WO1997000435A1

WO1997000435A1 - Ampule adapter

Info

Publication number: WO1997000435A1
Application number: PCT/IB1996/000580
Authority: WO
Inventors: James E. Rasmussen; Scott E. Duffy; Robert S. Potts; David L. Adriaansen; Michael P. Mcdonald
Original assignee: Chiron Diagnostics Corporation
Priority date: 1995-06-19
Filing date: 1996-06-17
Publication date: 1997-01-03
Also published as: KR19990022903A; PL324032A1; AU5843396A; CA2225036A1; JPH11507730A; EP0834062A1

Abstract

An adapter (2) for connecting an ampule (8) to a clinical instrument has been developed. The adapter (2) allows the continuous connection of the ampule (8) to the instrument so that the contents of the ampule (8) could remain protected from exposure to air, and aliquots of solution from the ampule (8) can be periodically, and easily, withdrawn from the ampule (8). In addition, the preferred embodiment permits usage of much of the contents of the ampule (8) and helps reduce the risk of technician exposure to the sharp glass edges of the open ampule.

Description

AMPULE ADAPTER

BACKGROUND

The present invention deals with a device (an adapter) which allows the connection of an ampule to an instrument, so that the instrument can periodically withdraw samples from the ampule.

In the use of clinical instruments, it is often desirable to utilize control materials which are packaged in ampules. Ampules, typically made of glass, are inert and generally retain the sample in a stable form . longer than if it were packaged in a container made of a different material. The disadvantages of an opened ampule include 1. there remains exposed a sharp edge of glass which is potentially dangerous to laboratory personnel, 2. there existed a risk of decomposition of the contents ofthe ampule when exposed to air and 3. there has been no way to keep the opened ampule in such a position that samples could easily be withdrawn from the ampule.

Existing techniques in use now for sampling from ampules require the user to manually move the ampule to a tube that withdraws samples from the ampule. Not only does this require technician time, preventing the worker from attending to other tasks in the laboratory, but it also allows for more exposure ofthe sample to air, thus risking degradation ofthe sample. Existing procedures are also variable due to the non-reproduceability of laboratory technique from worker to worker. SUMMARY

An adapter for connecting an ampule to a clinical instrument has been developed. The adapter allows the continuous connection ofthe ampule to the instrument so that the contents ofthe ampule could remain protected from exposure to air and aliquots of solution from the ampule can be periodically, and easily, withdrawn from the ampule. In addition, the preferred embodiment permits usage of much ofthe contents ofthe ampule and helps reduce the risk of technician exposure to the sharp glass edges ofthe open ampule.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 shows a side view ofthe adapter. Figure 2 shows an elevated view of the adapter. Figure 3 shows a view into the adapter. Figure 4 shows a view of an adapter actually in use, connecting the ampule to an instrument.

DETAILED DESCRIPTION

An adapter for connecting an ampule to an instrument has been developed. The adapter allows for the continuous connection of an opened ampule to an instrument, thus allowing the instrument to withdraw samples whenever necessary, without requiring intervention by the laboratory technician. The technician can be doing other tasks in the laboratory, thus providing a more cost- effective use ofthe technician's time. In addition, automated withdrawal of aliquots from the ampule is more reproducible that manual sampling, thus decreasing variations between samples. Although the adapter was intended for use with a clinical instrument, it can also be used on other instruments, such as a gas chromatograph, and any other instrument that requires the sampling one or more times from a container ofthe solution or component contained in that container, generally with the contents being aspirated via a probe inserted through the adapter. Although the device was intended primarily for connecting an ampule containing a control material, it could also be used to connect a large ampule or sealed flask of an air-sensitive reagent to an instrument or to glassware wherein a synthesis is being conducted. Although rigid containers were primarily contemplated, a flexible container (e.g., a pouch or balloon) containing a gaseous material could be connected via an ampule-like connector to the adapter, from which samples of gas could then be withdrawn.

Many variations ofthe adapter are contemplated. One preferred embodiment includes a special connecting device, namely a tapered joint that is similar to the tapered joint on a syringe, that allows the adapter to be connected, as a syringe would be, to the instrument. It also is designed with an angle between the body ofthe adapter and the syringe-like connector so that the ampule will be inclined, allowing most or all ofthe contents to be consumed. Any obtuse angle can be used, with the preferred angle being determined by the flow characteristics ofthe contents ofthe ampule, with more viscous materials requiring an angle closer to 90 degrees. (The discussion ofthe angle assumes that the inlet to the instrument is horizontal. If it is anything other than horizontal, the angle should be adjusted accordingly, with more viscous fluid contents ofthe ampule requiring the ampule to be closer to the vertical.) The preferred embodiment is shown in the figures. Figure 1 shows the side view ofthe adapter, with 1 being the outlet portion, a tapered joint, having the taper of a syringe, that is inserted into the instrument; 2 is the body ofthe adapter, which holds the ampule; 3 is the inlet portion ofthe adapter; 4 is an optional indicator which shows the user the top of the adapter to assure maximum flow ofthe contents ofthe ampule into the adapter; 5 are optional external ribs for simplifying the grasping ofthe adapter. 6 is the neck ofthe adapter, through which the probe extends when being inserted into the ampule or into the contents ofthe adapter which have flowed into the neck ofthe adapter. Figures 2 and 3 also shows the optional internal ribs, 7, which hold the ampule securely in the adapter. Figure 4 shows the insertion ofthe ampule 8, whereby the broken edge ofthe ampule projects farther into the adapter than the internal ribs and makes a tight connection with the adapter itself. Figure 4 also shows one means contemplated for sampling from the adapter, namely the insertion by the instrument of a probe 9 into the ampule to permit withdrawal ofthe control material.

Variations ofthe device are also contemplated. Although the device is intended primarily for sampling from ampules containing control materials, it is also contemplated that calibrators or other solutions or individual ingredients could be contained in the ampule. For example, the device could be sufficiently flexible or could contain an optional component therein which would allow the breaking ofthe ampule after it is inserted into the adapter, thus further reducing the exposure ofthe contents to air. This would also reduce the risk to the operator of exposure to the sharp edges on the broken ampule. Furthermore, the adapter could be designed with a screw thread, in order to allow the connection of a vial or bottle having a screw closure to the instrument. In addition, the adapter could be made entirely or in part of a material that would allow injection of a material, for example a solvent, into the ampule in order to allow the dissolution ofthe contents thereof. Further variations thereof will be contemplated by those having skill in the art.

It is contemplated that the adapter will be made from polypropylene, such as type 6331, natural color, made by Himont, or equivalent materials. However, the use of other materials, such as polyethylene, is also contemplated. Preferably, the adapter will be sufficiently rigid or semi-rigid to support the weight ofthe ampule and maintain it at the indicated angle so that the probe can extend through the neck ofthe adapter. The adapter should be inert to the ingredients in contact therewith. In addition, it must be sufficiently pliable to allow the tight connection ofthe ampule thereto. Variations described above contemplate the use of different materials in portions ofthe adapter in order to accomplish the added attributes described above. For example, if it is desired to inject a solvent into the ampule after it is connected to the adapter, a small portion ofthe adapter must be made of a material that allows injection ofthe solvent, followed by repair ofthe injection point, if the syringe needle is to be withdrawn subsequent to injection. If the needle is not to be subsequently withdrawn, a syringe containing a stopcock could be used on the syringe.

Furthermore, the partial use of a semi-rigid, flexible material or an "accordion" design (i.e., design allowing bending ofthe adapter) could be included if it is desired to break the ampule after insertion into the adapter. Variations in materials of construction will be contemplated by those with expertise in the properties of materials.

Claims

What is claimed is:

1. An adapter for connecting an ampule or other container to an instrument, said adapter being formed as a unitary plastic rigid or semi-rigid unit and comprising; a cylindrical body having opposite ends and a central bore defining a central axis of said cylinder therethrough; a partial closure to said body at one end terminating in an aperture about said axis; a tapered joint projecting from said apertaure and having an outer shape emulating that of a syringe outlet and an inner bore tilted with respect to said axis such that when said joint is positioned horizontally, said axis and said cylindrical body are angled to the horizontal; indicia associated with said body identifying when said cylindrical body is angled upwardly with respect to said joint in a horizontal position; said bore of said cylindrical body adapted to receive and hold an ampule with said ampule substantially filling said bore of said cylindrical body

2. An adapter of claim 1 in which said angle is obtuse.

3. An adapter of claim 1, wherein said cylindrical body contains ribs on at least one of an outer or bore facing surface.

4. An adapter of claim 1 which additionally contains a portion through which a material can be injected into said ampule or said adapter via use of a syringe.

5. An adapter of claim 1 which additionally contains a flexible portion which allows bending between the joint and cylindrical body and opening of an ampule inserted therein.

6. A unitary at least semi-rigid adapter for connecting an ampule to an instrument in lieu of a syringe, said adapter being made of plastic and comprising a. an outlet having the tapered design of a syringe outlet b. communicating at an obtuse angle with a body adapted to receive an ampule substantially entirely therein and c. said outlet and body being angled to permit a needle to extend without obstruction through said outlet and into a broken end of any ampule located within said body.

7. An adapter for connecting an ampule-type container of a fluid to an instrument for fluid withdrawal said adapter being fabricated of a rigid or semi¬ rigid material to comprise: a body portion in the form of a cylindrical wall extending a length in an axial direction for holding an ampule and having a dome-shaped end; the dome-shaped end being terminated with a tapering cylindrical syringe adapter portion set at an angle to said body portion and of a diameter a small fraction of a diameter of said body portion; said body portion having approximately a third ofthe cylindrical wall thereof removed form an end opposite said dome-shaped end over approximately a half the axial length ofthe cylindrical body portion; said cylindrical body portion further having a plurality of gripping ridges extending, on opposite sides of said cylindrical body portion, a short distance therearound over substantially the entire axial length of said cylindrical body portion to facilitate gripping; and said cylindrical body portion having on an interior surface thereof, a plurality of internal ribs extending axially within said cylinder and protruding progressively farther inwardly from said interior surface in the direction of said dome-shaped end.

8. The adapter of Claim 7 further including positioning indicia on said body portions.

9. The adapter of Claim 8 where said indicia is in the shape of an arrow.

10. The adapter of Claim 9 wherein said indicia is adjacent a region of removed cylindrical wall.

11. The adapter of Claim 10 further including a flexible portion which allows bending ofthe adapter and opening of an ampule inserted therein.

12. The adapter of Claim 10 adapted to receive a broken ampule.