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Cuvettes Used For Analysis Of Fluids And Process For Manufacturing The Same

Abstract: The present invention relates to miniature cuvette strips used in transmittance photometry for measurement and analysis of fluids and Process for simultaneously manufacturing multiple such cuvette strips. Theminiature cuvette strips comprising at least an adhesive sheet sandwiched between two optically clear sheets. Such that the cuvette strips are flat compact and contain an inlet for fluid entry, a capillary for suction of said fluid and at least one cavity for sampling and analyzing said fluid.

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Patent Information

Application #
Filing Date
21 May 2019
Publication Number
28/2020
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
Parent Application
Patent Number
Legal Status
Grant Date
2023-07-31
Renewal Date

Applicants

Biosense Technologies Pvt. Ltd.
A-233 Road #21Y, Wagle Industrial Estate, Thane 400604, Maharashtra, India

Inventors

1. Abhishek Sen
Biosense Technologies PVT. LTD., A-233 Road #21Y, Wagle Industrial Estate, Thane - 400604, Maharashtra, India
2. Anshul Tyagi
Biosense Technologies PVT. LTD., A-233 Road #21Y, Wagle Industrial Estate, Thane - 400604, Maharashtra, India
3. Sumit Mhaddolkar
Biosense Technologies PVT. LTD., A-233 Road #21Y, Wagle Industrial Estate, Thane - 400604, Maharashtra, India
4. Aashutosh Sharma
Biosense Technologies PVT. LTD., A-233 Road #21Y, Wagle Industrial Estate, Thane - 400604, Maharashtra, India
5. Ravi Patil
Biosense Technologies PVT. LTD., A-233 Road #21Y, Wagle Industrial Estate, Thane - 400604, Maharashtra, India

Specification

DESC:FIELD OF INVENTION
[001] The present invention relates to miniature Cuvette strips and a process for manufacturing the same. More specifically, it relates to cuvette strips that are used to perform assays of fluid components using small volume sample with high accuracy and a process for manufacturing the same.

BACKGROUND
[002] Devices meant for conducting photometric assays often function on the principle of transmittance photometry for measurement of fluid components, such as hemoglobin levels, blood sugar levels, urine HCG detection etc. These devices use cuvette strips containing whole blood sample or such other fluid to conduct the assays.

The cost of consumables (cuvette) involved in fluid assays from samples using transmittance photometry is high.

[003] Unfortunately, despite such escalated costs, cuvettes available in the market cannot ensure uniform distribution of fluids, simplified sampling processes, fixed volumes collected by capillary action of cuvette and often permit air bubbles in the fluid sample, each of these shortcomings considerably interfere in the assay results. Moreover, high costs of cuvettes make it difficult for users to acquire such devices in many parts of the world, especially in developing countries.

[004] In addition to the above shortcomings, state-of-the-art cuvettes often use reagents as can be seen in the following Patents: U.S. Pat. No. 3,874,852, U.S. Pat. No. 4,853,338 and US Publication no. US2003/0044995 A1. Reagents hinder the ease of storage of cuvettes that are coated with reagent(s) and are therefore not preferred. Considering the hygroscopic nature of most reagents, the shelf life is limited and storage of the cuvettes requires tedious measures. Moreover, in climates with high humidity, the cuvette has to be used within a few minutes of removal from its package in order to preserve the reagents and avoid inaccurate readings.

[005] A cuvette for sampling a fluid, mixing the sample with a reagent and directly making optical analysis of the sample mixed with the reagent is previously known from EP-A-287 883 and US patent 4,088,448.
[006] The Cuvette disclosed in US patent 4,088,448 simplifies the sampling procedure, reduces the number of devices needed and in most cases, depending on the type of analysis, considerably improves the accuracy of the analysis by making the analyzing procedure independent of the operation of the device. However, it has been discovered that the microcuvette described in US patent 4,088,488 may develop air bubbles that can interfere with the optical analysis. Air bubbles generally form in the cavity of the cuvettes because of unsatisfactory sample flow in the cuvette cavity. This is especially detrimental for hemoglobin measurements because of the strong absorption of the hemoglobin. In particular, in a photometric determination, the presence of a large air bubble in the light path traversing the measuring zone will result in an overall measured hemoglobin value below the actual level because the photosensor will read the bubble as a contribution of extremely low hemoglobin.
[007] Quality control is routinely carried out to discard those cuvettes which include air bubbles. A considerable number of cuvettes do not pass the quality control and have to be discarded, thereby increasing the overall cost of the cuvettes.

[008] An obvious disadvantage in the traditional method of manufacturing a cuvette is that each cuvette has to be molded in one piece which requires a mold, the initial investment for such molds is very high. The detailed molding also is a tedious task, there is an added cost to the cuvettes required for the mold parts, repairing molds inter alia. Another disadvantage is the comparatively short stability due to the decomposition of the reagent mixture which generally form part of the cuvette in e.g. the glucose cuvettes.

[009] Moreover, there is a lack of innovative process to manufacture well-engineered cuvettes, that ensure uniform distribution of fluids, simplified sample collection processes, fixed volumes collected by capillary action of cuvette and air-bubble free sampling.

[010] Multiple efforts have been made in the industry to overcome these shortcomings. Such as by adding reagents to the cuvette walls. However, none of the attempts have concluded in a successful result while controlling the costs effectively. In fact, most attempts have concluded in increasing the costs of the basic cuvettes available in the market.

[011]Therefore, there is a need for a cuvette and a process to make such cuvette which overcomes at least one of the abovementioned shortcomings.

OBJECT OF INVENTION
It has already been proposed that there is a need for a process that ensures at least low-cost manufacturing of cuvettes and cuvettes having low and predefined volume collection by capillary action and simplified sampling which is free of air-bubbles.

The principal object of the present invention is to provide a process for manufacturing cuvette strips, including at least the following steps as shown in Figure 4.:
a. Selecting at least two optically clear sheets and at least an adhesive sheet;
b. Pre-cutting the sheets in pre-defined positions;
c. make them hydrophilic;
d. Layering the adhesive sheet(s) in between the optically clear sheets;
e. Binding and laminating the layered assembly; and
f. Post-cutting the layered assembly to release individual cuvette strips from the assembly.
Another object of the present invention is to provide a miniature cuvette strip to perform assays of fluid components using small volume sample with high accuracy

A further object of the present invention is to provide a process for simultaneously manufacturing multiple cuvette strips
Yet another object of the present invention is to provide a miniature cuvette strip having one or more cavities with predefined dimensions, optical path and volume

Yet another object of the present invention is to provide a miniature cuvette strip having customized inlet dimensions, capillary & cavity dimensions

Yet another object of the present invention is to provide a miniature cuvette strip having customized wicking/suction speed achieved by modifying the dimensions of the inlet of cavity.


SUMMARY
An aspect of the present invention provides acuvette strip, wherein the strip consists of at least two optically clear sheets; and an adhesive strip of pre-defined geometric structure which provides an inlet, capillary & cavity for fluid sample collection

In another aspect of the invention, a process for manufacturing cuvette strips, wherein the steps include at least the following:
g. Selecting at least two optically clear sheets and at least an adhesive sheet;
h. Pre-cutting the sheets in pre-defined positions;
i. Washing, drying and treating the surfaces of the selected optically clear sheets;
j. Layering the adhesive sheet(s) in between the optically clear sheets, to form an assembly;
k. Post-cutting the assembly to release individual cuvette strips.

BRIEF DESCRIPTION OF THE DRAWINGS
a. Fig.1 shows the layering sequence of the cuvette. Specifically, it shows the pre-cut adhesive sheet (3) being layered in between pre-cut optically clear sheets (1)&(2)
b. Fig. 2 shows the layering sequence of the cuvette shows the pre-cut adhesive sheets (3) & (4) and an island (5) being layered in between pre-cut optically clear sheets (1)&(2)
c. Fig. 3 shows simultaneous layering sequence of multiple cuvette strips where the pre-cut adhesive sheet (3) is being layered in between pre-cut optically clear sheets (1)&(2)
d. Fig. 4 shows a flow chart of the process of assembling the layers and manufacturing the cuvette strips.

DESCRIPTION
[012] According to various embodiments of the present invention that are described below a miniaturized cuvette strip for sampling fluids and a process for manufacturing the same is disclosed. More specifically, the present invention relates to a low cost, disposable capillary cuvette having improved flow for sampling & analyzing a fluid, and a process for manufacturing the same, comprising at least the following steps:
a. Selecting at least two optically clear sheets (1) & (2) and at least an adhesive sheet (3);
b. Pre-cutting the sheets in pre-defined positions;
c. Washing, drying and treating the surfaces of the optically clear sheets;
d. Layering at least one pre-cut adhesive sheet (3) over a pre-cut optically clear sheet (1);
e. Optionally, layering an additional pre-cut optically clear sheet (5) over a portion of at least one pre-cut adhesive sheet;
f. Layering a final pre-cut optically clear sheet (2) over the adhesive sheet, to form an assembly of at least three layers;
g. Binding & Laminating the assembly; and
h. Post-cutting the assembly to release individual cuvette strips.

[013]In an embodiment of the present invention, the process results in simultaneous production of multiple cuvette strips each having identical and predefined optical paths; an inlet for fluid collection; at least one cavity with fixed dimension; and capillary action for drawing fluids as shown in Fig 3. The number of cuvette strips manufactured simultaneously can range from at least 100 to at least 300 for A4 size sheet

[014] In an embodiment of the present invention, pre-cutting the adhesive sheet provides for a cavity measuring 100-200um and having a volume of preferably5-25uL. Such cavity is enclosed after the second layer of optically clear sheet is layered over the adhesive sheet present in the double layer to form at least a triple layer. The walls of the cavity are formed by the inner surfaces of the two optically clear sheets while the volume and internal dimension of the cavity are formed by the pre-cut adhesive sheet which is sandwiched between the two optically clear sheets. Therefore, pre-cutting the adhesive sheet enables customized cavity dimensions and optical path lengths with predefined values.By modifying the dimensions of the inlet of cavity, the wicking / suction speed can be changed.

[015] Layering the second and/ or final optically clear sheet encloses the capillary such that the inner surface of the two optically clear sheets form the walls of the capillary and the space in between the optically clear sheets created by the pre-cut adhesive sheet forms the capillary extending into at least one cavity as shown in Fig 1.

[016] In another embodiment of the present invention, the adhesive sheet may be single, double, triple or multi- layered, cumulatively having thinness in the range of 50-250 microns, such that cutting said sheet may enable a variation of shape size and depth of cavity so formed as shown in Fig. 2.

[0017] In another embodiment of the present invention, the cuvette strip made using the process disclosed above, consists of more than two optically clear sheets and two or more adhesive strips of pre-defined geometric structure which provides a narrow inlet, capillary & cavity for fluid sample collection. Wherein the cuvette strip has at least one cavity containing an island (5) created by an adhesive sheet, an optically clear sheet, or a combination thereof as shown in Fig. 2.

[018] Washing and drying the sheet of optically clear sheets (1) & (2) is performed to clear the surface of any oil, dirt, dust or such other contaminants;

[019] Layering the sheets is performed by first providing a holder to place the sheets in fixed position followed by fixing the optically clear sheet (1) on the holder and placing at least one adhesive sheet over such first sheet, all while being placed on the holder to form a double layer; Finally layering the optically clear sheet (2) over last layer of adhesive sheet to form an assembly wherein the adhesive sheet(s) is sandwiched in between the two sheets of optically clear material (1) & (2); Laminating, binding and pressing the triple layer completes the layering process; Post-cutting the triple layer to release the individual cuvette strips from the assembly.

[020] In an embodiment of the present invention, the cuvette strip made using the process disclosed above, consists of at least two optically clear sheets; and at least an adhesive strip of pre-defined geometric structure which provides a narrow inlet, capillary & cavity for fluid sample collection. Wherein the cuvette strip has a compact flat size, predefined optical path length, predefined depth, and predefined cavity volume as low as 1uL and preferably 5-25uL

[021] In an embodiment of the present invention, the cuvette strip made using the process disclosed above, has an improved self-drawing of fluid by capillary action, sampling is void of any bubblesdue to its hydrophilic nature towards fluids having various viscosities including but not limited to whole blood, intestinal fluid, plasma, urine, seminal fluid, saliva, amniotic fluid, serum, vaginal secretion, breast milk, bile, amongst other fluids

[022] In one embodiment of the present invention the optically clear material for the first and second sheet are selected from but not limited to plastic, glass, Polycarbonates (PC), Monostyrene (MS), Polystyrene (PS), Polyester, Poly methyl methacrylate (PMMA) or such other optically transparent material.

[023] In one embodiment of the present invention the adhesive sheet is selected from but not limited to a double sided tape

[024] In one embodiment of the present invention the cutting processes used to cut the sheets include industrially acceptable cutting techniques selected from but not limited to laser cut or die cut techniques. The pre-cutting process compliments the process by providing guidance for precise application of adhesive material.

[025] In one embodiment of the present invention the surface treatment increases affinity of the sheet surface to fluids using techniques such as chemical coating or other processes such as plasma discharge to make the surface hydrophilic. The hydrophilic characteristic improves the affinity of the material surface towards samples having different viscosities (body fluids, blood, aqueous fluids etc.) The coating material can be varied depending on the sample type. The hydrophilic nature helps in self-drawing of fluid by capillary action. The fluid should completely fill the cuvette strip. If partially filled, fluid assay machines which use cuvette strips will give erroneous readings. It is therefore important to improve the capillary flow and ensure that cuvette strips are completely filled to be eligible for a fluid assay.

[026] In one embodiment of the present invention the adhesive sheets are cut in a manner to achieve cavity for sample, inlet for cavity along with desired level fastening. This adhesive layer allows desired cavity inside the cuvette to achieve exact volume of the sample and thickness of cavity. This adhesive layer has a pre-defined cavity inside the cuvette, the sample volume pulled up by the capillary action into the cuvette depends on the pre-defined cavity size. The optical path length of the cuvette depends on the pre-defined thickness of the cavity. The flexibility of customizing and pre-defining the cavity size allows the selection from a variety of sample volumes and optical path lengths, as preferred for a particular assay.

[027] The binding and pressing of the three sheets ensures that no air bubbles are formed within the cuvette. These layers can be pressed using methods selected from but not limited to lamination, hot gluing technique etc. to get a firm bonding between the layers.

[028] Cuvette strips made using the process of the present invention, have at least one cavity and respective opening for the cavity. The opening for cavity is at a single point of contact to achieve unambiguous fluid insertion within the cavity. The cavity size may vary with the requirement of amount of sample for desired measurement.

[029] In one embodiment of the present invention, the adhesive sheet has a thinness in the range of 50-250 micron. This uniform distance of the internal space between the two optically clear sheets generates a capillary action with uniform drawing of fluids.

[030] The cuvette strips made using the process of the present invention, comprises of at least three body members which includes two planar surfaces made up of either plastic or glass or any optically clear material to offer an optically clear path for light passage and can be placed at a predetermined distance from one another depending on the requirement, which is achieved with the help of uniform adhesive layer between the two surfaces, this adhesive layer defines a cavity for sample. Geometric structure of adhesive layer provides a narrow inlet for sample and this inlet ensures the capillary action for communicating said cavity with the exterior sample under examination.

[031] The surface treatment of the optically clear sheets makes the sheets hydrophilic in nature increasing the affinity of the internal cuvette walls towards fluids. Thereby contributing to the enhanced capillary action of the cuvette and enabling accurate drawing of fluid without any intervention. The cuvette strips of the present invention are compact, enable simultaneous sampling of fluid and analyzing of a fluid sample.

[032] The Cuvette strips made by the process of the present invention enable testing fluids without the need of any diluants, reagents or chemicals. This reduces the procedure involved in fluid sampling as compared to the traditional method. The lack of reagents and chemicals also provide for ease of storage and usage of Cuvette strips.

[033] The Cuvette strips made by the process of the present invention enable testing fluids including but not limited to whole blood, intestinal fluid, plasma, urine, seminal fluid, saliva, amniotic fluid, serum, vaginal secretion, breast milk, bile, amongst other fluids.

[034] According to the process of the present invention, a novel disposable strip of cuvette for sampling fluid is obtained.

[035] The present invention allows assembling the optically clear sheets using an adhesive sheet to achieve desired level of bonding while keeping the measurement cavity untouched and providing an inlet for the fluid sample to enter into this cavity.

[036] The novel process of making the cuvette strip ensures a predetermined cavity depth, optic path length, volume and a compact flat size and shape that permits easy storage, packaging and handling of cuvette strips.

[037] The middle layer of strip has a pre-defined thinness which ensures uniform distribution of the fluid through the cuvette, as the fluid is drawn by the capillary action generated by the cuvette structure.

[038] Such innovative strips of cuvettes made by the abovementioned process, enable determination of fluid concentration such as hemoglobin levels using a very small volume of fluid such as whole blood. The standardized volume and precise thickness of cavity of the Cuvette strips achieved by this novel process, enables a measuring system to predetermine the optical path length and therefore allows incorporating predetermined changes in algorithmic calculations which enable a precise outcome of assays successfully.

[039] In one embodiment of the present invention, the method of collecting a fluid sample involves simply placing a pointed edge or notch or extension of the cuvette over the surface of the fluid. A small drop of fluid is drawn into the cuvette strip using its capillary action void of any air-bubbles.


UTILITY
[040] Cuvette strips made using the process of the present invention, have at least the following advantages and utility:

1] Miniature sized cuvette strips which can be used easily in handheld devices.

2] Cuvette strips that can be used in devices that are based on the principle of transmittance photometry.

3]Cuvette strips that can have at least one cavity of a fixed volume to contain the sample fluid.

4] Cuvette strips that permit quick drawing of blood into the cavity by capillary action.

5] Cuvette strips having accurate amount of fluid drawn due to the explicit internal construction provided by the stacking process of the present invention.

6] Cuvettes in the form of strips which require less storage space than laboratory cuvettes.

7] Cuvette strips that provide capillary action which is fast enough to draw blood due to the surface treatment process for making the material hydrophilic and due to the structural characteristics of cavity.

8] Cuvette which ensure accurate results during measurement of fluid content while using very small volume of fluid.

9] Cuvette strips that are disposable and economical to manufacture.

10] Cuvette strips can be used for optical detection of blood properties for hemoglobin determination in whole blood either from venous or arteries without any reagent or dilution.

11] Cuvette strips that do not use any reagents

12] A process to manufacture cuvette strips which does not demand any requirement of additional parts in excess of the material involved in making of the cuvette itself (e.g. no requirement of a mold) Therefore reduces the overall cost of the process

13] A process that does not require high initial investment to manufacture cuvette strips

[041] Further, the invention is unique especially because of the following reasons:
• Disposable Cuvette
• Small sized Cuvette strips that require smaller systems. Therefore, enable compact systems
• Precise cuvette cavity enabling a defined cuvette volume which allows estimating the predetermined optical path
• Uniform distribution of whole blood (arterial and / or venous)
• Use of fluid volumes as low as 1uL
• The process involved makes it easy to manufacture at smaller setup with accurate output for cuvette strips
• Cuvette strip having customizedwicking / suction speed
[042] The foregoing description and drawings of the invention have been set merely to illustrate the invention and are not intended to be limiting. Since modifications of the disclosed embodiments incorporating the spirit and substance of the invention may occur to person skilled in the art, the invention should be construed to include everything within the scope of the disclosure.

Experimental Data:
[043]Clinical study of the device as mentioned in the aforesaid embodiments were performed at external clinical sites to evaluate the accuracy of the device disclosed in the present invention, using a pool of 508 patients. Venous K2-EDTA-anticoagulated blood was tested on 5 cuvette devices by using different consumable lots. The venous blood was transferred to sampler by pipette. All patient’s venous blood was tested by reference Sysmex XN1000 analyzer.
[045] Differences of mean values of total 508 results between cuvette device of the present invention and reference Lab values were found to be -0.4Hb for venus blood. Linear regression analysis was conducted to give results as following:

Slope Intercept Correction Coefficient
0.9272 1.1954 0.9712


The linear regression analysis shows test results of venous blood given by HbChek (analyzer device using cuvette of present invention) has good consistence with results from reference Sysmex XN1000 analyzer is 5 different devices.

[046] The clinical study was designed to be performed using 5 part analyser. Totally 19 patients’ fingertip capillary and venus K2-EDTA- anticoagulated blood were tested on two cuvette device of the present invention. The capillary blood was used from patient’s finger by consumable directly, and venous blood was transferred to consumable by pipette. All patient’s venous blood were tested by reference 5 part analyzer.

Sample No. Device 1 Device 2 CBC 1 CBC 2
1 12.5 13 13.7 13.9
2 16.4 17 16.7 16.7
3 14.3 14.1 16.3 16.3
4 13.1 13.3 14.3 14.3
5 12.8 13.9 13.7 13.7
6 14.6 16.5 14.8 14.8
7 14.6 14 14.5 14.6
8 10.7 9 10.8 10.8
9 13.3 12.3 14.3 14.4
10 11.3 10.6 12.5 12.5
11 11.4 12.5 13.6 13.6
12 14.6 13.7 15 15
15 14.1 14.1 15.4 15.3
17 15.1 15.2 15.4 15.4
18 8.4 8.6 8.9 8.8
19 13.3 13.1 13.8 13.7

[047] All results above also show the difference of capillary and venous blood will not cause significant variance to Hb results determined using the cuvette device of the present invention.

WORKING EXAMPLES
EXAMPLE 1
a. Providing a first sheet and a second sheet of optically clear plastic;
b. Pre-cutting the first and second sheet of optically clear plastic using laser cutting technique;
c. Washing and drying the first and second sheet of optically clear plastic to clear the surface of any oil, dirt, dust or such other contaminants;
d. Conducting surface treatment using plasma discharge technique on the first and second sheet of optically clear material;
e. Providing double sided tape (DST) as a third sheet;
f. Pre-cutting the third sheet to provide for a single cavity and capillary connected to said cavity;
g. Providing a holder to place the sheets in fixed position
h. Fixing the first sheet on the holder and placing the third sheet having adhesive properties over such first sheet, all while being placed on the holder to form a double layer;
i. Placing the second layer over the double layer to form a triple layer wherein the adhesive sheet is sandwiched in between the two sheets of optically clear material to form a 100 um cavity and capillary having a total volume of 5uL in each cuvette;
j. Laminating, binding and pressing the triple layer;
k. Post-cutting the triple layer to release 200 number of individual cuvette strips from the triple layer body using laser cut technology.

EXAMPLE 2
a. Providing a first sheet and a second sheet of optically clear acrylic;
b. Pre-cutting the first and second sheet of optically clear acrylic using die cutting technique;
c. Washing and drying the first and second sheet of optically clear glass to clear the surface of any oil, dirt, dust or such other contaminants;
d. Conducting surface treatment using chemical treatment technique on the first and second sheet of optically clear material;
e. Providing double sided tape (DST) having 2 layers, as a third sheet;
f. Pre-cutting the adhesive sheet to provide for a circular cavity having an island in the center and a capillary;
g. Providing a holder to place the sheets in fixed position
h. Fixing the first sheet on the holder and placing the third sheet having adhesive properties over such first sheet, all while being placed on the holder to form a double layer;
i. Placing the second layer over the double layer to form a triple layer wherein the adhesive sheet is sandwiched in between the two sheets of optically clear material to form a 200um cavity having a total volume of 8uL in each cuvette;
j. Laminating, binding and pressing the triple layer;
k. Post-cutting the triple layer to release 300 number of individual cuvette strips from the triple layer body using laser cut technology.

EXAMPLE 3
a. Providing a first, second and third sheet of optically clear plastic;
b. Pre-cutting the three sheets of optically clear plastic using laser cutting technique;
c. Washing and drying the first and second sheet of optically clear plasticto clear the surface of any oil, dirt, dust or such other contaminants;
d. Conducting surface treatment using plasma discharge technique on the three sheets of optically clear material;
e. Providing double sided tape (DST) as adhesive sheet;
f. Pre-cutting two sheets of DST (3) & (4) of Fig. 2, to provide for a multi-dimensional cavity and capillary connected to said cavity;
g. Pre-cutting the third sheet of optically clear material to provide for an island;
h. Providing a holder to place the sheets in fixed position
i. Fixing the first sheet on the holder and placing the DST (3) & (4)over such first sheet and placing the island (5) over DST(4) all while being placed on the holder to form a double layer as shown in Fig. 2.;
j. Placing the optical sheet (2) over all layers to form an assembly wherein the adhesive sheet and island are sandwiched in between the two sheets of optically clear material to form a 150 um cavity and capillary having a total volume of 7uL in each cuvette;
k. Laminating, binding and pressing the assembly;
l. Post-cutting the triple layer to release 150 number of individual cuvette strips from the triple layer body using laser cut technology.

,CLAIMS:
Claim 1] A process for manufacturing cuvette strips, comprising at least the following steps:
a. Selecting at least two optically clear sheets and at least an adhesive sheet;
b. Pre-cutting the sheets in pre-defined positions;
c. Washing, drying and treating the surfaces of the optically clear sheets;
d. Layering at least one pre-cut adhesive sheet over a pre-cut optically clear sheet;
e. Optionally, layering an additional pre-cut optically clear sheet over a portion of at least one pre-cut adhesive sheet;
f. Layering a final pre-cut optically clear sheet over the adhesive sheet, to form an assembly of at least three layers;
g. Binding & Laminating the assembly; and
h. Post-cutting the assembly to release individual cuvette strips.

Claim 2] The process as claimed in claim 1, wherein pre-cutting the adhesive sheet is performed using techniques selected from but not limited to laser cut or die cut techniques, to enable customized cavity volumes, optical path lengths with predefined values; such adhesive
sheet may be single, double, triple or multi- layered, cumulatively having thinness in the range of 50-250 microns, such that cutting said sheet may enable a variation of shape size and depth of cavity so formed.

Claim 3] The process as claimed in claim 1, wherein layering the second optically clear sheet to form at least a triple layer, develops a capillary such that the inner surface of the two optically clear sheets (1) & (2) form the walls of the capillary and the space in between the optically clear sheets created by the pre-cut adhesive sheet forms the capillary extending into at least one cavity.

Claim 4] The process as claimed in claim 1, wherein the optically clear sheets are treated using techniques selected from but not limited to chemical coating or plasma discharge, making the surface hydrophilic towards fluids including but not limited to whole blood, intestinal fluid, plasma, urine, seminal fluid, saliva, amniotic fluid, serum, vaginal secretion, breast milk, bile, amongst other fluids.

Claim 5] The process as claimed in claim 1, wherein the process results in simultaneous production of multiple cuvette strips each having identical and predefined optical paths; an inlet for fluid collection; at least one cavity with fixed dimension; and capillary action for drawing fluids

Claim 6] A cuvette strip, comprising at least two optically clear sheets; and at least an adhesive strip of pre-defined geometric structure which provides a narrow inlet, capillary & cavity for fluid sample collection

Claim 7] The cuvette strip as claimed in claim 6, wherein the strip has a compact flat size, predefined optical path length, predefined depth, predefined cavity volume as low as 1uL and preferably5-25uL

Claim 8] The cuvette strip as claimed in 6, wherein the optically clear sheet is selected from but not limited to plastic, glass, Polycarbonates (PC), Monostyrene (MS), Polystyrene (PS), Polyester, Poly methyl methacrylate (PMMA) or such other optically clear material and wherein the adhesive sheet is selected from but not limited to Double sided tape

Claim 9] The cuvette as claimed in claim 6, consists of more than two optically clear sheets and two or more adhesive strips of pre-defined geometric structure which provides a narrow inlet, capillary & cavity containing at least an island created by an adhesive sheet, an optically clear sheet, or a combination thereof as shown in Fig. 2.

[Claim 10] The cuvette as claimed in claim 6, wherein the cuvette has customized wicking/suction speed achieved by modifying the dimensions of the inlet of cavity and such sampling is void of any bubbles due to the cuvette’s hydrophilic nature towards fluids having various viscosities including but not limited to whole blood, intestinal fluid, plasma, urine, seminal fluid, saliva, amniotic fluid, serum, vaginal secretion, breast milk, bile, amongst other fluids

Documents

Application Documents

# Name Date
1 201921019995-PROVISIONAL SPECIFICATION [21-05-2019(online)].pdf 2019-05-21
2 201921019995-POWER OF AUTHORITY [21-05-2019(online)].pdf 2019-05-21
3 201921019995-FORM FOR SMALL ENTITY(FORM-28) [21-05-2019(online)].pdf 2019-05-21
4 201921019995-FORM FOR SMALL ENTITY [21-05-2019(online)].pdf 2019-05-21
5 201921019995-FORM 1 [21-05-2019(online)].pdf 2019-05-21
6 201921019995-EVIDENCE FOR REGISTRATION UNDER SSI(FORM-28) [21-05-2019(online)].pdf 2019-05-21
7 201921019995-EVIDENCE FOR REGISTRATION UNDER SSI [21-05-2019(online)].pdf 2019-05-21
8 201921019995-Proof of Right (MANDATORY) [31-05-2019(online)].pdf 2019-05-31
9 201921019995-RELEVANT DOCUMENTS [09-06-2019(online)].pdf 2019-06-09
10 201921019995-Proof of Right (MANDATORY) [09-06-2019(online)].pdf 2019-06-09
11 201921019995-MARKED COPIES OF AMENDEMENTS [09-06-2019(online)].pdf 2019-06-09
12 201921019995-FORM-26 [09-06-2019(online)].pdf 2019-06-09
13 201921019995-FORM 13 [09-06-2019(online)].pdf 2019-06-09
14 201921019995-AMMENDED DOCUMENTS [09-06-2019(online)].pdf 2019-06-09
15 201921019995-ORIGINAL UR 6(1A) STATEMENT OF NO OBJECTION FOR ADDITION OF INVENTORS-110619.pdf 2019-06-27
16 201921019995-ORIGINAL UR 6(1A) FORM 26-110619.pdf 2019-06-27
17 201921019995-ORIGINAL UR 6(1A) FORM 1-110619.pdf 2019-06-27
18 201921019995-ORIGINAL UR 6(1A) FORM 1--110619.pdf 2019-06-27
19 201921019995-FORM 3 [19-05-2020(online)].pdf 2020-05-19
20 201921019995-ENDORSEMENT BY INVENTORS [19-05-2020(online)].pdf 2020-05-19
21 201921019995-DRAWING [19-05-2020(online)].pdf 2020-05-19
22 201921019995-CORRESPONDENCE-OTHERS [19-05-2020(online)].pdf 2020-05-19
23 201921019995-COMPLETE SPECIFICATION [19-05-2020(online)].pdf 2020-05-19
24 201921019995-FORM-9 [24-05-2020(online)].pdf 2020-05-24
25 201921019995-FORM 18 [24-05-2020(online)].pdf 2020-05-24
26 Abstract1.jpg 2020-06-22
27 201921019995-FER.pdf 2022-10-31
28 201921019995-OTHERS [12-01-2023(online)].pdf 2023-01-12
29 201921019995-FORM 3 [12-01-2023(online)].pdf 2023-01-12
30 201921019995-FER_SER_REPLY [12-01-2023(online)].pdf 2023-01-12
31 201921019995-DRAWING [12-01-2023(online)].pdf 2023-01-12
32 201921019995-COMPLETE SPECIFICATION [12-01-2023(online)].pdf 2023-01-12
33 201921019995-CLAIMS [12-01-2023(online)].pdf 2023-01-12
34 201921019995-US(14)-HearingNotice-(HearingDate-27-07-2023).pdf 2023-06-27
35 201921019995-Correspondence to notify the Controller [10-07-2023(online)].pdf 2023-07-10
36 201921019995-Written submissions and relevant documents [28-07-2023(online)].pdf 2023-07-28
37 201921019995-Retyped Pages under Rule 14(1) [28-07-2023(online)].pdf 2023-07-28
38 201921019995-2. Marked Copy under Rule 14(2) [28-07-2023(online)].pdf 2023-07-28
39 201921019995-PatentCertificate31-07-2023.pdf 2023-07-31
40 201921019995-IntimationOfGrant31-07-2023.pdf 2023-07-31
41 201921019995-RELEVANT DOCUMENTS [30-09-2023(online)].pdf 2023-09-30
42 201921019995-RELEVANT DOCUMENTS [30-09-2023(online)]-3.pdf 2023-09-30
43 201921019995-RELEVANT DOCUMENTS [30-09-2023(online)]-2.pdf 2023-09-30
44 201921019995-RELEVANT DOCUMENTS [30-09-2023(online)]-1.pdf 2023-09-30
45 201921019995-FORM FOR SMALL ENTITY [09-05-2025(online)].pdf 2025-05-09
46 201921019995-EVIDENCE FOR REGISTRATION UNDER SSI [09-05-2025(online)].pdf 2025-05-09

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1 SearchHistoryE_27-10-2022.pdf

ERegister / Renewals

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