Intermittent catheters
The invention provides an intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and a lubricious additive, wherein the lubricious additive comprises an amphiphilic molecule having a hydrophilic-lipophilic balance below 8.
1 . A packaged intermittent catheter unit, comprising:
a packaging container;
a hydrophilic wetting agent disposed in the packaging container;
an intermittent catheter disposed in the packaging container and in contact with the wetting agent, the intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and a lubricious additive, wherein the base polymer is hydrophobic, wherein the lubricious additive comprises an amphiphilic molecule having a hydrophilic-lipophilic balance below 8 and the amphiphilic molecule comprises hydrophobic and hydrophilic monomer units, and wherein the additive has a hydrophobic to hydrophilic monomer unit ratio of at least 10 to thereby reduce migration of the lubricious additive out of the intermittent catheter; wherein the hydrophobic to hydrophilic monomer unit ratio of at least 10 causes hydrophobic-hydrophobic interactions between the hydrophobic base polymer and hydrophobic portions of the lubricious additive to overcome hydrophilic-hydrophilic interactions between the hydrophilic wetting agent and the hydrophilic portions of the lubricious additive, thereby reducing migration of the lubricious additive out of the catheter and into the hydrophilic wetting agent.
2 . The packaged intermittent catheter unit of claim 1 , wherein the amphiphilic molecule has a hydrophilic-lipophilic balance below 5.
3 . The packaged intermittent catheter unit of claim 1 , wherein the amphiphilic molecule comprises at least one hydrophobic and at least one hydrophilic portion, and wherein the molecular weight ratio of the at least one hydrophobic portion to the at least one hydrophilic portion is at least 6.
4 . The packaged intermittent catheter unit of claim 1 , wherein the additive is an A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block.
5 . The packaged intermittent catheter unit of claim 4 , wherein the B-block is a hydrophilic oligomer comprising at least one monomer unit, the at least one monomer unit derived from monomers selected from the group comprising: alkylene oxides, alkylene glycols, epihalohydrins, unsaturated carboxylic acids, alkylene imines, lactones, vinyl alcohol, and vinyl alkanoates.
6 . The packaged intermittent catheter unit of claim 4 , wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH 3 CH 2 (CH 2 CH 2 ) a where “a” is at least 26, and a hydrophilic B-block.
7 . The packaged intermittent catheter unit of claim 1 , wherein the additive is at and/or on at least 50% of the outer surface area of the polymeric tubular body.
8 . A method, comprising:
forming an intermittent catheter comprising a hollow polymeric tubular body comprising a hydrophobic base polymer and a lubricious additive comprising an amphiphilic molecule having a hydrophilic-lipophilic balance below 8, wherein the forming comprises mixing the lubricious additive with the hydrophobic base polymer before or during formation of the hollow polymeric tubular body; and
placing the intermittent catheter in a packaging along with a hydrophilic wetting agent;
wherein the additive has a hydrophobic to hydrophilic monomer unit ratio of at least 10 to thereby reduce migration of the lubricious additive out of the intermittent catheter; wherein the hydrophobic to hydrophilic monomer unit ratio of at least 10 causes hydrophobic-hydrophobic interactions between the hydrophobic base polymer and hydrophobic portions of the lubricious additive to overcome hydrophilic-hydrophilic interactions between the hydrophilic wetting agent and the hydrophilic portions of the lubricious additive, thereby reducing migration of the lubricious additive out of the catheter and into the hydrophilic wetting agent.
9 . The method of claim 8 , wherein the amphiphilic molecule has a hydrophilic-lipophilic balance below 5.
10 . The method of claim 8 , wherein the additive is an A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block.
11 . The method of claim 10 , wherein the B-block is a hydrophilic oligomer comprising at least one monomer unit, the at least one monomer unit derived from monomers selected from the group comprising: alkylene oxides, alkylene glycols, epihalohydrins, unsaturated carboxylic acids, alkylene imines, lactones, vinyl alcohol, and vinyl alkanoates.
12 . The method of claim 10 , wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH 3 CH 2 (CH 2 CH 2 ) a where “a” is at least 26, and a hydrophilic B-block.
13 . The method of claim 8 , wherein the base polymer and additive are provided in granulate or powder form and the method comprises mixing the granulate or powder base polymer and additive to form a mixture, and melt-extruding or injection-moulding the mixture to form the hollow polymeric tubular body.
14 . The method of claim 13 , wherein the method comprises melting the mixture of the base polymer and additive to form a second mixture before melt-extruding or injection-moulding the second mixture to form the hollow polymeric tubular body.
15 . The method of claim 8 , wherein the base polymer comprises a polymer selected from the group comprising:
polyolefins, polyesters, polyacrylates, polyamides, thermoplastic elastomeric material, polyether block amide, thermoplastic vulcanizates, thermoplastic copolyesters, thermoplastic polyamides and fluororubber, or combinations, blends or copolymers of any of the above materials.
16 . The method of claim 15 , wherein the base polymer comprises a polymer selected from the group comprising: polyolefins, polyvinyl chloride, styrene-butadiene copolymer (SBC), styrene-ethylene-butylene-styrene copolymer (SEBS), and thermoplastic elastomeric material or combinations, blends or copolymers of any of the above materials.
17 . The method of claim 8 , wherein the additive is at and/or on at least 50% of the outer surface area of the polymeric tubular body.