Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-10123712-B1
Publication Date
2018-11-13
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 document describes an anastomosis leak testing apparatus that includes an inflation pump that produces intermittent compression to generate uni-directional airflow for inflating a patient via a conduit part. The conduit part is insertable into an anus or attachable to a gastric tube, and it includes an interior space and an arm defining a second interior space. A pressure relief valve communicates with the interior space, and an aperture defines a passage between the second interior space and ambient atmosphere.
A movable indicator pin, separated from the pressure relief valve, provides a surgeon signal when bowel/organ pressure exceeds a predetermined pressure threshold. The pressure relief valve releases air when the predetermined pressure threshold is reached, and the released air causes the indicator pin to eject part of the indicator pin from the second interior space through a second opening to a position outside of the body. The indicator pin is arranged relative to the pressure relief valve and the aperture such that the pressure relief valve is not in flow communication with the aperture when the indicator pin is in a first position, and the pressure relief valve is in flow communication with the aperture when the indicator pin is in a second position.
The indicator pin occludes the second interior space at a location between the aperture and the pressure relief valve to prevent valve-to-aperture flow in the first position. When the indicator pin ejects past the aperture, the pressure relief valve becomes flow communicating with the aperture so that air can vent to ambient atmosphere, which is stated to prevent over-inflation. The document further describes a colorectal device having a forward insertion portion and an expanded lip for insertion limiting/sealing, and a gastrointestinal variant using a tubing-mate side arm for stomach insufflation.
Claims Coverage
The independent claim covers a conduit for testing leaks in an anastomosis, defining two interior spaces and an ambient-atmosphere aperture, together with a pressure relief valve/movable indicator pin arrangement that controls when the valve communicates with the aperture as the pin moves between first and second positions. Dependent claims further refine patient and conduit configurations and pressure-threshold behavior for the relief valve, and specify occlusion and ejection/retention behaviors of the indicator pin.
Conduit with first interior space, first opening, second interior space, and ambient aperture
A body including a first interior space receivable of air from an inflation device; a first opening communicating with the first interior space and adapted to communicate with an intestinal tract when used to test for leaks; an arm defining a second interior space; a second opening communicating with the second interior space; and an aperture defining a passage between the second interior space and ambient atmosphere.
Pressure relief valve between first and second interior spaces
A pressure relief valve communicating with the first interior space and interposed between the first interior space and the second interior space.
Movable indicator pin controlling valve-to-aperture flow
A movable indicator pin separated from the pressure relief valve, the indicator pin having a first position in the body and a second position in which part of the indicator pin is ejected from the second interior space through the second opening to a position outside of the body, the indicator pin occluding the second interior space 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 moving past the aperture upon exiting 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.
Pressure relief valve threshold behavior
The conduit includes a pressure relief valve that permits air to move from the first interior space to the second interior space only when the first interior space pressure exceeds a specified air pressure.
Patient-anus adaptation via first opening connection to tubular device
The conduit is configured so its first opening can be connected to a tubular device that is inserted into a patient or inserted into an anus of a patient.
Anal insertion limiting and sealing expanded section
The conduit includes a tubular forward section sized to be inserted into a patient's anus and a rear expanded section with a larger diameter than the forward tubular section that limits insertion of the body into the anus and seals the anal opening.
Overall, the claim coverage centers on a conduit with two interior spaces and an ambient-atmosphere aperture, where a pressure relief valve and a movable indicator pin cooperate to control when the relief valve communicates with the aperture, including occlusion in a first position and ejection/movement past the aperture in a second position. Dependent features add specified threshold pressure behavior, and refinement of how the conduit is adapted for patient and anus use including an expanded section for insertion limiting/sealing.
Stated Advantages
Provides a felt/visible surgeon signal that a target pressure is reached.
Venting to ambient atmosphere after the indicator pin changes position to prevent over-inflation.
Stated advantages over proctoscopes/gastroscopes.
Documented Applications
Colorectal use: a colorectal device with a forward insertion portion and an expanded lip is described for testing leaks in an anastomosis.
Gastrointestinal use: a gastrointestinal variant is described for stomach insufflation using a tubing-mate side arm as part of an anastomosis leak testing apparatus.
Surgeon use scenario involving testing for anastomosis leaks with a felt/visible signal indicating a target pressure threshold is reached and controlling venting to prevent over-inflation.
Interested in licensing this patent?