Surgical conduit leak testing

Patent metadata

Field	Value
Publication number	US-2016266004-A1
Application number	US-201615065720-A
Country	US
Kind code	A1
Filing date	Mar 9, 2016
Priority date	Mar 10, 2015
Publication date	Sep 15, 2016
Grant date	—

Abstract

Systems, devices, and methods for leak testing surgical conduit grafts or valved conduits such as aortic-valved conduits with a pressurized gas such as air. Air is non-destructive and especially useful for leak testing conduits that have coatings or sealants that may be functionally impacted when exposed to fluids such as water or saline. Open ends of the conduit are clamped and sealed, and a pressurized gas introduced into an inner lumen thereof. A change in mass flow rate is measured to quantify the leakage. One end of a tubular conduit may be clamped to a fixed manifold, and the opposite end to a manifold slidably mounted to accommodate any conduit elongation when pressurized. The clamping and sealing structure may be pneumatic and/or mechanical, and complementary contoured clamp members may be used to seal a scalloped external sealing ring of an aortic conduit.

First claim

What is claimed is:

1 . A surgical conduit leak testing system, comprising:
a manifold assembly mounted on a common support base including a pair of spaced apart manifolds having structure for clamping and sealing onto opposite ends of a surgical conduit, wherein a first manifold is fixed with respect to the support base and a second manifold is mounted on the support base for movement toward and away from the first manifold, and wherein one of the manifolds has gas flow passages between an external fitting and an internal port that opens to an interior of the surgical conduit when clamped thereon; a gas delivery hose connected to the external fitting; and a gas pressure controller to which the gas delivery hose attaches and which has a fitting for connection to a source of pressurized gas, the controller having sensors for measuring the pressure in the gas delivery hose and an output for the measured pressure.

2 . The system of claim 1 , wherein the manifold that has gas flow passages includes a first mandrel around which the surgical conduit fits and that terminates in the internal port within the surgical conduit, and the other manifold has a mandrel with no gas flow passages.

3 . The system of claim 1 , wherein the structure for clamping and sealing includes flow channels through both manifolds from external fittings, each manifold having an internal piston arranged to be displaced toward the surgical conduit when pressurized gas is introduced to the respective flow channels, and the structure includes an elastomeric ring that is compressed by piston displacement and positioned to expand inward and clamp and seal the surgical conduit against a rigid mandrel provided within the conduit.

4 . The system of claim 1 , wherein the surgical conduit comprises a valved conduit having a tubular graft portion and a one-way valve attached to a second end of the graft portion, the one way valve permitting flow from the second end to the first end but preventing flow in the opposite direction.

5 . The system of claim 4 , wherein the valved conduit includes a resilient sealing ring adjacent the one-way valve which extends radially outward from the graft, and wherein the structure for clamping and sealing includes a pair of rigid clamps sized and shaped to axially compress the sealing ring.

6 . The system of claim 5 , wherein the valved conduit is an aortic valve conduit and the sealing ring has a peripheral shape that undulates so as to mimic the aortic annulus, and the rigid clamps each have facing clamp surfaces that undulate to match the contours of the sealing ring.

7 . The system of claim 6 , wherein the structure for clamping and sealing includes flow channels through both manifolds from external fittings, each manifold having an internal piston arranged to be displaced toward the surgical conduit when pressurized gas is introduced to the respective flow channels, the piston in the manifold that receives the second end of the graft configured to contact one of the rigid clamps and compress it against the other, and the structure on the manifold that receives the first end of the graft includes an elastomeric ring that is compressed by piston displacement and positioned to expand inward and clamp and seal the graft against a rigid mandrel provided within the conduit.

8 . A surgical conduit leak testing system, comprising:
a manifold assembly including a first manifold spaced from a second manifold, each of the first and second manifolds sealingly clampable to a respective end of a surgical conduit, the first manifold fluidly coupling a lumen of the surgical conduit to a testing gas port when the surgical conduit is sealingly clamped thereto; and a meter fluidly coupled to the testing gas port, the meter suitable for determining at least one of a gas flow rate or a gas pressure.

9 . The leak testing system of claim 8 , wherein the gas meter includes a mass flow meter.

10 . The leak testing system of claim 8 , further comprising a pressure controller fluidly coupled to the testing gas port, the pressure controller suitable for controlling a pressure of a testing gas.

11 . The leak testing system of claim 8 , wherein
each of the first and second manifolds comprises a piston disposed in a chamber therein, the piston is reversibly displaceable within the chamber between a first position and a second position, wherein in the first position, the respective end of the surgical conduit is not sealingly clamped to the respective manifold and in the second position, the respective end of the surgical conduit is sealingly clamped to the respective manifold.

12 . The leak testing system of claim 11 , wherein
at least one of the first and second manifolds includes a mandrel, a portion of which is dimensioned to receive the respective end of the surgical conduit and an elastomeric clamping ring disposed around the portion of the mandrel, when the piston in the first position, the elastomeric clamping ring is radially spaced from the portion of the mandrel by a first distance, when the piston in the second position, the piston compresses the elastomeric clamping ring, urging the elastomeric clamping ring radially towards the portion of the mandrel to a radial space of a second distance, and the first distance is greater than the second distance.

13 . The leak testing system of claim 11 , wherein
one of the first and second manifolds includes a first end clamp and a second end clamp, the first end clamp and the second end clamp dimensioned to receive a flange of the surgical conduit therebetween, and when the piston is in the second position, the piston urges the first end clamp and the second end clamp together to sealingly clamp the flange of the surgical conduit to the manifold.

14 . The leak testing system of claim 11 , wherein the piston is displaceable from the first position to the second position by applying fluid pressure thereto.

15 . The leak testing system of claim 8 , wherein at least one of the first and second manifolds is moveable towards and away from the other of the first and second manifolds.

16 . A method for leak testing a surgical conduit, the method comprising:
pressurizing a lumen of a surgical conduit with an inert gas; and measuring at least one of a flow rate or a pressure of the inert gas.

17 . The method of claim 16 , further comprising sealing a first and a second end of the surgical conduit to a test fixture, wherein the first end and the second end of the surgical conduit are movable relative to each other.

18 . The method of claim 16 , wherein the pressuring with the inert gas comprises pressuring with air.

19 . The method of claim 16 , wherein measuring the flow rate comprises measuring a mass flow rate.

20 . The method claim 16 , wherein measuring the pressure comprises measuring a pressure drop over time.

21 . The method claim 16 , further comprising comparing the measured flow rate and/or pressure with a selected flow rate or pressure.

22 . A method for leak testing a surgical conduit, the method comprising:
pressurizing a lumen of a surgical conduit with an inert gas; and measuring at least one of a flow rate or a pressure of the inert gas over a period of time.

23 . The method claim 16 , comprising the steps of:
positioning a surgical conduit within a test fixture including a manifold assembly, the manifold assembly having structure for clamping and sealing onto opposite ends of

Assignees

• Edwards Lifesciences Corp

Inventors

• Van Nest Mark
• Kornswiet Alyssa E
• Lau Jackie P

Classifications

• G01M3/2876 Primary

  for valves (G01M3/30 takes precedence) · CPC title

• G01M3/2807 Primary

  for pipes (G01M3/2892, G01M3/30 take precedence) · CPC title

• G01M3/2815

  using pressure measurements · CPC title

• G01M3/2846

  for tubes (G01M3/30 takes precedence) · CPC title