**4. Discussion**

At this point, it needs to be restated that obesity is a disease that affects an individual as a whole. It interferes with mental, physical and social aspects, and is not a direct result of psychological disorders, but it is a target for prejudice and discrimination [19 ]. Hence, when obese people seek out a doctor for treatment, they are in search of not only a healthy body, but also to "discover themselves". However, there are many problems that these individuals face. Standing out from these issues are marital problems, mental disorders, anxiety, depression, excessive eating, low self-esteem, guilt complex and no self-acceptance [20].

There are many factors that cause obesity as already described in this study. But in general, the main cause of obesity remains to be an altered or inadequate eating behavior. From this point of view, it is of fundamental importance that those who are obese are not only seeking solutions in order to control their weight: it is essential to provide conditions for reeducating such people.

When researching currently available treatments for all ranges of obesity, one point in common was observed – decreasing food intake - because depending on how the treatments are carried out each technique in its own way, seeks to achieve this goal. However, the failures, having unfavorable consequences to the patient, amongst other drawbacks, point to the need for finding new techniques.

In light of such a necessity, a new device was designed in this study for treating such cases. The device presented in this study is called an esophageal flow control module (CFE). It must be emphasized that this is a totally original method using a natural raw material extracted from the *Heveabrasiliensis*. An extremely simple, handmade method is used for manufacturing it, which is based on observations and products that already exist in this surgical field.

In this sense, it is important to consider that in terms of the surgical procedures utilized here, the method (proposed here) qualifies as a restrictive technique. This is particularly because the objective of the procedures is to reduce the volume of food ingested. Acknowledging that the esophagus is the organ for placement, it should be pointed out that this technique has disadvantages and restrictions for placement, which have also been described in this study.

The basis for this proposal then is founded upon presenting a proposal for reducing food intake, however, with some significant differences that are listed here: 1) the organ for placement is the esophagus – in its upper third; 2) reduction of the lumen in the esophagus works mechanically, which blocks the quantity of food going from the mouth to the stomach, limiting the ingestion speed of solid foods; 3) placement takes place by means of endoscopy; 4) no alteration to the digestive tract is made, which neither brings about dysfunction nor compromises the absorption of nutrients; the procedure does not cause esophageal lesions, compared to the "gastric band" method which causes lesions in 10% of cases; 5) similar to the other methods, there is the necessity for chewing correctly, however, upon ingesting food of improper consistency, the food comes back up (before reaching the stomach), a positive point in this treatment, since in the other methods, vomiting crises triggered by incorrect mastication may develop into anorexia and bulimia; 6) similarly to the other methods, multi-professional treatment, dietary planning and exercise are also necessary.

182 Practical Applications in Biomedical Engineering

**4. Discussion** 

self-acceptance [20].

educating such people.

surgical field.

described in this study.

esophageal wall, after removal of the module, which was compared with the endoscopy that had been previously done. Nonetheless, after the endoscopic exam, it was observed that the entire esophageal wall was intact, i.e. a normal appearance of the esophageal wall was preserved having a bright and rosy coloring, without food residuals or ulcerations. The

At this point, it needs to be restated that obesity is a disease that affects an individual as a whole. It interferes with mental, physical and social aspects, and is not a direct result of psychological disorders, but it is a target for prejudice and discrimination [19 ]. Hence, when obese people seek out a doctor for treatment, they are in search of not only a healthy body, but also to "discover themselves". However, there are many problems that these individuals face. Standing out from these issues are marital problems, mental disorders, anxiety, depression, excessive eating, low self-esteem, guilt complex and no

There are many factors that cause obesity as already described in this study. But in general, the main cause of obesity remains to be an altered or inadequate eating behavior. From this point of view, it is of fundamental importance that those who are obese are not only seeking solutions in order to control their weight: it is essential to provide conditions for re-

When researching currently available treatments for all ranges of obesity, one point in common was observed – decreasing food intake - because depending on how the treatments are carried out each technique in its own way, seeks to achieve this goal. However, the failures, having unfavorable consequences to the patient, amongst other

In light of such a necessity, a new device was designed in this study for treating such cases. The device presented in this study is called an esophageal flow control module (CFE). It must be emphasized that this is a totally original method using a natural raw material extracted from the *Heveabrasiliensis*. An extremely simple, handmade method is used for manufacturing it, which is based on observations and products that already exist in this

In this sense, it is important to consider that in terms of the surgical procedures utilized here, the method (proposed here) qualifies as a restrictive technique. This is particularly because the objective of the procedures is to reduce the volume of food ingested. Acknowledging that the esophagus is the organ for placement, it should be pointed out that this technique has disadvantages and restrictions for placement, which have also been

The basis for this proposal then is founded upon presenting a proposal for reducing food intake, however, with some significant differences that are listed here: 1) the organ for

folds were normal as was the frequency of the peristaltic waves.

drawbacks, point to the need for finding new techniques.

In this study, the results show that placing a module inflated with gas in the esophagus, does not lead to behavior alterations in the animals. In humans, this feature had already been observed in studies that use esophageal balloon applications. In [21], short esophageal balloons are used (3 cm length and 1 cm in diameter) and long balloons (16 cm in length and 0,8 cm in diameter) for measuring the pressure of the esophageal wall. In [22], notations on the pressure inside the esophagus with a long balloon led to reports that the best results are reached when measurements are made at the middle third, showing that in this region the shape of the pressure *versus* volume curve is not affected by changes in body posture. Another application to be shown is aimed at tubular prostheses used to maintain patent malignant strictures of the esophagus and seal tracheo-esophageal fistulae, when they are fully expanded, reaching 18 mm to 25 mm in diameter and 8 cm to 14 cm length [23]. In the procedures that are involved in this study, no macroscopic damage was observed in the esophageal wall where the module was placed, or in the entire length of the esophagus. A great advantage of this module in relation to the other BIB® methods and the gastric band is how simple it is to manufacture, with the raw material "latex" estimated to be low-cost, easy to handle and highly biocompatible.

As for flow control in the esophagus, there are no reports in literature of studies with this objective. This may be because no one correlated a common denominator between esophageal illnesses that reduce the diameter of the esophagus and marked weight loss. To this end, the model presented in this study seeks to promote a reduction in the esophageal lumen to achieve weight loss.

So, mainly based on the results obtained and in the experiments conducted in dogs, a new procedure is revealed here for treating cases of obesity, derived from a natural source, which imbues it with a low-cost. But, it is probable that alterations and improvements will take place in the module aiming at obtaining better results for applying it in humans.

Thus, the results reached suggest the possibility of controlling the volume of food intake by means of a mechanical system placed in the esophagus. In obtaining results associated with weight loss – without causing significant harm or nutritional changes or alterations in the blood, and furthermore without altering the digestive tract –, through a minimally invasive procedure, is a fact that is appealing within the current context of society. But, in validation of the conclusions reached in the experiments that support this study, it was revealed that a desire such as this has not yet been achieved from the scientifically proven premises.

Prosthesis for Flow Control in the Esophagus as a New Technique for the Treatment of Obesity 185

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