PACKAGED INTERMITTENT CATHETERS

Abstract

The invention provides a packaged intermittent catheter, the intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and an amphiphilic lubricious additive, housed in a packaging container; and further comprising an aqueous solution in the packaging container; wherein the aqueous solution comprises at least one compound selected from the group comprising: a surfactant and/or poly (alkylene oxide) compound with a total concentration of at least 0.005 mmol/L; and a salt in a concentration of at least 5% w/v.

Claims

1. A packaged intermittent catheter, the intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and an amphiphilic lubricious additive, housed in a packaging container; and further comprising an aqueous solution in the packaging container; wherein the aqueous solution comprises at least one compound selected from the group comprising: a surfactant and/or poly (alkylene oxide) compound with a total concentration of at least 0.005 mmol/L; and a salt in a concentration of at least 5% w/v.

2. A packaged intermittent catheter as claimed in claim 1, wherein the aqueous solution comprises at least one salt in a concentration of at least 5% w/v.

3. A packaged intermittent catheter as claimed in claim 1, wherein the aqueous solution comprises at least one poly (alkylene oxide) or a derivative thereof in a concentration of at least 0.005 mmol/L.

4. A packaged intermittent catheter as claimed in, claim 1 wherein the aqueous solution comprises at least one surfactant in a concentration of at least 0.005 mmol/L.

5. A packaged intermittent catheter as claimed in claim 1, wherein the aqueous solution comprises at least one surfactant and at least one poly (alkylene oxide) compound with a combined concentration of at least 0.005 mmol/L.

6. A packaged intermittent catheter as claimed in claim 4, wherein the at least one surfactant comprises an amphiphilic molecule comprising a hydrophilic-lipophilic balance of at least 7.

7. A packaged intermittent catheter as claimed in claim 1, wherein the amphiphilic lubricious additive is polymeric or oligomeric.

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

9. A packaged intermittent catheter as claimed in claim 8, wherein the amphiphilic 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 5-25, and a hydrophilic B-block.

10-12. (canceled)

13. A packaged intermittent catheter as claimed in claim 1, wherein the aqueous solution is in direct contact with the intermittent catheter.

14. A packaged intermittent catheter as claimed in claim 13, wherein the intermittent catheter is submerged in the aqueous solution.

15. A packaged intermittent catheter as claimed in claim 1, wherein the aqueous solution is contained within a separate container located in the container housing and is not in direct contact with the intermittent catheter.

16. A packaged intermittent catheter as claimed in claim 15, wherein the separate container is pierceable, in use, to release the contained aqueous solution from the separate container and into direct contact with the intermittent catheter.

17. 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 an amphiphilic lubricious additive, the method comprising the step of packaging the intermittent catheter in a container comprising an aqueous solution, wherein at least part of the intermittent catheter is covered by the aqueous solution, and wherein the aqueous solution comprises at least one compound selected from the group comprising: a surfactant and/or poly (alkylene oxide) compound with a combined concentration of at least 0.005 mmol/L; and a salt in a concentration of at least 5% w/v.

18. A method of reducing migration as claimed in claim 17, wherein the aqueous solution comprises at least one salt in a concentration of at least 5% w/v.

19. A method of reducing migration as claimed in claim 17, wherein the aqueous solution comprises at least one poly (alkylene oxide) or a derivative thereof in a concentration of at least 0.005 mmol/L.

20. A method of reducing migration as claimed in claim 17, wherein the aqueous solution comprises at least one surfactant in a concentration of at least 0.005 mmol/L.

21. A method of reducing migration as claimed in claim 17, wherein the aqueous solution comprises at least one surfactant and at least one poly (alkylene oxide) compound with a combined concentration of at least 0.005 mmol/L.

22. (canceled)

23. (canceled)

24. A method of reducing migration as claimed in claim 17, wherein the method comprises submerging the intermittent catheter in the aqueous solution.

25. Use of an aqueous solution comprising at least one compound selected from the group comprising: a surfactant and/or poly (alkylene oxide) compound with a combined concentration of at least 0.005 mmol/L; and a salt in a concentration of at least 5% w/v; to reduce migration of a lubricious additive from a surface of an intermittent catheter, the intermittent catheter comprising a hollow polymeric tubular body comprising a base polymer and an amphiphilic lubricious additive.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0101] In order that the invention may be more clearly understood embodiments thereof will now be described, by way of example only:

EXAMPLE 1

[0102] A first embodiment of a packaged 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.15(OCH.sub.2CH.sub.2).sub.5OH. The amphiphilic additive comprises a hydrophilic block 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 lipophilic and hydrophobic block of the amphiphilic additive ensures that the hydrophilic block is secured to the base material.

[0103] The intermittent catheter may be prepared as described in US patents U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0104] The intermittent catheter is housed in a packaging container which also comprises an aqueous solution comprising 10% w/v of sodium chloride salt. The intermittent catheter is submerged in the aqueous solution.

[0105] The intermittent catheter is used in the conventional manner upon removal from the container.

[0106] The aqueous solution comprising sodium chloride salt in such a concentration confers high polarity to the aqueous solution. When this polar solution contacts the surface of the intermittent catheter, it makes it less energetically favourable for the hydrophobic, non-polar portion of the amphiphilic additive to go into solution and migrate out of the catheter. Due to the hydrophobic nature of the thermoplastic polypropylene base polymer, the hydrophobic portion of the additive has a strong preference to interact with the base polymer compared with the external aqueous salt solution meaning that migration of the additive out of the catheter is further reduced.

[0107] Along with reducing additive migration out of the catheter, the aqueous solution also encourages the hydrophilic portions of the amphiphilic additive molecules to seek towards the outer surface of the catheter due to their affinity with the hydrophilic aqueous solution. Increased numbers of hydrophilic portions of additive molecules at or on the outer surface increase the lubricity of the surface, which makes the catheter easier and less painful to insert and remove. No further wetting of the catheter outer surface is required to generate a lubricious surface prior to use.

[0108] 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 to a control packaged intermittent catheter in which water bathed the catheter. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

EXAMPLE 2

[0109] A second embodiment of a packaged 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.20(OCH.sub.2CH.sub.2).sub.8OH. The amphiphilic additive comprises a hydrophilic block 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 lipophilic and hydrophobic block of the amphiphilic additive ensures that the hydrophilic block is secured to the base material.

[0110] The intermittent catheter may be prepared as described in US patents U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0111] The intermittent catheter is housed in a packaging container which also comprises an aqueous solution comprising 3% w/v of sodium chloride salt and 3% w/v of trisodium citrate salt. The aqueous solution is contained within a sachet within the container housing and is not in direct contact with the catheter. The sachet is pierceable to release the contained aqueous solution.

[0112] Prior to inserting the intermittent catheter, the user releases the aqueous solution from the sachet and applies the solution to the outer surface of the catheter. No further wetting of the catheter outer surface is required prior to use.

[0113] The aqueous solution comprising sodium chloride and trisodium citrate salts in such concentrations confers high polarity to the aqueous solution. The mechanism of action of the aqueous solution is identical to that of Example 1. When the aqueous solution had been applied to its outer surface, the intermittent catheter of Example 2 conferred reduced migration of the amphiphilic additive from the surface of the catheter during both use and subsequent storage of the catheter. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

EXAMPLE 3

[0114] A third embodiment of a packaged 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.15(OCH.sub.2CH.sub.2).sub.5OH. The amphiphilic additive comprises a hydrophilic block 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 lipophilic and hydrophobic block of the amphiphilic additive ensures that the hydrophilic block is secured to the base material.

[0115] The intermittent catheter may be prepared as described in US patents U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0116] The intermittent catheter is housed in a packaging container which also comprises an aqueous solution comprising 5 mmol/L of polyethylene oxide with an average molecular weight of 400 g/mol. The intermittent catheter is submerged in the aqueous solution.

[0117] The intermittent catheter is used in the conventional manner upon removal from the container. No further wetting of the catheter outer surface is required prior to use.

[0118] The polyethylene oxide in the solution mimics the structure and hydrophilicity of the polyethylene oxide hydrophilic portion of the additive, which decreases the concentration gradient between the hydrophilic portions of the additive molecules and the solution. This makes it less energetically favourable for the additive to migrate out of the catheter and into solution. In addition, the poly (alkylene oxide) in the solution increases the viscosity of the solution, which in turn also makes it harder for the additive to migrate out of the catheter.

[0119] 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. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

EXAMPLE 4

[0120] A fourth embodiment of a packaged 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.15(OCH.sub.2CH.sub.2).sub.5OH. The amphiphilic additive comprises a hydrophilic block 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 lipophilic and hydrophobic block of the amphiphilic additive ensures that the hydrophilic block is secured to the base material.

[0121] The intermittent catheter may be prepared as described in US patents U.S. Pat. Nos. 10,058,638 B2 and 9,186,438 B2.

[0122] The intermittent catheter is housed in a packaging container which also comprises an aqueous solution comprising 5 mmol/L of sodium lauryl sulfate anionic surfactant. The intermittent catheter is submerged in the aqueous solution.

[0123] The intermittent catheter is used in the conventional manner upon removal from the container. No further wetting of the catheter outer surface is required prior to use.

[0124] The aqueous solution comprising sodium lauryl sulfate surfactant in such a concentration confers high polarity to the aqueous solution. The mechanism of action of the aqueous solution is identical to that of Example 1.

[0125] The intermittent catheter of Example 4 conferred reduced migration of the amphiphilic additive from the surface of the catheter during both storage/transport and through use of the catheter. It also provided reduced resistance to abrasion of the additive from the surface of the catheter on contact with external bodies.

[0126] 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.