METHOD OF LOADING CONSUMABLES INTO A SAMPLE PROCESSING INSTRUMENT
20240216920 ยท 2024-07-04
Inventors
Cpc classification
B01L9/543
PERFORMING OPERATIONS; TRANSPORTING
B65D25/108
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/048
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0829
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/02
PERFORMING OPERATIONS; TRANSPORTING
B01L2200/025
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/0609
PERFORMING OPERATIONS; TRANSPORTING
B01L9/06
PERFORMING OPERATIONS; TRANSPORTING
B01L9/523
PERFORMING OPERATIONS; TRANSPORTING
B65D2543/00444
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/047
PERFORMING OPERATIONS; TRANSPORTING
B01L2300/041
PERFORMING OPERATIONS; TRANSPORTING
G01N2035/00792
PHYSICS
B65D43/0202
PERFORMING OPERATIONS; TRANSPORTING
B65D2543/00935
PERFORMING OPERATIONS; TRANSPORTING
International classification
B01L3/00
PERFORMING OPERATIONS; TRANSPORTING
B01L9/06
PERFORMING OPERATIONS; TRANSPORTING
B01L9/00
PERFORMING OPERATIONS; TRANSPORTING
B65D25/10
PERFORMING OPERATIONS; TRANSPORTING
Abstract
A method of loading consumables into a sample processing instrument. In the method, a tray storing sample processing consumables is aligned with a support cavity defined by a support of the sample processing instrument. A flange is contacted with a portion of the support, where the flange extends outward from a wall of a cover coupled to the tray. The cover is decoupled from the tray by pressing a panel of the cover, and the tray is seated in the support cavity.
Claims
1. A method of loading consumables into a sample processing instrument, comprising: aligning a tray with a support cavity defined by a support of the sample processing instrument, the tray storing sample processing consumables; contacting a flange with a portion of the support, the flange extending outward from a wall of a cover coupled to the tray; decoupling the cover from the tray by pressing a panel of the cover; and seating the tray in the support cavity.
2. The method of claim 1, wherein the support comprises a support base and a support wall extending from the base, the support base and the support wall defining the support cavity; and wherein the support wall comprises the portion of the support the flange contacts.
3. The method of claim 1, wherein the aligning the tray with the support cavity comprises inserting a portion of the tray extending beyond a cover cavity defined by the cover into the support cavity.
4. The method of claim 1, wherein decoupling the cover from the tray and the seating the tray in the cavity occur simultaneously.
5. The method of claim 1, further comprising removing, after decoupling the cover from the tray, the cover from the sample processing instrument.
6. The method of claim 1, wherein the sample processing instrument is configured to perform an assay for determining the presence of an analyte in a sample.
7. The method of claim 1, wherein the sample processing instrument is configured to perform sample preparation.
8. The method of claim 1, wherein the sample processing consumables comprise receptacles.
9. The method of claim 1, wherein the sample processing consumables comprise caps for closing openings of the receptacles.
10. The method of claim 1, wherein the sample processing consumables comprise pipette tips.
11. The method of claim 1, wherein the sample processing consumables comprise reagent containers.
12. The method of claim 1, wherein the sample processing consumable is a cleaning member configured to clean or sterilize a component of the sample processing instrument.
13. The method of claim 1, wherein the seating the tray in the cavity comprises dropping the tray into the support cavity.
14. The method of claim 1, wherein the decoupling the cover from the tray by pressing the panel comprises applying a force that overcomes a press fit formed between the cover and the tray.
15. A method of loading consumables into a sample processing instrument, comprising: aligning a tray with a cavity defined by a support of the sample processing instrument, the tray storing consumables and being coupled to a cover; decoupling the cover from the tray by pressing a panel of the cover; generating sensory feedback when the cover is decoupled from the tray; seating the tray in the cavity defined by the support of the sample processing instrument.
16. The method of claim 15, wherein the sensory feedback comprises tactile feedback.
17. The method of claim 16, wherein the tactile feedback is generating by overcoming a press fit between the cover and the tray.
18. The method of claim 15, wherein the sensory feedback comprises audible feedback.
19. The method of claim 15, wherein the audible feedback is generating by bending of the panel of the cover.
20. The method of claim 15, wherein the sensory feedback comprises visual feedback.
21. The method of claim 15, wherein the decoupling the cover from the tray and the generating sensory feedback occur simultaneously.
22. The method of claim 15, wherein the decoupling the cover from the tray and the seating the tray in the cavity occur simultaneously.
Description
DESCRIPTION OF THE DRAWINGS
[0032] The accompanying drawings, which are incorporated herein and form a part of the specification, illustrate the embodiments and, together with the description, further serve to explain the principles of the embodiments and to enable a person skilled in the relevant art(s) to make and use the embodiments.
[0033]
[0034]
[0035]
[0036]
[0037]
[0038]
[0039] The features and advantages of the embodiments will become more apparent from the detailed description set forth below when taken in conjunction with the drawings, in which like reference characters identify corresponding elements throughout.
DETAILED DESCRIPTION
[0040] The present disclosure will now be described in detail with reference to embodiments thereof as illustrated in the accompanying drawings. References to one embodiment, an embodiment, some embodiments, an exemplary embodiment, for example, an example, exemplary, etc., indicate that the embodiment described may include a particular feature, structure, or characteristic, but every embodiment may not necessarily include the particular feature, structure, or characteristic. Moreover, such phrases are not necessarily referring to the same embodiment. Further, when a particular feature, structure, or characteristic is described in connection with an embodiment, it is submitted that it is within the knowledge of one skilled in the art to affect such feature, structure, or characteristic in connection with other embodiments whether or not explicitly described.
[0041] As used herein, a or an means at least one or one or more.
[0042] As used herein, a sample processing instrument refers to any instrument capable of performing a processing step on a sample contained within a receptacle. A sample processing instrument includes any instrument capable of performing an assay on a sample and rendering a result. For example, a sample processing instrument includes any instrument capable performing an assay on a sample to determine the presence of an analyte in the sample. Any instrument capable of performing a hybridization assay, a molecular assay including a nucleic-acid-based amplification reaction, a sequencing assay, an immunoassay, or chemistry assay on a sample is included in this definition of a sample processing instrument. Exemplary sample processing instruments instrument capable performing an assay on a sample to determine the presence of an analyte in the sample include the Tigris? and Panther? systems sold by Hologic, Inc., Bedford, MA, as well as any of the diagnostic instruments disclosed in U.S. Patent Application Publication No. 2016/0060680, published Mar. 3, 2016. A sample processing instrument also includes any instrument that only performs sample preparation steps and is not capable of analyzing a sample and/or rendering a result. For example, an instrument that transfers a sample from one receptacle to another receptacle or adds one substance to a receptacle containing a sample, but does not perform an assay on the sample, is a sample processing instrument. And, for example, an instrument that only performs sample preparation steps to isolate and/or purify an analyte of interest is a sample processing instrument. An exemplary sample processing instrument that only performs sample preparation steps is the Tomcat? system sold by Hologic, Inc., Bedford, MA.
[0043] As used herein, a sample refers to any material to be analyzed, regardless of the source. The material may be in its native form or any stage of processing (e.g., the material may be chemically altered or it may be one or more components of a sample that have been separated and/or purified from one or more other components of the sample). A sample may be obtained from any source, including, but not limited to, an animal, environmental, food, industrial or water source. Animal samples include, but are not limited to, peripheral blood, plasma, serum, bone marrow, urine, bile, mucus, phlegm, saliva, cerebrospinal fluid, stool, biopsy tissue including lymph nodes, respiratory tissue or exudates, gastrointestinal tissue, cervical swab samples, semen or other body or cellular fluids, tissues, or secretions. Samples can be diluted or contained within a receptacle containing diluents, transport media, preservative solution, or other fluids. As such, the term sample is intended to encompass samples contained within a diluent, transport media, and/or preservative or other fluid intended to hold a sample.
[0044] As used herein, a sample processing consumable is any consumable intended to be used with a sample processing instrument. Exemplary sample processing consumables include, but are not limited to, receptacles, caps for closing openings of receptacles, pipette tips, and reagent containers. Exemplary sample processing consumables also include any consumable intended to be used to maintain the sample processing instrument. Exemplary maintenance sample processing consumables include, but are not limited to, members configured to clean and/or sterilize various components of the sample processing instrument, such as optical elements, test receptacle wells, and any other components of a sample processing instrument. For example, maintenance sample processing consumables include any of the cleaning members (such as cleaning members made of a material that generates static attraction, or cleaning members made of absorbent material capable of retaining a cleaning fluid or sterilizing substance) as disclosed in U.S. Provisional Application No. 62/145,247, filed Apr. 9, 2015.
[0045] As used herein, a press fit refers to a releasable coupling of two separate components by friction at an interface between surfaces of the components. A press fit does not include a snap fit in which separate components are coupled together by interlocking surfaces such as complementary flanges, ridges, or grooves.
[0046] In some embodiments, an assembly for storing sample processing consumables includes a tray that stores a plurality of sample processing consumables, and a cover that secures the consumables on the tray. The cover can also prevent contamination of the consumables. The cover can be releasably coupled to the tray by a press fit in some embodiments. The press fit can allow a user to easily and quickly decouple the cover from the tray when loading the tray into a sample processing instrument. For example, the cover can be decoupled from the tray using only one hand and with minimal handling of the assembly. Such a configuration can minimize the amount of user handling required to load the tray into a sample processing instrument.
[0047]
[0048] Tray 104 is configured to store a plurality of sample processing consumables. Exemplary types of sample processing consumables include, but are not limited to, receptacles, caps for closing openings of receptacles, pipette tips, and reagent containers. Tray 104 can be configured to store other types of sample processing consumables.
[0049] Tray 104 can define a plurality of wells 106 each configured to receive one or more sample processing consumables. In some embodiments, each well of the plurality of wells 106 is configured to receive only one sample processing consumable. In other embodiments, each well of the plurality of wells 106 is configured to receive more than one, for example, two or three, sample processing consumables.
[0050] In some embodiments, each of the plurality of wells 106 is configured (for example, shaped and sized) to contain a single type of sample processing consumable. For example, each of the plurality of wells 106 is configured to contain a receptacle, or each of the plurality of wells 106 is configured to contain a pipette tip.
[0051] In other embodiments, the plurality of wells 106 are configured to contain different types of sample processing consumables. For example, the plurality of wells 106 contains both receptacles and caps for closing the openings of the receptacles, or the plurality of wells 106 contain pipette tips and reagent containers. In such embodiments, the plurality of wells 106 can include two or more subsets of wells 106, and each subset of wells 106 is configured (for example, shaped and sized) to contain a different type of sample processing consumable. For example, as shown in
[0052] In some embodiments as shown in
[0053] In some embodiments, wells 106 are sized such that the entire consumable (for example, receptacle 108 or cap 110) fits within a respective well 106, as shown in
[0054] In some embodiments, receptacles 108 are configured to receive and store fluid samples for subsequent analysis, including analysis with nucleic acid-based assays or immunoassays diagnostic for a particular analyte. Receptacle 108 can be a single-piece receptacle that includes a generally cylindrical upper portion and a tapered lower portion. The upper portion has an opening through which fluid samples can be deposited or removed from receptacle 108. The tapered lower closed portion can be either flat or rounded to provide optical communication with an optical system, for example, one or more optical fibers (not shown) of a biochemical analyzer such as those disclosed in U.S. Patent Application Publication No. 2014/0263984, published Sep. 18, 2014. Exemplary receptacles 108 include any of the receptacles disclosed in U.S. Pat. No. 9,162,228, issued Oct. 20, 2015. In some embodiments, caps 110 include a lower portion having an outer surface for sealing engagement of an inner surface of the upper portion of receptacle 108, and caps 110 can include an upper portion. The upper portion of cap 110 can include an opening for frictional attachment to a portion of a receptacle transport mechanism, such as a tubular probe of a pipettor or a pick-and-place robotic arm. Exemplary caps 110 include any of the caps disclosed in U.S. Pat. No. 9,162,228, issued Oct. 20, 2015.
[0055] Tray 104 can include a surface 122 defining the openings of the plurality of wells 106. Surface 122 is positioned at the top of tray 104 in some embodiments as shown in
[0056] In some embodiments, tray 104 includes a surface 126 extending from surface 122. Surface 126 can extend from the perimeter of surface 122 in a downward direction. Surface 126 can overlap wells 106 in a vertical direction in some embodiments as shown in
[0057] Tray 104 can be made of any suitable plastic material in some embodiments. In other embodiments, tray 104 can be made of any suitable metal material, for example, stainless steel.
[0058] Turning to cover 102, cover 102 defines a cavity 112 configured to receive at least a portion 113 of tray 104, as best seen in
[0059] In some embodiments, cover 102 includes a panel 114 and a wall 116 extending therefrom. Panel 114 and wall 116 collectively define cavity 112 of cover 102. Cavity 112 can have a shape and size that closely corresponds to the shape and size of tray 104. For example, tray 104 is a substantially rectangular prism, as shown in
[0060] Wall 116 extends downward from the perimeter of panel 114. In some embodiments, wall 116 surrounds the entire perimeter of panel 114, as shown in
[0061] Panel 114 of cover 102 can form the top of cover 102 in some embodiments, as shown in
[0062] Cover 102 can be configured to be decoupled from tray 104 by applying a force to a location on panel 114 of cover 102 that overcomes the press fit between cover 102 and tray 104. In some embodiments, the location where the force is applied is at a center of panel 114. Panel 114 can include indicia 119 that indicate to a user where to apply the force. Indicia 119 can be text (e.g., PUSH HERE TO REMOVE COVER, as shown in
[0063] In some embodiments, the magnitude of the force required to overcome the press fit between cover 102 and tray 104 is greater than the weight of tray 104. In such embodiments, tray 104 will not fall out of cavity 112 of cover 102 on its owndue to the force of gravity acting on tray 104. In some embodiments, the magnitude of the force required to overcome the press fit between cover 102 and tray 104 is such that a user can easily decouple tray 104 from cover 102, for example, by the push of a finger or two on panel 114 of cover 102. In some embodiments, the magnitude of force required to overcome the press fit between cover 102 and tray 104 can be in the range from about 1 N to about 15 N. For example, the required force magnitude can be in the range from about 3 N to about 11 N. In some embodiments, the required force magnitude can be at least 3 N.
[0064] Cover 102 can be configured such that wall 116 remains substantially stationary as cover 102 is decoupled from tray 104 by applying a force to panel 114 in some embodiments. That is, when a force is applied to panel 114 to overcome the press fit, wall 116 do not substantially deflect outward or inward relative to panel 114. The orientation of wall 116 relative to panel 114 stays substantially the same. Accordingly, cover 102 can be decoupled from tray 104 without wall 116 substantially deflecting relative to panel 114.
[0065] In other embodiments, cover 102 can be configured such that wall 116 bows slightly inward or outward as cover 102 is decoupled from tray 104.
[0066] Referring to
[0067] Wall 116 can define one or more hollow protrusions 150. Hollow protrusions 150 are configured to prevent a vacuum from forming in cavity 112 of cover 102 when portion 113 of tray 104 is received within cavity 112. Preventing a vacuum from forming in cavity 112 helps ensure that cover 102 can be easily decoupled from tray 104 by pressing panel 114.
[0068] Cover 102 includes a flange 120 extending outward from wall 116 in some embodiments. As shown in
[0069] In some embodiments, a portion of tray 104 is configured to be received within a cavity defined by a support 130.
[0070] In some embodiments, support 130 is part of a drawer or sliding surface of a sample processing instrument. In such embodiments, support 130 moves along with the drawer or sliding surface.
[0071] Support 130 defines a cavity 132 configured to receive at least a portion (e.g., the lower portion) of tray 104. Support 130 includes a base 134 and a wall 136 extending upward from the perimeter of base 134. Base 134 and wall 136 collectively define cavity 132 of support 130. In some embodiments, wall 136 surrounds the entire perimeter of base 134 as shown in
[0072] In some embodiments, base 134 has a substantially rectangular shape, when viewed from above, as shown in
[0073] Panel 114, wall 116, and flange 120 can be configured such that, when tray 104 is aligned with cavity 132 defined by support 130, a portion 146 of tray 104 is inserted within cavity 132, flange 120 contacts wall 136 of support 130, as shown in
[0074] Tray 104 has a dimension 144 between a bottom surface 138 of tray 104 and surface 122 defining the openings of wells 106 of tray 104. In some embodiments, dimension 144 is greater than dimension 142 between flange 120 and panel 114 of cover 102 such that portion 146 of tray 104 extends beyond flange 120 in a direction away panel 114 and toward base 134 of support 130. Portion 146 of tray 104 can be used to register the proper alignment between cavity 132 of support 130 and tray 104 before tray 104 is decoupled from cover 102.
[0075] In some embodiments, cavity 132 of support 130 can be omitted. In such embodiments, cover 102 and tray 104 can be positioned above a surface of support 130, and then a force can be applied to panel 114 of cover 102 that overcomes the press fit between cover 102 and tray 104, decoupling tray 104 from cover 102. Tray 104 then drops onto the surface of support 130.
[0076] In some embodiments, assembly 100 is devoid of shrink-wrap and peelable film. In some embodiments, assembly 100 is devoid of a cardboard sleeve or box surrounding cover 102 and tray 104.
[0077] Cover 102 can be made of any suitable plastic. In some embodiments, cover 102 is made of any suitable plastic that can be thermoformed. In some thermoformed embodiments, cover 102 is made of polyethylene terephthalate glycol (PETG), amorphous or crystallized polyethylene terephthalate (PET), polyvinyl chloride (PVC), or polystyrene (PS). In some embodiments, cover 102 is made of an FDA compliant plastic.
[0078] In some embodiments, cover 102 includes an electrostatic dissipative (ESD) coating on at least the surfaces facing tray 104the surfaces defining cavity 112. These surfaces include, for example, surface 128 of wall 116 and the cover surface adjacent to surface 122 of tray 104. The ESD coating can reduce the amount of static build up generated, for example, by the consumables moving within wells 106 of tray 104. Static build up can potentially cause cover 102 to stick to tray 104, preventing or making difficult the decoupling of cover 102 from tray 104.
[0079] In some embodiments, cover 102 has a thickness that provides sufficient rigidity to maintain engagement with tray 104, but the thickness is not too great, such that cover 102 is stiff and difficult to decouple from tray 104. For example, cover 102 can have a thickness in the range from about 10 mil to about 20 mil, such as 15 mil. In some embodiments, cover 102 has a thickness that allows cover 102 to be thermoformed without any voids in cover 102 being formed as the draws of cover 102 are formed.
[0080] In some embodiments, cover 102 is thermoformed. For example, cover 102 is made by heating a plastic sheet to a temperature at which the sheet is pliable and then forming the plastic sheet into the desired shape of cover 102 using a mold.
[0081] Tray 104 can be made of any suitable plastic. For example, tray 104 can be made of polypropylene (PP), polyethylene (PE), polystyrene (PS), polyester, or any other suitable plastic.
[0082] In some embodiments (not shown), cover 102 includes an RFID label to identify the consumable(s) contained in the wells 106 of tray 104.
[0083] Turning to methods of using assembly 100, assembly 100 can be used to load consumables into a sample processing instrument. In some embodiments, a loading method includes roughly aligning tray 104 with a desired location on support 130, for example, cavity 132 of support 130 or any desired surface of support 130. A user can hold assembly 100 by cover 102 using one hand, and then move assembly 100 such that portion 146 of tray 104 is roughly aligned with the desired location, for example, cavity 132 as shown in
[0084] Next, the user can move assembly 100 in a direction 152 toward support 130. Portion 146 of tray 104 is inserted into cavity 132 of support 130, registering the proper alignment between tray 104 and cavity 132 until flange 120 contacts an upper surface of wall 136 of support 130, as shown in
[0085] Next, a user can press down on panel 114 of cover 102 to apply a force 154 that overcomes the press fit formed between cover 102 and tray 104. In some embodiments, the user's finger(s), for example, the index finger and/or middle finger, can be used to apply force 154 to panel 114. As shown in
[0086] Sensory feedback to the user can be generated when cover 102 is decoupled from tray 104. Exemplary sensory feedback includes tactile, audible, and visual feedback. In some embodiments, tactile feedback is generated by overcoming the press fit between cover 102 and tray 104. As the user presses down on panel 114 of cover 102, the user can feel the press fit between cover 102 and tray 104 being overcome, and can feel tray 104 seating with cavity 132 of support 130. In some embodiments, audible feedback is generated as panel 114 bends from the user pressing against panel 114. As panel 114 bends, panel 114 generates an audible noise that the user can hear. And in some embodiments, visual feedback is generated as cover 102 and tray 104 are decoupled. For example, cover 102 can be transparent such that the user can see the position of tray 104 relative to cover 102. As the user presses down on panel 114 of cover 102, the user can see the position of tray 104 relative to cover 102. Consequently, the user can see when tray 104 is decoupled from cover 102 and seated within cavity 132 of support 130.
[0087] In some embodiments as the user presses down on panel 114, walls 116 remain substantially stationarywalls 116 do not deflect relative to panel 114 (inward or outward).
[0088] After tray 104 is seated within cavity 132 of support 130, the user can move cover 102 in direction 156 to remove cover 102 from tray 104 and from the sample processing instrument. At this point, the sample processing instrument has access to the consumables contained within wells 106 of tray 104. In some embodiments, the sample processing instrument can then perform an assay for determining the presence of an analyte in a sample using the consumables contained within wells 106. In some embodiments, the sample processing instrument can then perform sample preparation steps using consumables contained within wells 106.
[0089] Notably, in some embodiments, the user can load tray 104 onto support 130 using just one hand and gripping only cover 102 (i.e., no direct contact between the user's hand and tray 104). In such embodiments, the user never has to touch tray 104 for loading tray onto support 130 or for decoupling cover 102 from tray 104. This can make loading consumables into the sample processing instrument easy and reduces the risk of contamination to the consumables contained within wells 106. This also reduces the amount of user handling required.
[0090] Although the above embodiments are described using cover 102 and tray 104 to store sample processing consumables, cover 102 and tray 104 can be used to store consumables or other removable items that are not sample processing consumables. For example, cover 102 and tray 104 can be used with other consumables or other removable items that are not intended to be used with sample processing instruments or that are intended to be used in outside of the laboratory or clinical environments.
[0091] While the present disclosure has been described and shown in considerable detail with reference to certain illustrative embodiments, including various combinations and sub-combinations of features, those skilled in the art will readily appreciate other embodiments and variations and modifications thereof as encompassed within the scope of the present disclosure. Moreover, the descriptions of such embodiments, combinations, and sub-combinations are not intended to convey that the disclosure requires features or combinations of features other than those expressly recited in the claims. Accordingly, the present disclosure is deemed to include all modifications and variations encompassed within the spirit and scope of the following appended claims.
[0092] It is to be appreciated that the Detailed Description section, and not the Summary and Abstract sections, is intended to be used to interpret the claims. The Summary and Abstract sections may set forth one or more but not all exemplary embodiments of the present invention as contemplated by the inventor(s), and thus, are not intended to limit the present invention and the appended claims in any way.
[0093] Embodiments have been described above with the aid of functional building blocks illustrating the implementation of specified functions and relationships thereof. The boundaries of these functional building blocks have been arbitrarily defined herein for the convenience of the description. Alternate boundaries can be defined so long as the specified functions and relationships thereof are appropriately performed.
[0094] The foregoing description of the specific embodiments will so fully reveal the general nature of the invention that others can, by applying knowledge within the skill of the art, readily modify and/or adapt for various applications such specific embodiments, without undue experimentation, and without departing from the general concept of the present invention. Therefore, such adaptations and modifications are intended to be within the meaning and range of equivalents of the disclosed embodiments, based on the teaching and guidance presented herein. It is to be understood that the phraseology or terminology herein is for the purpose of description and not of limitation, such that the terminology or phraseology of the present specification is to be interpreted by the skilled artisan in light of the teachings and guidance.
[0095] The breadth and scope of the present invention should not be limited by any of the above-described exemplary embodiments, but should be defined only in accordance with the following claims and their equivalents.
[0096] While the invention has been described in connection with the above described embodiments, it is to be understood that the invention is not to be limited to the disclosed embodiments, but, on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.
[0097] All documents referred to herein are hereby incorporated by reference herein. No document, however, is admitted to be prior art to the claimed subject matter.
[0098] Furthermore, those of the appended claims which do not include language in the means for performing a specified function format permitted under 35 U.S.C. ? 112, 16, are not intended to be interpreted under 35 U.S.C. ? 112, 16, as being limited to the structure, material, or acts described in the present specification and their equivalents.