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US 2021/0196903 A1Published application
Catheter test apparatus, kits, and methods
AssigneeMerit Medical Systems, Inc.
InventorsFred Lampropoulos, Steven Weir, Gregory R. McArthur
Life of this patent
Estimating the term…
Abstract
Apparatus, methods, and kits are for testing a catheter for an obstruction with a lumen by a medical practitioner at the point of use. In some embodiments, an elongate member, including elongate members comprising a gauge portion, is inserted into the lumen configured to detect a reduced diameter condition.
Claims20
A catheter test apparatus, comprising:
- a body comprising:
- a chamber extending at least partially through the body, and
- a distal end cap including an aperture extending therethrough;
- a piston disposed within the chamber;
- and
- an elongate member configured to be disposed within a lumen of a catheter, wherein the elongate member is disposed through the aperture and is coupled to the piston such that longitudinal displacement of the elongate member correlates to displacement of the piston within the chamber,
- wherein the elongate member comprises a gauge portion disposed at a distal end of the elongate member, the gauge portion sized to be 1) displaceable within the lumen if a minimum inside diameter of the lumen is greater than a predetermined limit and 2) not displaceable within the lumen if the minimum inside diameter is below the predetermined limit;
- and
- wherein the catheter test apparatus is configured to provide an indication to a medical practitioner of a presence and/or an absence of an obstruction within the lumen such that, in use, 1) a position of the piston proximal of a predetermined distance from a hub of the catheter indicates the presence of the obstruction within the lumen, and 2) a position of the piston adjacent to or distal of a predetermined distance from the hub indicates the absence of the obstruction within the lumen.
6 more elements
A method of testing a catheter, comprising:
- providing a catheter test apparatus comprising an elongate member comprising a gauge portion disposed at a distal end of the elongate member, the gauge portion sized to be 1) displaceable within a lumen of a catheter if a minimum inside diameter of the lumen is greater than a predetermined limit and 2) not displaceable within the lumen if the minimum inside diameter is below the predetermined limit,
- wherein the catheter test apparatus is configured to provide an indication to a medical practitioner of a presence and/or an absence of an obstruction within the lumen such that, in use, 1) a position of a proximal end of the elongate member proximal of a predetermined distance from a hub of the catheter indicates the presence of an obstruction within the lumen, and 2) a position of the proximal end adjacent to or distal of a predetermined distance from the hub indicates the absence of the obstruction within the lumen;
- providing a catheter to be tested;
- inserting the gauge portion through a hub of the catheter and disposing the gauge portion adjacent a proximal opening of a lumen of the catheter;
- applying a force up to a predetermined magnitude distally to the elongate member;
- allowing the gauge portion to displace distally in response to the force;
- visually assessing the position of the proximal end of the elongate member with respect to the predetermined distance;
- and
- determining if the position of the proximal end of the elongate member is proximal of the predetermined distance.
6 more elements
A kit for testing a catheter comprising:
- a catheter test apparatus comprising an elongate member including a gauge portion disposed at a distal end of the elongate member, the gauge portion sized to be 1) displaceable within a lumen of a catheter if a minimum inside diameter of the lumen is greater than a predetermined limit and 2) not displaceable within the lumen if the minimum inside diameter is below the predetermined limit,
- wherein the catheter test apparatus is configured to provide an indication to a medical practitioner of a presence and/or an absence of an obstruction within the lumen such that, in use, 1) a position of the piston proximal of a predetermined distance from a hub of the catheter indicates the presence of an obstruction within the lumen, and 2) a position of the piston adjacent to or distal of a predetermined distance from the hub indicates the absence of the obstruction within the lumen;
- and
- a vascular device to be inserted within a lumen of a catheter to be tested;
- and
- a package configured to contain the catheter test apparatus and the vascular medical device, the package comprising at least two sterile compartments,
- wherein each of the catheter test apparatus and the vascular device is disposed individually within one of the at least two sterile compartments.
4 more elements
Dependencies are inferred from the claim text.