US2648334A - Hypodermic injection assembly - Google Patents

Description

Aug. 11, 1953 F. E. BROWN ETAL HYPODERMIC INJECTION ASSEMBLY Filed Oct. 28, 1949 /NVENTO/?$ FRANK E. BROWN FREOiR/CK M. Tue/v5 ULL BY THE/l? ATTORNEYS. 5, KIEcH, F05 TE)? & HH/FR/S M wx Patented Aug. 11, 1953 HYPODERMIC INJECTION ASSEMBLY Frank E. Brown, Burbank, and Frederick M.

Turnbull, Los Angeles, Calif. said Brown assignor to said. Turnbull Application October 28, 1949, Serial No. 124,061

Claims.

Our invention relates to hypodermic structures and more particularly to a multiple-dose hypodermic syringe for hypcdermically injecting exactly metered dosages of a medicament through a hypodermic needle. Many features of the invention are, however, applicable to single-dose syringes.

lhe most commonly used hypodermic structure includes a graduated barrel, a plunger slidable therein and a separate or permanently attached needle. These elements must be hot-sterilized between uses on the same or different patients. The needle is inserted through a rubber cap of a bottle or vial containing a multiple-dose volume of a medicament. Each penetration tends to dull the needle and any puncture after the first is considered unsterile under strict standards.

In use, the plunger is pulled back to draw into the syringe an amount of air corresponding to the desired dosage. Ihe needle is then forced through the rubber cap of the vial and this volume of air displaced into the vial whereupon the plunger is withdrawn While submerged in the medicament to draw into the barrel an amount of the medicament greater than the dosage required. The syringe is then upturned and the plunger advanced to expel any excess solution and any air, the plunger being stopped at the graduation on the barrel corresponding to the desired dosage. These graduations are hard to read, particularly in inexperienced hands, and the dosage often varies with the angle of sight, making it extremely dimcult to inject hypodermically exactly metered doses of the medicament.

The problems become increasingly severe in instances where insulin, for example, must be self-injected, often by children or adults removed from parental or medical supervision. The danger of lack of sterility of the needle and the danger of overdosage is particularly severe in such instances. The problem is accentuated if a hypodermic must be given under subdued light or by a person with impaired vision.

Proposals to solve the problem by use of singledose ampules have not proved entirely successful as these proposals involve sterilization of the exterior of the ampule, filing and breaking thereof with the danger of glass contaminating the medicament. In addition, the cost of such single-dose ampules is excessive. Similarly, attempts to solve the problems by use of Carpules or single-dose cartridges insertable into a syringe barrel have not been entirely satisfactory, being unduly costly and failing to obviate the chance of nonsterile needle conditions. In fact, any single-dosage systemmust necessarily be costly as the container must be marketed in a large number of sizes, to accommodate the dosage requirements of different persons.

It is an object of the present invention to provide a novel, multiple-dose syringe capable of injectin exactly needed dosages by a simple presetting operation.

Another object of the invention is to provide a hypodermic structure which is foolproof and easy to use, yet which can be manufactured at relatively low cost.

A further object is to provide a hypodermic structure capable of receiving a multi-dose hypodermic cartridge containing the medicament and from which the doses can be accurately metered by a stepwise movable actuator. Another object is to provide a structure whereby any ore-selected dose of medicament can be expelled from a standard-sized, multi-dose cartridge by a simple substitution of actuating elements, whereby the physician can prescribe or the druggist can supply a suitably formed and calibrated actuating element that will insure accurate injection doses of the desired volume.

Preparatory to use or between uses of a hypodermic needle, it is very desirable that the interior of the needle be flushed or cleansed of any sterilizing solution or other liquid. It is, therefore, an additional object of the present invention to provide a cartridge-type hypodermic syringe in which the needle can be flushed or cleansed with ease and preparatory to the use thereof. This is preferably accomplished by providing for automatic cleansing or flushing of the needle upon insertion of the cartridge into the barrel. Incidental auxiliary means may be provided for efllecting such flushing or cleansing.

The invention also provides a novel relationship between the barrel of the syringe and the hypodermic cartridge insertable thereinto. In this connection, it is an object of the invention to provide a piston-like action between these two elements upon assembly; also to provide for positively locking the barrel in predetermined position. Afurther object is to provide a hypodermic cartridge of novel form.

It is another object of the invention to provide a hypodermic barrel detachably receiving a hypodermic needle and carrying an inwardly-extending perforating needle which perforates the hypodermic cartridge upon insertion.

Further objects and advantages of the invention will be evident to those skilled in the art from the herein contained description of exemplary embodiments of the invention.

Referring to the drawings:

Fig. 1 is an exploded view, partially in section, showing the operative elements of another embodiment of the invention in positions preparatory to assembly;

Fig. 2 is a longitudinal View, partially in section, of the elements of the Fig. 1 embodiment of the invention when in assembled position and after injection of the first dose;

Fig. 3 is a transverse sectional view taken along the line 33 of Fig. 1;

Fig. 4 is a transverse view taken along the line 44 of Fig. 1 and showing the cartridge and barrel in unlocked position; and

Fig. 5 is a transverse view taken along the line 55 of Fig. 2 and showing the cartridge and barrel in locked position.

Referring particularly to Figs. 1 and 2, the invention includes a hypodermic structure or hypodermic syringe including a barrel 2!] providing an open end 2| and a closed needle-holding end 22, the open end 2| giving access to a chamber 23. The barrel may be formed of glass or metal but preferably is formed of a thermoplastic or thermosetting plastic material, usually a resintype material. For hot-sterilizing techniques, we may use a plastic known as Saran, a copolymer of vinylidene chloride, or a plastic known as Kel-F, the latter product being monochlorotrifluoroethylene. For cold-sterilizing techniques, we may use methyl methacrylate or polyethylene.

The closed needle-holding end 22 provides an 1.

attachment means for a detachable hypodermic needle structure indicated generally by the numeral 25, this attachment means being illustrated as a tapered tubular portion 26 mating with an appropriate attachment portion of the Extending into the closed end 22 of the barrel 20 is a cartridge-perforating needle 33 extending rearwardly into the chamber 23 and providing an angularly ground sharp tip 34. This needle as shown may be fixed against movement with respect to the barrel body. It may, however, be provided in any desired manner.

At the open end 2|, the barrel 20 provides a flange 35. In the preferred embodiment, this flange extends only a short distance beyond the periphery of the barrel 20 in a direction transverse to the paper in Fig. 2 but extends a further distance from such periphery in the plane of the paper to form wings 36 having arcuate edges 31 for a purpose to be described.

The open end 2| of the barrel 20 is adapted to receive a hypodermic cartridge or ampule shown as including a tubular member or portion 4| made of metal, glass or any suitable thermoplastic or thermosetting material, such as the materials exemplified above. The tubular member 4| is preferably a length of tubular-stock material somewhat longer than the interior of the barrel and provides front and rear open ends 42 and 43.

Closing the front open end 42 is a front stopper 44 made of rubber or other suitable material to be penetrated by the perforating needle 33 when the cartridge is in inserted position. The front stopper is pressed into the front open end 42 of the tubular member 4|, its innermost position being determined by a flexible flange 45 which serves a number of other functions. Thus, this flange seats against the closed end 22 of the barrel 20 when the cartridge is inserted, acting as a cushion for the tubular member 4| and acting to separate this tubular member from the closed end 22 of the barrel. In addition, the flange 45 is of a diameter to form a piston fit in the chamber 23. Accordingly, when the cartridge 40 is inserted into the chamber 23, inward movement of the cartridge builds up a superatmospheric pressure within the chamber ahead of the flange 45 to expel from the perforating needle 33 and the needle structure 25, if attached, any residual fluid remaining therein from prior sterilization or prior use. This cleansing action is automatic. When the tip 34 of the perforating needle 33 penetrates the stopper 44 further advancement of the cartridge forces the entrapped air rearwardly past the flange 45 and from the open end 2| of the barrel through the small annular space between the exterior of the tubular member 4| and the interior of the barrel 20.

The rear open end 43 of the tubular member 4| is initially closed by a rear piston type stopper or plunger 41, preferably formed of rubber and advanceable within the tubular member 4| by manually-applied pressure to decrease the volume of the space 48 between the stoppers and expel from this space through the needles 3| and 33 an incremental portion of a liquid medicament within this space.

The rear stopper 41 is preferably formed of a cylindrical rubber member with peripheral grooves. It provides suitable means for detachable connection to an actuator 50, this means being shown as a threaded metal member 5| with an enlarged base embedded or molded in the stopper 41.

While the penetration of the needle 33 into the front stopper 44 provides some degree of restraint against removal of the cartridge 4!], it is distinctly preferable to provide an interengaging means on the barrel and the cartridge for holding the latter in its advanced position within the barrel. It is also preferable that the cartridge provide a manually-engageable flange on its outer or rear end and of a greater size than the chamber 23 to aid in limiting and establishing the innermost position of the cartridge. These and other functions are performed by a flange 53 of a collared member, preferably formed of a plastic material and forming a press fit with the periphery of the tubular member 4|. The flange 53 is adapted to mate with the flange 35 and provides wings 54 extending in a direction perpendicular to the paper as viewed in Fig. 1. As shown in Fig. 4, the wings 54 carry depending members 55 of arcuate form and providing inwardly-extending lips 55 adapted to swing beneath the wings 36 of the barrel. As suggested in Fig. 4, the wings 54 advance in the inter-wing space of the barrel, between its wings 35, until the wings 54 engage the rear end of the barrel 20; the lips 56 being then at a level just beyond the wings 35. Turning of the cartridge 40 through an angle of will then interlock the wings 36 and 54; the wings 54 swinging into the same plane and being of substantially identical shape as the wings 36, thus definitely indicating to the operator the proper locking of the cartridge 46 and the barrel 20.

The, actuator 53 comprises a body portion 51 having a rear manually-engageable member 58 of larger diameter and typically of a diameter substantially the same as the diameter of the curved periphery 3? of the flanges 35. The rear face of the manually-engageable member 58 is preferably dished to receive the thumb of the operator.

The body portion 51' of the actuator 50 is of a size to be received by the tubular member 4|. Its forward end provides an attachment means, shown as a threaded cavity 59 permitting removable connection to the stopper or piston 41.

The invention includes a multiple-position stop means on the actuator 50 and movable stepwise therealong to determine the incremental advances of the stopper or piston 41 and thus determine with exactitude the volume of each .dose. As shown in Figs. 2 and 3, this stop means in cludes a stop member 60 of ring shape. adapted to move along and engage with stepped guiding means 6| on the body portion 51 of the actuator 501.

As shown in Figs. 2 and 3, the means 6| includes guiding and stop portions in the form of a successive series of longitudinally extending grooves 62 connected by transverse groove portions 63. These are formed on the outer face of the actuator. It is obvious that in lieu of grooves, other structures might be employed. The actuator is encircled by stop member 60 so that the latter may slide longitudinally of the actuator. A projection, 64, carried by member 60 cooperates with the groove portions 62 and 63. The stop member may be formed of any desired material and the projection may be secured thereto in any suitable manner as, for example, by adhesive.

Conveniently the stop member 60 is disposed upon the actuator and the projection 64 is introduced into the first or lowermost groove portion 62 shown in Fig. 1. This groove portion is then obstructed by, for example, a member 65 which may be adhesively secured to the actuator. In this manner, removal of the stop member from the body portion 51 is prevented. The length of each of the longitudinally extending grooves 62 are preferably identical. In its initial position stop member 66 may have its projection 64 riding within the first or lowermost transverse or stop groove 53. With the coupling 5! and 59 properly engaged, the spacing between stop member 60 and the ampule 60 will be equal to the distance between a pair of adjacent transverse grooves .63.

When the cartridge fill has been inserted and locked in position and the actuator 50 has been attached, the hypodermic syringe is ready for injecting the first metered dose. After intermuscular insertion of the needle 3|, the manually-engageable member 53 is forced inwardly until the stop member 60 engages the open end of the cartridge 40, the stop member advancing a predetermined distance and definitely controlling the advance of the stopper or piston 41 and thus metering the amount of medicament injected. The syringe elements will now be in the position shown in Fig. 2. To set the syringe for the metering of the second dose, the stop member so must be turned so that its guide memher at lies opposite the next longitudinal portion $2 whereupon the stop member may be advanced longitudinally until the guide member engages the succeeding shoulder.

There is no possibility of setting the stop member to meter more than one dose except as the stop member is deliberately advanced beyond the succeeding position. Additionally, the stop positions are sufiiciently widely spaced that close observation is not required when moving from one setting to the next, the proper advanced position being apparent from the feel of the stop member. Suitable numbered indicia may be applied to the actuator to identify the stop positions and in all instances indicia should be employed to indicate in units, cubic centimeters, etc., the dose calibration of the particular actuator.

The syringe can be sold with the particular actuator needed to secure the uniform doses prescribed by the physician. For office or hospital use, the physician or nurse need only select the proper-dose actuator from a supply of differentdose actuators at hand. In all instances, the cartridge may be of some standard or predetermined size and need carry no hard-to-read markings. If desired, the cartridge can even be made of opaque material although use of a transparent material is generally desirable.

vIt is desirable, also, that there be a releasable lock means for positively locking the stop member Bl] in a selected one of its stop positions. While various spring-loaded or frictional detent means can be employed, as will be later described, a very simple lock means is shown in Figs. 1 and 3 comprising extensions 66 of the transverse portions 63 of the raceway and extending to positions to one side of the intersecting longitudinal portion (see Fig. 1). These extensions 66 may provide an outwardly spiraling bottom wall El (Fig. 3) against which the guide member 64 may press and Wedge as the stop member 60 is turned from its stopposition. The resulting action locks the stop member against accidental turning during carrying or handling of the syringe and also during use thereof. To advance the stop member 68 to its next position, it is turned in a reverse direction until the guide member enters the adjacent longitudinal portion 62 of the raceway. The rearmost longitudinal portion and transverse portion may terminate adjacent the manually-engageable member 58 which may then act as the last stop or shoulder for the stop member 60, preparatory to injecting the last metered dose.

We have shown structures in which the stop member engages the wall of the cartridge 353 at its outer open end. This is distinctly preferable in insuring accurately metered doses. However, it is within the scope of the invention to engage the stop member with the open end of either the cartridge 45.? or the barrel 28.

Thus, among others, the several objects of the invention as specifically aforenoted are achieved. Obviously, numerous changes in construction and rearrangement of the parts might be resorted to Without departing from the spirit of the invention as defined by the claims.

We claim as our invention:

1. A hypodermic syringe assembly including in combination a barrel having an open end and an opposite end provided with a restricted discharge passage, a liquid medicament-containing ampule insertible into the open end of said barrel and presenting a rear portion to lie adjacent the open end of the latter, a piston type stopper Within said ampule adjacent the rear portion thereof, an actuator for projecting said stopper through said ampule to expel medicament through said discharge passage, said actuator being formed with a successive series of longitudinally extending a guide portions offset with respect to each other and interconnected by transverse guide portions, a stop member mounted by said actuator and engageable with part of said assembly to arrest movement of said actuator and piston stopper, means carried by said stop member and cooperable with said guide portions whereby said stop member and cooperable means may be shifted along said actuator throughout the length of one of said longitudinal guide portions and be held against further movement by one of said transverse guide portions and said actuator being formed with extensions of said transverse guide portions lying beyond the points of connection of the latter with said longitudinal portions to receive said eooperable means and lock the latter and the stop member against further movement through a successive longitudinal guide portion.

2. A hypodermic syringe assembly including in combination a barrel having an open end and an opposite end provided with a restricted discharge passage, a liquid medicament-containing ampule insertible into the open end of said barrel and presenting a rear portion to lie adjacent the open end of the latter, a piston type stopper within said ampule adjacent the rear portion thereof, an actuator for projecting said stopper through said ampule to expel medicament through said discharge passage, detachable coupling means forming parts of said actuator and stopper and providing the sole connection between said assembly and actuator to support the latter, said ampule having a length greater than said barrel whereby-with the former inserted into the latterits rear portion will project beyond the adjacent barrel end and coupling means carried by the rear portion of the ampule and also disposed in proximity to the adjacent barrel end for detachably engaging the latter and retaining said ampule against movements with respect to said barrel.

3. An injector assembly including in combination a hollow barrel presenting a rear open end and a closed forward end, an outwardly extending interrupted flange adjacent said open barrel end and fixed with respect to the barrel, an ampule of an exterior length greater than the bore length of said barrel and insertible into the same, said ampule presenting open rear and forward ends, an outwarchy extending wing portion fixed with respect to said ampule adjacent its rear end and to lie adjacent the barrel flange when the ampule is fully inserted into the barrel bore, said flange and wing portion presenting surfaces to interengage and prevent axial movement of said ampule with respect to said barrel when those parts are relatively rotated and said barrel presenting a needle mounting part at its forward end.

4. An injector assembly including in combination a hollow barrel presenting a rear open end and a closed forward end, an outwardly extending interrupted flange adjacent said open barrel end and fixed with respect to the barrel, an ampule of an exterior length greater than the bore length of said barrel and insertible into the same, said ampule presenting open rear and forward ends, an outwardly extending wing portion fixed with respect to said ampule adjacent its rear end and to lie adjacent the barrel flange when the ampule is fully inserted into the barrel bore, said flange and wing portion presenting surfaces to interengage and prevent axial movement of said ampule with respect to said barrel when those parts are relatively rotated, a pierceable stopper supported by the forward end of said ampule, a needle mounting part at the forward barrel end and a double ended needle supported by said part to extend into the interior of said barrel and pierce said stopper as said ampule is inserted into said barrel.

5. An injector' assembly including in combination a hollow barrel presenting a rear open end and a closed forward end, an outwardly extending interrupted flange adjacent said open barrel end and fixed with respect to the barrel, an ampule of an exterior length greater than the bore length of said barrel and insertible into the same, said ampule presenting open rear and forward ends, an outwardly extending wing portion fixed with respect to said ampule adjacent its rear end and to lie adjacent the barrel flange when the ampule is fully inserted into the barrel bore, said flange and wing portion presenting surfaces to interengage and prevent axial movement of said ampule with respect to said barrel when those parts are relatively rotated, said barrel presenting a needle mounting part at its forward end, a piston stopper mounted by said ampule adjacent its rear end, an actuator assembly bearing against the rear ampule end and means for connecting said assembly with said ampule stopper whereby the latter may be shifted axially of said ampule as parts of said assembly are shifted.

FRANK E. BROWN. FREDERICK M. TURNBULL.

References Cited in the file of this patent UNITED STATES PATENTS Number Name Date 1,174,673 Bye Mar. 7, 1916 1,393,720 Lomas et a1 Oct. 11, 1921 1,499,508 Deane July 1, 1924 1,712,070 Cressler May 7, 1929 1,770,633 Smith July 15, 1930 1,840,788 Nevin Jan. 12, 1932 1,929,247 Hein Oct. 3, 1933 1,967,439 Heinlman July 24, 1934 2,156,023 McKay Apr. 25, 1939 2,316,095 Mead, Jr. Apr. 6, 1943 2,373,520 Wallin Apr. 10, 1945 2,409,656 Austin Oct. 22, 1946 2,419,401 Hinds Apr. 22, 1947 2,453,589 Paux Nov. 9, 1948 2,457,859 Austin Jan. 4, 1949 FOREIGN PATENTS Number Country Date 5,503 Great Britain Nov. 14, 1912 267,729 Great Britain Mar. 24, 1927

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