HK1116035B - Controllable stomach band - Google Patents

Description

Controllable gastric band

Technical Field

The present invention relates to a controllable gastric band comprising an inextensible back and a chamber arranged on the gastro-oral side of the back for controlling the gastro-oral restriction by feeding or draining liquid or a fluid into or from the chamber.

The present invention relates to an extended structure for a controllable gastric band, as it is provided by a number of companies in a principally identical structural form (e.g., Schwedenband by Obtech (Johnson & Johnson), lapland by biointerics). It relates to a band for restricting food intake which is wrapped around and closed around the uppermost part of the stomach or esophagus.

Background

WO 01/24742 a1 describes a gastric band which is placed and secured around the stomach in a band-like manner. Adjustment of the stomal (Stoma) restriction can be made purely mechanically by restricting the stomach.

US 4592339A describes a gastric band in which a chamber is provided on the side of the gastric band facing the stomach, which may be filled with a liquid. Thereby controlling the stoma width. Fluid filling and emptying of the system can be performed through a port sewn subcutaneously, which communicates with the cavity of the gastric band through a hose.

WO 03/020183 a1 shows a gastric band which is surrounded by a viscoelastic material in order to protect the stomach.

Finally, WO2005/009305 a1 shows a gastric band that includes mechanically or electrically controlled and caused automatically adjusted changes in the width of the stoma to circumvent the problems that arise with currently used gastric bands and to achieve better long-lasting results. Since the currently used gastric bands, although in most cases giving good long-lasting results in terms of weight loss and patient satisfaction, also give rise to problems which occur in the anterior part, in particular at high degrees of gastric band filling. Many patients then report discomfort regarding vomiting or retching of saliva, primarily when lying down. Food residues may remain for a long time in the esophagus above the stoma, where fermentation starts and thereby causes irritation of the mucous membrane and corresponding pain in addition to unpleasant bad breath. The high stomal contractions, which are present without interruption, lead over time to a weakening of the motility of the esophagus or in some cases to a gradual dilation of the esophagus, whereby finally the sensitivity of the esophagus decreases and the gastric banding is lost, which then leads to a gradual increase in weight despite the highly filled gastric band.

WO2005/009305 a1 attempts to eliminate the problems that occur with currently used gastric bands in that the adjusted stoma width is not permanently kept the same but is automatically adjusted to change as required. The aim here is to gradually increase the restriction of the stoma during eating, which disappears again after the end of eating.

Disclosure of Invention

Starting from the prior art of currently used gastric bands and differing from the above-mentioned patent application WO2005/009305 a1, the object of the invention is to create a gastric band in which the stoma briefly becomes wider and thus a Bolus of food (Bolus) can pass through the stoma is achieved when the pressure in the chamber of the gastric band is correspondingly increased. The goal is to create a gastric band with a dynamically variable stoma width.

The object of the invention is achieved by a gastric band as described above, wherein a pressure chamber is provided outside the back, which is connected to the stoma-restricting chamber by means of a pressure valve. The stoma width of the gastric band is adjusted so narrowly that it is almost impossible for food that has already been consumed to pass through. Esophageal peristalsis delivers a bolus of food into a small portion of the stomach above the gastric band. The narrow gastric band helps to prevent the outflow of the bolus of food. This results in a high internal pressure of the mass, which finally reaches the pressure of the peristaltic wave (40-80 mmHg).

The pressure valve according to the invention is opened when the pressure rises through the food mass, a part of the liquid from the gastric band chamber bounding the stoma being transferred into the pressure chamber, whereby the stoma becomes wider and the food mass can pass through. By means of the gastric band according to the invention, a delayed effect of food passage and an early feeling of fullness for the gastric band wearer are achieved, and the amount of food ingested is thereby reduced. In currently available gastric bands, the adjusted stoma width generally remains rigid.

Advantageously, the opening characteristic of the pressure valve is designed to be controllable. The properties of the gastric band can be modified and adapted to the individual condition of the patient by adjusting the pressure valve accordingly.

According to a further feature of the invention, the pressure head of the pressure valve, at which the pressure valve opens, is designed to be controllable.

The control of the pressure valve can be effected, for example, mechanically.

It is possible here for the mechanical control of the pressure valve to be carried out by means of a liquid or a fluid.

Likewise, the mechanical control of the pressure valve can be performed via a second port chamber, which is connected to the pressure valve by means of a connecting hose.

Finally, the control of the pressure valves can also be carried out electronically.

Advantageously, the pressure chamber is designed to be elastic, so that it can store a volume under elevated pressure due to its elastic properties. This allows liquid or fluid under elevated pressure which flows into the pressure vessel when the pressure valve is open to be intermediately stored in the pressure chamber.

In order to enable the elevated pressure to be exerted on the stomach again by the stoma-restricting chamber after the passage of the bolus of food, the pressure chamber is connected to the stoma-restricting chamber via a return channel with a check valve. The liquid or the fluid intermediately stored in the pressure chamber is thereby emptied back into the stoma-restricting chamber of the gastric band via the return channel and the check valve directly after the passage of the bolus of food, and the initial state is reestablished.

Advantageously, the pressure valve is connected to a device for time control. The opening characteristic of the pressure valve can thereby be controlled in dependence on time. For example, the pressure valve can be adjusted during the evening so that the cavity bounding the stoma becomes wider already at low pressure rises, thereby enabling the passage of the bolus of food or the outflow of saliva. In contrast, the pressure at which the pressure valve opens can be adjusted higher in the morning, so that it becomes difficult to eat in the morning.

If a device for detecting peristaltic waves is provided in connection with the pressure valve, the opening characteristic of the pressure valve can also be influenced and controlled in dependence on the food intake. For example, at the beginning of a meal, i.e. when the peristaltic wave and thus the pressure increase are first carried out, the pressure valve can already be completely opened at a lower pressure increase of, for example, 30mmHg, so that the bolus of food can pass through without problems. After a few minutes a higher opening pressure is required and/or only every second or third pressure rise causes the pressure valve to open. The resulting food mass blocking pressure causes a gradually increasing feeling of fullness. Vomiting is prevented in that the resulting high pressure forces open the pressure valve, whereby the stoma is enlarged and a bolus of food can pass. A few minutes after the end of the meal time, the pressure valve regains its original characteristics and opens at a lower pressure rise. The secondary peristaltic wave, triggered when the bolus of food is not completely shed, enables the residual food to shed.

If at least one auxiliary chamber is provided on the peristomal side of the back, it is possible to achieve a matching of the gastric band to the thickness of the stomach wall and to the amount of fat and connective tissue additionally contained in the gastric band (which differs from person to person). By filling the at least one auxiliary chamber, the base pressure in the gastric band may be adjusted. As the fill volume of the auxiliary chamber gradually increases, the pressure within the stoma-restricting chamber also gradually increases. The at least one auxiliary chamber is preferably not included in the liquid circuit between the stoma-restricting chamber and the pressure chamber.

For regulating the basic pressure, the stoma-restricting chamber and/or the at least one auxiliary chamber are preferably connected with a port to be arranged subcutaneously. The base pressure may be adjusted by filling the port with a liquid or a fluid or sucking a liquid out of the port. Of course, may be an autonomously operating port by which liquid or fluid is moved from the reservoir into the stoma-restricting chamber or the at least one auxiliary chamber.

According to another embodiment of the invention, the pressure chamber is arranged in or beside the port. This means that the pressure chamber, which is connected via the pressure valve to the stoma-restricting chamber, must at times be arranged in the vicinity of the back of the gastric band, but may also be arranged, for example, in or beside a subcutaneously arranged port. When the pressure valve is opened at the lowest pressure, the gastric band must be pressure stabilized to affect this characteristic. The pressure rise in the stoma-restricting chamber is received in the pressure chamber and thereby attenuated. This feature and thus the properties of the gastric band depend on the elastic properties of the pressure chamber.

Drawings

The invention is explained in detail with the aid of the figures. In the drawings:

figure 1 shows a schematic cross-sectional view of an embodiment of a gastric band before the pressure valve is opened,

figure 2 shows a schematic cross-sectional view of the gastric band according to figure 1 after transfer of liquid into the pressure chamber,

figure 3 shows another embodiment of a gastric band with a port disposed subcutaneously,

figure 4 shows another embodiment of a gastric band with a subcutaneous port and a pressure chamber disposed adjacent thereto,

FIG. 5 shows another embodiment of a gastric band with at least one auxiliary lumen, an

FIG. 6 shows a schematic diagram of an implanted gastric band having a subcutaneously disposed port and sensors for detecting peristaltic waves and swallowing activity in a patient.

Detailed Description

Figure 1 shows a cross-sectional view of a gastric band 1 having a fluid-filled chamber 2 and an inextensible back 4. The liquid-filled chamber 2 rests against the stomach wall 3, so that the stomach can be more or less constricted depending on the degree of filling of the chamber. According to the invention, the stoma-restricting chamber 2 is connected via a pressure valve 5 to a pressure chamber 6 arranged outside the back 4. Through the return channel 7 with the non-return valve 8, the liquid from the pressure chamber 6 can be reintroduced back into the stoma-restricting chamber 2. Instead of a liquid, it is theoretically also possible to use a gas as filling for the chamber 2.

When the pressure in the chamber 2 rises, the pressure valve 5 opens and liquid from the chamber 2 is transferred into the pressure chamber 6. The pressure chamber 6 can be designed to be elastic and thus have the property of storing the liquid pressed in under elevated pressure. Whereby the stoma becomes wider and the bolus of food can pass through more easily. This situation is illustrated in fig. 2. After the passage of the food mass, the pressure in the chamber 2 is reduced again, so that the liquid stored intermediately under elevated pressure in the pressure chamber 6 can flow back into the chamber 2 again via the return channel 7 with the non-return valve 8.

The opening characteristic of the pressure valve 5 is preferably designed to be controllable, wherein the control can take place mechanically or electronically. Furthermore, the pressure valve 5 can be connected to a device 9 for time control, as shown in fig. 1 and 2. The pressure valve 5 can thus be controlled according to the time of day. For example, the pressure at which the pressure valve 5 is opened may be adjusted higher in the morning, making it difficult to eat in the morning. Likewise, the pressure at which the pressure valve 5 is opened can be lowered during the evening in order to allow saliva or food residues accumulated above the stoma to pass through and be removed.

Fig. 3 shows a variant of the gastric band 1 according to the invention, in which the stoma-restricting chamber 2 is connected via a corresponding catheter 11 to a port 10 to be arranged subcutaneously. Matching the gastric band 1 to various conditions can be achieved by inputting or outputting fluid to or from the stoma-restricting chamber 2 via the port 10.

In the embodiment of the gastric band 1 according to fig. 4, the pressure chamber 6 is not arranged directly behind the back 4 but beside the port 10. When the pressure in the stoma-restricting chamber 2 rises, this pressure is led further via the catheter 11 into the port 10, wherein the pressure valve 5 opens and liquid is led into the pressure chamber 6 when the corresponding pressure is reached. When the pressure in the stoma-restricting chamber 2 decreases, liquid is again directed from the pressure chamber 6 into the port 10. This can be achieved, for example, by a special pressure valve 5 (which acts in both directions) or via a return channel (as is shown in the embodiments according to fig. 1 to 3).

The embodiment of the gastric band 1 according to fig. 5 differs from the embodiment according to fig. 1 in that at least one auxiliary chamber 12 is arranged below the stoma-restricting chamber 2, for example in a ring shape, which is connected to a port 10 to be arranged subcutaneously via a catheter 11. By means of this auxiliary chamber 12, a basic adjustment of the pressure of the gastric band 1 can be performed. Here, the auxiliary chamber 12 is not included in the liquid circuit between the stoma-restricting chamber 2 and the pressure chamber 6. By feeding or discharging liquid to or from the port 10, it is possible to adapt the gastric band 1 to the various layer thicknesses of the stomach wall 3 and the adipose tissue enclosed by the gastric band 1.

Fig. 6 schematically shows the use of a gastric band 1 according to the invention, which surrounds the entrance of the stomach M of a patient. Via a catheter 11, the stoma-restricting chamber 2 (not shown) of the gastric band 1 is connected to a port 10 to be arranged subcutaneously, via which port 10 the basic pressure can be adjusted, which the gastric band 1 exerts on the stomach wall. The pressure valve 5 of the gastric band 1 can be connected, for example, with a device 13 for detecting peristaltic waves, so that the control of the pressure valve 5 can take place as a function of the peristaltic waves or food intake. Likewise, the pressure valve 5 may also be connected to a sensor 14 for measuring swallowing activity. The connection between the sensor 14 for measuring swallowing activity and the pressure valve 5 or corresponding electronics (not shown) can be made, for example, by radio.

Claims (14)

1. A controllable gastric band (1) comprising an inextensible back part (4) and a chamber (2) arranged on the stoma side of the back part (4) for controlling stoma restriction by feeding a fluid into the chamber (2) or discharging it from the chamber (2), wherein a pressure chamber (6) is arranged outside the back part (4) and is connected to the stoma restricting chamber (2) via a pressure valve (5), characterized in that the opening characteristics of the pressure valve (5) are designed to be controllable.

2. The gastric band (1) according to claim 1, characterised in that the pressure valve (5) is designed to be controllable in terms of its pressure head when it is opened.

3. The gastric band (1) according to claim 1, characterized in that the control of the pressure valve (5) is performed mechanically.

4. The gastric band (1) according to claim 3, characterized in that the mechanical control of the pressure valve (5) is performed by means of a fluid.

5. The gastric band (1) according to claim 3 or 4, characterized in that the mechanical control of the pressure valve (5) takes place via a second port chamber which is connected to the pressure valve (5) by means of a connecting hose.

6. The gastric band (1) according to claim 1 or 2, characterized in that the control of the pressure valve (5) is performed electronically.

7. The gastric band (1) according to claim 1, characterised in that the pressure chamber (6) is designed to be elastic, so that it can store a volume under elevated pressure due to its elastic properties.

8. The gastric band (1) according to claim 1, characterized in that the pressure chamber (6) is connected to the stoma-restricting chamber (2) via a return channel (7) with a non-return valve (8) so that liquid stored under elevated pressure in the pressure chamber (6) can be redirected back into the stoma-restricting chamber (2).

9. The gastric band (1) according to claim 1, characterised in that the pressure valve (5) is connected to a device (9) for time control.

10. Gastric band (1) according to claim 1, characterized in that a device (13) for detecting peristaltic waves is provided, which is connected to the pressure valve (5).

11. The gastric band (1) according to claim 1, characterized in that at least one auxiliary chamber (12) is provided on the stomatal side of the back (4).

12. The gastric band (1) according to claim 1, characterized in that the stoma-restricting chamber (2) and/or the at least one auxiliary chamber (12) are connected to a port (10) to be arranged subcutaneously.

13. The gastric band (1) according to claim 12, characterized in that a pressure chamber (6) is arranged in or beside the port (10).

14. The gastric band (1) according to claim 1, characterized in that a sensor for measuring swallowing activity is provided, which is connected to the pressure valve (5).