DE3540936C1

DE3540936C1 - Intragastric balloon

Info

Publication number: DE3540936C1
Application number: DE19853540936
Authority: DE
Inventors: Reinhard Dr.Med. Stricker; geb. Bräuer Andrea Dr.med. 2212 Brunsbüttel Stricker
Original assignee: Individual
Current assignee: Individual
Priority date: 1985-11-19
Filing date: 1985-11-19
Publication date: 1986-10-02

Abstract

The invention relates to an intragastric balloon having a filling capacity of 200 to 400 ml for use in therapy of obesity, which is characterised in that the balloon has a sheath, closed or sealed on all sides, of a semipermeable membrane or film which can be degraded after a certain residence time by gastric juice or by body-compatible medication or in the presence of film-degrading substances or cellulose, and in that the balloon is partially filled with a hyperosmolar or hygroscopic substance, the balloon partially filled therewith having a dimension which can still be taken orally and in the activated state after charging having a minimum diameter of 70 mm due to osmosis.

Description

Wesentlich ist auch die hygroskopische oder hyperosmolare Füllsubstanz des Ballons, die eine folienspezifi- sche und den Bedingungen des Magens entsprechende Aufnahmekapazität besitzen muß, die eine Aufblähung des Ballons in einem solchen Zeitraum bewirkt, daß vor Einsetzen der gegebenenfalls durch Medikamente verzögerten Peristaltik ein Aufblähen des Ballons auf seine Mindestabmessung von 70 mm gegeben ist, damit nicht ein vorzeitiger Abgang durch den Magenausgang erfolgt. The hygroscopic or hyperosmolar filling substance is also essential of the balloon, which is a film-specific Sche and the conditions of the The stomach must have the appropriate capacity to allow inflation of the balloon in such a period of time before the onset of possibly caused by medication delayed peristalsis, an inflation of the balloon to its minimum dimension of 70 mm is given so that there is no premature discharge through the gastric outlet.

Cellulosetriacetat oder entsprechend säureresistent gemachte Derivate sind besonders geeignet. Cellulose triacetate or derivatives made correspondingly acid-resistant are particularly suitable.

Als Füllsubstanz des Ballons ist jede hygroskopische oder hyperosmolare Substanz geeignet, die unter den entsprechenden Bedingungen des Magenmilieus zu einer schnellen Volumenvergrößerung führt; vorzugsweise wird als Ballonfüllung Dextran bzw. eine konzentrierte Dextranlösung bevorzugt. Selbstverständlich können auch andere Wasser anziehende Substanzen wie beispielsweise eine konzentrierte Magnesiumsulfatlösung eingesetzt werden. As a filling substance of the balloon is any hygroscopic or hyperosmolar Substance suitable to be used under the appropriate conditions of the gastric environment leads to a rapid increase in volume; dextran is preferably used as the balloon filling or a concentrated dextran solution is preferred. Of course you can too other water-attracting substances such as a concentrated magnesium sulphate solution can be used.

Besonders vorteilhaft ist es, wenn in dem verschlossenen Ballon neben der die Osmose bewirkenden Substanz noch Luft vorhanden ist. Eine derartige Luftblase in dem peroral eingenommenen kleinen zusammengeschrumpften intragastralen Ballon bewirkt im Magen eine Schaukelbewegung, der bereits mit diffundierter Flüssigkeit sich anfüllenden Füllung, wodurch der Balloninhalt ständig durchmischt wird und ein schnellerer Osmosevorgang bewirkt wird. It is particularly advantageous if in the closed balloon next to the substance causing the osmosis is still air. Such an air bubble in the small, shrunken intragastric balloon taken orally causes a rocking motion in the stomach that is already diffused with the liquid filling, which means that the contents of the balloon are constantly mixed and a faster osmosis process is effected.

Der Vorteil bei der Verwendung des erfindungsgemäßen intragastralen Ballons beruht darauf, daß er in einer wesentlich kleineren gefalteten, also stark volumenreduzierten peroral akzeptablen Form vom Patienten geschluckt werden kann und erst im Magen durch die osmotischen oder dialytischen Vorgänge die vorgesehene Größe erreicht. Diese Größe soll zumindest so bemessen sein, daß der durch osmotische Wasseraufnahme im Volumen vergrößerte Ballon nicht durch den Magenausgang vorzeitig abgeht. Zur beschleunigten Volumenvergrößerung des intragastralen Ballons wird dem Patienten ein erhebliches Flüssigkeitsvolumen verabfolgt, so daß sich der Ballon zu seiner vorgesehenen Größe aufbläht. Um ein längeres Verweilen dieses sich im Aufblähstadium befindlichen Ballons zu ermöglichen, kann dem Patienten noch ein die Peristaltik dämpfendes Pharmakon verabfolgt werden. The advantage of using the intragastric according to the invention Balloons is based on the fact that he is folded in a much smaller, so strong volume reduced perorally acceptable form can be swallowed by the patient and only in the stomach through the osmotic or dialytic processes the planned one Size reached. This size should at least be such that the osmotic Water absorption in the enlarged balloon volume did not prematurely through the gastric outlet going off. To accelerate the increase in volume of the intragastric balloon, the A significant volume of fluid is administered to the patient, so that the balloon inflates to its intended size. To linger this longer in the Allowing the patient to inflate balloons can still be a problem drugs that suppress the peristalsis may be administered.

Der Ballon verbleibt in diesem aufgeblähten Zustand hinreichend lange im Magen und bedingt durch physiologische Reflexe beim Essen ein vorzeitiges Sättigungsgefühl. Je nach Erfordernis kann das Wandmaterial des Ballons so ausgewählt werden, daß er hinreichend lange im Magen verbleibt oder aber therapiegerecht nach einer gewissen Zeit von etwa 2 bis 10 Wochen abgebaut werden kann. Je nach Auswahl des Wandmaterials für den Ballon kann dieser auch fermentativ beispielsweise durch Verabfolgung von Cellulase oder auf andere Weise vorzeitig aufgelöst werden, wobei seine Reste nebst Inhalt auf natürliche Weise abgehen können. The balloon remains in this inflated state for a sufficiently long time in the stomach and, due to physiological reflexes when eating, a premature feeling of satiety. Depending on requirements, the wall material of the balloon can be selected so that it remains in the stomach for a long enough time or it is suitable for therapy after a certain amount of time Time of about 2 to 10 weeks can be broken down. Depending on the choice of wall material for the balloon, this can also be fermentative, for example by administering Cellulase or otherwise prematurely dissolved, with its remnants along with Content to come off naturally.

Ferner hat es sich als zweckmäßig erwiesen, dem Balloninhalt noch Zusätze zuzugeben, die gegenüber Röntgenstrahlen kontrastreich wirken, um in Zweifelsfällen die genaue Position des intragastralen Ballons feststellen zu können. Besonders geeignet hierfür sind kleine Metallfäden. It has also proven to be useful to add the contents of the balloon Add additives that have a high contrast to X-rays, in case of doubt to be able to determine the exact position of the intragastric balloon. Particularly small metal threads are suitable for this.

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Claims

Claims: 1. Intragastric balloon with a filling volume of 200-400 ml for use in obesity therapy, characterized in that the balloon is a closed or sealed envelope made of a semipermeable one Has membrane or film, which after a dwell time by gastric juice or through medication that is tolerated by the body or in the presence of substances that break down the film or cellulase is degradable and the balloon partially with a hyperosmolar or hygroscopic substance is filled, with the balloon partially filled with it has a dimension that can still be taken orally and in the activated stage Backfilling by osmosis has a minimum diameter of 70 mm.

2. Balloon according to claim 1, characterized in that the semipermeable Membrane made of a gastric environment containing pepsin and containing hydrochloric acid at least 10 days resistant film.

3. Balloon according to one of claims 1 to 2, characterized in that that the hyperosmolar or hygroscopic filling substance of the balloon is film-specific and has the capacity corresponding to the conditions of the stomach, the one Inflation of the balloon in one before the onset of the possibly delayed peristalsis given period of time.

4. Balloon according to one of claims 1 to 3, characterized in that that the semipermeable membrane made of cellulose triacetate or an acid-resistant Derivative of this.

5. Balloon according to one of claims 1 to 4, characterized in that that the filling material of the balloon is dextran or a concentrated dextran solution.

6. Balloon according to one of claims 1 to 5, characterized in that that in the closed balloon next to the hyperosmolar or hygroscopic substance there is still air in it.

7. Balloon according to one of claims 1 to 6, characterized in that that the balloon contains at least one small metal thread.

The invention relates to an intragastric balloon with a filling volume from 200-400 ml for use in obesity therapy.

Air-filled double-walled gastric balloons to reduce the stomach volume are after A. E. Henning »Inn. Med. "6 (1979), 149 known. You run through artificially reduced stomach volume leads to continuous weight reduction if you have an appetite but a reduced feeling of hunger and premature satiety. The disadvantage of these gastric balloons was based on the fact that up to now a complicated introduction and extraction process was necessary: according to Willmen et al in Dtsch. med. Wschr. 109 (1984), 1200 liquid-filled silicone balloons proposed according to A. E. Hennig in "Klinikarzt" 14 1985 100 ff after local anesthesia of the throat or under short anesthesia with an applicator inserted as a deflated balloon peronally into the stomach can be. The empty balloon becomes through a complicated double probe system introduced, filled and sealed and left free in the stomach after application. The extraction is done endoscopically, after perforation with an endoscopic one introduced hypodermic needle or opening with endoscopic scissors Balloon is removed.

However, such methods lead to a significant burden of the patient and require both in terms of application and in terms of removal of the balloon endoscopic surgery, sometimes under general anesthesia. the Invention has set itself the task, instead of the implantation of a series Manufactured silicone balloons treat obesity with simpler means and to do it in a simpler way.

From EP 00 48 541 A1 a dispensing container for liquids is known, with which liquid can be released through an osmotically induced pressure increase, this container consists of a non-deformable semi-permeable outer sleeve made from cellulose acetate butyrate and polymethylene methacrylate. Located in the container a bag made of impermeable material with the liquid to be dispensed, whose Bag opening is led out of the dispensing container. Located in the dispensing container There is also an osmotic fluid that is released when the container is immersed in water further water from the outside through the rigid, semi-permeable outer wall of the container of the container and thereby a pressure on the one in the container Exercises bag and thus the liquid contained in this pushes out or pumps out.

This device cannot be used as a gastric balloon, as it is their outer shape not changed.

In order to achieve the object of the invention, an intragastric Proposed balloon according to the characterizing part of the main claim, preferred embodiments are mentioned in the subclaims.

Surprisingly, it has been shown that a balloon from an all-round closed or sealed envelope made of a semipermeable Membrane or foil with a partial filling of a hyperosmolar or hygroscopic Substance in an orally ingestible size and manufactured by the patient can be swallowed and due to the chemical-osmotic processes only in the stomach is brought to the intended size when the balloon and its contents are activated Stage after osmosis has a minimum dimension of 50 mm.

It is essential that the semipermeable membrane of the balloon consists of a in the physiological hydrochloric acid, pepsin-containing gastric environment for the residence time of preferably at least 10 days resistant but degradable film. For this cellulose triacetate films or corresponding acid-resistant derivatives can be used be used. Other membrane materials can also be used, such as bacterial cellulose, Polyvinyl alcohol, polyurethane, polyvinyl butyral and polytetrafluoroethylene, provided they are compatible with the body and meet the osmometric requirements and afterwards the desired residence time either through gastric juice or medication, such as B. Administration of cellulosase are degradable. The permeability of such semipermeable membranes can be adjusted in a manner known per se, be it through the incorporation of higher fatty acids or through further esterification.