[0001] The present application claims the filing benefit of co-pending U.S.

Provisional Application No. 61 /277,804, filed September 30, 2009, and U.S. Serial No. 12/893,732, filed September 29, 201 0, each disclosure of which is incorporated herein by reference in its entirety.

FIELD OF THE INVENTION

[0002] The present invention relates generally to tissue processing cassettes and, more particularly, to a cassette that can be used during handling and processing of a sample by automated equipment.

BACKGROUND OF THE INVENTION

[0003] Since the introduction of tissue cassettes more than forty years ago, these devices have become routinely used for processing tissue specimens. During the past forty years, chemical processing and embedding has become automated and many different tissue processors are now commercially available. Further, labeling of cassettes with patient information has also become automated with the

introduction of instruments such as the Tissue-Tek® AutoWrite™ cassette printer (Sakura Finetek), and the Shandon MicroWriter™ cassette labeler or PrintMate™ cassette labeler (both from Thermo Fisher Scientific).

[0004] Automation has contributed to an increase in processing capacity.

However, the chemical reactions necessary for proper preservation of tissues have fixed lower time limits. In addition, the number of cassettes contained by a processor instrument is limited by the size of its retort chamber, with the goal of most equipment design being to conserve valuable laboratory space, whether floor space or counter-top space. Therefore, automated instrumentation intended for use in a typical laboratory has limits as to the number of specimens that can be processed during a given period of time and other means of increasing the processing capacity of tissue specimens besides improvement to processing instruments have been sought.

[0005] One solution is a multi-chambered cassette such as described in

Yamamoto et al., U.S. Patent No. 5,061 ,452. Because instruments associated with automated labeling and handling of cassettes are adapted to function with a particular cassette size or "footprint", generally 20-30 mm by 30-40 mm, a multi- chambered cassette with 3-9 chambers as recommended by Yamamoto et al. must fit the standard footprint, making each of the individual chambers suitable for small samples only. Moreover, a multi-chambered cassette is further limited to containing tissue samples from the same patient because each cassette is labeled with only one identification number or code. Generally, laboratories prefer a one-on-one relationship between a specimen and the cassette that contains it.

[0006] There is a need for a cassette which holds a single specimen, increases processing capacity and has a standard footprint to permit automated handling.

SUMMARY OF THE INVENTION

[0007] The present invention overcomes the foregoing and other shortcomings and drawbacks of tissue processing cassettes heretofore known for use in processing tissue specimens. While the invention will be described in connection with certain embodiments, it will be understood that the invention is not limited to these embodiments. On the contrary, the invention includes all alternatives, modifications and equivalents as may be included within the spirit and scope of the present invention.

[0008] The present invention, in its broad aspect, is a size-adjustable device for use during handling and processing of a sample wherein the device includes a sample processing cassette and an extension member coupled thereto that present a first footprint of a standard sized cassette for use during certain automated steps designed to function with standard sized cassettes, such as labeling, embedding, and sectioning (microtomy), and a second reduced footprint for use during chemical processing, such as fixation and dehydration, thereby increasing the processing capacity.

[0009] The above and other objects and advantages of the present invention shall be made apparent from the accompanying drawings and the description thereof.

BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with a general description of the invention given above, and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0011] FIG. 1 is a perspective view of a device, including a sample processing cassette having a sample container portion and an extension member, according to one embodiment of the present invention, showing the extension member extending away from the sample container portion;

[0012] FIG. 2 is a perspective view of the device of FIG. 1 , showing the extension member forming a lid covering the sample container portion;

[0013] FIG. 3 is an inverted cross-sectional view of the device shown in FIG. 1 , taken along lines 3-3 of FIG. 1 ;

[0014] FIG. 4 is an inverted cross-sectional view of the device shown in FIG. 2, taken along lines 4-4 of FIG. 2;

[0015] FIG. 5 is a perspective view of a device, including a sample processing cassette and an extension member, according to another embodiment of the present invention, showing the extension member detached from the sample container portion;

[0016] FIG. 6 is a perspective view of the device of FIG. 5, showing the extension member interlocked with the sample container portion;

[0017] FIG. 7 is a cross-sectional view of the device shown in FIG. 6, taken along lines 7-7 of FIG. 6; and

[0018] FIG. 8 is a cross-sectional view of the device shown in FIG. 7, taken along lines 8-8 of FIG. 7.

DETAILED DESCRIPTION OF THE INVENTION

[0019] Referring now to the figures, and to FIGS. 1 -4 in particular, a device 10 is shown according to one embodiment for use during handling and processing of a sample, such as a tissue specimen by way of example. The device 10 includes a sample processing cassette 1 2 having a sample container portion 14 that is configured to receive a tissue specimen (not shown) therein. The sample container portion 14 has a cavity 16 formed therein that is bounded by a pair of opposite side walls 18, a pair of opposite end walls 20 and a bottom wall 22. A labeling surface 24, as will be described in greater detail below, is provided external to the sample container portion 14. It will be appreciated that the term "bottom" is used herein in reference to a particular orientation of the device 10 as shown in the figures and thus this term should not be considered limiting but rather depending on a particular orientation of the device 10.

[0020] According to one aspect of the present invention, the sample container portion 14 is reduced in area compared to that of a standard cassette (not shown) due to a decrease in length and, optionally, in width. FIG. 1 shows one embodiment of an exemplary sample processing cassette 12 wherein the labeling surface 24 is of standard width "W", for example, approximately 29 mm, but the sample container portion 14 is reduced in width, for example, with an outer width "W ₀ " of approximately 22 mm and an inner width "W " of approximately 20 mm. However, other dimensions are anticipated. The length "L" of the sample processing cassette 1 2 is also reduced, for example, to approximately 25 mm, with the length of the sample container portion 14 being about 12 mm. It will be appreciated that these

measurements are purely exemplary and other dimensions are possible. By comparison, a standard cassette (not shown) of the prior art may have a footprint of approximately 29 mm x 40 mm.

[0021] In accordance with one aspect of the present invention, to form a device 10 having a standard footprint (i.e., a footprint similar to the footprint of a standard cassette as described above), an extension member 26 may be pivotally or rotatably attached or coupled to the sample processing cassette 12 so that it extends away from the sample container portion 14 as shown in FIGS. 1 and 3. For example, according to one embodiment a shown in FIGS. 1 -4, a hinge connection 28 may be provided to operatively couple the extension member 26 to the sample container portion 14 so that the extension member 26 is foldable relative to the sample container portion 14 between a first position as shown In FIG. 1 and 3, wherein the extension member 26 extends away from the sample container portion 14, to a second position as shown in FIGS. 2 and 4, wherein the extension member 26 overlies the sample container portion 14. In the second position, the extension member 26 forms a lid covering the sample container portion 14. As shown in FIGS. 3 and 4, selected portions of the sample container portion 14 and the extension member 26 may have essentially the same height "H". [0022] It will be appreciated that the hinge connection 28 may be a mechanical hinge connection as shown in FIGS. 1 -4. Alternatively, the hinge connection may be provided by a living hinge or any other suitable hinge connection that allows the extension member 26 to be folded relative to the sample container portion 14 to the first and second positions as shown in FIGS. 1 -4.

[0023] When the extension member 26 is folded to the first position as shown in FIGS. 1 and 3, the overall length "L _d " of the device 10 is increased to approximate that of a standard cassette, for example, approximately 40 mm. This provides a standard footprint so that the sample processing cassette 12 may be manipulated by equipment designed to manipulate standard-sized cassettes, for example, automated cassette labelers, microtome specimen holders, and the like.

[0024] Because the sample container portion 14 is reduced in width as described above, when the extension member 26 is folded to the first position in place over the sample container portion 14, the total width of the sample processing cassette 1 2 does not exceed the standard width of approximately 29 mm, since the sidewalls 30 of the extension member 26 fit in the recessed areas 32 provided on the outside of the sample container portion 14. In the folded configuration of the device 1 0 as shown in FIGS. 2 and 4, the device 1 0 has a reduced footprint that is advantageous during chemical processing, such as fixation and dehydration for example, thereby increasing the processing capacity of automated processing equipment.

[0025] In yet another embodiment, the end 34 of the sample container portion 14 opposite the labeling surface 24 may contain locking structure (not shown) such as tabs or notches that releasably interlock with cooperating locking structure (not shown) provided on a confronting end 36 of the extension member 26. Those of ordinary skill in the art will readily appreciate the various locking structures that may be provided on the sample container portion 14 and the extension member 26 so as to provide a releasable interlocking engagement therebetween.

[0026] When the extension member 26 is attached to the sample processing cassette 12 in this manner as shown in FIGS. 1 and 3, the overall length "L _d " of the device 10 is increased to approximate that of a standard cassette, for example, approximately 40 mm. This also provides a standard footprint so that the sample processing cassette 12 may be manipulated by equipment designed to manipulate standard-sized cassettes, for example, automated cassette labelers, microtome specimen holders, and the like. Preferably, when the extension member 26 is detached from the sample processing cassette 1 2, the extension member 26 may serve as a lid for the sample container portion 14 as shown in FIGS. 2 and 4. As shown in FIGS. 3 and 4, selected portions of the sample container portion 14 and the extension member 26 may have essentially the same height "H".

[0027] Alternatively, the locking structures (not shown) provided on the sample container portion 14 and the extension member 26 may interact in such a way so as to permit the extension member 26 to rotate in a folding motion so as to form a lid to enclose the sample container portion 14 as shown in FIGS. 2 and 4. Alternatively, the sample processing cassette 12 may be provided with a separate lid (not shown) of a conventional design known to those of ordinary skill in the art.

[0028] Referring now to FIGS. 5-8, a device 100 is shown according to another exemplary embodiment of the present invention. In this embodiment, the length and width of the sample container portion 1 14 of the sample processing cassette 1 12 is reduced compared to a standard cassette but the labeling surface 124 is

approximately 29 mm in width. An extension member 126, including an arm 127 on each of the opposing sides 129 of the extension member 126, defines a space 1 31 sized to receive the sample container portion 1 14. The arms 1 27 may contain features, such as tracks, grooves or ridges that form a secure fit with a pair of resilient tabs 133 provided on the sample container portion 1 14. Those of ordinary skill in the art will readily appreciate other suitable locking structures that may be provided on the extension member 126 and the sample container portion 1 14 to provide a releasable locking engagement therebetween without departing from the spirit and scope of the present invention.

[0029] When assembled as a combination comprising the sample container portion 1 14 and extension member 1 26 as shown in FIGS. 6-8, the total length "L _d " of the device 100 is about 40 mm and the total width "W" at the widest point is approximately 29 mm. Optionally, the sample processing cassette 1 12 has a lid 1 35 formed as a separate piece as shown in FIGS. 6-7 or the lid may be connected to the sample container portion 1 14 by a living hinge or mechanical hinge as will be appreciated by those of ordinary skill in the art. With the extension member 126 detached from the sample container portion 1 14 as shown in FIG. 5, the device 1 00 also has a reduced footprint that is advantageous during chemical processing, such as fixation and dehydration for example, thereby increasing the processing capacity of automated processing equipment.

[0030] In each embodiment of the devices 10 and 100 shown in the figures, the bottom walls 22 and 122 of the sample container portions 14, 1 14 may be perforated with one or more holes, slots, apertures or other openings 37, 137 to allow for fluid passage both into and out of the sample processing cassette 12 or 1 1 2 to facilitate exposure of tissues to reagents and drainage of the reagents from the cassette. The openings 37, 1 37 may be formed in a variety of sizes, shapes and numbers as long as they permit fluid exchange and drainage without loss of the tissue specimen from the sample container portions 14, 1 14. Similarly, the lid 135 or the extension member 26, 1 26, particularly if used as a lid, may contain openings 39, 1 39 to facilitate fluid exchange and drainage.

[0031] The labeling surface 24 or 124 may be formed with its anterior surface at an angle of approximately 45° to accommodate most automated labelers. The positional relationship of the labeling surface 24, 124 to the sample container portion 14, 1 14 may be such that the open face of the sample container portion 14, 1 14 is in the same plane as the vertex 41 , 141 of the angled labeling surface 24, 1 24 as shown in FIGS. 1 -4. Alternatively, the bottom wall 22, 122 of the sample container portion 14, 1 14 may be in the same plane as the vertex 41 , 141 of the angled labeling surface 24, 124 as shown in FIGS. 5-8. The scope of the present invention encompasses any combination of features described herein.

[0032] The sample processing cassette 12, 1 12, lid 135, and/or extension member 26, 126 may be formed of any suitable material or materials. For example, the cassette 12, 1 1 2, lid 1 35, and/or extension member 26, 1 26 may be molded from a polymer material including, without limitation, polyester, polyamide, polyacetal, polycarbonate, nylon, or fluoroplastic, or formed from metal, such as stainless steel, or any combination of suitable materials. In general, the selected material or materials should be resistant to the types of chemicals and solvents typically used to process tissue specimens, including alcohols, acetone, and xylene. Generally, it is preferred to make at least the cassette 12, 1 12 from a sturdy but inexpensive material so as to be disposable. Alternatively, any one or more of the cassette 12, 1 12, lid 135, or extension member 26, 126 may be composed of a more durable material for repeat use. [0033] The invention has been described herein specific embodiments for illustrative purposes only and not with an intent to limit the invention to these specific embodiments. The present invention covers other modifications, changes, and alternative embodiments as may be apparent to those skilled in the art.

[0034] Although for most uses, a lid for covering the sample container portion 14, 1 14 is useful, the type of lid is not critical to the invention. The lid may be hinged, for example with a "living" hinge or a mechanical hinge, or the lid may be a separate and removable piece as shown in FIGS. 5-7.

WHAT IS CLAIMED IS: