Low particulate lubricious coating with vinyl pyrrolidone and acidic polymer-containing layers
Embodiments of the disclosure include lubricious coatings. In an embodiment the disclosure includes a lubricious coating for a medical device including first and second coated layers. The first coated layer is between the second coated layer and the device surface and includes a vinyl pyrrolidone polymer and a photo reactive group. The second coated layer is in direct contact with the first coated layer and is a top coating that includes an acrylic acid polymer. The second coated layer can optionally include photoreactive groups. The coating was found to have a very low number of particulates (e.g., 10 μm or greater) which is very desirable for in vivo use.
1. A method for forming a lubricious coating on a medical device comprising:
(a) obtaining a medical device comprising a coated layer comprising a vinyl pyrrolidone polymer; and
(b) applying a coating composition comprising an acrylic acid polymer to at least a portion of the coated layer comprising the vinyl pyrrolidone polymer to form a second coated layer that is a top coating comprising the acrylic acid polymer, wherein the second coated layer is different in composition than, and is in direct contact with, the coated layer comprising the vinyl pyrrolidone polymer, wherein the coated layer comprising the vinyl pyrrolidone polymer is between the second coated layer and a substrate surface,
wherein the coated layer comprising the vinyl pyrrolidone polymer does not include the acrylic acid polymer of the second coated layer, and the second coated layer does not include the vinyl pyrrolidone polymer.
2. The method of claim 1 where, in step (a) the medical device comprising the coated layer comprising the vinyl pyrrolidone polymer is provided in sterile form prior to step (b).
3. The method of claim 1 where, in step (a) the medical device comprising the coated layer comprising the vinyl pyrrolidone polymer is provided in a package prior to step (b).
4. The method of claim 1 wherein step (b) is performed in a setting wherein insertion of the medical device into a patient is performed.
5. The method of claim 4 wherein the setting is a hospital or medical clinic or a hospital.
6. The method of claim 1 wherein step (b) comprises use of a kit comprising an acrylic acid polymer.
7. The method of claim 1 wherein the vinyl pyrrolidone polymer is a vinyl pyrrolidone polymer homopolymer (poly(vinyl pyrrolidone)).
8. The method of claim 1 wherein the acrylic acid polymer is an acrylic acid homopolymer (poly(acrylic acid)).
9. The method of claim 1 , wherein the acrylic acid polymer has an average molecular weight of 150 kDa or greater.
10. The method of claim 1 wherein the coating composition further comprises a photoreactive group and in step (b) further comprises treating the coating composition with UV light.
11. The method of claim 10 wherein the second coated layer comprises a cross-linking reagent of formula Photo 1 -LG-Photo 2 , wherein Photo 1 and Photo 2 , independently represent at least one photoreactive group and LG represents a linking group comprising at least one silicon or at least one phosphorus atom, there is a covalent linkage between at least one photoreactive group and the linking group, wherein the covalent linkage between at least one photoreactive group and the linking group is interrupted by at least one heteroatom.
12. The method of claim 11 wherein the cross-linking agents is a compound of formula selected from:
(a)
wherein R 1 , R 2 , R 8 and R 9 are any substitution; R 3 , R 4 , R 6 and R 7 are alkyl, aryl, or a combination thereof; R 5 is any substitution; and each X, independently, is O, N, Se, S, or alkyl, or a combination thereof;
(b)
wherein R 1 and R 5 are any substitution; R 2 and R 4 can be any substitution, except OH; R 3 can be alkyl, aryl, or a combination thereof; and each X, independently, is O, N, Se, S, alkyl or a combination thereof;
(c)
wherein R 1 , R 2 , R 4 and R 5 are any substitution; R 3 is any substitution; R 6 and R 7 are alkyl, aryl, or a combination thereof; and each X, independently, is O, N, Se, S, alkyl, or a combination thereof; and
(d)
13. The method of claim 12 wherein the cross-linking agent(s) is sodium bis(4-benzoylphenyl) phosphate.
14. The method of claim 1 , wherein the coating releases particulates of less than 3,000 particles greater than 10 microns.
15. The method of claim 1 , wherein the thickness of the coated layers combined is between about 100 and 1000 nm when dry.
16. The method of claim 1 wherein at least a portion of the medical device comprises polyamide, polyimide, polyether block amide (PEBAX), polyether ether ketone (PEEK), high density polyethylene (HDPE), polyethylene, polyurethane, or polyethylene vinyl acetate.
17. The method of claim 1 wherein the medical device comprises a catheter.
18. The method of claim 1 wherein the medical device comprises a metal substrate, or that is selected from the group consisting of embolic protection devices and mapping/ablation catheters.
19. A kit for carrying out the method of claim 1 comprising the acrylic acid polymer, and optionally one or more further components selected from the group consisting of crosslinker, secondary polymer, detection agent, bioactive agent, and further optionally receptacle configured for a coating process, or a an applicator for applying the acrylic acid polymer to the device.
20. A method for forming a lubricious coating on a medical device comprising:
(a) obtaining a medical device comprising a coated layer comprising a sole polymeric component that is a vinyl pyrrolidone polymer; and
(b) applying a coating composition comprising a sole polymeric component that is an acrylic acid polymer to at least a portion of the coated layer comprising the vinyl pyrrolidone polymer to form a second coated layer that is a top coating comprising the acrylic acid polymer, wherein the second coated layer is in direct contact with the coated layer comprising the vinyl pyrrolidone polymer, wherein the coated layer comprising the vinyl pyrrolidone polymer is between the second coated layer and a substrate surface, and wherein there is hydrogen bonding between the vinyl pyrrolidone polymer and the acrylic acid polymer of the second coated layer.
21. A method for forming a lubricious coating on a medical device comprising:
(I) obtaining a medical device comprising a coated layer comprising a vinyl pyrrolidone polymer; and
(II) applying a coating composition comprising an acrylic acid polymer to at least a portion of the coated layer comprising the vinyl pyrrolidone polymer to form a second coated layer that is a top coating comprising the acrylic acid polymer, wherein the second coated layer is different in composition than, and is in direct contact with, the coated layer comprising the vinyl pyrrolidone polymer, wherein the coated layer comprising the vinyl pyrrolidone polymer is between the second coated layer and a substrate surface, wherein:
(a) the first coated layer comprises (i) a vinyl pyrrolidone polymer without photoreactive groups and (ii) a vinyl pyrrolidone polymer comprising a photoreactive group;
(b) the second coated layer further comprises an acrylamide polymer comprising at least one photo reactive group; or
both (a) and (b).
22. A method for forming a lubricious coating on a medical device comprising:
(a) obtaining a medical device comprising a first coated layer consisting essentially of a vinyl pyrrolidone polymer or consisting essentially of a vinyl pyrrolidone polymer and photogroups; and
(b) applying a coating composition consisting essentially of an acrylic acid polymer to at least a portion of the first coated layer to form a second coated layer that is a top coating, wherein the second coated layer is in direct contact with the first coated layer, wherein the first coated layer is between the second coated layer and a surface of the medical device.