Intragastric volume-occupying device and method for fabricating same
Intragastric volume-occupying devices and methods for treating obesity are provided. The devices, which are inflated by carbon dioxide, include an aluminum or silicon oxide barrier layer providing carbon dioxide retention and an alkylene vinyl alcohol polymer layer providing structural integrity in vivo.
1. An intragastric balloon system comprising:
a) an intragastric balloon in a compacted state in an outer capsule, wherein the intragastric balloon is configured to traverse the alimentary canal, the intragastric balloon comprising
i) a polymeric film defining a central lumen and configured to maintain a CO 2 leak rate of less than or equal to 40 cc/m 2 /day at 37° C. wherein the polymeric film is configured such that its CO 2 barrier properties and mechanical strength are not substantially affected by exposure to pH or humidity levels within the gastric environment or within the central lumen,
ii) a self-sealing valve attached to an inner surface of the polymeric film such that a shear force of greater than 40 N is required to dislodge the self-sealing valve, wherein the self sealing valve is configured for inflation of the intragastric balloon by injection of a liquid inflation agent into the central lumen, and
iii) a deflation subcomponent configured to self-deflate the intragastric balloon after a period of time has lapsed since deployment of the intragastric balloon in the patient's stomach, wherein the deflation component comprises a material that dissolves over time; and
b) a delivery tool adapted to deliver the intragastric balloon into the mouth, through the esophagus, and into the stomach, the delivery tool engaging the self-sealing valve and configured for injecting the liquid inflation agent into the central lumen of the intragastric balloon, wherein the delivery tool comprises a plunger, a reservoir adapted to contain the liquid inflation agent, and an injection needle, wherein the plunger is adapted to, when pushed and either in sequence or approximately simultaneously, force the injection needle into the device and inject the liquid inflation agent contained in reservoir into the central lumen of the intragastric balloon, and wherein the plunger is adapted to, upon subsequent application of a force to the plunger, push the intragastric balloon out of the delivery tool.
2. The intragastric balloon system of claim 1 , wherein the delivery tool is configured to push the intragastric balloon into a desired location within a patient.
3. The intragastric balloon system of claim 2 , wherein the delivery tool is configured for the application of a force so as to push the intragastric balloon into the desired location within the patient.
4. The intragastric balloon system of claim 1 , wherein the deflation subcomponent comprises an outer portion held together by a faster degrading centerpiece.
5. The intragastric balloon system of claim 1 , wherein the deflation subcomponent comprises a slower degrading outer half and a faster degrading inner half.
6. The intragastric balloon system of claim 5 , wherein the deflation subcomponent comprises an inner portion partially held together by a water soluble adhesive configured to, in vivo and upon degradation of the outer half of the deflation subcomponent, come in contact with contents of the stomach, resulting in accelerated disintegration of the inner portion of the deflation subcomponent.
7. The intragastric balloon system of claim 5 , comprising a plurality of deflation subcomponents.
8. The intragastric balloon system of claim 7 , wherein the deflation subcomponent comprises a tension element.
9. The intragastric balloon system of claim 7 , wherein the tension element is selected from the group consisting of a spring, a degradable link, and one or more plugs.
10. The intragastric balloon system of claim 1 , wherein the deflation subcomponent comprises a material configured to degrade upon contact with the liquid inflation agent.
11. The intragastric balloon system of claim 1 , wherein the liquid inflation agent comprises water or saline.
12. The intragastric balloon system of claim 1 , wherein the polymeric film comprises a polyethylene terephthalate layer.
13. The intragastric balloon system of claim 1 , wherein the polymeric film comprises at least two layers, wherein at least one of the layers comprises a polyethylene layer.
14. The intragastric balloon system of claim 1 , wherein the polymeric film comprises at least two layers, wherein at least one of the layers comprises an ethylene vinyl alcohol layer.
15. The intragastric balloon system of claim 14 wherein the ethylene vinyl alcohol layer is co-extruded with a layer of polyethylene.
16. The intragastric balloon system of claim 1 , wherein the intragastric balloon is configured to be swallowable by normal peristalsis.
17. The intragastric balloon system of claim 1 , wherein the intragastric balloon is configured to be swallowable and self-inflating.
18. The intragastric balloon system of claim 1 , further comprising an inner container within the central lumen of the intragastric balloon, the inner container containing from about 0.28 grams to about 4 grams of an inflation agent, wherein up to about 80 wt. % of a total amount of the inflation agent is powdered citric acid, with a remainder of the inflation agent comprising powdered sodium bicarbonate.