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US 12,741,045 B2Granted
Reprocessing a single-use medical device
AssigneeInnovative Health
InventorsBlessan C. Joseph, Rafal Chudzik, Haley C. Ellis
Life of this patent
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Abstract
The present invention provides a method for reprocessing single-use medical devices. The method can include removing a coating from a single-use medical device, validating the removal of the coating, cleaning the single-use medical device, and applying a new coating to the single-use medical device.
Claims7
A method for reprocessing a single-use medical device comprising:
- removing one or more polymeric coatings on a surface of the single-use medical device by contacting the one or more polymeric coatings on the surface of the single-use medical device to, or with, one or more solvents;
- preparing the surface of the single-use medical device for a polymeric recoating;
- applying the polymeric recoating on the surface of the single-use medical device;
- and
- validating the polymeric recoating on the single-use medical device,
- wherein validating the polymeric recoating comprises:
- hydrating the polymeric recoating;
- performing a friction force test on the polymeric recoating to test a lubricity of the polymeric recoating, wherein the lubricity is measured in grams grand average force over a 15 pull test cycle;
- and
- confirming the polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force,
- wherein the friction force test is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500 grams, a velocity of the single-use medical device through the clamps of 1 cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
8 more elements
A method for reprocessing a single-use medical device comprising:
- removing one or more polymeric coatings on a surface of the single-use medical device by contacting the one or more polymeric coatings to, or with, one or more solvents;
- applying at least one polymeric recoating on the surface of the single-use medical device;
- and
- validating the at least one polymeric recoating on the single-use medical device,
- wherein validating the at least one polymeric recoating comprises:
- hydrating the at least one polymeric recoating;
- performing a friction force test on the at least one polymeric recoating to test a lubricity of the at least one polymeric recoating over a 15 pull test cycle, wherein the lubricity is measured in grams grand average force;
- and
- confirming the at least one polymeric recoating has a lubricity within an acceptance criteria, wherein the acceptance criteria includes a grams grand average force of less than or equal to 171 grams grand average force
- wherein the friction force test is conducted using a friction force test system operable to provide the friction force test using a clamp force of 500grams, a velocity of the single-use medical device through the clamps of 1cm/second, an acceleration time of the single-use medical device of 1 second, a pull distance of 10 cm, and a sample rate of 1 sample/mm.
7 more elements
Dependencies are inferred from the claim text.