WO2008068715A2

WO2008068715A2 - Gastric restrictive procedure for the treatment of obesity and associated co morbidities

Info

Publication number: WO2008068715A2
Application number: PCT/IB2007/054920
Authority: WO
Inventors: Jean-Marie Calmes; Teresa Sewell
Original assignee: Jean-Marie Calmes
Priority date: 2006-12-05
Filing date: 2007-12-04
Publication date: 2008-06-12
Also published as: WO2008068715A3

Abstract

The inventions concerns a surgical method for the treatment of obesity comprising a step which consists in the creation of an isolated small proximal gastric pouch (3), said pouch (3) being obtained from the stomach proximal part and being connected to the other part of the stomach (6) through an anastomotic channel (8).

Description

Gastric restrictive procedure for the treatment of obesity and associated co morbidities.

Field of the invention

The present invention relates to the treatment of obesity and more precisely to surgical procedures comprising a step where a restriction is created on or near to the stomach. Such a restriction reduces the food and calories intake and results therefore in a weight loss and/or a weight maintenance.

These procedures are carried out by surgery, either by laparotomy or by laparoscopy.

State of the art Treatment of obesity may be proceeded in many ways, from the use of specific drugs, jaw wiring to dieting. The aim of these methods is to reduce the amount of daily food intake thus resulting in weight loss. Surgery for the obesity appeared more than fifty years ago. Two main surgical approaches have been developed :

- The first approach is based on the observation that as food intake volume does not change, the efficacy of food absorption is reduced (jejuno ileal bypass, bilio pancreatic diversion). This first type of procedure has many complications especially liver, kidney or bone failures.

- The second approach consists in a food restriction provided by a small gastric reservoir or pouch. The first described procedure was the proximal part of gastric bypass (E. Masson, 1966). From there, many other procedures were described using gastric partition principle mainly vertical gastroplasty and horizontal gastroplasty. Physical partition was brought by suturing or stapling the circumscribed small gastric pouch. Other ways to produce reduction of the overall gastric volume were operation as gastric wrapping (with synthetic mesh) or ablative surgery of the major part of the gastric reservoir (Magen Strasse Mill procedure). All the previously described procedures were associated sometimes with peri gastric devices to prevent the risk of the dilatation of the passage between the small pouch and the rest of the stomach (vertical banded gastroplasty i.e.). It is important to note that none of the previously described operations implied an anatomical interruption of the gastric wall continuity. Finally, the small proximal gastric pouch could be created by different constrictive devices placed around the proximal part of the stomach. Mainly ring gastroplasty, adjustable gastric banding as described in patent Forsell.

Those last years, other devices placed in the proximal gastric lumen aimed to create a volume partition of the stomach have been described. However, those recent approaches are limited to the addition of an artificial device acting as an isolated pouch, the stomach itself is not modified. There is for instance no interruption of the gastric wall continuity.

General description of the invention The invention refers to a surgical method consisting in the creation of an isolated small proximal gastric pouch (ISPG) which is obtained from the stomach proximal part, the ISPG being connected to the other part of the stomach through a calibrated passage ( anastomotic channel). The interruption of the anatomical continuity of the gastric wall resulting from the creation of the ISPG prevents gastric wall nerve communication. Thus, it provides an early sensation of satiety but preserving the efficiency of the gastro oesophageal junction. This configuration prevents reflux of gastric content or even vomiting, as it may be observed with patients having undergone gastric bypass procedure in which the small proximal gastric pouch empties directly in the small bowel. Those patients experienced a superior eating comfort when compared to those with pure restrictive procedure (pure gastric or external mediated gastric partition). In the other hand, pure restrictive gastric procedures have the advantage to preserve the physiologic food path in human when compared to bypass surgery. The later are associated with long term nutritional deficiencies (20 to 50% of the cases) with potential life threatening consequences.

Pure restrictive operations including external prosthetic devices are also efficient for weight loss but are associated to a high long term failure of those devices (up to 40%).

The procedure according to the invention preserves physiologic food pass, without using any prosthetic device, and with a proved eating comfort and an easy reversibility of the restrictive effect by intra gastric trans oral manipulations. Moreover, the other advantages of the procedure according to the invention are to overcome the well known complications associated to other dedicated gastric restrictive surgical or non surgical procedures.

Some of the avantages provided by the procedure according to the invention are summarized below : - No need to use an artificial prosthesis to provide restriction. In some cases, a ring may however be used to strengthen the calibrated passage, but such an element is much less important than a complete restriction artificial device,

- No risks of staple line disruption - Low risk of proximal pouch dilatation

- Low risk of anastomotic/channel dilatation

- Easy reversible retriction by transoral intragastric procedure.

- No partial gastrectomy or mutilating surgery.

- Decrease risk of per and post operative specific morbidity - Decrease risk of mortality

- Short operative time

- No anastomotic ulcer.

An example using the procedure according to the invention is presented below and illustrated by figures 1 to 4 which include the following numerical references :

1 . Esophagus

2. Z-line

3. Gastric cardia and subsequent small isolated gastric pouch 4. Gastric small curvature

5. Full thickness disruption of the gastric wall

6. Distal gastric cavity

7. Pulorus

8. Calibrated channel (gastro-gastric anastomosis) In the first part of the procedure, a proximal gastric pouch is realised over the cardial part of the stomach and has a volume of 20 to 25 ml. The pouch is created by cutting the proximal part of the stomach, starting at lesser curvature. This may be done by cutting and closing the tissues, either by sewing or with a stapler. At that point, the proximal pouch is isolated to the rest of the stomach.

In the second part of the procedure, the isolated proximal gastric pouch is connected (anastomosis) to the stomach trough a calibrated channel (gastro-gastrostomy). This connection is calibrated by a defined oro-gasthc tube that have a precise diameter (e.g. 1 ,2cm) and the isolated pouch is hand sewn over the calibration tube to the remaining part of the stomach (distal). The channel could also be created with a linear or circular stapler. In the case of circular stapling, the anvil of the stapler could be inserted in the proximal pouch by transoral route. The circular stapler is introduced in the remaining part of the stomach through an insision in his anterior part. This incision must be closed at the end of the procedure.

Different materials as bovine pericardium or PTFE could be added to the stapler to diminish the risk of anastomotic intraluminal haemorrhage and/or to prevent further anastomotic dilatation over time. Any other adjustable or non adjustable device/material could be added around the gastro gastric channel in order to modify and adjust it size.

The isolated proximal pouch could be stimulated with any electrical device such as a pacing device to increase the restrictive effects and neurological brain effects. Two stage approach to treat extreme obesity. This new procedure has to be integrated in a global approach and treatment of obesity. This will achieve long term weight control and prevent weight regain. In any case, the procedure could be easily reversed either by open or laparoscopic surgery. The reverse conversion is as follows : After entering in the abdomen and after the distal stomach is clear from previous adhesions, a 10mm opening is made few centimetres below the gastro-gastric anastomosis on the small curvature of the distal stomach. A 30mm roticulated linear cutting stapler is introduced in the distal stomach. The distal part of the stapler is guided across the gastrogastric anastomosis with the assistance of a transoral gastroscope. The stapling-cutting device is fired thus enlarging a fourfold the previous anastomosis. At the end of the procedure, the distal gastric opening is closed. In order to avoid a transabdominal approach, the procedure could be done or reverse by Natural Orifice Transluminal Endoscopic Surgery (NOTES) using flexible stapling- cutting devices and other kind of dedicated instruments.

In conclusion, key features of the invention are listed below : a) To create an isolated small proximal gastric pouch that is connected to the remaining stomach through a calibrated anastomotic channel. b) To produce a restriction of food and calories intake in human and therefore to produce weight loss and corrections of over weight linked co morbidities. c) This procedure is done by surgery either trough laparotomy, laparoscopy or

Natural Orifice Transluminal Endoscopic Surgery (NOTES), d) The isolated pouch is created by hand cutting and sewing or by stapler-cutter devices applied on the proximal part of the stomach (cardia), starting at the level of the lesser curvature. e) The isolated pouch is connected (anastomosis) to the stomach trough a calibrated channel (e.g. 1 ,2cm gastro-gastrostomy). f) The channel could also be created with a linear or circular stapler. g) The anvil of the circular stapler could be inserted in the proximal pouch by transoral route. h) Various materials as bovine pericardium or PTFE could be added to the linear or circular staplers to diminish the risk of haemorrhage, leaks and/or to prevent further anastomotic dilatation over time. i) Any other adjustable or non adjustable device/material added around the gastro gastric channel in order to modify and adjust it size. j) The isolated gastric pouch could be stimulated with electrical device such as a pacemaker, k) The procedure could be reverse either by open, laparoscopic or Natural

Orifice Transluminal Endoscopic Surgery (NOTES). A transoral intragastric endoscopic procedure could also be used by the mean of a flexible endoscopic stapling-cutting device.

Claims

1. Surgical method for the treatment of obesity comprising a step which consists in the creation of an isolated small proximal gastric pouch (3), said pouch (3) being obtained from the stomach proximal part and being connected to the other part of the stomach (6) through an anastomotic channel (8).

2. Surgical method according to claim 1 wherein said pouch (3) is created by initially cutting the proximal part of the stomach and then closing the distal side of said pouch (3) , for instance by sewing or with staples.

3. Surgical method according to claim 2 furthermore comprising the closing of the proximal side of said other part of the stomach (6) .

4. Surgical method according to claim 3 furthermore comprising the creation of said anastomotic channel (8) between said pouch (3) and said other part of the stomach (6).

5. Surgical method according to claim 4 wherein said anastomotic channel (8) has a diameter of about 1 .2 cm.

6. Surgical method according to claim 2 wherein said cutting is started at a level of lesser curvature.