System for detecting an intragastric balloon

• US 10,350,100 B2
• Filed: 03/16/2017
• Issued: 07/16/2019
• Est. Priority Date: 04/12/2016
• Status: Active Grant

• Current Assignee: ReShape LifeSciences, Inc.
• Original Assignee: Obalon Therapeutics, Inc. (ReShape LifeSciences, Inc.)
• Inventors: Nelson, Sheldon, Drake, Neil R.
• Primary Examiner(s): Stransky, Katrina M
• Application Number:
  US15/461,293
• Publication Number:
  US 20170290693A1
• Time in Patent Office: 852 Days
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61B 5/065 Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe
• CPC Class Codes: A61B 5/4887 Locating particular structures in or on the body
• 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

Abstract

Devices and methods for treating obesity are provided, including intragastric devices and methods of fabricating, deploying, inflating, locating, tracking, monitoring, deflating, and retrieving the same. In one embodiment, a device includes a balloon capsule having a distal end, a catheter having a proximal end and a distal end, a connector, a light sensor, and a balloon valve. At least one optical fiber extends along the length of the interior of the catheter and through the valve such that a distal end of the optical fiber is positioned at a distal end of the balloon capsule when the catheter is placed within the balloon capsule, and such that a proximal end of the optical fiber can be received by the light sensor.

Claims

1. An optical system for locating a volume-occupying intragastric device inside the body, the system comprising:

an optical sensor configured to sense electromagnetic radiation;

a volume-occupying intragastric device, the volume-occupying intragastric device comprising an intragastric balloon having a polymeric wall, a lumen, and a valve system configured for introducing an initial fill fluid into the lumen of the intragastric balloon when the intragastric balloon is in an in vivo gastric environment, the valve system comprising a swallowable catheter configured to releasably couple with the volume-occupying intragastric device; and

a swallowable light-emitting marker configured to produce electromagnetic radiation, in an in vivo gastric environment, indicative of a location of the volume-occupying intragastric device or a component associated therewith.

2. The system of claim 1, wherein the light-emitting marker is configured to couple with the swallowable catheter.

3. The system of claim 1, further comprising a swallowable capsule configured to contain the intragastric balloon in an uninflated and compacted state, wherein the light-emitting marker is configured to couple with the volume-occupying intragastric device.

4. The system of claim 1, wherein the light-emitting marker is configured to couple with the volume-occupying intragastric device.

5. The system of claim 1, further comprising a sensor interface unit configured to electrically communicate with the optical sensor.

6. The system of claim 5, further comprising a system control unit configured to electrically communicate with the sensor interface unit and with the optical sensor.

7. The system of claim 6, further comprising a computer configured to electrically communicate with the system control unit and to display an identifier indicating the location of the light-emitting marker inside the body.

8. The system of claim 1, further comprising an initial fill fluid, wherein the polymeric wall is configured to have, under conditions of the 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 the lumen of the intragastric balloon through the polymeric wall is controlled, at least in part, by a concentration of an inert gas in the initial fill fluid.

9. The system of claim 8, wherein the polymeric wall comprises a layer selected from the group consisting of:

a CO₂ barrier material comprising an ethylene vinyl alcohol layer,

a two layer CO₂ barrier material comprising a nylon layer and a polyethylene layer,

a three layer CO₂ barrier material comprising a nylon layer, a polyvinylidene chloride layer, and a polyethylene layer, and

a three layer CO₂ barrier material comprising a nylon layer, an ethylene vinyl alcohol layer, and a polyethylene layer.

10. The system of claim 8, wherein the initial fill fluid comprises SF₆ in one or more of liquid form, vapor form, or gaseous form.

11. The system of claim 8, wherein the initial fill fluid comprises gaseous N₂ and gaseous SF₆.

12. A method for optically locating a volume-occupying intragastric device inside a body of a patient, the method comprising:

introducing into the body of the patient, via swallowing, a volume-occupying intragastric device, the volume-occupying intragastric device releasably coupled with a catheter;

introducing into the body of the patient, via swallowing, a light-emitting marker configured to be sensed by an optical sensor;

sensing the light emitted by the light-emitting marker with the optical sensor; and

confirming a location of the volume-occupying intragastric device inside the patient based on sensing the light emitted by the light-emitting marker.

13. The method of claim 12, wherein the volume-occupying intragastric device comprises an intragastric balloon in an uninflated state, and wherein the location of the intragastric balloon is inside the patient'"'"'s stomach.

14. The method of claim 13, wherein the volume-occupying intragastric device comprises an intragastric balloon having a polymeric wall and lumen, the method further comprising:

introducing an initial fill fluid into the lumen of the intragastric balloon through the catheter so as to inflate the intragastric balloon, 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; and

exposing the inflated intragastric balloon to the in vivo intragastric environment for a useful life of at least 30 days, wherein a rate and an amount of diffusion of CO₂ from the in vivo gastric environment into the lumen of the intragastric balloon through the polymeric wall is controlled, at least in part, by a concentration of an inert gas in an initial fill fluid.

15. The method of claim 14, wherein the polymeric wall comprises a layer selected from the group consisting of:

a CO₂ barrier material comprising an ethylene vinyl alcohol layer,

a two layer CO₂ barrier material comprising a nylon layer and a polyethylene layer,

a three layer CO₂ barrier material comprising a nylon layer, a polyvinylidene chloride layer, and a polyethylene layer, and

a three layer CO₂ barrier material comprising a nylon layer, an ethylene vinyl alcohol layer, and a polyethylene layer.

16. The method of claim 14, wherein the initial fill fluid comprises SF₆ in one or more of liquid form, vapor form, or gaseous form.

17. The method of claim 14, wherein the initial fill fluid comprises gaseous N₂ and gaseous SF₆.

18. The method of claim 12, further comprising displaying on a computer an identifier indicating the location of the light-emitting marker.

19. The method of claim 12, wherein the intragastric balloon is in an uninflated and compacted state inside a swallowable capsule, wherein the light-emitting marker is coupled with the capsule.

20. The method of claim 12, wherein the optical sensor is coupled with volume-occupying intragastric device.