Intragastric device

• US 7,854,745 B2
• Filed: 02/19/2010
• Issued: 12/21/2010
• Est. Priority Date: 10/16/2008
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: VandenBerg, Amy D. L., Markovic, Dubravka, Llevares, Antonio C., Brister, Mark C., Drake, Neil R., Patel, Kaushik A., Quintana, Nelson, Rasdal, Andrew P.
• Primary Examiner(s): TRUONG, KEVIN THAO
• Application Number:
  US12/709,344
• Publication Number:
  US 20100137897A1
• Time in Patent Office: 305 Days
• Field of Search: 606/1, 606/151, 606/153, 606/192, 606/196, 606/197, 606/199, 604/270, 604/506, 604/539, 604/890.1, 128/898, 206/522, 424/453, 446/186, 446/213, 446/224
• US Class Current: 606/196
• 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

An implant configured for ingestion by a patient. After the implant has been swallowed by the patient and is disposed within the target location, e.g. the patient'"'"'s stomach, an inflation subcomponent causes the implant to expand from a compact delivery state to an expanded, volume-occupying, deployed state. In the deployed state the implant creates a sensation of satiety in the patient stomach and thereby aids in limiting food intake and obesity. After a predetermined time a deflation subcomponent is actuated and the implant reduces in size so as to allow it to pass through the remainder of the patient'"'"'s digestive track. The device may further incorporate tracking and visualization subcomponents, as well as pharmaceutical delivery subcomponents.

Claims

1. A swallowable, self-inflating, intragastric balloon system comprising:

a balloon comprising a valve system, wherein the valve system is self-sealing, attached to a 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 radio-opaque continuous ring, wherein the septum has a durometer of about 20 Shore A to about 60 Shore D, wherein the retaining structure has a durometer of from about 40 Shore D to about 70 Shore D, wherein the durometer of the septum is less than the durometer of the retaining structure, wherein the continuous ring is configured to exert a compressive force on the septum, wherein the balloon is fully sealed with no external opening or orifice to the central lumen, 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, an internal nominal pressure at about 37°

C. of from about 0 Pa to about 103421 Pa, a nominal radius of from about 2.5 cm to about 7.6 cm, and a nominal height of from about 0.6 cm to about 7.6 cm;

an inner container, the inner container comprising gelatin and situated 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 the inflation agent comprises citric acid and sodium bicarbonate, wherein from about 10 wt. % to about 80 wt. % of a total amount of the inflation agent is citric acid, wherein the inner container has a longest dimension of from about 1.9 cm to 2.7 cm, a width of from about 0.6 cm to about 1 cm, and a volume of from about 0.41 ml to about 1.37 ml;

an inoculation spacer, wherein the inoculation spacer situated in the central lumen of the balloon and adjacent to the septum, wherein the inoculation spacer is in a form of a tube or a cylinder;

and an outer container, wherein the outer container is configured to be swallowed by a patient without assistance, the outer container comprising a gelatin material, wherein the outer container has a longest dimension of from about 2.4 cm to 6.3 cm, a width of from about 0.9 cm to about 2.4 cm, and a volume of from about 1.2 ml to about 8.25 ml, and wherein the balloon is situated in the outer container in a deflated and compacted state, wherein folds of the balloon in the deflated and compacted state are configured to localize an activation agent adjacent to the inner container upon injection of the activation agent into the central lumen of the balloon.

2. The system of claim 1, further comprising an activation agent comprising citric acid, wherein the activation agent is an aqueous solution of up to about 50% citric acid, wherein the activation agent is configured for injection into the central lumen of the balloon, and wherein a total amount of citric acid in the inflation agent and the activation agent combined creates a pH of about 6 or less in a residual liquid remaining after completion of a CO₂ generating reaction of the inflation agent.

3. The system of claim 1, wherein walls of the balloon in the deflated and compacted state are configured to form a pocket around the inner container, wherein the pocket is configured to contain an activation agent injected through the self-sealing valve system in an area of less than 10% of an entire balloon surface area.

4. The system of claim 1, further comprising a void space configured for occupation by the activation agent upon injection of the activation agent into the central lumen of the balloon, wherein a volume of the void space is from about 0.3 ml to about 4.5 ml.

5. A method for fabricating a swallowable, self-inflating, smooth surfaced intragastric balloon, the method comprising:

adhering a valve system to a first half of a wall of a balloon, wherein the valve system is a self-sealing valve system, by an adhesive, wherein the adhesive has a shear force greater than about 40 N, wherein the self-sealing valve system comprises a septum, a retaining structure, and a radio-opaque continuous ring, wherein the septum has a durometer of about 20 Shore A to about 60 Shore D, wherein the retaining structure has a durometer of from about 40 Shore D to about 70 Shore D, wherein the durometer of the septum is less than the durometer of the retaining structure, wherein the continuous ring is configured to exert a compressive force on the septum;

joining the first half of the wall of the balloon to a second half of the wall of the balloon by heat welding or adhesively bonding the two halves together, wherein the first half of the wall of the balloon or the second half of the wall of the balloon 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;

inverting the balloon through the hole such that the self-sealing valve system is situated in a central lumen of the inverted balloon;

placing an inner container within the central lumen of the inverted balloon, the inner container containing from about 0.28 grams to about 4 grams of an inflation agent, wherein the inflation agent comprises citric acid and sodium bicarbonate, wherein from about 10 wt. % to about 80 wt. % of a total amount of the inflation agent is citric acid;

placing an inoculation spacer in the central lumen of the balloon, wherein the inoculation spacer is in a form of a tube or a cylinder;

deflating the balloon such that the balloon is flat, with an inverted seam extending around the perimeter of the balloon, wherein the self-sealing valve is placed ½

r±

¼

r from a center of the first half of the wall of the balloon, wherein r is a radius of the first half of the wall of the balloon along a line extending from the center of the first half of the wall of the balloon through the septum;

applying a patch of a material to seal the hole;

positioning the inoculation spacer adjacent to the septum, and vertically aligning the inner container with the self-sealing valve system such that the septum and inoculation spacer are situated directly above a tip of the inner container;

folding a top approximate ¼

of the wall of the deflated balloon over the inner container;

forming pleats in the wall of the deflated balloon adjacent to the inner container;

accordioning a bottom approximate ¾

of the wall of the deflated balloon using no more than 2 creases and folding the accordioned bottom of the wall of the deflated balloon over the inner container so as to form a wing on a first side of the inner container and a wing on a second side of the inner container;

folding the wing on the first side of the inner container over the wing on the second side of the inner container such that the wings touch;

rolling the wings around the inner container, whereby a folded and compacted balloon is obtained, wherein the balloon has a weight of less than about 15 g, wherein the balloon is configured 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.

6. The method of claim 5, wherein the walls of the folded and compacted balloon form a pocket around the inner container which is configured to contain a liquid injected through the self-sealing valve system in an area of less than 10% of an entire balloon surface area.

7. A method for inflating a swallowable self-inflating intragastric balloon, comprising:

providing a balloon system, the system comprising;

a self-inflating intragastric balloon comprising a valve system, wherein the valve system is a self-sealing valve system, and wherein the valve system is attached to a wall of the balloon in a central lumen of the balloon by an adhesive with a shear force greater than about 40 N, the valve system comprising a septum, a retaining structure, and a radio-opaque continuous ring, wherein the septum has a durometer of about 20 Shore A to about 60 Shore D, wherein the retaining structure has a durometer of from about 40 Shore D to about 70 Shore D, wherein the durometer of the septum is less than the durometer of the retaining structure, wherein the continuous ring is configured to exert a compressive force on the septum, wherein the balloon is fully sealed with no external opening or orifice to the central lumen, 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 an occupyable volume of from about 90 cm³ to about 350 cm³ upon full inflation;

an inner container within the central lumen of the balloon, the inner container comprising gelatin and containing from about 0.28 grams to about 4 grams of an inflation agent, wherein the inflation agent comprises sodium bicarbonate and citric acid;

and wherein from about 10 wt. % to about 80 wt. % of a total amount of the inflation agent is citric acid;

an inoculation spacer situated in the central lumen of the balloon adjacent to the septum, wherein the inoculation spacer is in a form of a tube or a cylinder;

and an outer container, wherein the outer container is configured to be swallowed by a patient without assistance, the outer container comprising a gelatin material, wherein the balloon is situated in the outer container in a deflated and compacted state, wherein walls of the balloon in the deflated and compacted state are configured to form a pocket around the inner container;

thereafter injecting an activation agent into the central lumen of the balloon through the wall of the balloon atop the septum and through the septum itself using the inoculation spacer as a guide, wherein the activation agent is substantially localized in the pocket, whereby degradation of the inner container by the activation agent is initiated, the activation agent comprising an aqueous solution of up to about 50% citric acid;

thereafter allowing the system to be swallowed, via normal peristalsis, by a patient in need thereof;

thereafter degrading the outer container in a stomach of the patient;

initiating inflation by contact and reaction of the activation agent with the inflation agent via degradation of the inner container, wherein inflation is initiated no earlier than about 30 seconds after injection of the activation agent;

and unfolding the balloon via inflation from about 60 seconds to about 15 minutes after injection of the activation agent, wherein the balloon is compacted so as to unfold upon inflation in a manner that creates a surface area sufficiently large so as to prohibit the balloon from passing through the pyloric sphincter, wherein at least about 10% of the occupyable volume of the balloon is filled within about 30 minutes, at least about 60% of the occupyable volume of the balloon is filled within about 12 hours, and at least about 90% of the occupyable volume of the balloon is filled within about 24 hours, wherein a pH of a remnant liquid inside the central lumen of the balloon after completion of the reaction of the inflation agent and the activation agent is acidic such that any balloon leakage or breach that allows stomach acid to enter the balloon does not initiate re-inflation of the balloon.

8. The method of claim 7, wherein the pocket contains the activation agent upon injection in an area of less than 10% of an entire balloon surface area.