DESC:FIELD OF THE INVENTION:
This invention relates to the field of biomedical engineering.

Particularly, this invention relates to the field of diagnostics.

Specifically, this invention relates to a menstrual fluid sampling device, aiming to facilitate diagnostic and health assessments of menstruating women

BACKGROUND OF THE INVENTION:
Healthcare plays a vital role for maintaining good health, preventing illnesses, and managing existing conditions effectively. Regular check-ups, preventive care, and timely treatment contribute to improved overall well-being and a higher quality of life.

However, for diagnosis of a few infectious diseases, disease biomarkers, and others, bio-analyte presents several challenges and problems when a bio-specimen needs to be sampled from female subjects; typically, from lower abdominals areas, when it comes to reproductive health and infectious diseases diagnosis.

Mostly, according to available procedures of the prior art, there includes pap smear, liquid-based cytology, endocervical curettage, colposcopy-directed biopsy, and the like procedures. Nevertheless, these practices are very painful and cumbersome towards patients because of cells / tissue sample obtained through a small surgery with special tools and techniques.

Also, this process needs healthcare professionals to collect the bio-specimen for diagnosis requirement and necessitates a sophisticated environment and setup.

Furthermore, societal stigma and cultural beliefs surrounding reproductive health and sexuality may discourage women from seeking regular screenings or discussing symptoms related to cervical related disease.

Menstrual fluid is a complex biological fluid comprising blood, mucus and endometrial tissue from the uterine lining. Numerous research studies have substantiated menstrual fluid as a valuable specimen for disease diagnosis, primarily due to the presence of diverse biomarkers and other bio-analytes derived from the blood, mucus, infected basal epithelia cells or endometrial tissues. Furthermore, menstrual fluid serves as a rich source of stem cells, which can be easily isolated non-invasively. The isolated stem cells exhibit high proliferation and multi-lineage differentiation potency. Thus, menstrual fluid emerges as an excellent alternative as a bio-specimen for disease screening, diagnosis, and a potential source for tissue engineering applications.

To address the current issues related to sample collection, there is a need for a device designed to collect menstrual fluids from females during their menstrual periods, which can be utilized for diagnostic, research, and medical applications.

OBJECTS OF THE INVENTION:
An object of the invention is to provide a device designed to collect menstrual fluids from females during their menstrual cycles, and preserve it in a dried matrix form, which can be utilized for diagnostic, research, and medical applications.

Another object of the invention is to provide a device, being a non-invasive device, for easier collection of the menstrual fluids, remotely, at patient’s privacy for diagnostic and medical requirements.

Another object of the invention is to provide a self-sampling device for women’s health assessment and disease diagnosis based on menstrual fluid.

Another object of the invention is to provide easier sample storage, transportation, and laboratory processing for downstream and upstream diagnostic, research and medical application.

SUMMARY OF THE INVENTION:
According to this invention, there is provided a menstrual fluid sampling device.

This invention pertains to an improved approach for collecting menstrual samples from females, specifically for diagnostic purposes and various medical applications. The proposed solution is a non-invasive method of collecting menstrual fluid samples, which could be very affordable as compared to current available screening and diagnostic options. The device is designed in a manner for easier collection of the menstrual fluids, remotely, at patient’s privacy for diagnostic and medical requirement. The device comprises a special proprietary material, which collects and stores menstrual bio-fluid for analysis. The material is designed in a manner to collect a predefined volume of fluid, thus it could be considered for downstream or upstream applications such as quantifications of bio-analyte and tissue engineering, respectively.

According to this invention, there is provided a menstrual fluid sampling device comprising:
- a strip made with a super-macroporous material, which collects and stores bio-fluids for analysis, said material being formed into blobs and placed atop said strip, in a discrete manner such that two adjacent blobs are spaced apart from each other, each of said blobs serve as receptacle material for biological fluids, said blobs sandwiched in between two membrane layers;
o said two membrane layers consisting, essentially, of an upper layer having:
? one or more chambers, each of said blobs being stored in corresponding chambers by way of encapsulation;
? perforations, with openings, which allow fluid inside said one or mode chambers by capillary action; and
o said two membrane layers consisting, essentially, of a lower layer having:
? a removable layer configured to be peeled off before use.

In at least an emnbodiment, said device comprising a matrix formed by said two membrane layers and said blobs.

In at least an embodiment, said blobs being hemispherical blobs with their bases being supported by said lower layer.

In at least an embodiment, said strip comprising a linearly, axially, extending narrow extension for handling said strip after collecting said sample.

In at least an embodiment, blobs being encapsulated under said corresponding openings, located on an operative top of each of the chambers of the upper layer, such that fluid from a body reaches said openings and into said blobs underneath.

In at least an embodiment, said super-macroporous material being a hydrophilic super-macroporous material having an interconnected porous network capable to:
- absorb biological fluid through capillary action; and
- hold absorbed biological fluid within the porous network.

In at least an embodiment, said super-macroporous material being a hydrophilic super-macroporous material having pore size ranging from 10-120 µM with porosity of the material ranging from 90-95%.

In at least an embodiment, said super-macroporous material being coated with antimicrobial agents selected from a group consisting of Chlorine Compounds (Chlorine dioxide or sodium hypochlorite), Silver nanoparticles, benzalkonium chloride, and Triclosan.

In at least an embodiment, said super-macroporous material being enzymatically treated with enzymes selected from a group consisting of DNase inhibitors, RNase Inhibitors, Protease Inhibitors.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS:
The invention will now be described in relation to the accompanying drawings, in which:
Figure 1 illustrates a the entire device;
Figure 2 illustrates a top view of a strip;
Figure 3 illustrates an exploded view of a strip;
Figure 4 illustrates a cross sectional view of the strip showing the porous material arrangement inside the membranes;
Figures 5a, 5b, 5c illustrate top views of the device;
Figures 6a, 6b, 6c illustrate side views of the device; and
Figure 7 illustrates a strip handling within a cartridge for laboratory sample analysis;
Figure 8a illustrates the device before blood loading; and
Figure 8b illustrates the device after blood loading.

DETAILED DESCRIPTION OF THE ACCOMPANYING DRAWINGS:
According to this invention, there is provided a menstrual fluid sampling device.

Figure 1 illustrates a the entire device;
Figure 2 illustrates a top view of a strip;
Figure 3 illustrates an exploded view of a strip;
Figure 4 illustrates a cross sectional view of the strip showing the porous material arrangement inside the membranes;

In at least an embodiment, there is provided a strip (S) made with a super-macroporous material, which collects and stores menstrual bio-fluid for analysis. The material is hydrophilic in nature having interconnected porous network capable to:
- absorb the biological fluid through capillary action; and
- hold absorbed biological fluid within the porous network.

Porous Material Description:
30 µL 50 µL 100 µL
Height 1.6 ± 0.2 mm 2.3 ± 0.2 mm
3.5 ± 0.2 mm
Volume 19±2 mm3 32 ± 2 mm3 52 ± 2 mm3
Weight (mg) 1.8 ± 0.2 mg 3.0 ± 0.7 mg 6.5 ± 0.7 mg
Porosity % 94 ± 2 %
Swelling Index 15± 2
Blood collection Time, when contacted with enough blood pool 2-3 seconds 4-6 seconds 6-8 seconds

Pore size of the material is from 10-120 µM; thus, it can easily absorb and store blood, endometrial cells, vaginal fluid, and any other complex biological fluids. Porosity of material is in the range of 90-95%. The material can be treated with certain chemical and agents, for desired results, such as antimicrobials, stabilizers, enzymes. In other words, the blobs (B) need to be removed from the encapsulant of the strip (S) through cutting along the upper membrane (UL) and lower membrane (LL); thus, the blob (B) can be utilized for laboratory analysis.etc.The porous materials can be detached from the strip when analysis is required. The material is designed in a manner to collect a predefined volume of fluid range from 10 µL to 1 ml precisely with different size of porous material variant; thus, the collected bio-specimen shall be used for qualitative and quantification of bio-markers, viral loads and proteins, etc. This material is formed into blobs (B) so that they serve as receptacle material for menstrual fluids, and these are sandwiched in between two layers (UL, LL) of membranes (typically, plastic membrane). Typically, this strip (S) has, atop it, discretely placed, one or more blobs (B) of porous proprietary material (hydroporous material) which is predefined for volume collection and sandwiched in between the two membranes (UL, LL) of the material. Each blob (b) porous material is stored within a separate chamber (CH), formed in the upper layer (UL), by way of encapsulation. The position and arrangement of the blobs (B) porous materials in strip is kept in a manner such that it could easily be exposed to the menstrual flow through an opening (O) on an operative top of each of the chambers (CH) of the upper layer (UL). Collection will occur simultaneously across all blobs (B), facilitated by individual openings (O), for each blob (B), to capture the fluid / biospecimen. The strip is extended with a narrow extension (Se), intend to easily remove the strip after menstruation without contamination by an operator.

The two layers (UL, LL) and the blobs (B) of the hydroporous material, therebetween, forms a matrix of this invention.

In at least an embodiment, an upper layer (UL), of the two layers, is perforated with small openings (O), which allow fluid to flow inside the chamber (CH) of membrane. Thus, the material gets exposes and collects the menstrual fluid inside the material by capillary action. The upper layer is directed towards vaginal openings.

In at least an embodiment, a lower layer (LL), of the two layers, allows integration with a menstrual pad. This lower layer (LL) is configured to be, partially, adhered with a menstrual pad and has an extension to easily peel off / remove and handle the entire strip matrix for further downstream or upstream applications and to avoid cross contamination and biohazard while handling the sampled matrix.

The developed device collects menstrual blood, in the blobs (B), within a few minutes after its discharge, and stores it into the supermacro porous material in the device.

In terms of treatment of the supermacro porous material, in preferred embodiment, can undergo treatment with various chemicals and reagents to enable storage and stabilization of biospeciments / fluids for various medical and omics applications.

According to a non-limiting exemplary embodiment, in order to obtain antimicrobial nature in the porous material, this can be achieved by material treatment or coating with the antimicrobial agents such as Chlorine Compounds (Chlorine dioxide or sodium hypochlorite), Silver nanoparticles, benzalkonium chloride, Triclosan, and the like.

According to a non-limiting exemplary embodiment, enzyme treatment can be done in order to stabilize Nucleic acid, inactivation of nucleases and biochemical reaction to enhance sample recovery and quality for analytical outcome such as DNase inhibitors, RNase Inhibitors, Protease Inhibitors, and the like.

In at least an embodiment, the invention comprises a cartridge for storage and shipment purposes. It is specifically designed to facilitate the storage and transportation of the sampled matrix to a laboratory or other desired locations for diagnostic and medical applications. The cartridge is completely sealed and air tight to prevent any environmental biohazard, and its design ensures that the matrix remains centred and does not adhere to the walls of the cartridge. The cartridge's design facilitates insertion of strip edges longitudinally running through guiding rails, ensuring the samples remain centered. This arrangement effectively prevents the samples from contacting the cartridge walls, thereby avoiding damage and wear. Moreover, the cartridge provides ample space for desiccants, which effectively maintain the material in a dry state for long-term preservation, specifically intended for research, bio-banking purposes. The cartridge is designed for the storage and transportation of sampled strip without contaminating environment and other specimens. The design keeps the strip centred to avoid sample contamination with the walls of cartridge. Typically, the porous collection matrix, in strip, is a 3D dimensional porous material that is in a geometric shape, capable to collect precise volume irrespective of nature of menstrual fluid. Naturally material is in the hemisphere in shape, base is positioned on the lower layer (LL). There are multiple hemisphere-shaped porous materials arranged in the strip, having similar dimensions and characteristics. The strip may also contain plural porous materials, exhibiting similar or varied chemical compositions achieved through chemical modification using specific chemicals and reagents, to achieve a desired outcome. These materials can be conveniently – removed and placed either within a laboratory tube or in the wells of an extraction plate manually or through automated setup. This allows for the easy retrieval of samples from the porous materials for both downstream and upstream applications. The bio-analytes from the porous matrix are easily retrievable in organic and inorganic solvents and can be utilized for further analysis. After obtaining the extract the genetic material, proteins, drugs, bio-analyte etc will be processed further with available standard laboratory assay methods for analysis or medical use. The porous material can be pretreated with certain chemicals and reagents to obtain desired interest of applications.

The device is, specifically, a kit which includes a strip and cartridge and is specifically designed to easier collection, storage, transportation and analysis of menstrual fluid for diagnostic and medical applications.

The following steps disclose a procedure of sampling using this invention:
1) Wash hands thoroughly with soap and water before handling the kit to maintain hygiene during the sample collection
2) Install the strip with a menstrual pad carefully at its centre by removing its adhesive backing and gently pressing an edge of the strip over the menstrual pad;
3) Ensure that the adhesive sticks firmly to the menstrual pad;
4) Place the pad inside underwear;
5) Ensure that the perforated opening side faces vaginal opening - the pad should be centered and positioned to catch menstrual flow;
6) Expose the menstrual pad for few hours during menstruation, until it absorbs the menstrual flow in the strip;
7) Remove the pad from underwear, use the provided outside extension to peel off or remove the strip, ensuring hygiene and preventing cross-contamination;
8) Store the strip into the provided cartridge, and then hand it over to medical personnel for diagnosis, research and medical use.

Following steps discloses a procedure for sample extraction using this invention.
1) The super-macroporous material need to remove manually from the strip;
2) The material needs to immerse into the respective volume of distilled water or extraction media, and allow it stand at room temperature or incubator at least 15-20 minutes;
3) Later add 3-5-fold extraction media and stand it for at least 15-20 minutes at room temperature or incubator;
4) Later sample will be subject to nucleic acid extraction, drug extraction and biochemical analysis as per the available standard laboratory assay methods.

This device utilizes menstrual blood for diagnosis and research applications. Menstrual blood contains numerous biomarkers, cells, proteins, and enzymes that can aid in early diagnosis as well as for the tissue engineering applications.

Figures 5a, 5b, 5c illustrate a diagrammatic view of device collecting blood within a porous material.
Figures 6a, 6b, 6c illustrate diagrammatic side views of the device collecting blood within the porous materials

In Figure 5b and Figure 6b, it is shown that blood is discharged from menstruation onto the device.
In Figure 5c and Figure 6c, it is shown that after wearing for some time, the super macroporous material of the device becomes fully red and saturated, with excess blood accumulating on its top surface of upper membrane.

Figure 7 illustrates a strip handling within a cartridge for laboratory sample analysis.

According to a non-limiting exemplary embodiment, device design performance was evaluated through a simulated laboratory experiment utilizing human blood. The invented device was exposed to simulated menstrual flow in laboratory conditions with human blood to evaluate its performance and effectiveness in menstrual blood collection and storage in the porous matrix for subsequent laboratory analysis. The objective was to:
1) Design performance assessment of M-Strip device for menstrual blood collection and storage; and
2) Volumetric Measurement of sampled blood through gravimetric analysis.

Methodology:
Five devices were exposed to sequential blood loading through a micropipette to simulate menstrual blood flow exposure. Each device underwent two blood loading events through the micropipette, with a 2-minute interval between them. The blood was discharged on the upper membrane of each experimental M-strip Device. Following the first blood discharge, most porous matrices became fully saturated, as indicated by the complete expansion and fully red-colored material. The volume of blood collected was assessed using gravimetric analysis. Before exposure, each individual porous material was weighed and assembled into the device. The weight of the saturated material after 2nd blood loading was then measured using a laboratory weighing balance to determine the volume of blood absorption, based on the gravimetric method for volume analysis.

Figure 8a illustrates the device before blood loading.
Figure 8b illustrates the device after blood loading.

The following observation table was plotted:

A1, A2 and A3 denotes embedded porous material in the M-strip Device.
T1- indicates the porous material achieved complete absorption after the 1sts blood loading.
T2- indicates the porous material achieved complete absorption after the 2nd blood loading.

All devices exhibited complete absorption of discharged blood, following the 2nd blood loading. This porous material collection was facilitated by capillary mechanisms of small openings on the upper membrane and the supermacroporous hydrophilic nature of the porous material. However, excess blood was observed on the upper membrane of the M-strip that indicates porous material will predominantly absorb blood during the menstrual flow. The whole blood absorption process occurred within 15 to 30 seconds after enough blood pooling. Across all matrices within the devices consistently absorbed of 50 ± 5 µL of blood, irrespective of the blood's viscosity and the arrangement of materials within the devices.

TECHNICAL ADVANTAGES
1. Non-invasive and painless sample collection using menstrual biofluid;
2. User-friendly and easy to handle device;
3. No need for specialized tools or techniques;
4. No requirement for healthcare professionals to collect bio-specimen;
5. No need for a sophisticated environment and setup for sample collection.

The TECHNICAL ADVANCEMENT of this invention lies in providing a the bio-sampling kit with a strip, of this invention, which allows for controlled gathering of menstrual sample when used with a menstrual pad; the strip is such that it is capable to collect precise volume irrespective of nature of menstrual fluid. Along with its cartridge, the kit provides hazard-free and contamination-free storage and transportation. This kit allows the end-user to conveniently collect their own samples at home; which was, hitherto, not possible.

While this detailed description has disclosed certain specific embodiments for illustrative purposes, various modifications will be apparent to those skilled in the art which do not constitute departures from the spirit and scope of the invention as defined in the following claims, and it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.

,CLAIMS:WE CLAIM,

1. A menstrual fluid sampling device comprising:
- a strip (S) made with a super-macroporous material, which collects and stores bio-fluids for analysis, said material being formed into blobs (B) and placed atop said strip (S), in a discrete manner such that two adjacent blobs (B) are spaced apart from each other, each of said blobs (B) serve as receptacle material for biological fluids, said blobs (B) sandwiched in between two membrane layers (UL, LL);
o said two membrane layers (UL, LL) consisting, essentially, of an upper layer (UL) having:
? one or more chambers (CH), each of said blobs being stored in corresponding chambers (CH) by way of encapsulation;
? perforations, with openings (O), which allow fluid inside said one or mode chambers (CH) by capillary action; and
o said two membrane layers (UL, LL) consisting, essentially, of a lower layer (LL) having:
? a removable layer configured to be peeled off before use.

2. The menstrual fluid sampling device as claimed in claim 1 wherein, said device comprising a matrix formed by said two membrane layers (UL, LL) and said blobs (B).

3. The menstrual fluid sampling device as claimed in claim 1 wherein, said blobs (B) being hemispherical blobs with their bases being supported by said lower layer (LL).

4. The menstrual fluid sampling device as claimed in claim 1 wherein, said strip (S) comprising a linearly, axially, extending narrow extension (Se) for handling said strip (S) after collecting said sample.

5. The menstrual fluid sampling device as claimed in claim 1 wherein, blobs (B) being encapsulated under said corresponding openings (O), located on an operative top of each of the chambers (CH) of the upper layer (UL), such that fluid from a body reaches said openings (O) and into said blobs (B) underneath.

6. The menstrual fluid sampling device as claimed in claim 1 wherein, said super-macroporous material being a hydrophilic super-macroporous material having an interconnected porous network capable to:
- absorb biological fluid through capillary action; and
- hold absorbed biological fluid within the porous network.

7. The menstrual fluid sampling device as claimed in claim 1 wherein, said super-macroporous material being a hydrophilic super-macroporous material having pore size ranging from 10-120 µM with porosity of the material ranging from 90-95%.

8. The menstrual fluid sampling device as claimed in claim 1 wherein, said super-macroporous material being coated with antimicrobial agents selected from a group consisting of Chlorine Compounds (Chlorine dioxide or sodium hypochlorite), Silver nanoparticles, benzalkonium chloride, and Triclosan.

9. The menstrual fluid sampling device as claimed in claim 1 wherein, said super-macroporous material being enzymatically treated with enzymes selected from a group consisting of DNase inhibitors, RNase Inhibitors, Protease Inhibitors.

Dated this 11th day of March, 2024

CHIRAG TANNA
of INK IDÉE
APPLICANT’S PATENT AGENT
REGN. NO. IN/PA - 1785