Sutures with expanded antibacterial properties
The present invention is directed to coated medical devices, such as implantable and coatable devices, such as sutures, with expanded antibacterial properties, handling, knot slide and in-situ performance and processes for their manufacture and use.
1 . A coated medical device comprising at least one implantable segment having a coating of:
an effective amount of triclosan;
and
b. A triclophilic component that is lubricious or a triclophilic component and a lubricious component, or combinations thereof;
wherein
(i) the amount of triclosan is between about 150 micrograms per meter and about 2500 micrograms per meter, and
(ii) the coating is substantially homogeneous and has a density in the coating of triclosan between about 40 micrograms per cubic
millimeter (μg/mm 3 ) and about 1000 μg/mm 3 .
2 . A coated medical device of claim 1 wherein the triclophilic component is lubricious.
3 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds 150 μg (micrograms) per meter of suture (μg/m), has a triclosan density in the triclophilic components greater than about 40 μg/mm 3 , and consistently sustains at least 3 millimeters (mm) Zone of Inhibition against E. cloacae at 24 hours.
4 . A coated medical device according to claim 3 that is a suture having a USP size 2 through 3/0 and the weight percent of the coating to suture weight is between 0.5% and 8%.
5 . A coated medical device according to claim 3 that is a suture having a USP size 4/0 and the weight percent of the coating to suture weight is between 4% and 10%.
6 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds 100 μg (micrograms) per meter of suture (ug/m), has a triclosan density in the triclophilic components greater than about 40 μg/mm 3 , and consistently sustains at least 3 millimeters (mm) Zone of Inhibition against E. cloacae at 24 hours.
7 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds 150 μg/m of suture and sustains at least 3 mm Zone of Inhibition against E. cloacae for at least 3 days.
8 . A coated medical device according to claim 7 that is a braided suture and has a suture coating in which the triclosan density in the coating exceeds 70 ug/mm 3 , and sustains at least 3 mm Zone of Inhibition against E. cloacae for at least 3 days.
9 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds about 150 μg/m and reduces bacterial attachment of E. cloacae with at least one 3 log reduction in 20% Serum:Saline:Tryptic soy Broth (TSB) (SST) containing media relative to a non-triclosan containing suture of the same chemical nature, architecture and size.
10 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds 200 μg/m of suture, and sustains at least 3 log reduction against E. cloacae in 5% SST containing media relative to a non-triclosan containing suture of the same chemical nature, architecture and size for at least 2 days.
11 . A coated medical device according to claim 1 that is a braided suture and has a suture coating in which the amount of triclosan exceeds 300 μg/m of suture and wherein coating thickness exceeds about 2 micrometer (μm), and sustains at least 3 log reduction against E. cloacae in 5% SST containing media relative to a non-triclosan containing suture of the same chemical nature, architecture and size for at least 3 days.
12 . A coated medical device according to claim 1 that is a suture having a suture USP size between and including sizes 0 to 4/0 that is braided and a quantitative knot slide value of less than 60 N/m.
13 . A coated medical device according to claim 1 that is a suture having a suture USP size between and including sizes 0 to 4/0 that is braided wherein the triclosan density in the coating is less than about 1000 ug/mm 3 .
14 . A coated medical device according to claim 1 that is a suture having a suture USP size 1 that is braided and a quantitative knot slide value of less than 85 N/m.
15 . A coated medical device according to claim 1 that is a suture having a suture USP size 1 that is braided wherein the triclosan density in the coating is less than 400 ug/mm 3 .
16 . A coated medical device according to claim 1 that is a suture having a suture USP size 2 that is braided and a quantitative knot slide value of less than 130 N/m.
17 . A coated medical device according to claim 1 that is a suture having a suture USP size 2 that is braided wherein the triclosan density in the coating is less than 400 ug/mm 3 .
18 . A coated medical device according to claim 1 that is a suture having a suture USP size between and includes sizes 2 to 4/0.
19 . A coated medical device according to claim 1 that is a suture in the form of a coated, multifilament braid of polyglactin 910.
20 . A coated medical device according to claim 1 wherein the triclophilic component is a coating of poly(e-caprolactone-co-glycolide) 90/10, poly(glycolide-co-lactide) 65/35, or combinations thereof.
21 . A coated medical device according to claim 1 wherein the weight ratio of poly(glycolide-co-lactide) 65/35 to poly(e-caprolactone-go-glycolide) 90/10 is 0 to 1.0.
22 . A coated medical device according to claim 1 that is a suture in a sealed package with antimicrobial
agent on an interior surface or embedded within the material of the package.
23 . A coated medical device according to claim 22 wherein the sealed package is made of polypropylene, high density polyethylene (HDPE), paper, or combinations thereof.
24 . A coating solution for coating a medical device according to claim 1, or 2 which is a braided suture of USP size 2 through 3/0 comprising:
a. about 3 weight percent to at least about 8 weight percent of poly(e-caprolactone-co-glycolide) having a monomer ratio of caprolactone to glycolide of 90/10, and
b. about 0 to about 6 weight percent of poly(glycolide-co-lactide) having a monomer ratio of glycolide to lactide of 65/35.
25 . A coating solution according to claim 24 comprising:
a. from about 4 weight percent to about 8 weight percent of poly(e-caprolactone-co-glycolide) having a monomer ratio of caprolactone to glycolide of 90/10 and
b. from about 0 to about 4 weight percent of poly(glycolide-co-lactide) having a monomer ratio of glycolide to lactide of 65/35.
26 . A coating solution for coating a medical device according to claim 1, or 2 which is a braided suture of USP size 4/0 compromising:
a. about 8 weight percent to at least about 16 weight percent of poly(e-caprolactone-co-glycolide) having a monomer ratio of caprolactone to glycolide of 90/10, and
b. about from 5 to 8 weight percent of poly(glycolide-co-lactide) having a monomer ratio of glycolide to lactide of 65/35.
27 . A method of introducing triclosan into the medical device according to claim 1 wherein the medical device is a coated braided suture, by exposing the coated suture to patches having a reservoir of triclosan, wherein the transfer occurs under raised temperature and/or reduced pressure.
28 . A method of introducing triclosan into the medical device according to claim 1 wherein the medical device is a coated braided suture, exposing the suture to a reservoir of triclosan located or embedded within dosed trays, wherein the transfer occurs under raised temperature and/or reduced pressure.