Method of surface modifying a medical tubing

• US 20030094736A1
• Filed: 12/20/2002
• Published: 05/22/2003
• Est. Priority Date: 05/03/1996
• Status: Abandoned Application

• Current Assignee: Birendra K. Lal, Chuan Qin, Donna L. Rostron, Lecon Woo, Michael T.K. Ling, Patrick T. Ryan, Susan R. Mizener, Yuanpang S. Ding
• Original Assignee: Birendra K. Lal, Chuan Qin, Donna L. Rostron, Lecon Woo, Michael T.K. Ling, Patrick T. Ryan, Susan R. Mizener, Yuanpang S. Ding
• Inventors: Ding, Yuanpang S., Mizener, Susan R., Rostron, Donna L., Qin, Chuan, Lal, Birendra K., Ryan, Patrick T., Woo, Lecon, Ling, Michael T.K.
• Application Number:
  US10/327,263
• Publication Number:
  US 20030094736A1
• Time in Patent Office: Days
• US Class Current: 264/485
• CPC Class Codes: A61L 29/041 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 29/049 Mixtures of macromolecular compounds
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor
• CPC Class Codes: A61M 5/14228 with linear peristaltic action, i.e. comprising at least three pressurising members or a helical member
• CPC Class Codes: B28B 1/52 specially adapted for producing articles from mixtures containing fibres, e.g. asbestos cementby wrapping on to mandrels B28B1/42
• CPC Class Codes: B28B 7/007 with moulding surfaces simulating natural effets, e.g. wood or stone
• CPC Class Codes: B28B 7/344 from absorbent or liquid- or gas-permeable materials, e.g. plaster moulds in general
• CPC Class Codes: B28B 7/46 for humidifying or dehumidifying
• CPC Class Codes: B29C 2035/085 using gamma-ray
• CPC Class Codes: B29C 2035/0877 using electron radiation, e.g. beta-rays
• CPC Class Codes: B29C 48/0015 producing hollow articles having components brought in contact outside the extrusion die
• CPC Class Codes: B29C 48/022 characterised by the choice of material
• CPC Class Codes: B29C 48/09 Articles with cross-sections having partially or fully enclosed cavities, e.g. pipes or channels
• CPC Class Codes: B29C 48/21 the layers being joined at their surfaces
• CPC Class Codes: B29C 48/91 Heating, e.g. for cross linking
• CPC Class Codes: B29C 48/9115 of hollow articles
• CPC Class Codes: B29C 48/919 using a bath, e.g. extruding into an open bath to coagulate or cool the material
• CPC Class Codes: B29C 55/22 of tubes B29C61/08 takes precedence
• CPC Class Codes: B29C 71/04 by wave energy or particle radiation , e.g. for curing or vulcanising preformed articles during moulding, e.g. in a mould B29C35/08
• CPC Class Codes: B29L 2009/00 : Layered products
• CPC Class Codes: B29L 2031/753 : Medical equipment; Accessories therefor bloodbags, medical bags B29L2031/7148; artificial eyes B29L2011/0008
• CPC Class Codes: C08J 2323/04 : Homopolymers or copolymers of ethene
• CPC Class Codes: C08J 7/043 : Improving the adhesiveness of the coatings per se, e.g. forming primers adhesives in the form of films or foils characterised by the primer layers between the polymer carriers and the adhesives C09J7/50
• CPC Class Codes: C08J 7/065 : Low-molecular-weight organic substances, e.g. absorption of additives in the surface of the article
• CPC Class Codes: C08L 23/06 : Polyethene
• CPC Class Codes: C08L 31/04 : Homopolymers or copolymers of vinyl acetate

Abstract

The present invention provides a method of using a medical tubing with a pump for administering measured amounts of a beneficial fluid over time to a patient. The method includes the steps of providing a material selected from the group consisting of ethylene homopolymers and ethylene copolymers, wherein the ethylene copolymers are obtained by copolymerizing ethylene with a comonomer selected from the group consisting of alkyl olefins, alkyl esters of a carboxylic acid and lower alkene esters of a carboxylic acid, or blends thereof; providing an extruder with an extrusion die; extruding the material into a medical tubing; providing a surface modifier solution; preheating the surface modifier solution to a temperature within the range of 30-95° C.; applying the preheated solution onto the tubing at it exits the extrusion die when the tubing is in a molten state or a semi-molten state; and pumping fluid through the tubing with the pump.

Claims

1. A method of using a medical tubing with a pump for administering measured amounts of a beneficial fluid over time to a patient comprising the steps of:

providing a material selected from the group consisting of ethylene homopolymers and ethylene copolymers, wherein the ethylene copolymers are obtained by copolymerizing ethylene with a comonomer selected from the group consisting of alkyl olefins, alkyl esters of a carboxylic acid and alkene esters of a carboxylic acid;

providing an extruder with an extrusion die;

extruding the material into a medical tubing;

providing a surface modifier solution;

preheating the surface modifier solution to a temperature within the range of 30-95°

C.;

applying the preheated solution onto the tubing at it exits the extrusion die when the tubing is in a molten state or a semi-molten state; and

pumping fluid through the tubing with the pump.

2. The method of claim 1, further comprising the step of exposing the tubing to a sterilization dosage of radiation of from about 15 to about 45 kGys.

3. The method of claim 2, wherein the step of exposing the tubing to sterilization dosage of radiation comprises the step of exposing the tubing to a source of radiation selected from the group consisting of gamma rays, ultra-violet rays, and electron beam.

4. The method of claim 1, wherein the material is an ethylene vinyl acetate copolymer having a vinyl acetate content of not more than 36% vinyl acetate by weight of the copolymer.

5. The method of claim 4, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 5.0 g/10 minutes.

6. The method of claim 4, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 1.0 g/10 minutes.

7. The method of claim 6, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 0.80 g /10 minutes.

8. The method of claim 1, wherein the material is an ethylene and α

-olefin copolymer.

9. The method of claim 8, wherein the ethylene and α

-olefin copolymer has a density less than 0.910 g/cc.

10. The method of claim 9, wherein the ethylene and α

-olefin copolymer is obtained using a metallocene catalyst.

11. The method of claim 1, wherein the surface modifier solution includes as a component selected from the group consisting of an aliphatic or aromatic hydrocarbon having greater than 5 carbon atoms but less than 500 and an electron negative group selected from the group of amines;

amides;

hydroxyls;

acids;

acetate, ammonium salts;

organometallic compounds such as metal alcoholates, metal carboxylates, and metal complexes of numerous 1,3 dicarbonyl compounds;

phenyl phosphines;

pyridines;

pyrrolidones;

imidazoline, and oxazolines.

12. The method of claim 11, wherein the hydrocarbon has less than 200 carbons.

13. The method of claim 11, wherein the hydrocarbon has less than 100 carbons.

14. The method of claim 13, wherein the functional group is an amide.

15. The method of claim 14, wherein the component is selected from the group consisting of polyoxyethylene(5)oleylamine, bis(2-hydroxyethyl)soyaamine, bis(2-hydroxyethyl)oleylamine, and polyoxyethylene(5)octadecylamine.

16. The method of claim 1, wherein the surface modifier solution includes as a component selected from the group consisting of polyurethane, and copolymers of ethylene copolymerized with comonomers selected from the group consisting of alkyl substituted carboxylic acids, alkene substituted carboxylic acids, ester, anhydride and saponified derivatives thereof.

17. The method of claim 11, wherein the surface modifier solution further comprises a solvent containing a member selected from the group consisting of water, ketones, aldehydes, aliphatic alcohols, freon, freon replacement solvents.

18. The method of claim 4, wherein the step of extruding a tubing further includes the step of providing a tubing with a second layer concentrically disposed within the first layer of the tubing.

19. The method of claim 18, wherein the second layer has a modulus of elasticity that is greater than the modulus of elasticity of the first layer.

20. The method of claim 19, wherein the second layer is selected from homopolymers and copolymers of α

-olefins.

21. The method of claim 20, wherein the second layer is an ultra-low density polyethylene.

22. A method of fabricating medical tubing comprising the steps of:

extruding a multilayered tubing having a first layer and a second layer, the first layer of an ethylene monomer copolymerized with at least one monomer selected from the group consisting of alkyl esters of a carboxylic acid and alkene esters of a carboxylic acid, the second layer of homopolymers and copolymers of α

-olefins, the second layer being disposed concentrically within the first layer and having a modulus of elasticity greater than a modulus of elasticity of the first layer;

providing a surface modifier solution;

preheating the surface modifier solution to a temperature within the range of 30-95°

C.; and

applying the preheated solution onto the tubing at it exits the extrusion die when the tubing is in a molten state or a semi-molten state.

23. The method of claim 22, further comprising the step of exposing the tubing to a sterilization dosage of radiation of from about 15 to about 45 kGys.

24. The method of claim 22, wherein the first layer is an ethylene vinyl acetate copolymer having a vinyl acetate content of not more than 36% vinyl acetate by weight of the copolymer.

25. The method of claim 24, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 5.0 g/10 minutes.

26. The method of claim 24, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 1.0 g/10 minutes.

27. The method of claim 24, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 0.80 g /10 minutes.

28. The method of claim 22, wherein the second layer is an ethylene and α

-olefin copolymer.

29. The method of claim 28, wherein the ethylene and α

-olefin copolymer has a density less than 0.910 g/cc.

30. The method of claim 29, wherein the ethylene and α

-olefin copolymer is obtained using a metallocene catalyst.

31. The method of claim 22, wherein the surface modifier solution includes as a component selected from the group consisting of an aliphatic or aromatic hydrocarbon having greater than 5 carbon atoms but less than 500 and an electron negative group selected from the group of amines;

amides;

hydroxyls;

acids;

acetate, ammonium salts;

organometallic compounds such as metal alcoholates, metal carboxylates, and metal complexes of numerous 1,3 dicarbonyl compounds;

phenyl phosphines;

pyridines;

pyrrolidones;

imidazoline, and oxazolines.

32. The method of claim 31, wherein the hydrocarbon has less than 200 carbons.

33. The method of claim 31, wherein the hydrocarbon has less than 100 carbons.

34. The method of claim 33, wherein the functional group is an amide.

35. The method of claim 33, wherein the component is selected from the group consisting of polyoxyethylene(5)oleylamine, bis(2-hydroxyethyl)soyaamine, bis(2-hydroxyethyl)oleylamine, and polyoxyethylene(5)octadecylamine.

36. The method of claim 22, wherein the surface modifier solution contains as a component a polymer selected from the group comprising polyurethane, and copolymers of ethylene copolymerized with comonomers selected from the group consisting of lower alkyl substituted carboxylic acids, lower alkene substituted carboxylic acids, ester, anhydride and saponified derivatives thereof.

37. The method of claim 32, wherein the surface modifier solution further comprises a solvent containing a member selected from the group consisting of water, ketones, aldehydes, aliphatic alcohols, freon, and freon replacement solvents.

38. A method for fabricating medical tubing comprising the steps of:

extruding with an extruder having an extrusion die a tubing having a first layer selected from the group consisting of ethylene homopolymers and ethylene copolymers, wherein the copolymers of ethylene are an ethylene monomer copolymerized with at least one monomer selected from the group consisting of alkyl olefins, alkyl esters of a carboxylic acid, and lower alkene esters of a carboxylic acid;

providing a surface modifier solution;

preheating the surface modifier solution to a temperature within the range of 30-95°

C.;

applying the preheated solution onto the tubing at it exits the extrusion die when the tubing is in a molten state or a semi-molten state;

cooling the tubing to a solid state to define an initial diameter; and

stretching the tubing in a direction along a longitudinal axis of the tubing to define an oriented diameter that is less than the initial diameter.

39. The method of claim 38, wherein the initial diameter is from 10%-300% greater than the oriented diameter.

40. The method of claim 38, wherein the initial diameter is from 20%-120% greater than the oriented diameter.

41. The method of claim 38, wherein the initial diameter is from 30%-100% greater than the oriented diameter.

42. The method of claim 38, wherein the first layer is an ethylene vinyl acetate copolymer.

43. The method of claim 42, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 5.0 g/10 minutes.

44. The method of claim 42, wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 1.0 g/10 minutes.

45. The method of claim 42,wherein the ethylene vinyl acetate copolymer has a melt flow index of less than about 0.80 g/10 minutes.

46. The method of claim 42, further comprising a second layer concentrically disposed within the first layer, the second layer having a modulus of elasticity greater than a modulus of elasticity of the first layer.

47. The method of claim 46, wherein the second layer is an ethylene and α

-olefin copolymer wherein the α

-olefin has from 3 to 8 carbons.

48. The method of claim 47, wherein the second layer is an ultra-low density polyethylene.

49. The method of claim 38, further comprising the step of exposing the tubing to a sterilization dosage of radiation of from about 15 to about 45 kGys.

50. The method of claim 38. wherein the surface modifier solution includes as a component selected from the group consisting of an aliphatic or aromatic hydrocarbon having greater than 5 carbon atoms but less than 500 and an electron negative group selected from the group of amines;

amides;

hydroxyls;

acids;

acetate, ammonium salts;

organometallic compounds such as metal alcoholates, metal carboxylates, and metal complexes of numerous 1,3 dicarbonyl compounds;

phenyl phosphines;

pyridines;

pyrrolidones;

imidazoline, and oxazolines.

51. The method of claim 50, wherein the hydrocarbon has less than 200 carbons.

52. The method of claim 50, wherein the hydrocarbon has less than 100 carbons.

53. The method of claim 50, wherein the functional group is an amide.

54. The method of claim 50, wherein the component is selected from the group consisting of polyoxyethylene(5)oleylamine, bis(2-hydroxyethyl)soyaamine, bis(2-hydroxyethyl)oleylamine, and polyoxyethylene(5)octadecylamine.

55. The method of claim 38, wherein the additive solution contains as a component a polymer selected from the group comprising polyurethane, and copolymers of ethylene copolymerized with comonomers selected from the group consisting of alkyl substituted carboxylic acids, alkene substituted carboxylic acids, ester, anhydride and saponified derivatives thereof.

56. The method of claim 50, wherein the surface modifier solution further comprises a solvent containing a member selected from the group consisting of water, ketones, aldehydes, aliphatic alcohols, freon, and freon replacement solvents.