Anastomosis leak testing apparatus and methods
Inventors
Assignees
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Publication Number
US-8216159-B1
Publication Date
2012-07-10
Expiration Date
Abstract
Anastomosis leak testers for testing for leaks in gastrointestinal anastomoses in patients include an inflation pump and a conduit part. The inflation pump has a compressible portion and a mechanism for providing a uni-directional flow of air through the inflation pump upon intermittent compressing thereof. Conduit parts have an interior space, a portion to be inserted into an anus of a patient or arm to be mated to a gastric tube, rectal tube or endoscope, a pressure relief valve and an indicator pin, and a rearward arm connected to the inflation pump. Upon actuation of the inflation pump, air flows through the inflation pump and through the conduit part into the patient's bowel. When the air pressure in the bowel exceeds a specified pressure, air is released through the pressure relief valve and ejects the indicator pin, which alerts the surgeon that the desired rectal pressure has been reached.
Core Innovation
The invention provides an anastomosis leak tester and a method for gastrointestinal anastomosis leak testing in which a conduit part with an interior space and an opening communicating with a partially occluded gastrointestinal tract is used to distend a gastrointestinal anastomosis. The conduit part includes a pressure relief valve communicating with the interior space and an opening that leads to the ambient atmosphere through a conduit between a lumen and the ambient atmosphere.
The system further includes a movable indicator pin separate from the pressure relief valve. The indicator pin is arranged relative to the pressure relief valve and the aperture so that it has a first position in which the pressure relief valve is not in flow communication with the aperture, and a second position in which the pressure relief valve is in flow communication with the aperture. In the first position, the indicator pin occludes the lumen at a location between the aperture and the pressure relief valve to prevent pressure-relief flow to the aperture.
During testing, the anastomosis is submerged in fluid, the conduit part is placed in communication with the gastrointestinal tract, and air is continued to be directed into the interior space until air passes through the pressure relief valve. When this occurs, the indicator pin moves from the first position to the second position past the aperture, thereby allowing air flow from the pressure relief valve to escape to the ambient atmosphere through the aperture and providing pressure release from the interior space. Anastomotic leaks are checked based on the presence of air bubbles in the fluid around the anastomosis.
Claims Coverage
The partial content contains one independent claim (clm-00001). The inventive features center on a conduit part with an opening to ambient atmosphere, a pressure relief valve, and a movable indicator pin that occludes and then releases a flow path to vent air and signal a pressure-reached condition while leak testing is performed by bubble detection.
Conduit part with interior space and aperture to ambient atmosphere
A conduit part having an interior space, an opening communicating with the interior space that is adapted to communicate with a partially occluded gastrointestinal tract, and an arm defining a lumen and an aperture defining a conduit between the lumen and the ambient atmosphere.
Pressure relief valve communicating with interior space
A pressure relief valve communicating with the interior space.
Movable indicator pin occluding lumen and enabling venting
A movable indicator pin separate from the pressure relief valve, the indicator pin being at least partly arranged in the lumen and relative to the pressure relief valve and the aperture such that the indicator pin has a first position in which the pressure relief valve is not in flow communication with the aperture and a second position in which the pressure relief valve is in flow communication with the aperture; the indicator pin occluding the lumen at a location between the aperture and the pressure relief valve to prevent the pressure relief valve from being in flow communication with the aperture when the indicator pin is in the first position; and being arranged to be movable from the first position to the second position past the aperture upon outflow of air from the pressure relief valve to cause the pressure relief valve to be in flow communication with the aperture when the indicator pin is in the second position.
Submerging, air-directed distension, and bubble-based leak checking
Submersing the anastomosis in fluid; placing the conduit part in communication with the gastrointestinal tract and directing air into the interior space of the conduit part such that the air flows out of the interior space of the conduit part through the opening into the gastrointestinal tract to thereby distend the anastomosis; continuing to direct air until air is caused to pass through the pressure relief valve and moves the indicator pin from the first position to the second position thereby allowing air flow from the pressure relief valve to escape to the ambient atmosphere through the aperture and providing pressure release from the interior space; and then checking for anastomotic leaks based on the presence of air bubbles in the fluid around the anastomosis.
Across the independent claim, the core coverage is a gastrointestinal anastomosis leak testing method that combines submersion and bubble-based leak checking with a tester in which a pressure relief valve vent path to an aperture is controlled by a movable indicator pin that occludes the lumen in a first position and shifts to a second position to allow venting and pressure release to ambient atmosphere.
Stated Advantages
Provides pressure release from the interior space of the conduit part by allowing air flow from the pressure relief valve to escape to the ambient atmosphere through the aperture.
Allows checking for anastomotic leaks based on the presence of air bubbles in the fluid around the anastomosis.
Documented Applications
No documented applications found
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