Capsule enteric coating for controlling balloon expansion start time
Inventors
Trinh, Phat Bao • Freitas, Amy • Trollsas, Mikael
Assignees
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Publication Number
US-11116390-B2
Publication Date
2021-09-14
Expiration Date
Abstract
The present invention discloses a capsule endoscope with specific gravity control. The capsule endoscope comprises a housing to enclose various components, an inflatable device attached to a first longitudinal end of the capsule unit and an enteric coated shell attached to the first longitudinal end of the capsule unit to enclose the inflatable device between the enteric coated shell and the capsule unit. The various components include a camera sub-system for capturing image frames. The inflatable device comprises an inflatable membrane and an effervescent formulation inside the inflatable membrane. The enteric coated shell fits tightly onto the first longitudinal end of the capsule unit to prevent body liquid from leaking into a space between the enteric coated shell and the capsule unit when the capsule unit travels in human gastrointestinal tract after being swallowed.
Core Innovation
The invention relates to a swallowable capsule endoscope with specific gravity control. The capsule unit includes a battery, a light source, a camera sub-system for capturing image frames, and a housing adapted to be swallowed, with the battery, light source, and camera sub-system enclosed in the housing.
An inflatable device is attached to a first longitudinal end of the capsule unit and includes an inflatable balloon containing an effervescent formulation inside the inflatable balloon. The inflatable device is enclosed between an enteric coated shell and the capsule unit, with the enteric coated shell attached to the first longitudinal end to enclose the inflatable device.
The enteric coated shell prevents or delays body liquid infusion or dissolution when the capsule unit is in the stomach due to acidic pH, and then dissolves in higher pH intestinal regions. As the shell dissolves, body liquid enters the inflatable balloon and contacts the effervescent formulation, generating gas that inflates the balloon to switch capsule buoyancy through specific gravity control.
The partial content further describes use of a 50:50 ratio of Eudragit FS 30 D and Eudragit L30D-55 for the enteric coating on the enteric coated shell. It also describes laboratory and clinical evaluation results indicating inflation and deflation over GI transit and an improved behavior and completion rate.
Claims Coverage
The partial content includes one independent claim that covers an enteric-coated, balloon-effervescent capsule endoscope configured to control inflation timing and therefore buoyancy/specific gravity during GI transit.
Inflatable balloon with internal effervescent formulation enclosed by an enteric coated shell
An inflatable device attached to a first longitudinal end, wherein the inflatable device comprises an inflatable balloon and an effervescent formulation inside the inflatable balloon, and an enteric coated shell attached to the first longitudinal end to enclose the inflatable device between the enteric coated shell and the capsule unit.
50:50 Eudragit FS 30 D and Eudragit L30D-55 stomach protection for the enteric coated shell
A 50:50 ratio of Eudragit FS 30 D and Eudragit L30D-55 is used for enteric coating on the enteric coated shell to prevent or delay body liquid infusion or dissolution when the capsule unit is in the stomach.
Inflation triggered after enteric shell dissolution by body liquid contacting effervescent formulation
The inflatable device starts to inflate when the enteric coated shell is dissolved and the body liquid enters the inflatable balloon and gets in touch with the effervescent formulation inside the inflatable balloon.
Across the independent claim, the inventive concept is the combination of an enteric coated shell with a specified Eudragit FS 30 D/L30D-55 ratio that prevents or delays dissolution in the stomach, together with an inflatable balloon containing an effervescent formulation that inflates after dissolution when body liquid enters and contacts the effervescent formulation for specific gravity control.
Stated Advantages
Improved behavior and completion rate, as supported by laboratory and clinical evaluation results.
Documented Applications
A capsule endoscope operation in the GI tract, including control of inflation/deflation over GI transit and release/completion timing in higher pH intestinal regions.
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