Intragastric volume-occupying device and method for fabricating same

• US 9,072,583 B2
• Filed: 10/15/2009
• Issued: 07/07/2015
• Est. Priority Date: 10/16/2008
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Brister, Mark C., Patel, Kaushik A., Rasdal, Andrew P., Quintana, Nelson, Drake, Neil R., Llevares, Antonio C., Markovic, Dubravka, VandenBerg, Amy D. L.
• Primary Examiner(s): Dowe, Katherine
• Assistant Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US12/580,044
• Publication Number:
  US 20100100116A1
• Time in Patent Office: 2,091 Days
• Field of Search: 606/1, 606/151, 606/153, 606/192, 606/196, 606/197, 606/199, 128/898, 604/270, 604/506, 604/539, 604/890.1, 206/522, 424/453, 446/186, 446/213, 446/224, 623/2.17, 623/2.18, 623/1.26
• US Class Current: 1/1
• 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 volume occupying subcomponent and a deflation subcomponent, wherein the deflation subcomponent is configured to deflate the intragastric balloon system after a preselected period of time has lapsed since deployment of the system in vivo, wherein the deflation subcomponent comprises a biodegradable or dissolvable head that is configured to, upon degradation, allow fluid to escape from the volume-occupying subcomponent, wherein a first portion of the head is configured to degrade faster than a second portion of the head, wherein the first portion of the head is configured to stabilize the second portion of the head such that, in vivo, when the first portion of the head degrades, the second portion of the head destabilizes and is released from the head, thereby accelerating a process of deflation of the volume occupying subcomponent, wherein the volume occupying subcomponent comprises a composite wall configured to maintain a CO₂ leak rate of less than or equal to 40 cc/m²/day at 37°

C., wherein the composite wall comprises multiple layers of materials, the multiple layers of materials including;

a polyethylene outer supporting layer having a Young'"'"'s Modulus of 500 Mpa or greater and configured to be proximal to the gastric environment or the central lumen of the balloon;

an ethylene vinyl alcohol inner CO₂ barrier layer configured to not be directly exposed to the gastric environment or a central lumen of the balloon, 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;

a nylon inner CO₂ barrier layer configured to not be directly exposed to the gastric environment or a central lumen of the balloon, such that its CO₂ barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures; and

an outer layer on an opposite side of the composite wall from the polyethylene outer supporting layer,

wherein the intragastric balloon system is configured to retain more than 75% of an original nominal volume in the gastric environment for at least 25 days.

2. The intragastric balloon system of claim 1, wherein the ethylene vinyl alcohol inner CO₂ barrier layer has a thickness of at least about 2 microns.

3. The intragastric balloon system of claim 1, wherein the ethylene vinyl alcohol inner CO₂ barrier layer is situated between two polyethylene layers, and wherein the ethylene vinyl alcohol inner CO₂ barrier layer and the two polyethylene layers are bonded together with tie layers.

4. The intragastric balloon system of claim 1, wherein the intragastric balloon system is configured to be swallowable, the system 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.

5. The intragastric balloon system of claim 1, wherein the head comprises an outer portion held together by a faster degrading centerpiece.

6. The intragastric balloon system of claim 1, wherein the head comprises a slower degrading outer half and faster degrading inner half.

7. The intragastric balloon system of claim 1, wherein the head 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 head, come in contact with contents of the stomach, resulting in accelerated disintegration of the inner portion of the head.

8. The intragastric balloon system of claim 1, comprising a plurality of heads.

9. The intragastric balloon system of claim 1, wherein the head contains materials configured to be degraded by enzymes that are normally present in a stomach.

10. The intragastric balloon system of claim 9, wherein the head contains materials configured to be degraded by pepsin or other proteases.

11. The intragastric balloon system of claim 1, wherein the head incorporates a tension element.

12. The intragastric balloon system of claim 11, wherein the tension element is selected from the group consisting of a spring, a degradable link, and one or more plugs.

13. The intragastric balloon system of claim 1, wherein the deflation subcomponent comprises a material configured to degrade upon contact with a substance ingested by a patient.

14. The intragastric balloon system of claim 13, wherein the material forms a portion of the volume-occupying subcomponent or a sealing element incorporated within the volume-occupying subcomponent.

15. The intragastric balloon system of claim 14, wherein the material is a polymer that is degraded by one or more preselected enzymes or bacteria, wherein the substance is the one or more preselected enzymes or bacteria.

16. The intragastric balloon system of claim 1, wherein the volume-occupying subcomponent incorporates an elastomeric material that forms a sheath or wall configured to apply a contracting force on the volume-occupying subcomponent and facilitate deflation once the volume-occupying subcomponent has been breached.

17. The intragastric balloon system of claim 16, wherein the contracting force applied by sheath or wall is applied primarily along a longitudinal axis such that the deflated volume-occupying subcomponent has a first dimension that is greater than a second dimension.

18. The intragastric balloon system of claim 1, wherein the deflation component comprises a duct valve or other type of valve configured to allow fluid to exit the volume-occupying subcomponent upon initiation of deflation but that permits little or no fluid to enter or flow back into the volume-occupying subcomponent.

19. An intragastric balloon system comprising a volume occupying subcomponent and a deflation subcomponent, wherein the deflation subcomponent is configured to deflate the intragastric balloon system after a preselected period of time has lapsed since deployment of the system in vivo, wherein the deflation subcomponent comprises a biodegradable or dissolvable head that is configured to, upon degradation, allow fluid to escape from the volume-occupying subcomponent, wherein a first portion of the head is configured to degrade faster than a second portion of the head, wherein the head incorporates a tension element comprising a plug, wherein a degradable link is configured to secure the tension element around the plug such that, upon degradation of the degradable link, the tension element releases all or part of the plug from the head, thereby allowing for the escape of fluid from the volume-occupying subcomponent, wherein the volume occupying subcomponent comprises a composite wall configured to maintain a CO₂ leak rate of less than or equal to 40 cc/m²/day at 37°

C., wherein the composite wall comprises multiple layers of materials, the multiple layers of materials including;

a polyethylene outer supporting Young'"'"'s Modulus of 500 Mpa or greater and configured to be proximal to the gastric environment or the central lumen of the balloon;

an ethylene vinyl alcohol inner CO₂ barrier layer configured to not be directly exposed to the gastric environment or a central lumen of the balloon, 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;

a nylon inner CO₂ barrier layer configured to not be directly exposed to the gastric environment or a central lumen of the balloon, such that its CO₂ barrier properties are not substantially affected by mechanical forces during processing, compacting, or application of external gastric pressures; and

an outer layer on an opposite side of the composite wall from the polyethylene outer supporting layer,

wherein the intragastric balloon system is configured to retain more than 75% of an original nominal volume in the gastric environment for at least 25 days.