초록 ▼

A unit dose, gas-filled syringe is provided which is filled with gas and packaged in a gas barrier material prior to use to increase shelf-life, that is, to minimize gas leakage and dilution of the contents of the syringe. The syringe is filled with a selected gas and sealed inside a container made

A unit dose, gas-filled syringe is provided which is filled with gas and packaged in a gas barrier material prior to use to increase shelf-life, that is, to minimize gas leakage and dilution of the contents of the syringe. The syringe is filled with a selected gas and sealed inside a container made from a high gas barrier material. The container is also filled with the selected gas. The container material is selected to have a gas transmission rate sufficient to prevent the selected gas from diffusing out of the container into the atmosphere. The volume of gas in the container is greater that atmospheric pressure to prevent atmospheric contaminants from entering the container and syringe.

대표청구항 ▼

1. A gas syringe unit for injecting a gas into the body of an animal, said syringe unit comprising:a prefilled gas syringe containing a unit dose of a pharmaceutically acceptable gas, said gas being substantially in the absence of air, said syringe including a syringe barrel with a gas delivery outl

1. A gas syringe unit for injecting a gas into the body of an animal, said syringe unit comprising:a prefilled gas syringe containing a unit dose of a pharmaceutically acceptable gas, said gas being substantially in the absence of air, said syringe including a syringe barrel with a gas delivery outlet, and a plunger slidably received in said syringe barrel for expelling said unit dose of said gas through said delivery outlet; and a container having an internal volume and being configured and arranged to enclose said gas syringe within the internal volume and so to prevent contact of said gas syringe with air and contaminants external to said container, the internal volume containing said pharmaceutically acceptable gas substantially in the absence of air, wherein said container is made of a material characterized as having a gas transmission rate sufficient to essentially prevent said pharmaceutically acceptable gas from diffusing out of the container internal volume and to essentially prevent atmospheric contaminants from diffusing into the container interior volume, and said container having an internal pressure to inhibit diffusion of air and contaminants into said container. 2. The gas syringe of claim 1, wherein said container has an internal surface area defining said unit dose of said gas, and said gas in said syringe has a purity of at least about 95%, said gas having a shelf life of at least one year, said container material having a maximum allowable gas transmission rate determined using V×(1 ?p)/(A×S), wherein V is a volume of said container, p is the purity of said gas, A is the internal surface area of said container, and S is said shelf life.3. The gas syringe of claim 1, wherein said gas is selected from the group consisting of nitric oxide, nitric oxide-releasing compounds, carbon dioxide, perfluoropropane, perfluorobutane, perfluoroethane, helium, and sulfur hexafluoride.4. The gas syringe of claim 1, wherein said container material is selected from the group consisting of a metal foil, an aluminized foil laminate, and a laminate having at least one metallized layer of at least one layer of nylon, polypropylene, ethylene vinyl alcohol, polyethylene terephthalate, low density polyethylene, medium density polyethylene or cellophane.5. The syringe of claim 1, wherein said gas delivery outlet is a needle.6. The syringe of claim 1, wherein said gas is substantially free of oxygen and is at least about 93% by volume pure.7. The syringe of claim 1, wherein said gas in said container is at a pressure above atmospheric pressure.8. The syringe of claim 1, wherein said container is made from a metal foil laminate.9. The syringe of claim 1, further comprising a canister containing said pressurized gas, said canister having an outlet removably coupled to said delivery outlet for supplying said gas to said syringe.10. A method of forming a gas bubble in the body of a patient, said comprising the steps of:providing a clean and sterile packaged, prefilled syringe having a syringe barrel, delivery outlet and plunger, said syringe containing a unit dose of a pharmaceutically acceptable gas, said gas being substantially free of air, wherein said prefilled syringe is enclosed in a container, said container being formed from a material characterized as having a gas transmission rate sufficient to essentially prevent said gas from diffusing out of the container and to essentially prevent atmospheric contaminants from diffusing into the container interior volume and having an internal volume surrounding said syringe and being filled with said gas at a pressure at least substantially equal to atmospheric pressure, removing said syringe from said container, introducing said syringe delivery outlet into the patient, and injecting said pharmaceutically acceptable gas via the syringe delivery outlet into the patient, thereby forming a gas bubble of the pharmaceutically acceptable gas within the patient. 11. The method of claim 10, wherein said delivery outlet is a needle or cannula.12. The method of claim 10, wherein said pharmaceutically acceptable gas has a purity of at least about 70% by volume.13. The method of claim 10, wherein said pharmaceutically acceptable gas has a purity of about 93% to 98% by volume.14. The method of claim 10, wherein said container has a gas permeability to provide a shelf life of said gas in said syringe of at least one year.15. The method of claim 10, wherein said pharmaceutically acceptable gas is selected from the group consisting of nitric oxide, nitric oxide-releasing compounds, carbon dioxide, perfluoropropane, perfluoroethane, perfluorobutane, helium and sulfur hexafluoride.16. The method of claim 10, wherein said container material is made from a laminate material having at least one metal foil layer and a layer selected from the group consisting of nylon, polypropylene, polyethylene, ethylene vinyl alcohol, polyethylene terephthalate and cellophane.17. The method of claim 10, wherein said container material has a sufficiently low gas permeability whereby the purity of said pharmaceutically acceptable gas in said container is substantially unchanged after about one year.18. The method of claim 10, wherein said container material is substantially oxygen impermeable material.19. The method of claim 10, wherein said pharmaceutically acceptable gas in said container is at a pressure above atmospheric.20. A method of forming a gas bubble in an eye of a patient during eye surgery, said method comprising the steps ofproviding a clean and sterile prefilled syringe containing a unit dose of a pharmaceutically acceptable gas and being substantially free of air and oxygen, said syringe having a syringe barrel, a gas delivery outlet, and a plunger, said syringe being completely enclosed in a container of a material characterized as having a gas transmission rate sufficient to essentially prevent said gas from diffusing out of the container and to essentially prevent atmospheric contaminants from diffusing into the container interior volume, said container having an internal volume surrounding said syringe and being filled with said pharmaceutically acceptable gas at a pressure at least substantially equal to atmospheric pressure, removing said syringe from said container, introducing said gas delivery outlet of said syringe into the eye of the patient and introducing said pharmaceutically acceptable gas into the eye so as to form the gas bubble within the eye, and wherein said pharmaceutically acceptable gas is selected from the group consisting of nitric oxide, nitric oxide-releasing compounds, carbon dioxide, perfluoropropane, perfluoroethane, perfluorobutane, helium and sulfur hexafluoride. 21. The method of claim 20, wherein said pharmaceutically acceptable gas has a purity of at least about 93% to 98% by volume.22. A method for preparing a gas syringe unit, comprising the steps of:forming a container from a substantially gas impermeable material, the container having an internal volume; providing a prefilled gas syringe containing a unit dose of a pharmaceutically acceptable gas, said gas being substantially in the absence of air, said syringe including a syringe barrel with a gas delivery outlet, and a plunger slidably received in said syringe barrel for expelling said unit dose of said gas through said delivery outlet; disposing the prefilled gas syringe within the container internal volume; filling the container internal volume with the pharmaceutically acceptable gas so the gas within the internal volume is at a pressure at least substantially equal to atmospheric pressure. 23. The method of claim 22, wherein said disposing includes sealing the container so as to retain the prefilled gas syringe within the container; and whrrein said method further comprises the step of:evacuating the sealed container and thereafter filling the container internal volume with the pharmaceutically acceptable gas. 24. The method of claim 23, wherein the container is configured and arranged so as to include a valve and wherein said evacuating and said filling is accomplished using the valve.