METHOD OF STERILIZING MEDICAL DEVICE

Abstract

A method of sterilizing a cartridge (10), the cartridge (10) having a side wall (12) and a medicant therein; placing the cartridge (10) within an outer sleeve (18); sealing the sleeve in the side wall (12) of the cartridge (10) with a wiper seal (34) to form a hermetic microbial barrier; providing a breathable microbial membrane (38) over one end of the sleeve (18); subjecting the cartridge (10) and the outer sleeve (18) to a gas sterilization; and removing any sterilizing gas remaining after sterilization.

Claims

1. A method of sterilizing a cartridge (10), said cartridge(10) having a side wall (12) and a medicant therein; placing said cartridge (10) within an outer sleeve (18); sealing said sleeve in said side wall (12) of said cartridge (10) with a wiper seal (34) to form a hermetic microbial barrier; providing a breathable microbial membrane (38) over one end of said sleeve (18); subjecting said cartridge (10) and said outer sleeve (18) to a gas sterilization; and removing any sterilizing gas remaining after sterilization.

2. The method of claim 1 further including the step of covering said breathable microbial membrane (38) with a cap.

3. The method of claim 1 wherein said step of subjecting said cartridge and said outer sleeve to a gas sterilization comprises the step of subjecting said cartridge and said outer sleeve to ethylene oxide.

4. A sterilization arrangement comprising: an enclosed space; a cartridge (10) having a side wall (12), a piston (13) at a first end of said cartridge (10) and a septum (16) at a second end thereof, a medicant within said cartridge (10), a sleeve (18) extending about said cartridge; a needle hub (20); a needle (22) having a first piercing tip (24)and a second piercing tip (26), said needle being mounted in said needle hub (20), said first piercing tip (24) being located proximate said septum (16) and said second piercing tip (26) being located proximate an end of said sleeve (18); a wiper seal (34) between said side wall (12) of said cartridge (10) and said sleeve (18), said wiper seal (34) forming a hermetic seal; a pierceable breathable microbial membrane (38) extending across said sleeve (18) proximate said second piercing tip (26); and means for filling said enclosed space with a sterilizing gas.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0016] FIG. 1 is a side sectional view of a sterilization arrangement according to an embodiment of the present invention;

[0017] FIG. 2 is side elevational view thereof;

[0018] FIG. 3 is a sectional view showing operation of the device during the needle extension phase;

[0019] FIG. 4 is a side elevational view thereof;

[0020] FIG. 5 is a sectional view illustrating piercing of the cartridge;

[0021] FIG. 6 is a side elevational view thereof;

[0022] FIG. 7 is a sectional view illustrating the arrangement during an injection;

[0023] FIG. 8 is a side elevational view thereof;

[0024] FIG. 9 is a sectional view illustrating retraction of the needle within the cartridge sleeve; and

[0025] FIG. 10 is a side elevational view thereof.

DETAILED DESCRIPTION OF THE INVENTION

[0026] Referring to the drawings in greater detail and by reference characters thereto, there is illustrated a cartridge which is generally designated by reference numeral 10. Cartridge 10 is substantially conventional and has a side wall 12 which defines a cylindrical configuration. At one end of cartridge 10, there is provided a neck 14. Neck 14 includes a pierceable septum 16. At the other end of cartridge 10, there is provided a conventional piston 13.

[0027] Extending about cartridge 10 is a cartridge sleeve or holder generally designated by reference numeral 18.

[0028] A needle hub 20 is mounted in operative relationship with respect to cartridge 10. Needle hub 20 includes a needle 22 extending therethrough and having a first piercing tip 24 and a second piercing tip 26. A coil spring 28 abuts the top of cartridge 10 and also abuts a ledge 30 formed at the end of sleeve 18.

[0029] Interposed between sleeve 18 and cartridge side wall 12 is a sleeve washer 32. There is also included a wiper seal 34 which seals off all air passageways between sleeve 18 and side wall 12. Wiper seal 34 forms a hermetic microbial barrier and could typically be made of elastomeric materials like TPE and silicon.

[0030] As may be seen in the drawings, there is provided gas passageway 36 which will permit a sterilizing gas to pass and sterilize the upper area of cartridge 12 including neck 14.

[0031] At the end of sleeve 18, there is provided a breathable microbial barrier which will permit the passage of a sterilizing gas therethrough while also preventing the entry of any microbial material. The breathable barrier may be made of a polyethelene fiber membrane such as Tyvek™.

[0032] After sterilization, the sterilizing gas is removed. This could be by vacuum or equivalent methods.

[0033] Subsequently, a membrane cap may be optionally placed over a sleeve and cartridge end.

[0034] It will be understood that the above described embodiments are for purposes of illustration only and that changes and modifications may be made thereto without departing from the spirit and scope of the invention.