US3128917A

US3128917A - krause

Info

Publication number: US3128917A
Authority: US
Publication date: 1964-04-14
Anticipated expiration: 1981-04-14

Description

April 14, 1964 l. J. KRAUSE 3,128,917

DEVICE FOR PERENTERAL SOLUTIONS Filed July 26, 1960 2 Sheets-Sheet l Inventor Ir a Jag, Krause April 14, 1964 l. J. KRAUSE 3,128,917

DEVICE FOR PERENTERAL SOLUTIONS Filed July 26. 1960 2 Sheets-Sheet 2 Invenlox Ira Jag Krause fl-flzomzg lOl United States Patent Ofiice 3,128,917 Patented Apr. 14, 1964 3,128,?17 DEVICE FUR PARENTERAL SULIJ'IHONE'I Ira .lay Krause, Winthrop Harbor, Iil., assignor to Abbott Laboratories, North Chicago, Ill., a corporation oi Illinois Filed July 26, 196i), Ser. No. 45,402 2 Claims. (Cl. 222-190) This invention relates to a device for the administration of parenteral liquids. More particularly, this invention is concerned with a combined storage, mixing and dispensing means for sterile medicaments from which sterile solutions are prepared.

In the administration of parenteral solutions, it is standard practice to prepare the solutions from sterile powders or liquids immediately before administration. This must be done because of the instability of most medicaments when placed in solution. It is common procedure in preparing relatively large quantities of parenteral solutions, such as a volume of 500 cc., to supply a sterile medicament in a separate container and sterile water in another. This procedure poses many problems sterilitywise in the transferring of the medicament into the container of sterile water. ment is contained in an ampoule, the ampoule must be broken with the chance that small particles of broken glass will fall into the medicament or into the bottle of water. Also, where an ampoule is employed, the operators fingers can easily come into contact with the surfaces of the ampoule or the bottle into which the medicament is poured. In the instance of a medicament in powder form, if it should tend to adhere to the interior of the ampoule, or the container in which it is stored, it will have to be washed therefrom or removed in some other manner it full and accurate dosages are to be obtained and the medicament not wasted.

Once the solution is composed, some sort of dispensing apparatus must be employed in order to administer the solution. This necessitates the handling of another piece of apparatus with the further danger that contamination can occur when the apparatus is connected to the bottle.

It is therefore an object of the present invention to provide a single unit, storing, mixing and dispensing device for parenteral solution which substantially reduces contamination of the sterile solution.

It is another object of the present invention to provide a sterile means for storing and mixing sterile powders and liquids, and dispensing sterile solutions formed therefrom, without any waste of the medicament and insuring accurate dosages thereof.

It is a further object of the present invention to provide a device for storing, mixing and dispensing solutions of sterile powders in which the device is of a single unit construction and is economical to manufacture.

Other objects of the present invention will be apparent from the detail description and claims to follow.

In the drawing:

FIGURE 1 is a view in side elevation of the present invention operatively mounted on a solution bottle at one end having a hypodermic syringe engaged at the other end.

FIGURE 2 is an enlarged view in side elevation and partially in vertical section of the novel device of this invention with sealing caps placed thereon.

FIGURE 3 is a top plan view of the device shown in FIGURE 2 with the sealing cap removed therefrom.

FIGURE 4 is a fragmentary view of the device shown in FIGURE 2, partially in vertical section, and in pouring contact with a solution bottle.

FIGURE 5 is a view in side elevation and partially in vertical section of an alternative embodiment of this invention.

For example, where the medica- FIGURE 6 is an enlarged view in vertical section of another alternative embodiment of this invention.

The device of the present invention, as shown in FIG- URE 1, is operatively mounted on a glass solution container 10 containing a parenteral solution, having external threads 11 on neck 12. The device shown generally at 13 is comprised of a cylindrical body section 14 having an open end 15a and having a cylindrical skirt or wall 15 with internal threads 16 which engage threads 11 on the container iii. The body section 14 is preferably formed of a stable plastic material such as polyethylene.

Securedly attached to body section 14 is a cylindrical storage compartment 17 which in this instance is formed from glass. At the end opposite body section 14, an end closure 18 is provided on compartment 17 for engagement with a hypodermic syringe 19. End closure 18 is formed of the same material as body section 14. Molded integrally in end wall 2% of body section 14 is a tubular air vent 21. Referring to FIGURE 2, it will be seen that air vent 21 has a passageway 22 communicating with the inside of body section 14. Over the outer end of passageway 22 is placed a valve means 23 which has a cylindrical skirt 24 and a shoulder portion 25 for engagement with the end of tubular vent 21. Valve means 23 has a passageway 26 placed in alignment with passageway 22 of vent Z1. Disposed transversely across passageway 22 is a liquid impervious barrier of fibers 27 that are pervious to air. The types of fibers employed in this instance are described in U.S. Patent 2,775,240.

Extending outwardly from end wall 20 of body section 14 and spaced in a parallel manner from air vent 21 is a tubular portion 28 having a locking portion 29' defined by two

circumferential grooves

29 and 30 therein. Grooves 29 and 3d accommodate a mating locking portion 31' defined by

circumferential rings

31 and 32, respectively, formed on the constricted neck portion 33 of storage compartment 17. The upper open end 33a of neck portion 33 abuts against the outer edge of end wall 255 and a fluid-tight engagement is thereby formed between body section 14 and compartment 17. Through end wall Zti an opening 34 is formed. Formed integrally with end wall it) adjacent opening 34 is a semi-circular pouring lip 35 which extends upwardly from the end wall 20. This is best illustrated in FIGURE 3. Since the pouring lip 35 surrounds only a portion of the opening 34, the powder is able to be observed as it is being poured over the pouring lip 35.

End closure 18 is secured to a second opposing neck portion 36 of compartment 17 in the same manner as neck portion 33 is attached to the tubular porton 28. Two

circumferential grooves

37 and 33 disposed in the inside of the U-shaped wall section 39 of closure 18 accommodate two circumferential rings 40 and 41, respectively, of neck portion 36. A discharge passage 42 extends through closure 18, the outer portion of which is provided with an inwardly Luer tapering surface 43. Passage 42 is sealed in a closed manner by means of a Passage 42 is sealed in a closed manner by means of cylindrical plug 44 having a skirt portion 45 and a stepped projection 46 which extends into passage 42.

Sterile powder 47 is stored in compartment 17 and is retained therein by means of plug 44 at one end and a downwardly depending stopper 48 at the other. Stopper id is molded integrally with sealing cap 49 which also prevents contamination of the interior of body section 14.

In operation, sealing cap 49 with stopper 48 is removed and storage compartment 17 is filled under sterile conditions with sterile powder 47. Sealing cap 49 is then secured on body section 14 with stopper 48 disposed in sealing engagement with neck portion 33. The unit is then ready for shipment and storage. When it is desired to compose a solution of powder 47 for parenteral administration, cap 49 with stopper 48, is removed and semicircular pouring lip 35 is placed in contact with the mouth of bottle 10 as shown in FIGURE 4. Sterile powder 47 flows out through constricted neck portion 33 of compartment 17 onto lip 35 and into the container 1'1) containing a sterile liquid. If desired, and should powder 47 tend to adhere to the interior of compartment 17, body section 14 can be screwed onto the container 19 as shown in FIGURE 1 and the novel device 13 inverted with the container 10. In this position, the liquid from the container 10 will flow into compartment 17. With device 13 attached to the container 18, further dissolving of powder 47 can be effected by shaking the attached units in an appropriate manner. When powder 4-7 is completely dissolved, the container 10 is placed in an upright position and plug 44 is removed from end closure 18. Hypodermic syringe 19 having a Luer taper 49 at the outer end thereof, and without a needle, is inserted into tapering surface 42 of end closure 18. Tie container 10 is then inverted and the sterile solution containing powder 47 is drawn into syringe 19 by manipulating syringe 19 in a normal manner, as illustrated in FIGURE 1. Solution flows out of the container 19 through the opening 34 and compartment 17 and into syringe 19. To replace the volume of solution withdrawn, air travels through air vent 21 and into container 10. After withdrawing a predetermined volume of solution, bottle 10 is returned to an upright position, syringe 19 is removed and plug 4 is replaced in end closure 18.

An alternative embodiment 60 of the present invention is illustrated in FIGURE having a cylindrical body section 61 and an end wall 62 composed of the same materials as body section 14. Internal threaded portion 63 is provided in the inside of body section 61. Disposed through end wall 62 are air vent 64 with valve means 65 and discharge passageway 66 with closure plug 67. For all practical purposes, air vent 64 with valve means 65 and passageway 66 are of the same construction as air vent 21 with valve means 23 and discharge passageway 42, respectively. A reduced diameter storage portion, which is shown to be a cylindrical glass insert 63, is placed inside cylindrical wall portion 69 of body section 61 and extends from the inside of end wall 62 to a point a short distance below screw threads 63. A sealing ring 7t) which is accommodated in wall portion 69 by groove 79 is placed over the end of insert 68 and thereby holds the insert in place. It will be seen that

wall portions

69 and 62 along with glass insert 68 form a compartment similar to compartment 17 for sterile powder 71. A sealing cap 72 with integral plug 73 is provided for the same purpose as that described previously for sealing cap 49 and stopper 48 in embodiment 13. The alternative device 69 likewise operates in substantially the same manner as that described for the unit in FIGURES 1-4.

FIGURE 6 illustrates a further alternative embodiment 80 of this invention, somewhat similar to that of device 13, having a cylindrical body section 81 with skirt 82 and internal threads 83. Body section 81 like body section 14 of device 13 is formed of plasticized polyethylene.

End wall 84 has a tubular passageway 35 formed by an upwardly extending tubular portion 86 and a down wardly extending tubular portion 87. Integrally molded in the tubular portion 87 is air vent 88 with valve means 89 which are exact duplicates of air vent 21 and valve means 23 of device 13. The tubular portion 87 is provided with a locking portion 90 defined by

circumferential grooves

90 and 91 to accommodate a mating locking portion 92' defined by

circumferential rings

92 and 93, respectively, of glass compartment 94 and serves as a secure means of attachment. Secured to the end of compartment 94 is end closure 95 having

circumferential grooves

96 and 97 for accommodating circumferential rings 98 and 99, respectively. A discharge passage 199 is provided in end closure 95 having a resealable closure piug 1 11 which is pierceable with the needle (not shown) of a hypodermic syringe as basically shown in FIGURE 1.

Compartment 94 contains sterile powder 102 retained therein by means of plug 191 as well as plug 103 which is molded in cover cap 104.

Embodiment 30 is operated in substantially the same manner as that described for the device in FIGURES 1-4 with the exception that a smooth pouring surface is formed in passageway by the tubular portions 86 and S7. The tubular portion 86, at a point opposite air vent 88, thereby serves as a pouring lip. A further exception is that a syringe, similar to 19 but having a hypodermic needle, is employed to withdraw the desired amount of solution.

While

body sections

14, 61 and 81 have been described as being composed of a plastic material such as polyethylene, it should be understood that other plastics and other materials can be used such as nylon, polystyrenes, polyvinylchloride, rubber and glass. Instead of forming

compartments

17 and 94 of glass which in some instances is necessary because of the instability of some medicinal powders, it could be formed as an integral part of the cap and of the same material.

The embodiments of this invention have been described for use with powders which are ultimately mixed into solutions. It should be understood that lyopholized materials or liquids could likewise be employed in place of the powder in

compartments

17 and 94 as well as the comparable compartment formed in alternative device 60. The mixing procedure would be the same as that described for the powder.

It will thus be seen that applicant has provided a compact device for mixing and dispensing sterile solutions wherein the same device also serves as a storage and shipping container for unstable sterile powders or liquids. Also, the novel device serves as a closure means, once mixing is completed. All of the foregoing functions are accomplished by a single unit apparatus with the sterility of the powder or liquid, as well as the consequent solution formed, being maintained at all times. It should also be observed that by withdrawing the solution through the storage compartment, complete mixing of the powder or liquid is effected which insures the administration of accurate doses and prevents waste of the medicament.

Others can practice the invention in any of the numerous ways which will be suggested by this disclosure to one skilled in the art. All such practice of the invention is considered to be a part hereof provided it falls within the scope of the appended claims.

Iclaim:

1. A device for the sterile storing and mixing of medicinal powders, and for the dispensing of parenteral solutions formed therefrom comprising in combination: a plastic, cylindrical body section having an end wall and a skirt portion with internal threads at the outer end thereof to form a fluid-tight, detachable connection with the outlet of a fluid container; a cylindrical glass insert, the external diameter of which is approximately the same as the internal diameter of said skirt portion, said insert resting against said end wall at one end and extending to a point a short distance below said threads; an internal groove in said skirt portion accommodating a ring therein, said ring contacting the other end of said insert and holding said insert securely in said body section; a plug in sealing engagement with the inside of said insert; a sealing cap detachably secured to the outer surface of said skirt portion until such time as said device is attached to said outlet of said fluid container to protect the interior of said body section against contamination, said sealing cap being integrally attached to said sealing plug, said sealing plug and said insert with said end wall forming a storage compartment partially filled with said medicinal powders in said body section; an air vent with valve means associated therewith communicating with the interior of said body section through said end wall; a liquid discharge passage in said end wall spaced in a parallel manner with said air vent; said passage having at the outer end thereof an inwardly tapering surface adapted to receive in sealing engagement a hypodermic syringe hub; and a sealing plug mounted on said end closure in the absence of said huh.

2. A device for the sterile storing and mixing of medicinal powders, and for the dispensing of parenteral solutions formed therefrom comprising in combination: a plastic body section with an end wall and a skirt portion extending from said end wall with internal threads to form a fluid-tight, detachable connection with the external threads of a fluid container; a sealing cap detachably secured to the outer surface of said body section until such time as said device is attached to said outlet of said fluid container to protect said body section against contamination; a passageway extending through said end wall; a glass, tubular storage compartment partially filled with said medicinal powders, one end of said compartment in fluid-tight engagement with said passageway, said tubular storage compartment being of substantially greater diameter than said passageway; a tubular air vent with valve means associated therewith extending transversely in an outward manner from said end wall and parallel to said passageway; a semi-circular pouring lip adjacent said passageway and extending inwardly from said end wall, said pouring lip positioned between said passageway and said air vent; a plug in sealing engagement in said passageway and extending a short distance inwardly into said compartment, said plug being integrally attached to said sealing cap; an end closure for said storage compartment at the other end thereof, having a liquid discharge passage therethrough, said passage having at the outer end thereof an inwardly tapering surface adapted to receive a hypodermic syringe hub; and a sealing plug mounted on said end closure in the absence of said hub.

References Cited in the file of this patent UNITED STATES PATENTS 225,440 Vasseur Mar. 9, 1880 318,637 Marshall May 26, 1885 2,455,645 Barton Dec. 7, 1948 2,626,730 Gabler Ian. 27, 1953 2,775,240 Morrisey et al. Dec. 25, 1956 2,812,117 Butkus et al. Nov. 5, 1957 2,852,024 Ryan Sept. 16, 1958 2,966,282 Geisler Dec. 27, 1960 3,001,525 Hendricks Sept. 26, 1961 FOREIGN PATENTS 817,097 Germany Oct. 15, 1951

Claims

1. A DEVICE FOR THE STERILE STORING AND MIXING OF MEDICINAL POWDERS, AND FOR THE DISPENSING OF PARENTERAL SOLUTIONS FORMED THEREFROM COMPRISING IN COMBINATION: A PLASTIC, CYLINDRICAL BODY SECTION HAVING AN END WALL AND A SKIRT PORTION WITH INTERNAL THREADS AT THE OUTER END THEREOF TO FORM A FLUID-TIGHT, DETACHABLE CONNECTION WITH THE OUTLET OF A FLUID CONTAINER; A CYLINDRICAL GLASS INSERT, THE EXTERNAL DIAMETER OF WHICH IS APPROXIMATELY THE SAME AS THE INTERNAL DIAMETER OF SAID SKIRT PORTION, SAID INSERT RESTING AGAINST SAID END WALL AT ONE END AND EXTENDING TO A POINT A SHORT DISTANCE BELOW SAID THREADS; AN INTERNAL GROOVE IN SAID SKIRT PORTION ACCOMODATING A RING THEREIN, SAID RING CONTCTING THE OTHER END OF SAID INSERT AND HOLDING SAID INSERT SECURELY IN SAID BODY SECTION; A PLUG ION SEALING ENGAGEMENT WITH THE INSIDE OF SAID INSERT; A SEALING CAP DETACHABLY SECURED TO THE OUTER SURFACE OF SAID SKIRT PORTION UNTIL SUCH TIME AS SAID DEVICE IS ATTACHED TO SAID OUTLET OF SAID FLUID CONTAINER TO PROTECT THE INTERIOR OF SAID BODY SECITON AGIANST CONTAMINATION, SAID SEALIANG CAP BEING INTEGRALLY ATTACHED TO SAID SCALING PLUG, SAID SEALING PLUG AND SAID INSERT WITH SAID END WALL FORMING A STORAGE COMPARTMENT PARTIALLY FILLED WITH SAID MEDICINAL POWDERS IN SAID BODY SECTION; AN AIR VENT WITH VALVE MEANS ASSOCIATED THERE WITH COMMUNICATING WITH THE INTERIOR OF SAID BODY SECTION THROUGH SAID END WALL; A LIQUID DISCHARGE PASSAGE IN SAID END WALL SPACED IN A PARALLEL MANNER WITH SAID AIR VENT; SAID PASSAGE HAVING AT THE OUTER END THEREOF AN INWARDLY TAPERING SURFACE ADAPTED TO RECEIVE IN SEALING ENGAGEMENT A HYPODERMIC SYRINGE HUB; AND A SEALING PLUG MOUNTED ON SAID END CLOSURE IN THE ABSENCE OF SAID HUB.