CA1203449A

CA1203449A - Arrangement for the reduction of the stomach reservoir through an intragastrally-applicable cushion

Info

Publication number: CA1203449A
Application number: CA000421576A
Authority: CA
Inventors: Ferdinand Frimberger; Eckart Frimberger
Original assignee: Individual
Current assignee: Individual
Priority date: 1982-02-19
Filing date: 1983-02-14
Publication date: 1986-04-22
Also published as: EP0101476A1; WO1983002888A1; DE3277291D1; IT1235492B; IT8367189A0; DK479483D0; DK479483A; EP0086862B1; NO833790L; DE3206118A1; JPS59501654A; EP0086862A1; ATE29660T1

Abstract

ABSTRACT OF THE DISCLOSURE

An arrangement for the reduction of the stomach reservoir through an intragastrally-applicable cushion formed of a gastric juice-compatible material, which is detachably connected with a perorally-introduceable appli-cator, which can be filled through the applicator with a gastric tract-and intestinal tract-compatible fluid, and which includes an opening closeable valve-like by detachment of the applicator from the cushion during the extraction of the applicator. When the positioned cushion becomes unsealed then, in a simple manner, it can discharge through the intestine with the feces. There is no danger that the cushion will remain suspended at a restricted location within the intestinal tract (for example, at the transition from the small to the large intestine, the ileosocal valve).
When a filling with water is employed, then the cushion is located proximate the pylorus, whereas with an air filling it is located proximate the fundus, especially when the stomach is filled.

Description

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BACKGROUND OF THE INVENTION
1. Field of the Invention The present invention relates to an arrangement for the reduction of the stomach reservoir through an intergastrally-applicable cushion formed of a gastric juice-compatible material, which is detachably connected with a perorally-introduceable applicator, which can be filled through the applicator with a gastric tract-and intestinal tract-compatible fluid, and which includes an opening closeable valve-like by detachment of the applicator from the cushion during the extraction of the applicator.
Overweight (adiposis, obesity) can be viewed as essentially an illness of civilization which, in any case, is one of the most significant illness-causing factors of our current time. The adiposis is the result of a calorie intake which exceeds calorie consumption. Ordinarily the treatment is effected through a reduction in the calorie intake by means of a dietetic cuisine or reducing diet.
Through the intake of appetizer suppressors or through operative reduction of the stomach, there can be rendered easier for the adiposant the maintenance of the reducing diet. Widespread are also other surgical procedures, such as a jejunoileostomy (bypass of the jejunum and small in-testine), and the bypassing of the stomach itself.
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1 Independent of the fact that these surgical procedures are relatively difficult, there can be encountered serious complication~. Even instances of fatalities have been des-cribed as a result of such measures. A further semi-surgica 5procedure is to the so-called jaw wiring which renders difficult the intaXe of nourishment. Also in this instance~
risks are to be expected.

2. Discussion of the Prior Art -In order to overcome these problems, Hennig has 0described an arrangement of the above-mentioned tvpe ~Inn Med., 6 (1979), pages 149 to 152). Hennig, through the use of a stomach tube or in an endoscopic manner has introduced a pear-shaped double-walled balloon consisting of rubber casings into the stomach cavity. Arranged between the two 15balloons is an agueous solution of methylene blue. After the placement, by means of a Teflon catheter, the inner positioned cushion is inflated, and there is also injected an agueous solution of methylene blue. ~fter the filling of the inner balloon, the Teflon catheter is withdrawn. A
20non-return valve, as well as a rubber-elastic valve due to its inherent elasticity, sealingly close the two balloons with rcspect to the outside. ~t an unsealed valve closure, or at perforation of the balloon casing, within three to four hours there will be encountered an intensive blue 25 coloring of the urine. -

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1 For the tested patients there have been determine~
significant weight reductions. Th.e weight reduction apparently is predicated on that the stomach reservoir is reduced and thereby, during intake of nourishment there 5 occurs a significantly earlier satted feeling in the tested patient. Investigations by E. Frimberger, W. ~uhner, J. ~eingart, R. Ottenjahn (l~unch. med. ~ischr. 124 ~19S2)2, pages 39-~0) can attest to the results of Hennig insofar as, that through an intragastral balloon, the reduction in body ~ weight is actually rendered easier. Frimberger utili~es a thin W2l led cushion having an 0.06 mm wall thickness. Throu~h the undertaken reduction in the wall thickness, this can easily lead to air escape through the cushion wall, which is retarded by a coating of silicon oil. Also Nieben and 15 Harboe ~The Lancet, (23rd January 1982), pages 198-199) have employed an intragastrally-appliable balloon, wherein for the application apparently, as in Hennig, there were utilized two mutually inserted probes.
In intragastrally appliable balloons of that type, 20problems are encountered during the removal of the balloon from the stomach as well as durina application.
The double-walled balloon according to Henni~ is extracted with the diathermic sling pursuant to Deyle-Seuberth under gastroscopic sighting after previous perforation 25with an endoscopically introduced injection needle. In effect, the extraction is thus effectuated orally, and is relati~ely time consuming and also considered thought to ~2~3~

; be subject to com~lications. If such a balloon bursts, then due to its spatial requirements it cannot pass through the intestines, which can lead to intestinal blockages which must be surgically removed.
This problem is overcome by the thin-walled cushion according to Frimberqer et al., and the balloon according to Nieben and Harboe. Buth balloon-types are thin-walled so as to be able, subse~uent to bursting, to be ejected through the intestine essentially without 10 complication and can be discharged with the feces. Thus, it can even occur that the patient or the tested volunteer will not even notice the discharge of the balloon.
However, the application of the balloon is problematic. During the insertion of the applicator with 15 balloon through the pharynx (throat) and the esophegus (eating tube), it can ha~pen to even a very careful operator that the balloon and the applicator are inadvertently introduced into the trachea tbreathing tube). In the then immediately encountered acute choking attack, the applicator 20 together with the balloon must be immediately withdrawn fro~
the trachea. In the connection between the applicator and balloon as explained by Hennig, in which merelv a tube is conveyed through a cuff encompassing the rim of the balloon, it can readily occur that the tube is pulied out of the vent .-25 valve, in effect, the balloon is detached from the applicator and xemains in the trachea. This can result in life-endangering complications when an exnerienced physician is .... - _ ' ' -~ ,.-

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1 not immediately available with the reguired instruments in order to be able to renove the balloon fro~ the trachea.
Neither from Hennig nor from other writerS can there be ta~en any suggestions for the overcoming of this problem.

5 Furthermore, the non-return valve which is utilized by Hennig, which apparently relates to a ball valve, apparently only relates to the filling of the balloon with the fluid, wherein, when the balloon is filled to a degree in which the patient exPeriences an uncomfortable feeling, any 10 emptying thereof is no longer possible. In such a case, the cushion of the arrangement according to Hennig must be removed in the above-described manner.
SU~lIARY OF THE INVENTION
Accordingly, it is a primary object of the invention 15 to provide an arrangement of the above-described type which renders possible a rapid and safe application of a cushion for the reduction of the stomach reservoir.
In accordance with the foregoing, under the concept of a cushion there is to be understood that this relates to 20 a hollow container which is brought into its prescribed configuration through the fluid without substantial expansion of its walls. In particular, through the intermediarv of the invention it is possible to provide an uncomplicated appli- ~
cation for the patient-tested volunteer, and an uncomplicated 25 application of the cushion itself is achieved. Finally, it is also possible to have an ambulatory application. More-over, the removal of the cushion is oossible in a simple I

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1 manner. It is important that for the positioning of the cushion in the stomach there is attained a safe and stable connection between the applicator and the cushion although, other then Hennig, there is merely usedYi single-walled 5 cushion having a thin wall thic~ness. Furthermore, it is essential that, subsequent to the filling in the stomach, the cushion can in the same operating procedure be also either completely or partially emptied, when complaints are indicated by the patient. ~hen the positioned cushion 10 becomes unsealed then, in a simple manner, it can discharge through the intestine with the eces. There is no danger that the cushion will remain suspended at a restricted locationwithin the intestinal tract (for example, at the transition from the small to the large intestine, the 15 ileosocal valve). ~hen a filling with water is employed, then the cushion is located proximate the pylorus, whereas with an air filling i. is located proximate the fundus, especially when the stomach is fillea.
The cushion during placement is not precisely 20 localized in the region of the pylorous or in the region of the fundus, but it spontaneously assumes the respective position. During water filling, due to its weight it sinks to the lowest position in the stomach, with a gas or air filling it floats on the gastric juice, or on the stomach 25 contents.

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1 However, it is essential for tne inventive arrangement that the application can be effected without any danaer since the arrangement itself, when it is inadver-tently inserted into the trachea, can be again rapidly and 5 safely withdrawn without creating t}le danger that the cushion will detach itself from the applicator. In particular through ~ folds across the adjoining section of the applicator or ! through encompassing with an additional casing there can ~4,`
be avoided an uncomfortable, and also psychological, feeling 10 for the patient during the insertion. For a thin-walled cushion the unsealing of the cushion after a predetermined carrying period will not produce the undesired affect that the cushion will be discharged rapidly and possibly unnoticed by the patient. The same can occur when, with an air ¦ 15 filling, due to the air permeabilitv or the material of the cushion, this filling escapes the cushion is then discharged. `~
The removal of the cushion from the stomach can also be achieved in a simple manner in that its wall is ripped oPen by an endoscopically introduced worktool. This can also be ~ achieved when the patient takes in an agent which ~ill ;
decompose the wall of the cushion, but for the remainder ,~
will, naturally, be a gastricallv compatible mediuT~
Finally, it is also to be mentioned that the discharging cushion itself, when due to a still excessive 25 filling remains stuck in the small intestine, can be perforated through l;nDwn and practically riskless transabdominal ~i thin-needle perforation, and thereby released from its filling.

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1 Additionally, when it is desired that the patient be capable bf determining when the cushion is derective (not sealed) or has burst, that there be introduced into the cushion a suitable quantity of a bio-neutral and harmless 5 colorinq agent in li~uid or solid form already during the production of the arrangement. The coloring agent such as, for example, methylene blue, exits from the unsealed cushion and is discharged with the thereby blue-colored urine.
Moreover, there can also be added a germicidal mediu~.
It is also mentioned that reference has been made to an intragastrally apPliable cushion in which the applicator is not removed, wherein a tube which is connected with the "!
cushion extends out of the mouth of the patient and is there closed with a stopper (refer to European Rubber Journal, (July 198]) page 37). This arrangement is apparently swallowed by the patient and is then filled with air and~or water, in which there can further be included a radiological contrast medium. For purposes of removal, the cushion is again orally withdrawn by means of the tube. The above-mentioned 20 problems encountered in a cushion which a detachable applicator will not be present in an arrange~ent of that type.
BRIEF DESCRIPTION OF THE DRAWINGS
Reference may now be had to the following detailed 25 description of cxemplary embodiments of the invention, taken in conjunction with the accompanying drawings; in which:

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1 Figure l schematicallY il]ustrates in section an inventive arrangement in its appliable condition;
Figure 2 illustrates the cushion of the arrangement during filling with a fluid;
Figure 3 sche~atically illustrates the applied, fluid-filled cushion;
Figure 4 illustrates details of the arrangment of the applicator and the closure member;
Figure 5 schematically illustrates another embodiment 10 of the engaging components;
Figure 6 illustrates scheMatically the engaging components pursuant to Fig. 5 which are shown in an disengaged condition;
Figure 7 schematically illustrates another embodiment 15 o the inventive arrangement; and Figure 8 to ll illustrate further modified embodi~ents of the engaging components.
DETAILED DESCRIPTION
Figure l schenatically illustrates a first embodiment 20 of an inventive arrangement l.
The arrangement consists of an intragastral~ in essence, within the stomach, appliable cushion 2 constituted of a soft, non-toxic ~aterial which is only sliahtly subject to attac~ by the gastric juices, such as a rubber, poly-ethylene (PE), polytetrafluoroethylene (PTFE~ for instanceTeflon), polyvinyl chloride (PVC), siliccn or the like.

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The cushion 2 has a filling volume of about 100 to 1000 ml.
There can also be provided a plurality of cushions of different stepped sizes. The cushion 2 pursuant to Figure 1 includes, at its forward end, a small nose-like protuberance 3, as well as a small opening 4 at its opposite and rear end. Inserted into the opening 4 is a ring 5 which can consist of a rubber or plastic material, as will be elucidated further herein-below. The arrangement 1 further includes an applicator 6 which ls fixedly but detachably connected with the cushion 2 at the end which includes the opening 4.
The applicator 6 consists of a yieldable, resiliently elastic material and serves for applying the cushion 2 perorally through the pharynx ~throat) and esophegus (eating tube) into the ventriculus (stomach). In accordance therewith, the two interconnected portions of the arrangement 1, in essence, the cushion 2 and the appli-cator 6, evidence a total length in the magnitude of about 70cm.
The applicator 6 consists of two probes arranged within each other and guidable relative to each other, in essence, an inner probe 7 and outer probe 8. The outer probe 8 possesses an external diameter in the magnitude of 5mm, and the inner probe 7 possesses an outer diameter in the magnitude of 3mm with an internal diameter in the magnitude of about 2.6 mm.

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The probes 7 and 8, which are constructed as hoses or tubes, consist of a non-toxic plastic material, such as a polye-thylene (PE), polvinyl chloride (PVC), or polytetrafluoroethylene (PTFE). Suitably, the inner and outer probes 7, 8 possess an X-ray per~eability which is lesser than that of the surrounding tissue, in such a manner, that their position can be perused on the X-ray screen.
Furthermore, the ring 5, as well as a closure member 16 discussed further hereinbelow, possess an X-ray permeability which is lesser than that of the surrounding tissue, in such a manner, that its position can be followed on the ~-ray screen. This is of advantage when, during the discharge of the cushion, its position is to be determined within the intestinal tract, in effect, is to be monitored.
Introduceable through the internal probe, in accordance with an intragastral application of the cushion 2, is a fluid, such as water and/or air, whereby the cushion 2 is filled to a desired measure. For the filling there can also be utilized another fluid which, however, is non-toxic and must be gastrically compatible. The fluid can incorporate indicator agents, by means of which there can be determined the unsealing and, resultingly, the escape of the fluid, or the discharge of the cushion 2. For example, when produced, the cushion can already contain methylene blue which, upon discharge with the fluid into the stomach reservoir produces a blue-coloring of the urine.
A simple fixed but detachable connection between the applicator 6 and the cushion 2 consists of in that the ring 5, at least in the region of its central opening 9, is ~rc~

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constituted of an elastic material, whose internal diameter is significantly smaller than the outer diameter of the inner probe 7. In the inserted condition of the cushion 2, the ring 5 enco~passes the inner probe 7. Subseouent to 5 the pulling out of the inner probe 7 from the cushion 2 through the ring 5 for the re~oval of the apnl;cator 6 fr~m the cushion 2, the walls of the ring 5 sealingly close with each other about thc central opening 9~ and thereby close the cushion 2. This, for example, is achieved in 10 that the central opening ~ is formed slit-like. ~his sealed closure 9 ~ust remain intact at least up to a predetermined pressure of the fluid within the cushion 2 acting on the ring 5. ~owever, it is not necessary that the sealed condition be maintained up to the bursting limit of the 15 cushion 2.
During the insertion of such an arrangement through the esophegus it can also happen to an experienced physician :~ that the arrangement is inadvertently introduced into the trachea ~breathing tube). At the then i~mediately encountered 20 acute choking attack, the applicator together with the cushion must be immediately withdrawn from the trachea. In that tvpe of situation, were the cushion to detach from the applicator and to remain in the trachea, dangerous, life-threatening co~plications~ can occur when a skilled physician 25 does not immediately act with the renuired instruments.
}~erewith there must be mentioned that a large number of ph~sicians do not ~ossess the skill for carrying out a - ` ' :

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In order to overcome this probler~l, the inventive arrangement 1 provides a safeguard ~hich is so contructed that the cushion 2 and the applicator 6 remain securely ' .
5 in engagc~ent for so long until through a predetermined movement of the inner probe, there is reached a release of the engagement and thereby facilitated is a separation between the applicator 6 and the cushion 2.
In the embodiment illustrated in Fi~ure 1, 10 fastened on the cushion 2 ~c the region of its ring 5 is a thread loop 10,-~d which is conducted through a side opening 11 at the closeiend section of the outer probe 8 into the interior of the outer probe 8 so that the loop is passed through by the inner probe 7.
Applicator S and cushion 2 are thereby only separable from each other when the inner probe 7 is pulled through the thread loop 10.
According to Pigure ~, ihe safeguara can also be so constructed that a thread loop 69 is fastened to the outer 20 probe 68 of the applicator 66 and is introduced through a transverSe opening 64 in the ring 65 in the cushion 2 into the ~iddle opening 63 of the ring 65, wherein the inner probe 67 of the applicator 66 passes through the thread loop 69.
~lso here the applicators 66 and the cushion 62 are separable 25 from each ot31er only when the inner probe 67 is pulled through the thread loop 69.

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~L2~3~9 - 1 In order to Prevent that inadvertently only the inner probe 7 will move, especially pulled out, furthermore, the inner probe 7 and outer probe 8 are fixedly but detachably interconnected with each other at the distal end, in effect, 5 at the end which projects out of the mouth of the patient during application. This connection suitably is effected through quick-connect coupling such as a luer lock connection, or a bayonet closure. In the embodiment pursuant to Figure 1, the distal end of the outer probe 3 supports an inner 10 coupling component 12 which is adapted to be superimposed by an outer coupling component 13, which is fastened to the inner probe 7. Furthermore, Figure 1 shows the distal end 1 of the inner probe 7 which serves for filling the fluid into the intragastrally applied cushion, and is suitablv constructed ~5 for coupling onto a corresponding filling device.
In order to be able~to remove the applicator 6, subsequent to release of the engagement between applicator

6 and cushion 2, as rapidly as possible from the esophegus, there is provided a detecting device by ~eans of which there 20 can be determined that the probe 7 has left the cushion 2 and possibly has passed through the thread loop 10. In the embodiment pursuant to Figure 1, the inner probe 7 and the outer probe ~ are fastened together at the distal end, in this instance the two coupling elements 12 and 13 through a 25 deformable, but in its longitudinal extent not expandable, connection 15, the length of which corresponds to at least the extent of movement of the inner probe 7 between the .~:
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1 ensa~ed condition of the coupling components 12 and 13 D ~ f and the f~*s~ passing through the thread loop 10. Thus, ` if the connection 15 between the coupling cor.~ponents 12 and 11 is stretched, then the applicator 6 and cushion 2 5 are not in engagement and the applicator 6 then can in its entirely be rapidly removed from the esophegus.
~ s mentioned, it can be adequate that the rin~ 5, a~ter removal of the inner probe 7, attains a sealed closure.
Such a sealed closure can be improved still further when 10 the middle opening 9 of the ring 5 is coated with a silicon ~ oil or a comparable sealing medium.
However, the ring 5 can also consist of an essentially non-deformable or only slightly deformable materlal, so that the middle opening 9 after removal of - 15 the inner probe 9, will not be fully closed.
The mentioned closure capab;lity does, however, have a further disadvantage. Herein, when the arrangement is employed as an applicable finish packed unit in which the inner probe of the applicator passes through the middle opening, 20 then due to the positioning the inner probe can be deformed and/or the slit closure also can be permanently deformed due to material fatigue or the like so that, during filling and subsequent to removal of the inner probe, a sealed closure of the cushion can no longer be afforded, in eEfect, the 25 utilization of the arrangement can no longer be viewed as being safe.

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1 It has already been previously proposed by Hennig to employ a closable valve, such as a non-return valve, presumabl~ a ball valve. ~ non-return valve has the basic disadvantase that operation is possible merely 5 in one direction, here for the filling of the cushion.
When the cushion is filled to such an extent that the patient will have a mishap or have an unwell feeling, then in the known valve the cushion can no longer be emptied.
Usually the cushion must be ripped open in the described 10 manner and again removed from the stomach. Inasmuch as, according to circumstances, this can occur a number of times in the same patient, this manner of proceeding is unsuitable for ambulatory treatment.
In order to overcome this problem, inventively, 15 during the removal of the inner probe 7 there is inserted - a closure member 16, such as a stopper of a compatible material, into the middle opening 9. The closure me~ber 16 '~ ~hra~
incorporates a ~hoat section 17 and a reinforced, in this instance a spherically-shaped section 18, wherein the throat 20 section 17 at the proximal end of the inner probe is applied thereto and, upon removal of the inner probe 7 through the middle opening 9 through contact of the reinforced section 18 aoainst the ring 5 is detached from the inner probe 7 and is inserted into the middle opening 9 for the sealed 25 closing of the cushion 7.
This is elucidated in greater detail in connection with rigures 2 through 4 of the drawings.

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-16- - , 1 At the proximal end 19 of the inner probe 7, bv means of a partition wall 20 a hollow space 21 is separated fror.l the remaining inner area of the inner probe 7. Inserted into the hollow space 21 is the closure members 16 with its 5 throat section 17. The outer diameter of the neck section 17 hereby corresponds to at least the inner diameter of the hollow space 21 in which, as is illustrated in Figure 4, the inner diameter of the hollow space 21 can be somewhat larger than the inner diameter of the remaining inner probe 10 7, and in effect by about 0.2 to ~.0 m~. However, the inner probe 7 in this can also consist of an elastically deformable Material.
In order to be able to fill the fluid into the cushion 2, the inner probe 7 incorporates perforations 22 ~5 in the regior. ~hich it connects to the partition wall 20, through which there can flow out the fluid which is introduced from the distal end 1~ into the cushion 2. The inner probe 7 is pulled out from the cushion after the filling of the cushion 2. The extent of.the filling is, 20 in general, determined by the comments or expressions of the patient during filling; however, can also be surveilled or monitored, for example, through observation on the X-ray screen or the provision of suitable measuring instruments at the distal opening 17 of the inner probe 7.
Figure 2 illustrates, in phantom lines, the cushion 2 ~lithout fluid filling, in effect, in the condition ' .~:
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1 in which it is aDplied intragastrally, and the cushion 2, is illustrated in solid lines as at least partially filled with fluid.
~hen the cushion 2 is filled with the fluid to 5 the desired e~tent, then the inner probe 7 together with the closure member 16 is pulled out through the ring 5 upwardly so that the reinforced or heavier section 18 of the closure member 16 comes into contact against the ring 5, and as a result, the closure member 16 is pu]led out of the hollow space 21 and with its throat sections 17 remains in the middle opening 9 of the ring 5 for effecting the sealed closure of the cushion 2. ~3 ¦ Figure ~ illustrates that a perforation~3 can also - be formed in the hollow space 21 which in this instance is 15closed by the throat section 17 of the closure member 16 which is insertea into the hollow space 21. ~hen during the pulling out of the inner probe 7 the reinforced or heavier section 18 comes into contact against the ring 5, then after a short displacement the perforation 23 is exposed 20so that no aspirating vacuum can be produced between the en~
of the throat section 17 facing towards the separating ~all 20 and the separatins wall 20 whereby once again, there is aaain rendered easier the drawin~ off of the inner probe 7 or, in essence, its proximate end 19, from the throat section 17.
251~owever, the perforation 23 can also be completely or partially exposed.

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1 As mentioned, the safe but detachable connection between the applicator 6 and cushion 2 is of essential significance.
Illustrated in Figures 5 and 6 is another basic 5 embodiment of an inventive arxangement 24.
The cushion 25, which corresponds to the cushion 2, is connected in a aifferent manner with the applicator 26, which corresponds to the applicator 6, and which includes an inner probe 27 and outer probe 28. The cushion 25 again 0 includes a ring 30 at its opening 29, which herein consists.
of an essentiable non~deformable material, such as a plastic material. In its central opening 31 the ring 30 initially includes an elastically deformable seal ~hich faces towards the cushion 25, and is formea from an 0-ring 33 of elastic 15 material inserted into an annular groove 32, whose inner diameter is smaller than the outer dianeter of the inner probe 27 and also sma~ler than the outer aiameter of the throat section 3q of the closure menber 36, which also includes a thic~ened or heavier section 35 and can be inserted in the 20 same manner as the closure member 16 pursuant to Figures 1 to 4 (not shown in detail).
In the region of the middle opening 29 facing towards the applicator 26, the ring 30 includes a further larger annular groove 37 which forms an engaging component for the Z5 secure connection between applicator 26 and cushion 25.

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Formed in the proximal end surface 38 of the outer probe 28 are four hook elements 39 which are shaped for ensagement into the annular groove 37. The hool; elements 39 can incorporate a radiallv inwardlv airected prestressing 5 so that, without any counter-force, the~ cannot come into engagement with the annular groove 37, as is illustrated in Figure 6. However, when the inner orobe 27 is conveyed l~ast the hook elements 39, as is illustrated in Figure 5, then the hs~ok elements 39 are pressed radially outwardly and as a 10 consequence, engage into the annular groove 37 in the ring 30, and are there retained in position by the inner probe 37.
It is also important that by means of the inner probe 27 which is inserted into the cushion 25, the hook elements 39 securely engage into the annular groove 37 and 15 that, as in the embodiment pursuant to Figure l, the engage-ment between the applicator 26 and the cushion 25 is only releasable when the inner p~obe 27 is pulled out of the cushion 25 past the hook elements 39 in the airection towards the distal end so that, for example, due to the radially acting 20 prestressing, the hook elements will move inwardly and disengage from the annular groove 37 in the ring 30.
Other embodiments are further elucidated hereinbelow' in con~unction with Figures 9 through ll.
The retcntion of the closure member 36 on the inner 25 probe 27 can be effected in the sa~e manner as is elucidatecl in connection with Figures l to 3. I~t the distal end, the inner probe and outer probe 27 and 28 can be constructed in 3~ ' . ' .f:

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1 the same manner as explained in connection with Figure 1.
Figure 7 illustrates a further embodi~ent of the invention whose elements are basically also applicable to the two previously mentioned embodiments.
The arrangement 41 according to Figure 7 discloses a cushion 42, which can also include a protuberance 43, and which includes a ring 45 in its opening 44. The cushion 42 is hereby fixedly but detachably connected with an applicator 46 which is constructed of an inner probe 47 10 and outer probe 48, in a manner as explained in Figure 1, in essence, it includes a thread loop 49 rastened on the ring 45 which is conducted through an opening SO in the proximal section of the outer probe 4~, and is passed through by the inner probe 47. Naturally, there can be also provided 15 a different connection operating in the same manner, such as through hook elements, as shown in Figures 5, 6 and 9 through 11.
The inner probe 47 supports at its proximal end, in the already described manner, a closure member 51 for the 20 sealed closing of the cushion 42 upon the pulling out of the inner probe 47. ~.s illustrated, the cushion 42 can be arranged in folds 52 between theend on the closure member 51 which includes the protuberance 43 and the end fastened to the ring q5, so as to extend over the innér probe 47 and/or tlle outer probe 48.

Essentially forthis e~bodiment is that at the proxi~al section distal to the opening 50 there is fastened a .

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1 hose-like sleeve 53 at one end 56 Dn the outer probe 48.
As shown, the sleeve 53, in the ready-for-application arangenent 41 can ?roject somewhat beyond the proximal end of the inner probe 47, and particularlv beyond 5 the protuberance g3 of the cushion 42. Howcver, the sleeve 53 may not project heyond the proximal end of the inner probe 47, for example, it can also terminate in the height of the closure ~ember 51 at the transition of its throat section into its wideninq section. Furthermore, the proximal 10 end 54 of the sleeve 53 need not necessarily be closed but, as illustrated, can also be open. The sleeve 53 has the effect that the folded cushion 42 is fixed by at least one of its folds 52 and that the cushion is so held together that, prior to its insertion, it appears optically smaller so as to have a positive psychological effect on the patient. Furthermore, the sleeve 53 represents for the application a protector for the relatively sensitive cushion 92, however if must be easily removable, for instance, during filling of the cushion with the fluid. During filling the 20 cushion 92 displaces itself for the unfolding of the folds 52 in an axial direction and hereby slides itself out of the sleeve 53 at its end 59. The sleeve 53 is hereby displaced rearwardlv and can thereby be rolled open herein, it advantaceously consists of a more easily expandable material 25 than the cushion. The sleeve 53 can, however, also consist of more resistant and less elastic material than the cushion 52, such as a rubber or plastic material. It then 3~ -.. . .. . . .
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1 advantageously contains a tear line 55, as is schematically illustrated in Figure 7, which will tear open along the sleeve 53 during the filling of the cushion 42. Finally, the wall thickness of the sleeve 53 can gradually or step-5 wise reduce from the end 56 which is fastened to the outerprobe 58 up to the proximal end 5~, so that the release of the sleeve 53 from the cushion 42 being filled is rendered easier. The sleeve S' hereby remains on the outer probe 58, and after the detaching of the applicator 46 from the cushion 10 42 is again extracted with the applicator.
Similar to the embodiment shown in Figure 1, the inner probe and outer probe 47 and 48 are fixedly but detachably connected to each other at their distal end through coupling elements 57 or 5S. Herein, the inwardly 15 located coupling element 57 is fastene~ to the inner probe 47, whereas the outwardly located coupling eleDent 58, which extends beyond the inwardly located coupling element, is fastened to the outer probe 48. FurtherJnore, there can also be provided a connection 59 corresponding to the connection 20 15 shown in Figure 1.
In this embodi~ent it is also important:that at least one of the two probes 47, 48 includes a r.arked area.
By means of a marked area 60 provided on the 25 i~ner probe 47, there can be deterrnined the act.ual position bf the inner probe 47 with respect to the outer probe 48 to indicate to what extent the rnarking field 60 at the distal .
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and of the outer probe 48 towards the coupling elemen-t 58 has exited. Thereby, there can be subsequently determined when the closure member 51 is inserted into the ring 45 ~or the closing of the cushion 42, and there can be ~urther determined as to whether the inner probe 47 has released the engagement of the engaging components.
Furthermore, the outer pro~e 4~ can also be transparent at least at itc distal end section and include at least a single marking by means of which the movement iO and, as a result, the actual position of the inner probe with regard to the outer probe 48 can be more accurately observed.
Moreover, the outer probe 48 can also include a marking field 61 at its distal end section. The las-t-mentioned marking field 61 on the outer probe 48 provides advantages durlng application. By means of this marking field on the outer probe 48 there can be determined the extent in which the arrangement 41, and thereby the cushion 42 has reached the stomach and has been inserted therein, and can thus be filled. The marking field 61 can consist, for example, of an approximately 10 cm long colored 20ne at a distance range of between 50 and 60 cm from the forward section of the arrangement, herein the leading end oE the protuberance 43 and/or the closure member 51, which corresponds to the average distance between the stomach and the mouth opening. For smaller patients, the arrangement 41 is inserted up to the beginning of the marking field 61, for larger 3~
patients up to -the end of the marking region 61. The marking field 61, in lieu or in addition to the colored regions, can also incorporate ring-shaped markings, as is illustrated in Figure 7.
It is to be mentioned that the coupling elements 57 and 58 can be in threaded engagement or connected to each other with a kind of a bayonet closure.
In the event that the sleeve 53 is fixedly closed, it can form a sterile protector for the cushion 52.
It is indicated that the inventive arrangement can be utilized as a single-use or throw-away unit;
however, that the applicator 6 or 26 or 46 can, without difficulties, also be repeatedly utilized.
In the intragastral application of the cushion 2, or 25 or 42, the following procedure is effected:
The inventive arrangement, after the precedent examination of the patient, is conducted through the pharynx and esophegus into the eventriculus (stomach). As required, through observation on an X-ray screen or through marking fields, the cushion can be precisely located in the stomach proximate the fundus or proximate the pylorus. Thereafter, the cushion is filled through the inner probe from its distal end with the desired fluid, for example, water and/or gas, such as air, and if desired also with an indicator. When, during the filling procedure, complaints are raised by the patient, for instance if the fill volume is selected too large in relationship to stomach size, then the cushion can jrc~

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1 without difficulty be either completely or partially emptied and, if re~uired, can also again be extracted.
I~hen the present fill volume is toleratea, then the cou~ling elements on the distal end of the inner probe and outer 5 probe are disengaged, and the inner probe is drawn back so far within the outer probe as allowed by the connection therebetween, or as appears to be suitable based on the marking fields. Through the drawing back of the inner probe at an unchanged position of the outer probe, consequently 10 the closure member is pulled into the ring and~ through fastenin~ therein, the filled cushion is closed. Thereafter, either the thread loop is released or the hook elements are disengaged from the associated groove. In this manner the applicator and cushion are separated fro~ each other.
15 The applicator is then extracted, and the placement of the cushion is completed.
When the cushion with the applicator is inadv~rtently conducted into the trachea during insertion, then the choking situation can be eliminated without any risk through the 20 ir~ediate pulling back of the applicator, since any detachment of the cushion from the applicator is safely prevented. Through the coupling element at the distal side, there is further safely prevented that inadvertently only the inner probe will be pulled back, through which the 25 connection between the cushion and appllcator could be separated.

. .... __.. . . ... . ;
. -26- -~, : : , 3~9 When the cushion in the stomach begins to leak or has burst, for example, because the gastric juices have too intensely attacked the material of the cushion, then this condition can be determined by the patient through the enclosed indicator. For example, when methylene coloring agent escapes from the defective cushion, it is absorbed through the intestinal tract and passed out with the urine, which is then colored blue. This indication is, however, not necessary since the cushion can be discharged without complications with the feces.
As mentioned, the invention has two essential advantages. One advantage is that a slipping off of the cushion from the applicator is not possible since it is fixedly connected either by means of the threaded loops 10, 49, or through the hook elements 39 which engage into the groove 37. The separation between the applicator and cushion is possible only through a predetermined known and not an inadvertent manipulation. Furthermore, there is present a constructional unit which can be already formed during manufacture, in which there is produced the entire arrangement, for example, also introduced into a sterile tear-open package, and in actual practice is then quite rapidly available. The engagement, in effect, the placement of the cushion can be carried out rapidly and ambulatory, whereby there is aEforded the secure sealed closing of the cushion after filling with the fluid.

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1 Furthermore, filled into the cushion can be a powdered or liquid germicidal mediun, such as an antibiotic, a chemotherapeutic, a disinEectant or the like, which suitably dissolve in the fluid during filling of the 5 cushion with the fluid, herein preferably a liquid fluid, in view of which the growth of possibly deleterious bacteria will be inhibited.
It is not possible to dependably prevent the introduction of bacteria into the cushion, which would ! 10 otherwise multiply at body temperature within the fluid and, upon bursting of the cushion, flood the intestinal tract in large number which, in accordance with the damaging nature of the bacteria, can result in very un~leasant conseguences.
~s mentioned, it is essential that there be achieved a secure connection between the applicator and cushion. With respect to the embodimeni pursuant to Figures S and 6, further modifications are also possible, as is further eluciæated hereinbelow in connection with Figures 9 20 to ll.
In the embodiment pursuant to Figure 9, hoo~-like elements 75 are formed at the proximal end of the outer probe 78 of the applicator 76 as engaging elements; in that spherical elements 71 are connected through a thread-liXe 25 connection 79 wi~h the proximal end of the outer probe 78, which are pressed by the inner probe 77 of the applicator 76 into the annular groove 7~ of the ring 73 o~ cushion 72.

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1 ~en the inner probe 77 is pulled out, then the hook-shaped elements 75, due to their thread-like connection 79 are easily deformable and can be simply re~oved out of the annular groove 74 through a light pulling on the applicator 5 76 whereby the cushion 72 is detached from the applicator 76.
Figure 10 illustrates that it is not necessarily required to proviae an annular groove in t,he ring and to apply the hook-shaped elements on the outer probe. In the er,lbodiment pursuant to Pigure 10, the outer prcbe'88 10 of the applicator 86 evidences at its proximal end an inner annular groove 84, and hook-shaped elements 85 are applied on distal end of the ring fastened in the cushion 82, which as in the embodiment pursuant to Figure 9, consists of a spherical element 81 and a thread-like connection 89. Ps 5 in the embodiment pursuant to Figure 9, the inner probe 87 of the applicator 86 presses.the spherical elements ~l into the annular groove 84 and, as a result achieves the secure connection between the applicator 86 and cushion 82.
~pon drawing out of the inner probe 87, the engagement between 20 the groove 8~ and the spherical element 81 is released through light pulling on the applicator 86.
The e~odiment pursuant to Figure 11 is similar to that of Figure 5 in the provision of hook-shaped elements 95. These, however, similar to the construction 25 pursllant to Figure 10, are located on the distal end of the ring 93 of the cushion 92, in particular formed therewith, and as in the e~bodiment pursuant to Figure 5, can be imparted a radially inwardly acting prestressing. The hook-shaped - .~';

-29- , elements 95 are pressed by the inner probe 97 o~ the applicator 96 into an annular groove 94 in the proxi~al end of the outer probe 98 of the applicator 96. hlhen the inner ~robe 97 is drawn out the, in a manner as explained ;.
5 with regard to ~igures 5 and 6, the engagement between the groove 94 and the hook shaped-elements 95 is released, and the cushion 92 and applicator 96 are detached from each other.
While there has been shown and described what - ~
10 are considered to be preferred embodiments of the invention, it should be understood that variations in form and aetail could readily be made without departing from the spirit of the invention. It is therefore intenaed that the invention be not limited to the exact form and detail shown herein 15 and described, nor to anything other than the whole of the invention as hereinafter claimed.

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.

Claims

THE EMBODIMENTS OF THE INVENTION IN WHICH AN EXCLUSIVE
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:

1. In an arrangement for the reduction of the stomach reservoir including an intragastrally-appliable cushion of a gastric juice-compatible material, a perorally-intro-duceable applicator detachably connected with said cushion, said cushion being fillable with a stomach and intestinal tract-compatible fluid through said applicator, a valve-like opening in said cushion which is closeable upon detach-ment of the applicator from the cushion during extraction of the applicator; the improvement comprising: said appli-cator including inner and outer relatively moveable probes, said inner probe extending into said cushion such that said fluid is fillable into said cushion through the inner probe;
said outer probe being releasably connected to said cushion;
and one of said probes and said cushion each including engagement means which are engaged during placement of the cushion and are disengageable responsive to movement of the inner probe in the extracting direction relative to the outer probe for releasing said cushion from the applicator.

2. Arrangement as claimed in claim 1, wherein one com-ponent of said engagement means is a thread loop fasten-ed to the cushion and another component of said engagement means is formed by the inner probe wherein, for effecting engagement, the thread loop is conducted through an open-ing adjacent the proximal end of the outer probe into a portion of said outer probe and said inner probe is passed through the thread loop.

3. Arrangement as claimed in claim 1, wherein one component of said engagement means is a thread loop fastened to the outer probe and another component of said engagement means is formed by the inner probe wherein, for effecting engagement, the thread loop is conducted through an opening in said cushion and said inner probe is passed through the thread loop within said cushion.

4. Arrangement as claimed in claim 1, wherein one component of said engagement means comprises a groove formed proximate the opening of the cushion, and the other component of said engagement means comprises at least one pivotable hook element extending from the proximal end of the outer probe.

5. Arrangement as claimed in claim 4, said hook element being arranged on the proximal end of the outer probe in the region of the opening of said cushion.

6. Arrangement as claimed in claim 1, comprising a ring being fastened in the opening of said cushion and having a middle opening through which the inner probe projects interiorly of said cushion and is closeable responsive to withdrawal of the inner probe.

7. Arrangement as claimed in claim 6, wherein one component of said engagement means comprises a groove formed proximate the opening of the cushion, and the other component of said engagement means comprises at least one pivotable hook element extending from the proximal end of the outer probe.

8. Arrangement as claimed in claim 7, said groove being formed in said ring.

9. Arrangement as claimed in claim 6, wherein at least the region of said ring encompassing the middle opening is elastically constructed so as to maintain said middle opening in an open condition up to a pre-determined fluid pressure after pulling out of said inner probe.

10. Arrangement for the reduction of the stomach reservoir including an intragastrally-appliable cushion of a gastric juice-compatible material, a perorally-intro-duceable applicator detachably connected with said cushion, said cushion being fillable through said applicator with a stomach and intestinal tract-compatible fluid, and an opening in said cushion closeable in a valve-like manner responsive to detachment of the applicator from said cushion during extraction of the applicator, said applicator being formed by inner and outer probes, said outer probe being releasably connected to said cushion and said inner probe extending into said cushion so that said fluid is fillable into said cushion through said inner probe, the opening including a ring extending thereabout having a middle opening which is passed through by said inner probe, at least the region of the ring encompassing the middle open-ing being elastic, and the inner probe at its forward end including a closure member introduceable into the middle opening during withdrawal of the probe so as to close said middle opening in a fluid-tight manner.

11. Arrangement as claimed in claim 10, said ring being formed of a non-deformable material, and including in its middle opening an O ring of elastic material in-sertable into an annular groove in said ring.

12. Arrangement as claimed in claim 10, said closure member including a throat section insertable into the proximate portion of the inner probe, said inner probe including a plurality of perforations adjacent said proximate portion for the filling of said cushion.

13. Arrangement as claimed in claim 12, comprising a separating wall for dividing said proximate portion.

14. Arrangement as claimed in claim 13, including a perforation in the separated section of said inner probe, closeable by said throat section during placement of said cushion.

15. Arrangement as claimed in claim 12, wherein the outer diameter of said throat section of said closure member is larger than the inner diameter of the undeformed elastic portion of the ring.

16. Arrangement as claimed in claim 15, wherein the outer diameter of the throat section of the closure member is at least as large as the outer diameter of the inner probe.

17. Arrangement as claimed in claim 16, wherein the proximal section of the inner probe is expanded so as to receive the throat section of the closure member.

18. Arrangement according to claim 12, wherein the closure member includes an expanded section formed on the throat section.

19. Arrangement as claimed in claim 18, wherein the expanded section is spherically-shaped.

20. Arrangement according to claim 10, wherein the inner probe and the outer probe are detachably inter-connected at their distal ends.

21. Arrangement as claimed in claim 20, including a quick-connect coupling, such as a luer-lock threading.

22. Arrangement as claimed in claim 10, including detecting means on the distal end of the applicator for detecting the extent of relative movement between the inner probe and the outer probe.

23. Arrangement as claimed in claim 22, wherein said detecting means is formed by a marking field on the inner probe.

24. Arrangement as claimed in claim 23, wherein said outer probe includes a transparent section at least at the distal end thereof.

25. Arrangement as claimed in claim 22, wherein said detecting means includes a deformable connection, which is not expandable in the longitudinal direction between the inner probe and the outer probe at the distal ends thereof, the length of said connection corresponding at least to the extent of movement required for detachment of the cushion from said applicator.

26. Arrangement as claimed in claim 1 or 10, wherein the outer probe includes a marking field at its distal end indicative of the extent of insertion of the arrangement into the stomach.

27. Arrangement as claimed in claim 10, including a hose-like casing encompassing said cushion over at least its length at the proximal end section of the outer probe, said casing being removable with said applicator subsequent to placement of said cushion.

28. Arrangement as claimed in claim 27, wherein said casing includes an easily tearable tear line.

29. Arrangement as claimed in claim 27 or 28, said casing having a reducing wall thickness extending from the distal end towards the proximal end.

30. Arrangement as claimed in claim 10, said cushion being at least partially folded during application into the stomach.

31. Arrangement as claimed in claim 30, said cushion being at least partially folded or bent during application within the inner probe and the outer probe.

32. Arrangement as claimed in claim 1, wherein said cushion is of a material selected from the group consist-ing of rubber, polyethylene, polytetrafluoroethylene, poly-vinyl chloride or silicon.

33. Arrangement as claimed in claim 27, wherein the region of frictional contact between the cushion and the applicator, the cushion and the casing, and the closure member and the inner probe is coated with a lubricating and sealing medium, such as silicon oil.

34. Arrangement as claimed in claim 1, wherein the outer surface of the cushion, is coated with a lubricating and sealing medium, such as silicon oil.

35. Arrangement as claimed in claim 1 or 10, wherein said filling fluid comprises water or air.

36. Arrangement as claimed in claim 1 or 10, wherein said cushion includes an indicator, such as a powdered or liquid urine-coloring, bioneutral coloring agent, such as methylene blue.

37. Arrangement as claimed in claim 10, wherein at least the applicator, said ring and closure member consist of a material which is of a lower X-ray permeability than the surrounding tissue during placement.

38. Arrangement as claimed in claim 1 or 10, wherein said applicator is more flexible at its distal end section than at its proximal end section.

39. Arrangement as claimed in claim 1 or 10, having a length in the magnitude of about 70 cm in the placeable condition.

40. Arrangement as claimed in claim 1 or 10, wherein the inner diameter of the inner probe is in the magnitude within the range of about 2.5 to 2.7 mm.

41. Arrangement as claimed in claim 1 or 10, wherein said outer probe has an external diameter in the magnitude of about 5 mm.

42. Arrangement as claimed in claim 1 or 10, wherein said cushion has a fill volume in the magnitude of about 100 to 1000 mm.

43. Arrangement as claimed in claim 1 or 10, wherein said cushion includes a medium which, with respect to the fluid, is a germicidal medium, such as an antibiotic, a chemotherapeutic, a disinfectant, in liquid or powder form.