Disposable needle container

Aug. 1, 1967

3,333,682

G. K. BURKE

DISPOSABLE NEEDLE CONTAINER

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ATTORNEYS

United States Patent Office 3,333,682 _________________________________ Patented Aug. 1, 1967 tion provides a sterile atmosphere for retaining the supported hypodermic needle in a sterile condition, and in addition the container is specifically designed so as to be positively tamper-proof. In order to accomplish this, the comamer includes a body means and a closure means which snaps into engagement with the body means, a rib and groove interengagement being provided which effectively locks these members together so that they cannot be taken apart without destroying the parts. An additional feature of the arrangement is the fact that the outwardly «/A ^su5^{face of the closure means} is substantially flush with the adjacent portions of the body means. With this flush arrangement, it is virtually impossible to remove the closure means from the body means without destroying or severely marring the members so that it would be read!,L^aPfr^nt J-° ^a.^nyo“^{e that the} device had been tampered with. Accordingly, the two components of the container cannot possibly be separated once they have been assembled m locked relationship without revealing the fact that the apparatus has been tampered with.

It is of course apparent that once the frangible portion of the body means has been broken away the apparatus has clearly been employed and is not to be used again, and must be thrown away. This assures that the eedle disposed within the container cannot be used more than one time as is the intended object of the inven. A further feature of the present invention is the provision of a polygonal socket portion within the body means which is adapted to engage a complementary polygonal surface formed on the hub of a hypodermic needle. An internal shoulder formed on the body means limits movement of the hypodermic needle with respect to the body “terengagement of the aforesaid polygonal surfaces enables the removable portion of the body means to be broken away and the needle may be mounted on a suitable portion of a syringe without actually touching the needle. This will be described in more detail hereinalter.

An object of the present invention is to provide a new and novel disposable needle container which provides a sterile arrangement and which remains in a sterile condition until used, and further which is especially adapted ^t0 j ,^use&lt;^^{Just one time an(}f then thrown away and disvdl CieCl.

Another object of the invention is the provision of a disposable needle container including means for effectively destroying the container to prevent re-use thereof once it has been opened.

Still another object of the invention is to provide a disposable needle container which is substantially tamperproof and wherein the parts must either be completely destroyed or severely marred in order to separate the components thereof so that any tampering with the apparatus will be clearly evident.

A further object of the invention is to provide a disposable needle container including means to enable an associated needle to be placed upon a syringe while the needle is still retained in a portion of the container without actually touching the associated needle.

Still another object of the invention is the provision of a disposable needle container which is quite simple and inexpensive in construction, and yet at the same time

3,333,682

DISPOSABLE NEEDLE CONTAINER

George K. Burke, Bethlehem, Pa., assignor to Burron Medical Products, Inc., Bethlehem, Pa., a corporation of Pennsylvania

Filed Aug. 18, 1965, Ser. No. 480,629

Claims. (CI. 206—43)

The present invention relates to a new and novel disposable needle container, and more particularly to a needle container which is adapted to be effectively destroyed after a single use thereof so as to prevent re-use of the apparatus for the intended function.

The present invention is directed particularly to the medical field wherein it is of primary consideration to 15 provide apparatus which is sterile and which remains sterile up until the time of use. The disposable needle container of the present invention is adapted to be employed in shipping needles to a desired location and when the needle is to be used, a portion of the container is 20 broken away in such a manner as to prevent re-use thereof for the same purpose.

The needle container of the present invention includes a body means having a frangible portion which enables part of the device to be broken away so that it cannot be 25 placed back in its original position and serve its original purpose in providing a closed sealed container.

An especially desirable material for use in this type of container is polypropylene plastic. This material however presents a particular problem in that it does not 30 readily break and is not of a brittle nature, but on the contrary is somewhat flexible and very difficult to break off. This is true even though the wall thickness may be weakened or made quite thin under normal molding techniques.

The present invention employs a unique concept in providing a frangible or breakaway portion in polyproylene material or material of a similar nature. In the present invention, the frangible portion is afforded by molding the area which it is desired to break in a very particular and special manner.

The frangible area in the polypropylene or similar material of the body means of the present invention is provided by creating areas of stress which are prone to structural weakness when subjected to external forces as by manually bending such frangible portion. In order to obtain the desired internal stresses and concentration of stresses in the frangible area, the wall portion at this particular area is appreciably less in thickness than the thickness of the adjacent wall portions of the apparatus.

In addition, the length of the stress area is approximately the same as the thickness of the wall at the frangible portion and under no circumstances should the length of the stress area be more than twice the thickness of the wall.

In order to provide the desired pre-stressed area, the mold is so designed that the finished product which comprises the body means includes annular shoulders formed on the inner and outer surfaces of the body means, the frangible portion being defined between these shoulders. Each of these annular shoulders is defined by a surface which extends substantially 90 degrees to the associated inner or outer surface. These shoulders are also offset longitudinally of the body means. This particular portion . -------,----— of the body means is additionally designed so that the ^{63 wilic}h is quite effective and reliable in use. surfaces of the shoulders should define an angle of approximately 45 degrees with respect to a line drawn between the closest points of the internal corners defined by the intersection of the shoulders with their associated inner and outer surfaces.

The disposable needle container of the present inven40

Other objects and many attendant advantages of the invention will become more apparent when considered in connection with the specification and accompanying drawings, wherein:

FIG. 1 is a view of the needle container of the present invention partially broken away and in section and illus70

3,333,682 jacent wall portions on either side of the thin wall area. It has been found that the length of this stress area extending longitudinally of the body means should be approximately the same dimension as the thickness of the thin wall pre-stressed frangible area, and under no circumstances should the length of the stress area be more than twice the thickness of this thin wall area.

A phantom line x—x has been drawn between the closest points on the two internal corners 48 and 50, and the various surfaces defining an angle with respect to line x—x as seen in FIG. 3 define angles of approximately 45 degrees. In other words, the surfaces of annular shoulders 44 and 46 each define an angle of approximately 45 degrees with respect to the line x—x, as do the outer and inner surfaces of the body means adjacent thereto. .

The principal reason for the development of the desired internal stresses in this frangible area, in this type of material is the sudden change in wall thickness which .causes uneven and different cooling rates during the molding operation, and subsequent further cooling after the molded part has been removed from the mold. Sometimes it may require a few minutes to several hours for final cooling and formation of “maximum” intemal. stresses. Smce shrinkage accompanies this cooling, the intemal stresses are developed. There are no appreciable radii formed adjacent the frangible area, but rather the comers are sharp. The material employed is of high melt index and ot low molecular weight and is hard flowing and sets up very quickly in the mold. The mold area, around the frangible portion is maintained quite cold during the nt°Ming operation and high pressure is utilized to pack, the plastic material into the mold when filling the cavities. These techniques cause the desired formation of. stresses when the structure is designed as illustrated herein.

It has been found in actual practice that a material such as polypropylene is ordinarily very difficult to break off even when the wall sections are quite thin. On the other hand, it has been found that with the particular construction as discussed above which develops the deble portion can be readily broken with just an average amount, of manual effort. Accordingly the present invention provides a unique manner of affording the desired characteristic of forming a readily breakable area at a constructed as to “have 45 particular portion of the structure ,

Referrmg again particularly to FIGS. 1 and 2, tne body portion 38 has formed integrally on the outer surface thereof a plurality of longitudinally extending flutes 60 which project outwardly from portion 38, these flutes 38 and being for example six in number. Body portion 38 has formed at the terminal end thereof an outwardly projecting flange portion 62 which may have diametrically oppositely disposed flats formed thereon, one of these flats being indicated in FIG. 1 by reference numeral 64. These flats will also tend to resist rolling movement of the container when disposed on a supporting surface.

As seen particularly in FIG. 2, the intemal bore surface 34 joins with a generally radially extending surface 66 which in turn intersects with an outwardly flared surface 68. Surface 68 in turn joins with a further outwardly flared surface 70 intersecting a generally cylindrical surface 72 which in turn intersects with an inwardly tapered surface 74. Surface 74 in turn joins with a further outwardly tapered surface 76. Surfaces 70 and 74.may each define an angle of approximately 20 degrees with respect to a line extending substantially parallel with the longitudinal axis of· the body means, and it will be noted that surfaces 70, 72 and 74 cooperate to define an intemal groove 80 formed in the body means adjacent the open end thereof. The surface 76 may define an angle of approximately 5 degrees with respect to a line extending substantially parallel with the longitudinal axis of the body means.

Closure means 12 includes a central cavity 84 formed trating a conventional hypodermic needle disposed therewithin; .

FIG. 2 is an exploded view of a portion of the body means and the associated closure means, showing these two components in vertical section; and

FIG. 3 is an enlarged view of a portion of the structure shown in FIG. 2.

Referring now to the drawings wherein like reference characters designate corresponding parts throughout the several views, the needle container of the present inven- j tion includes a body means indicated generally by reference numeral 10 and a closure means indicated generally by reference numeral 12, each of these components being formed of a material such as polypropylene or the like.

Body means 10 includes an elongated slightly tapered portion 20 closed at the end 20' thereof and defining a hollow bore 22 therewithin which tapers to a smaller dimension in a direction from right to left as seen in the drawings. Portion 20 joins with an angularly directed portion 24 which flares to a larger dimension from left to right as seen in the drawings and which defines an internal shoulder portion 26.

Portion 24 in turn is joined with a portion 28 which also flares to a larger dimension toward, the right as seen in the drawings. A plurality of longitudinally extending ribs 30 are formed integral with the outer portions of the body portions 20, 24 and 28, these ribs being equally spaced about the outer periphery of the body means and being illustrated as six in number. These nbs serve to reinforce the body means and to also resist rolling movement thereof on a supporting surface.

Portion 28 of the body means defines internal surfaces 32 and 34, surface 32 being of polygonal.configuration and in a typical example being hexagonal in shape, surface 34 being generally frusto-conical. and flaring to a larger dimension in a direction to the right as seen in the drawings. .

Portion 28 is joined with a further body portion 38 by HU ----x _t - i_t_J reference numeral 40. As mentioned previously, the body means is formed of a material such as polypropylene which is normally very difficult to break. In order to render this frangible portion readily breakable^ by manual efforts, the frangible portion is so &lt;------------built-in internal stresses wherein the stresses are concentrated in the frangible portion area, this pre-stressed area providing a portion which is prone to structural weakness when subjected to external forces such as bending beingTqufiy spaced about the outer periphery of portion

Referring particuarlly to FIG. 3, the particular struc 50 „.,_nlni_P ;_n number. Bodv portion ture of the frangible portion is most clearly illustrated.

The frangible portion is formed by providing the annular shoulders 44 and 46 on the outer and inner surfaces of the barrel means respectively. Certain critical relationships exist in order to provide the desired internal stresses. Firstly, each of the annular shoulders defines an angle ot approximately 90 degrees with respect to the associated surfaces of the body means. In other words, shoulder 44 defines an angle a of approximately 90 degrees with respect to the adjacent outer surfaces of the body means, while shoulder 46 forms an angle b of approximately 90 degrees with respect to the adjacent inner surface of the body means.

The corners as defined adjacent the frangible areas are sharp, and two intemal corners as indicated by reference numerals 48 and 50 are defined by the shoulders 44 and 46 respectively where these shoulders intersect the associated outer and inner surfaces of the body means.

I should be realized that a particular object of this construction is to cause the stresses to be concentrated in the thin wall area defined between the inner and outer surfaces of the barrel and between the planes defined by the annular shoulders 44 and 46. The thickness of the wall portion of the frangible area as defined between these limits is appreciably less than the thickness of the ad’ortion 28 is joined.witht a turner boay poroon y _{4Q intemal stresses at the frang}ible portion, this frangiintermediate frangible portion indicated generally oy _{ran he readilv} broken with just an average

3,333,682 therewithin so as to enable the closure means to be as light as possible and yet at the same time retain the necessary rigidity and strength. Proceeding in a direction from left to right as seen in FIG. 2, the outer surface of closure means 12 includes a first outwardly flared surface 86 which joins with a second outwardly flared surface 88 which in turn joins with a further outwardly flared surface 90 which joins with a substantially cylindrical surface 92 which joins with an inwardly tapered surface 94 which in turn joins with a further surface 96 which is generally cylindrical. The outer face of the closure means 12 is indicated by reference numeral 100.

Surface 94 defines an angle of approximately 60 degrees with respect to a plane extending perpendicular to the longitudinal axis of the closure means, the longitudinal axis of the closure means corresponding with the longitudinal axis of the body means when the two components are in assembled relationship as shown in FIG. 1. It will be noted as seen in FIG. 1 that when the closure means is inserted and forced into its operative position, surfaces 88, 90, 92 and 94 will be disposed in contact with the surfaces 68, 70, 72 and 74 respectively of the body means.

The engagement of surface 88 with surface 68 on the two components of the container will ensure a sterile seal, 25 and it will be noted that surfaces 90, 92 and 94 of the closure means define an external peripherally extending outwardly directed rib 104 which is adapted to fit within the groove 80 formed in the body means to form an interlocking rib and groove arrangement so that when the closure means is inserted into the operative position shown in FIG. 1, the closure means is locked in position and cannot be readily removed from the body means.

It will further be noted as seen in FIG. 1 that when the closure means is in operative position, the outwardly 35 directed surface 100 thereof is substantially flush with the adjacent end surface 106 of the body means. When these surfaces are in such flush relationship, the container is substantially tamper-proof since a person cannot readily gain access to the closure means and it is virtually impos- 40 sible to remove the closure means without breaking or severely damaging the parts.

As seen in FIG. 1, a hypodermic needle is illustrated as disposed in operative position within the body means, the hypodermic needle including a hub portion 110 having a hexagonal shaped outer portion 112 substantially complementary to the surface portion 32 formed in the body means. The hub portion of the needle is also provided with a surface 114 which is adapted to engage the internal shoulder 26 formed on the body means so as to limit inward movement of the needle with respect to the body means. The needle is further provided with the conventional elongated hollow cannula portion 116 which terminates in a sharp point. It will also be noted that when the closure means is in the operative position shown in FIG. 1, the innermost surface 120 thereof is disposed closely adjacent the end surface 122 of the hub means of the needle so that the movement of the needle to the right as seen in this figure of the drawing is limited. This serves to retain the needle in the desired operative tween the needle and the associated container. ~~

It will further be noted that the relative dimensions of the parts are such that when the right-hand portion of the body means as seen in the drawings is bent so as to break it away about the frangible portion 40, the righthand portion of the body means will pivot over the'adjacent hub portion of the needle so as to ensure that there will not be any interference between the broken-off por^tl0° °^{f the b}°^d^ ^{means and the hub} Ρ^0Γίϊθη of the needle.

When sterilizing the container, the components are first assembled in the relationship shown in FIG. 1, wherein the entire container and the enclosed hypodermic needle is placed within a chamber which is evacuated to an equivalent of 14 p.s.i. negative pressure which pulls cut the ¹⁶ original air in the package. The chamber is then pressurized up to about 20 p.s.i. with a sterilizing gas such as a combination of carbon dioxide and ethylene oxide which may be used either in the proportions of 90% carbon dioxide, 10% ethylene oxide, or 80% carbon dioxide, 20% ethylene oxide. This causes the entire assembly to be automatically filled with sterilizing gas. Even if the ethylene oxide escapes by penetrating through the plastic walls of the container until the internal pressure is equalized with the outside atmospheric pressure, the carbon dioxide which will not penetrate the walls remains within the container and is extremely inert and does not support bacterial growth. The interengagement of the surfaces 88 and 68 of the closure means and the body means as well as the mterengagement of the various surfaces of the rib and groove formed on these components will form a sterile seal so that the inert gas is trapped within the container to maintain sterility control.

It is apparent from the foregoing that there is provided according to the present invention a new and novel disposable sterile needle container which provides a sterile package and which remains in a sterile condition until used, and further which is especially adapted to be used only one time and then thrown away. The frangible portion of the body means provides a means for effectively destroying the device when gaining access to the hypodermic needle disposed within the container and to prevent re-use of the container for the intended purpose. The device is substantially tamper-proof since the closure means locks into the flush position shown in FIG. 1 so that it cannot be removed without destroying or severely damaging the parts so that if any tampering occurs, it is readily evident. The socket portion of generally hexagonal shape disposed within the body means snugly receives a correspondingly shaped surface formed on the hypodermic needle, and when the frangible portion of the body means has been broken away, the needle can be mounted upon a syringe or the like without touching the needle since the body means may be manipulated so as to move the needle into the desired operative position. The apparatus of the present invention is qiute simple and inexpensive in construction, and yet at the same time is effective and reliable in use.

.As this invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, the present embodiment is therefore illustrative and not restrictive, and since the scope of the invention is defined by the appended claims, all changes that fall within the metes and bounds of the claims or that form their functional as well as conjointly cooperative equivalents are therefore intended to be embraced by those claims.