Disposable sterile syringes, needle containers and the like having prestressed frangible portions therein

Feb. 28, 1967 g. _K burke 3,306,291

DISPOSABLE STERILE SYRINGES , NEEDLE CONTAINERS AND ’ THE LIKE HAVING FRESTRESSED FRANGIBLE

Filed April 14, 1964

PORTIONS THEREIN

Sheets-Sheet 1

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ATTORNEYS

Feb. 28, 1967

DISPOSABLE

THE

Filed April 14, 1964

g. k. burke 3,306,291

STERILE SYRINGES, NEEDLE CONTAINERS AND

LIKE HAVING PRESTRESSED FRANGIBLE

PORTIONS THEREIN

Sheets-Sheet 2

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ATTORNEYS

Feb. 28, 1967 g. _K. burke 3,306,291

DISPOSABLE STERILE SYRINGES, NEEDLE CONTAINERS AND THE LIKE HAVING PRESTRESSED FRANGIBLE

PORTIONS THEREIN

Filed April 14, 1964 5 Sheets-Sheet 3

<img file="US3306291A_D0004.tif" />

ATTORNEYS

Feb. 28, 1967

DISPOSABLE

THE

Filed April 14, 1964

g. k. burke 3,306,291

STERILE SYRINGES, NEEDLE CONTAINERS AND LIKE HAVING PRESTRESSED FRANGIBLE PORTIONS THEREIN

Sheets-Sheet 4

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ATTORNEYS

Feb. 28, 1967

DISPOSABLE STERILE

g. k. burke 3,306,291

SYRINGES, NEEDLE CONTAINERS AND

THE LIKE HAVING PRESTRBSSED FRANGIBLE

Filed April 14, 1964

PORTIONS THEREIN

Sheets-Sheet 5

<img file="US3306291A_D0007.tif" />

484

ATTORNEYS

Feb. 28, 1967 g. κ. burke 3,306,291

DISPOSABLE STERILE SYRINGES, NEEDLE CONTAINERS AND THE LIKE HAVING PRESTRESSED FRANGIBLE

PORTIONS THEREIN

Filed April 14, 1964 6 Sheets-Sheet 6

<img file="US3306291A_D0008.tif" />

ATTORNEYS

United States Patent Office „ 3,306,291

Patented Feb. 28, 1967

2

3,306,291

DISPOSABLE STERILE SYRINGES, NEEDLE CONTAINERS AND THE LIKE HAVING PRESTRESSED FRANGIBLE PORTIONS 5 THEREIN

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

Filed Apr. 14, 1964, Ser. No. 359,674

Claims. (CI. 128—218) 10

The present invention relates to a new and novel disposable sterile device, and more particularly to a sterile device which is adapted to be effectively destroyed after a single use thereof so as to prevent re-use of the ap- ¹⁰paratus for the intended function.

The present invention is directed particularly to the medical field wherein it is of primary consideration to provide apparatus which is sterile and which remains sterile up until the time of use. In the present invention the particular disposable device may comprise either a throw away syringe or a hypodermic needle container or package. In either event, these devices are adapted to be used once for the intended use and then broken away _o. in such a manner as to prevent effective re-use thereof “° for the same purpose.

It. is a particular important feature of the present invention that the disposable device includes a frangible portion which enables part of the device to be broken away in such a manner that it cannot be placed back in ' its original position and serve its original purpose. In the case of a disposable syringe, the boss portion upon which the hypodermic needle is positioned is broken off, and in the case of the needle container, the cap of the con- ,.tainer is broken off. ' °

Disposable devices of a similar nature have been provided in the prior art, and the materials employed in such devices have been generally of a nature such that they can be readily broken. For example, disposable syringes ₄₀have been manufactured of polystyrene plastic and provided with a weakened area by forming an indentation therein which permits this type of material to be readily broken.

However, the materials employed for similar devices ₄₃in the prior art have not proved satisfactory due to other characteristics thereof. Such prior art materials have not proven to always be inert to the solvents and carriers as may be used in medicaments, and accordingly, in many instances the specifications for this type of apparatus re- ₅₀quires the use of a different type of material. The present invention employs a more desirable type of material insofar as being inert to solvents and carriers is concerned. For example, a particular substance which may be used is polypropylene plastic. This material meets all of the ₅₅present-day specifications and requirements for this type of apparatus, but it presents a particular problem in that it does not readily break and is not of a brittle nature, but rather is somewhat flexible and very difficult to break off. This is true even though the wall thicknesses may be ₆₀weakened or made quite thin under normal molding techniques. This has proved to be the case in actual use since supposedly disposable devices of this nature have been manufactured of polypropylene or similar substances and have exhibited the characteristic that they are extremely ₆difficult to break away or destroy in the field, and accord- ³ingly they have not proved satisfactory due to this characteristic.

The present invention employs a unique concept in providing a frangible or break-away portion in poly- -₀propylene 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 away in a. very particular and special manner.

. It is a specific object of the present invention to provide a frangible area in polypropylene or similar material by creating areas of stress which are prone to structural weakness when subjected to external forces as by manually bending, this particular 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 should be 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 a body means having a frangible area includes an annular shoulder formed on the inner and outer surfaces of the body means. 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 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 shoulders as will be hereinafter more fully explained.

The disposable, syringe of the present invention is utilized only one time and then broken away so as not to be re-used. The syringe is initially sterilized as by chemical gas or the like, and the syringe may comprise a sterile package until used for administering a dosage of suitable medicament. It is of course apparent that the construction of the syringe must be extremely inexpensive in order to provide a practical economic situation, and accordingly the present invention is especially constructed of relatively inexpensive materials which can be quickly and easily , assembled.

The utilization of the disposable syringe according to the present invention saves considerable time which is normally involved in processing sterilizing equipment when using syringes which .are not disposable, and in addition, the syringe of the present invention is quite con-. venient to use and provides maximum comfort for the patient particularly in view of the fact that a new sharp needle is used for every injection.

In many applications, it is quite important to obtain a very accurate reading so as to enable exact dosages to be given. In order to accomplish this result, the barrel of the present invention syringe which is transparent or nearly transparent is provided with relatively fine indicia, thereon. Additionally, the resilient piston means mounted at the end of the plunger of the syringe is fixed for rotation with the plunger so that very fine adjustment of the piston means and plunger may be obtained by twisting the piston means within the barrel. It will be recognized that if the plunger is rotatable with respect to the piston means, the fine adjustment of the piston means can only be made by a lateral movement of the plunger which generally cannot be accomplished in very smooth degrees as is possible when the piston can be twisted and moved longitudinally at the same time.

The piston means is additionally provided with external ribs or rings thereon which engage the inner surface of the barrel and one of the rings having a very sharp corner or edge or line thereon which enables an accurate visible indication to be obtained of the exact, position of the piston means within the barrel.

3,306,291

It is also important to provide a syringe arrangement which assures that substantially all of the medicament is expelled therefrom when the plunger is pushed inwardly.

In order to accomplish this result, the inner end wall of the barrel is of a generally concave configuration and the resilient piston means is of a similar complementary configuration so as to fit relatively snugly with the inner end wall at the innermost limit of movement of the plunger. This arrangement assures that all of the medicament will be expelled from the barrel. In one modification of the present invention, the syringe is provided with an auxiliary means in the form of a skirt extending from the barrel for ensuring that the hypodermic needle remains in place on the boss of the syringe. The needle is normally retained in place by means of a conventional tapered arrangement, and the skirt additionally assures that the needle will remain in its proper position. The skirt further provides a shoulder for attachment of the needle guard, thus reducing the area of “medicament loss” by about %2-inch or more.

A further modified form of the syringe provides an arrangement wherein a space is provided within the piston means and the associated end portion of the plunger such that the hydraulic forces developed during use of the device can flatten out the piston means and assure that it is pressed very tightly against the inner wall of the barrel.

The needle container of the present invention as discussed previously provides a . sterile atmosphere for retaining the supported hypodermic needle in a sterile condition, and in addition, the needle container is specifically designed so as to be positively tamper-proof. In order to accomplish this, the needle container includes a pair of portions which snap into engagement with one another and effectively lock together so that they cannot be taken apart without completely destroying the parts. One of the portions of which the needle container is constructed is provided with the aforesaid frangible portion so as to permit this particular part of the container to be broken away and permanently destroyed so that it cannot be re-used.

An object of the present invention is to provide a new and novel disposable sterile device which provides a sterile package and which remains in a sterile condition until used, and further which is especially adapted to be used just one time and then thrown away and discarded.

Another object of the invention is to provide a disposable sterile device including means for effectively destroying the device to prevent re-use thereof for the intended purpose.

A further object of the invention is the provision of a disposable syringe which saves the time of a user, which is quite convenient to use and which provides a maximum degree of comfort for the patient while eliminating the danger of cross contamination.

Yet another object of the invention is to provide a disposable syringe including means for providing a very sharp line to give an accurate reading of exact dosages and further which is so constructed as to permit very fine adjustment of the position of the piston means within the barrel.

A still further object of the invention is the provision of a disposable syringe including means for effectively filtering the aspirated air and for assuring that all of the medicament is expelled during use.

Still another object of the invention is the provision of a disposable syringe in one modification which includes auxiliary means to hold the needle in place and to attach the needle guard, and in another modification which includes an arrangement to enable hydraulic pressure to urge the piston means tightly against the sides of the barrel.

Still another object of the invention is to provide a disposable needle container which is sterile and which is substantially tamper-proof and must be destroyed in order to open.

Other objects and many attendant advantages of the invention will become more apparent when considered in 5 connection with the specification and accompanying drawings, wherein:

FIG. 1 is a perspective view of a first modification of a disposable syringe according to the present invention;

FIG. 2 is a longitudinal section taken through the syringe shown in FIG. 1;

FIG. 3 is a sectional exploded view illustrating the details of construction of the syringe;

FIG. 4 is a sectional view taken substantially along line 4—4 of FIG. 2 looking in the direction of the 15 arrows;

FIG. 5 is a view taken along line 5—5 of FIG. 3 looking in the direction of the arrows;

FIG. 6 is a view partly in section taken substantially along line 6—6 of FIG. 3 looking in the direction of the 20 arrows;

FIG. 7 is a longitudinal section partly broken away through a second modification of the present invention;

FIG. 8 is an enlarged exploded view principally in section illustrating the details of construction of various 25 of the components shown in FIG. 7.

FIG. 9 is a view taken substantially along line 9—9 of FIG. 8 looking in the direction of the arrows;

FIG. 10 is a view partly in section taken substantially along line 10—10 of FIG. 8 looking in the direction of 30 the arrows;

FIG. 11 is a view taken substantially along line 11—11 of FIG. 7 looking in the direction of the arrows;

FIG. 12 is a longitudinal sectional view partly broken away illustrating a third modified form of the disposable 35 syringe;

FIG. 13 is an enlarged exploded view principally in section illustrating the details of construction of certain components of the structure shown in FIG. 12;

FIG. 14 is a view taken substantially along line 14—14 40 of FIG. 13 looking in the direction of the arrows;

FIG. 15 is a view taken substantially along line 15—15 of FIG. 13 looking in the direction of the arrows;

FIG. 16 is a view taken substantially along line 16—16 of FIG. 13 looking in the direction of the arrows;

FIG. 17 illustrates an adapter means positioned over the end of the barrel shown in FIG. 12;

FIG. 18 is a longitudinal section through a fourth modified form of the disposable syringe according to the present invention;

SO FIG. 19 is a sectional view taken substantially along line 19—19 of FIG. 18 looking in the direction of the arrows;

FIG. 20 is an enlarged exploded view principally in section illustrating the details of construction of certain 55 of the components shown in FIG. 18;

FIG. 21 is a sectional view taken substantially along line 21—21 of FIG. 20 looking in the direction of the arrows;

FIG. 22 is a sectional view taken substantially along 60 line 22—22 of FIG. 20 looking in the direction of the arrows;

FIG. 23 is a view partly broken away illustrating the indicia on the barrel and the manner in which the piston means provides a very clear and accurate reading as to 65 its relative position;

FIG. 24 is a top perspective view of a needle container according to the present invention;

FIG. 25 is a view similar to FIG. 24 illustrating the manner in which the end portion of the body means is 70 adapted to be broken away to expose the hub of the needle;

FIG. 26 is a sectional view taken substantially along line 26—26 of FIG. 24 looking in the direction of the arrows;

FIG. 27 is a sectional view taken substantially along

3,308,291 s

line 27—27 of FIG. 26 looking in the direction of the arrows;

FIG. 28 is a sectional view taken substantially along line 28—28 of FIG. 26 looking in the direction of the arrows; 5

FIG. 29 is an enlarged view illustrating the details of construction of the frangible portion of the body means;

FIG. 30 illustrates a longitudinal sectional view of the modified form of the body means of the needle container of the present invention; ₁₀

FIG. 31 is a longitudinal sectional view of a modified form of the enclosure means of the needle container, and;

FIG. 32 is a longitudinal section through a modified form of the invention employing a unique arrangement for retaining the needle hub in position on the body 15 means of a syringe.

Referring now to the drawings wherein like reference characters designate corresponding parts throughout the several views, there is shown in FIGS. 1 through 6 inclusive a first modification of the invention which may 20 for example comprise a tuberculin type 1 cc. syringe. This syringe includes a barrel or body means 40 which is formed of a material which is normally difficult to break such as polypropylene having the desired characteristics mentioned hereinbefore. This barrel is trans- 25 parent or nearly so and is provided with suitable indicia thereon as indicated generally by reference numeral 41. The barrel is provided with an integral laterally extending flange portion 42 at one end thereof terminating in a bead 44, this flange portion serving as an area for grip- 30 ping by the fingers Of an operator and also preventing rolling by having opposite flat sides.

A boss 46 projects longitudinally from the opposite end of the barrel and is indicated by reference numeral 46, it being noted that the boss is of less cross sectional 35 dimension than the barrel, the boss being interconnected with the barrel by a frangible portion indicated generally by reference numeral 47 and which will be described more fully hereinafter.

The boss is provided with a taper 48 on the outer sur- ⁴⁰face thereof which may comprise a Luer taper of well known construction for receiving the hub portion of a hypodermic needle having a cooperating taper and for retaining the hypodermic needle thereon. The inner end wall 50 of the ball is of a generally arcuate configuration 4 5 and may for example comprise a portion of a spherical surface, this inner end wall having a recess 52 formed adjacent thereto and in communication with a bore 54 extending longitudinally through the boss.

Referring now particularly to FIG. 3 of the drawings, 50 the details of construction of the frangible portion 47 may be more clearly understood. As mentioned previously, the barrel is formed of a material such as polypropylene which is normally very difficult to break. In order to render this frangible portion readily breakable 55 by manual effort, this frangible portion is so constructed as to have built-in internal stresses wherein the stresses are concentrated in the frangible portion area, this prestressed area providing a portion which is prone to structural weakness when subjected to external forces such eo as bending.

The frangible portion is formed by providing the annular shoulders 60 and 62 on the outer and inner surfaces of the barrel means respectively. It will of course be realized that the surface of shoulder 62 is formed within 55 the boss portion of the barrel and that shoulder 60 is formed at the end of the barrel as seen in FIG. 3. The particular locations of these shoulders may be varied as will become apparent in connection with the description of the other modifications of the invention, but in each 70 case certain critical relationships exist.

Each of the annular shoulders defines an angle of approximately 90 degrees with respect to the associated inner surface of the barrel. In other words, the angles a and b as seen in FIG. 3 are substantially 90 degrees. 75 (5

The corners as defined adjacent the frangible areas are sharp, and two internal corners as indicated by reference numerals 64 and 66 are defined by the shoulders 60 and 62 respectively where these shoulders intersect the associated surfaces.

It will 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 60 and 62. It should be noted that the thickness of the wall portion of the frangible area as defined between these limits as set forth above its appreciably less than the thickness of the adjacent 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 barrel 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 two internal corners 64 and 66. This line has been drawn between the closest points on these two internal corners, and it will be noted that the various surfaces defining an angle with respect to line x—x define angles of approximately 45 degrees. In other words, the surfaces of annular shoulders 60 and 62 each define an angle of approximately 45 degrees with respect to the line x—x as do the outer and inner surfaces of the barrel 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” internal stresses. Since shrinkage accompanies this cooling, the internal stresses are developed. There are no appreciable radii formed adjacent the frangible area, but rather the corners are, sharp. The material employed is of high melt index and of 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 molding operation and high pressure is utilized to packthe plastic material into the mold when filling the cavities. These techniques cause the desired formation of stresses when the structure is designed as illustrated here-, in.

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 de-, sired internal stresses at the frangible portion, this frangible 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 particular portion of the structure.

A plunger is slidably disposed within the barrel and includes a main elongated substantially cylindrical portion 70 having an enlarged end portion 72 at one end thereof which is adapted to be manually engaged by the thumb or the like for operating the plunger in the usual manner. The plunger is preferably formed of a material such as high impact styrene or a similar material. A plurality of laterally extending and angularly spaced ribs 74 are provided, at the enlarged end of the plunger for reinforcing and rigidifying this manually engageable end portion.

The opposite end of the plunger includes a reduced end portion indicated generally by reference numeral 76 which has a particular construction as seen most clearly in FIGS. 3 and 5. As seen in these figures, the reduced

3,306,291 end portion includes a rectangular shank portion 78 extending integrally from the main body portion 70 of the plunger, this shank portion joining with a substantially disc-shaped portion 80. Extending outwardly from discshaped portion 80 is a pair of spaced portions 82 and 84 defining a groove 86 therebetween. The outer surfaces of portions 82 and 84 include flat surfaces 90 and 92 each of which is substantially frusto-triangular in configuration as seen in FIG. 3 and which additionally is sloped as seen in FIG. 5 so as to define an oblique angle with respect to the longitudinal axis of the plunger.

Referring now particularly to FIG. 3, a resilient piston means 100 is provided, this piston being formed preferably of pharmaceutical or medical grade rubber or a similar substance. The piston means is provided with a recess for receiving the reduced end portion of the plunger and is completely complementary thereto. Referring now particularly to FIGS. 3 and 6, a tapered entrance portion 102 is provided into the recess of the piston means to facilitate entry of the reduced end portion, this tapered entrance portion being in communication with a longitudinally extending rectangular bore 104 which snugly receives the portion 78 of the reduced end of the plunger. A recess portion 106 is adapted to receive the portion '80 of the reduced end of the plunger, and a rib 108 is provided in the center of the recess within the piston means, this rib 108 fitting snugly within the slot or groove 86 defined between the portions 82 and 84 of the plunger end. A pair of recesses 109 and 110 are provided within the piston means at either side of the rib 108 and are adapted to receive the two portions 82 and 84 of the reduced end of the plunger. With this over-all arrangement, it is apparent that the piston means is snugly received on the end of the plunger and is movable longitudinal therewith and cannot rotate with respect to the plunger thereby enabling very fine adjustments of the apparatus.

As seen particularly in FIG. 3, the outer end 111 of the piston means is provided with a substantially arcuate configuration and may comprise a portion of a spherical surface, this configuration being substantially complementary to the inner end wall 50 of the barrel such that the piston means is adapted to fit snugly against the end of the barrel when moved to its innermost position thereby assuring that all of the medicament within the barrel will be expelled as the plunger is moved to its full “in” position.

A pair of peripherally extending ribs 112 and 114 are formed on the outer surface of the piston means and are adapted to engage the inner wall of the barrel to provide an effective fluid-tight and sterile seal therewith. The rib portion 114 is provided with a very sharp corner 116 which in operation provides a means for obtaining a very accurate and definite visual indication or definition of the exact position of the piston means with respect to the indicia formed on the barrel.

As seen particularly in FIGS. 1, 2 and 3, a needle guard is indicated generally by reference numeral 120 and may be formed for example of polyethylene or the like. A plurality of spaced ribs 122 are provided on the outer surface of the needle guard to help prevent the needle guard from rolling along a supporting surface and to facilitate gripping and removal at the time of use.

The needle guard includes a main elongated hollow body portion 124 which terminates in an enlarged open end portion 126 fitting about the barrel 40. A peripherally extending sealing rib 128 extends inwardly from the inner surface of the open end portion of the needle guard and engages the outer surface of the barrel for providing a frictional contact therewith which not only serves to retain the needle guard in operative position on the barrel but which also provides a sterile seal therewith. An annular shoulder 130 formed on the inner surface of the needle guard is adapted to abut up against the end portion of the barrel as seen in FIG. 2.

⁸

The opposite end portion of the needle guard is provided with a hole 132 through which air may be aspirated into the interior of the needle guard, a rib or ring portion 134 being provided at this end of the needle guard 5 for retaining a body of cotton 136 or other suitable filter media in position adjacent hole 132. It is apparent that any sort of sterile filter means may be employed, and absorbent cotton is preferred for this purpose, this cotton serving to maintain any air aspirated into the needle ₁₀ guard in the sterile condition. Air is filtered when aspirated into the barrel before the guard is removed and the needle inserted into a multi-dose vial. Filtered air pressurizes the vial and facilitates the withdrawal of medicament. Without this air, vacuum resulting after 15 withdrawal of medicament would tend to “suck in” atmospheric air with bacteria. The bacteria could eventually reduce the potency of the injectable and subsequently be injected into patients.

A conventional hypodermic needle is disposed within 20 the needle guard and is mounted upon the boss 46 of the barrel, the needle including a hub portion 140 formed of an anodized aluminum alloy for example, this hub being knurled and having an internal taper thereon complementary to the taper formed on the outer surface of 25 boss 46 for retaining the hypodermic needle in operative position on the boss.

The needle also includes a hollow elongated portion 142 which terminates in a sharp point 144, portion 142 being preferably formed of stainless steel or similar substance. 30 It is apparent that the needle guard may be mounted in operative position simply by slipping it over the barrel after the hypodermic needle has been mounted in operative position, a beveled inner edge 127 as seen in FIG. 3 being provided on the needle guard for facilitating its 35 mounting in operative position. The apparatus is normally sterilized by utilizing a sterilizing gas such as a combination of carbon dioxide and ethylene oxide which may be used either in the proportions of 90 percent carbon dioxide, 10 percent ethylene oxide, or 80 percent car40 bon dioxide, 20 percent ethylene oxide. This sterilizing gas will fill the assembly during the sterilizing operation, and after having been sterilized, the sealing portion 128 will maintain a sterile seal within the needle guard in combination with the cotton filter means 136, and the ₄- piston means will also serve to provide a sterile seal with respect to the barrel thereby preventing any contamination of the hypodermic needle until the needle guard is removed for actual use of the apparatus.

It should be noted at this time that the various mod50 ifications as described hereinafter are in many respects similar to the structure discussed above, and in each case the principles involved in designing the frangible area are the same, and accordingly it is not considered necessary to repeat in detail the particular principles involved in ₅₅ forming the frangible area, it being realized that the same concepts are involved throughout the instant application in each of the different modifications.

Referring now particularly to FIGS. 7 through 11 inclusive, a modified form of the invention is illustrated ₆₀ which may comprise for example a 1 cc. insulin syringe. This particular syringe includes a barrel having a main body portion 140 formed of polypropylene or similar material and which is generally cylindrical and hollow as the previous barrel construction and transparent with in05 dicia formed thereon. A radially extending flange 142 is provided at the open end of the barrel adjacent a beveled portiton 143 for facilitating entry of the plunger into the barrel, a bead 144 being formed at the outer surface of flange 142.

7θ A boss 146 projects longitudinally from the opposite end of the barrel and is provided with an outer tapered surface 148 similar to the tapered surface provided on the previously described boss. Boss 146 is connected with the main body portion 140 of the barrel by a frangible 75 portion 150.

3,306,291 to the longitudinal axis of the plunger, or in other words these edges if extended would define an angle of approximately 20 degrees with the longitudinal axis of the plunger. The other edges 204, 206, 203 and 210 each define an angle of approximately 60 degrees with respect to the longitudinal axis of the plunger or with respect to the adjacent side surface of an adjacent rib.

A resilient piston means is indicated generally by reference numeral 220 and is preferably formed of pharmaceutical or medical grade rubber or the like. This piston means includes a recess which is complementary to the reduced portion of the plunger and includes a tapered entry portion 222 for facilitating entry of the reduced portion thereinto. Tapered portion 222 joins with a recess portion 224 adapted to snugly receive the portion 200 of the reduced end of the plunger.

A recess 226 formed within the piston means is adapted to receive the portion 202 of the plunger, and four spaced recesses 230, 232, 234, 236 are provided for receiving the four ribs formed on the plunger, each of the lastmentioned recesses being complementary to the ribs. It is apparent that when the reduced portion of the plunger is inserted in the piston means, the piston means will move longitudinally with the plunger and cannot rotate with respect thereto in order to enable fine adjustments thereof.

The piston means is provided with a pah of peripherally extending ribs 240 and 244 formed on the outer surface thereof and adapted to engage the inner wall of the barrel. Rib 242 is provided with a sharp edge 244 so as to provide good visual indication of the position of the piston within the transparent, or nearly transparent, barrel and to provide a good reading in cooperation with the indicia formed on the barrel.

A needle guard indicated generaly by reference numeral 250 is similar to the needle guard previously described and comprises an elongated hollow generally cylindrical main body portion 252 and an enlarged open end portion 254 which is adapted to fit about the skirt 160 and to have the terminal end thereof in abuting relationship with the adjacent end portion of the barrel. A peripherally extending sealing lip 256 is formed within the open end portion 254 and is adapted to engage the outer surface of the skirt so as to retain the needle guard on the skirt and to provide a sterile seal with respect thereto.

When in the operative position as shown in FIG. 7, a shoulder 257 formed on the needle guard will abut up against the end surface of the skirt. A plurality of spaced longitudinally extending ribs 258 are provided on the outer a supporting surface and to facilitate removal of the* guard before use.

Opening means 260 is provided at the opposite end of the needle guard for aspirating air thereinto, a rib 262 ’ ^;-ig provided for maintaining a body of sterile filter material such as cotton 264 adjacent to the opening 260 to ensure that the air aspirated within the needle guard remain sterile.

It will be apparent that the operation and use of the

- , _Φ--------, _A Λ substantially identical with that described in connection with FIGS. 1 through 6 inclusive, and in each case the device will remain sterile until used whereupon the boss portion of the barrel including the attached hypodermic 65 needle may be broken away preferably by reinserting the needle guard in operative position and then bending it laterally so as to cause the frangible portion of the barrel to break away. It is apparent that once the boss and the needle have been broken away, the device is destroyed

Referring now particularly to FIGS. 12 through 17, a further modified form of the disposable syringe according to the present invention is illustrated and which for example comprise a 10 cc. syringe. In this modification, 75 a barrel includes a main body portion 270 having a

The frangible portion 150 is constructed similar to that previously described, this frangible portion including internal stresses built thereinto and being formed by providing an outer annular shoulder 152 on the outer surface of the barrel and an inner annular shoulder 154. As in the previous modification, these shoulders define angles of substantially 90 degrees with respect to the associated outer and internal surfaces, these 90 degree angles being indicated by the angles a and b. As in the previously described modification, a line L—L is drawn through the nearest points on the internal corners as indicated by reference numerals 156 and 158.

Here again, it will be noted that the thickness of the wad at the frangible portion is appreciably less than the thickness of the adjacent wall portions at either side thereof and the length of the stress area should be approximately the same dimension as the thickness of the wall and not more than twice such dimension. The surfaces defining the annular shoulders 152 and 154 as well as the intersecting surfaces of the inner and outer sur- 20 faces of the barrel define angles of approximately 45 degrees with respect to the line L—L. *

Referring particularly to FIGS. 7 and 8, a skirt portion indicated by reference numeral 160 projects longitudinally from barrel 140 and is formed integral therewith, the 25 outer surface of the skirt being of less cross sectional dimension than the outer surface of the barrel. An inner beveled edge 162 is provided on the skirt, and an inner surface 164 of the skirt is spaced outwardly of the tapered outer surface of the boss 146 and provides an annular 30 space within which is received the hub 170 of a conventional hypodermic needle. It will be noted that the enlarged end portion 171 of the hub is adapted to be clamped between the outer surface of boss 146 and the inner surface of the skirt so as to securely retain the hy- 35 podermic needle in the operative position as shown. The skirt also serves to accept the needle guard. As in the previous modification, the needle may include a knurled hub portion of anodized aluminum and an elongated tubular portion 172 of stainless steel or the like ⁴⁰which terminates in a sharp point 174.

As seen particularly in FIG. 8, the inner end wall 130 of the barrel is of generally concave arcuate configuration as in the previously described modification and may for example define a portion of the surface of a sphere. 45 This inner end wall is in communication with a recess portion 182 which in turn is in communication with a tapered portion 184 which joins with the bore 186 formed through the boss 146. The intercooperation of the con- „-----------, --------_{uu Lllc UULC} cave inner end wall and the tapered surface 184 is such 50 surface of the needle guard to prevent rolling thereof alon· as to assure that substantially all of the medicament -----------------be expelled from the barrel.

A plunger is slidably disposed within the barrel and includes a substantially cylindrical hollow portion 190 ____ .

having a radially extending flange 192 formed at one end 55 bein; thereof and adapted to be manually engaged as by the thumb for pushing the plunger in or for grasping by the fingers to pull the plunger out, reinforcing ribs 194 being formed immediately beneath flange 192 on the outer surface of the plunger. “ / ~ ' ________ end portion 196 at the opposite end thereof of novel configuration.

As seen particularly in FIGS. 8 and 9, the reduced end portion 196 of the plunger includes a shank portion 200 extending longitudinally of the plunger 190 and being integral with a disc-shaped portion 202. Extending longitudinally from portion 202 are four spaced ribs 204, 206, 208 and 210, these ribs being angularly spaced approximately 90 degrees from one another. _awa

Each of these ribs is provided with a pair of angularly 70 for any effective re-use thereof disposed outer edges, these edges being identified by the reference numerals 204', 204, 206', 206, 208', 208, 210', 210 respectively. The first series of edges 204'” 206', 208' and 210' define an angle of approximately 70 degrees with respect to a plane extending perpendicular will rp, . - -- ' IUUI U11V VjJCl dllUll dllU UiSc OI me . 1 he plunger also includes a reduced 60 disposably syringe illustrated in FIGS. 7 through 11 is thft ΩΤ&gt;ΠΠ21ίΑ P.nH tnATiarv-F r\f nntial , U-4-_ 11 · 1 _ .· &lt; . . ®

3,306,291 ιι radially extending flange portion 272 provided at one end thereof terminating in a peripheral bead 274, the barrel being substantially cylindrical and hollow and with a tapered entrance portion 276 to facilitate entry of the plunger thereinto. As in the previous modifications, the barrel in this modification is also formed of a material which is difficult to break such as polypropylene.

A boss portion 288 extends longitudinally from the barrel 270 and includes a tapered outer surface 282 which joins with a substantially cylindrical surface 284 which in turn joins with a body portion 286 extending outwardly from the barrel and joined therewith by a frangible portion 288. Body portion 286 is provided with a plurality of angularly spaced and longitudinally extending holes 287 to facilitate uniform cooling of the body portion and to prevent dimples from being formed therein.

As in the previously described modifications, this frangible portion 288 is defined between inner and outer surfaces of the barrel and is a thin walled annular portion of appreciably less thickness than the wall thicknesses at either side thereof. This frangible area is formed by a pair of annular shoulders 299 and 292 formed on the outer and inner surfaces of the barrel respectively and spaced longitudinally with respect to the barrel. These annular shoulders each define angles of substantially 90 degrees with respect to the associated inner and outer surfaces as indicated by the angles a and b. The length of the stress area again is approximately the same as the thickness of the thin wall portion and not more than twice this dimension. The annular surfaces defining shoulders 290 and 292 as well as the intersecting inner and outer surfaces each define an angle of approximately 45 degrees with respect to a phantom line M·—M drawn through the closest points on the internal corners 294 and 296 formed at the outer and inner surfaces respectively.

A peripherally extending cutout portion 300 defining a substantially right angle is provided around the end of the barrel, this cutout being provided for facilitating removal of the barrel from its mold during the manufacturing process.

The inner end wall 302 of the barrel is of generally concave configuration and has a central recess 304 formed therein which in turn is in communication v/ith a tapered portion 308 which is in communication with a longitudinally extending bore 310 formed through the central portion of boss 280. The cooperation of the concave shaped inner end wall portion 302 and the tapered portion 308 is such as to assure that substantially all of the medicament is expelled from the barrel during operation of the apparatus.

The plunger means of this modification may be formed of a suitable substance such as polyethylene and includes an elongated substantially cylindrical hollow body portion 320 having spaced internal ribs 322 formed thereon to rigidify the structure. An enlarged end portion 324 is provided on the plunger for manual engagement, and external ribs 326 are formed on the outer surface of the plunger to strengthen the manually engaged end portion thereof.

The opposite end portion of the plunger includes a first reduced portion 30 having an outer four-sided symmetrical configuration with each of the sides flat and of substantially the same extent, portion 330 in turn joining with a second portion 332 which is substantially cylindrical in configuration on its outer surface and which in turn joins with a slightly enlarged portion 334 which also defines a cylindrical outer surface.

A resilient piston means is indicated generally by reference numeral 340, this piston means being formed of pharmaceutical or medical grade rubber or the like and having a recess formed therein complementary to the reduced end portion of the plunger. The recess in the piston means includes a first four-sided flat surfaced recess 342 for snugly receiving the portion 330 of the plunger.

The recess also includes a cylindrical portion 344 for snugly receiving the portion 332 of the plunger and a further cylindrical recess portion 346 is adapted to snugly receive the portion 334 of the plunger. It is apparent that when the plunger is inserted in operative position within the recess in the piston means, the piston means will be mounted for movement with the plunger and at the same time cannot rotate with respect thereto so as to enable accurate and fine adjustment of the apparatus.

The piston means is provided with a pair of peripherally extending ribs 348 and 350 on the outer surface thereof for engaging the inner wall of the barrel. Rib 350 is provided with a sharp edge portion 352 for providing accurate readings in combination with suitable indicia provided on the transparent barrel portion 270.

The piston means is provided with an outer end Avail 354 of generally concave configuration which is substantially complementary to that of the inner end wall 302 of the barrel when the plunger is moved into its innermost position as shown in FIG. 12 such that the piston means will fit snugly up against the inner wall of the plunger thereby assuring that substantially all of the medicament is expelled from the barrel.

A space 356 is provided between the bottom of the recess formed in the resilient piston means 340 and the outer end wall portion 357 of the reduced end of the plunger. This space enables the end of the piston to be deformed into the position shown in FIG. 12 wherein the space is flattened out and the ribs formed on the outer surface of the piston means are pressed firmly into engagement with the inner wall of the barrel. This flattening out of the piston means is caused by the hydraulic forces generated within the apparatus during operation.

Referring now particularly to FIG. 17 of the drawings, an arrangement is shov/n wherein the syringe may be sold and shipped without a hypodermic needle attached thereto. In such a case, it is desirable to provide a sterile package, and for this purpose an adaptor cap indicated generally by reference numeral 360 is provided. This adaptor cap comprises a generally cup-shaped hollow body portion formed of polyethylene or the like having an open end 362 which fits snugly about the skirt 286 of the barrel so as to form a sterile seal therewith. The adaptor cap is provided with a plurality of spaced longitudinally extending reinforcing ribs 364 on the outer surface thereof. It is apparent that after the syringe assembly has been shipped with the adaptor cap in place, it is merely necessary to slip the adapter cap off of the skirt and insert a hypodermic needle in position on the boss portion wherein the apparatus is ready for use.

A needle guard is illustrated in FIG. 12 and is indicated by reference numeral 370, this needle guard including an open end portion 372 adapted to fit about the skirt 286. The open end portion 372 is provided with an inner peripherally extending rib 374 adapted to snugly engage the outer surface of skirt 286 to retain the needle guard in operative position and to provide a sterile seal therewith.

As in the previous modifications, needle guard 370 is of hollow elongated configuration so as to enclose the hypodermic needle and to be spaced therefrom. The opposite closed end of the needle guard is provided with opening means 376 through which air is adapted to be aspirated. A rib 378 serves to hold a body of sterile absorbent cotton 380 in place adjacent to the opening means 376 so as to filter any air aspirated into the needle guard and to retain the interior of the needle guard in a sterile condition.

The hypodermic needle in this particular modification may be identical with that previously discussed having a hub portion 382 which fits on the boss 280 so as to be snugly retained thereon by the outer tapered surface 282 thereof, the needle including an elongated hollow portion 384 which terminates in a sharpened point 386.

Referring now particularly to FIGS. 18 through 23 inclusive, a modified form of a disposable syringe is illus3,308,291 trated including a barrel 390 formed of a material such as polypropylene which is of hollow elongate configuration and which is generally cylindrical and includes an outwardly extending circumferential flange 392 formed at the open end thereof and having a bead 394 formed at the periphery thereof. A tapered entrance portion 396 is provided for facilitating entry of the plunger.

A longitudinally extending boss 397 extends from the opposite end of the barrel and includes a tapered outer surface 398 which joins with a substantially cylindrical surface 399. This cylindrical surface in turn joins with an enlarged body portion 499 formed integral with the barrel and having a plurality of spaced holes 401 formed therein to facilitate more uniform shrinkage and to prevent dimples being formed in the plastic. The boss and body portion are joined with the main barrel portion by a frangible portion 402 extending annularly about the apparatus.

As in the previous modifications, the frangible portion is provided with built-in internal stresses in the manner aforedescribed, the frangible portion being formed by providing a first annular shoulder 404 on the outer surface of the barrel and a second annular shoulder 406 formed on the inner surface of the barrel. As in the previous modifications, the shoulders 404 and 406 define angles a and b of substantially 90 degrees with respect to the associated outer and inner surfaces respectively.

A phantom line N—N has been drawn between the closest points on the internal corners as indicated by reference numerals 498 and 410 defined by the outer and 30 inner shoulders respectively. The thickness of the wall portion of the frangible area is appreciably less in thickness than the normal thickness of the adjacent wall portions at either side thereof, it being noted especially as do not interfere with this relationship. The longitudinal extent of the stress area is again approximately the same as the thickness of the frangible wall and not more than twice such dimension. Tire surfaces defining the annular shoulders 404 and 405 as well as the inner and outer sur- 40 faces intersecting these shoulder surfaces define an angle of approximately 45 degrees with respect to the line N—N. Here again, this interrelationship creates such stresses in the material that it can be readily broken with manual effort.

The inner end wall 412 of the barrel is of generally concave configuration and may define a portion of a spherical surface. This inner end wall has a central recess 414 formed therein which in turn is in communication with a ________ ...- , tapered portion 416 which joins with the bore 418 formed ₅₀ of stainless” steel/ through the boss portion. Here again, the cooperation of the concave inner end wall portion along with the recess 414 and the tapered portion 416 ensures that substantially all of the medicament will be expelled from the barrel during operation.

The plunger of this particular modification may also be formed of polyethylene or similar substance and includes an elongated hollow body portion 420 having three peripherally extending internal ridges 421, 422 and 423 ________ _________ formed thereon and spaced longitudinally thereof, these 60 within the needle guard for retaining a body 476 of sterile tnfarn ο 1 vm z4 rtAr in ™ _n 7 x7- -.-7..-. .&lt;· _ .. -.- - * of the apparatus and not visible in this particular view, all of the ribs being equidistantly spaced from one another. The outer surfaces of each of the ribs is substantially planar and defines an oblique angle with respect to the longitudinal axis of the plunger, the three outer surfaces visible in FIG. 20 being indicated by reference numerals 434', 435' and 436' respectively.

A resilient piston means is indicated generally by reference numeral 449 in FIG. 20 and is formed of a suitable material such as pharmaceutical or medical grade rubber, this resilient piston means having a recess formed therein complementary to the reduced end portion of the plunger. This recess includes a tapered entrance portion 442 which joins with a hole 444 complementary to and adapted to snugly receive the portion 430 of the plunger.

Recess portion 444 is in turn in communication with a recess portion 446 which snugly receives portion 432 of the plunger. Four spaced recesses 448, three of which are visible in FIG. 20 are provided for snugly receiving each of the ribs provided at the outer end of a reduced portion of the plunger.

It is apparent that the interrelationship of the reduced end of the plunger and the resilient piston means will be such as to cause the piston means to move longitudinally with the plunger and also to prevent relative rotation between the piston means and the plunger so as to enable accurate adjustments of the apparatus.

A pair of peripherally extending spaced ribs 459 and 452 are provided on the outer surface of the piston and are adapted to engage the inner wall of the barrel. The rib 452 is provided with a sharp edge 454 so as to provide a good reading in cooperation with the indicia 456 provided on the barrel as indicated in FIG. 23.

The outer end surface 456 of the resilient piston means • । z—λ , · ^Α * ' x« v —— x o mi j. uv v o xz xz xZ X. dXXZ X Xz OXXXxzXX X0 CxZXX XXX Xz CXXXO seen in FIG. 20 tnat the holes 401 at widely spaced points 35 of this modification is also provided with a generally concave configuration which is substantially complementary with the inner end wall 412 of the barrel such that the outer end wall of the piston means is adapted to fit snugly against the inner end wall of the barrel to ensure that all of the medicament is expelled when the plunger is moved inwardly.

The hypodermic needle of this modification includes a hub portion 460 having an inner tapered surface substantially complementary to the outer tapered surface of the 45 hub so that the needle will be retained in place on the hub. The hypodermic needle also includes an elongated hollow portion 462 terminating in a sharp point 464. The needle hub may be knurled and formed of an aluminum alloy while the portion 462 thereof is preferably formed

A needle guard is indicated generally by reference numeral 466 and includes an open end portion 468 having a peripherally extending internal rib 470 which engages the outer surface 399 of the boss for engaging the outer 5a surface of the skirt portion 400 of the barrel for retaining the needle guard in position on the skirt and for providing a sterile seal therewith. The opposite end of the needle guard is provided with opening means 472 through which air may be aspirated, and a rib 474 is provided internal ridges facilitating removal of the plunger from the mold cavity during manufacturing. The open end of the plunger is provided with an outwardly extending peripheral flange 425 adapted to be manually engaged, and a plurality of reinforcing ribs 426 are provided on the 65 outer surface thereof.

As seen particularly in FIG. 20, the opposite end of the plunger 429 is indicated by reference numeral 428 and as of reduced dimension, this reduced end portion includ- „_________lululwl ing a longitudinally extending shank portion 430 whicn is 70 terial such as polypropylene, and an enclosure means in. „ . dicated generally by reference numeral 482 is formed of a material such as linear polyethylene which is a soft plastic which will not damage the sharp needle point should the point accidentally contact a portion of the enclosure cotton or other filter means in position adjacent the opening means 472 for filtering any air which may enter within the needle guard and for retaining a sterile atmosphere therewithin.

Referring now particularly to FIGS. 24 through 29 inclusive, there is illustrated a first modification of a sterile disposable needle container for shipping hypodermic needles. This container includes a body means indicated generally by reference numeral 480 and formed of a mainterconnected with a disc like portion 432. Four spaced similar ribs extend outwardly from portion 432, three of these ribs being visible in FIG. 20 and being indicated by reference numerals 434, 435 and 436, it being apparent that a rib similar to 435 is provided on the opposite side 75 means.

3,206,291

The body means 480 includes a first substantially cylindrical portion 484 defining an open end portion 485, portion 484 having a plurality of spaced longitudinally extending flutes 486 extending therearound to facilitate grasping of the body means. The body means also includes an integral portion 488 of reduced diameter as compared to portion 484, portion 488 having a plurality of spaced longitudinally extending flutes 490 formed therearound. The two portions 434 and 488 of the 'body means are joined by a frangible portion 492 extending annularly about the body means.

Referring now particularly to FIG. 29, the details of construction of the frangible portion 492 are more clearly illustrated. As seen in this figure, the frangible portion comprises a pre-stressed area formed by providing a first annularly extending shoulder 500 on the outer surface of the body means and a second annularly extending shoulder 502 formed on the inner surface of the body means. These two surfaces are offset with respect to one another longitudinally of the body means and define angles of substantially 90 degrees with the associated intersecting outer and inner surfaces respectively.

As in the previous modifications of the invention, the wall thickness of the frangible portion is appreciably less than that of the normal thickness of the adjacent wall portions. The length of the stress area is approximately the same as the thickness of the wall and under no circumstances more than twice the thickness of the wall. A phantom line O—O has been drawn through the nearest points on the internal corners 504 and 506 as defined respectively by intersection of the annular shoulders with the outer and inner surfaces of the body means. The surfaces defining the annular shoulders as well as the inner and outer surfaces each define an angle of approximately 45 degrees with respect to line O—O. As in the previous modifications, this particular construction provides an arrangement whereby the frangible portion may be readily broken by hand.

The upper closed end of the body means as seen in FIGS. 26 and 27 is provided with four spaced internal ribs 510 which extend radially inwardly of the portion 488 of the body means and extend longitudinally thereof. The purpose of these ribs will be hereinafter described.

A beveled edge 512 is provided around the body means just below the frangible portion as seen in FIGS. 24 and 26 and suitable printing is provided on this surface indicating that the body means is to be bent at that particular point so as to break away the upper reduced portion 483 of the body means. The body means is shown as being intact in FIG. 24 and as seen in FIG. 25, the frangible portion has been broken so as to leave an uneven edge 514, the portion 488 thereby being removed to expose a hypodermic needle indicated generally by reference numeral 516 which is disposed within the container.

The dimensions of the upper portion 488 are such as to permit the portion 488 to be bent to one side and to pivot over the end of the hypodermic needle without contacting the needle. In other words, as seen in FIG. 26 if lateral force were applied to the left hand side of the portion 488 as seen, the left hand portion of the frangible area would be the first to break and the part 488 would tend to pivot about the frangible portion as seen at the right of FIG. 26 with the portion 488 clearing the upper edge of the hypodermic needle so as to not interfere with the needle in any respect.

The lower open end 485 of the body means is provided with a beveled entrance portion 520 to facilitate movement of the body means over the telescoping end portion of the enclosure means as hereinafter described. A peripherally extending groove 522 is provided in the inner surface of the lower open end portion of the body means and is provided with opposite sloping side surfaces 524 .and 526.

The lower open end portion 485 of the body means is also provided with four longitudinally extending slots spaced substantially 90 degrees from one another. These slots are provided for the purpose of obtaining a certain degree of resilience at the lower open end of the body means such that it can be slightly expanded so as to be moved into the operative position shown in FIG. 26 as will be clear from the following description.

The enclosure means 482 includes a main elongated hollow body portion 530 which is normally disposed in spaced relationship to the enclosed hypodermic needle and which includes a lower closed end portion 531. Four longitudinally extending ribs 532 are formed on the cuter surface of portion 530. These ribs 532 are disposed substantially 90 degrees apart and are adapted to fit within the slots formed in the lower open end portion of the body means when the two portions 480 and 482 of the container are snapped into operative position as shown in FIG. 26.

The upper portion cf the enclosure means as seen in FIG. 26 is provided with a peripherally radially outwardly extending attaching shoulder 536 having opposite sloping side surfaces 538 and 540. This attaching shoulder is adapted to fit snugly within the groove 522 provided in the body means, and when the two portions 482 and 489 have been snapped into the telescopic relation shown in FIG. 26, the two members will be locked together and cannot be removed simply by applying effort to pull them apart longitudinally. It is apparent that the beveled entrance portion 520 will facilitate movement of the parts into the assembled relation shown as will the slotted open end portion 485 of the body means.

The upper portion of the enclosure means is also provided with a peripherally extending sealing rib 542 formed on the outer surface thereof which is adapted to engage the adjacent inner surface of the portion 484 of the body means so as to provide a sterile seal therewith.

It will also be noted that the uppermost open end of the enclosure means is provided with a beveled portion 544 which is adapted to cooperate with the beveled portion 520 formed on the body means for facilitating entry of the enclosure means into the body means.

The enclosure means includes a central bore 546 for receiving the main part of the hypodermic needle, and a hexagonal socket portion 548 is provided at the open upper end thereof for snugly receiving a correspondingly shaped portion of the hub of the needle. The thickened upper portion of the enclosure means is provided with a plurality of spaced longitudinally extending holes 550 formed about the central bore therethrough, these holes serving to ensure more uniform cooling of this portion of the enclosure means and to prevent dimpling thereof.

The hypodermic needle includes a hub of an anodized aluminum alloy and an elongated portion 554 formed of stainless steel.

When assembling the container as shown in FIG. 26, the portions 480 and 482 are initially separate from one another and the hypodermic needle will be inserted in operative position in the socket portion 548 of the enclosure means as shown.

The body means 489 will then be moved into telescoping relationship with the upper end of the enclosure means until the shoulder 536 on the enclosure means snaps into the groove 522 provided in the body means, and with the upper end of the ribs 532 of the enclosure means fitting within the slots 528 of the body means.

The body means is formed of polypropylene and is sufficiently resilient to be snapped into the operative position shown in FIG. 26, but it cannot be pulled back to “off.” With this arrangement, the container is tamperproof since it must be broken or destroyed in order to open the container. In addition, this permanent attachment of the body means to the enclosure means is an important consideration in obtaining and retaining a sterile condition within the container. After the members have been snapped into position as shown, a closed capsule or

3,306,291 housing is provided which is adapted to retain sterilizing gas as hereafter described. Accordingly, the hypodermic needle is maintained in a sterile condition and further is protected from damage during shipment and up until the time it is actually desired to be used.

When the body means 480 is pushed into the operative position as shown in FIG. 26, the ribs 510 will tend to move the hypodermic needle downwardly as seen in FIG. 26 by engaging the upper surface thereof so as to ensure that the needle is properly seated within the enclosure means socket. Additionally, these ribs will prevent the needle from coming out of the socket in the enclosure means 'and thereby serve to retain the needle in its proper operative position within the container.

When sterilizing this package or container with the needle therein, the whole package is placed within a chamber which is evacuated to an equivalent to 14 p.s.i. negative pressure which “pulls out” the original air in the package. The chamber is then pressurized up to 20 p.s.i. with a sterilizing gas as mentioned hereinbefore whereby the entire assembly is automatically filled with the 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 hot support bacterial growth. The sealing ring 542 will hold from 3 to 10 p.s.i. within the package, and accordingly, it is apparent that an inert gas will be trapped within the container to maintain sterility control. This same feature is also incorporated in the modification illustrated in FIGS. 30 and 31.

Referring now to FIGS. 30 and 31, modified forms of the body means and enclosure means are illustrated respectively. It is apparent that these two portions are adapted to be snapped into operative position as are the portions 480 and 482 respectively for retaining a hypodermic needle therein.

Referring now particularly to FIG. 30, a modified form of the body means is illustrated including a first substantially cylindrical portion 560 having a plurality of spaced longitudinally extending flutes 562 formed in the outer surface thereof for facilitating grasping thereof. The open end portion 563 of the body means is provided with a laterally extending flange portion 564 which is provided with flats on the outer surface thereof to prevent rolling of the body means and the attached enclosure means along a supporting surface. This provision of the flats on the body means further ensures the prevention of rolling, the ribs formed on the enclosure means of both of the modifications of the needle container also serving this same function.

The body means shown in FIG. 30 also includes a portion 566 of reduced diameter having a plurality of spaced longitudinally flutes 568 formed on the outer surface thereof. Reduced portion 566 is interconnected with portion 560 by means of a frangible portion indicated generally by reference numeral 570.

The body means of this modification is also formed of polypropylene and the frangible portion 570 is provided with the desired characteristics by providing a particular construction so as to render it readily breakable with manual effort.

A pair of annular shoulders 572 and 574 are provided on the outer and inner surfaces of the body means respectively and are offset or spaced from one another longitudinally of the body means. Each of these annular shoulders defines an angle of approximately 90 degrees with the intersecting associated outer and inner surfaces respectively. These angles are indicated by the letters a and b respectively.

A phantom line P—P has been drawn through the nearest points on the internal corners 576 and 578 defined by the intersection of the annular shoulders with the outer and inner surfaces of the body means.

The thickness of the wall of the frangible portion is again appreciably less than the normal thickness of the walls at either side thereof, and the length of the stress area should be approximately the same as the thickness 5 of the wall and not more than twice such dimension. The annular surfaces defining shoulders 572 and 574 as well as the adjacent intersecting inner and outer surfaces each define an angle of approximately 45 degrees with respect to the phantom line P—P. With this over-all arrange10 ment, the frangible area is again rendered readily breakable by manual effort when lateral forces are applied to the body means outer closed end portion. As in the previous needle container, this end portion of the body means which is broken away is so designed and related to the 15 upper end of the hypodermic needle that it will pivot over the needle without touching or interfering with the needle when it is broken away.

The upper closed end of the body means is provided with a plurality of ribs 580 which extend radially inwardly 20 from the inner wall thereof and which extend longitudinally of the body means. These ribs serve the same purpose as the ribs 510 discussed in connection with the previous modification for moving the hypodermic needle in its proper operative position and for retaining it in such 25 position until used.

A beveled surface 582 extends peripherally about the body means and may be provided with suitable printing thereon to indicate that the body means is to be broken adjacent such point in order to open the container.

The open end of the body means is provided with a beveled entrance portion 584 which may be beveled at an angle of approximately 30 degrees with the respective inner surface of the body means so as to facilitate entry of the enclosure means thereinto as will be well under35 stood.

A peripherally extending internal groove 586 is provided within the body means and is provided with opposite sloping side surfaces 588 and 590, this groove being adapted to receive the attaching shoulder provided on 4° the enclosure means hereinafter described.

In this particular modification, the body means is not provided with any longitudinally extending slots as is the previously described modification, and the enclosure means is simply forced into position within the body 45 means utilizing the natural resilience of the plastic parts.

Referring now particularly to FIG. 31 of the drawings, a modified form of the enclosure means is illustrated which includes a main elongated hollow body portion 600 which may be formed of a material such as linear 50 polyethylene. This body portion has a closed end 602 and an open opposite end portion 604. A plurality of spaced ribs 606 are provided on the outer portion of body 600, the ribs preferably being four in number and equally spaced from one another although any desired number 55 of ribs may be employed. In this particular modification, the ribs terminate at the point 610 and do not extend into any slot portions formed in the body means since in this particular case the body means is not provided with any slots for receiving the ribs.

A peripherally extending sealing rib 612 is formed on the outer surface of the open end portion 604 of the enclosure means, this rib being adapted to engage the inner surface of the body means so as to provide a sterile seal therewith in the same manner in which rib 542 on the 65 enclosure means illustrated in FIG. 26 provides a sterile seal with its associated body means.

A peripherally extending attaching shoulder 614 is provided on the outer surface of the enclosure means and is provided with a first side surface 616 and a second 70 sloping side surface 618. It will be noted that the side surface 616 forms an angle of approximately 90 degrees with the associated outer surface of the enclosure means while the surface 618 slopes at an oblique angle to the same outer surface.

As in the previously described modification of the

3,306,291 needle container, the attaching shoulder 614 is adapted to snap into place within the internal groove 586 provided in the body means so that the body means and its associated enclosure means when in telescoping arrangement cannot be separated from one another without destroying the 5 package. The surface 616 being formed at right angles to the outer surface additionally ensures that it will be even more difficult to remove the body means from the enclosure means, and accordingly the only manner in which the enclosed hypodermic needle can be removed is by ιθ breaking away the body means thereby preventing re-use of the container and making the container tamper-proof.

The enclosure means is provided with a central boss 620 which receives the tubular portion of the hypodermic needle, and a hexagonal socket 622 is provided for receiv- 15 ing a correspondingly shaped portion of the hub of the needle. A plurality of spaced longitudinally extending holes 624 are provided in surrounding relationship to the bore within the enclosure means, these holes serving to ensure substantially uniform cooling of the enclosure 20 means and to prevent dimpling thereof.

In each modification of the needle container means, a beveled inner edge is provided in the body means for facilitating sliding of the enclosure means thereinto. Also in each modification, the side surface of the attaching 25 shoulder closest to the open end of the enclosure means is provided with a sloping configuration so as to cooperate with the inner beveled edge on the body means to cam the open end of the body means over such attaching shoulder and to permit the attaching shoulder to snap into opera- ³θ tive position as aforedescribed.

In each modification of the needle container means, the closed end of the body means may be provided with any suitable identification in the form of printing or embossments to identify the particular type of hypodermic needle ³⁵carried within the container.

It will of course be realized that the modification illustrated in FIGS. 30 and 31 when in assembled relationship can be sterilized in the same manner as discussed in connection with the modification shown in FIGS. 24-29, and ⁴⁰furthermore the portion 566 of the body means shown in FIG. 30 can be broken off along the annular frangible portion 570 and pivoted in such a manner as not to interfere with or contact a hypodermic needle disposed within the container. 45

Referring now to FIG. 32 of the drawings, a modification of the disposable syringe mechanism is illustrated wherein the boss 630 may be Similar to the bosses provided on the different barrels of the various modifications of the invention, it being understood that this particular 50 modification can be incorporated with different ones of the disposable syringe modifications as previously described.

The boss portion 630 is interconnected by means of a frangible portion indicated generally by reference numeral 55 632 with the main body portion of the barrel as will be well understood from a description of the previous modifications. The boss portion 630 is provided with a tapered outer surface 634 as previously described which is complementary to an internal taper 636 formed on the hub ⁶⁰portion 638 of a hypodermic needle indicated generally by reference numeral 640.

As pointed out previously, this type of taper in the hub portion of the hypodermic needle is known as a Luer taper, but it has been found that even though the boss ⁶⁵portion may be pressed quite tightly within the hub portion of a needle of this type, the needle will eventually become loose because of the tendency of the polypropylene material of the boss portion to conform or cold flow to the contour of the hub of the needle whereupon the θ holding power or resistance to movement is lost.

As in the previous modifications, the boss portion 630 is provided with an internal bore 642 which joins with a tapered portion 644 which in turn connects with a recess i D portion 646 formed in the central, part of the end wall of the barrel as previously discussed.

A skirt portion indicated by reference numeral 650 is disposed in surrounding spaced relationship to the boss portion 630 and is disposed in surrounding relation to a part of the tapered portion of the boss. It will be noted that a short portion 630' of the boss defines a cylindrical surface which in turn joins with the tapered outer surface 634 at a point indicated by reference numeral 635.

The end of the skirit portion includes a tapered entrance area 652 the tapered surface of which facilitates entry of the end portion of the hub within the skirit means as will be apparent.

The skirt portion also includes an annular shoulder portion 654 which extends peripherally around the interior of the skirt portion and projects inwardly therefrom. This shoulder defines an angle with a line drawn parallel with the longitudinal axis of the body means which is indicated by the letter h in the drawing, this angle being approximately 60 degrees.

The terminal end of the hub portion 638 of the hypodermic needle includes an enlarged portion 660 having an annular peripherally extending shoulder 662 formed thereon. As seen in FIG. 32, this shoulder is so arranged as to abut snugly against the shoulder 654 formed on the skirt portion.

It is apparent that when the hypodermic needle is assembled in operative position within the skirt portion as shown in FIG. 32, the needle hub will be adapted to snap into the position shown whereupon the cooperation of shoulders 654 and 662 will prevent withdrawal of the hub from the body means of the syringe. The hub thereby snaps in place and is permanently held and cannot be removed or withdrawn.

It is apparent from the foregoing that there is provided according to the present invention a new and novel disposable sterile device which remains a sterile package until used and which is adapted to be used only one time and then thrown away and completely discarded. The device of each modification includes means for effectively destroying the device by breaking away a portion thereof to prevent re-use for the intended purpose.

The disposable syringes of the present invention eliminate possible cross contamination, save the time of the operator and further are convenient and comfortable for the patient. These disposable syringes provide means for effectively filtrating the aspirated air drawn into the needle guards thereof and furthermore provide an arrangement which assures that substantially all of the medicament will be expelled from the syringes during operation. Each of the syringes is provided with resilient piston means having a very sharp line thereon to give accurate readings thereby indicating exact dosages in cooperation with the indicia provided on the barrels of the syringes. In each case, the resilient piston means is fixed to the associated plunger and cannot rotate with respect thereto which enables the plunger and piston means to be twisted as well as moved longitudinally within the barrel to obtain very fine adjustments.

In one modification of the adjustable syringe means, an auxiliary means is provided for holding a hypodermic needle in place in the form of a skirt disposed in surrounding relationship to the boss which supports the needle. In another modification of the invention, a unique arrangement is provided for enabling hydraulic pressure to urge the piston means outwardly such that the ribs on the outer surface thereof are pressed tightly against the inner surface of the associated barrel.

In each modification of the needle container means of the present invention, a tamper-proof arrangement is provided which necessitates the breaking away of a portion thereof so as to render the package in such a condition that it cannot be re-used for the intended purpose. Additionally, a sterile atmosphere· is retained within, the

3,306,291 needle container means until the body means thereof is broken.

As this invention may be embodied in several forms without departing from the spirit or essential characteristics thereof, the present embodiment is therefore illus- 5 trative 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 ₁₀those claims.