Pressure control system for intragastric device
Inventors
Brister, Mark C. • Drake, Neil R. • Proctor, Daniel J. • Campbell, Madeline
Assignees
Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11819433-B2
Publication Date
2023-11-21
Expiration Date
Abstract
Devices and methods for treating obesity are provided. More particularly, intragastric devices and devices for inflating and methods of fabricating, deploying, inflating, monitoring, and retrieving the same are provided.
Core Innovation
The invention provides a system for performing an inflation procedure to inflate an inflatable intragastric balloon using an inflation fluid container and a fluid pathway connecting the container and the balloon. The system includes at least one valve disposed along the fluid pathway to control a volume of gas flowing into the balloon, and a pressure gauge positioned along the fluid pathway to measure a balloon pressure within the balloon.
A computing device receives balloon pressure measurements and determines whether the balloon is located within a constrained space or an unconstrained space based on pressure and pressure-decrease rate measurements. The constrained-space determination is made when a pressure of between 17.2 kPa and 60 kPa is measured and a rate of pressure decrease less than 0.2 kPa/s is measured, while the unconstrained-space determination is made when a pressure of less than 17.2 kPa is measured in an absence of a rate of change of less than 0.2 kPa/s in 3 seconds.
The computing device provides instructions to control the inflation procedure by dispensing and blocking inflation fluid through the fluid pathway, with different behaviors depending on the determined location. In the unconstrained space, the computing device determines an amount of inflation fluid to achieve a target pressure within the balloon and provides instructions to dispense inflation fluid, while in the constrained space it provides instructions to perform a fail-safe procedure.
In refined configurations, the system further includes a fluid pathway that comprises a pressure sensor, a first pressure regulator configured to reduce pressure to less than a constrained space-damaging pressure, and an exhaust configured to vent inflation fluid from the balloon.
Claims Coverage
The independent claims cover valve-controlled balloon inflation with pressure-gauge-based location determination using specified pressure and pressure-decrease-rate criteria. The identified features include dispensing and blocking control, constrained versus unconstrained space classification, target-pressure-based inflation control, and regulated venting in a fail-safe configuration.
Valve-controlled inflation along a fluid pathway
A system comprising an inflation fluid container with an inflation fluid, an inflatable intragastric balloon, a fluid pathway fluidly connecting the inflation fluid container and the balloon, and at least one valve disposed along the fluid pathway and configured to control a volume of gas flowing through the fluid pathway into the balloon.
Pressure gauge measuring balloon pressure along the pathway
A pressure gauge positioned along the fluid pathway so as to measure a balloon pressure within the balloon.
Computing-device instructions and constrained-space determination
A computing device configured to provide instructions to the at least one valve to dispense a volume of inflation fluid into the fluid pathway; provide instructions to the at least one valve to block the flow of the inflation fluid into the fluid pathway; receive balloon pressure measurements from the pressure gauge; and determine if the balloon is located within a constrained space based upon the balloon pressure measurements, wherein the balloon is determined to be located within the constrained space when a pressure of between 17.2 kPa and 60 kPa is measured and a rate of pressure decrease less than 0.2 kPa/s is measured, and wherein the location is determined to be in an unconstrained space when a pressure of less than 17.2 kPa is measured in an absence of a rate of change of less than 0.2 kPa/s in 3 seconds.
Target-pressure-based decision to vent, continue, or terminate
The computing device compares balloon pressure measurements to a target balloon pressure and selects instructions to vent inflation fluid, continue inflation, or terminate the inflation procedure depending on whether the measured balloon pressure is above the target balloon pressure.
Regulated fluid pathway with exhaust venting and fail-safe instructions
A processing unit receives pressure measurements from a pressure sensor in a fluid pathway comprising a first pressure regulator configured to reduce inflation fluid pressure to a pressure less than a constrained space-damaging pressure and a first valve configured to control flow, determines balloon location as constrained space or unconstrained space using the specified pressure and pressure-decrease-rate criteria, and when constrained provides instructions to perform a fail-safe procedure, with an exhaust configured to vent inflation fluid from the balloon.
The inventive coverage centers on using pressure and pressure-decrease-rate thresholds to classify balloon location as constrained versus unconstrained and then controlling valve dispensing, blocking, target-pressure inflation, fail-safe termination, and venting accordingly.
Stated Advantages
Detects whether the balloon is located within a constrained space versus an unconstrained space using balloon pressure measurements based on specified pressure and pressure-decrease-rate criteria.
Enables fail-safe behavior when constrained-space placement is detected, including terminating inflation and directing the physician to a fail-safe procedure.
May vent gas to reduce tissue stress during constrained-space handling.
Demonstrated constrained-space detection behavior and exhaustion/deflation behavior without observed trauma in tested animals.
Documented Applications
Intragastric balloon inflation procedures using a Touch Dispenser system that includes constrained-space detection and corresponding fail-safe actions such as terminating inflation and venting gas.
Animal testing to demonstrate constrained-space detection and exhaustion/deflation behavior.
Interested in licensing this patent?