Patent Publication Number: US-2023147124-A1

Title: Placement device for an inflatable intra-gastric balloon system for treating obesity in an individual comprising such a placement device

Description:
TECHNICAL FIELD 
     The present invention relates to a placement device for an inflatable gastric balloon intended to be inserted into the stomach of an individual and to a system for treating obesity comprising such a placement device. 
     PRIOR ART 
     For the past few years, there has been an increase in obesity in the world population. One of the known treatments for treating individuals suffering from obesity is to fit an inflatable gastric balloon in the stomach. 
     The gastric balloon may notably be introduced endoscopically. The deflated gastric balloon is positioned at the end of a duct, for example a catheter, and the duct is then inserted into the mouth and then the oesophagus of the individual suffering from obesity until the gastric balloon reaches the stomach of the individual. The gastric balloon is then inflated with physiological serum, air or a mixture of the two, conveyed via the duct. 
     Once inflated, the gastric balloon is detached from the duct and remains implanted in the stomach, notably at the fundus. 
     This treatment is easy to perform and minimally invasive. However, it would be appropriate to find a system that allows better monitoring of the detachment of the gastric balloon from the duct, and makes it possible to ensure that the gastric balloon is correctly positioned in the stomach, for example in the fundus. 
     SUMMARY 
     The present invention seeks to meet the abovementioned need. 
     To this end, according to a first aspect, the invention provides a placement device for an inflatable gastric balloon for the placement of the gastric balloon in a stomach, the gastric balloon having a deflated state and an inflated state, the placement device comprising:
         an elastically deformable casing delimiting a cavity configured to receive the gastric balloon in the deflated state, the casing extending along a longitudinal axis and comprising a lateral wall extending around the longitudinal axis between a connection end and an insertion end,   a duct configured to be supplied with a fluid and to convey the fluid to inflate the gastric balloon, the duct being attached to the connection end of the casing, and comprising an end piece configured to removably attach the gastric balloon, characterized in that the end piece has an inflation position in which said end piece extends into the cavity of the casing,
 
and in that the lateral wall of the casing has a lateral opening configured to allow the gastric balloon to exit the cavity when said gastric balloon passes from the deflated state to the inflated state.
       

     Thus, the collaboration between the end piece of the duct and the gastric balloon ensures simplified detachment of the gastric balloon from the duct. 
     In addition, the lateral opening ensures correct positioning of the gastric balloon in the stomach when the gastric balloon is detached from the duct. This is because the lateral opening provides control over the direction in which the gastric balloon is released into the stomach, and thus allows it to be guided towards the fundus. 
     The placement of the gastric balloon in the stomach is thus facilitated. 
     According to a variant of the invention, the duct comprises a sheath attached to the connection end of the casing and a catheter extending inside the sheath, the catheter being mounted with the ability to slide with respect to the sheath and comprising a proximal end configured to be supplied with fluid and a distal end, the distal end comprising the end piece and projecting from the sheath in the inflation position. 
     The catheter can slide in the sheath to cause the end piece to exit the cavity, thus allowing the gastric balloon to be positioned on the end piece when the latter is outside of the cavity. The fitting of the gastric balloon to the end piece is therefore facilitated. In addition, the catheter can also slide in the sheath in order to allow the gastric balloon to be detached from the end piece. 
     According to a variant of the invention, the lateral wall of the casing has a bearing surface, opposite the lateral opening and configured so that the gastric balloon bears against said bearing surface when said gastric balloon passes from the deflated state to the inflated state. 
     The bearing surface thus guides the gastric balloon towards the lateral opening. 
     According to a variant, the lateral opening of the casing has a bearing edge configured so that the gastric balloon bears against said bearing edge for detaching the gastric balloon from the end piece. 
     The gastric balloon can thus be detached from the end piece without the gastric balloon bearing against the wall of the stomach. 
     According to a variant, in the inflation position, the end piece extends along the longitudinal axis and is positioned between the connection end of the casing and the lateral opening of the casing along the longitudinal axis. 
     This position of the end piece makes it possible to optimize the positioning of the gastric balloon in the cavity when the balloon passes from the deflated state to the inflated state, so as to allow the gastric balloon to exit the casing automatically via the lateral opening. 
     According to a variant, the placement device is specially designed for a gastric balloon comprising a valve configured to collaborate with the end piece of the duct and having an open state allowing fluid to pass and a closed state blocking the fluid, and the end piece is configured to be push-fitted removably into the valve of the gastric balloon. 
     The push-fitting makes it easier for the gastric balloon to be positioned on the end piece in the deflated state while at the same time ensuring the detachment of the gastric balloon in the inflated state. 
     Where appropriate, the end piece may have an end piece axis and comprise at least one shoulder extending transversely with respect to the end piece axis. 
     The shoulder contributes to holding the gastric balloon on the end piece in the deflated state and when the gastric balloon is passing from the deflated state to the inflated state, while at the same time allowing the detachment of the gastric balloon in the inflated state. 
     According to a variant, the lateral opening has a shape that is oblong along the longitudinal axis. 
     According to a variant, the placement device is specially designed for a spherical gastric balloon having a diameter in the inflated state, and the cavity of the casing and the lateral opening each have a length considered along the longitudinal axis and a width considered perpendicular to the longitudinal axis such that:
         a ratio of the diameter of the gastric balloon to the length of the cavity of the casing is comprised between 0.44 and 0.83,   a ratio of the diameter of the gastric balloon to the width of the cavity of the casing is comprised between 3.2 and 6.7,   a ratio of the length of the lateral opening of the casing to the length of the cavity of the casing 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.       

     According to a variant, the placement device is specially designed for a spherical gastric balloon having a diameter comprised between 8 cm and 10 cm in the inflated state, and:
         the length of the cavity of the casing is comprised between 12 cm and 18 cm, and the width of the cavity of the casing is comprised between 1.5 cm and 2.5 cm,   the length of the lateral opening of the casing is comprised between 3 cm and 8 cm and the width of the lateral opening of the casing is comprised between 0.6 cm and 1.0 cm.       

     According to a variant, the casing is a cylinder along the longitudinal axis, of circular cross section. 
     This shape of the casing limits the risk of creating lesions in the natural tracts of the human body into which the casing is inserted. 
     According to a variant, the insertion end of the casing is convex towards the outside of the cavity, preferably hemispherical, so that the placement device can be introduced into a natural tract of the human body. 
     This convex, or even hemispherical, shape of the casing makes the casing easier to insert into the natural tracts of the human body while limiting the risk of lesions. 
     According to a second aspect of the invention, the invention proposes a system for treating obesity in an individual, comprising:
         a placement device according to the first aspect of the invention, and   an inflatable gastric balloon having an inflated state and a deflated state.       

     According to a variant, the gastric balloon is made of silicone. Silicone allows the gastric balloon to deform without tearing. 
     According to a variant, the gastric balloon comprises a valve configured to collaborate with the end piece of the duct and having an open state allowing fluid to pass and a closed state blocking the fluid. 
     In the open state, the valve allows fluid to pass from the duct into the gastric balloon, thus allowing the gastric balloon to pass from the deflated state to the inflated state. In the closed state, the valve prevents the fluid situated in the gastric balloon from leaving the gastric balloon. The valve may for example be a one-way valve and have a direction that allows flow, in which the direction the fluid can circulate from the duct into the gastric balloon, and a direction that blocks flow, in which direction it prevents the fluid from circulating, preventing the fluid situated in the gastric balloon from leaving the gastric balloon. 
     The invention can be employed in a method for treating obesity in an individual. 
     In particular, the treatment system according to the second aspect of the invention can be employed in a method for treating obesity in an individual, wherein
         the gastric balloon in the deflated state is attached to the end piece of the duct of the placement device,   the casing of the placement device is inserted into the stomach of the individual,   the duct is supplied with a fluid and the duct conveys the fluid to inflate the gastric balloon,   the gastric balloon exits the casing inside the stomach via the lateral opening in the lateral wall of the casing, and is detached from the end piece in the inflated state,   the duct of the placement device is withdrawn from the stomach of the individual.       

     According to a variant, in order to attach the gastric balloon in the deflated state to the end piece of the duct, the catheter is slid in the sheath in order to cause the end piece to exit the cavity of the casing. 
     According to a variant, the gastric balloon bears on the bearing surface of the lateral wall of the casing when the gastric balloon passes from the deflated state to the inflated state. 
     According to a variant, the gastric balloon automatically exits the casing via the lateral opening when the gastric balloon passes from the deflated state to the inflated state. 
     According to a variant, the casing of the placement device is inserted via the insertion end into a natural tract of the body of the individual. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Further features, details and advantages will become apparent from reading the following detailed description and from studying the attached drawings, in which: 
         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; 
         FIG.  2    shows the placement device of the system for treating obesity of  FIG.  1   ; 
         FIG.  3    shows the gastric balloon of the system for treating obesity of  FIG.  1   , in the deflated state; 
         FIG.  4    shows the gastric balloon of the system for treating obesity of  FIG.  1    in the inflated state; 
         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; 
         FIG.  6    shows an enlarged view of the region referenced VI in the system for treating obesity of  FIG.  1   ; 
         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; 
         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 
     In the figures, the same references refer to elements that are identical or analogous. 
       FIG.  1    depicts a system  40  for treating obesity in an individual, comprising a placement device  10  and an inflatable gastric balloon  30 . 
     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. 
     The gastric balloon  30  is made of silicone. Alternatively, it could be made of any other elastically deformable and biocompatible material. 
     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. 
     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. 
     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. 
     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 . 
     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. 
     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. 
     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. 
     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 . 
     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. 
     The cavity  12  of the casing  11  has a length L 12  considered along the longitudinal axis L and a width I 12  considered perpendicular to the longitudinal axis. The length L 12  of the cavity  12  of the casing  11  is considered from the connection end  14  as far as the insertion end  15 . 
     The lateral opening  16  has a length L 16  considered along the longitudinal axis L and a width I 16  considered perpendicular to the longitudinal axis L. The length L 16  of the lateral opening is considered from a vertex S 1  of one of the arcs of a circle joining the ends of the two parallel sides of the lateral opening  16  to a vertex S 2  of the other arc of a circle joining the ends of the two parallel sides of the lateral opening  16 . 
     The vertex S 2  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 . 
     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. 
     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 . 
     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. 
     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 . 
     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. 
     By way of illustration, in one nonlimiting particular example, the treatment system is employed with the following dimensions. 
     A ratio of the diameter D of the gastric balloon  30  to the length L 12  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 I 12  of the cavity  12  of the casing  11  may be comprised between 3.2 and 6.7. A ratio of the length L 16  of the lateral opening  16  of the casing  11  to the length L 12  of the cavity  12  of the casing  11  may be comprised between 0.17 and 0.67. A ratio of the width I 16  of the lateral opening  16  of the casing  11  to the width I 12  of the cavity of the casing could be comprised between 0.24 and 0.67. 
     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 L 12  of the cavity  12  of the casing  11  may be comprised between 12 cm and 18 cm, and the width I 12  of the cavity  12  of the casing  11  may be comprised between 1.5 cm and 2.5 cm. 
     Further, the length L 16  of the lateral opening  16  may be comprised between 3 cm and 8 cm, and the width I 16  of the lateral opening  16  may be comprised between 0.6 cm and 1.0 cm. 
     In one exemplary embodiment, the ratio of the diameter D of the gastric balloon  30  to the length L 12  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 I 12  of the cavity  12  of the casing  11  is equal to 4.5. The ratio of the length L 16  of the lateral opening  16  of the casing  11  to the length L 12  of the cavity  12  of the casing  11  is equal to 0.3. The ratio of the width I 16  of the lateral opening of the casing  11  to the width I 12  of the cavity of the casing is equal to 0.4. 
     In one exemplary embodiment, the diameter D of the gastric balloon  30  is equal to 9 cm. The length L 12  of the cavity  12  of the casing  11  is equal to 15 cm and the width I 12  of the cavity  12  of the casing  11  is equal to 2 cm. The length L 16  of the lateral opening  16  is equal to 4.5 cm and the width I 16  of the lateral opening  16  is equal to 0.8 cm. 
     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 . 
     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 . 
     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 . 
     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. 
     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 . 
     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. 
     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 . 
     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 S 2  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. 
     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. 
     The placement device  10  is then withdrawn from the oesophagus and from the mouth of the individual.