What is the Plastic Sleeve and what does it do?

The Plastic Sleeve is a medical device for the treatment of type 2 diabetes and obesity which is worn inside of the body. Plastic Sleeve is essentially a gastrointestinal impermeable liner designed to prevent food from coming in contact with the wall of the intestine. It is a thin plastic sleeve which lines the first 60 cm of the small intestine, causing food to be absorbed further down in the intestine.

How does the it works?

The Endo Barrier works by preventing the body from digesting food within the upper part of the small intestine The body reacts to food in a different way when the first part of the small intestine is blocked. This may have an effect on the patient’s uptake of both nutrients and calories. It may also have a metabolic effect that is similar to Roux-en-Y gastric bypass surgery, which produces significant weight loss and resolution of type 2 diabetes. However, the Plastic Sleeve is placed and removed endoscopically. As with many endoscopic procedures, it may provide a safer alternative with more rapid recovery and lower costs. It is a reversible procedure. The procedure can be performed in under an hour, with the patient under anesthetic. The sleeve is inserted via the mouth, through the stomach to the small intestine where it is fixed in place by a sprung metal anchor to prevent it slipping out.

The Plastic Sleeve works by preventing the body from digesting food within the upper part of the small intestine. Cutting out this part of digestion means that the body reacts differently to food you eat. You feel more full after a smaller meal. The liner also changes the way the body manages blood sugar so that in most patients their blood sugar level rapidly come down into the normal range.

The fact that digestion is delayed by the sleeve, changes the way the body’s hormones are activated, which helps the body feel full and improves glucose tolerance.

The concept is therefore similar to that of having as gastric bypass, but does not involve invasive surgery, is safer, not permanent and is less expensive.

Who is the Plastic Sleeve suitable for?

The Plastic Sleeve is suitable for people:

• With type 2 diabetes

• Aged 18 – 60 years old

• With a BMI between 30 and 50

• And an HbA1c between 7.5 and 10.5%

• And taking either oral glycemics or less than 150 units per day.

Would anything rule out having the Plastic Sleeve?

The most common conditions which would prevent a patient having the Plastic Sleeve are:

• Stomach ulcers (peptic ulcers)

• Bleeding disorders (e.g. people with hemophilia or on anti-arthritis drugs)

• Major digestive surgery in the past

The possible side effects:

• Abdominal pain on the right side

• Bloating

In earlier trials, the Plastic Sleeve had to be removed, in a small percentage of cases, after becoming dislodged. However the sprung anchor has since been improved. GI Dynamics, a company out of Lexington MA, is called Plastic Sleeve as an EndoBarrier™.

Placement   The EndoBarri er is delivered endoscopically. The anchor is positioned in the duodenal bulb and the EndoBarrier extends approximately two feet through the duodenum and proximal jejunum.	Mechanism   Partially digested food passes through the stomach and into the EndoBarrier. Peristalsis moves this food through the inside of the EndoBarrier, while bile and enzymes pass outside the EndoBarrier. These then mix together at the end of the Endo Barrier.	Removal   The Endo Barrier is removed using GI Dynamics’ custom made retrieval system in a short endoscopic procedure.