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Title:
LIQUID INHALATIONAL ANESTHETIC CONTAINER
Document Type and Number:
WIPO Patent Application WO/2013/149263
Kind Code:
A1
Abstract:
A pliable container for a liquid inhalational anesthetic is disclosed. In various configurations, a pliable container comprises a pliable container body, a threaded spout, and a liquid inhalational anesthetic. The pliable container body can comprise a laminate, such as a laminate comprising at least one aluminum layer and at least one polymer layer. In some configurations, the liquid inhalational anesthetic can be in contact with a polymer layer. In some configurations, the liquid inhalational anesthetic can be in contact with an aluminum layer. In various configurations, a pliable container can further comprise a key collar, a cap, and a seal.

Inventors:
PERNIKOFF DOUGLAS STEVEN (US)
Application Number:
PCT/US2013/034863
Publication Date:
October 03, 2013
Filing Date:
April 01, 2013
Export Citation:
Click for automatic bibliography generation   Help
Assignee:
PORTABLE ANESTHESIA SOLUTIONS LLC (US)
PERNIKOFF DOUGLAS STEVEN (US)
International Classes:
A61D7/04; A61J1/00; A61M16/01; B32B1/02; B32B15/085
Domestic Patent References:
WO2003032890A12003-04-24
Foreign References:
US7066913B22006-06-27
US5687777A1997-11-18
US4278716A1981-07-14
US20100218762A12010-09-02
US4684643A1987-08-04
Other References:
See also references of EP 2830569A4
Attorney, Agent or Firm:
ZACKSON LAW LLC et al. (Suite 211Creve Coeur, Missouri, US)
Download PDF:
Claims:
Claims

What is claimed is:

J . A pliable container for a liquid inhalational anesthetic, comprising;

a pliable container body;

a threaded spout; and

a liquid inhalational anesthetic.

2. A pliable container in accordance with claim 1. wherein, the pliable container body

comprises a laminate comprising an aluminum layer and a first polymer layer,

3. A pliable container in accordance with claim 2, wherein the liquid inhalational anesthetic is in contact with the first polymer layer.

4. A pliable container in accordance with claim 2, wherein the liquid inhalational anesthetic is in contact with the aluminum layer.

5. A pliable container in accordance with any one of claims 1 -4, wherein the liquid inhalational anesthetic is a fiuorocarbon anesthetic.

6. A pliable container in accordance with any one of claims 1 -4, wherein the liquid inhalational anesthetic is selected from the group consisting of sevoflurane. desflurane, isoflurane. halothane, niethoxyflurane, ethrane and ether.

7. A pl iable container in accordance with any one of claims 1 -4, wherein the inhalational anesthetic is sevoflurane.

8. A pliable container in accordance with any one of claims 1 -4, wherein the inhalational anesthetic is desflurane,

9. A pliable container in accordance w ith any one of claims 1 -4, wherein the inhalational anesthetic is isoflurane,

10. A pliable container in accordance wi th any one of claims 1 -4, wherein the inhalational anesthetic is halothane.

1 1. A pliable container in accordance with any one of claims 1-4, wherein the inhalational anesthetic is methoxyflurane.

12. A pliable container in accordance with any one of claims 1 -4, wherein the inhalational anesthetic is ethrane.

13. A pliable container in accordance with, any one of claims 1-4, wherein the inhalational anesthetic is ether.

14. A pliable container in accordance with any one of claims 1 -4, further comprising a key collar,

15. A pliable container in accordance with any one of claims 1 -4, farther comprising a key collar corresponding to an ISO standard key collar tor an inhalational anesthetic bottle.

16. A pliable container in accordance with any one of claims 1.-4. further comprising a seal which covers the threaded spout.

3 7. A pliable container in accordance with claim 16. wherein the seal is a detachable seal

18. A pliable container in accordance with any one of claims 1-4, wherein the threaded spout comprises a screw thread,

1 . A pliable container in accordance with any one of claims 2-4, wherein the first polymer layer comprises cyclic olefin co-polymer.

20. A pliable container in accordance with any one of claims 2-4, wherein the first polymer layer comprises, cyclic olefin co-polymer (COC) and graft copolymer of ethylene and ocfene.

21. A pliable container in accordance with any one of claims 2-4, wherei the first polymer layer comprises nylon.

22. A pliab le container in accordance with any one of claims 2-4, wherein the first polymer layer comprises a polyethylene.

23. A pliable container in accordance with claim 22, wherein the polyethylene is linear low- density polyethylen (LLDPE).

24. A pliable container in accordance with claim 22. wherein the polyethylene is biaxially- ori en ted po l e th ylene terepht ha I ate .

25. A pl able container in accordance with any one of claims 2-4, wherein the first polymer layer comprises polypropylene.

26. A pliable container in accordance with any one of claims 2 -4, wherein the laminate further comprises a second polymer layer.

27. A pliable container in accordance with claim 26, wherein the second polymer layer comprises cyclic olefin co-polymer.

28. A pliable container in accordance with claim 26, wherein the second polymer layer comprises cyclic olefin co-polymer and graft co-polymer of ethylene and oetene.

29. A pliable container in accordance with claim 26, wherein the second polymer layer comprises nylon.

30. A pliable container in accordance with claim 26, wherein the second polymer layer comprises a polyethylene.

31 . A pliable container in accordance with claim 30, wherein the polyethy lene of the second polymer layer is linear low-density polyethylene (LLDPE).

32. A pliable container in accordance with claim 30, wherein the polyethylene of the second polymer layer is biaxialJy-oriented polyethylene terephthalate.

33. A pliable container in accordance with claim 26, wherein the second polymer layer comprises polypropylene.

34. A pliable container in accordance with claim 26, wherein the first polymer layer comprises LLDPE and the second polymer layer comprises nylon.

35. A pliable container in accordance with claim 26, wherein the first polymer layer comprises biaxi ally-oriented polyethylene terephthalate and the second polymer layer comprises nylon.

36. A pliable container in accordance with claim 26, wherein the laminate comprises nylon sandwiched betwee aluminum and LLDPE.

37. A pliable container in accordance with claim 26, wherein the laminate comprises nylon sandwiched betwee aluminum and biaxialiy-orienied polyethylene terephthalate.

38. A pliable container in accordance with one of claims 1-4, forther comprising a cap.

39. A pliable container in accordance with claim 38, wherein the cap consists of a polymer selected from the group consisting of high density polyethylene, LLDPE and biaxial !y~ oriented polyethylene terephthalate.

40. A method of anesthetizing a subject, comprising:

fondly connecting a container of any one of claims 1-4 to an anesthesia machine; fluidly connecting the anesthesia machine to a subject; and

administering an anesthetic-ally effective amount of the inhalational anesthetic to the subject. 1. A method of anesthetizing a subject in accordance with claim 40, wherein the subject is a human.

42. A method of anesthetizing a s ubjec t in accordance with claim 40, wherein the subject is an animal.

43. A method of anesthetizing a subject in accordance with claim .40, wherein the liquid inhalational anesthetic is a fluorocarbon anesthetic.

44. A method of anesthetizing a subject in accordance with claim 40, wherein the liquid inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane, emoxyflurane, ethrane and ether.

45. A method of anesthetizing a subject in accordance with claim 40, wherein the inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane and methoxyflurane,

46. A method of anesthetizing a subject in accordance with claim 40, wherein the container forther comprises a key collar.

47. A method of anesthetizing a subject in accordance with claim 40, wherein the container forther comprises a key collar corresponding to an ISO standard key collar for an inhalational anesthetic bottle.

48. A method of delivering a liquid inhalational anesthetic to an anesthetic vaporizer reservoir, corapri sing : attaching a container of any one of claims 1 -4 to a key fi ll adaptor ; and transferring the liquid anesthetic to the vaporizer reservoir.

49. A method in accordance with claim 48, wherein the liquid inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane, methoxyflnrane, ethrane and ether.

50. A method of anesthetizing a subject in accordance with claim 48, wherein the inhalational anesthetic is selected from the group consisting of sevoflurane, desfiuraoe. isoflurane, halothane and methoxyfTurane.

51. method of anesthetizing a subject in accordance with claim 48, wherein the container f rther comprises a key collar.

52. A method of anesthetizing a subject in accordance with claim 48, wherein the container further comprises a key collar corresponding to an ISO standard key collar for an inhalational anesthetic bottle.

53. A method of anesthetizing a subject in accordance with claim 48, wherein the container comprises an anesthetic-specific key collar and the key fill adaptor comprises a

complementary key fitting,

54. A kit comprising;

a pliable container for a liquid inhalational anesthetic, wherein the pliable container comprises a pliable container body and a threaded spout; and

at least one liquid inhalational anesthetic.

55. A kit in accordance with claim 54, wherein the pliable container comprises a laminate comprising an aluminum layer and first polymer layer,

56. A kit in accordance with claim 54, wherein the first polymer layer is in contact with the interior of the container.

57. A kit in accordance with claim 54, wherein the aluminum layer is in contact with the interior of the container.

58. A kit in accordance with any one of claims 54-57, wherein the first polymer layer comprises cyclic olefin co-polymer.

59. A kit in accordance with any one of claims 54-57. wherein the first polymer layer comprises cyclic olefin co-polymer (COC) and graft copolymer of ethylene and oetene.

60. A kit in accordance with any one of claims 54-57, wherein the first polymer layer comprises nylon.

61. A kit in accordance with any one of claims 54-57. wherein the first polymer layer comprises a polyethylene.

62. A kit in accordance with claim 75, wherein the polyethylene is selected from the group consisting of LLDPE and biaxial I -oriented polyethylene terephthalate.

63. A kit in accordance with any one of claims 54-57, wherein the first polymer layer comprises polypropylene .

64. A kit in accordance with any one of claims 54-57, wherein the laminate further compris a second polymer layer.

65. A kit in accordance with claim 64, wherem the second polymer layer comprises cyclic olefin co-polymer.

66. A kit in accordance with claim 64, wherein the second polymer layer comprises cyclic olefin co-polymer and graft co-polymer of ethylene arid octene.

67. A kit in accordance with claim 64, wherein the second polymer layer comprises nylon.

68. A kit in accordance with claim 64, wherein the second polymer layer comprises a polyethylene.

69. A kit in accordance with claim 83, wherein the polyethylene is selected from the group consisting of linear low-density polyethylene (LLDPE) and hiaxially-oriented polyethylene terephthalate.

70. A kit in accordance with claim 64, wherem the second polymer layer comprises polypropylene.

71. A kit in accordance with claim 64, wherein the first polymer layer comprises a

polyethylene and the second polymer layer comprises nylon.

72. A kit in accordance with claim 64, wherein the first polymer layer is a polyethylene layer, the second polymer layer is a nylon layer, and the laminate comprises the nylon layer sandwiched between the aluminum layer and the polyethylene layer.

73. A kit in accordance with claim 64, wherein the first polyraer layer is a polyethylene layer, the second polymer layer is a nylon layer, and the laminate comprises the aluminum layer sandwiched between the nylon layer and the polyethylene layer.

74. Use of a material comprising aluminum foil, a first polymer, and a second polymer in the manufacture of a pliable container for storing a liquid mhalational anesthetic.

Description:
Liquid inhalationai Anesthetic Container Priority Statement

This application claims the benefit of and priority to U.S. Provisional Application No. 6.1 /686.08G, .filed on. March 30, 2012, which is incorporated herein by reference in its entirety.

Introduction

The present invention is in the field of packaging for inhalationai anesthetics.

Previously disclosed liquid inhalationai anesthetic containers are rigid and non- pliable. For example, many inhalations! anesthetics, including liquid inhalationai anesthetics, are typically supplied t medical institutions and medical practitioners in glass bottles. Such bottles are connected directly to an anesthesia machine or vaporizer, or indirectl through an intermediate adapter. In addition, inhalationai anesthetic bottles for anesthetics such as sevofiurane, desflurane, isoflurane, halothane, tnethoxyflurane, ethraue arid ether are usually provided with a key collar which includes protrusions and/or notches. The receiving device to which the bottle attaches can include a complementary key. such that each type of

inhalationai anesthetic has a unique key to minimize the likelihood of attaching a bottle comprising one anesthetic to a connection intended for a different anesthetic. FIG. I displays an example of an anesthetic bottle and adapter. FIG, I A shows a prior art anesthetic bottle 10 separate from a vaporizer filler adapter 90. An anesthetic bottle connected with an. adapier is shown in FIG. I B . In FIG. J OA. anesthetic bottle 10 includes a spout 1 1 hav ing a rim of standard outer diameter (22 mm. tinder ISO standards), screw thread 20, key collar 13 having protrusions 14. An adapter which receives the anesthetic bottle includes tube 91 , connector 92, key 93 having slots 94. When the anesthetic bottled and adapter are properly connected (FIG. I B), the protrusions 14 of the bottle's key collar match with the slots 94 of the adapter's key (see, e.g., US Patent Application Publication 2008/0308179 of Daneisen; US Patent Application Publication 2004/0206417 of Falligant; PCT application publication WO 95/13972 of De Rubeis et al). The key collars and adapter keys can further be color coded, for example following industry standards such as those set by the ISO.

FIG, 1 depicts an example of a prior art anesthetic glass bottle and a vaporizer filler adapter. As illustrated in FIG. t A, glass bottle 10 includes spout with circular lip 11 , screw threads 12, key collar 13, and key protrusions 14. The key collar can include at least 2 protrusions, wherein the key collar has protrusions patterned to serve as a key unique to a species of liquid inhalation anesthetic. A. vaporizer filler adaptor 90 includes a connector 92, and a key 93. The key 93 includes slots 94 complementary to the patterned protrusions on key collar 13, The pattern of protrusions and the complementary slots are configured to be unique for each species of liquid inhalation anesthetic. When the bottle and the adaptor are connected as shown in FIG. I B, the protrusions 14 and slots 94 match up to reduce the possibilit of improper connection between a bottled liquid inhalational anesthetic and a filler adapter.

However, standard anesthetic bottles, being made from nonpliahle glass, are subject to breakage and shattering. Furthermore, glass containers can be considered heavy to transport, and some liquid inhalational anesthetics are believed to react with or corrode glass or components thereof. For example, the fluorocarbon anesthetic sevotlurane as supplied by commercial suppliers in glass containers has been found to include contaminants such as hydrogen fluoride, speculated glass, and Lewis acids (Baker, M.T., Anesthesia & Analgesia 108, 1725-1726, 2009; Kharasch, E.D., et al., Anesthesia & Analgesia 108, 1796-1802, 2009; O'Neill, B. s et al. Anesthesia 62, 421, 2007; US Patent Application Publication

2010/0218762 of Jiang; US Patent 5,990,176 to Bfenura et al..),.

Alternatives to glass as packaging material for liquid inhalational anesthetics have been proposed. For example, U.S. Pat. No. 4,250,334 teaches the use of "Kel-F" plastic for a container for holding the fluorocarbon anesthetic sevoflurane, "Kel-F" is onderstood to be the trade name for chiorotritlnoroethylene, U.S. Pat, No. 5,679,576 teaches the use of a container lined with polytetrafJuoroethylene fPTFE). for holding the fluorocarbon anesthetic sevoflurane. U.S. Pat. No. 5,505,236, teaches the use of a plastic container with an inhalational anesthetic. While not specifical ly naming the inhalational anesthetic, it is believed that the commercial embodiment of the system shown in the '236 patent has been used with the fluorocarbon anesthetic sevoflurane. Additional patents have taught the use of particular types of plastic for containers to hold sevoflurane. See, e.g., U.S. Pat. Nos..

6,074,608 (polyethylene napthalate), 6,083,514 (polyniethyipentene) and 6, 1 2,443

(polypropylene, polyethylene and ionorneric resins). In addition, containers for inhalational anesthetics made of certain plastics have been proposed. Cf, WO 99/34762, U.S. Pat. Nos. 6,074,668 to Flament-Garcia et al, 6,162,443 to Flament-Garcia et al, and U.S. Patent Application Publication No. U.S. 2001/0000729 Al of Flament-Garcia et al. While plastic containers are less likely to break than glass containers, rigid plastic containers are still susceptible to breakage under common use conditions.

Containers for sevoflurane have also been made of stainless steel. For example, U .S . Pat. No. 5,990, 176 describes a container made of glass, plastic or stainless steel for holding sevoflurane. U.S. Pat. No. 6,008,273 describes an epoxy resin for coating the inside of a metal container for use as a food or beverage container. US Patent application

piiblicatioo201 10284418 of Riidzmski et al. discloses an alominum container for inhalational anesthetics. However, the aluminum container is not described as pliable, deformab!e. or flexible. US Patent, application publication 20100286648 of Freed discloses a receptacle

Summary

The present inventor has developed pliable containers for liquid inhalational anesthetics, hi various embodiments, the packaging can comprise a pliable material, in various embodiments, a pliable container of the present teachings can comprise or consist of: a pliable container body; a threaded spout; and a liquid inhalational anesthetic. In various embodiments, a pliable container body can comprise or consist of a laminate such as a multilaye 1 " j ini.

In various embodiments, a laminate of a container body of the present teachings can comprise or consist of at least one layer of alominum such as aluminum foil, and at l east one layer of a polymer which is in contact w ith a l iquid inhalational anesthetic, In various embodiments, a laminate of a container body of the present teachings can comprise or consist of at least one layer of a polymer, and at least one layer of aluminum such as aluminum foil which is in contact with a. liquid inhalational anesthetic.

In various embodiments, a laminate of a container body of the present teachings can comprise or consist of at least one layer of al uminum such as aluminum foil, and two or more layers of polymer(s). including a polymer layer which is in contact with a liquid inhalational anesthetic. In various embodiments, a laminate of a container body of the present teachings can comprise or consist of two or more layers of polymer(s), and at least one layer of aluminum such as aluminum, foil which, is in contact with a liquid inhalational anesthetic, in these embodiments, the polymers can be the same or different.

In various embodiments of the present teachings, a liquid inhalational anesthetic of the present teachings can be any liquid inhalational anesthetic known to skilled artisans. In. some configurations, an inhalational anesthetic can be a fiuoraearbon anesthetic, such as, withoiii limitation, sevo.fiurane, desfiurane, isoflurane, haiothane or met oxvflurane. In some configurations, a liquid inhalational anesthetic can be selected from the group consisting of sevoflurane. desfiurane, isoflurane, haiothane, methoxyflurane, ethrane and ether.

In various embodiments, a pliable container of the present teachings can further comprise a key collar. Key collars of the present teachings are well known to skilled artisans, and follow industry standards for anesthetic bottles such as, without, limitation, standards established by the ISO. in various embodiments, a spout of a container of the present teachings can h ave dimensions that accord with industry standards, such as, without limitation, ISO standards for liquid inhalational anesthetic bottles, such as a cylindrical spout having a -29 mm outside diameter, and can be made of a plastic, such as a bard, non-deformable plastic such as, without limitation, high density polyethylene, i various configurations, the thread of a spout can be a screw thread. In various embodiments, a pl iable contai ner of the present teachings can further comprise seal which covers the spout. The seal can comprise a plastic and/or a metal such as aluminum foil, and can function to maintain a liquid inhalational anesthetic within the container, and also to prevent evaporation. The seal can he maintained intact during storage, and can be detached or punctured to allow flow of the liquid inhalational anesthetic through the spout, i some aspects, the seal can be configured to be a removable seal,

A container body of a. pliable container of the present teachings can be adapted, for holding a volume of an inhalational anesthetic, which can be, for example and wi thout limitation from about 50 ml to about 250 ml, or greater, such as 50 ml, 100 ml, 150 ml, 200 ml, 240 n l, 250 ml, or greater.

The materiai of a container body of the present teaching can comprise any flexible material that, includes a pliable polymer and/or a pliable metal sheet, such as an aluminum sheet (aluminum foil). In various configurations, the material and its component layers can serve as a barrier to leakage or evaporation of a liquid inhalational anesthetic, and can be adapted from published references. For example, PCX application publication WO 03/097355 of Manabe discloses a plastic container for storing liquid medicines. The materiai disclosed in this publication is a multi-layer film having an a surface layer of eihy!ene-«~olefin copolymer, a pliable layer of an eilrylene-a-olefin copolymer, a barrier layer of a cyclic olefin polymer and an et ylene-a-o efin copolymer, and a seal layer of an ethylene-a-oiefin. In other configurations of the present teachings, a polymer layer ca be a cyclic olefin copolymer, or a cyclic olefin co-polymer (COC) and graft copolymer of ethylene and octene. in some configurations, a polymer layer of a pliable container body of the present teachings can be a layer of a polymer such as nylon, polyethylene or polypropylene. In various

configurations, a polyethylene layer can be a linear low-density polyethylene (LLDPE), In various configurations, a polyethylene layer can be a biaxiaily-oriented polyethylene terephthalate (MYLAR® (Dupont Corp,}}. In some configurations, the Mylar® can be metallized by vapor deposition to produce a thin film of an evaporated metal such as aluminum or gold. In some configurations, a first polymer layer, which can be in contact with a liquid inhalational anesthetic, can be LLDPE, while a second polymer layer can be nylon, in some configurations, a first layer can be biaxiaily-oriented -polyethylene terephthalate and the second polymer layer can be nylon. In some configurations, a laminate can be triiaminate, and can comprise or consist of nylon sandwiched between aluminum and LLDPE. In. some configurations, a laminate can comprise or consist of nylon sandwiched between aluminum and biaxiaily-oriented polyethylene terephthalate. In some configurations, a laminate can comprise or consist of alum mum sandwiched between nylon and LLDPE. In some configurations, a laminate can comprise or consist of aluminum sandwiched between nylon and biaxiaily-oriented polyethylene terephthalate. In some configurations, a laminate can comprise or consist of LLDPE sandwiched between, nylon and aluminum. In some

configurations, a laminate can comprise or consist of biax iaily-oriented polyethylene terephthalate sandwiched between nylon and aluminum.

In some embodiments, a pliable container of the present teachings can further include a cap. In various configurations, a cap can comprise or consist of a polymer selected from the group consisting of high density polyethylene, LLDPE and biaxiaily-oriented polyethylene terephthalate. In various configurations, a cap can comprise or consist of aluminum. In various configurations, a cap can comprise or consist of a combination of a polymer and aluminum.

Embodiments of the present teachings include methods of anesthetizing a subject. In various configurations, these methods include tliiidly connecting a container disclosed herein to an anesthesia machine; fluidly connecting the anesthesia machine to a subject; and administering an anesthetieal ly effecti ve amount of the inhalational anesthetic to the subject. In various configurations, a connection between a container and an anesthesia machine can be direct or indirect, e.g., through an adapter, hi various configurations, a subject can be a human or an animal, and the anesthetic can be any liquid inhaiational anesthetic, such as a tluorocarbon anesthetic, hi various configurations, the anesthetic can be selected from the group consisting of sevofl urane, desflurane, isoflurane, halothane, methoxyflurane, ethrane and ether, or selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane and methoxyflurane. In various configurations, a container can further coraprise a key collar, and can be connected to a machine or adapter comprising a complementary key. In various configuratio s, a key collar and key can correspond to ISO standards.

Embodiments of the present teachings include methods of delivering a liquid inhaiational anesthetic to an anesthetic vaporizer reservoir, in various configurations, these methods comprise attaching a container disclosed herein comprising a liquid inhaiational anesthetic to a key fill adaptor, and transferring the liquid anesthetic to the vaporizer reservoir. A liquid inhaiational anesthetic of these embodiments can be any liquid inhaiational anesthetic disclosed herein, such as, without limitation, sevoflurane, desflurane, isofi urane, halothane, methoxyflurane, ethrane or ether. In some configurations, a pliable container of these embodiments can comprise a key collar, such as a key collar which meets ISO standards for an inhaiational anesthetic bottle key collar. In some configurations, a device for receiving a pliable container can comprise a key fill adaptor which comprises a complementary key fitting.

Embodiments of the present teachings also include various kits. A kit of the present teaching, in various configurations, can comprise a pliable container for a liquid inhaiational anesthetic, wherein the pliable container comprises a pliable container body and a threaded spout; and at least one liquid inhaiational anesthetic. In various configurations, a pliable container can comprise a laminate as described herein.

Embodiments of the present teachings include use of a material comprising aluminum foil, a .first polymer, and a second polymer in the manufacture of a pliable container for storing a liquid inhaiational anesthetic.

The present teachings include, without limitation, the following aspects,

1, A pliable container for a liquid inhaiational anesthetic, comprising:

a pliable container body; a threaded spout; and

a liquid inhalaiionai. anesthetic.

2. A pliable container in accordance with aspect 1, wherein the pliable container body comprises a laminate comprising an aluminum layer and a first polymer layer.

3. A pliable container in accordance with aspect 2, wherein the liquid inhalaiionai anesthetic is in contact with the first polymer layer.

4. A pliable container in accordance with aspect 2, wherein the liquid inhalaiionai anesthetic is in contact with the aluminum layer.

5. A pliable container in accordance with any one of aspects 1-4, wherein the liquid inhalaiionai anesthetic is a fluoroearbon anesthetic.

6. A pliable container in accordance with any one of aspects 1-4, wherein the liquid inhalations! anesthetic is selected from the group consisting of sevoflurane, desflurane, isof!urane, halothane, methoxyf!arane, ethrane and ether.

7. A pliable container in accordance with any one of aspects 1-4, wherein the inliaiational anesthetic is sevoflurane.

8. A pliable container in accordance with any one of aspects 1-4, wherein the inliaiational anesthetic is desflurane.

9. A pliabie container in accordance with any one of aspects 1-4, wherein the inliaiational anesthetic is iso.fiurane.

10. A pliable container in accordance with any one of aspects 1-4, wherein, the inhalaiionai anesthetic is halot ane.

1 1 . A pl iabie container in accordance with any one of aspects 1 -4, wherein the inhalational anesthetic is .rn.ethoxy.fi urane.

12. A pliabie container in accordance with any one of aspects 1-4, wherein the inhalaiionai anesthetic is ethrane,

13. A pliable container in accordance with any one of aspects 1-4, wherein the inhalaiionai anesthetic is ether. 14. A pliable container in accordance with any one of aspects 1-4, further comprising a key collar.

15. A pliable container in accordance with any one of aspects 1-4, farther comprising a key collar corresponding to an ISO standard key col ar for an inhalationa! anesthetic bottle.

16. A pliable container in accordance with any one of aspects 1 -4, further comprising a seal which covers the threaded spout.

17. A pliable container in accordance with aspect 1 , wherein the seal is a detachable seal.

18. A pliable container in accordance with any one of aspects 1-4, wherein the threaded spoilt composes a screw thread.

19. A pliable container in accordance with any one of aspects 2-4, wherein the first polymer layer comprises cyclic olefin co-polymer.

20. A pliable container in accordance with any one of aspects 2-4, wherein the first polymer layer comprises cyclic olefin co-polymer (COC) and graft copolymer of ethylene and octeoe.

21 . A pliable container in accordance with any one of aspects 2-4, wherein the first polymer layer comprises nylon,

22. A pliable container in accordance with any one of aspects 2-4, wherein the first polymer layer comprises a polyethylene.

23. A pliable container in accordance with aspect 22 s wherein the polyethylene is linear low- density polyethylene (LLDPE).

24. A pliable container in accordance with aspect 22, wherein the polyethylene is biaxially- oriented polyethylene terephfchalate.

25. A pliable container in accordance with any one of aspects 2-4, wherein, the first, polymer layer comprises polypropylene.

26. A pliable container in accordance with any one of aspec ts 2-4, wherein the laminate further comprises a second polymer layer.

27. A pliable container in accordance with aspect 26, wherein the second polymer layer comprises cyclic olefin co-polymer. 28. A pliable container in accordance with aspect 26, wherein the second polymer layer comprises cyclic olefin co-polymer and graft co-polymer of ethylene and octane.

29. A pliable container in accordance with aspect 26, wherein the second polymer layer comprises nylon.

30. A pliable container i accordance with aspect 26, wherein the second polymer layer comprises a polyethylene.

31. A pliable container in accordance with aspect 30, wherein the polyethylene of the second polymer layer is linear low-density polyethylene (LLDPE).

32. A pliable container in accordance with aspect 30, wherein the polyethylene of the second polymer layer is biaxially-oriented polyethylene terephthalate,

33. A pliable container i accordance with aspect 26, wherein the second polymer layer comprises polypropylene.

34. A pliable container in accordance with aspect 26, wherein the first polymer layer comprises LLDPE and the second polymer layer comprises nylon.

35. A pliable container in accordance with aspect 26, wherein the first polymer layer comprises biaxially-oriented polyethylene terephthalate and the second polymer layer comprises nylon.

36. A pliable container in accordance with aspect 26, wherein the laminate comprises nylon sandwiched between aluminum and LLDPE.

37. A pliable container in accordance with aspect 26, wherein the laminate comprises nylon sandwiched between aluminum and biaxially-oriented polyethylene terephthalate.

38. A pliable container in accordance with one of aspects 1-4, further comprising a cap.

39. A pliable container in accordance with aspect 38, wherein the cap consists, of a polymer selected from the group consisting of high density polyethylene. LLDPE and biaxially- oriented polyethylene terephthalate.

40. A method of anesthetizing a subject, comprising:

flnklly connecting a container of anyone of aspects 1.-4 to an anesthesia machine; !uidly connecting the anesthesia machine to a subject; and administering an anesthetically effective amount of the inhalational anesthetic to the subject.

41. A method of anesthetizing a subject in accordance with aspect 40, wherein the subject is a human.

42. A method of anesthetizing a subject in accordance with aspect 40, wherein the subject is an animal.

43. A method of anesthetizing a subject in accordance with aspect 40, wherein the liquid inhalational anesthetic is a fluorocarbon anesthetic.

44. A method of anesthetizing a subject in accordance with aspect 40, wherein the liquid inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane, methoxyfiurane, ethrane and ether.

45. A method of anesthetizing a subject in accordance with aspect 40, wherein the

inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isoflurane, halothane and methoxyfiurane.

46. A method of anesthetizing a subject in accordance with aspect 40, wherein, the container further comprises a key collar.

47. A method of anesthetizing a subject in accordance with aspect 40, wherein the container further comprises a key collar corresponding to an ISO standard key collar for an inhalational anesthetic bottle.

48. A method of deliveri ng a liquid inhalational anesthetic to a anesthetic vaporizer reservoir, comprising:

attaching a container of any one of aspects .1-4 to a key fill adaptor; and

transferring the liquid anesthetic to the vaporizer reservoir.

49. A. method in accordance with aspect 48, wherein the liquid inhal tional anesthetic is selected .from the group consisting of sevoflurane, desflurane, isofiurane, halothane, methoxyfiurane, ethrane and ether.

50. A method, of anesthetizing a subject in accordance with aspect 48, wherein the

inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isofiurane, halothane and methoxyfiurane. 51. A method of anesthetizing a subject in accordance with aspect 48, wherein the container further comprises a key collar ,

52. A method of anesthetizing a subject in accordance with aspect 48, wherein the container further comprises a key collar corresponding to an ISO standard key collar- for an inhalational anesthetic bottle.

53. A method of anesthetizing a subject, in accordance with aspect 48, wherein the container comprises an anesthetic-specific key collar and the key fill adaptor comprises a

complementary key fitting.

54. A kit comprising:

a pliable container for a liquid, inhalational anesthetic, wherein the pliable container comprises a pliable container body and a threaded spout and

at. least one liquid inha!ationai anesthetic.

55. A kit in accordance with aspect 54, wherein the pliable container comprises a laminate comprising an aluminum layer and a first polymer layer.

56. A kit in accordance with aspect 54, wherein the first polymer layer is in contact with the intenor of the container.

57. A kit in accordance with aspect 54, wherein the aluminum layer is in contact with, the interior of the container.

58. A kit in accordance wit any one of aspects 54-57, wherein the at least one liquid inhalational anesthetic is a fiuorocarbon anesthetic.

59. A kit in accordance with any one of aspects 54-57, wherein the at least one liquid inhalational anesthetic is selected from the group consisting of sevoflurane, desflurane, isofhjrane, halothane, methoxyfiurane, ethrane and ether.

60. A. kit in accordance with any one of aspects 54-57, wherein the at least one li qui d inhalational anesthetic is sevoflurane.

61. A ki t in accordance with any one of aspects 54-57, wherein the at least one liquid inhalational anesthetic is desflurane. 62. A kit in accordance with any one of aspects 54-57, wherein the at least one liquid inhaiationai anesthetic is isoflurane.

63. A kit in accordance with any one of aspects 54-57. wherein the at least one liquid inhaiationai anesthetic is halothane.

64. A kit n accordance with any one of aspects 54-57, wherein the at least one liquid inhalational anesthetic is methoxyflurane.

65. A kit in accordance with any one of aspects 54-57, wherein the at least one liquid inhalational anesthetic is ethrane.

66. A kit in accordance with any one of aspects 54-57, wherein the at least one liquid inhaiationai anesthetic is ether.

67. A kit in accordance with any one of aspects 54-57, farther comprising at least one key collar.

68. A kit in accordance with any one of aspects 54-57, further compri sing at least one key collar corresponding to an ISO standard key collar for an inhaiationai anesthetic bottle.

69. A kit in accordance with any one of aspects 54-57, wherein the pliable container further comprises a sea! which covers the threaded spout.

70. A kit in accordance with aspect 69, wherein the seal is a detachable seal.

71. A kit in accordance with any one of aspects 54-57, wherein the threaded spout comprises a screw thread.

72. A kit in accordance with any one of aspects 54-57, wherein the first polymer layer comprises cyclic olefin co-polymer.

73. A kit in accordance with any one of aspects 54-57, wherein the .first polymer layer comprises cyclic olefin co-polymer (COC) and graft copolymer of ethylene and octene,

74. A kit in accordance with any one of aspects 54-57, wherein the first polymer layer comprises nylon.

75. A kit in accordance with any one of aspects 54-57, wherein the first polymer layer comprises a polyethylene. 76. A kit in accordance with aspect 75, wherein the polyethylene is LLDPE.

77. A kit in accordance with aspect 75. wherein the polyethylene is hiaxiaiiy-oriented polyethylene terephthalaie.

78. A ki t in accordance with any one of aspects 54-57, wherein the first polymer laye comprises polypropylene.

79. A kit in accordance with any one of aspects 54-57. wherein the laminate further

comprises a second polymer layer,

80. A kit in accordance with aspect 79, wherei the second poiymer laye comprises cyclic olefin co-p lymer,

81. A kit in accordance with aspect 79, wherein the second polymer layer comprises cyclic olefin co-polymer and graft, co-polymer of ethylene and octene.

82. A kit in accordance with aspect 79, wherein the second polymer layer comprises nylon.

83. A kit in accordance wit aspect 79, wherein the second polymer layer comprises a polyethylene,

84. A kit in accordance with aspect 83, wherein the polyethylene of the second polymer layer is linear low-density polyethylene (LLDPE)..

85. A kit in accordance with aspect 83, wherein the polyethylene of the second polymer layer is biaxia!ly-oriented polyethylene terephtbalate.

86. A kit in accordance with aspect 79, wherein the second polymer layer comprises polypropylene.

87. A kit in accordance with aspect 79, wherein the first polymer layer comprises a polyethylene and the second poiymer layer comprises nylon.

88. A kit in accordance with aspect 79, wherein the first polymer layer is a polyethylene layer, the second polymer layer is a nylon layer, and the laminate comprises the nylon layer sandwiched between the aluminum layer and the polyethylene layer. 89. A kit in accordance with aspect 79. wherein the first polymer layer is a polyethylene layer, the second pol mer layer is a nylon layer, and the laminate comprises the aluminum layer sandwiched between the nylon layer and the polyethylene layer.

90. Use of a material comprising aluminum foil, a first polymer, and a second polymer in the manufacture of a pliable container for storing a liquid inhalational anesthetic.

Brief Description of the Drawings.

FIG, 1 illustrates an example of a prior art liquid inhalational anesthetic glass bottle and adapter, wherein FIG. 1 A illustrates a glass bottle separate from an adapter, and FIG. I B illustrates a glass bottle connected to an adapter.

FIG. 2 illustrates a configuration of the present teachings resembling a toothpaste tube. FIG. 2 A illustrates piiabie container separate from an adapter, and FIG. 2B illustrates a pliable container connected to an adapter.

FIG, 3 illustrates a configuration of the present, teachings in the shape resembling a flask. FIG. 3A illustrates a pliable container separate from an adapter, and FIG. 3B illustrates a pliable container connected to an adapter,

FIG. 4 illustrates a configuratio of the present teachings in the shape resembling a flask. FIG. A. illustrates a pliable container separate from an. adapter, and FIG. 4B illustrates a pliable container connected to an adapter.

FIG. 5 illustrates a configuration of the present teachings in the shape resembling a disposable juice container. FIG. 4A illustrates a pliable container separate from an adapter, and FIG. 4B illustrates a pliable container connected to an adapter.

Detailed Description

The present inventor has developed pliable containers for liquid inhalational anesthetics. In various embodiments, the packaging can comprise a pliable material. In various embodiments, a pliable container of the present teachings can comprise or consist of: a pliable container body; a threaded spout; and a liquid inhalational anesthetic. In various embodiments, a pliable container body can comprise or consist of a laminate such as a multilayer film. In various embodiments, a laminate of a container body of the present teachings can comprise or consist of at least one layer of aluminum such as aluminum foil, and at least one layer of a polymer wherein the polymer layer is in contact with a liquid iiihalationa! anesthetic. In various embodiments, a laminate of a container body of the present teachings can comprise or consist of at least one layer of a polymer, and at least one layer of aluminum such as aluminum foil wherein the aluminum layer is in contact with a liquid inhalations! anesthetic, in various con figurations, a polymer of a Iaminate of the preseni disclosure can be any polymer which can form a flexible material In some configurations, a polymer can also serve as a flexible barrier to liquid anesthetic flow and evaporation. Non-limiting examples of polymers, films and laminates which can be produced and used in a container body of the present teachings are disclosed in publications such as US Patent Application Publication 20100218762 of Jiang; US Patent Application Publication 20070243293 of Janssen et a!.; US Patent Application Publica«on20080071046 ofLeelerc et al; US Patent 5,837,787 to

Harrington; US Patent Application Publication 20080299370 of Briggs; US Patent

Application Publication 20070026251 of Umana; US Patent Application Publication

20070088145 of Mgaya et al, US Patent Application Publication 2008009914! of Booth et al, US Patent 7,384,674 to Andersson et a!., US Patent Application Publication 20120238955 of Wyss; US Patent 8 J 9,03 ! to Ling et al; and US Patent Application Publication

20 ! 10064955 of Bertolino et al.

A container body of the present teachings can comprise or consist of, in non-limiting example, a polyethylene layer that can be a biaxial!y-oriented polyethylene terephtha!ate (Mylar®) film. In various configurations, a flexible container body of the preseni teachings can comprise at least one layer of a polymer such as a cyclic olefin co-polymer, for example TOP AS® 8007 (Polyplastics Co., Lid. } or Exact™ P!astomers (EXACT 5061. ExxonMobil Chemical), in various configurations, a container body of the present teachings can have, in non-limiting examples, thickness of 0.002, 0.0048, 0.005, 0.0075, 0.010 or 0.014 inch. In some configurations, a container body can comprise 5 mil Mylar®, in some configurations, 5 mil thick Mylar® can be used having a middle layer of aluminum (0.00035"). In some configurations, an aluminum layer can be from .00035" to .078" thick, such as, for example, about 0.001." thick. In some configurations, a pliable container body can be made from a 0.35mil (9um) thick. Mylar® film sandwiched between two layers of 0.18 mi! (4.5pm) thick aluminum foil that are bonded together, in some configurations, a. pliable container body can be made of alurninized Mylar® film thai can be laminated with a layer of polyethylene. Polymers and metal foils and laminate materials can be formed using methods well known to skilled artisans. Furthermore, materials can be shaped and containers assembled using methods known to skilled artisans.

Key collars can correspond to industry standards, and fiirthermore can he color-coded in accordance with industry standards, for example yellow for sevofturane, purple for isoflurane, red for halothane, and blue for destlurane.

FIG. 2 depicts an example of a container of the present teachings, and a vaporizer filler adapter. As illustrated in FIG. 2 , a configuration resembling a toothpaste tube 20 includes spout with, circular lip 21 , screw threads 22, key collar 23, and key protrusions 24. The key collar can include at least 2 protrusions, wherein the key collar has protrusions patterned to serve as a key unique to a species of liquid inhalation anesthetic. A vaporizer filler adaptor 90 includes a connector 92, and a key 93.The key 93 includes slots 94

complementary to the patterned protrusions on key collar 23. The pattern of protrusions and the complementary slots are configured to be unique for each species of liquid inhalation anesthetic. When the bottle and the adaptor are connected as shown in FIG, 2B, the

protrusions 24 and slots 94 match up to reduce the possibility of improper connection between a bottled liquid inhalational anesthetic and a filler adapter, in various aspects, a container of this configuration can have either a tapered or a pinched base.

FIG. 3 depicts an example of a container of the present teachings, and a vaporizer filler adapter. As illustrated in FIG, 3 A, a configuration resembling a flask 30 includes spout with circular lip 3.1, screw threads 32, key collar 33, and key protrusions 34. The key collar can include at least 2 protrusions, wherein the key collar has protrusions patterned to serve as a key unique t a species of liquid inhalation anesthetic, A vaporizer filler adaptor 90 includes a connector 92, and a key 93. The key 93 includes slots 94 complementary to the patterned protrusions on key collar 33. The pattern of protrusions and the complementary slots are configured to be unique for each species of liquid inhalation anesthetic. When the bottle and the adaptor are connected as shown in FIG. 3B, the protrusions 34 and slots 94 match up to reduce the possibility of improper connection between a bottled liquid

mh.aiatio.nai anesthetic and a filer adapter. In various aspects, a container of this

configuration can incl ude a gusset, at the base to allow expansion upon introduction of a liquid inhalational anesthetic, or contractio during draining of the anesthetic. FIG. 4 depicts an example of a container of the present teachings, and vaporizer filler adapter. As illustrated in FIG. 4A, a flask-like configuration.40 includes spout with circular lip 41 , screw threads 42, key collar 43, and key protrusions 44. The key collar can include at least 2 protrusions, wherein the key collar has protrusions patterned to serve as a key unique to a species of liquid inhalation anesthetic. A vaporizer filler adaptor 90 includes a connector 92. and a key 93. The key 93 includes slots 94 complementary to the patterned protrusions on key collar 43. The pat tern of protrusions and the complementary slots are configured to be unique for eac species of liquid inhalation anesthetic. When the bottle and the adaptor are connected as shown in F1G.4B, the protrusions 44 and slots 94 match up to reduce the possibility of improper connection between a bottled liquid inhalational anesthetic and a filler adapter, in various aspects, a container of this configuration can include a gusset as in FIG. 3.

FIG. 5 depicts an example of a container of the present teachings, and a vaporizer filler adapter. As illustrated in FIG. 5 A, a configuration resembling disposable juice container 50 include spout with circular lip 51, screw threads 52, key collar 53, and key protmsions 54. The key collar can include at least 2 protrusions, wherein the key collar has protrusions patterned to serve as a key unique to a species of liquid inhalation anesthetic. A vaporizer filler adaptor 90 includes a connector 92, and a key 93.The key 93 includes slots 94 complementary to the patterned protrusions on key collar 53. The pattern of protrusions and the complementary slots are configured to be unique for each species of liquid inhalation anesthetic. When the bottle and the adaptor are connected as shown in FIG.5B. the

protrusions 54 and slots 94 match up to reduce the possibility of improper connection between a bottled liquid inhalational anesthetic and a filler adapter.

All references cited are incorporated herein by reference, each in its entirety.