Self-inflating intragastric volume-occupying device

• US 6,981,980 B2
• Filed: 03/19/2003
• Issued: 01/03/2006
• Est. Priority Date: 03/19/2003
• Status: Expired due to Term

• Current Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Original Assignee: Phagia-Gel Technologies LLC
• Inventors: Sampson, Douglas C., Zanakis, Michael
• Primary Examiner(s): THALER, MICHAEL H
• Application Number:
  US10/390,902
• Publication Number:
  US 20040186502A1
• Time in Patent Office: 1,021 Days
• Field of Search: 606/192, 606/195, 604/97.01
• US Class Current: 606/192
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61M 2205/8225 using incorporated gas cartridges for the driving gas
• CPC Class Codes: A61M 2210/1053 Stomach
• CPC Class Codes: A61M 25/10 Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A self-inflating, intragastric balloon device is activated by addition of an activating liquid into an acid or water soluble vessel located within the balloon. After an approximately pre-determined time period post-activation, the activating liquid breaches the vessel wall and causes contact between an acid in liquid form and an emissive substance within the balloon, causing it to inflate. The device is conveniently provided to medical personnel as part of a kit that further contains a syringe and the activating liquid. The device also can have acid or pepsin degradable portions that cause it to deflate after residing in the stomach for a prolonged period of time during which it imparts a feeling of satiety in the patient.

Claims

1. A self-inflating intragastric medical device comprising:

1) an uninflated, ingestible, substantially liquid-impermeable balloon having an exterior surface and an interior surface, the interior surface bounding a lumen;

2) an emissive substance enclosed within the balloon, wherein the emissive substance is a substance that liberates gas when contacted with a reactants;

3) a vessel enclosed within the balloon and enclosing a space within the balloon separate from the lumen, wherein at least a portion of the vessel is fabricated of a gelatin that is soluble in at least one liquid selected from the group consisting of;

1. water,

2. organic acids that are liquid at room temperature, and

3. solutions of mineral or organic acids;

and wherein the vessel comprises a receptacle fabricated of the gelatin and having a mouth, further wherein the receptacle is attached at the mouth to a septum by a liquid-impermeable seal; and

4) a self-sealing valve providing fluid communication into the vessel from outside the balloon, wherein the self-sealing valve is the septum.

2. The self-inflating intragastric device of claim 1 wherein the receptacle is attached to the septum by an adhesive.

3. The self-inflating intragastric device of claim 1 wherein the balloon comprises a bladder formed of non-self-sealing material having an opening, further wherein the opening is closed to passage of a liquid by the self-sealing valve.

4. The self-inflating intragastric device of claim 3 wherein the bladder is formed of a material selected from the group consisting of Dacron®

, rubber, latex, silicone and nylon.

5. The self-inflating intragastric device of claim 3 wherein the self-sealing valve is positioned in the opening of the bladder and is held in the opening with a substantially liquid-impermeable seal.

6. The self-inflating intragastric device of claim 5 wherein the seal is effected by sealing means selected from the group consisting of partial melting, an adhesive substance and a clamp.

7. The self-inflating intragastric device of claim 6 wherein the seal is effected by a clamp and the clamp is a band encircling the open end of the bladder around the self-sealing valve.

8. The self-inflating intragastric device of claim 7 further comprising a rigid sleeve encircling the self-sealing valve and mediating the seal between the self-sealing valve and the bladder.

9. The self-inflating intragastric medical device of claim 7 wherein under conditions of use the band slowly erodes causing the liquid-impermeable seal between the self-sealing valve and the bladder to break after an approximately predetermined period of time resulting in deflation of the balloon.

10. The self-inflating intragastric medical device of claim 9 wherein the band is resorbable suture string.

11. The self-inflating intragastric medical device of claim 1 further comprising a container enclosing the balloon and sized to allow passage through the esophagus.

12. A kit comprising:

1) the self-inflating intragastric medical device of claim 1 and

2) a syringe.

13. The kit of claim 12 wherein the syringe is pre-filled with an activating liquid selected from the group consisting of water, organic acids that are liquid at room temperature, solutions of mineral acids, and solutions of organic acids.

14. The kit of claim 13 wherein the activating liquid is selected from the group consisting of a solution of citric acid, acetic acid, aqueous acetic acid and aqueous hydrochloric acid.

15. The kit of claim 14 wherein the activating liquid is comprised of a mixture of from about 25% to about 50% (v/v) acetic acid and from about 50% to about 75% (v/v) water.

16. The kit of claim 13 wherein the activating liquid is comprised of a mixture of about 33% acetic acid and about 67% (v/v) water.

17. The kit of claim 12 further comprising printed instructions describing how to orally administer the self-inflating intragastric medical device.

18. A self-inflating intragastric medical device comprising:

1) an uninflated, ingestible, substantially liquid-impermeable balloon having an exterior surface and an interior surface, the interior surface bounding a lumen;

2) an emissive substance enclosed within the balloon, wherein the emissive substance is a substance that liberates gas when contacted with a reactant;

3) a vessel enclosed within the balloon and enclosing a space within the balloon separate from the lumen, wherein at least a portion of the vessel is fabricated of a gelatin that is soluble in at least one liquid selected from the group consisting of;

1. water,

2. organic acids that are liquid at room temperature, and

3. solutions of mineral or organic acids;

and wherein the vessel comprises a receptacle fabricated of the gelatin and having a mouth, further wherein the receptacle is attached at the mouth to a septum by a liquid-impermeable seal; and

4) a self-sealing valve providing fluid communication into the vessel from outside the balloon, wherein the self-sealing valve is the septum, and wherein the receptacle is attached to the septum by;

1) moistening the mouth of the receptacle with water, thereby causing the gelatin proximate to the mouth to soften,

2) contacting the mouth of the receptacle with the septum, and

3) hardening the softened gelatin to form a liquid-impermeable seal between the septum and receptacle.

19. A self-inflating intragastric medical device comprising:

1) an uninflated, ingestible, substantially liquid-impermeable balloon having an exterior surface and an interior surface, the interior surface bounding a lumen,

2) an emissive substance enclosed within the balloon, wherein the emissive substance is a substance that liberates gas when contacted with a reactant,

3) a vessel enclosed within the balloon and enclosing a space within the balloon separate from the lumen, wherein at least a portion of the vessel is fabricated of a material that is soluble in at least one liquid selected from the group consisting of

1. water,

2. organic acids that are liquid at room temperature, and

3. solutions of mineral or organic acids, and

4) a self-sealing valve providing fluid communication into the vessel from outside the balloon, wherein the self-sealing valve is a septum, and further comprising a reactant enclosed within the vessel and separated from the emissive substance by the vessel wall.

20. The self-inflating intragastric medical device of claim 19, wherein the reactant is in a solid state.

21. The self-inflating intragastric medical device of claim 19, wherein the reactant is in a liquid state.

22. The self-inflating intragastric medical device of claim 19, wherein the reactant is an acid.