US6306176B1 — Bonding layers for medical device surface coatings

Claim 1

Independent Claim 133 words

An insertable medical device comprising an abrasion resistant biocompatible surface coating applied to an inert surface of the device, the inert surface having no reactive functional groups, the surface coating comprising: (a) a coherent bond coat layer applied to the inert surface comprising at least one bonding polymer bonded with non-covalent bonds with the inert surface of the device without the need for penetration into the inert surface, and further comprising (b) at least one outer layer applied to the bond coat layer that adheres to the bond coat layer, the coating remaining adherent to the surface and resistant to abrasion and to removal from the device after soaking in water relative to a coating without the bond coat layer, and the coating remaining adherent when subjected to bending through a small radius.

Claim 2

Dependent Claim 133 words

An insertable medical device comprising an abrasion resistant biocompatible surface coating applied to an inert surface of the device, the inert surface having no reactive functional groups, the surface coating comprising: (a) a coherent bond coat layer applied to the inert surface comprising at least one bonding polymer bonded with non-covalent bonds with the inert surface of the device without the need for penetration into the inert surface, and further comprising (b) at least one outer layer applied to the bond coat layer that adheres to the bond coat layer, the coating remaining adherent to the surface and resistant to abrasion and to removal from the device after soaking in water relative to a coating without the bond coat layer, and the coating remaining adherent when subjected to bending through a small radius.

Claim 3

Dependent Claim 16 words

A device according to claim 1 , wherein the bonding polymer does not comprise chlorinated polyolefins.

Claim 4

Dependent Claim 25 words

A device according to claim 1 , wherein the bonding polymer does not comprise a copolymer of a vinyl monomer and a carboxylic acid monomer.

Claim 5

Dependent Claim 20 words

A device according to claim 1 , wherein the small radius has a diameter of less than about 3 cm.

Claim 6

Dependent Claim 20 words

A device according to claim 1 , wherein the small radius has a diameter of less than about 1 cm.

Claim 7

Dependent Claim 19 words

A device according to claim 1 , the inert surface having been pretreated with plasma or other ionizing pretreatment.

Claim 8

Dependent Claim 19 words

A device according to claim 6 , said coating having been applied more than one day after the pretreatment.

Claim 9

Dependent Claim 80 words

A device according to claim 1 , in which the bonding polymer is selected from the group consisting of acetals, ethylene copolymers, polymers containing hydroxyl, amine, carboxyl, or amide reactive groups, styrene acrylic polymer, ethylene acrylic acid copolymer, carboxyl function acrylic polymer, hydroxyl function acrylic polymer, acrylic dispersion polymers, methyl methacrylate, butyl methacrylate, isobutyl methacrylate, ethyl methacrylate, methyl acrylate, ethyl acrylate, acrylic acid, styrene methacrylate, and styrene acrylate, polyvinylpyrrolidone, vinylpyrrolidone-vinylacetate copolymers, ethylene acrylic acid copolymers, epoxy polymers, and copolymers thereof.

Claim 10

Dependent Claim 14 words

A device according to claim 1 , wherein the bonding polymer includes reactive groups.

Claim 11

Dependent Claim 27 words

A device according to claim 9 , the bond coat layer having been formed with a cross linker that interacts with reactive groups of the bonding polymer.

Claim 12

Dependent Claim 25 words

A device according to claim 10 , wherein the cross linker is selected from the group consisting of urea resins, melamines, isocyanates, epoxies, and phenolics.

Claim 13

Dependent Claim 21 words

A device according to claim 1 , wherein the bond coat layer has a thickness of less than about 100 microns.

Claim 14

Dependent Claim 21 words

A device according to claim 1 , in which the bond coat thickness is between about 1 and about 10 microns.

Claim 15

Dependent Claim 23 words

A device according to claim 1 , in which the surface coating has a total coating thickness of less than about 40 microns.

Claim 16

Dependent Claim 40 words

A device according to claim 1 , in which the inert surface comprises a material selected from the group consisting of stainless steel, nickel, gold, chrome, nickel titanium alloy, platinum, metals, silicone, polyesters, polyolefins, polyethylene, polyprolylene, latex rubbers and polyisocyanates.

Claim 17

Dependent Claim 38 words

A device according to claim 1 selected from the group consisting of needles, guide wires, catheters, surgical instruments, equipment for endoscopy, wires, stents, angioplasty balloons, wound drains, arteriovenuous shunts, gastroenteric tubes, urethral inserts, laproscopic equipment, pellets, and implants.

Claim 18

Dependent Claim 30 words

A device according to claim 1 , wherein the outer layer comprises at least one of a lubricious coating, a medicated coating, a colored coating and an abrasion resistant coating.

Claim 19

Dependent Claim 22 words

A device according to claim 1 , further comprising covalent bonds between the bond coat layer and the surface of the device.

Claim 20

Dependent Claim 19 words

A device according to claim 1 , wherein the coating is resistant to removal by adhesive tape after soaking.

Claim 21

Dependent Claim 24 words

A device according to claim 1 , wherein the coating is applied without subjecting the coating to heating for more than about six hours.

Claim 22

Dependent Claim 28 words

A device according to claim 1 , wherein the outer layer is hydrophilic and the bond coat layer resists penetration of water to the surface of the device.

Claim 23

Dependent Claim 32 words

A device according to claim 1 , prepared by a method comprising the steps of forming the bond coat layer and then forming the coating layer over the preformed bond coat layer.

Claim 24

Dependent Claim 99 words

A composition adapted for forming a biocompatible surface coating on an inert surface of a medical device, the composition comprising a biocompatible bonding polymer that bonds non-covalently with the inert surface of the device without the need for penetration into the inert surface to form a bond coat, the bonding polymer further being selected to adhere to an outer layer applied over the bond coat layer, the coating remaining adherent to the substrate and resistant to abrasion and removal by adhesive tape after soaking in water and the coating remaining adherent when subjected to bending through a small radius.

Claim 25

Dependent Claim 99 words

A composition adapted for forming a biocompatible surface coating on an inert surface of a medical device, the composition comprising a biocompatible bonding polymer that bonds non-covalently with the inert surface of the device without the need for penetration into the inert surface to form a bond coat, the bonding polymer further being selected to adhere to an outer layer applied over the bond coat layer, the coating remaining adherent to the substrate and resistant to abrasion and removal by adhesive tape after soaking in water and the coating remaining adherent when subjected to bending through a small radius.

Claim 26

Dependent Claim 17 words

A composition according to claim 23 , wherein the bonding polymer does not comprise a chlorinated polyolefin.

Claim 27

Dependent Claim 24 words

A composition according to claim 23 , wherein the bonding polymer is not a copolymer of a vinyl monomer with a carboxylic acid monomer.

Claim 28

Dependent Claim 111 words

In a biocompatible coating comprising an outer layer on an insertable medical device having an inert surface without reactive functional groups, the improvement comprising a coherent bond coat layer formed by a bonding polymer that bonds non-covalently with the inert surface of the device without the need for penetration into the inert surface, the bonding polymer further adhering to an outer layer applied over the bond coat layer, the coating remaining adherent to the substrate and resistant to abrasion and removal during a period of insertion relative to a coating without the bond coat and the coating remaining adherent when subjected to bending through a small radius of about 3 cm.

Claim 29

Dependent Claim 111 words

In a biocompatible coating comprising an outer layer on an insertable medical device having an inert surface without reactive functional groups, the improvement comprising a coherent bond coat layer formed by a bonding polymer that bonds non-covalently with the inert surface of the device without the need for penetration into the inert surface, the bonding polymer further adhering to an outer layer applied over the bond coat layer, the coating remaining adherent to the substrate and resistant to abrasion and removal during a period of insertion relative to a coating without the bond coat and the coating remaining adherent when subjected to bending through a small radius of about 3 cm.

Claim 30

Dependent Claim 124 words

An abrasion-resistant coating applied to an insertable medical device comprising an inert surface that does not have reactive functional groups, the coating comprising: (a) a coherent bond coat layer applied to the inert surface comprising at least one bonding polymer bonded with non-covalent bonds with the inert surface of the device without the need for penetration into the device, and further comprising (b) at least one outer layer applied to the bond coat layer that adheres to the bond coat layer, the coating remaining adherent to the surface and resistant to abrasion and to removal from the device after soaking in water relative to a coating without the bond coat layer, and the coating remaining adherent when subjected to bending through a small radius.

Claim 31

Dependent Claim 124 words

An abrasion-resistant coating applied to an insertable medical device comprising an inert surface that does not have reactive functional groups, the coating comprising: (a) a coherent bond coat layer applied to the inert surface comprising at least one bonding polymer bonded with non-covalent bonds with the inert surface of the device without the need for penetration into the device, and further comprising (b) at least one outer layer applied to the bond coat layer that adheres to the bond coat layer, the coating remaining adherent to the surface and resistant to abrasion and to removal from the device after soaking in water relative to a coating without the bond coat layer, and the coating remaining adherent when subjected to bending through a small radius.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2004-10-22	2005-04-23	2005-10-23	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2008-10-22	2009-04-23	2009-10-23	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2012-10-22	2013-04-23	2013-10-23	$7700.00	Window Closed / Lapsed

Bonding layers for medical device surface coatings

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