Apparatus and method for intragastric balloon with in situ adjustment means
View Patent ↗An intragastric balloon and method of adding and/or removing fluid therefrom are disclosed. The intragastric balloon includes a shell, a grasping tab, and a self-sealing portion. A gastroscopic instrument which includes a grasping tool is inserted into the stomach of a patient and used to grasp the grasping tab located on the surface of the shell. Using the grasping tool, the intragastric balloon is securely fastened to the gastroscopic instrument. A filling instrument, such as a needle, is advanced through the self-sealing portion of the shell for the filling or deflating of the intragastric balloon. After inflation or deflation is complete, the filling instrument is then withdrawn from the balloon and the gastroscopic instrument withdrawn from the stomach.
1. An inflatable intragastric balloon, comprising:
an acid resistant shell having an outer surface and defining a fillable cavity for containing a volume of fluid; and
a grasping tab/valve assembly coupled to the acid resistant shell, the grasping tab/valve assembly comprising:
a valve for adjusting the volume of fluid of the inflatable intragastric balloon in situ; and
a grasping tab in which the valve is received, the grasping tab including:
a distal flange surrounding the valve and extending outward from the valve, and surrounding a hole for a needle to pass through in order to pass through the valve, the distal flange having a proximal surface having a first edge at a first diameter and a distal surface having a second edge at a second diameter less than the first diameter, and wherein the distal flange has a convex circumferential surface that extends between the first edge and the second edge;
a graspable button ridge having a diameter that is less than the first diameter of the distal flange;
a proximal flange positioned such that the graspable button ridge is positioned between the proximal flange and the distal flange, and extending outward from the graspable button ridge to form a diameter that is greater than the first and second diameters of the distal flange and greater than the diameter of the graspable button ridge, and being spaced apart from the distal flange and inseparably connected to the distal flange and having a proximal surface oppositely facing the outer surface of the acid resistant shell; and
a depending portion extending, at a first end at the proximal surface of the proximal flange to a second end axially spaced from the first end, the depending portion having a larger diameter at the first end than at the second end, the depending portion extending into and connected to the acid resistant shell,
wherein the depending portion is defined by a concave sidewall surface between its first and second ends, and wherein the concave sidewall surface is concave when the valve is received in the grasping tab and when the valve is closed.
2. The intragastric balloon of claim 1 , wherein said valve is a septum.
3. The intragastric balloon of claim 1 , wherein said valve is a slit valve.
4. The intragastric balloon of claim 1 , wherein said shell comprises at least one of diphenyl silicone, PTFE, silicone-polyurethane elastomer, HDPE, LDPE or parylene.
5. The intragastric balloon of claim 1 wherein the valve comprises a self-sealing septum.
6. The intragastric balloon of claim 1 wherein the valve comprises a silicone disc.
7. The intragastric balloon of claim 1 wherein the valve comprises a compressed silicone disc.
8. The intragastric balloon of claim 1 wherein the depending portion is located in an interior space of the Tillable cavity.
9. The inflatable intragastric balloon of claim 1 , wherein the proximal flange has a distal surface opposite the proximal surface, the distal surface having a flat shape.
10. The inflatable intragastric balloon of claim 9 , wherein the distal flange has a proximal surface with a flat shape that faces and extends parallel to the distal surface of the proximal flange.
11. The inflatable intragastric balloon of claim 10 , wherein the graspable button ridge extends away from the proximal flange in a direction, the distal surface of the proximal flange and the proximal surface of the distal flange both extending in a direction that is perpendicular to the direction of the graspable button ridge.
12. The inflatable intragastric balloon of claim 1 , wherein an outer edge of the distal flange has a circular shape that surrounds the valve.
13. The inflatable intragastric balloon of claim 1 , wherein an outer edge of the proximal flange has a circular shape.
14. The inflatable intragastric balloon of claim 1 , wherein the hole has a circular shape.
15. The inflatable intragastric balloon of claim 1 , wherein the diameter of the proximal flange is larger than the diameter of the first end of the depending portion.
16. The inflatable intragastric balloon of claim 1 , wherein the depending portion is defined by a depending surface between the first end at the proximal surface of the proximal flange and the second end, wherein a portion of the depending surface that extends at least from the first end is continuously tapered.
17. The inflatable intragastric balloon of claim 16 , wherein the taper of the portion of the depending surface is concave and wherein the acid resistant shell contacts the concave surface.
18. An inflatable intragastric balloon, comprising:
an acid resistant shell having an outer surface and defining a fillable cavity for containing a volume of fluid;
a grasping tab/valve assembly coupled to the acid resistant shell, the grasping tab/valve assembly comprising:
a valve for enabling adjustment of the volume of fluid of the inflatable intragastric balloon in situ; and
a grasping tab in which the valve is received, the grasping tab including:
a distal flange surrounding the valve and extending outward from the valve, and surrounding a hole for a needle to pass through in order to pass through the valve, the distal flange having a proximal surface having a first diameter and a distal surface having a second diameter smaller than the first diameter;
a graspable button ridge having a diameter that is less than the first diameter of the distal flange;
a proximal flange positioned such that the graspable button ridge is positioned between the proximal flange and the distal flange, and extending outward from the graspable button ridge to form a diameter that is greater than the first and second diameters of the distal flange and greater than the diameter of the graspable button ridge, and being spaced apart from the distal flange and inseparably connected to the distal flange and having a proximal surface oppositely facing the outer surface of the acid resistant shell; and
a depending portion extending, at a first end at the proximal surface of the proximal flange to a second end axially spaced from the first end, the depending portion having a larger diameter at the first end than at the second end,
wherein the depending portion is defined by a depending sidewall surface between the first end at the proximal surface and the second end, and a portion of the depending surface extending from the first end is concave, and
wherein the acid resistant shell is attached to the concave portion of the depending surface, and
wherein the concave surface is concave when the valve is received in the grasping tab and when the valve is closed.
19. The inflatable intragastric balloon of claim 18 wherein the valve is a septum.
20. The inflatable intragastric balloon of claim 18 wherein the valve comprises a self-sealing septum.
21. The inflatable intragastric balloon of claim 18 wherein said valve is a slit valve.
22. The valve assembly of claim 18 wherein the valve comprises a silicone disc.
23. The valve assembly of claim 18 wherein the valve comprises a compressed silicone disc.