US2731965A - haralson - Google Patents

Description

24, 1956 R. H- HARALSON, JR

PHARMACEUTICAL DISPENSER Filed Sept. 26, 1952 II 'ILI II' I I I ROBERT H. HARALSOBLJR.

INVEN TOR.

l BY WK QW ATTOR/L/[V United States Patent PHARMACEUTICAL DISPENSER Robert H. Haralson, Jr., Maryville, Tenn. Application September 26, 1952, Serial No. 311,749

9 Claims. (Cl. 128-272) This invention relates to a device for marketing and/ or dispensing certain pharmaceutical preparations.

The principal object of the present invention is to provide a solvent container with an ampule disposed therein adapted for quick preparation of pharmaceutical materials for emergency or normal treatment of patients as required.

Another object of this invention is to provide a device for the preparation of therapeutic materials in a quantity suitable for a number of treatments requiring the same a device for the ultimate preparation of pharmaceutical materials for dispensing promptly and in a most economical manner.

The pharmaceutical dispenser of the present invention is essentially the combination of a solvent or diluent container, a closure for said solvent container adapted for the ready withdrawal of prepared solution therefrom, a sealed solute container within said solvent container, and means for the rupture of the wall of said solute container extending through said solvent container closure. The application of external force may then be applied to produce the rupture of the solute container and result in the immediate dilution: or solution of the solute in the solvent.

In the accompanying drawing wherein the same reference numeral refers to the same part in the various views,

Fig. 1 is a substantially vertical sectional view of one embodiment of the present invention wherein the rupture of the solute container is produced by a rapid withdrawal of at least a part of the rupturing element through the solvent container closure,

Fig. 2 is a substantially vertical sectional view of another form of this invention wherein the rupture of the solute container is produced by sharp impact on that portion of the rupturing element extending outside the solvent container closure,

Fig. ,3 is a view similar to Fig. 1, except that a substantially rigid support for the solute container is provided, and

Fig. 4 is a view similar to Fig. 2, except that a substantially rigid positioning means for the solute container is provided.

In all of the figures, solvent container 1 holds solvent 3 and solute container 5 with solute 7 therein, and is provided with closure 9. Closure 9.is penetrated by air inlet 11, which extends to the bottom of solvent container 1, and is perforated in part to provide outlet 13 through 2,731,965 Patented Jan. 24, 1956 which a hypodermic needle or the inlet of any other type of liquid administration set (not shown) may be inserted. Closure 9 and inlet 11 are covered by separable diaphragm 15, which is in turn protected by covering seal 17.

In Fig. 1 and Fig. 3, a rupture means 19 consists of a wirelike member which engages solute container 5, extends through closure 9, and terminates in loop 21. Diaphragm 15 covers closure 9, inlet 11 and loop 21 securely and protects the entire top of the assembly during and after sterilization of the dispenser combination.

In Fig. 3 restraining means 23 holds solute container 5 in a predetermined position by engagement with closure 9.

In preparing solute 7 for dispensing, seal 17 and diaphragm 15 are removed. Loop 21 of rupture means 19 is raised and withdrawn rapidly and to the extent that the wall of solute container 5 is ruptured by sharp contact with either the shoulder of solvent container 1, or the restraining means 23. Solute 7 dissolves immediately in solvent 3 with agitation at least to the extent of producing a uniform concentration throughout. A hypodermic needle or the inlet of anadministration set (not shown) is introduced into outlet 13, the entire dispenser combina tion inverted and supported, and a predetermined amount of solution withdrawn from container 1, or the solution is withdrawn at a predetermined rate from container 1 until the required amount of solution is dispensed. On again inverting the dispenser combination to its original position and removing the administration set inlet, the diaphragm 15 and seal 17 may be replaced and the remainder of the solution in container 1 retained for subsequent dispensing of successive portions of the solution.

In Fig. 2 and Fig. 4, a rupture means 25 consists of a rodlike member, just engaging the solute container 5, extends through closure 9 and a short distance beyond as terminal 27. Diaphragm 15 and seal 17 cover closure 9, inlet 11, and terminal 27, thereby protecting these elements of the combination during and after sterilization.

In preparing solute 7 for dispensing, seal 17 and diaphragm 15 are removed, a sharp impact applied to terminal 27 to the extent that the wall of solute container 5 is ruptured by contact with the bottom of container 1. Mixing and dispensing are carried out as described above.

In Fig. 4 the solute container 5 is held in place by restraining element 29.

The term solvent as used in the description and claims refers to that constituent of the ultimate solution for dispensing which is present in the larger amount, or which is liquid in the original or pure state. Such solvent may be distilled water, or any base suitable for the preparation of the material being dispensed, such as solutions of dextrose, invert sugar, or salt in water.

The term solute refers to that constituent of the ultimate solution which is considered to be dissolved in the other constituent, called solvent. The solute is usually either a liquid or solid. Such solute may be a material required for therapeutic treatment in a diluting medium of a suitable solvent, or in admixture with other desirable materials already in solution. Examples of solutes requiring dissolution before injection include thionembutal, thiopental and thioseconal, which may be used in appropriate concentrations to produce amnesia or anesthesia. Blood plasma concentrate may also be used in preparations for intravenous introduction.

The solvent container may be any suitably shaped bottle or flask with at least a medium sized neck and mouth for accommodation of a closure for same together with other elements associated therewith as set forth herein. The bottle or flask serving as solvent container preferably should be cylindrical and marked with appropriate volumetric graduations.

The solute container is of the type normally employed in packaging and distributing concentrated and/or perishable material through the usual channels of trade to hospitals and/ or physicians. Such containers, or ampoules, usually are sealed, thin-walled glass containers so constructed as to be readily fractured or ruptured at the end or middle thereof. Of course, any such container constructed from any other friable, plastic material is adequate for the purpose of this invention.

The means for rupture of the solute container must be in juxtaposition to the container in such a manner that the application of force from the outside of the solvent container through such rupture means will result in breaking the wall of the solute container at least to the extent that the solute therein will be fully exposed to solvent surrounding it. The rupture means may be actually attached to the solute container, or may be so closely associated with such container that the application of the external force will cause rupture of the wall of the container.

The rupture means extends from the solute container up through the solvent container closure to such an extent that force may be applied thereto externally in respect to the solvent container to cause rupture of the solute container.

When it is desired to apply such external force by traction, or rapid withdrawal, the rupture means may be a Wire-like element attached to the solute container, extending through the solvent container closure, and provided with a looped end, or other suitable configuration for grasping, which may fit snugly on the top of said closure. After grasping such loop, a rapid withdrawal of a portion of the Wire through the closure will cause the rupture of the thin-walled, solute container, either by the resulting impact against the shoulder below the neck of the solvent container, or by impact with other restraining means as hereinafter described in detail.

When it is desired to apply such external force by transmitted impact, a relatively rigid rupture means is provided with one end so shaped and positioned as to gently engage the solute container. This rigid rod extends through and beyond the solvent container closure, but preferably not above the top of the neck of the solvent container. A sharp impact on the exposed terminal portion of this rod produces the rupture of the solute container.

The closure for the solvent container is of such composition, size and construction as to accommodate the rupture means, the solute container restraining means if used, the air inlet conduit and the solution outlet corresponding to the location of the administration set inlet. The solution outlet is preferably a preformed aperture in the closure which does not extend completely through the top of the closure, thereby permitting the introduction of either a hypodermic needle or the tube of a standard administration set.

A filtering screen or sieve may be associated with said closure in order to filter the resulting solution being dispensed, if required. However, administration sets usually contain some type of filtering element.

A separable diaphragm on top of the solvent container neck covers the solvent container closure, the rupture means terminal, the air inlet and the solution outlet zone. This diaphragm may be a separate member, or a part of a unitary element which serves both as a gas-tight cover and a seal for full protection of the entire dispenser combination during sterilization, distribution and/ or storage. The configuration of the seal is such as to conform to, and at the same time protect, that portion of the rupture means above the top of the closure from accidental application of external force.

On removing the seal and diaphragm, the solute container can then be ruptured by the application of external force and the desired solution produced. After introduction of a hyperderrnic needle or administration set inlet to the solution outlet in the solvent container closure,

the entire dispenser assembly is inverted and the desired amount of solution withdrawn. Thereafter, the assembly is returned to its original position, the administration inlet withdrawn and the assembly closed by diaphragm and seal replacement.

The solvent container may be provided with a means for restraining the solute container in a predetermined position in order to apply more effectively the external force for rupturing the wall of the solute container.

Such restraining means may be constructed of wirelike er rcdlike elements depending on the character of force to be applied, tractive or impact. The configuration of the restraining element is such as to hold the solute container in a relatively fixed position and be anchored to the closure of the solvent container.

Alternately, the configuration of the solvent container may be changed from the aforesaid cylindrical type of vessel by suitable indentations or other change in shape in order to engage the solute container in a suitable position. such as near the top or near the bottom of the solvent container.

1 claim:

1. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means for shock rupture of the wall of said solute container in juxtaposition to said solute container and extending through said solvent container closure, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

2. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by rapid withdrawal of that portion extending above said closure, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

3. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container Within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by sharp impact on that portion thereof extending above said closure, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

4. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by rapid withdrawal of that portion extending above said closure, means for restraining said solute container in a predetermined position Within said solvent container, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

5. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute i l l i container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by sharp impact on that portion thereof extending above said closure, means for restraining said solute container in a predetermined position within said solvent container, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

6. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by rapid withdrawal of that portion extending above said closure, means for restraining said solute container in a predetermined position within said solvent container held in position by engagement with said solvent container closure, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough. 7. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted for shock rupture of the wall of said solute container by sharp impact on that portion thereof extending above said closure, means for restraining said solute conatiner in a predetermined position within said solvent container held in position by engagement with said solvent container closure, and a gas-tight sealing element covering said solvent container closure and that portion of said rupture means extending therethrough.

8. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted to shock rupture of the Wall of said solute container by rapid withdrawal of that portion extending above said closure, means for restraining said solute container in a predetermined position within said solvent container held in position by engagement with said solvent container closure, a separable diaphram covering said solvent container closure and that portion of said rupture means extending therethrough, and a seal over said diaphram.

9. A pharmaceutical dispenser comprising a solvent container, a closure for said solvent container, an air conduit through said closure to the bottom of said solvent container, a sealed solute container Within said solvent container, means in juxtaposition to said solute container extending through said solvent container closure and the upper end thereof extending through the top of said closure adapted to shock rupture of the Wall of said solute container by sharp impact on that portion thereof extending above said closure, means for restraining said solute container in a predetermined position within said solvent container held in position by engagement with said solvent container closure, a separable diaphram covering said solvent container closure and that portion of said rupture means extending therethrough, and a seal over said diaphram.

References Cited in the file of this patent UNITED STATES PATENTS 2,236,491 Campbell Mar. 25, 1941 2,275,567 Smith Mar. 10, 1942 2,387,978 Casey Oct. 30, 1945 2,619,448 Larsen Nov. 25, 1952 FOREIGN PATENTS 122,370 Australia Oct. 10, 1946 716,477 France Oct. 6, 1931

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