Inflatable retention system for an enteral feeding device

摘要

An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen or cavity of the body by insertion through a stoma from outside the body. The retention system includes a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen. The retention system also includes an inflatable balloon located at a distal end of the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, a predetermined spheroid shape, and a volume at which a fluid in the balloon is under no pressure such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve.

主权项

1. An inflatable retention system for an enteral feeding tube having a base deployed outside the human body and an indwelling retainer which is deployed within a lumen of the body by insertion through a stoma from outside the body, the retention system comprising:
a tube having a proximal end, a distal end, an external tube diameter, and tube walls defining a feeding lumen and an inflation lumen; and an inflatable balloon located at a distal end of the tube in fluid communication with the inflation lumen, the balloon having thin, flexible walls, a predetermined spheroid shape, a reserve volume having a lower limit that is greater than 0.5 milliliters of a fluid and an upper limit at a transition between a non-distended state and a distended state of the balloon in which a fluid in the balloon is under no pressure, and a predetermined fill volume about 1.01 to about 1.5 times greater than an upper limit of the reserve volume, such that upon inflation with a fluid to pressurize fluid in the balloon, the balloon assumes a stable spheroid shape and exhibits a substantially linear pressure versus volume curve to at least the predetermined fill volume and when the balloon is inflated to a volume that is up to 40% greater than its predetermined fill volume, the balloon remains stable.