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1. (WO2017019139) CONVENIENCE KITS FOR TRANSPORTING AND ACCESSING MEDICAL VIALS
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The Claims:

1. A convenience kit which provides a flexible, transparent bag for perpetually enclosing and therein spiking a vial which is displaced into the shield prior to being spiked, the bag not requiring further opening through medical procedure and disposal, said kit being characterized by:

a vial adapter having a vial spike for piercing a vial septum on one end and a fluid dispensing portion on the opposite end thereof, said fluid dispensing portion comprising a hollow cylindrical tube comprising internal geometry consistent with a female luer fitting and distally disposed outwardly protruding flanges structured for mating with a male luer locking connector and further comprising a cylindrical outer surface of predetermined length and diameter proximally disposed relative to said flanges;

a fluid communicating device comprising a male luer part which further comprises a luer locking connector and associated male luer fitting which provides a luer locking interface for flanges and geometry of said female luer fitting, said luer locking interface comprising a hollow cylindrical shape of predetermined radial diameter and linear length;

a hollow cylindrical elastic gasket having an internal diameter which is sized to fit tightly about said outer surface when relaxed but having sufficient elasticity to be stretched without permanent deformation to be displaced over said flanges, said gasket being characterized by proximal and distal edges which define a length which is less than the predetermined length of the cylindrical outer surface of the dispensing portion and a wall thickness which is sized to contact circumferentially said luer locking interface;

the flexible bag comprising a flexible exterior with a top opening which can be sealed closed to provide for complete bag closure at a vial introduction end and further comprising an otherwise closed bag including a bag bottom at an end opposite the top opening; and

said bag being characterized by a perforation which is sealed closed about the fluid dispensing portion of said vial adapter by complimentary, compressive displacement of said gasket and said male luer part to permit fluid flow only through said fluid dispensing portion; and

a vial septum cleaning fluid containment vessel comprising an outer compressible housing, a capsule disposed within said housing, a predetermined quantity of cleaning fluid disposed within the capsule and a porous wipe for communicating cleaning fluid to the vial septum;

said capsule further comprising wall structure which is fractured by pressure applied to the exterior of the bag and through said outer housing to release cleaning fluid which wets the wipe for cleaning the vial septum prior to spiking.

2. A convenience kit according to Claim 1 assembled for Pharmacy applications being characterized by a needleless connector as the fluid communicating device.

3. A convenience kit according to Claim 1 assembled for Operating Room applications being characterized by a male adapter plug as the fluid communicating device.

4. A convenience kit according to Claim 1 wherein said cleaning fluid is alcohol.

5. A convenience kit according to Claim 1 wherein said vial adapter is vented.

6. A convenience kit according to Claim 1 wherein said male luer part is adhesively affixed to said vial adapter to unitize said luer part to said vial adapter.

7. A convenience kit according to Claim 1 wherein said gasket is adhesively affixed to said vial adapter to unitize said gasket to said vial adapter.

8. A convenience kit according to Claim 1 wherein said bag comprises a zipper seal for closing the open end after displacement of a vial into said bag.

9. A convenience kit according to Claim 1 wherein said bag is characterized by a heat seal for closing the open end after displacement of a vial into said bag.

10. A convenience kit according to Claim 1 wherein said vial adapter comprises a vent whereby gas pressure is relieved when fluid pressure is changed within an associated vial.

11. A convenience kit according to Claim 10 wherein said vial adapter comprises a plug affixed thereto for obstructing fluid displacement through said vent.

12. A method for making a convenience kit sealable vial adapter enclosing safety convenience kit being characterized by the steps of:

(a) providing and assembling parts as follows:

(i) a vial adapter having a vial spike for piercing a vial septum on one end and a fluid dispensing portion on the opposite end thereof, said fluid dispensing portion comprising a hollow cylindrical tube comprising internal geometry consistent with a female luer fitting and distally disposed outwardly protruding flanges structured for mating with a male luer locking connector and further comprising a cylindrical outer surface of predetermined length and diameter proximally disposed relative to said flanges;

(ii) a fluid communicating device comprising a male luer part which further comprises a luer locking connector and associated male luer fitting which provides a luer locking interface for flanges and geometry of said female luer fitting, said luer locking interface comprising a hollow cylindrical shape of predetermined radial diameter;

(iii) a hollow cylindrical elastic gasket being characterized by an internal diameter which is sized to fit tightly about said outer surface when relaxed but having sufficient elasticity to be stretched without permanent deformation to be displaced over said flanges, said gasket having proximal and distal edges which define a length which is less than the predetermined length of the cylindrical outer surface of the dispensing portion and a wall thickness which is sized to contact circumferentially said luer locking interface;

(iv) a plastic bag comprising a top opening having a close-able seal which provides for complete bag closure at an otherwise open end of the bag and further comprising an otherwise closed bag including the bag bottom at an end opposite the top opening; and

(v) a bag puncture and gasket expander tool by which said gasket is elastically expanded to be displaced over the flanges to be disposed upon said cylindrical outer surface;

(vi) a vial septum cleaning fluid containment vessel comprising an outer compressible housing, a capsule disposed within said housing, a predetermined quantity of cleaning fluid disposed within the capsule and a porous wipe for communicating cleaning fluid to the vial septum; said capsule further comprising wall structure which is fractured by pressure applied to the exterior of the bag and through said outer housing to release cleaning fluid which wets the wipe for cleaning the vial septum prior to spiking.

(b) disposing said vial adapter such that access is permitted to the dispensing portion;

(c) disposing the puncture and expander tool in communication with the dispensing portion;

(d) forcibly displacing the gasket over said puncture and expander tool such that the gasket is elastically expanded and thereby displaced over the flanges of the dispensing portion to be thereby disposed in a relaxed state in tight communication with said outer surface such that the distal edge thereof is sufficiently close to the flanges to impedingly communicate with a the male luer locking connector when affixed to the flanges;

(e) creating a hole in the bag bottom which is sufficiently large to permit the bag to be displaced over the flanges yet which is smaller than the diameter of the cylindrical outer surface of the gasket such that, when gasket and hole are compressibly disposed together, the distal edge of the gasket entirely overlays the circumference of the hole;

(f) displacing said dispensing portion and associated flanges through the hole in the bag until the bag is in contact with the gasket;

(g) disposing the male luer fitting into the female luer fitting to make a secure fluid tight connection;

(h) securely affixing the luer locking connector in tight communication with the flanges thereby forcing the gasket proximally against frictional forces to assure a sealing interface between said luer locking connector, bag and gasket to ensure, after closing the seal of said bag and then spiking a vial with the vial spike, vial originated effluents, other than fluid delivered through luer fittings of said fluid dispensing portion, are fully contained within said bag; and

(i) disposing said fluid containment vessel within said bag as an integral part of said convenience kit in preparation for packaging for sterilization and delivery.

13. A method for making a sealable vial adapter safety shield according to Claim 12 wherein the fluid communicating device providing step comprises providing a needleless connector which provides a valve for selectively permitting bidirectional fluid flow through said dispensing portion and of which the luer locking connector is an integral part.

14. A method for making a sealable vial adapter safety shield according to Claim 12 wherein the gasket providing step comprises providing a gasket made from medical grade PVC tubing.

15. A method for making a sealable vial adapter safety shield according to Claim 12 wherein said bag providing step comprises providing a bag with a zipper seal.

16. A method for making a sealable vial adapter safety shield according to Claim 12 wherein the hole creating step comprises using said puncture and expander tool to puncture the bag bottom to provide the hole in the bag bottom.

17. A method for making a sealable vial adapter safety shield according to Claim 12 wherein the gasket using step comprises applying adhesive to the dispensing portion outer surface at the site where the gasket is disposed to create a unitized structure between the gasket and dispensing portion.

18. A method for making a sealable vial adapter safety shield according to Claim 12 wherein the luer locking connector affixing step comprises applying adhesive to securely affix the luer locking connector to the flanges, creating a unitized structure, thereby.

19. A convenience kit according to Claim 12 wherein said vial adapter is characterized by a vented vial adapter having a closable vent with a filter for adapting pressure inside an associated vial and further comprising a step of closing said vent upon rupture of the filter.

20. A method for using a kit which comprises said safety shield made according to Claim 12 in a medical procedure is characterized by the steps of:

(a) after gaining access to said bag from a transport package, displacing a medical vial into said bag through said top opening;

(b) sealing said bag;

(c) removing any previously unremoved septum protecting cap from the vial via exterior bag manipulation in preparation for spiking the vial;

(d) at any time after sealing the bag, fracturing the housing of the vial septum cleaning fluid containment vessel by applying pressure to the exterior of the bag to thereby wet the porous wipe preparatory to cleaning the vial septum; and

(e) spiking the vial for accessing contents thereof through the fluid communicating device.