Ultrasonic systems and methods for locating and/or characterizing intragastric devices

• US 9,895,248 B2
• Filed: 10/07/2015
• Issued: 02/20/2018
• Est. Priority Date: 10/09/2014
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Brister, Mark C., Drake, Neil R., Nelson, Sheldon
• Primary Examiner(s): Woo, Julian W
• Application Number:
  US14/877,846
• Publication Number:
  US 20160100970A1
• Time in Patent Office: 867 Days
• CPC Class Codes: A61F 2005/002 for sensing mechanical parameters
• CPC Class Codes: A61F 5/003 inflatable
• CPC Class Codes: A61F 5/0036 Intragastrical devices
• CPC Class Codes: A61F 5/0043 using injection ports
• CPC Class Codes: A61F 5/0046 with wireless means

Abstract

Devices and methods for treating obesity are provided. More particularly, intragastric devices and methods of fabricating, deploying, inflating, locating, tracking, monitoring, deflating, and retrieving the same are provided.

Claims

1. An intragastric balloon configured to have a useful life in an in vivo gastric environment of at least 30 days, comprising:

a component configured for detection by an ultrasonic detector;

a polymeric wall configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 10 cc/m²/day, such that a rate and an amount of diffusion of CO₂ from the in vivo gastric environment into a lumen of the intragastric balloon through the polymeric wall is controlled, at least in part, by a concentration of CO₂ and a concentration of a gas selected from the group consisting of N₂, SF₆, C₂F₆, C₃F₈, C₄F₁₀, C₄F₈, C₃F₆, CF₄, CC1F₂-CF₃, and mixtures thereof in an initial fill gas, wherein the concentration of CO₂ in the initial fill gas is characteristic of gastric pCO₂; and

a valve system configured for introducing the initial fill gas into the lumen of the intragastric balloon in the in vivo gastric environment;

wherein the component configured for detection by an ultrasonic detector comprises a first coiled conductor coupled with the intragastric balloon and a second coiled conductor separate from the intragastric balloon, and wherein the ultrasonic detector comprises a spectrum analyzer configured to measure resonant frequencies associated with the intragastric balloon.

2. The intragastric balloon of claim 1, wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 50 cc/m²/day.

3. A method for positioning an intragastric balloon, comprising:

introducing into a patient, via swallowing, an intragastric balloon comprising an ultrasonic component configured for detection by an ultrasonic detector, and a polymeric wall, wherein the intragastric balloon is in a compacted, solid form;

confirming, by sensing resonant frequencies associated with the intragastric balloon in a compacted, solid form, a location of the intragastric balloon, wherein the location is the patient'"'"'s stomach;

thereafter

introducing an initial fill gas into a lumen of the intragastric balloon, wherein the initial fill gas comprises a gas selected from the group consisting of N₂, SF₆, C₂F₆, C₃F₈, C₄F₁₀, C₄F₈, C₃F₆, CF₄, CC1F₂-CF₃, and mixtures thereof; and

exposing the intragastric balloon to the in vivo intragastric environment for a useful life of at least 30 days, wherein the intragastric balloon maintains a volume of 75% to 125% of its original nominal volume over the useful life;

after the exposing the intragastric balloon to the in vivo intragastric environment, deflating the intragastric balloon, wherein the deflating comprises bursting the intragastric balloon by administration of an ultrasonic or acoustic pulse.

4. The method of claim 3, further comprising, after introducing the initial fill gas, confirming, by sensing resonant frequencies associated with the intragastric balloon in inflated form, complete inflation of the intragastric balloon.

5. The method of claim 3, further comprising, during the exposing the intragastric balloon to the in vivo intragastric environment, a degree of inflation of the intragastric balloon.

6. The method of claim 3, wherein the initial fill gas further comprises CO₂.

7. The method of claim 3,

wherein the ultrasonic component comprises a first coiled conductor coupled with the intragastric balloon and a second coiled conductor separate from the intragastric balloon, and wherein the ultrasonic detector comprises a spectrum analyzer configured to measure resonant frequencies associated with the intragastric balloon.

8. The method of claim 7, wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 10 cc/m²/day.

9. The method of claim 7, wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 10 cc/m²/day, such that a rate and an amount of diffusion of CO₂ from the in vivo gastric environment into a lumen of the intragastric balloon through the polymeric wall is controlled, at least in part, by a concentration of an inert gas and a concentration of CO₂ in an initial fill gas, wherein the concentration of CO₂ in the initial fill gas is characteristic of gastric pCO₂.

10. The method of claim 7, wherein the polymeric wall is configured to have, under conditions of an in vivo gastric environment, a permeability to CO₂ of more than 50 cc/m²/day.