Surgical conduit leak testing

• US 10,119,882 B2
• Filed: 03/09/2016
• Issued: 11/06/2018
• Est. Priority Date: 03/10/2015
• Status: Active Grant

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Edwards Lifesciences Corporation
• Inventors: Van Nest, Mark, Kornswiet, Alyssa E., Lau, Jackie P.
• Primary Examiner(s): Macchiarolo, Peter
• Assistant Examiner(s): Kolb, Nathaniel
• Application Number:
  US15/065,720
• Publication Number:
  US 20160266004A1
• Time in Patent Office: 972 Days
• Field of Search: 73 37- 498
• CPC Class Codes: G01M 3/2846 for tubes G01M3/30 takes precedence
• CPC Class Codes: G01M 3/2876 for valves G01M3/30 takes precedence

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.

Claims

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;

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;

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;

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

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 portion 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 portion includes an elastomeric ring that is compressed by piston displacement and positioned to expand inward and clamp and seal the graft portion against a rigid mandrel provided within the conduit.

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 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.

4. 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;

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;

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; and

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 is 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.

5. The leak testing system of claim 4, wherein the gas meter includes a mass flow meter.

6. The leak testing system of claim 4, further comprising a pressure controller fluidly coupled to the testing gas port, the pressure controller suitable for controlling a pressure of a testing gas.

7. The leak testing system of claim 4, 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.

8. The leak testing system of claim 4, wherein the piston is displaceable from the first position to the second position by applying fluid pressure thereto.

9. The leak testing system of claim 4, wherein at least one of the first and second manifolds is moveable towards and away from the other of the first and second manifolds.

10. A method for leak testing a surgical conduit, the method comprising:

positioning a surgical conduit within a test fixture including first and second spaced apart manifolds, each manifold having structure for clamping and sealing onto opposite ends of the surgical conduit, 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;

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;

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, and when the piston is in the second position the piston compresses the elastomeric clamping ring to seal around the end of the surgical conduit;

pressurizing a lumen of a surgical conduit with an inert gas;

measuring a flow rate of the inert gas;

wherein the step of pressurizing a lumen of a surgical conduit with an inert gas includes introducing the inert gas to the external fitting until a predetermined pressure within the conduit is reached;

maintaining the internal pressure for the period of time while performing the step of measuring; and

determining if there is a leak in the surgical conduit based on the measured flow rate.

11. The method of claim 10, 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.

12. The method of claim 10, wherein the pressuring with the inert gas comprises pressuring with air.

13. The method of claim 10, wherein measuring the flow rate comprises measuring a mass flow rate.

14. The method claim 10, further comprising comparing the measured flow rate with a selected flow rate.

15. A method for leak testing a surgical conduit, the method comprising:

positioning a surgical conduit having a tubular graft portion within a test fixture including first and second spaced apart manifolds, each manifold having structure for clamping and sealing onto opposite ends of the surgical conduit, 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;

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;

wherein the surgical conduit includes a resilient sealing ring on a first end which extends radially outward from the tubular graft portion, and wherein the structure for clamping and sealing on the first manifold includes a pair of rigid clamps sized and shaped to axially compress the sealing ring;

pressurizing a lumen of a surgical conduit with an inert gas;

measuring at least one of a flow rate or a pressure of the inert gas over a period of time;

wherein the step of pressurizing a lumen of a surgical conduit with an inert gas includes introducing the inert gas to the external fitting until a predetermined pressure within the conduit is reached;

maintaining the internal pressure for the period of time while performing the step of measuring; and

determining if there is a leak in the surgical conduit based on the measured flow rate.

16. The system of claim 15, wherein the surgical 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.