HK1020900B - Reagent cartridge - Google Patents

Description

Reagent storage box

This application is a continuation-in-part of U.S. patent application 08/675,586 filed on 3/7/1996.

Various reagent storage cassettes for protein analyzers and other automated clinical analyzers are known.

Us patent 5,075,082 discloses a reagent cartridge for use in an automated clinical analyzer having a plurality of individual reservoirs and comprising a body member and a bottom wall. The body member and the bottom wall are formed by injection molding, respectively, and then the two divided portions are welded together by a metal plate heated to a high temperature which melts the joining surfaces of the body member and the bottom wall. In the cartridge of the above-mentioned us patent, the storage chamber for storing the liquid is formed by a connecting portion of the bottom wall on the body.

Us 5,031,797 discloses a reagent cartridge having a plurality of chambers for holding liquid reagents, each chamber having an inlet for receiving a sampler for removing reagents from the cartridge and a resealable sealing means. A sealing tape or adhesive tape-like vent is provided on the top cover of each chamber. At one end of the storage case is an outwardly extending flange having a plurality of vertically aligned apertures or windows capable of transmitting optical signals. The bottom of each chamber has a neck with an inlet opening which is sealed by a synthetic rubber membrane which can be pierced by a sampler to remove the liquid reagent. The bottom, side and dividing walls of the storage case are all molded as a single piece. The top closure is secured to the side walls and the divider walls by ultrasonic welding or by adhesive. However, ultrasonic welding is difficult to handle, often results in a large number of poorly bonded parts, and is prone to cracking. Furthermore, the use of ultrasonic welding often results in local denaturation of the resin from which the individual components are made. Thus, the two components, which are bonded by welding or adhesive, are not all chemically unitary.

The cartridge of the present invention is a one-piece design that uses an inexpensive commercial resin that is recyclable, whereas in the two-piece design of the prior art, it is either heat welded to join them together on a specially made heated metal plate fixture or joined together with an adhesive that is not recyclable. This two-piece design also places a significant limitation on the types of resins that can be used, as both resins must be inert to the reagents and also capable of bonding to each other. For the above reasons, and with the elimination of assembly tools and procedures, the cartridge of the present invention is inexpensive to produce. The one-piece storage cassette of the present invention has threads molded for one or more reagent chambers to accept a screw-on lid including a screw-on vent cap. Such a single-piece cartridge may also contain "thinned" regions at strategic locations to allow ready observation of the level of liquid within the chamber. The above and other advantages of the present invention will become more apparent to those skilled in the art from the following detailed description.

The present invention provides a single piece reagent cartridge for use in a clinical instrument having a reagent storage device including a transport mechanism for storing reagent cartridges, the reagent cartridge comprising:

at least one storage chamber having a side wall and a closed bottom wall, said side wall having an upper end portion including an inlet aperture, an

An alignment guide integral with the cartridge body and extending from one end thereof, the free end of said guide being connectable to means on the transport mechanism for limiting radial or lateral movement of said cartridge therein.

The present invention also relates to a molded one-piece reagent cartridge for use in a clinical instrument, said instrument comprising a storage device having means capable of supporting said reagent cartridge. The reagent cartridge comprises one or more storage chambers in a line in fixed relation. Each storage chamber is generally cylindrical in shape, having a side wall and a closed bottom wall. The side wall has an upper end portion with an inlet opening. An integrally formed hollow housing is open at the bottom wall and also substantially surrounds the reservoir from a point below the end, forming a hollow space within the housing around the exterior of the reservoir. This space allows conditioned air to circulate around the reservoir to maintain or control the temperature of the liquid composition. Another open space is formed between the lower ends of the storage chambers to accommodate the means for supporting.

In one embodiment, the present invention provides an injection molded one-piece reagent cartridge for use in a clinical instrument, the instrument including a storage device having means for supporting the reagent cartridge. The reagent cartridge comprises a plurality of reservoirs in a fixed relationship in a line, each reservoir having a side wall and a closed bottom wall, the side wall having a threaded end portion with an access opening and being capable of receiving a threaded closure engageable with the threads on the end portion to form a liquid tight seal over each reservoir. This embodiment also includes an integrally formed hollow housing open at the bottom wall to allow conditioned air to circulate within the housing around the exterior of the reservoir, but to substantially surround the reservoir, forming a hollow space within the housing from a point below the threaded end around the exterior of the reservoir. The open space between the lower ends of the storage chambers can be used to accommodate a device for support.

The invention also includes a reagent cartridge storage apparatus having a transport mechanism or carousel for storing a reagent cartridge for use in a clinical instrument, wherein the transport mechanism has means for supporting the reagent cartridge on the transport mechanism. The reagent cartridge itself comprises a molded, one-piece body having a plurality of storage compartments in a fixed relationship in a line, each compartment having side walls and a closed bottom wall; the sidewall has an upper end with an inlet opening. It has been noted that the integrally formed hollow housing is open at the bottom wall, forming a hollow space within the housing around the exterior of the reservoir. The open space between the lower ends of the storage chambers can accommodate means for supporting and holding the reagent storage cartridge at a predetermined position on the transport mechanism. This device may have a circular or square aperture on one or both sides of the cartridge housing which engages a feature on the delivery mechanism to form a "snap" fit.

The present invention also provides a reagent cartridge storage apparatus comprising a transport mechanism for storing a reagent cartridge for use in a clinical instrument, wherein said transport mechanism has means for receiving a guide formed on said cartridge, said reagent cartridge comprising a moulded, single piece body having:

at least one storage compartment having a side wall and a closed bottom wall; said sidewall having an upper end portion including an inlet opening; and

a guide member integrally formed with the cartridge body and extending from one end of the body, a free end of the guide member being engageable with the receiving means to limit radial or lateral movement of the cartridge body on the cartridge.

In another important aspect of the present invention, there is also provided an injection molded one-piece reagent cartridge for use in a clinical instrument including a storage device having means for supporting said reagent cartridge, said reagent cartridge being formed of a transparent plastic material, comprising:

an integrally formed hollow housing open at the bottom wall to allow conditioned air to circulate within the housing around the exterior of the reservoir and substantially surround the reservoir, a hollow space being formed within the housing around the exterior of the reservoir from a point below the threaded end, wherein the housing has a thinned region forming a see-through panel to allow the level of liquid within the reservoir to be viewed through the thinned region.

Hereinafter, embodiments of the present invention will be described in detail with reference to the accompanying drawings. In the drawings:

FIG. 1 is a perspective view of a preferred embodiment of the present invention;

FIG. 2 is a perspective view of the embodiment of FIG. 1 with different reference numerals;

FIG. 3 is a top view of the embodiment of FIGS. 1 and 2;

FIG. 4 is a top view showing the embodiment of FIG. 1 inserted into a reagent delivery mechanism of an analyzer device;

FIG. 5 is a cross-sectional view of the embodiment of FIG. 3 taken along line 5-5;

FIG. 6 is a side view of the embodiment of FIGS. 1-5;

FIG. 7 is a sectional view taken along line 7-7 of FIG. 6;

FIG. 8 is a cross-sectional view of the saddle and wedge fin taken along line 8-8 of FIG. 4 showing a latch mechanism for locking the cartridge in the reagent delivery mechanism of the analyzer device described above.

The present invention provides a low cost, one-piece, multi-compartment cartridge that is particularly suited for use in the analytical device of U.S. patent application 08/746,313 filed 11/12 1996. Such cartridges are inert to reagents and are generally useful in clinical analyzers because they are typically made from injection molded hair using a high density polyethylene (a recyclable material). The structural design is easy to adopt automatic filling equipment, and the standard screw cap with low cost can be utilized. Such a cartridge can be filled with chemical components used in the chemical analysis of two proteins. In some cases, both reservoirs may also be filled with the same reagents, or buffer solvents required for a particular assay.

In a preferred embodiment, the cartridge is uniquely shaped and can be assembled in a row of 24 cartridges in a small space in an assay facility. It is easily installed in the transport mechanism, but is securely fixed. The cartridge is suitable for use in both linear and rotary type devices, since it is substantially rectangular in shape (except for a wedge-shaped "nose" to allow for more compact packaging on the transport mechanism).

As shown in the drawings, the one-piece case 10 includes a molded handle 12, a hollow housing 14, a molded guide 16, a wedge-shaped "nose" 18, and a plurality of ribs 20 to attach a label 22 to one or both of the exterior sides of the housing 14. The illustrated cartridge has a pair of integral, spaced apart storage compartments 24 and 26, each having a closed bottom wall 28, a cylindrical side wall 30, and integrally molded external threads 32 at the neck adjacent an upper inlet opening 34. The reservoirs 24 and 26 are surrounded by the housing 14 beginning at a point where a flat top surface or flange 36 projects outwardly from the housing 14 and joins the outer surfaces of the reservoirs 24 and 26 below the threaded portion to the bottom wall 28 of the reservoir. The hollow case 14 has a skirt-like shape and surrounds the storage compartment on its side, and has an open bottom. The hollow housing 14 is spaced from the reservoir on the whole at each side thereof, and the lower ends of the sides thereof are substantially flush with the bottom wall of the reservoir. A threaded closure 38 is threadably connected to threads 32 on the neck of each of reservoirs 24 and 26.

As shown in FIG. 4, guides 16 aligned with the centerlines of reservoirs 24 and 26 are inserted into corresponding slots 40 in molded posts 42, which posts 42 are disposed in a reagent carousel or transport mechanism 44 of a rotary clinical analyzer. The guide 16 is attached to the slot 40 in the same manner as the key and keyway connection. The open spaces between the reservoirs on the cartridge 10 fit over saddles 48 molded into the rim 50 of the reagent delivery mechanism. This prevents the cartridge 10 from rotating about the guide 16. As shown in fig. 4-8, a wedge-shaped fin 65 is molded into the center of each saddle 48 to provide a slight secure fit for the cartridge 10. A boss or peg 68 is molded into one side of the fin 65. When the cartridge 10 is placed on the rim 50 of the reagent delivery mechanism, the cartridge 10 is pressed onto the saddle since a through hole 67 is formed in one side of the hollow housing 14 to engage the pin 68. The force to load and unload the cartridge 10 is determined by the entrance angle 69 and exit angle 70 on the upper and lower sides of the latch 68. Since the bottom of the housing 14 surrounding the cartridge 10 is empty (see fig. 5), the outer walls of the storage chambers 24 and 26, which are inside the housing 14, can be exposed to the ambient atmosphere and temperature surrounding the cartridge 10. The reagent delivery mechanism 44 also has corresponding apertures to allow conditioned air to circulate around the reservoirs 24 and 26 within the housing 14, either for cooling or heating. The free circulation of temperature controlled air within the housing 14 (as indicated by the arrows in fig. 5), and around the exterior of the storage chambers 24 and 26, facilitates maintaining a desired temperature of the contents in the storage chambers. In general, many reagents contained in a storage chamber are sensitive to temperature and temperature variations, and if the temperature cannot be maintained within acceptable limits, the quality of the reagent will be reduced.

The wedge-shaped "nose" 18 enables the cartridge to be placed more closely to reduce the diameter of the delivery mechanism, making it smaller and less inertial.

Fig. 3 and 6 are top and side views, respectively, of the cartridge showing thinned areas in the molded housing 14 to form interposed see-through panels 52 between the ribs 20 so that the level 54 of the liquid can be seen through the housing 14 and the transparent plastic wall 30 of the reservoir. At the insert panel 52, the housing 14 and the transparent storage chamber wall 30 are typically fused together to form a single piece of reduced overall thickness plastic. In preparation for insertion of the cartridge into the reagent delivery mechanism 44, the threaded closure 38 is removed and replaced with the evaporative closure 56. Such an evaporation cover 56, typically made of silicone rubber, is provided with two cross-shaped slits 58 which fit over the reservoirs to reduce evaporation of the valuable reagents when the cartridge is mounted on the clinical analyzer. The cross slit 58 is self-closing. As noted above, the cartridge is provided with an aperture 67 in one or both walls of the housing 14 between the two storage chambers 24 and 26 which engages a raised portion on the means for supporting the reagent cartridge. This securing prevents the sampler in the storage device of the reagent cartridge from lifting or sinking the cartridge from its original position when it is inserted or lifted through the slit evaporation cover.

Various labels 60 (see fig. 2) may be used which can be wrapped around the exposed end of the cartridge, with bar codes providing information such as lot numbers, reagent data, all of which can be read by a bar code reader 64 (fig. 3).

In a preferred embodiment, handle 12 forms a bridge between reservoirs 24 and 26. Which is generally parallel to the flat top surface 36. The handle 12 is integral with a vertical web 66, the web 66 being connected between the lower surface of the handle 12 and the top surface 36.

The concept of the reagent cartridge can be extended to any number of chambers but still be made in one piece. Although the maximum volume of the reservoirs used is typically about 10ml, this volume can be increased by making the reservoirs deeper or larger in diameter. The diameter of the reservoir is increased and the closure must be increased because the mouth of the reservoir must be at least as large as the diameter of the reservoir. If it is desired to make the reagent volume of the reservoir very large, the reservoir may be oblong or oval and a press-on lid of the same shape may be used. Furthermore, because the cartridge 10 is substantially rectangular in shape, it works well on both "linear" and rotary conveyors.

The storage box device of the invention has the following basic advantages: a) the cost is low; b) one-piece (no assembly required); c) commercial resin (which can be used for mass production and is low in price) is adopted; d) unique mounting of the cartridge on the analyzer assembly (key inserted into slot); e) the injection molding manufacturing method has high productivity and short production period, and further reduces the cost; f) recyclable plastic resin (environment-friendly) is adopted; g) the reinforcing ribs are beneficial to labeling; h) reduced evaporation (evaporative cover is provided); and i) can be securely fixed to the transport mechanism by means of a press fit between the latch on the transport device and the hole in the wall of the magazine.

The walls of the storage case are preferably made of a thin, flexible resin. This flexibility enables the cartridge to be repeatedly inserted and removed in the delivery device; the latches of the reagent delivery mechanism do not wear excessively, nor do they require latching parts to maintain close tolerances.

Although only certain preferred embodiments of the invention have been described above, it is to be understood that the scope of the invention is to be determined by the claims.

Claims (16)

1. A reagent cartridge for use in a clinical instrument having a reagent storage device including a transport mechanism for storing at least one reagent cartridge, said reagent cartridge being characterized by a single-piece body comprising:

at least two spaced apart storage chambers, each storage chamber having side walls and a closed bottom wall and an upper inlet aperture;

an integrally formed hollow housing is open at the bottom wall and also substantially surrounds the storage chambers from below the inlet opening, forming a hollow space inside the housing around the exterior of the storage chambers.

2. The reagent cartridge of claim 1 wherein the transport mechanism includes means for restraining the reagent cartridge and the reagent cartridge further includes an alignment guide integrally formed with and extending from the housing for engaging the restraining means on the transport mechanism.

3. The reagent cartridge of claim 2 wherein the restraining means on the transport mechanism comprises a key slot-like slot and the alignment member on the reagent cartridge comprises a projecting key.

4. The reagent cartridge of claim 1 wherein the one-piece body is injection molded.

5. The reagent cartridge of claim 1 wherein one end of the single piece body is wedge shaped.

6. The reagent cartridge of claim 1 wherein the side wall of each reservoir chamber has a threaded end adjacent the access opening, a sealing cap being threadably mounted to provide a fluid seal over each reservoir chamber.

7. The reagent cartridge of claim 1 wherein the transport mechanism has means for supporting and retaining the reagent cartridge at a predetermined position on the transport mechanism, the single-piece body of the reagent cartridge having an open space between the lower ends of the compartments for receiving the means for supporting and retaining the reagent cartridge on the transport mechanism.

8. The reagent cartridge of claim 7 wherein the support and holding means on the transport mechanism has at least one projection and the hollow housing has at least one aperture between the storage chambers for engaging the at least one projection.

9. The reagent cartridge of claim 1, wherein the reagent cartridge further comprises an integrally molded handle defining a bridge portion between the at least two chambers.

10. The reagent cartridge of claim 1 wherein the hollow housing has a side surface with a region for labeling and bar code information.

11. The reagent cartridge of claim 1 wherein the hollow housing has a thinned area forming a see-through panel to allow the level of liquid in the reservoir to be viewed through the thinned area.

12. The reagent cartridge of claim 1 wherein the one-piece body is made of transparent high density polyethylene.

13. The reagent cartridge of claim 1 wherein the side walls of the storage chamber are made of a thin, flexible resin.

14. A reagent cartridge storage apparatus having a transport mechanism for storing a reagent cartridge for use in a clinical instrument, wherein the transport mechanism has an alignment guide integrally formed with and extending from a housing containing a reagent cartridge according to claim 1, the alignment guide having a free end engageable with the receiving means to receive and restrain the cartridge for radial or lateral movement therein.

15. A reagent cartridge storage apparatus having a transport mechanism for storing a reagent cartridge for use in a clinical instrument, wherein the transport mechanism has means for supporting and holding the reagent cartridge of claim 1 at a predetermined position on the transport mechanism, the means being supported by an open space between lower ends of storage chambers of the reagent cartridge.

16. A reagent cartridge storage apparatus having a transport mechanism for storing reagent cartridges for use on a clinical instrument, wherein the transport mechanism has a keyway-like slot for engaging with the raised key-like alignment guide integrally formed with the reagent cartridge of claim 2.