# US 2013/0158488 A1 · Luminal modifications for catheters > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 2013/0158488 A1 - Document ID: US20130158488A1 - Status: Published application - Kind: A1 - Application number: 13/715,141 - Filed: 2012-12-14 - Published: 2013-06-20 - Earliest claimed: 2011-12-14 - Assignees: Semprus Biosciences Corp. - Inventors: Douglas WEAVER; Zheng ZHANG; Jun LI; Matt SKINNER; Laurence ROTH; Michael BOUCHARD; Eric W. MARCHESE; Abby N. DELEAULT; Abbe MILLER; Chad HUVAL; Christopher R. LOOSE; Arthur COURY - Web page: https://patentgrep.com/patent/US20130158488A1 ## CPC - A61M 25/0021: {characterised by the form of the tubing (A61M25/0054 takes precedence)} - A61L 29/085: {Macromolecular materials} - A61L 29/14: Materials characterised by their function or physical properties {, e.g. lubricating compositions} - A61M 25/00: Catheters; Hollow probes (dilators A61M29/00; {peritoneal catheters A61M1/285; tracheal tubes A61M16/04; for drainage A61M27/00; for uterus, vagina or rectum A61M31/00} ; for measuring or testing A61B; {materials for catheters A61L29/00}) - A61M 25/0009: {Making of catheters or other medical or surgical tubes} - A61M 25/0043: {characterised by structural features} - B05D 7/22: to internal surfaces, e.g. of tubes - B05D 7/24: for applying particular liquids or other fluent materials - A61M 2025/0019: {Cleaning catheters or the like, e.g. for reuse of the device, for avoiding replacement} - A61M 2025/0047: {the inner layer having a higher lubricity} - Y10T 428/1352: Polymer or resin containing [i.e., natural or synthetic] - Y10T 428/1393: Multilayer [continuous layer] - A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)} - A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K) - B05D: PROCESSES FOR APPLYING FLUENT MATERIALS TO SURFACES, IN GENERAL (conveying articles or workpieces through baths of liquid B65G, e.g. B65G49/02) - Y10T: TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION ## Abstract Catheters and a method of preparation thereof comprising a catheter body and at least one connector. The catheter body has an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer has an average dry thickness of at least about 50 nanometers. ## Claims ### Claim 1 A catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer having an Average Dry Thickness wherein the Average Dry Thickness is at least about 200 nanometers. ### Claim 2 (depends on 1) The catheter of claim 1 wherein the catheter additionally comprises as component parts thereof a juncture hub having an exterior and at least one lumen having an intraluminal surface, and at least one extension line having an exterior surface and a lumen having an intraluminal surface. ### Claim 3 (depends on 2) The catheter of claim 2 wherein at least one lumen of the catheter body, juncture hub, extension line or connecter has an aspect ratio of at least 10:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon having a thickness of at least about 200 nm. ### Claim 4 (depends on 2) The catheter of claim 2 wherein at least one lumen of the catheter body, juncture hub, extension line or connecter has a proximal end, a distal end, a Midpoint Region located between 40% and 60% of the distance between the proximal and distal ends and an intraluminal surface comprising a hydrophilic polymer layer thereon having a thickness of at least about 200 nm in the Midpoint Region. ### Claim 5 (depends on 2) The catheter of claim 2 wherein the hydrophilic polymer layer on at least one intraluminal surface of a lumen comprised by the catheter body, juncture hub, extension line(s) or connector(s) is conformal at a level of 500 mm2. ### Claim 6 (depends on 2) The catheter of claim 2 wherein the catheter body, juncture hub, extension line(s) or connector(s) have an exterior surface and a hydrophilic polymer layer thereon, the hydrophilic polymer layer having a thickness of at least about 200 nm. ### Claim 7 (depends on 2) The catheter of claim 2 wherein the hydrophilic polymer layer on the exterior surface of the catheter body, juncture hub, extension line(s) or connector(s) is conformal at a level of 500 mm2. ### Claim 8 (depends on 2) The catheter of claim 2 wherein at least one of the catheter body, juncture hub, extension lines comprises a polyurethane polymer or copolymer. ### Claim 9 (depends on 1) The catheter of claim 1 wherein the catheter body has a proximal end, a distal end and a tip region having a length of 5 cm measured from the distal end of the catheter body, and a hydrophilic polymer layer having a thickness of at least about 50 nm on the exterior surface of the catheter body in the tip region or on an intraluminal surface of at least one lumen comprised by the catheter body in the tip region. ### Claim 10 (depends on 9) The catheter of claim 9 wherein the hydrophilic polymer layer on the exterior surface of the catheter body in the tip region or on at least one intraluminal surface of a lumen comprised by the catheter body in the tip region is conformal at a level of 0.5 mm2. ### Claim 11 (depends on 1) The catheter of claim 1 wherein the catheter body has a size of 1 French to 16 French. ### Claim 12 (depends on 1) The catheter of claim 1 wherein the catheter is a hemodialysis catheter, peripherally inserted central catheter, or central venous catheter. ### Claim 13 (depends on 1) The catheter of claim 1 wherein the catheter body comprises a radiopacifying agent. ### Claim 14 (depends on 13) The catheter of claim 13 wherein the catheter body comprises bismuth subcarbonate or barium sulfate. ### Claim 15 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer layer has a global average dry thickness wherein the standard deviation of the global average dry thickness of the grafted polymer layer does not exceed 100% of the global average dry thickness of the hydrophilic polymer layer. ### Claim 16 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer layer and the intraluminal surface or external surface, in combination, constitute a modified surface modified surface having a fibrinogen adsorption of less than about 90 ng/cm2 in a fibrinogen binding assay in which the modified surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml 1-125 radiolabeled fibrinogen. ### Claim 17 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer is non-fouling. ### Claim 18 (depends on 17) The catheter of claim 17 wherein the hydrophilic polymer is a zwitterionic polymer. ### Claim 19 (depends on 17) The catheter of claim 17 wherein the hydrophilic polymer is a carboxybetaine polymer or a sulfobetaine polymer. ### Claim 20 (depends on 17) The catheter of claim 17 wherein the hydrophilic polymer comprises repeat units at least 30% of which are derived from hydrophilic monomers. ### Claim 21 (depends on 17) The catheter of claim 17 wherein the hydrophilic polymer comprises alkoxylated moieties. ### Claim 22 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer layer and the intraluminal surface or external surface, in combination, constitute a modified surface, the hydrophilic polymer layer has an average dry thickness and a standard deviation of the average dry thickness wherein the standard deviation of the average dry thickness does not exceed 100% of the average dry thickness of the hydrophilic polymer layer. ### Claim 23 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer layer has an average dry thickness that is at least equal to the global average Rrms surface roughness of the intraluminal or external surface modified by the hydrophilic polymer layer. ### Claim 24 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer comprises repeat units corresponding to Formula 3: wherein X44 comprises an oxylated alkylene moiety, a zwitterionic moiety, an anionic moiety, or a cationic moiety. ### Claim 25 (depends on 1) The catheter of claim 1 wherein at least 30% of the repeat units of hydrophilic polymer layer are derived from zwitterionic monomers. ### Claim 26 (depends on 1) The catheter of claim 1 wherein the hydrophilic polymer is a homopolymer of zwitterionic monomers. ### Claim 27 A catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 250:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer having an Average Dry Thickness of at least about 50 nanometers. ### Claim 28 (depends on 27) The catheter of claim 27 wherein the catheter additionally comprises as component parts thereof a juncture hub having an exterior and at least one lumen having an intraluminal surface, and at least one extension line having an exterior surface and a lumen having an intraluminal surface. ### Claim 29 A catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon, the hydrophilic polymer layer having an Average Dry Thickness wherein (i) the Average Dry Thickness is at least about 50 nanometers and the hydrophilic polymer comprises repeat units, at least 30% of which are derived from a hydrophilic monomer, (ii) the Average Dry Thickness is at least about 50 nanometers and the standard deviation of the Average Dry Thickness of the hydrophilic polymer layer does not exceed 100% of the Average Dry Thickness of the hydrophilic polymer layer, or (iiii) the Average Dry Thickness is at least about 50 nanometers and the hydrophilic polymer layer is conformal at a level of 1 mm2. ### Claim 30 (depends on 29) The catheter of claim 29 wherein the catheter additionally comprises as component parts thereof a juncture hub having an exterior and at least one lumen having an intraluminal surface, and at least one extension line having an exterior surface and a lumen having an intraluminal surface. ### Claim 31 (depends on 30) The catheter of claim 30 wherein at least one lumen of the catheter body, juncture hub, extension line or connecter has a proximal end, a distal end, a Midpoint Region located between 40% and 60% of the distance between the proximal and distal ends and an intraluminal surface comprising a hydrophilic polymer layer thereon having a thickness of at least about 50 nm in the Midpoint Region. ### Claim 32 A catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface having a global average Rrms surface roughness and comprising a hydrophilic polymer layer thereon, wherein (i) the hydrophilic polymer layer has an Average Dry Thickness that exceeds the global average Rrms surface roughness of the intraluminal surface and is at least about 50 nm, or (ii) the hydrophilic polymer layer has a thickness of at least about 50 nm, the intraluminal surface and the hydrophilic polymer layer, in combination, constitute a modified surface having a global average Rrms surface roughness that is less than the global average Rrms surface roughness of the substrate surface. ### Claim 33 (depends on 32) The catheter of claim 32 wherein the catheter additionally comprises as component parts thereof a juncture hub having an exterior and at least one lumen having an intraluminal surface, and at least one extension line having an exterior surface and a lumen having an intraluminal surface. ### Claim 34 (depends on 33) The catheter of claim 33 wherein at least one lumen of the catheter body, juncture hub, extension line or connecter has an aspect ratio of at least 10:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon having a thickness of at least about 50 nm. ### Claim 35 (depends on 34) The catheter of claim 34 wherein the hydrophilic polymer layer on at least one intraluminal surface of a lumen comprised by the catheter body, juncture hub, extension line(s) or connector(s) is conformal at a level of 500 mm2. ### Claim 36 A catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface comprising a hydrophilic polymer layer thereon having a thickness of at least about 50 nm, the intraluminal surface and the hydrophilic polymer layer, in combination, constituting a modified surface having a fibrinogen adsorption of less than about 125 ng/cm2 in a fibrinogen binding assay in which the modified surface is incubated for 60 minutes at 37° C. in a composition containing 70 μg/ml fibrinogen derived from human plasma and 1.4 μg/ml 1-125 radiolabeled fibrinogen. ### Claim 37 A process for the preparation of a catheter comprising as component parts thereof a catheter body and at least one connector, the catheter body having an exterior surface and at least one lumen having an aspect ratio of at least 3:1 and an intraluminal surface, the process comprising forming a reaction mixture comprising a hydrophilic monomer, a free radical initiator and a solvent system, charging the reaction mixture into said catheter body lumen and polymerizing the monomer in the reaction mixture to graft a polymer from the intraluminal surface of said lumen, the reaction mixture having a viscosity of less than 30 cP during polymerization and continuously or intermittently replacing the reaction mixture charged into said catheter body lumen until the grafted polymer layer has an Average Dry Thickness that exceeds at least about 200 nanometers.