INSULATED INTRAVENOUS ADMINISTRATION TUBING

• US 20020061375A1
• Filed: 08/13/1999
• Published: 05/23/2002
• Est. Priority Date: 08/13/1999
• Status: Active Grant

• Current Assignee: Veracon Biomedical, LLC
• Original Assignee: Veracon Biomedical, LLC
• Inventors: CARTLEDGE, RICHARD G., SMISSON, HUGH F. III
• Granted Patent: US 6,830,794 B2
• Time in Patent Office: Days
• US Class Current: 428/36.9
• CPC Class Codes: A61M 2205/3633 thermally insulated
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor
• CPC Class Codes: F16L 11/045 with four or more layers without reinforcement
• CPC Class Codes: F16L 59/153 for flexible pipes
• CPC Class Codes: F16L 9/18 Double-walled pipes; Multi-channel pipes or pipe assemblies
• CPC Class Codes: Y10T 428/139 Open-ended, self-supporting conduit, cylinder, or tube-type article
• CPC Class Codes: Y10T 428/1393 Multilayer [continuous layer]
• CPC Class Codes: Y10T 428/24975 No layer or component greater than 5 mils thick

Abstract

Insulated intravenous administration tubing is disclosed. One embodiment of the present invention includes a single medical solution or I.V. tubing manufactured of a polymeric material having good flexibility and comprising an insulation polymer or having an insulation medium applied to the inner or outer surface of the tube or blended into the tube during or after forming, with Mylar being an advantageous insulation material. The present invention may also consist of a long tubular-like structure which consists of two concentric channels, an inner channel and an outer channel. The inner channel accepts and encloses the tubing in which warm fluid flows. Three key functions are, achieved: the inner channel is centered within the outer channel; this provides for maximum insulation efficiency/properties with the minimum of separating space, transparency may be provided; i.e. the more transparent the insulation the better the ability of the user to see the quality of the warm fluid flowing within, i.e. detect air bubbles, ease of set-up and usability is provided. All components may be made of clear, flexible, light-weight materials to permit insulation and visualization of I.V. fluids and air bubbles. The insulated tubing has particular use, but not limited to, preventing convective heat loss of warmed I.V. fluid as it flows through the I.V. tubing, that would otherwise be exposed to ambient room temperature.

Claims

1. A tubing useful for medical applications comprising:

(a) a first layer comprising a naturally occurring or synthetically produced material, and

(b) a second layer of heat reflective or heat resistant insulation material bonded to a surface of the first layer.

2. The tubing of claim 1 wherein the insulation material is substantially a solid.

3. The tubing of claim 1 wherein the insulation material is selected from the group consisting of mylar and other heat reflective materials.

4. The tubing of claim 1 wherein the first layer is an inner layer.

5. The tubing of claim 1 wherein the second layer is an outer layer.

6. The tubing of claim 1 wherein the synthetically produced material is a polymer.

7. The tubing of claim 6 wherein the first layer is selected from the group consisting of polypropylene, ethylene propylene copolymer, modified ethylene propylene copolymer and the like polymers.

8. The tubing of claim 1 wherein the second layer is selected from the group consisting of copolyester, polypropylene, ethylene propylene copolymer, polyurethane, polyvinyl chloride, a blend of copolyester and ethylene vinyl acetate copolymer and the like insulation materials.

9. The polymeric tubing of claim 6 wherein the tubing is cross-linked.

10. The polymeric tubing of claim 9 wherein the tubing is cross-linked by irradiation.

14. The tubing of claim 10 wherein the insulating medium is substantially vacuum spaces within the polymeric material.

15. The tubing of claim 10 wherein the insulating medium consists of air or gas bubbles within the polymeric material.

11. A tubing useful for medical applications comprised of a polymeric material having therein an insulating medium.

12. The tubing of claim 11 wherein the insulating medium is blended into the polymeric material.

13. The tubing of claim 11 wherein the insulating medium is impregnated into the polymeric material.

17. The tubing of claim 16 further including support means comprising a plurality of spaced structures for maintaining the interior channel generally centered within the exterior wall so as to maintain said insulating space between the interior and exterior walls.

18. The tubing of claim 17 wherein the said plurality of spaced structures extend along the length of the interior and exterior walls and are positioned in the insulation space.

19. The tubing of claim 16 wherein the insulation space is at least partially filled with an insulation medium.

20. The tubing of claim 19 wherein the insulation medium is a gas.

21. The tubing of claim 19 wherein the insulation medium is a liquid.

22. The tubing of claim 19 wherein the insulation medium is a solid.

23. The tubing of claim 19 wherein the insulation medium is substantially a vacuum.

24. The tubing of claim 19 wherein the insulation medium consists of air or gas bubbles within the tubing material.

25. The combination of claim 16, wherein said material assembly is substantially transparent.

27. The combination of claim 26, wherein said insulation space is at least partially filled with an insulation medium.

28. The combination of claim 26, wherein said wrap material assembly is substantially transparent.

29. The tubing of claim 27 wherein the insulation medium is a gas.

30. The tubing of claim 27 wherein the insulation medium is a liquid.

31. The tubing of claim 27 wherein the insulation medium is a solid.

32. The tubing of claim 27 wherein the insulation medium is substantially a vacuum.

33. The tubing of claim 27 wherein the insulation medium consists of air or gas bubbles within the tubing material.

35. A double-walled tube assembly according to claim 34, wherein said outer and inner tubes are concentric with each other.

37. A tubing in accordance with claim 36 wherein said outer layer includes trioctyl trimellitate as a plasticizer.

38. A tubing in accordance with claim 37 wherein the intermediate layer has a vinyl acetate content of about 28 percent by weight of said copolymer.

40. The non-PVC medical grade tubing of claim 39 wherein the intermediate layer (b) includes a blend of (i) polyester, (ii) polypropylene copolymer, (iii) styrene-ethylene-butylene-styrene copolymer, and (iv) ethylene vinyl acetate.

16. Improved intravenous tubing comprising:

a flexible material assembly surrounding and insulating the intravenous tubing, said material assembly including means defining an interior wall having an inner surface and an outer surface, said inner surface of said interior wall defining an interior channel;

an exterior wall having an inner surface and an outer surface, said exterior wall being spaced from said interior wall so as to define an insulation space therebetween.

26. Insulated intravenous tubing comprising:

a wrap assembly encircling and insulating the intravenous tubing, the wrap assembly having an inner wall for defining an interior channel extending along the length thereof;

said inner wall having inner and outer surfaces;

an outer wall spaced from said inner wall, said outer wall having inner and outer surfaces;

an insulation space being defined between said inner and outer walls.

34. A double-walled tube assembly comprising:

an elongate inner tube of thermoplastic resin;

an elongate extruded outer tube of thermoplastic resin including a plurality of ribs having a constant height longitudinally of the outer tube and extending over the entire length of the outer tube, said ribs projecting from the inner wall surface of the outer tube toward the center of said outer tube forming an insulation space therebetween.

36. A coextruded tri-layered medical-surgical tubing for the administration of common medicines such as insulin and nitroglycerin solutions, said tubing comprising an outer layer of polyvinyl chloride, a core layer of low-density polyethylene, and an intermediate layer of an ethylene-vinyl acetate copolymer interposed between said outer layer and said core layer, wherein at least one layer is an insulating layer.

39. A non-PVC coextruded medical grade tubing comprising a multi-layer tubing having:

(a) an outer layer including a blend of (i) polypropylene copolymer and (ii) styrene-ethylene-butylene-styrene copolymer;

(b) an intermediate layer disposed adjacent and bonded to the outer layer (a); and

(c) a core layer disposed adjacent and bonded to said tie layer (b) opposite said outer layer (a) including a blend of (i) polyamide and (ii) ethylene vinyl acetate,

wherein at least one layer is an insulation layer.

41. An I.V. tube, comprising:

a polymeric material comprising a blend of a thermoplastic ionomer and a non-ionic thermoplastic polymer, wherein the thermoplastic ionomer is present in an amount between about 10 and 50% by weight and the non-ionic thermoplastic polymer is present in an amount between about 50 and 90% by weight, wherein at least one material is an insulating material.

42. A tube according to claim 41, wherein the thermoplastic ionomer comprises an organic backbone and has pendant acidic groups selected from the group consisting of carboxylic acid groups and sulfonic acid groups.

43. A tube according to claim 41, wherein the non-ionic thermoplastic polymer is selected from the group consisting of polymers of olefin monomers and copolymers of olefin monomers and substituted olefin monomers.

44. A tube according to claim 41, wherein the non-ionic thermoplastic polymer is selected from the group consisting of polymers of a C₂ to C₄ mono-unsaturated alkene;

copolymers of a majority of a C₂ to C₄ mono-unsaturated alkene with a minority of a substituted C₄ to C₁₄ mono-unsaturated alkene; and

copolymers of a majority of a C₂ to C₄ mono-unsaturated alkene with a minority of a substituted C₂ to C₆ mono-unsaturated alkene having a substituent carboxylic acid ester group.

45. A tube according to claim 41, which contains essentially no medically harmful substance capable of leaching into an aqueous based or organic based fluid in contact with the inside surface of the film.

46. A tube according to claim 41, which is essentially free of chlorine.

48. The radial block copolymer mixture as defined in claim 47 wherein said polymeric material is methyl methacrylate-styrene-butadiene copolymer.

49. The radial block copolymer mixture as defined in claim 47 wherein said polymeric material is methyl methacrylate-acrylonitrile-styrene-butadiene copolymer.

47. An I.V. tubing formed of a unvulcanized radial block copolymer mixture having a high degree of clarity and consisting essentially of (a) from about 10-90% by weight of a butadiene-styrene radial block copolymer having a butadiene content the range of about 15-40% by weight, (b) from about 90-10% by weight of a butadiene-styrene radial block copolymer having a different butadiene-styrene content in the range of about 85-60% by weight and styrene content in the range of about 15-40% by weight and (c) about 5-75% by weight of said radial block copolymer mixture of clear polymeric methacrylate-styrene-butadiene copolymers and mixtures of said clear polymeric material, wherein at least one copolymer is an insulating material.

50. A multilayered medical tubing having a bore and inside and outside surfaces comprising:

a) at least one inner layer of at least one chlorine-free first thermoplastic polymer; and

having a flexibility measured by its Young'"'"'s modulus, within a range of from about 2 to about 60 mega Pascals;

b) at least an outside surface layer of at least one tough, chlorine-free second thermoplastic polymer having a Young'"'"'s modulus not more than about fifteen times the Young'"'"'s modulus of the first thermoplastic polymer, wherein said bore has a diameter of less than 12.7 min,

wherein at least one layer is an insulating layer.

51. A multilayered tubing according to claim 50 having at least three layers, those layers at least being the outside surface layer, the inner layer and an inside surface layer of at least one tough, chlorine-free third thermoplastic polymer having a Young'"'"'s modulus like that of the second thermoplastic polymer.

52. A multilayered tubing according to claim 50 having two layers wherein the inner layer forms the inside surface of the tubing.

53. A multilayered tubing according to claim 50 having at least three layers, those layers at least being the outside surface layer, the inner layer and an inside surface layer of at least one tough, chlorine-free third thermoplastic polymer having a Young'"'"'s modulus up to about fifteen times that of the first thermoplastic polymer.

54. A multilayered tubing according to claim 51 having additional layers between the outside and inside surface layers, those additional layers being comprised of at least one of the first, second and third thermoplastic polymers.

55. A multilayered tubing according to claim 54 wherein the first and second thermoplastic polymers have backbones that are linear, cross-linked, branched, random, grafted, block, crystalline-amorphous domain, pseudo-cross-linked or ionomeric.

56. A multilayered tubing according to claim 50 wherein the first and second thermoplastic polymers are polymers of olefin monomer or are copolymers of olefin monomer and substituted olefin monomer.

57. A multilayer tubing according to claim 56 wherein the olefin monomer is a C₂ to C₄ mono-unsaturated alkene.

58. A multilayered tubing according to claim 57 wherein the substituted olefin monomer is a C₄ to C₁₄ mono-unsaturated alkene, a C₈ to C₁₄ aryl alkene, or a C₂ to C₆ mono-unsaturated alkene having a moiety selected from the group consisting of oxyalkanoyl, carboxy, carboxamide and alkoxycarbonyl of 1 to 6 carbons.

59. A multilayered tubing according to claim 50 wherein the first thermoplastic polymer is a copolymer of ethylene and vinylacetate, a copolymer of ethylene arid n-butylacrylate, a copolymer of ethylene and butene or a copolymer of ethylene octene;

the second thermoplastic polymer is an ionomeric ethylene-methacrylic acid copolymer with zinc, an ionomeric propylene-methacrylic acid copolymer with zinc, an ionomeric ethylene-methacrylic acid copolymer with sodium, an ionomeric propylene-methacrylic acid, copolymer with sodium, a copolymer of ethylene and butene, a copolymer of ethylene and acrylic acid, a copolymer of ethylene and vinylacetate, a copolymer of ethylene and n-butylacrylate, a copolymer of ethylene and methacrylic acid or polyethylene and the third thermoplastic polymer, if present, is an ionomeric ethylene-methacrylic acid copolymer with zinc, an ionomeric propylene-methacrylic acid copolymer with zinc, an ionomeric ethylene-methacrylic acid copolymer with sodium, an ionomeric propylene-methacrylic acid copolymer with sodium, a copolymer of ethylene and butene, a copolymer of ethylene and vinylacetate, a copolymer of ethylene and n-butyl acrylate, a copolymer of ethylene and methacrylic acid or a copolymer of ethylene and acrylic acid.

60. A multilayered tubing according to claim 57 wherein the first thermoplastic polymer is a copolymer of ethylene and vinylacetate, a copolymer of ethylene and n-butylacrylate, a copolymer of ethylene and butene or a copolymer of ethylene octene;

the second thermoplastic polymer is an ionomeric ethylene-methacrylic acid copolymer with zinc, an ionomeric propylene-methacrylic acid copolymer with zinc, an ionomeric ethylene-methacrylic acid copolymer with sodium, an ionomeric propylene-methacrylic acid copolymer with sodium, a copolymer of ethylene and butene, a copolymer of ethylene and acrylic acid, a copolymer of ethylene and vinylacetate, a copolymer of ethylene and n-butylacrylate, a copolymer of ethylene and methacrylic acid or polyethylene and the third thermoplastic polymer, if present, is an ionomeric ethylene-methacrylic acid copolymer with zinc, an ionomeric propylene-methacrylic acid copolymer with zinc, an ionomeric ethylene-methacrylic acid copolymer with sodium, an ionomeric propylene-methacrylic acid copolymer with sodium, a copolymer of ethylene and butene, a copolymer of ethylene and vinylacetate, a copolymer of ethylene and n-butyl acrylate, a copolymer of ethylene and methacrylic acid or a copolymer of ethylene and acrylic acid.

61. A multilayered tube according to claim 50 wherein the tube is provided in a medical device selected from the group consisting of intravenous fluid administration sets, arthroscopy fluid control systems, cardiovascular systems, blood gas monitoring systems, coronary artery bypass tubes, infusion pump tubes, catheters, dialysis tubes, peritoneal lavage tubes, respiratory tubes, endotracheal tubes, gastric feeding tubes, wound drainage tubes, urinary catheter tubes, and angioplasty tubes.