pressure was being measured with a sphygmomanometer. For marketed devices, a balloon pump controller allows accurate monitoring of the balloon pressure and automatic inflation and deflation of the balloon with the touch of a button, which reduces the time required for the examination.

Tsuneo Nishiguchi, the president of Nisco, cooperated to an extraordinary extent in developing the double-balloon endoscope. Prototypes of a balloon-attached overtube, a balloon at the endoscope tip, and a balloon pump controller were made in cooperation with Nishiguchi. He introduced me to Fuji Photo Optical (currently Fujinon), which made prototypes of dedicated endoscopes. The clinical study results of prototypes demonstrated their usefulness, and the Fujinon double-balloon electronic endoscopy system was put on the market in November 2003 [2, 3]. Engineers at Fujinon made a great contribution to commercializing this endoscopy system. I must especially express my gratitude to Shuichi Yamataka, director of the Medical Equipment Department of Fujinon, and Tetsuo Udagawa, president of Fujinon Toshiba ES Systems.

The development of the double-balloon endoscope paralleled that of the capsule endoscope. Many people expressed concern that practical application of capsule endoscopes in the near future would make the new method of enteroscope insertion obsolete. I insisted, however, that the widespread use of capsule endoscopes would not eliminate but increase the need for enteroscopes that allowed access to the entire area of the small intestine. I believed that capsule endoscopes that could reveal abnormalities would increase the need for a thorough examination by enteroscopy. My belief is now being proven [4].

The widespread use of double-balloon endoscopes and capsule endoscopes will increase interest in intestinal diseases and the need for enteroscopy. I hope this book helps popularize the technique for safe and appropriate insertion of the double-balloon endoscope.

■ References

1. Yamamoto H, Sekine Y, Sato Y, et al (2001) Total enteroscopy with a non-surgical steerable double-balloon method. Gastrointest Endosc 53:216—220

2. Yamamoto H, Yano T, Kita H, et al (2003) New system of double-balloon enteroscopy for diagnosis and treatment of small intestinal disorders. Gastroenterology 125:1556

3. Yamamoto H, Sugano K (2003) A new method of enteroscopy: the double-balloon method. Can J Gastroenterol 17:273-274

4. Yamamoto H, Kita H, Sunada K, et al (2004) Clinical outcomes of double-balloon endoscopy for the diagnosis and treatment of small intestinal diseases. Clin Gastroenterol Hepatol 2:1010-1016

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