WO2007133757A2

WO2007133757A2 - Reusable slide assembly

Info

Publication number: WO2007133757A2
Application number: PCT/US2007/011589
Authority: WO
Inventors: Jeffrey Aaronsen; Greg Witchel; Andrew Soncha
Original assignee: Diasys Corporation
Priority date: 2006-05-15
Filing date: 2007-05-15
Publication date: 2007-11-22
Also published as: WO2007133757A3

Abstract

A reusable slide assembly is described, including a body portion having at least one sample fluid flow pathway, the pathway including at least one examination region in communication with inlet and outlet regions, wherein the body may be e.g., an injection-molded piece at least partially defining on a portion thereof the sample fluid flow pathway or bonded glass pieces defining a fluid flow path between the outer extremities, thereof.

Description

REUSABLE SLIDE ASSEMBLY

BACKGROUND

[0001] The present disclosure relates generally to an apparatus and method for standardizing the handling of diverse body fluids. The present disclosure specifically relates to a slide assembly. In an exemplary embodiment, such slide assembly is an optical slide assembly used for manual counting, identification, and manipulation of microscopic elements in liquid suspensions and fluids with a microscope positioned to view the liquid suspension in the slide assembly.

[0002] In another exemplary embodiment, such a slide assembly may be useful in a process that controllably draws a sample selected from a specimen container, such as a test tube, into an optical slide assembly for examination and that controllably purges the sample therefrom upon completion of such examination.

[0003] Systems and devices for fecal analysis and urinalysis are extensively used and practiced in clinics, laboratories and the like. With the increased presence of infectious diseases, such as AIDS, in biological materials, the need for safe systems and devices to minimize the handling of these potentially dangerous substances becomes evident.

[0004] As described by U.S. Patent Nos. 4,393, 466 and 4,612,614, urine sediment examination typically involves pouring a sample into a tube, which is then spun in a centrifuge to separate the sediment from its suspending fluid. After centrifugation, the cleared suspending fluid is poured out and the sediment is re-suspended in the remaining fluid. A sample of the re-suspended sample must then be transferred to a microscopic slide for examination with a microscope.

[0005] U.S. Pat. Nos. 4,804,267, 5,393,494 and 5,895,762 to Greenfield et al., the contents of which are specifically incorporated herein by reference, also describe fluid sample analyzing systems, wherein a pump is used to pull a sample or a flushing fluid through a slide assembly, also known as a flow cell, having an optical window. PRIOR ART FIGURE 1 illustrates such a slide assembly 26. The slide assembly 26 includes separately formed glass enclosures, or viewing chambers 30, 32, which are each similar to the transparent glass enclosures as shown and described in the aforementioned and incorporated by reference U.S. Patent No. 5,393, 494 in its FIGS. 17-22. The viewing chambers 30, 32 are mounted within frame 110. A pair of elongate side-by-side parallel recesses 11 1.1 and 111.2 is provided in the frame to receive and retain the glass enclosures 30, 32. Each glass enclosure 30, 32 overlies an opening 112 in the frame 110 to enable a back lighting for enhanced viewing.

[0006] Referring still to PRIOR ART FIGURE 1, glass enclosures 30, 32 are connected to fluid tubings 38.1 and 38.2 via a plurality of connectors, including 36.1 and 36.2, among others. Similar connectors (38.3 and 38.4, among others) are provided at an outlet end of the assembly.

[0007] Problems encountered with such slide assemblies have included high production costs, including labor and tooling for creating reproducible slide volumes, complex component assemblies, expensive component materials, sample fouling of the slide assemblies, and the like. When the flow cell is made with plastic components through which either the microscope views the test sample or through which illuminating light passes, distortions also tend to appear in the field of view of the microscope.

[0008] Additionally, conventional slide assembly constructions, including the constructions of the flow chambers as well as the rest of the slide, are fragile and are prone to breakage during use. Indeed, such prior constructions are often, or are often as fragile as drawn glass tubes (e.g., with wall thicknesses of less than about .005 inch), which will break if an objective lens presses on the slide. This possibility of breakage constitutes a significant contamination risk.

[0009] Also, in areas where the passageway into the viewing chamber of the slide assembly has relatively abrupt turns, tiny bubbles tend to form. Such bubbles may be entrained into the viewing chamber where they obscure or confuse the clarity of the field of view of the microscope. [0010] Furthering the problems laid out above, the importance that slide assemblies be sufficiently thin to enable mounting to any microscope without interference with different lenses of a microscope turret should be noted. It should also be noted that the slide assembly should be useful with a variety of microscopic techniques such as the one commonly known as "bright field" and other techniques generally referred to as Hoffman modulation, phase contrast, polarized light and fluorescence. It is furthermore desirable that relatively small amounts of test fluid be used to fill a viewing chamber of a slide assembly so that more than one examination can be made with the same test fluid.

[0011] There is a demand for a reusable slide assembly free from the above-described problems.

SUMMARY

[0012] The above and other problems and disadvantages of the prior art are overcome and alleviated by the presently described reusable slide assembly, which comprises at least one body portion having at least one sample fluid flow pathway. In an exemplary embodiment, the fluid flow pathway includes at least one examination region in communication with inlet and outlet regions. In another exemplary embodiment, the body comprises at least one injection-molded piece at least partially defining on a portion thereof an integral sample fluid flow pathway. In another exemplary embodiment, such body comprises two injection-molded pieces that may be joined to define at least one sample fluid flow pathway. In another exemplary embodiment, such body comprises two glass pieces, and such glass pieces are bonded to end pieces. In another exemplary embodiment, the two end pieces are plastic end pieces. In another exemplary embodiment, such examination region comprises at least one transparent area in the body on both sides of the fluid flow pathway.

[0013] In another exemplary embodiment, the fluid flow pathway comprises a molded or otherwise formed channel in a body portion or between body portions, the channel in fluid communication with inlet and outlet regions. In another exemplary embodiment, such end pieces are plastic end pieces, which are bonded to two glass pieces having a fluid flow pathway between the outer extremities thereof. Such fluid flow pathway may be at least partially integral to one or both body portions (e.g., ground into a lower, glass body portion), or such fluid flow pathway may be defined between two body portions, e.g., by flow pathway defining material, such as adhesive, gasket material, spacers, etc.). In another exemplary embodiment, inlet and outlet regions are molded or otherwise formed in the same body portion(s) described above. In another exemplary embodiment, the inlet and outlet portions formed in said body portion are sized to receive tubing for transport of samples into or out of the inlet and outlet regions- The inlet and outlet portions may be sized to securely fit such tubing therein such that the tubing may be secured, e.g., by application of adhesive at the outside portion of the inlet and outlet regions (i.e., adhesive does not contact the fluid path). In another exemplary embodiment, the inlet and outlet portions are formed at an angle relative to the fluid flow path in the examination region.

[0014] In another exemplary embodiment, the slide assembly is outfitted with an end of life indicator. In one such embodiment, such slide assembly must be unpacked before installation. Exposure to air causes a change in a visual property of at least a portion of the slide (e.g., a color change). End of life may be indicated according to the level of change in such visual property. In another such embodiment, such slide assembly undergoes a visual property change upon exposure to heat (such as might be generated by a microscope). In another exemplary embodiment, an electronic chip is included on or in a portion of the slide, which chip is configured to interface with electronics on a slide workstation. Such chip is designed to store information relevant to the use of the slide within that given workstation, e.g., how many times the slide has been used. In one exemplary embodiment, the slide or workstation is configured to reject use of the slide after a predetermined maximum parameter (e.g., maximum number of uses) is attained. Such body portion may also be configured with a protruding portion configured to receive such chip.

[0015] In another exemplary embodiment, the slide incorporates a counting grid overlying a region overlying the fluid pathway, which grid permits a visual demarcation of a size/length measurement (e.g., in microliters). [0016] The above discussed and other features and advantages of the reusable slide assembly will be appreciated and understood by those skilled in the art from the following detailed description and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0017] Referring now to the drawings, wherein like elements are numbered alike in the several

FIGURES:

[0018] PRIOR ART FIGURE 1 illustrates a top view of a multi-component optical slide assembly;

[0019] FIGURE 2 illustrates a cross sectional side view of an exemplary slide assembly upper body component;

[0020] FIGURE 3 illustrates a top view of the exemplary slide assembly upper body component illustrated in FIGURE 2;

[0021] FIGURE 4 illustrates a cross sectional side view of an exemplary side assembly lower body component;

[0022] FIGURE 5 illustrates a top view of the slide assembly lower body component illustrated in FIGURE 4;

[0023] FIGURE 6 illustrates a cross sectional side view of an exemplary inlet or outlet port;

[0024] FIGURES 7-10 illustrate exemplary dimensions and alternate embodiments of the present slide assembly;

[0025] FIGURE 11 illustrates top elevation and side elevation views of an exemplary dual pathway slide;

[0026] FIGURE 12 illustrates top elevation and side elevation views of an exemplary single pathway slide;

[0027] FIGURE 13 illustrates top plan views of exemplary carrier inserts, which inserts assist in defining fluid flow pathways; and

[0028] FIGURE 14 illustrates exemplary aspects of an exemplary end piece, which end piece connects to the slide body portion(s). DETAILED DESCRIPTION

[0029] Reference will now be made in detail to exemplary embodiments, examples of which are illustrated in the accompanying drawings.

[0030] With reference to FIGURES. 2-5, exemplary slide assembly components are illustrated. FIGURES 2 and 3 illustrate an upper body portion, shown generally at 10. The upper body portion 10 at least partially defines a fluid flow pathway 11 as at least part of a recess 13. The fluid flow pathway 11 comprises an examination region, shown generally at 14, and fluid inlet and outlet regions, shown generally at 16 and 18. In the illustrated exemplary embodiment, the examination region 14 includes at least one optically transparent region adjacent the fluid flow pathway 11. Such transparent region may be provided, for example, by injection molding the entire upper portion out of transparent plastic, by dual shot molding an optically transparent plastic in with a second plastic, by adhering a transparent window over a hole in the upper body portion, or by some equivalent process. In another exemplary embodiment, the walls of the fluid flow pathway are about .007 inch or above. In another embodiment, such fluid flow pathway is configured such that an objective lens strattles the fluid flow pathway and would impact the side portions around the fluid flow pathway rather than the pathway itself. In either and both of the last two described embodiments, a particularly robust slide assembly results.

[0031] Referring to FIGURES 11 and 12, another exemplary embodiment illustrates dual and single flow pathways 1 Ia, 1 Ib, provided between the outer surfaces of an upper body portion 40 and a lower body portion 42. The fluid flow pathways may be defined by any convenient method, including, as described above, injection molding techniques, etching fluid pathways into one of the body portions (e.g., etching into a lower, glass body portion), by defining the pathways between the bodies with insert material, such as adhesive, gasket materials, spacers, or the like, such as with FIGURE 13. In the embodiments illustrated at FIGURES 11 and 12, end pieces 44 are illustrated as connected to the slide. Exemplary such end pieces are illustrated at FIGURE 14 (It is to be noted with regard to any of the FIGURES that noted dimensions are merely exemplary and by no means limiting). Also, a counting grid may be seen generally at 46 in FIGURE 12. Such grid may be integral with the top body portion 40 or may be provided as an overlying print, film, etc.

[0032] Referring again to FIGURES 2 and 3, the illustrated exemplary inlet and outlet regions 16, 18 are configured to receive tubing (not shown), which transports fluid to and from the slide assembly. The tubing may be inserted in the apertures 20, 22. Such tubing may subsequently be secured to the inlet and outlet regions 16, 18 by any number of ways, including placing adhesive at, for example, position 24. The tubing may also be held by friction fit, threading, clamping or the like, among others.

[0033] Referring now to FIGURES 4 and 5, an exemplary lower body portion is illustrated generally at 28. The illustrated exemplary lower body portion 28 is sized to be received at least partially within the recess 13 of the upper body portion 10. The fit of the lower body portion 28 within the recess defines the fluid flow pathway 11. The lower body portion 28 may be adhered or otherwise affixed to the upper body portion 10 to complete the assembly. The illustrated lower body portion 28 includes at least one transparent region 34 to facilitate analysis of the fluid sample.

[0034] While the illustrated exemplary embodiment shows a lower body portion 28 configured to be received at least partially within the recess 13 of the upper body portion 10, the lower body portion 28 may alternately be configured to be flush with or to receive a portion of the upper body portion 10. Additionally, the lower body portion 28 and/or the upper body portion 10 may be molded or otherwise contoured to further define the boundaries of the fluid flow pathway 11 (e.g., to define multiple pathways).

[0035] Referring now to the exemplary inlet or outlet port 16, 18 illustrated by FIGURE 6, the inlet or outlet port 16, 18 may be inclined by an angle 0 relative to the fluid flow path 11. While illustrated angle is approximately 15 degrees, any angle above zero degrees and less than 90 degrees is contemplated. [0036] Specific exemplary dimensions and additional embodiments (e.g., a dual path embodiment with two sets of inlets and outlets) are illustrated at FIGURES 7-10.

[0037] An exemplary electronic end of life indicator or other parameter measurement device (in addition to or in the alternative to the visual indicators, discussed above) may be included on or in the optical slide. For example, with reference to FIGURE 11, such chip may be provided on protruding portion 48 at FIGURE 11.

[0038] It will be apparent to those skilled in the art that, while exemplary embodiments have been shown and described, various modifications and variations can be made to the slide assembly and/or applications utilizing a slide assembly disclosed herein without departing from the spirit or scope of the invention. Accordingly, it is to be understood that the various embodiments have been described by way of illustration and not limitation.

[0039] What is claimed is:

Claims

1. A slide assembly, comprising: at least one body portion having at least one sample fluid flow pathway having at least one examination region in communication with inlet and outlet regions.

2. The slide assembly in accordance with claim 1, wherein the examination region includes at least one optically transparent portion adjacent said fluid flow pathway.

3. The slide assembly in accordance with claim 1, wherein the at least one body portion includes a recess at least partially defining said fluid flow pathway as well as at least one of said inlet and outlet regions configured to interface with a fluid delivery conduit.

4. The slide assembly in accordance with claim I₃ wherein at least one of said inlet and outlet regions is configured to the external contours of a fluid delivery conduit such that the fluid delivery conduit may engage said inlet and outlet region as a fluid-tight fit.

5. The slide assembly in accordance with claim 1, wherein at least one of said inlet and outlet regions is configured at an angle relative to the examination region of said fluid flow pathway.

6. The slide assembly in accordance with claim 1, further comprising a lower body portion configured to engage said upper body portion to define the boundaries of said fluid flow pathway.

7. The slide assembly in accordance with claim 6, wherein said lower body portion is at least partially received in the recess of said at least one body portion to define the boundaries of said fluid flow pathway.

8. The slide assembly in accordance with claim 7, wherein said at least one body portion and said lower body portion cooperate to define at least two fluid flow pathways.

9. The slide assembly in accordance with claim 6, wherein the lower body portion is adhesively bonded to said at least one body portion.

10. The slide assembly in accordance with claim.1 , wherein said at least one body portion is outfitted with an end of life indicator.

11. The slide assembly in accordance with claim 10, wherein said end of life indicator is activated by exposure to air or exposure to heat or exposure to light.

12. The slide assembly in accordance with claim 11, wherein said end of life indicator generates a visual property change indicative of end of life of the slide assembly.

13. The slide assembly in accordance with claim 1, further comprising an electronic chip provided on or within said slide assembly.

14. The slide assembly in accordance with claim 13, wherein said electronic chip stores data relating to the number of uses of said slide assembly.

15. The slide assembly in accordance with claim 14, wherein said electronic chip indicates an end of life according to a predetermined maximum number of uses of said slide assembly.

16. The slide assembly in accordance with claim 1, wherein the slide comprises an upper body portion, a lower body portion, and at least one fluid flow pathway provided between the outer extremities of said body portions.

17. The slide assembly in accordance with claim 16, wherein said body portions are glass.

18. The slide assembly in accordance with claim 16, wherein said upper and lower body portions are bounded on two sides by end pieces.

19. The slide assembly in accordance with claim 18, wherein said end pieces are plastic.

20. The slide assembly in accordance with claim 16, wherein said fluid flow pathway is ground out of one or both of the body portions, integral to a molded portion of said body portions, and/or at least partially defined by an insert material, such as an adhesive, a gasket material, a spacer material or the like.

21. The slide assembly in accordance with claim 2, wherein said optically transparent portion includes a counting grid portion.