US3123211A - Multiple sterile zone package - Google Patents

Description

J. L. SORENSON MULTIPLE STERILE ZONE PACKAGE STRUCTURE Filed Oct. 25, 1961 March 3, 1964 INVENTOR.

77265 1. farensan aw/8%- ATTO EYS United States Patent 3,123,211 MULTIPLE STERILE ZONE PACKAGE STRUCTURE James L. Sorenson, 2341 Logan Circle, Salt Lake City 5, Utah Filed Oct. 25, 1961, Ser. No. 147,661 1 Claim. (Cl. 20663.2)

This invention relates to packaging for sterile surgical apparatus or the like, and more particularly to a multiple sterile zone packaging construction.

Heretofore, there has been considerable complexity of construction in surgical instrument packages such as packages for catheters and the like, with attendant dii'ficulties in maintaining desirable standards of sterility. The present invention overcomes these difficulties and problems by means of a multiple zone sterile packaging construction wherein a first sterile zone is afforded by a plastic, preferably pliant envelope which may be used for a catheter and a needle, and a second sterile zone is formed by a fully protective envelope cooperatively surrounding the apparatus and the envelope forming the first sterile zone.

Further in accordance with the invention, the first sterile zone is releasably defined by a tear strip or string which may surround the needle hub in the embodiment referred to, while the second sterile zone is similarly secured by a tear strip or string at an end of the external envelope.

Accordingly, it is an object of the present invention to provide a multiple sterile zone packaging construction for sterile instruments and the like which permits the security of a basic packaging construction to be maintained intact despite hazards in shipping, storage and the like.

Another object of the invention is to provide a device as described which permits successive breaching of the security zones so that, for example, a needle may be utilized upon opening of the outer sterile zone and the encompassing package, with a second zone being opened when desired upon use of the needle.

Another object of the invention is to provide a device as described wherein the needle may be similarly retained in sterile condition by an envelope which can be penetrated thereby, although it is also within the scope of the invention to utilize a simple, relatively rigid cap for the needle since the basic apparatus is protected by the outer sterile zone.

Another object of the invention is to provide a device as described which permits access to the successive sterile zones by means of tear strip or string structures located for ready access as needed.

Yet another object of the invention is to provide a device which is simple in construction, easily manipulated without expensive training or skills for the purpose, and Which is inexpensive to manufacture so that it may be utilized in automated production lines.

Other objects and advantages of the invention will become apparents as the description proceeds in accordance with the drawings in which a multiple zone sterile packaging construction is shown according to the present invention.

Referring to the drawing, a packaging construction is provided which includes an outer envelope 12 of flexible plastic or the like, an inner envelope 14 of similar flexible plastic or the like, a needle hub 16 in snugly sealing relationship with a reduced end 18 of the envelope 14 and an envelope extension 20 also in preferably sealing relationship with the hub 16, although being alternatively made as a separable rigid cover in accordance with the understanding of those skilled in the art.

In the embodiment shown, the instrument apparatus includes a needle 22 for veni-puncture or the like and of hollow construction for reception of a catheter 24 extend- 3,123,211 Patented Mar. 3, 1964 ing into the hub 16 and releasably closed by a cap 26 also as understood by those skilled in the art.

In order to permit multiple breach of successive sterile zones defined by the packaging construction described, the outer encompassing envelope 12 is provided with a tear string or tear strip 27 at at least one end thereof, or at a convenient location for opening the said outer envelope; and with a closure 28 at the other end, which may be a heat-seal scam in a preferred form of the invention.

Correspondingly, the inner envelope 14 at the reduced neck portion 18 thereof is provided With a tear string or strip 2? in juxtaposition with the hub 16 so that upon opening of the outer envelope by means of the strip or string 27, the strip or string 29 may be operated to open the inner envelope 14 as hereinafter described.

It will thus be seen that the combined structures disclosed provide and define an outer sterile zone 30 between the outer envelope 12 and the inner envelope 14 and associated envelope structure, together with an inner sterile zone 32 specifically defined by the said inner envelope 14. In this connection, it may be noted that a further sterile zone 34 may be formed by the forward envelope portion 20 when an envelope extension at the forward portion of the inner apparatus is utilized as shown.

Accordingly, sterility in depth is afforded by the multiple sterile zone construction defined, with the outer sterile zone being breachable by stripping off the tear strip or string 27 to place the inner apparatus in position for immediate use. Until such time, inadvertent destruction of the sterility of the apparatus is precluded.

Thereupon, the needle 22 may be maneuvered through the sac or envelope 20 and into a body cavity, as understood by those skilled in the art. Alternatively, an outer elongate rigid cap of polyethylene or the like may be removed, with the advantage that with the double sterile zone provided there is no penetration of the areas around the needle by a loose fit in such a cap, as in previously available devices.

The outer envelope 12 may be maintained in surrounding relationship to the inner apparatus, or alternatively, may be stripped off so that the manipulation of the catheter 24 may be accomplished through the inner sterile zone envelope 14, with the result that even though the outer sterile zone is penetrated, a sterile relationship is maintained until the ultimate moment of use. Thus, the tear strip or string 29 may be taken olf when full access to the catheter 24 is desired for medicinal infusions or the like. In this connection, it is noted that whereas the reduced end 18 of the envelope 14 is pro vided with the tear strip 29, the outer end of this envelope may be a heat seal seam 36.

The construction of the invention which affords sterility in depth through multiple sterile zones, thus has application in a wide variety of surgical and health situations.

Although I have described my invention with respect to certain specific principles in details thereof, it will be understood that the invention is not limited thereto, but is to be construed in accordance with the scope and spirit of the hereunto appended claims.

I claim as my invention:

In a sterile surgical package, a hollow needle, a hollow hub on said needle, a catheter extending into said hub for ultimate advancement through said needle, a flexible envelope enclosing said catheter and having one end closed and the other end sealed around said hub to maintain the catheter sterile, a second flexible envelope enclosing said needle and having one end in sealing engagement with said hub and the other end closed to maintain said needle sterile, a tear strip associated with said envelopes around said hub to effect complete removal of the envelopes one at a time when desired, a third envelope enclosing the other two envelopes and having both ends closed to provide a sterile zone outside the other two envelopes, and a tear strip at one end of said third envelope, whereby upon removal of the third envelope the needle may be advanced through the second envelope into the body of a patient and the catheter advanced while in the first said envelope before cornplete removal of the first and second envelopes.

Hill Oct. 26, 1886 Pittenger Jan. 27, 1925 Brewer Mar. 9, 1943 Johnson May 25, 1943 Long Nov. 25, 1952 Doherty Sept. 1, 1959 Cutter Dec. 1, 1959 Garth Aug. 2, 1960 Bechtold May 1, 1962 Rasmussen et al May 22, 1962 Ballard Sept. 25, 1962 FOREIGN PATENTS France Apr. 1, 1953

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