INTERMITTENT CATHETERS

Abstract

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.

Claims

1. 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.

2. An intermittent catheter as claimed in claim 1, wherein the amphiphilic molecule has a hydrophilic-lipophilic balance below 5.

3. An intermittent catheter as claimed in claim 1, wherein 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.

4. An intermittent catheter as claimed in 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.

5. An intermittent catheter as claimed in claim 4, wherein the lubricious additive amphiphilic molecule has a hydrophilic-lipophilic balance below 8.

6. An intermittent catheter as claimed in claim 1, wherein the additive is an A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block.

7. An intermittent catheter as claimed in claim 6, 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.

8. An intermittent catheter as claimed in claim 6, wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH.sub.3CH.sub.2(CH.sub.2CH.sub.2).sub.a where “a” is at least 26, and a hydrophilic B-block.

9. (canceled)

10. (canceled)

11. An intermittent catheter as claimed in claim 1, wherein the additive is at and/or on at least 50% of the outer surface area of the polymeric tubular body.

12. A method of reducing migration of an additive from a surface of an intermittent catheter, the intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and a lubricious additive comprising an amphiphilic molecule having a hydrophilic-lipophilic balance below 8, wherein the method comprises mixing the lubricious additive with the base polymer before or during formation of the hollow polymeric tubular body.

13. A method of reducing migration as claimed in claim 12, wherein the amphiphilic molecule has a hydrophilic-lipophilic balance below 5, or below 4.

14-16. (canceled)

17. A method of reducing migration as claimed in claim 12, wherein the additive is an A-B block copolymer comprising a hydrophobic hydrocarbon A-block and a hydrophilic B-block.

18. A method of reducing migration as claimed in claim 17, 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.

19. A method of reducing migration as claimed in claim 17, wherein the additive is an A-B block copolymer comprising an A-block comprising a hydrocarbon chain block of the formula CH.sub.3CH.sub.2(CH.sub.2CH.sub.2).sub.a where “a” is at least 26, and a hydrophilic B-block.

20. A method of reducing migration as claimed in claim 12, 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.

21. A method of reducing migration as claimed in claim 20, 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.

22. A method of reducing migration as claimed in claim 12, 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, fluororubber, and water disintegrable or enzymatically hydrolysable material or combinations, blends or copolymers of any of the above materials.

23. A method of reducing migration as claimed in claim 22, wherein the base polymer comprises a polymer selected from the group comprising: polyolefins, polyvinyl chloride, polyurethane, 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.

24. A method of reducing migration as claimed in claim 12, wherein the additive is at and/or on at least 50% of the outer surface area of the polymeric tubular body.

25. A packaged intermittent catheter comprising a packaging container in which is located an intermittent catheter according to claim 1, and a wetting agent.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0142] In order that the invention may be more clearly understood embodiments thereof will now be described, by way of example only:

Example 1

[0143] A first embodiment of an intermittent catheter of the invention comprises an intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer formed of thermoplastic polypropylene and further comprising an amphiphilic additive of the formula CH.sub.3CH.sub.2(CH.sub.2CH.sub.2).sub.27(OCH.sub.2CH.sub.2).sub.6OH.

[0144] The amphiphilic additive comprises an HLB value of approximately 5.

[0145] The additive comprises a polyethylene oxide hydrophilic portion which seeks towards the outer surface of the body due to its incompatibility with the base polymer, the outer surface becoming lubricious as a result. The additive also comprises a polyethylene lipophilic and hydrophobic portion which ensures that the hydrophilic portion is secured to the base polymer.

[0146] The intermittent catheter may be prepared as described in U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0147] The intermittent catheter is used in the conventional manner.

[0148] The HLB value of 5 provides a beneficial ratio of the degree to which the additive is hydrophobic and hydrophilic that allows for hydrophobic-hydrophobic interactions between the hydrophobic portion and the base polymer to overcome the hydrophilic-hydrophilic interactions between the hydrophilic portion and a hydrophilic external environment (often comprising a transportation or wetting agent aqueous solution). This allows for reduced migration of the additive out of the catheter, even when the surface of the catheter is scraped. Such an HLB value nonetheless also allows the hydrophilic portion of the additive to seek towards the outer surface of the intermittent catheter due to its affinity with the hydrophilic external environment and its incompatibility with the hydrophobic base polymer. The amphiphilic additive at the outer surface of the intermittent catheter body confers high lubricity to the outer surface of the intermittent catheter, making it both easier to insert and remove.

[0149] The intermittent catheter of Example 1 conferred reduced migration of the amphiphilic additive from the surface of the catheter during both storage/transport and through use of the catheter compared with a similar additive with an HLB greater than 8. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

Example 2

[0150] A second embodiment of an intermittent catheter of the invention comprises an intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer formed of thermoplastic polyethylene and further comprising an amphiphilic additive of the formula CH.sub.3CH.sub.2(CH.sub.2CH.sub.2).sub.30(OCH.sub.2CH.sub.2).sub.2OH.

[0151] The amphiphilic additive comprises an HLB value of approximately 2.

[0152] The amphiphilic additive has a hydrophobic to hydrophilic monomer unit ratio of 15.5.

[0153] The molecular weight ratio of the hydrophobic to the hydrophilic portion of the additive is approximately 8.3.

[0154] The additive comprises a polyethylene oxide hydrophilic portion which seeks towards the outer surface of the body due to its incompatibility with the base polymer, the outer surface becoming lubricious as a result. The additive also comprises a polyethylene lipophilic and hydrophobic portion which ensures that the hydrophilic portion is secured to the base polymer.

[0155] The intermittent catheter may be prepared as described in U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0156] The intermittent catheter is used in the conventional manner.

[0157] The mechanism of action of the amphiphilic additive is as described in Example 1 above.

[0158] The intermittent catheter of Example 2 conferred reduced migration of the amphiphilic additive from the surface of the catheter during both storage/transport and through use of the catheter, compared with a similar additive with less than 53 carbons in the hydrophobic portion of the amphiphilic molecule. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

Example 3

[0159] A third embodiment of an intermittent catheter of the invention comprises an intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer formed of thermoplastic polyethylene and further comprising an amphiphilic additive of the formula CH.sub.3CH.sub.2(CH.sub.2CH.sub.2).sub.21(OCH.sub.2CH.sub.2).sub.2OH.

[0160] The amphiphilic additive has an HLB value of approximately 3.

[0161] The amphiphilic additive has a hydrophobic to hydrophilic monomer unit ratio of 11.

[0162] The additive comprises a polyethylene oxide hydrophilic portion which seeks towards the outer surface of the body due to its incompatibility with the base polymer, the outer surface becoming lubricious as a result. The additive also comprises a polyethylene lipophilic and hydrophobic portion which ensures that the hydrophilic portion is secured to the base polymer.

[0163] The intermittent catheter may be prepared as described in U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0164] The intermittent catheter is used in the conventional manner.

[0165] The mechanism of action of the amphiphilic additive is as described in Example 1 above.

[0166] The intermittent catheter of Example 3 conferred reduced migration of the amphiphilic additive from the surface of the catheter during both storage/transport and through use of the catheter compared with a similar additive with an HLB greater than 8. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

[0167] The above embodiments are described by way of example only. Many variations are possible without departing from the scope of the invention as defined in the appended claims.