FR3044216A1 - INTRA-GASTRIC BALLOON WITH GASTRIC FLOW LIMITER, REALIZATION ASSEMBLY OF SUCH A BALLOON AND ASSOCIATED METHOD - Google Patents

Abstract

The present invention relates to a variable volume intra-gastric device for reducing the volume of a patient's stomach, comprising: a balloon (18), intended to be implanted endoscopically in the patient's stomach and suitable for receive a filling fluid; and a flexible tube (30) connected to said balloon; said device further comprising a member (22, 122) for reducing a gastric flow between the stomach and the duodenum (16) of the patient, said flow reducing member being connected to the flexible tube and intended to be disposed in the duodenum of the patient. Said flux reducing member comprises: a fixing sleeve disposed around an axis and inserted around the flexible tube; and a retaining member integral with said sleeve and extending radially outwardly from said sleeve.

Description

Intragastric balloon with gastric flow limiter, assembly for producing such a balloon and associated method

The present invention relates to an intra-gastric device for reducing the volume of a patient's stomach, comprising: a balloon, intended to be implanted endoscopically in the patient's stomach, the balloon comprising a flexible pouch defining a interior space adapted to receive a filling fluid; and a flexible tube having a first end fixedly and sealingly connected to said flexible bag for introducing filling fluid into said interior space; said device further comprising at least a first member for reducing a gastric flow between the stomach and duodenum of the patient, said first flow reducing member being connected to the flexible tube and intended to be disposed in the duodenum of the patient.

Such devices are implantable in the human body as part of an aesthetic treatment of overweight or therapeutic treatment of obesity.

The balloon of the intragastric device is placed in the stomach, including endoscopically, to reduce the space available for food. Patients then report a quick feeling of fullness and lose weight.

Intragastric devices of the aforementioned type are known from documents FR2906132 and FR3020266.

The filling tube or catheter attached to the balloon is generally left free in the patient's stomach and duodenum. Sometimes there are problems such as knots or loops around the balloon.

The present invention aims to provide an intragastric device to prevent the catheter to remain in the stomach. The present invention also aims to provide an intragastric device providing the patient an improved sensation of satiety. For this purpose, the subject of the invention is an intra-gastric device of the aforementioned type, in which the first flow reduction member comprises: a fixing sleeve disposed around an axis and inserted around the flexible tube; and a retaining member integral with said sleeve and extending radially outwardly from said sleeve.

According to other advantageous aspects of the invention, the intragastric device comprises one or more of the following characteristics, taken individually or in any technically possible combination: the intragastric device further comprises at least one second organ reduction of a gastric flow between the stomach and the duodenum of the patient, said second reduction member comprising: a fixing sleeve disposed about an axis and inserted around the flexible tube; and a retainer, integral with said sleeve and extending radially outwardly from said sleeve; - The retaining element of at least the first flow reduction member comprises a deformable surface, substantially frustoconical, said surface having one or more orifices for passage of the gastric flow; - The deformable surface, substantially frustoconical, comprises a continuous ring disposed around the axis of the fixing sleeve, said ring being disposed at a distance from said fixing sleeve; - The deformable surface, substantially frustoconical, is inclined at rest relative to the axis of the sleeve, an angle between 30 ° and 70 °, more preferably between 45 ° and 55 °; - The deformable surface, substantially frustoconical, flares along the axis of the sleeve towards the first end of the flexible tube; a length of the sleeve along the axis is greater than an internal diameter of said sleeve. The invention furthermore relates to an assembly for producing an intra-gastric device as described above, comprising: a balloon, intended to be implanted endoscopically in the patient's stomach, the balloon comprising a flexible pouch defining an interior space adapted to receive a filling fluid; and a flexible tube having a first end fixedly and sealingly connected to said flexible bag for introducing filling fluid into said interior space; the assembly further comprising at least a first member for reducing a gastric flow between the stomach and the duodenum of the patient, said first flow reduction member being able to be connected to the flexible tube, said first reduction member of flow comprising: a fixing sleeve disposed about an axis and adapted to be inserted around the flexible tube; and a retaining member integral with said sleeve and extending radially outwardly from said sleeve.

Preferably, the assembly further comprises at least one second reduction member of a gastric flow between the stomach and the duodenum of the patient, said second flow reduction member being adapted to be connected to the flexible tube, said first flow reduction member comprising: a fixing sleeve arranged around an axis and able to be inserted around the flexible tube; and a retaining member integral with said sleeve and extending radially outwardly from said sleeve. The invention further relates to a method of producing an intra-gastric device as described above, comprising the following steps: insertion of the attachment sleeve of the first flow-reducing member around the flexible tube, so providing a first distance along said tube between said sleeve and the first end of said tube; and optionally, securing to the flexible tube of said fixing sleeve.

Preferably, the method then comprises the following steps: insertion of the fixing sleeve of the second flow reduction member around the flexible tube, so as to provide a second distance along said tube between the sleeves of the first and second reduction members ; and optionally, securing to the flexible tube of said fixing sleeve. The invention will be better understood on reading the description which follows, given solely by way of example and with reference to the appended drawings, in which: FIG. 1 is a partial schematic view of an apparatus gastric system according to one embodiment of the invention; - Figure 2 is a top view of a member of the intragastric device of Figure 1; - Figure 3 is a sectional view of the member of Figure 2; - Figure 4 is a view of an alternative embodiment of the member of Figures 2 and 3; and - Figure 5 is a schematic view of an intragastric device according to another embodiment of the invention, installed in the stomach and duodenum of a patient.

Figures 1 and 5 show intragastric devices 10, 12 according to two embodiments of the invention. The intragastric device 12 of Figure 5 is shown installed in the stomach 14 and duodenum 16 of a patient.

Unless otherwise specified, the following description corresponds to each of the intragastric devices 10 and 12.

The device 10, 12 comprises a balloon 18 intended to take place in the stomach 14 of a patient, as can be seen in FIG. 6. The device 10, 12 further comprises a filling catheter 20 fixed to the balloon 18.

The device 10, 12 also comprises at least one member 22 for reducing a gastric flow between the patient's stomach and duodenum, the at least one reduction member 22 being attached to the catheter 20.

The balloon 18 comprises a flexible bag 24, shown in section in FIG. 1. An internal volume 26 of the bag 24 is variable according to the quantity of filling fluid injected into said bag 24.

The pocket 24 is formed from at least one layer of a polymer, preferably chosen from: an olefin thermoplastic polymer such as polypropylene or polyethylene, a silicone or a polyurethane. The thickness of the layer forming the pocket 24 is for example between 0.5 and 3 mm.

The pocket 24 is deformable to the touch. The internal volume 26 varies between a minimum volume, in which the bag 24 is contracted, and a maximum volume before rupture of said bag. By way of example, the minimum volume is less than 100 ml and the maximum volume is greater than 1000 ml. The shape of the bag 24 is adapted to the shape of the stomach 14 of the patient as long as the volume of the bag is less than a certain value of the maximum volume of the bag 24, for example less than 80% of said maximum volume.

Filling catheter 20 comprises a flexible, hollow, cylindrical tube whose first end 32 is fixedly connected and sealed to the balloon 18. For example, a fastening flange 34 connects the first end 32 to an opening 36 in the pocket 24

A second free end 38 of the tube 30 is adapted to be connected to a device for supplying or withdrawing fluid, such as a syringe, for modulating the volume of the bag 24. The free end 38 is also able to be closed by a permanent closure device (not shown), such as a plug, to prevent any fluid outlet from the device 10, 12.

A length of the tube 30 in the deployed position is substantially greater than the distance between the stomach 4 and the mouth 40 of the patient (FIG. 5). More specifically, the length of the tube 30 is adapted to allow the removal of the device 10,12 of the stomach 14 endoscopically, during a pull on the tube 30 from outside the mouth 40 of the patient. The length of the tube 30 is for example about 70 cm. An outer diameter of the tube 30 is for example between 3 mm and 15 mm.

The pocket 24, the tube 30 and the flange 34 are obtained from flexible materials, biocompatible, assembled by welding or gluing. Preferably, the tube 30 and the flange 36 are formed in one piece.

An intragastric device comprising a balloon and a filling catheter as described above is in particular known from document FR3020266.

In the embodiments of FIGS. 1 and 5, the intra-gastric devices 10, 12 also comprise a plurality of substantially identical reduction members 22. According to another embodiment of the invention, the intragastric device comprises several reduction organs, of different size and / or shape, attached to the catheter 20.

Figures 2 and 3 show a reduction member 22 of the device 10 of Figure 1.

FIG. 4 shows a reduction member 122 according to an alternative embodiment, able to replace the reduction member 22 in the devices 10, 12. In the description which follows, the elements common to the reduction members 22 and 122 are described with the same reference numbers. The reduction member 22, 122 comprises a fixing sleeve 50 and a retaining element 52, integral with said sleeve 50.

The fixing sleeve 50 has substantially a cylindrical shape of revolution along an axis 54. The sleeve 50 comprises in particular an inner surface 56 whose minimum diameter 58 is substantially equal to or slightly smaller than the outside diameter of the tube 30.

Optionally, the inner surface 56 has grooves 60 of diameter slightly greater than the minimum diameter 58.

The fixing sleeve 50 has a length 62 along the axis 54. The length 62 is preferably greater than the internal diameter 58 of said sleeve 50, more preferably greater than twice said internal diameter 58. The retention element 52 is integral with an outer lateral surface 64 of the sleeve 50 and extends radially outwardly from said surface 64. The retaining element 52 is made of a more rigid material than the bag 24 of the balloon and the flexible tube 30 Said material of the retaining element 52, however, has sufficient deformability, preferably sufficient flexibility, to be deformed by muscular contractions of the stomach and / or duodenum.

Preferably, the retaining element 52 and the fixing sleeve 50 are formed in one piece.

Preferably, the retaining element 52 comprises a deformable surface 66, 166 substantially frustoconical at rest. The substantially frustoconical surface 66, 166 is inclined with respect to the axis 54 by an angle α (FIG. 3) preferably between 30 ° and 70 °, more preferably between 45 ° and 55 °. As an indication, for a minimum diameter 58 of the sleeve of about 3 mm, a maximum diameter of the substantially frustoconical surface 66, 166 is between 5 mm and 25 mm.

The substantially frustoconical surface 66, 166 is preferably discontinuous; more precisely, said surface 66, 166 preferably comprises one or more orifices 68, 168 for the passage of the gastric flow.

According to an alternative embodiment, not shown, the substantially frustoconical surface is continuous around the axis 54 and has no orifices.

In the alternative embodiment of Figures 2 and 3, the substantially frustoconical surface 66 is embodied by a frustoconical skirt, comprising openings 68 angularly arranged regularly about the axis 54. The openings 68 are for example three in number. An edge 70 of the skirt 66, opposite the attachment sleeve 50, forms a continuous ring around the axis 54. The ring 70 is deformable, in particular flexible.

Alternatively, the ring 70 is removed at the openings 68, in particular to give more flexibility to the skirt. The ring 70 is for example cut by a practitioner during assembly of the intragastric device, as described below.

In the variant embodiment of FIG. 4, the substantially frustoconical surface 166 is embodied by a plurality of petals 72 arranged angularly in a regular manner about the axis 54. Preferably, the petals 72 forming the surface 166 are at least three in number more preferably between four and eight. The reduction member 122 of FIG. 4 comprises four substantially identical petals 72.

Each petal 72 has a contour 74 substantially circular or oblong, or rectangular or trapezoidal with rounded edges. According to a first embodiment, each petal 72 forms a frustoconical surface portion 166. According to a second embodiment, each petal 72 is substantially plane and the angular dispositions of said petals 72 define a substantially frustoconical envelope surface 166.

Each petal 72 is connected to the sleeve 50 by a contact zone 76, of dimensions significantly smaller than the dimensions of said petal. For example, a surface of the contact zone 76 is less than 5% of a surface of a petal 72.

Spaces 168 formed between the petals form discontinuities of the substantially frustoconical surface 166, allowing passage of the gastric flow.

In particular, each petal 72 has a radial edge 78 located opposite the contact zone 76. The radial edges 78 correspond to a maximum flaring of the substantially frustoconical surface 166. The radial edges 78 of the different petals 72 are spaced apart. each other by spaces 168. Thus, the deformable petals 72 can move closer and away from the sleeve 50 depending on the muscular contractions of the stomach and / or the duodenum.

In the embodiment of Figure 4, to strengthen the connection between the petals 72, the surface 166 comprises a continuous ring 80 disposed around the axis 54 of the sleeve 50. The continuous ring 80 interconnects the petals 72 The continuous ring 80 is disposed at a distance from the sleeve 50, between the contact zone 76 and the radial edge 78 of each petal 72. The continuous ring 80 is deformable, in particular flexible.

To give the skirt more flexibility, the ring 80 can be cut by a practitioner during assembly of the intragastric device, as described below.

According to another variant, the surface 166 does not comprise a ring 80, the petals 72 being only connected to the sleeve 50 by the contact zones 76.

As shown in FIGS. 1 and 5, the reduction member or members 22, 122 of the device 10, 12 are threaded onto the tube 30. According to the embodiments shown, all the reduction members are oriented so that the substantially frustoconical surface 66, 166 flares towards the first end 32 of the flexible tube. Alternatively, some of said members, or all of said members, are oriented in opposite directions, so that the substantially frustoconical surface 66, 166 flares towards the second end 38 of the flexible tube.

A first distance 86 is provided along the tube 30 between said first end 32 and the closest reduction member 22. The first distance 86 is preferably configured to have the reduction member 22 near the biliary papilla in the duodenum. This distance can be determined by a practitioner based on his clinical judgment.

In the case where the device 10, 12 comprises several reduction members 22, two of said members are in contact with each other along the tube 30, or a second non-zero distance 88 is formed along the tube 30. between two of said organs. Figure 1 shows a combination of these two alternatives, the device 10 comprising four reduction members 22. The device 12 of Figure 5 comprises three reduction members 22 separated by non-zero distances.

According to one embodiment of the invention, an assembly for producing an intragastric device 10, 12 comprises on the one hand a balloon 18 fixed to a catheter 20, as described above, and on the other hand one or more reduction members 22, 122. According to a first variant, all the reduction members 22, 122 of the assembly are identical. According to a second variant, the assembly comprises several reduction members of different size and / or shape.

A method of manufacturing an intragastric device 10, 12 from such an assembly will now be described. Firstly, optionally, an adhesive is disposed in the grooves 60 of the inner surface 56 of the sleeve 50 of a first reduction member 22. This is for example a polyurethane type glue.

Then, the second free end 38 of the tube 30 is inserted into the sleeve 50, the flare of the frustoconical surface 66, 166 being suitably disposed. Said sleeve is threaded onto said tube 30, until the first desired distance 86 is obtained between said sleeve and the first end 32.

In the case where glue is used, the latter provides the connection between the tube 30 and the first reduction member 22. Alternatively, the tube 30 and the reduction member 22 may be welded, for example by ultrasound.

In the absence of glue or solder, the inner diameter 56 of the sleeve 50 and the outer diameter of the tube are preferably chosen so as to forcefully insert the tube into the sleeve. Thus, the contact forces prevent an inadvertent displacement of the sleeve 50 along the tube 30. A sufficient traction nevertheless makes it possible to dissociate the tube 30 and the reduction member 22.

Preferably, the above steps are repeated to insert one or more other reduction members 22 on the tube 30. A second distance 88 is for example formed between two of said reduction members.

A practitioner can thus arrange himself or the reduction members 22, 122 along the tube 30. The practitioner can thus choose the size, the shape and the number of said reduction members of the device 10, 12, the orientation of the flaring of the frustoconical surfaces 66, 166, as well as the distances 86, 88, depending on each patient.

A method of using the intragastric device 12 will now be described in support of Figure 5. The balloon 18 of the intragastric device 12 is first implanted by the practitioner in the stomach 14 of the patient, by endoscopic route, via the mouth 40 and esophagus 90 of the patient. During this step, the second free end 38 of the tube 30 remains accessible outside the patient's mouth. During this installation, the pocket 24 is deflated so that the balloon 18 occupies a reduced volume, which facilitates the implantation of the latter. Preferably, during this step, the flexibility of the reduction members 22 is sufficient not to hinder the deployment of the tube 30 in the esophagus. In the next step, the bag 24 is filled by introducing the filling fluid via the catheter 20. The second free end 38 of the tube 30 is then closed.

Said free end 38 of the tube 30 is then introduced endoscopically into the stomach 14 and then into the duodenum 16. Preferably, the tube 30 is arranged so that at least a portion of the reduction members 22, and preferably all the reduction members 22 are arranged in the duodenum. The flexibility of the retainer 52 allows each reduction member 22 to pass the pyloric ring 92 towards the duodenum.

In the case where the frustoconical shape of the reduction member 22 flares towards the balloon 18, said frustoconical shape prevents an inadvertent return of the reduction member 22 in the stomach 16, under the effect muscle contractions. The edge 70 or 78 of the retaining element 52 is in fact blocked by the pyloric ring 92. The catheter 20 of the device 12 is thus kept away from the stomach, which prevents it from winding up. around the balloon 18.

The intragastric device 12 is thus arranged so that the balloon 18 occupies part of the volume of the stomach 14, in order to induce a feeling of satiety in the patient. Furthermore, the catheter 20 and the reduction members 22 are disposed in the duodenum 16. Said members 22 are thus able to limit a gastric flow between the stomach and the duodenum, by partially blocking said duodenum. The feeling of satiety is therefore reinforced in the patient.

The orifices 68, 168, however, prevent total occlusion of the duodenum. In addition, in the case where the frustoconical shape of the reduction member 22 flares away from the balloon 18, a large gastric flow induces a folding of the retaining element 52 towards the sleeve 50, to release the space required for such a flow.

Moreover, the flexibility of the retaining element 52 prevents damage to the internal tissues of the digestive tract.

In order to remove the device 12 from the patient's stomach, the free end 38 of the tube 30 is recovered endoscopically using a suitable tool and then removed from the duodenum. During this step, the reduction members 22 are optionally compressed by said tool in order to cross the pyloric channel. The free end 38 is then extracted by the patient's mouth, which makes it possible to deflate the balloon 18 by sucking up the filling fluid, to then extract said balloon by pulling on the catheter 20.

Claims (11)

1. - intragastric device (10, 12) for reducing the volume of the stomach (14) of a patient, comprising: - a balloon (18) intended to be implanted endoscopically in the stomach of the patient; patient, the balloon having a flexible bag (24) defining an interior space (26) adapted to receive a filling fluid; and - a flexible tube (30) having a first end (32) fixedly and sealingly connected to said flexible bag for introduction of filling fluid into said interior space; said device further comprising at least a first member (22, 122) for reducing a gastric flow between the stomach and the duodenum (16) of the patient, said first flow reducing member being connected to the flexible tube and intended for being disposed in the duodenum of the patient, characterized in that said first flow reduction member comprises: a fixing sleeve (50) disposed about an axis (54) and inserted around the flexible tube; and a retainer (52) integral with said sleeve and extending radially outwardly from said sleeve. 2, - intragastric device according to claim 1, further comprising at least a second member (22) for reducing a gastric flow between the stomach and the duodenum of the patient, said second reduction member comprising: a sleeve of fastener (50) disposed about an axis (54) and inserted around the flexible tube; and a retainer (52) integral with said sleeve and extending radially outwardly from said sleeve. The intragastric device according to claim 1 or claim 2, wherein the retaining element (52) of at least the first flow-reducing member (22, 122) has a deformable surface (66, 166). ), substantially frustoconical, said surface having one or more orifices (68, 168) for passage of the gastric flow. 4, - intragastric device according to claim 3, wherein the deformable surface, substantially frustoconical, comprises a continuous ring (70, 80) disposed around the axis of the fixing sleeve, said ring being disposed at a distance from said sleeve of fixation. 5. - intragastric device according to claim 3 or claim 4, wherein the deformable surface (66, 166), substantially frustoconical, is inclined at rest relative to the axis of the sleeve, an angle (a) between 30 ° and 70 °, more preferably between 45 ° and 55 °. 6. - intragastric device according to one of claims 3 to 5, wherein the deformable surface, substantially frustoconical, flares along the axis of the sleeve towards the first end (32) of the flexible tube. 7. - intra-gastric device according to one of the preceding claims, wherein a length (62) of the sleeve along the axis is greater than an inner diameter (58) of said sleeve. 8. - Set for producing an intragastric device according to one of the preceding claims, comprising a balloon (18) intended to be implanted endoscopically in the stomach of the patient, the balloon comprising a flexible bag ( 24) defining an interior space adapted to receive a filling fluid; and a flexible tube (30) having a first end (32) fixedly and sealingly connected to said flexible bag for introducing filling fluid into said interior space; the assembly further comprising at least a first member (22, 122) for reducing a gastric flow between the stomach and the duodenum (16) of the patient, said first flow reduction member being able to be connected to the tube flexible, said first flow reduction member comprising: a fixing sleeve (50) disposed about an axis (54) and adapted to be inserted around the flexible tube; and a retainer (52) integral with said sleeve and extending radially outwardly from said sleeve. The assembly of claim 8, further comprising at least a second member (22, 122) for reducing a gastric flow between the stomach and the duodenum (16) of the patient, said second flow reducing member being adapted to be connected to the flexible tube, said first flow reduction member comprising: a fixing sleeve (50) disposed about an axis (54) and able to be inserted around the flexible tube; and a retainer (52) integral with said sleeve and extending radially outwardly from said sleeve. 10. - A method of manufacturing an intragastric device (10, 12) according to one of claims 1 to 7 from an assembly according to one of claims 8 or 9, comprising the following steps: - insertion the fixing sleeve (50) of the first flux reducing member around the flexible tube (30), so as to provide a first distance (86) along said tube between said sleeve and the first end of said tube; then - optionally, secured to the flexible tube of said fixing sleeve. 11. - The manufacturing method according to claim 10 from an assembly according to claim 9, said method then comprising the following steps: - insertion of the attachment sleeve (50) of the second flow-reducing member around the flexible tube ( 30) so as to provide a second distance (88) along said tube between the sleeves of the first and second reduction members; then - optionally, secured to the flexible tube of said fixing sleeve.