PLACEMENT DEVICE FOR AN INFLATABLE INTRA-GASTRIC BALLOON SYSTEM FOR TREATING OBESITY IN AN INDIVIDUAL COMPRISING SUCH A PLACEMENT DEVICE

Abstract

A device for implanting an inflatable intra-gastric balloon for implanting the intra-gastric balloon into a stomach, comprising: —an elastically deformable sheath configured to receive the intra-gastric balloon in the deflated state, the sheath comprising a side wall, —a tube configured to be supplied with a fluid and to cause the fluid to inflate the intra-gastric balloon, the tube comprising a mouthpiece, the intra-gastric balloon being attached to the mouthpiece in the deflated state and being detached from the mouthpiece in the inflated state, the mouthpiece having an inflation position wherein the mouthpiece extends in the cavity of the sheath, and the side wall of the sheath having a side opening configured to release the intra-gastric balloon from the cavity when the intra-gastric balloon moves from the deflated state to the inflated state.

Claims

1. Placement device (10) for an inflatable gastric balloon (30) for the placement of the gastric balloon (30) in a stomach, the gastric balloon (30) having a deflated state and an inflated state, the placement device (10) comprising: an elastically deformable casing (11) delimiting a cavity (12) configured to receive the gastric balloon (30) in the deflated state, the casing (11) extending along a longitudinal axis (L) and comprising a lateral wall (13) extending around the longitudinal axis (L) between a connection end (14) and an insertion end (15), a duct (21) configured to be supplied with a fluid and to convey the fluid to inflate the gastric balloon (30), the duct (21) being attached to the connection end (14) of the casing (11), and comprising an end piece (22) configured to removably attach the gastric balloon (30), wherein the end piece (22) has an inflation position in which said end piece (22) extends into the cavity (12) of the casing (11), and the lateral wall (13) of the casing (11) has a lateral opening (16) configured to allow the gastric balloon (30) to exit the cavity (12) when said gastric balloon (30) passes from the deflated state to the inflated state.

2. Placement device (10) according to claim 1, wherein the duct (21) comprises a sheath (24) attached to the connection end (14) of the casing (11) and a catheter (25) extending inside the sheath (24), the catheter (25) being mounted with the ability to slide with respect to the sheath (24) and comprising a proximal end (26) configured to be supplied with fluid and a distal end (27), the distal end (27) comprising the end piece (22) and projecting from the sheath (24) in the inflation position.

3. Placement device (10) according to claim 1, wherein the lateral wall (13) of the casing (11) has a bearing surface (17), opposite the lateral opening (16) and configured so that the gastric balloon (30) bears against said bearing surface (17) when said gastric balloon (30) passes from the deflated state to the inflated state.

4. Placement device (10) according to claim 1, wherein the lateral opening (16) of the casing (11) has a bearing edge configured so that the gastric balloon (30) bears against said bearing edge for detaching the gastric balloon (30) from the end piece (22).

5. Placement device (10) according to claim 1, wherein, in the inflation position, the end piece (22) extends along the longitudinal axis (L) and is positioned between the connection end (14) of the casing (11) and the lateral opening (16) of the casing (11) along the longitudinal axis L.

6. Placement device (10) according to claim 1, specially designed for a gastric balloon (30) comprising a valve (32) configured to collaborate with the end piece (22) of the duct (21) and having an open state allowing fluid to pass and a closed state blocking the fluid, and wherein the end piece (22) is configured to be push-fitted removably into the valve (32) of the gastric balloon (30).

7. Placement device (10) according to claim 6, wherein the end piece (22) has an end piece axis and comprises at least one shoulder (23) extending transversely with respect to the end piece axis.

8. Placement device (10) according to claim 1, wherein the lateral opening (16) has a shape that is oblong along the longitudinal axis (L).

9. Placement device (10) according to claim 1, specially designed for a spherical gastric balloon (30) having a diameter D in the inflated state, and wherein the cavity (12) of the casing (11) and the lateral opening (16) each have a length (L12, L16) considered along the longitudinal axis (L) and a width (I12, I16) considered perpendicular to the longitudinal axis (L) such that: a ratio of the diameter D of the gastric balloon (30) to the length (L12) of the cavity (12) of the casing (11) is comprised between 0.44 and 0.83, a ratio of the diameter D of the gastric balloon (30) to the width (I12) of the cavity (12) of the casing (11) is comprised between 3.2 and 6.7, a ratio of the length (L16) of the lateral opening (16) of the casing (11) to the length (L12) of the cavity (12) of the casing (11) is comprised between 0.17 and 0.67, a ratio of the width of the lateral opening of the casing to the width of the cavity of the casing is comprised between 0.24 and 0.67.

10. Placement device (10) according to claim 9, specially designed for a spherical gastric balloon (30) having a diameter D comprised between 8 cm and 10 cm in the inflated state, wherein: the length (L12) of the cavity (12) of the casing (11) is comprised between 12 cm and 18 cm, and the width (I12) of the cavity (12) of the casing (11) is comprised between 1.5 cm and 2.5 cm, the length (L16) of the lateral opening (16) of the casing (11) is comprised between 3 cm and 8 cm and the width (I16) of the lateral opening (16) of the casing (11) is comprised between 0.6 cm and 1 cm.

11. Placement device (10) according to claim 1, wherein the casing (11) is a cylinder along the longitudinal axis (L), of circular cross section.

12. Placement device (10) according to claim 1, wherein the insertion end (15) of the casing (11) is convex towards the outside of the cavity (12), so that the placement device (10) can be introduced into a natural tract of the human body.

13. System (40) for treating obesity in an individual, comprising: a placement device (10) according to claim 1, and an inflatable gastric balloon (30) having an inflated state and a deflated state.

14. System (40) for treating obesity in an individual according to claim 15, wherein the gastric balloon (30) comprises a valve (32) configured to collaborate with the end piece (22) of the duct (21) and having an open state allowing fluid to pass and a closed state blocking the fluid.

15. Placement device (10) according to claim 12, wherein the insertion end (15) of the casing (11) is hemispherical.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0055] Further features, details and advantages will become apparent from reading the following detailed description and from studying the attached drawings, in which:

[0056] FIG. 1 shows a system for treating obesity in an individual according to the invention comprising a placement device comprising a casing and an inflatable gastric balloon, the gastric balloon being positioned in the casing in a deflated state;

[0057] FIG. 2 shows the placement device of the system for treating obesity of FIG. 1;

[0058] FIG. 3 shows the gastric balloon of the system for treating obesity of FIG. 1, in the deflated state;

[0059] FIG. 4 shows the gastric balloon of the system for treating obesity of FIG. 1 in the inflated state;

[0060] FIG. 5 shows the system for treating obesity of FIG. 1 comprising a duct comprising a sheath and a catheter sliding in the sheath, and in which the catheter has been slid in the sheath so that the end piece exits the cavity of the casing;

[0061] FIG. 6 shows an enlarged view of the region referenced VI in the system for treating obesity of FIG. 1;

[0062] FIG. 7 shows the system for treating obesity of FIG. 1 in which the placement device comprises an end piece, the end piece being in an inflation position, and in which the gastric balloon is attached to the end piece, is between the deflated state and the inflated state and partially emerges from the casing via a lateral opening therein;

[0063] FIG. 8 shows the system for treating obesity of FIG. 1 in which the gastric balloon is detached from the end piece and is in the inflated state.

DESCRIPTION OF THE EMBODIMENTS

[0064] In the figures, the same references refer to elements that are identical or analogous.

[0065] FIG. 1 depicts a system 40 for treating obesity in an individual, comprising a placement device 10 and an inflatable gastric balloon 30.

[0066] The placement device 10 allows the placement of the inflatable gastric balloon 30 in the stomach of the individual. In particular, placement may be done endoscopically, via a natural tract of the body of the individual, such as, for example, via their mouth and their oesophagus.

[0067] The gastric balloon 30 is made of silicone. Alternatively, it could be made of any other elastically deformable and biocompatible material.

[0068] The gastric balloon 30 has a deflated state depicted in FIG. 3 and an inflated state depicted in FIG. 4. The gastric balloon 30 is implanted into the stomach of the individual in the inflated state. The gastric balloon 30 passes from the deflated state to the inflated state by being filled with a fluid such as physiological serum, air or a mixture of physiological serum and air.

[0069] The gastric balloon 30 comprises a valve 32 having an open state allowing the fluid to pass and a closed state blocking the fluid. In the open state, the valve 32 allows the fluid to enter the gastric balloon 30, which allows the gastric balloon 30 to be inflated. In the closed state, the valve 32 prevents the fluid situated inside the gastric balloon 30 from leaving the gastric balloon 30. The valve 32 therefore allows the gastric balloon 30 to be kept in the inflated state inside the stomach of the individual.

[0070] In the deflated state, the gastric balloon 30 is folded on itself. In the inflated state, the gastric balloon 30 is spherical and has a diameter D. Alternatively, it could adopt an ovoid or ellipsoid shape.

[0071] The placement device 10 is depicted in FIG. 2. It comprises a casing 11 and a duct 21. The casing 11 is able to accept the gastric balloon 30, and the duct 21 allows the gastric balloon 30 to be attached and positioned in the casing 11. The duct 21 can be supplied with a fluid and allows the fluid to be conveyed as far as the gastric balloon 30 to inflate the gastric balloon 30.

[0072] The casing 11 is elastically deformable. The casing 11 is cylindrical about a longitudinal axis L. It comprises a lateral wall 13 extending about the longitudinal axis between a connection end 14 and an insertion end 15. The cross section of the lateral wall 13 on a plane perpendicular to the longitudinal axis L is a circular cross section. Alternatively, the cross section could be an elliptical cross section or an oval cross section. The casing 11 thus has no sharp edges. When the casing 11 is introduced via a natural tract of the human body, it is thus less liable to cause lesions in this natural tract of the human body.

[0073] The insertion end 15 of the casing 11 is hemispherical. Alternatively, it could adopt some other convex shape, for example a portion of a hemisphere. This shape makes the placement device 10 easier to insert endoscopically while limiting the risk of causing lesions in the natural tract of the human body into which the placement device is introduced.

[0074] The lateral wall 13 has a lateral opening 16. The lateral opening 16 has a shape that is oblong along the longitudinal axis L. It has two sides that are parallel to one another and to the longitudinal axis L and the same length. Each end of one of the two sides is joined to one of the ends of the other side by an arc of a circle.

[0075] The lateral wall 13 has a bearing surface 17, opposite the lateral opening 16 and configured so that the gastric balloon 30 bears upon it when the gastric balloon 30 passes from the deflated state to the inflated state. The bearing surface 17 guides the gastric balloon 30 towards the lateral opening 16.

[0076] The casing 11 delimits a cavity 12 able to accept the gastric balloon 30 in the deflated state. As the gastric balloon 30 passes from the deflated state to the inflated state, namely when it is in the process of becoming inflated, the lateral opening 16 of the lateral wall 13 of the casing 11 allows the gastric balloon to exit the cavity.

[0077] The cavity 12 of the casing 11 has a length L12 considered along the longitudinal axis L and a width I12 considered perpendicular to the longitudinal axis. The length L12 of the cavity 12 of the casing 11 is considered from the connection end 14 as far as the insertion end 15.

[0078] The lateral opening 16 has a length L16 considered along the longitudinal axis L and a width I16 considered perpendicular to the longitudinal axis L. The length L16 of the lateral opening is considered from a vertex S1 of one of the arcs of a circle joining the ends of the two parallel sides of the lateral opening 16 to a vertex S2 of the other arc of a circle joining the ends of the two parallel sides of the lateral opening 16.

[0079] The vertex S2 forms a bearing edge against which the gastric balloon 30 can bear so as to allow the gastric balloon 30 to become detached from the duct 21, thus preventing the gastric balloon 30 from pressing against a wall of the stomach of the individual in order to detach itself from the duct 21.

[0080] The duct 21 is attached to the connection end 14 of the casing 11. In this example, the duct 21 comprises a sheath 24 attached to the connection end 14 of the casing 11 and a catheter 25 extending inside the sheath 24. The catheter 25 is mounted with the ability to slide with respect to the sheath 24. It comprises a proximal end 26 and a distal end 27 at the opposite end to the proximal end 26. The distal end 27 projects from the sheath 24. In this example, the proximal end 26 of the catheter 25 is supplied with fluid and the catheter 25 conveys the fluid as far as the distal end 27. In another example which has not been depicted, the duct 21 could consist solely of a catheter.

[0081] The distal end 27 comprises an end piece 22. The end piece 22 allows the gastric balloon 30 to be attached removably. In particular, in the deflated state, the gastric balloon 30 can be attached to the end piece 22 and in the inflated state, the gastric balloon 30 can be detached from the end piece 22.

[0082] The end piece 22 is depicted in an inflation position. The end piece 22 is in this inflation position notably when the gastric balloon 30 passes from the deflated state to the inflated state. In this inflation position, the end piece 22 extends into the cavity 12 of the casing 11. In particular, the end piece 22 extends along the longitudinal axis L and is positioned between the connection end 14 of the casing 11 and the lateral opening 16 of the casing 11 along the longitudinal axis L. This positioning allows the gastric balloon 30 to exit the casing automatically via the lateral opening 16 when the gastric balloon 30 passes from the deflated state to the inflated state.

[0083] In order to convey the fluid as far as the gastric balloon 30, the end piece 22 collaborates with the valve 32 of the gastric balloon 30. The end piece 22 is push-fitted removably into the valve 32 of the gastric balloon 30.

[0084] The end piece 22 extends along an end piece axis and comprises a shoulder 23 extending transversely with respect to the end piece axis. This shoulder 23 helps with push-fitting the gastric balloon 30 onto the end piece 22 removably. In particular, the gastric balloon 30 can be push-fitted onto the end piece 22 in the deflated state, it can be kept push-fitted on the end piece 22 of the duct 21 during the inflation process, and it can be detached from the end piece 22 of the duct 21 in the inflated state.

[0085] By way of illustration, in one nonlimiting particular example, the treatment system is employed with the following dimensions.

[0086] A ratio of the diameter D of the gastric balloon 30 to the length L12 of the cavity 12 of the casing 11 may be comprised between 0.44 and 0.83. A ratio of the diameter D of the gastric balloon 30 to the width I12 of the cavity 12 of the casing 11 may be comprised between 3.2 and 6.7. A ratio of the length L16 of the lateral opening 16 of the casing 11 to the length L12 of the cavity 12 of the casing 11 may be comprised between 0.17 and 0.67. A ratio of the width I16 of the lateral opening 16 of the casing 11 to the width I12 of the cavity of the casing could be comprised between 0.24 and 0.67.

[0087] The diameter D of the gastric balloon 30 may be comprised between 8 cm and 10 cm. For such a diameter D of the gastric balloon, the length L12 of the cavity 12 of the casing 11 may be comprised between 12 cm and 18 cm, and the width I12 of the cavity 12 of the casing 11 may be comprised between 1.5 cm and 2.5 cm.

[0088] Further, the length L16 of the lateral opening 16 may be comprised between 3 cm and 8 cm, and the width I16 of the lateral opening 16 may be comprised between 0.6 cm and 1.0 cm.

[0089] In one exemplary embodiment, the ratio of the diameter D of the gastric balloon 30 to the length L12 of the cavity 12 of the casing 11 is equal to 0.6. The ratio of the diameter D of the gastric balloon 30 to the width I12 of the cavity 12 of the casing 11 is equal to 4.5. The ratio of the length L16 of the lateral opening 16 of the casing 11 to the length L12 of the cavity 12 of the casing 11 is equal to 0.3. The ratio of the width I16 of the lateral opening of the casing 11 to the width I12 of the cavity of the casing is equal to 0.4.

[0090] In one exemplary embodiment, the diameter D of the gastric balloon 30 is equal to 9 cm. The length L12 of the cavity 12 of the casing 11 is equal to 15 cm and the width I12 of the cavity 12 of the casing 11 is equal to 2 cm. The length L16 of the lateral opening 16 is equal to 4.5 cm and the width I16 of the lateral opening 16 is equal to 0.8 cm.

[0091] The placement of the gastric balloon 30 on the end piece 22 of the duct 21 is described in connection with FIG. 5. The catheter 25 has been slid in the sheath 24 in such a way that the end piece 22 enters the lateral opening 16 of the casing and exits the cavity 12 of the casing 11. The end piece 22 is thus positioned outside of the cavity 12 of the casing 11.

[0092] The gastric balloon 30 is in the deflated state. It is attached to the end piece 22 of the duct 21 via the valve 32.

[0093] The catheter 25 can then be slid again in the sheath 24, so that the end piece 22 is positioned in the inflation position, as depicted in FIG. 6. The gastric balloon 30 is housed entirely inside the casing 11.

[0094] The placement device 10 is then inserted via the insertion end 15 of the casing 11 into the mouth and the oesophagus of the individual until the casing 11 reaches the stomach of the individual.

[0095] As depicted in FIG. 7, the gastric balloon 30 is then inflated. The duct 21 is supplied at the proximal end 26 of the catheter 25 with a fluid, and the catheter 25 conveys the fluid as far as the gastric balloon 30 via the end piece 22 which collaborates with the valve 32.

[0096] The fluid is introduced into the valve 32 in the open state. The fluid in the duct 21 creates a pressure at the end piece 22, which in turn creates a pressure on the valve 32. This opens the valve 32. The gastric balloon 30 can thus receive the fluid and become inflated, to pass from the deflated state to the inflated state.

[0097] When the gastric balloon 30 is in the process of being inflated, namely as it is passing from the deflated state to the inflated state, the gastric balloon 30 bears against the bearing surface 17 of the lateral wall 13 of the casing. The bearing surface 17 guides the gastric balloon 30 towards the lateral opening 16. Part 31 of the gastric balloon 30 therefore enters the lateral opening 16 and automatically leaves the casing 11 via the lateral opening 16.

[0098] Once the gastric balloon 30 is in the inflated state, it is detached from the end piece 22. The gastric balloon 30 may for example be detached from the end piece 22 as a result of the sliding of the catheter 25 in the sheath 24 allowing the gastric balloon 30 to be brought into contact with the bearing edge formed by the vertex S2 of the lateral opening 16. The gastric balloon 30 is therefore held out of the casing 11 by butting against the bearing edge and the end piece 22 is therefore carried into the sheath 24, which causes the gastric balloon 30 to become detached from the casing 11. The gastric balloon 30 thus finds itself outside of the casing 11 and disconnected from the placement device 10, as has been depicted in FIG. 8. The gastric balloon 30 is thus implanted in the stomach of the individual, in the fundus.

[0099] The valve 32 of the gastric balloon 30, in the closed state, prevents the fluid contained in the gastric balloon from leaving the gastric balloon 30, and the balloon remains in the inflated state in the stomach of the individual.

[0100] The placement device 10 is then withdrawn from the oesophagus and from the mouth of the individual.