US2445477A - Ampoule - Google Patents

Description

July 20, 1948. M. FOLKMAN AMPOULE Filed March 12, 1945 Patented July 20, 1948 AMPOULE Marvin L. Folkman, Shaker Heights, Ohio Application March 12, 1945, Serial No. 582,399

Claims. Cl. 12S-272) My present invention involves improvements in the construction of ampoules of the class de- Signed to be inserted into the barrel or body of a hypodermic syringe and from which a medicament may be expelled for administering to a pat ent.

More specifically speaking, the ampoule of my invention is of the type in which a medicament, preferably in solid or powdered form, is contained in a medicament chamber, and by movement of a certain member or members of the ampoule is caused to be liquefied preliminary to administering said medicament by the operation of the syringe.

An object of my invention is to simplify the operation of causing the mixing of the water with the medicament in the preparation of the ampoule for the expelling of medicament in liquefied form. It has been proposed heretofore to use ampoules in which the dry medicament is admixed with a liquefying agent, an action brought about by the same plunger which causes ejection of the medicament, and the ejection and mixing have occurred simultaneously. This is a somewhat dangerous practice for ampoule construction, for the first fraction oi solution injected is at times practically free of medicament, whereas the last portions will be too concentrated. Furthermore, oftentimes all of the solution may be injected before all of the medicament has become dissolved, and therefore there is no uniformity in the solution administered. Thus, if the solution were used for different patients, different concentrations of the solution might be administered to such patients, and obviously, this is not the desired result. With my present improved ampoule construction the foregoing difficulties are obviated.

Another disadvantage incident to the use of present types of ampoules or cartridges of the class of my invention arises in the fact that there is either a diaphragm between the medicament and the solution, which diaphragm has to be dislodged by movement in the ampoule, or there is a trap-door diaphragm which is required to be opened, or a plug required to be pushed out in order that the solution may be mixed with the medicament. In such types of construction the displaceable diaphragm, movable trap-door diaphragm, or plug, when forced out of normal position, interfere with the travel of the medicament ejecting or expelling piston or plunger, and prevent the complete travel of the latter in such a way as to prevent administration of considerable of the medicated solution.

It is a further object of my invention to avoid the disadvantages of the types of construction last referred to.

With the foregoing objects in view I have devised a construction of syringe ampoule or cartridge 'which is water-tight, which is greatly simpliiied in regard to the number and formation of the several parts, and therefore inexpensive to manufacture, which affords a perfect seal between the medicament compartment and the solution compartment containing the solution to be mixed with the medicament, and which ampoule is very easily insertable into the syringe for use. Moreover, in my construction I am enabled to effect the liquefying of themedicament without requiring a great amountof movement of the internal parts of the ampoule.

Another object of my invention has been to produce a novel construction of ampoule wherein the dry medicament is not only enabled to be liquefied in the advantageous manner previously referred to, but in which, also, gas may be generated providing the pressure medium for the expulsion of the vmedicament through the syringe instrumentalities, including the needle, by movement of a special expelling or ejecting plunger forming a part of the ampoule unit. My invention has to do especially with detail improvements in relation to the type of ampoule last referred to, one which is readily adapted to beyused in conjunction with a special construction of syringe of my invention disclosed in my pending application for patent, Serial No. 361,781, filed October 18, 1940, now Patent Number 2,390,246.

A full understanding of my invention will be had upon reference to the accompanying drawings, in which modified constructions of my ampoule are shown, and also in which drawings- Figure 1 is a longitudinal sectional view of my ampoule in the condition in which it is manufactured and supplied to the user for employment in the syringe, by which the medicament in the ampoule is to be administered.

Figure 2 is a view similar to Figure 1, showing the medicament mixing plunger as when it has been moved in order to causel the medicament to be mixed with the liquefying water, and showing the expelling plunger just about in the position in which it displaces the closure between said last mentioned plunger and the liquid chamber containing the liquid for generating the gas. In this view dotted lines show'the syringe instrumentalities that may be used' for moving the mixing plunger initially to cause the medicament to be placed in Solution.

position expelling a large portion of the medica' ment.

Figure 4 is a view similar to Figure 1, but illustrating a somewhat modified form of my invention.

Figure is a transverse sectional view taken about on the line 5-5 of Figure 3.

Figure 6 is a transverse sectional view taken on the line 6-6 of Figure 2.

Describing my invention specifically, and reierring to Figure 1 particularly, my ampoule in the state of its completed manufacture is constructed of the following primary parts: the

`tube I of glass, the mixing plunger 2 which may be of plastic or similar material and which is provided with a medicament chamber 3 consisting of a hollow or tubular extension of the body of the plunger 2, a rubber o'r similar plug 4 for the outer end of the mixing plunger 2 and seated in a recess in said end so as to provide a closure for the adjacent end of the medicament chamber 5. Additionally, my ampoule construction comprises the expelling plunger 6 having the skirt portion 6a extending toward the mixing plunger 2, the diaphragm or the partition 1 having the closure or plug 8 for normally closing a central opening 9 of said diaphragm or' partition 1, and an end closure member III which is of the same construction, preferably, as the expelling plunger 8 with its skirt 6a, so that these parts are interchangeable in the manufacture of the ampoule.

It is notable that, in addition to the foregoing l y l used is one the construction of the special operat- A ing parts of which is illustrated in Figure 2 of parts, I provide a gasket and guide ring I I fixedly mounted in the tube or body I, so that in the normal position o! parts as seen in Figure 1, certain ports or openings I2 at the sides oi the inner end of the medicament tubular extension 3 are closed by the said gasket or guide rings II. In the medicament chamber 5 of the member 3 there will be received dry medicament, designated I3, and in the space or chamber provided between the expelling plunger 6 and the fixed partition 1 there will be received a gas generating substance in tablet or powdered form, as designated at I4.

In the construction as above set forth, it is contemplated that the parts 4, II, 6, 6a, 1, 8, and Il shall be made preferably of rubber. The parts II, 1, and I0 are immovably implaced in the glass tube I.

When the mixing plunger 2 is moved sufliciently that the ports I2 are disposed to theright of the guide or gasket ring I I as seen in'Figure 1, the liquid designated I5, .and contained in the space between the parts 3, II, and 6, will be free to enter the medicament chamber and liquefy the dry medicament I3 in the latter.

When the expelling plunger 6 is moved to the right as seen in Figure 1, from the position shown in said gure, the plug 8 will be displaced from the opening 9 of the diaphragm 1 and liquid contained between the plug 8, diaphragm 1, and member I0, will act upon the gas generating substance I4 and convert the latter into gas the drawings by dotted lines. Such a syringe will include a barrel or body into which the ampoule is introduced, and when introduced, the ampoule is given a slight longitudinal movement to cause 'a hollow needle I8 of the syringe to penetrate or puncture the closure 4, and at the same time an abutment member 23 in which said needle I8 is located engages the rubber plug or closure 4 and .causes the mixing plunger 2 to be. forced inwardly into the tube I of the ampoule so that the ports or openings I2 of the medicament containing extension 3 of the plunger 2 are carried to the right beyond the gasket and guide ring II. This permits the distilled water or liquid I5 to enter the medicament chamber 5 and liquefy the dry medicament in the latter. As a result of this action, the mixing plunger 2 is disposed in the position shown in Figure 2, and by reason of the movement of said plunger and its member 3, and the fact that initially, lincident to such movement, the liquid I5 is incompressible, results in the transmission of the movement of the plunger 2 and part 3 to the expelling plunger 6 for shifting of the latter rightward into the position shown in Figure 2 also. 'I'he rightward movement of the expelling plunger 6 causes it, by im pact, to displace the plug or closure member 8 from the diaphragm or partition 1 and the water I6 between the parts 1 and I0 is permitted to act upon the dry gas generating substance I4 to generate gas between the parts 6 and I0, which gas places the expelling plunger 6 under pressure ready to expel the now liqueed dry medicament between the plunger 6 and the mixing plunger 2.

It will be seen from the foregoing that the medicament is still trapped in the ampoulel along with the gas under pressure, and has thus far not been administered. However, referring to Figure 2, it will be seen that the abutment 23 extends from a valve chamber I9 containing a flexible tubular valve 20 which is normally closed by the under pressure in the chamber between the parts 1,'8 and III. The liquid in the chamber between the parts ,1, 8, and I0 is designated at I6.

I in a syringe.

The syringe with which my ampoule may be plunger 22 of a spring actuated lever 2 I In alinement with the opening through the tubular valve 20 is the penetrating needle VI1 adapted to be introduced to the flesh or person to whom the medicament is to be administered. Thus, when the lever 2i is depressed so as to open the valve 2li, the now liquefied medicament in the space between the expelling plunger 6 and the mixing plunger 2 will be expelled from the amopule through the puncturing needle I8, the valve 2D, and the penetrating administering needle I1. In this operation, of course, the gas, which is generated in the chamber between the parts I0 and Ii acts, by its pressure, upon the expelling plunger 6 and causes the latter to move toward the mixing plunger 2 to some such position as shown in Figure 3, dependent upon how long the lever 2l is depressed to maintain the valve 2li open. In accomplishing its expelling function the plunger 6 is assisted by the skirt 6a because the latter is adapted to enter the space between the medicament chamber extension 3 and the interior wall of the tube I. Said skirt member 6a is of sutilciently narrow cross section as not to close the communication between the chamber 5 and the space between the parts 6, 2, and 3. The guide or gasket ring II, the partition 1, and the closure member I0 are always stationary relatively to the tube I.

Figure 3 shows the condition of the ampoule as when the expelling piston or plunger 8 has moved to expel a portion of the liquefied medicament features ofthe syringe permit of the operation of the parts in thevmanner which I yhave described in reference to my ampoule of Figures 1to 3 in- I elusive.' Figures 5 and 6.

I now refer to Figure 4 of my drawings, wherein I show a modification of my invention, and in this modification those parts which are the same as used in my previously described construction are designated in the same manner by like reference characters.

In this modication, however, I provide an expelling plunger 52. In this instance the expelling plunger is a rubber ring 32, fastened securely to a tubular chamber 26, containing the dry gas generating chemical. Integral with this tubular chemical containing chamber is a cylindrical extension 24.l This is the part which will telescope over chamber 3 to expel medicament liquid after the syringe valve is opened.

This cylindrical extension has a central orifice 24a normally closed by a rubber stopper 25. The dry gas generating substance i4 is placed in the chamber located in 26. l

The right hand end of this chemical containing i tube 26 is closed by a displaceable closure-member 26 which in turn is held in place by a ring 26 bearing tightly against the inside of the glass tube.

In the right hand end of the tube l of the ampoule of this modification there is located a closure member 30 having a central long recess 3i and made of rubber for effecting sealing.

The operation of my last mentioned ampoule is as follows: When the ampoule is inserted in the syringe, the mixing plunger 2 is moved rightward in the same manner as previously described, and

the rubber plug or member 4 is punctured. This permits the distilled water or liquid I5 to enter the medicament chamber 5 and convert the me- ,dicament into solution. Simultaneously with the movement of the plunger 2 to the right, as seen in Figure 4, the liquid I5, by being compressed, is caused to force the plunger 32, along with its entire assembly 24, 25 and 26 to the right. The cylindrical tube 26 forces the closure member 29 away from its retaining ring and holder 28 and displaces it between the parts 28 and 30 which space contains the liquid for acting on the dry gas generating substance i4 in the member 26, generating sufiicient gas under pressure to act upon the plug or closure 25 and the expelling plunger assembly 32, 26, 25, 24 to perform the medicament expelling function when, by operation of valve means such as in Figure 2, the medicament is released to flow from the medicament chamber and portion of the tube I in which the liquefied medicament may be disposed.

In the modified construction of Figure 4, therefore, it will be understood that the mixing plunger 2 moves to the right, as before, and the expelling plunger assembly 24, 32, 26, first moves to the right on dissolving of the medicament, and then, under the pressure of gas generated, will move to the left upon release of the medicament to flow out of the ampoule.

It will be apparent that in reference to both the modified embodiments of my invention, the various parts may be assembled in a, very easy manner, are simple of manufacture, and enable the ampoule to be produced at a relatively lowl cost, thus obtaining the advantages first outlined herein as attributable to my construction.

In the syringe in which my ampoule is used,

one such as is disclosed in my identified copendingapplication, the syringe is made to provide an abutment to-engage the outer face of the closures I0 or 30, as the case may be. so this part 5 will be held from outward displacement, when the gas under pressure ls generated in the gas chamber of the tube or body I.

and before the ampoule is'thrown away.'the part I0 or4 30, is punctured by a hollow needle to permit the gas to exhaust from the ampoule, so no possibility of exploding of the latter, by dropping or mishandling, will arise.

Having thus described-my invention, what I claim as new and desire to secure by Letters Patent of the United States, is:

1. An ampoule comprising a tubular body, a mixing plunger at one end of the body, movable thereinto, and comprising a puncturable plug, a stationary closure at the other end ofthe body, said mixing plunger having a hollow portion forming a medicament containing` chamber, `said .chamber having ports for establishing communication between the interior of the chamber and the space within the body, a member stationary in the body normally closing said ports until the mixing plunger and chamber are moved inwardly of the body, and a medicament ejecting plunger spaced from. the mixing plunger and providing a space in the body for a medicament liquefying agent. A

2. An ampoule comprising a tubular body, a mixing plunger at one end of the body, movable thereinto, and comprising a Duncturable plug, a stationary closure at the other end of the body, said mixing c plunger having a hollow portion forming a medicament containing chamber of smaller diameter than the said plunger and movable therewith and extending inwardly therefrom, 40 said chamber having lateral ports for establishing communication between the interior of the chamber and the space within the body, a member stationary in the body normally closing said ports until the mixing plunger and chamber are moved inwardlyof the body, and a medicament electing plunger spaced from the mixing vplunger and providing a space in the body for a. medicament liquefying agent. v

3. An ampoule as claimed in claim 1, in which 0 said port closing member is a gasket ring surrounding the medicament chamber.

4. An ampoule as claimed in claim l, in which the chamber is smaller in diameter than the mixing plunger and spaced from the inner walls of the body, and the ports closing member is a ring surrounding the medicament chamber.

5. An ampoule as claimed in claim 2, in which the electing plunger is formed with anaxial skirt extension adapted to enter the space between the medicament chamber and the Walls of the body for medicament expelling action.

6. An ampoule as claimed in claim 2, in which the ejecting plunger is formed with an axial skirt extension adapted to enter the space between the u medicament. chamber and the walls of the body Likewise, after' the medicament of the ampoule is administered,

` tionary closure of the body.

8. An ampoule as claimed in claim 1, combined with. a partition having an opening therethrough and spaced from the electing piston on the side opposite the mixing plunger to form' a compartment for a gas generating substance, a closure for the opening of the partition displaceable from the opening by abutment with the electing piston,

liquid between the medicament chamber and ports closing member, and the electing plunger, and liquid between the partition and the stationary closure of'the body, the electing plunger having a portion for engaging the `closure of the par-tition, for opening the compartment for the gas'A generating substance to the last mentioned liquid, and means sealing the last compartment from the 'liquid' between the mixing and ejecting plungers.

9. An ampoule comprising a tubular body, a first mixing plunger at one end of the body movable inwardly in the body and comprising a needle puncturable plug, a stationary closure closing the other end of the body, a second medicament ejecting plunger in the body between and spaced from the first plunger and the closure to provide a liquid space between it and the first plunger and a pressure space between it and the closure, one of the said plungers having a medicament holding chamber having means to establish communication between it and the liquid space between the first plunger and the electing plunger, a normally stationary member in the body disposed so as to normally close the medicament chamber, a liquid between the flrst plunger and the electing plunger, the first plunger being movable inwardly in the body to act on said liquid 8 n and to enect movement of the medicament chamb er while the said stationary member is stationary, whereby to open up the medicament chamber for receiving the said liquid for providing fresh medicament to be administered from the ampoule. 10. lAn ampoule comprising a tubular body, a first mixing plunger at one end of the body movable inwardly in the body and comprising a needle puncturable plug, a second medicament electing plunger in the body spaced from the first plunger, one of said plungers having a medicament holding chamber having means to establish communication betweenit and the space between said plungers, a. membernormally stationary in the body and positioned to `cl'ose'the medicament chamber against the communication mentioned, a liquid between said plungers, the first plunger being movable inwardly in the body to eiIect movement of the medicament chamber while the said stationary member remains stationary to open communication of the medicament chamber to the liquid space, for producing freshly made medicament, and means for effecting ejectin movement oi' the electing piston.v

MARVIN L. FOLKMAN; REFERENCES orrnn The following references are of record in the file of this patent:

UNITED STATES PATENTS

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