INTRAGASTRIC VOLUME-OCCUPYING DEVICE AND METHOD FOR FABRICATING SAME

• US 20100100116A1
• Filed: 10/15/2009
• Published: 04/22/2010
• Est. Priority Date: 10/16/2008
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Markovic, Dubravka, Llevares, Antonio C., Brister, Mark C., VandenBerg, Amy D.L., Drake, Neil R., Patel, Kaushik A., Quintana, Nelson, Rasdal, Andrew P.
• Granted Patent: US 9,072,583 B2
• Time in Patent Office: Days
• US Class Current: 606/192
• CPC Class Codes: A61B 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12099 characterised by the location of the occluder
• CPC Class Codes: A61B 2090/3966 Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0073 in the abdominal cavity, e.g. not attached to the stomach
• CPC Class Codes: A61F 5/0083 Reducing the size of the stomach, e.g. gastroplasty surgical interventions A61B17/00
• CPC Class Codes: A61L 2400/16 Materials with shape-memory or superelastic properties
• CPC Class Codes: A61L 2420/02 Methods for coating medical devices
• CPC Class Codes: A61L 2420/08 Coatings comprising two or more layers
• CPC Class Codes: A61L 31/088 Other specific inorganic materials not covered by A61L31/084 or A61L31/086
• CPC Class Codes: A61L 31/10 Macromolecular materials
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/105 having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
• CPC Class Codes: A61M 25/10185 Valves
• CPC Class Codes: A61M 25/1027 Making of balloon catheters
• CPC Class Codes: A61M 25/1029 Production methods of the balloon members, e.g. blow-moulding, extruding, deposition or by wrapping a plurality of layers of balloon material around a mandril
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: Y10T 156/1051 by folding

Abstract

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.

Claims

1. An intragastric balloon system comprising a composite wall structure configured to maintain a CO₂ leak rate of less than or equal to 40 cc/m²/day at 37°

C., wherein the composite wall structure comprises;

a supporting film structure having a Young'"'"'s Modulus of 500 Mpa or greater;

a first CO₂ barrier layer configured such that its CO₂ barrier properties are not substantially affected by exposure to humidity levels within the gastric environment or within a central lumen of the balloon; and

a second CO₂ barrier layer configured such that its CO₂ barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures.

2. The intragastric balloon system of claim 1, wherein the first CO₂ barrier layer comprises a silicon dioxide layer having a thickness of from about 100 Å

to about 800 Å

.

3. The intragastric balloon system of claim 1, wherein the second CO₂ barrier layer comprises an ethylene vinyl alcohol layer having a thickness of at least about 2 microns.

4. The intragastric balloon system of claim 1, wherein the first CO₂ barrier layer comprises a silicon dioxide layer having a thickness of from about 100 Å

to about 800 Å and

the second CO₂ barrier layer comprises an ethylene vinyl alcohol layer having a thickness of at least about 2 microns.

5. The intragastric balloon system of claim 4, wherein the supporting film structure comprises a polyethylene terephthalate layer.

6. The intragastric balloon system of claim 5, wherein the silicon dioxide layer is provided as a coating on one side of the polyethylene terephthalate layer.

7. The intragastric balloon system of claim 6, wherein the ethylene vinyl alcohol layer is situated between two polyethylene layers, wherein the ethylene vinyl alcohol layer and the two polyethylene layers are bonded together with tie layers, and wherein the silicon dioxide layer is adhesively bonded to one of the polyethylene layers.

8. The intragastric balloon system of claim 4, wherein the ethylene vinyl alcohol layer is extruded.

9. The intragastric balloon system of claim 8, wherein the ethylene vinyl alcohol layer is co-extruded with one or more layers of polyethylene.

10. The intragastric balloon system of claim 8, wherein the ethylene vinyl alcohol layer is sandwiched between two polyethylene layers.

11. The intragastric balloon system of claim 4, wherein the intragastric balloon system is configured to be swallowable.

12. The intragastric balloon system of claim 4, wherein the intragastric balloon system is configured to be self-inflating.

13. The intragastric balloon system of claim 4, wherein the intragastric balloon system is configured to be swallowable and self-inflating.

14. The intragastric balloon system of claim 13, further comprising a self-sealing valve system attached to the composite wall of the balloon in a central lumen of the balloon by an adhesive with a shear force greater than about 40 N, the self-sealing valve system comprising a septum, a retaining structure, and a continuous ring, wherein the septum has a durometer that is less than a durometer of the retaining structure, wherein the continuous ring is configured to exert a compressive force on the septum, wherein the balloon has a weight of less than about 15 g, wherein the balloon is configured to have a shape upon full inflation selected from the group consisting of ellipsoid, spheroid, and oblate spheroid, and wherein the balloon is configured to have a volume of from about 90 cm³ to about 350 cm³ upon full inflation.

15. The intragastric balloon system of claim 14, further comprising an inner container within the central lumen of the 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.

16. A method for fabricating a composite wall for use in an intragastric balloon system, comprising:

providing a polyethylene terephthalate layer coated with a silicon dioxide layer having a thickness of from about 100 Å

to about 800 Å

;

providing a trilayer system comprising ethylene vinyl alcohol layer sandwiched between polyethylene layers; and

adhesively bonding the silicon dioxide layer to one of the polyethylene layers, whereby a composite wall structure configured to maintain a CO₂ leak rate of less than or equal to 40 cc/m²/day at 37°

C. is obtained.

17. The method of claim 16, wherein a thickness of the composite wall structure is 2.5 mil or less.

18. The method of claim 16, wherein the ethylene vinyl alcohol layer is bonded to the polyethylene layers via tie layers.

19. The method of claim 16, further comprising:

forming the composite wall into two components, each component having a same shape selected from the group consisting of elliptical, circular, and oval, wherein one of the components further comprises a hole having a smallest dimension of at least about 0.6 cm, and a largest dimension of no more than about 3.8 cm;

bonding the components together to form a wall of a balloon;

inverting the wall of the balloon through the hole; and

applying a patch of a material to seal the hole, whereby a balloon having a smooth outer surface is obtained, wherein the balloon is configured to have a volume of from about 90 cm³ to about 350 cm³ upon full inflation.

20. The method of claim 19, further comprising, before bonding, adhering a self-sealing valve system to one of the components by an adhesive with a shear force greater than about 40 N, the self-sealing valve system comprising a septum, a retaining structure, and a continuous ring, wherein the septum has a durometer that is less than a durometer of the retaining structure, wherein the continuous ring is configured to exert a compressive force on the septum.

21. The method of claim 20, further comprising, after inverting and before applying a patch, a step of placing an inner container within the inverted 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, wherein the balloon has a weight of less than about 15 g.