|Publication number||US2559231 A|
|Publication date||3 Jul 1951|
|Filing date||13 Dec 1949|
|Priority date||13 Dec 1949|
|Publication number||US 2559231 A, US 2559231A, US-A-2559231, US2559231 A, US2559231A|
|Inventors||Seemar George H|
|Original Assignee||Seemar George H|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (6), Referenced by (15), Classifications (21)|
|External Links: USPTO, USPTO Assignment, Espacenet|
July 3, 1951 SEEMAR 2,559,231
I-COMPARTMENT PACKAGI PLUR NG AND DISPENSING CONTAINER FOR HYPODERMIC INJECTION INGREDIENTS Filed Dec. 13, 1949 4,775 277,717 0JJIIIIIIIIIJIIIJWIIJ 1a ff 4 Patented July 3, 1951 UNITED s'r'res DISPENSING CONTAINER FOR HYPO- DERMIC INJECTION INGREDIENTS George H. Seemar, Chatham, N. J.
Application December 13, 1949, Serial No. 132,648
15 Claims. '5
The invention relates in general to pharmaceutical accessories and has particular reference to aseptic packaging containers for medicaments that are administered by hypodermic injection. Narcotic drugs and other medicaments that are to be administered by use of a hypodermic syringe usually are preserved in their free state separate from the liquid vehicle therefor until a time immediately preceding actual administration of the injection. At that time, the medicament is dissolved in its appropriate vehicle to form the final injection solution, which in consequence of this procedure will be fresh and of maximum potency.
The particular manner in which the medicament and its related solvent vehicle are separately packaged depends upon the type of hypodermic syringe that is to be used. There is a specially constructed, complicated type of syringe that is adapted to be loaded internally with a multi-compartment cartridge or ampule in which the several ingredients of a hypodermic injection charge are separately stored. My improved packaging container, although similar in some respects to the cartridges for syringes of that type, is not to be confused with such cartridges. The hypodermic syringe with which my invention is concerned is of the commonly used, conventional type which has a single reservoir into which a charge of the prepared injection solution is sucked, by a plunger operating in the reservoir, through the usual hollow needle for momentary storage preceding the actual injection treatment, which latter involves employment of the same needle and reverse motion of the plunger.
In accordance with the old practice, each narcotic drug or other medicament, which generally is in a dry and solid state, is packaged in a container that is separate and distinct from the container in which the liquid vehicle is packaged. Usually these separate containers have been in the form of small bottles having puncturable sealing caps for their filling openings. In effecting a mixture of the respective contents of any two related bottles, the needle of the hypodermic syringe is first inserted into the bottle containing the vehicle through its puncturable cap. After sucking the liquid contents of that bottle into the syringe reservoir by plunger action, the needle must be withdrawn from the bottle cap and moved through the outside air before the next operational step, which is insertion of the needle through the cap of the related bottle containing the medicament. The solvent is then expelled by plunger action from the syringe reservoir into the medicament bottle and is caused to take up 2 the medicament in solution by imparting shaking motion to the bottle and syringe in their united condition. Thereafter, the solution is sucked into the syringe reservoir and the needle is withdrawn through the bottle cap.
The use of separate bottles for the ingredients of an injection solution is objectionable for several reasons. In the first place, bottles of this kind are more expensive to manufacture than my improved packaging container, as will be made more clear later herein. Then, there is the everpresent responsibility of establishing the identity of the ingredients that go together in the preparation of a particular injection solution. If the Wrong vehicle is used by mistake, there may be serious results; if the bottle containing the proper vehicle becomes misplaced, there will be failure of preparation possibly at a critical time. Assuming that the right bottles have been assembled, the operational procedure of effecting a mixture of ingredients is inconvenient and timeconsuming, for each bottle must be picked up, penetrated and set down, as compared with much more simplified manipulation when using my improved container. However, a disadvantage of a more serious nature is the necessity for removal of the syringe needle from one bottle before penetration of the other. In such handling, there is great danger that air, which is usually dust and germ laden, will enter the syringe needle and be injected into the medicament bottle for intimate mixture with the otherwise sterile contents.
In the accomplishment of my purpose, I have provided a single multi-compartment container that somewhat resembles the cartridge or ampule used as the internal component of the special type of hypodermic syringe previously described,
but which is specifically intended for external use entirely in lieu of the two separate bottles that heretofore have been used to package the ingredients for the common type of syringe. My improved unitary container is so constructed that the complete operation of mixing the respective ingredients and charging the syringe reservoir with the final injection solution takes place while the needle of the syringe is protectively shielded within the sterile compartments and contents of the container. No withdrawal of the needle in between steps of the charge-preparing process is required.
Another object of the invention is to provide a multi-compartment container whose separate compartments or chambers are sealed against intercommunication by a puncturable membrane composed of a material that is non-toxic, nonfrangible, and in all respects meets the rigid requirements imposed by the medical profession in the interest of sterility and protection of the patient from accidental injection of solid substances into the blood stream. To be more explicit, I use pyroxylin as the material from which the membrane is made.
A further object is the provision of a novel and inexpensive method of making and installing the pyroxylin membrane.
Other objects and advantages of the invention will become apparent as the following specific description is read in connection with the accompanying drawing, in which:
Fig. l is a side elevation of the container when loaded with the ingredients for a hypodermic injection solution;
Fig. '2 is a longitudinal cross-sectional view of the same, showing the container being held between the fingers and with the needle of a syringe about to be inserted through the end cap into the compartment containing the solvent vehicle;
Fig. 3 is a similar view, showing the position of the needle after insertion into the solvent vehicle compartment and during back-sucking of the solvent vehicle;
Fig. 4 is a similar view, showing the position 7 of the needle after subsequent penetration of the membrane that intervenes between the two coinpartments, after mixing of the ingredients in the medicament compartment, and during backsucking of the injection solution charge therefrom;
Fig. 5 is a similar view after complete evacuation of both compartments and withdrawal of the needle therefrom;
Fig. 6 is a transverse cross-sectional view on line 6-6 of Fig. l; and
Fig. '7 is a similar view on line 1-1 of Fig. 1.
Referring in detail to the drawing, wherein like reference characters, designate corresponding parts in the several views, it will be observed that the body I ll of my improved compartmented packaging container is in the general form of an' open-ended tube. Obviously, container bodies of this simple form may be produced with great facility by cutting a long stock tube of suitable material into sections of the required initial length. The advantage of this feature in the adaptation of my invention to low cost quantity production processes should be apparent.
As to the material from which container bodies I6 are made, glass has been chosen because it possesses certain qualities that are very desirable. Glass can be modeled readily when softened by heating, so the tubular body I0 may be modified in structural form, for a purpose which will appear presently, by resort to well known glassworking technique. Glass also is chemically inert in relation to the intended contents of the container and is transparent. These three qualities are enough to make glass preferable, although it is to be understood that any other material that meets the requirements may be substituted without departing from the scope of the invention.
Since the primary use for which I have devised my packaginge container involves the separate confinement of only two ingredients, the illustrative embodiment of the invention appearing in the drawing has just two compartments. However, I do not intend to be restricted to any particular number of compartments. In the present instance, a medial wall I I partitions body IE into compartments I2 and I3.
Although partitioning wall II may have some other form, I prefer the specific structure shown in the drawing, because it is easily formed by glass-working treatment without weakening body It] at the wall location. Furthermore, it is practicable by the same treatment to provide a central through passage I4 of just the desired opp0- sitely flaring shape and also to provide a shallow external depression or groove I5 of annular form surrounding wall II for finger engagement to facilitate firm grasp on the container during the intended operational manipulation which will be described later.
The glass-working method by which the precise desired structure of partitioning wall I I, passage M and finger groove I5 is achieved is very simple. The initial length of each tube section must be greater than the final length of container body I9 due to axial shrinkage that occurs in the course of the re-working treatment. Each tube section is grasped at both ends and held with its central portion exposed to the flame of a Bunsen burner. l/Vhile heat is being applied, the tube section should be rotated in the fingers so that it will be heated uniformly around its periphery. When it appears that the mid-portion is soft enough for modeling, the ends are first pulled axially outward to constrict the central portion of the bore and at the same time form external groove I5. The glass worker then removes the tube section from the flame, and blows through the bore to chill the constricted portion and prevent excessive constriction. He then looks through the bore to determine the degree of contraction and re-applies the flame to the midportion. Care must be, taken during rotation of the tube section to avoid twisting of the plastic mid-portion. When the mid-portion is again sufiiciently soft, the ends of the tube section are pressed axially inward instead of the previous reverse pulling action. This treatment causes thickening of the wall II with smooth rounding of the flaring mouths of constricted passage I4 and at the same time causes further constriction. After removal from the fiame, quick blowing through the bore, and a visual check for the second time, if passage I4 is not quite small enough, the heating, rolling, pressing, blowing and visual inspection steps are repeated until passage It. has attained the correct diameter. That diameter should be slightly greater than the external diameter of the conventional hypodermic needle in order to afford proper clearance for easy penetration. Having completed the formation of the mid-portion of container body It), the latter is ready for application of additional partitioning means of an impervious but puncturable nature.
Before proceeding with description of the said additional partitioning means, it may be mentioned that the ends of body III are annealed by use of the Bunsen burner flame so that their edges will be slightly enlarged and rounded for more secure fit'within the puncturable closure caps I6 that are to be used as closures for the outer ends of compartments l2 and I3. Incidentally, while these caps I6 are essential components of my improved container in its final packaging condition, I am not making any claim to invention of any particular cap structure. In order to be sufiiciently durable in their exposed applied positions on the ends of body I0, these caps I6 should be made of tough, elastic material such as high grade soft rubber or latex. The caps that have been used for the individual bottles that my integral container is intended to 5 supersede may be used. Consequently, it undoubtedly will be the practice to procure the caps ready-made to fit the ends of my container body ID from a subvendor.
In further reference to the specific structure of partitioning wall II as given to it by the glass working method described, it may be pointed out that the container body I has thereby been increased in strength at the location where firm finger pressure is intended to be applied. Finger groove I is so shallow that the strength of the central handle portion of container body I0 is not impaired, but is deep enough to resist lengthwise slipping out of the finger grasp during the most strenuous operational manipulations that may be involved in the mixing of ingredients by cooperative use of a hypodermic syringe.
Another important feature is the smoothly rounded, oppositely flaring form of passage when viewed in axial section. This form presents a guiding surface for smoothly directing the point of a hypodermic needle into and through the narrow medial part of passage I4 without any danger of bending, blunting or otherwise rendering the needle point unfit for the delicate purpose for which it is intended, and, conversely, without danger of glass fragments being chipped off the wall by the needle point. Further advantages will appear presently.
The partitioning of container body I0 is completed by provision of a sealing membrane II that covers one end of passage I4. This membrane I1 is intended to interrupt communication between compartments I2 and I3 temporarily pending intermingling of the ingredients confined therein. The rubber or like material usually adopted for the manufacture of impervious, puncturable closure caps, such as those used in connection with the superseded bottles and which are suitable for use as caps I6 of my container, probably would be satisfactory for construction of my sealing membrane except for the impracticability of installing a membrane of that material in the required interior location. What seemed for a long time to be an insuperable problem was finally solved, after exhaustive experimentation with various materials and methods of application, by my discovery that pyroxylin, a material that meets all the strict medical requirements, could be used in the formation and installation of a perfectly satisfactory sealing membrane when pursuing a novel method that I devised. Pyroxylin meets the requirements because in its solid state it is elastic, flexible, nonfrangible, non-toxic, inert, leak-proof, non-absorbent, easily needle-penetrated, and highly adhesive to glass. Furthermore, it is admirably suited to my method when in solution in ether or other highly volatile solvent in the form known as collodion, because of its inherently adhesive quality in this state and tendency to adhere tenaciously to a glass surface upon solidification after being deposited thereon.
In accordance with the successful method that developed from my experiments, each tubular body I0 preferably is first prepared by grinding the side of wall II that is to receive application of the membrane I'I so as to abrade the naturally smooth surface and make it rough, as at I8 in the drawing, to form an anchoring face. It does not make any difference which side face of wall II is abraded, because both side faces and both flaring mouths of passage I4 are alike, but it may be pointed out that it is preferable to confine the liquid vehicle in the compartment that is directly faced by membrane I! so that pressure of the liquid, which is subject to surge, will not tend to loosen the membrane from its anchorage to wall II. It is for that reason that membrane I1 is shown in the drawing as being on the side of wall II that faces compartment I2.
The grinding tool (not shown) that is used to abrade wall II should be tapered in order to extend anchoring face I8 into the flaring mouth of passage I4. After anchoring face I8 and the entire inner surfaces of body II) have been tho-roughly cleaned to insure removal of all glass particles produced by the grinding operation, the said body is caused to stand on end, or otherwise supported in a position with its longitudinal axis vertical and with compartment I2 uppermost. Then, a fairly large drop of collodion is deposited on the upper face of wall I I This is accomplished preferably by releasing the drop at a point directly above and in line with the upper mouth of passage I4. In either case, the drop will be guided into a perfectly centered position by the said mouth, due to its form and disposition. The size of the collodion drop should be such that its diameter exceeds that of passage I4 at its most narrow part and preferably equals the maximum diameter of the anchoring face I8.
When the collodoin drop is deposited on anchoring face I8, it will penetrate all indentations of the roughened surface. Due to the inherently highly adhesive nature of collodion, the drop will adhere to anchoring face I8 with such tenacity that it will not slip through passage I4. Actually, satisfactory adhesion will occur even if the mouth of passage I4 is left smooth instead of being roughened, but it is preferred to have it roughened. As the ether solvent evaporates, shrinking of the drop will take place and the central portion will sag until the previously substantially spherical drop has become a thin, parallelsided sheet of pure solid pyroxylin in the concavo-convex form shown. Because of the behavior just mentioned, collodion may be termed self-adhering.
After the drop of collodion has been deposited on anchoring face I8, all that remains to be done under my method is to maintain body II] in its vertical position until the ether solvent has evaporated sufficiently to cause membrane I! to become stabilized or set in its sheet-like form. In quantity production in a processing machine (not shown), the required time for evaporation should transpire during progress of each container body on a movable conveyor from the drop releasing station to the discharge outlet for the finished container body.
While the above-described method is preferred, it is to be understood that I claim to be the originator of a pyroxylin membrane regardless of the precise method of production and installation. Other practical methods may be evolved within the scope of my invention, such, for example, as cutting circular discs from a sheet of pyroxylin and applying them to the walls of container bodies II] in closing relation to passages I4, which I have tried and found to be practical but not nearly so good as the collodion drop method. When applying cut pyroxylin membranes, each one must be centered in position by means of a holding device and the mid-portion of body II) must be heated in order to cause softening of the applied face of the membrane disc. Otherwise, the disc will not adhere to the glass anchoring face I8. The collodion drop method is far superior to the alternative method just mentioned. From the foregoing description of the various paztsof my unitary packaging container in its illustrative two-compartment embodiment, the operational use thereof in the preparation of an injection charge for a hypodermic syringe may be readily understood. Referring again to Figs. 1 to 5 of the drawing in particular, it will be observed that compartments I2 and I3, respectively, have been loaded with a solvent vehicle 8 and medicament M in precisely the correct proportions for a prescribed hypodermic injection. Caps I6 seal the outer ends of compartments I2 and I3 against external leakage and membrane ll seals passage 14 against any leakage of solvent vehicle S from compartment I2 into compartment I3.
Assuming now that it is desired to mix the ingredients, the doctor or nurse will grasp the handle portion of container body In between fingers F of one hand in the manner shown in Figs. 2 to 5. With the other hand, the needle N of hypodermic syringe H is directed toward the thin puncturable center of cap l6 for compartment l2 and moved in the direction of the arrow in Fig. 2 until the said cap has been punctured and needle N has penetrated compartment l2. When needle N is in the general position shown in Fig. 3, the plunger (not shown) of syringe H is operated to suck the entire contents of compartment l2 into the syringe reservoir. In so doing, oscillation of container body l about the transverse axis of its handle portion may be necessary. This action is readily accomplished by simply rotating the wrist of the hand that is holding the container.
The next step is to press needle N further inward until membrane I! has been penetrated and the needle point is in the general position shown in Fig. 4 projecting into compartment [3. The provision of external finger groove l5 at the handle portion makes it very easy to resist the thrust of needleN. Now, the vehicle S is forced from the syringe reservoir through needle N into compartment I3 for mixing with medicament M, which mixing may be expedited by shaking the container and rocking it about the said transverse handle axis. This agitating motion, of course, is imparted to both the container and syringe H in their united condition depicted in Fig. ll After thorough mixing has been accomplished, the
syringe needle N is withdrawn completely from the container as indicated by the arrow in Fig. 5, thereby leaving the container body ii] in a completely evacuated condition but in its original serviceable condition except for the needle perforation 19 in membrane l1. Caps 16 also have been perforated, but they are replaceable and it is practicable to restore body IE] to serviceable condition in every respect by removing membrane [1, sterilizing the said body, and applying a new membrane, preferably by the collodion drop method previously described. Container body ID with its strong partitioning wall II is far more durable than the bottles that I have undertaken to supersede, so my container is capable of re-use if desired.
It is to be noted that, during the entire operation of mixing the ingredients and charging the hypodermic syringe with the final injection solution, the needle of the syringe has not been withdrawn from the sterile interior of the container. It is in consequence of this important feature of my container that the danger of contamination of the injection charge has been reduced to a minimum. Certainly, the danger is far less than in the use of the two-bottle ingredient packaging facilities.
Having thus described my invention, I claim:
1. As a new article of manufacture, a tubular body for a unitary container for separately packaging the related ingredients of a hypodermic injection charge prior to intermixture, a partitionirig wall dividing said body into adjoining compartments for reception of the respective ingredients, said wall havingan oppositely flaring through passage for penetration of a hypodermic needle, and a puncturable sealing membrane in the form of a concave-convex disc disposed in closing relation to one side of the partitioning wall with its convex face contiguous to the said wall and bearing against the flaring mouth of the said passage in the wall, the marginal portions of the sealing membrane being adhesively affixed to the wall and the mouth of the passage.
2. A new article of manufacture as defined in claim 1, wherein the sealing membrane is composed of pyroxylin.
3. The method of producing and installing the sealing membrane for a tubular packaging container of the class described which consists in applying a drop of collodion to the interior of said container in marginal contact with the glass body thereof.
4. The method of producing and installing the sealing membrane for the through passage in the partitioning wall of the tubular body of a compartment-ed packaging container of the class described which consists in applying a drop of collodion to the partitioning wall in closing relation to the passage therein.
5. The method of producing and installing the sealing membrane for the through passage in the partitioning wall of the tubular body of a compartmented packaging container of the class described Which consists in disposing the container body with its longitudinal axis substantially vertical, depositing on the partitioning wall in closing relation to the passage a drop of collodion, and maintaining the container in its vertical position until the solvent for the pyroxylin base of thecollodion has evaporated sufiiciently for the membrane to be self-sustaining in symmetrical form.
6. The method of producing and installing the sealing membrane for the flaring mouth of the through passage in the partitioning Wall of the tubular body of a compartmented packaging container of the class described which consists in disposing the container body with its longitudinal axis substantially vertical, depositing on the partitioning wall in closing relation to the passage mouth a drop of collodion of a size exceeding the diameter of the said mouth, and maintaining the container in its vertical position until the solvent for the pyroxylin base of the collodion has evaporated sufficiently for the membrane to be self-sustaining in symmetrical form.
7. The method as defined in claim 5, wherein the face of the wall to which the collodion drop will adhere is roughened preceding the drop depositing step. 8. The method as defined in claim 6, wherein the mouth of the flaring passage to which the collodion drop will adhere is roughened preceding the drop depositing step.
9. As a new article of manufacture, a tubular glass body for a compartmented container adapted to separately package the related ingredients of a hypodermic injection charge, and a partitioning wall formed in said body integral therewith and having an axial through passage, said wall being constructed of substantially the same axial and radial thickness whereby the body is reinforced in strength in the region of said passage.
10. A new article of manufacture as defined in claim 9, wherein the wall passage is oppositely flaring with mouths smoothly rounded in an axial plane.
11. A new article of manufacture as defined in claim 9, wherein the tubular body is provided with a shallow annular peripheral finger groove surrounding the partitioning wall to form a handle portion.
12. A unitary container for separately packaging the related ingredients of a hypodermic injection charge prior to intermixture comprising an open-ended tubular body, a partitioning wall dividing said body into adjoining compartments for reception of the respective ingredients, said wall having a through passage for penetration by the needle of a hypodermic syringe, a puncturable sealing membrane marginally afiixed adhesively to the partitioning wall in closing relation to the said passage, said sealing membrane being composed of pyroxylin solidified from an original deposit of collodion, and puncturable closures for the opposite ends of the said body.
13. As a new article of manufacture, a tubular body for a unitary container for separately packaging the related ingredients of a hypodermic injection charge prior to intermixture, a partitioning wall integral with said body and dividing the same into adjoining compartments for reception of the respective ingredients, said wall having a through passage for penetration of a hypodermic needle, and a puncturable sealing membrane marginally affixed adhesively to the partitioning wall in closing relation to said passage, said sealing membrane being composed of pyroxylin solidified from an original deposit of collodion.
14. As a new article of manufacture, a tubular body for a unitary container for separately packaging the related ingredients of a hypodermic injection charge prior to intermixture, a parti-. tioning wall integral with said body and dividing the same into adjoining compartments for reception of the respective ingredients, said wall having a through passage for penetration by a hypodermic needle and being constructed to flare outwardly toward one compartment of the tubular body, and a puncturable sealing membrane marginally affixed adhesively to the partitioning wall in closing relation to said passage, said sealing membrane being composed of pyroxylin solidified from an original drop of collodion deposited upon the side of the partitioning wall through which the flaring end portion of the passage therein opens while the tubular body is disposed in a vertical position with said flaring passage portion directed upward and thereby is concavo-convex and in closely adhered conformation to said flaring passage portion.
15. In a container of the class described, a hollow body having a wall provided with a through passage for needle penetration, and a puncturable sealing membrane marginally affixed adhesively to the body wall in closing relation to said passage, said sealing membrane being composed of pyroxylin solidified from an original deposit of collodion.
GEORGE H. SEEMAR.
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|U.S. Classification||604/415, 264/265, 206/219, 206/222, 604/416, 264/342.00R, 206/571, 264/259|
|International Classification||B65D25/04, B65D25/08, A61J1/00, A61J1/20, A61J1/14|
|Cooperative Classification||A61J1/2093, A61J2001/201, B65D25/08, A61J2001/2027, A61J1/2096|
|European Classification||A61J1/20F, A61J1/20D, B65D25/08|