Patent Application
20160279640
The disclosures herein relate generally to patient specimen testing, and more specifically to apparatus for more efficiently testing patient specimens. The testing of patient specimens requires a great deal of precision and accuracy, which necessarily consume a large amount of time in conventional patient specimen testing protocols. It is desirable to maintain this precision and accuracy while processing patient specimen more efficiently.
In one embodiment, a self-contained sample processing cartridge, is disclosed. The sample processing cartridge includes a first cartridge portion including a receiver that receives a specimen slide. The sample processing cartridge further includes a second cartridge portion that closes on the first cartridge portion to form a chamber interior to the cartridge, wherein the specimen slide forms a surface of the chamber. In one embodiment, the specimen slide forms one wall of the chamber to effectively complete the chamber. In one embodiment, the receiver of the first cartridge portion includes an open region adjacent which the specimen slide is received. In one embodiment, the second cartridge portion includes a plurality of fluid inputs and at least one fluid output. The plurality of fluid inputs couples to the chamber by a plurality of channels respectively therebetween. In one embodiment, at least one of the plurality of channels includes a reagent reservoir. In one embodiment, at least one of the plurality of channels includes a blocking reservoir.
The appended drawings illustrate only exemplary embodiments of the invention and therefore do not limit its scope because the inventive concepts lend themselves to other equally effective embodiments.
In one embodiment, a self-contained sample processing cartridge is disclosed. The cartridge includes a lower member with a slide receiver that receives a slide with a sample thereon. The cartridge also includes an upper member configured such that when the upper member is closed upon the lower member, a chamber is formed between the upper member and the lower member. The slide being situated within the sample processing cartridge effectively completes the cartridge chamber and provides one of the major surfaces of the cartridge chamber. The sample processing cartridge includes multiple fluid inputs and at least one fluid output. In one embodiment, the upper member of the cartridge includes multiple fluid channels. One or more of the fluid channels include reservoirs, such as reagent reservoirs and fluid blocking reservoirs, as explained in more detail below. In one embodiment, the user is provided with a complete cartridge assembly except for the glass slide on which the specimen is placed. The reservoirs in the channels of the cartridge assembly are preloaded with reagents required for the particular testing protocol corresponding to the sample on the glass slide of the cartridge. Such reagents may include antibodies, DNA/RNA oligonucleotides and enzymes. When the user places the glass slide in the lower member and closes the upper member, the glass slide forms one of the interior walls of the sealed chamber.
Lower member 200 includes fluid inputs 211, 212, 213, 214 and 215 to which different fluids such as chemical reagents may be supplied when cartridge 100 is fully assembled with glass slide 300 therein. Lower member 200 also includes a fluid output 220 through which all fluids from the chamber within cartridge 100 exit when testing such as staining of the sample (not shown) on the slide 300 within the cartridge is complete.
Cartridge 100 includes gasket 400 that may be fabricated from rubber or similar elastomeric material that provides sealing properties. Gasket 400 includes gasket holes 411, 412, 413, 414 and 415 that mate with fluid inputs 211, 212, 213, 214 and 215, respectively, of lower member 200. Gasket 400 further includes an open region 420 that defines the dimensions of chamber 422. Gasket 400 includes five walls 422-1, 422-2, 422-3, 422-4 and 422-5 that provide the vertical dimension of chamber 422 as depicted in
The output end 424 of chamber 422 is V-shaped to promote better flow of reagents through chamber 422 toward the output of the cartridge. Gasket 400 includes a plurality of check valves such as valve 430 that seat in the corresponding holes such as hole 1-4 that extend to the lower or interior major surface 500C of upper member 500. The plurality of check valves such as valve 430 prevent or limit the undesired backflow of reagents from chamber 422 back toward the fluid inputs 211-215 of cartridge 100.
Cartridge 100 includes 5 fluid channels designated 1, 2, 3, 4 and 5. It is noted that channel 5 snakes around fluid channel 4 in
Cartridge 100 also includes upper member 500 that exhibits four fluid channels that are formed extending into the major surface 502 thereof. These four fluid channels are input channels that are designated 1, 2, 3 and 4 adjacent input end 500A. Upper member 500 also includes an output fluid channel 6 adjacent output end 500B. The lower or interior major surface 500C of upper member 500 provides the top surface, i.e. roof, of chamber 422 when cartridge 100 is completely assembled and closed. In one embodiment, a sealing layer 530 is situated at major surface 502 to seal the fluid channels, input holes, output holes, and reservoirs thereof within cartridge 100. In
A representative fluid flow through a fully assembled closed cartridge 100 containing a sample specimen is now discussed. The fully assembled closed cartridge 100 is placed in one of multiple bays in a test instrument that is discussed in more detail below. While cartridge 100 stores multiple low-volume reagents on board the cartridge itself for a particular test protocol, the test instrument provides higher volume reagents as needed for the particular test. The test instrument acts as a source of higher volume reagents that is external to the cartridge itself. These higher volume reagents may include general reagents and buffers, water, alcohol, and application(s) specific wash reagents and specimen processing reagents. The higher volume reagents are supplied via dedicated reagent port/channel on the cartridge. In actual practice, higher volume reagents pass through reagent fluid channel 4, namely the channel that snakes around channel 4.
For example, if a particular test protocol requires a higher volume of reagent, the test instrument provides the required reagent to a representative fluid input 212 of lower member 200. While
Port 1-1 is a port for incoming lyophilized reagent rehydration water/buffer. Protocol specific Lyophilized reagent (antibodies, DNA/RNA oligonucleotides or enzymes) can be located in position 1-2, and/or 1-3, and/or 1-4. In one embodiment, lyophilized reagent can be located in 1-2 and lyophilized “blank” buffer (without reagents antibodies or DNA/RNA or enzyme) “blocking pellet?” can be “packed” in 1-3, and/or 1-4. In another embodiment, lyophilized reagent can be located within the channel structure (not in reservoir) between the reservoirs and lyophilized “blank” buffer can be “packed” in 1-2 and/or 1-3 and/or 1-4. The lyophilized “blank” buffer acts as chemically dissolvable valves protecting the lyophilized reagents from chamber back-flow or vapors from within the bay manifold or chamber. Packing of the lyophilized blank buffer makes the channel air tight and traps any vapor or moisture entering the channel thus protecting the lyophilized reagent from premature rehydration or vapor contamination prior to its use. When a channel is opened for flow, the rehydration water or buffer flows through that channel rehydrating the lyophilized “blank” buffer and lyophilized reagent and dispensing into the chamber. Each channel 1-4 can contain a unique lyophilized reagent or same. The normally closed check valves within the chamber sealing 1-4 channels also isolate the channels from chamber. When rehydration water or buffer flows through the channel, it rehydrates all lyophilized reagents in its path and pushes the check valve open into the chamber. The purpose of check valves and dissolvable channel block is same as preventing back flow from chamber into the channel and acting as vapor barrier to protect the lyophilized reagent located within that channel path/reservoirs. It is possible to have an embodiment where check valves are not designed in and only blocking lyophilized pellet is utilized as check valves to prevent back flow from chamber into a channel.
A representative fluid channel 1 extends between hole 1-1 and hole 1-5, as shown. The reagent fluid flows from hole 1-1 along channel 1, by reservoir 1-2, by reservoir 1-3, by reservoir 1-4, to exit hole 1-5.
After flowing through fluid channel 1, the reagent exits hole 1-5. The reagent flows downward in the direction of gravity and pressure as indicated by arrow C. Prior to fluid flowing through channel 1, check valve 430 is closed, i.e. check valve 430 rests in a corresponding hole such as 1-4 or 1-5 to prevent backflow of fluids in chamber 422 toward the fluid inputs of cartridge 100. However, once fluid from fluid input 212 passes through channel 1 and reaches valve 430, valve 430 flexibly opens downward in the direction of gravity under the pressure of fluid flow from the input which is under pressure supplied by a pump in the test instrument described below. The reagent provided to input 212 thus reaches chamber 422 and the sample (not shown) on glass slide 400. After passing through chamber 422, the reagent and other fluids in chamber 422 will pass from V-shaped chamber end 422 up to hole 1-6 as indicated by arrow D. The fluids then travel along liquid channel 6 to hole 1-7. From hole 1-7, the fluids travel through gasket output hole 416 as indicated by arrow E. The fluids then travel from gasket whole 416 to fluid output hole 220 in lower member 220, as indicated by arrow F, at which point the fluids are exhausted from cartridge 100 for collection and proper disposal. Once the fluids are drained from the cartridge, the cartridge may be opened and the user removes the slide removed from the cartridge. The specimen on the slide may then be studied under a microscope. Such viewing under a microscope is post-processing, i.e. post-staining or post treatment by the liquid chemicals that were in chamber 422.
In one embodiment, cartridge 100 may include multiple interior alignment pins and corresponding holes that assist in aligning, mating and closing upper member 502 to lower member 200.
The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms “a”, “an” and “the” are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms “comprises” and/or “comprising,” when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof.
The corresponding structures, materials, acts, and equivalents of all means or step plus function elements in the claims below are intended to include any structure, material, or act for performing the function in combination with other claimed elements as specifically claimed. The description of the present invention has been presented for purposes of illustration and description, but is not intended to be exhaustive or limited to the invention in the form disclosed. Many modifications and variations will be apparent to those of ordinary skill in the art without departing from the scope and spirit of the invention. The embodiment was chosen and described in order to best explain the principles of the invention and the practical application, and to enable others of ordinary skill in the art to understand the invention for various embodiments with various modifications as are suited to the particular use contemplated.
