Anastomosis leak testing apparatus and methods

• US 8,216,159 B1
• Filed: 10/08/2008
• Issued: 07/10/2012
• Est. Priority Date: 10/08/2007
• Status: Active Grant

• Current Assignee: Tools for Surgery, LLC
• Original Assignee: Tools for Surgery, LLC
• Inventors: Leiboff, Arnold R.
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): EISEMAN, ADAM JARED
• Application Number:
  US12/247,257
• Time in Patent Office: 1,371 Days
• Field of Search: 600/561, 600/587, 600/593
• US Class Current: 600/593
• CPC Class Codes: A61B 17/1114 of the digestive tract, e.g. bowels or oesophagus
• CPC Class Codes: A61B 2017/00022 Sensing or detecting at the treatment site
• CPC Class Codes: A61B 2090/064 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61B 5/03 Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs A61B5/205 takes precedence
• CPC Class Codes: A61B 5/4255 Intestines, colon or appendix
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for

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.

Claims

1. A method for gastrointestinal anastomosis leak testing, comprising:

providing an anastomosis leak tester comprising;

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, an arm defining a lumen and an aperture defining a conduit between the lumen and the ambient atmosphere,

a pressure relief valve communicating with the interior space, and

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, the indicator pin 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,

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 of the conduit part into the gastrointestinal tract to thereby distend the anastomosis;

continuing to direct air into the interior space of the conduit part 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 of the conduit part; and

then

checking for anastomotic leaks based on the presence of air bubbles in the fluid around the anastomosis.

2. The method of claim 1, wherein the interior space of the conduit part is receivable of a connector from a gastric tube, rectal tube, or endoscope, further comprising:

connecting the conduit part to a gastric tube, rectal tube or endoscope.

3. The method of claim 1, wherein the conduit part has a forward tubular section having the opening communicating with the interior space, and an expanded section rearward of the forward tubular section, further comprising:

inserting the forward tubular section having the opening communicating with the interior space into the anus of a patient and pressing the expanded section against the anus to seal the anal opening;

filling the pelvis of the patient with fluid;

occluding the bowel above the anastomosis; and

directing air into the interior space of the conduit part to cause air to flow into the interior space of the conduit part and out of the opening into the rectum to thereby distend the anastomosis.

4. The method of claim 1, wherein the indicator pin is configured relative to the arm to be retained partly within the arm after moving from the first position to the second position.

5. The method of claim 1, further comprising retaining part of the indicator pin in the arm after the indicator pin moves from the first position to the second position.

6. The method of claim 1, further comprising configuring the interior space of the conduit part to be receivable of a connector from a gastric tube, rectal tube, or endoscope.

7. The method of claim 1, further comprising arranging the pressure relief valve partly in the lumen.

8. The method of claim 1, further comprising providing the indicator pin with a head that extends across the lumen to thereby occlude the lumen and prevent the pressure relief valve from being in flow communication with the aperture when the indicator pin is in the first position.

9. The method of claim 8, further comprising providing the indicator pin with a shaft projecting rearward from the head, the aperture facing a part of the shaft when the indicator pin is in the first position.

10. The method of claim 8, further comprising positioning the head in the lumen and constructing the lumen such that the head is retained within the lumen as the indicator pin moves from the first position to the second position.

11. The method of claim 1, further comprising constructing the conduit part such that air can only be directed into the interior space of the conduit part through a lumen defined by an additional arm of the conduit part and that communicates with the interior space of the conduit part.

12. The method of claim 11, further comprising coupling an inflation pump to the lumen defined by the additional arm and actuating the inflation pump to thereby direct air into the interior space of the conduit part.

13. The method of claim 1, further comprising positioning the pressure relief valve and the indicator pin in the lumen with a space therebetween.

14. The method of claim 1, further comprising positioning the pressure relief valve partly in the interior space of the conduit part.

15. The method of claim 1, further comprising configuring the pressure relief valve to open and allow flow of air therethrough when air pressure in the interior space is at a specific pressure.

16. The method of claim 1, further comprising configuring the anastomosis leak tester such that the movement of the indicator pin from the first position to the second position provides a signal when air pressure within the gastrointestinal tract reaches a specified pressure and the pressure relief valve and the movement of the indicator pin from the first position to the second position prevents air pressure within the gastrointestinal tract from exceeding this specified pressure.