Sanitary napkin collection system

Abstract

Systems for collecting menstrual blood and vaginal secretions for diagnostic and health monitoring purposes are provided, particularly systems that include strips or patches for collecting bodily fluids on absorbent materials such as feminine hygiene pads and urine pads. Desiccant-containing containers are provided for transporting and storing collected samples to laboratories for analysis of dried menstrual blood samples (DMS), dried menstrual plasma samples (DMPS), dried blood spots (DBS), and / or dried plasma spots (DPS). Desiccant-free containers are also provided that maintain sufficient moisture to keep collected cells intact for analysis using methods such as DNA testing, slide-based analysis, or cell culture. Various collection strip configurations, sample collection, and collection strip retention, which can be used for the collection and / or separation of not only menstrual blood and vaginal secretions, but also venous blood and capillary blood, are also provided. Functional pad design elements are also provided for facilitating rapid pad manufacturing.

Description

[Technical Field]

[0001] The present invention relates to a system for collecting menstrual blood or vaginal secretions for diagnostic or health monitoring purposes, particularly a system that uses strips or patches for collecting bodily fluids on absorbent materials such as feminine hygiene pads or urine pads. A shipping container containing a desiccant or sample transport medium is provided for storing the collected sample, allowing sample types such as dried menstrual blood samples (DMS), dried menstrual plasma samples (DMPS), dried blood spots (DBS), and dried plasma spots (DPS) to be mailed to a laboratory for analysis using a variety of research methods. Transport and storage containers can include both desiccants to keep samples dry or liquids to maintain hydration and cell viability and can be used for a variety of laboratory analytical methods and targets, including RNA sequencing, qRT-PCR, ctDNA testing, cfDNA, enzyme-linked immunosorbent assay (ELISA), cell culture growth and analysis, immunohistochemistry, flow cytometry, mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, gas / liquid chromatography, PCR, microarray analysis, metabolomic profiling, cell culture assays, crystallography, electrophoresis, spectrophotometry, microscopy, and more. They also include functional pad design elements to assist with sample collection, collection strip retention, and facilitate high-speed manufacturing. [Background technology]

[0002] Previously, the only way to obtain systemic blood for diagnostic analysis was through invasive procedures such as syringe withdrawal or fingerstick. Analysis of endometrial tissue and collection of samples from the vaginal canal required cervical or endometrial biopsies or scrapings, both of which are invasive and uncomfortable procedures. While vaginal samples, endometrial tissue, and systemic blood are known to contain important biomarkers used in women's health assessments, known collection methods for collecting samples for testing are inconvenient, costly, and time-consuming.

[0003] The introduction of menstrual blood sample collection systems that can be integrated into feminine hygiene products or pads has changed this. A collection device, such as a strip, is placed inside the pad and used to collect the fluid. The strip containing the collected fluid is then transported to a laboratory for analysis. This means that collecting a menstrual blood sample for analysis is no longer invasive or uncomfortable.

[0004] In this system, the absorbent pad is comprised of a fluid-permeable top sheet, a fluid-absorbent layer, a fluid-impermeable back sheet, and a collection device, such as a collection strip, disposed between the top sheet and the fluid-absorbent layer. The fluid collection strip may be disposed within a recess or pocket in fluid contact with the absorbent layer. The recess or pocket has an opening sized to allow removal and / or insertion of the collection strip. The collection strip is semi-rigid and is formed with a grippable pull tab extending from its edge to facilitate easy removal from the pad. Summary of the Invention [Problem to be solved by the invention]

[0005] The collection strip is typically inserted through a slit in the top sheet or a gap in the end seal. The end seal may be created by adhesive and / or mechanical crimping. To facilitate an opening for inserting the strip, a portion of the end seal may be left unsealed, or a slit may be formed when the top sheet is applied. The two-pad manufacturing process slows down production, and the drape or flexibility of the end seals makes the strip insertion process slow and difficult during assembly.

[0006] After sample collection, the collection strip is removed from the pad and placed in a container for transport to the laboratory for analysis and storage. Dried menstrual blood samples (DMS), dried menstrual plasma samples (DMPS), dried blood spots (DBS), and dried plasma spots (DPS) must be dried and preserved during transport for laboratory analysis. Other samples include viable cells, which must remain moist during transport for analytical testing using laboratory methods and targets, such as RNA sequencing, qRT-PCR, ctDNA testing, cfDNA, enzyme-linked immunosorbent assay (ELISA), cell culture growth and analysis, immunohistochemistry, flow cytometry, mass spectrometry, nuclear magnetic resonance (NMR) spectroscopy, gas / liquid chromatography, PCR, microarray analysis, metabolomic profiling, cell culture assays, crystallography, electrophoresis, spectrophotometry, and microscopy. Depending on the type of analysis being performed, special containers may be required for transport. [Means for solving the problem]

[0007] One aspect of the present invention relates to an absorbent pad structure. The pad includes a fluid-permeable top sheet, a fluid-absorbent layer, and a fluid-impermeable back sheet, which are sealed together along their periphery. A pocket is formed between the top sheet and the fluid-absorbent layer. A bodily fluid collection device is disposed within the pocket for collecting bodily fluid for analysis. The collection device is provided with a pull tab extending from the body of the collection device, which a user can grasp to easily remove the collection device. The pad includes a notch extending inward from the periphery of the pad that aligns with and slightly overlaps the pocket to expose the collection device pull tab.

[0008] The pad preferably includes an oval (or other shaped) indicator printed on the top sheet that is centered below the vaginal canal. The oval helps to properly position the pad pocket during use. The oval is also sized to match the time it takes a user to fill the oval with fluid to the time it takes for the fluid collection device to complete fluid collection.

[0009] The pad may have directional markings on the top sheet near the notch, which may indicate the correct orientation when the pad is worn in underwear.

[0010] Another aspect of the invention relates to a container for transporting a fluid collection device of the type used in an absorbent pad to collect a sample, or for transporting a liquid sample applied directly to a strip without the use of an absorbent pad. The liquid sample applied directly to the strip may be, for example, a menstrual blood sample collected from a cup or tampon, venous blood collected using venipuncture, or capillary blood obtained using a lancet. The container preferably includes a slot for receiving the fluid collection device and a desiccant. The container includes a channel connecting the slot and the desiccant to transfer vapor from the fluid collection device to dehydrate the sample during transport.

[0011] Another aspect of the present invention relates to a strip sample container that is manufactured so that it can be molded as a unitary structure.

[0012] Another aspect of the present invention relates to a collection strip used in an absorbent pad to collect fluid for analysis. The strip can also be used directly by placing the strip on a surface and manually applying a liquid sample onto the collection paper. The liquid sample may be, for example, a liquid sample collected using a menstrual cup or tampon, venous blood collection or capillary puncture, or a urine sample. The collection strip is flexible and includes collection paper, a thin plastic base film, and a bottom frame. The collection paper is attached to the thin plastic base film by the bottom frame. The bottom frame may be single-sided medical tape coated with an adhesive.

[0013] Another aspect of the present invention relates to a plasma collection strip that attaches to an absorbent pad to collect a plasma sample. The strip can also be used directly by placing the collection strip on a surface and manually administering a liquid sample to the collection paper, filter surface, and / or introduction port. The liquid sample can be collected, for example, using a menstrual cup or tampon, venous blood collection or capillary puncture, or a urine sample. The collection strip includes one or more collection papers and at least one filter. The filter filters blood and separates the collection paper from unfiltered blood. The collection paper can receive filtrate from the filter through its entire surface, allowing collection only, or it can receive whole blood or filtrate at the edge of the paper, allowing fluid to move through the lattice structure of the collection paper and also allowing lateral blood separation. Furthermore, a filter can be incorporated into the layer of the strip that the user removes after collection, accelerating the drying of the collection paper and reducing the possibility of hemolyzed blood migrating to the collection layer during drying.

[0014] In a preferred embodiment of the plasma collection strip, the filter includes a single-layer track-etch (TE) membrane, and the collection paper is disposed between the TE membrane and the base film. After collection, the user can peel off the TE membrane to speed up drying of the collection paper and reduce the possibility of hemolyzed blood transferring to the collection layer during drying.

[0015] In another preferred embodiment of the plasma collection strip, the filter comprises an irregular channel filter formed in sandwiched layers of medical tape.

[0016] In another preferred embodiment of the plasma collection strip, the filter comprises a tortuous path depth filter, either alone or in combination with a track-etch membrane as the primary filter.

[0017] Another aspect of the present invention relates to a cell collection strip for use with an absorbent pad. The strip is used to collect live cell samples and transport the cells in a hydrated state to a laboratory for analysis. The strip includes a base film, an adhesive frame, and a cell collection medium. The cell collection medium is disposed between the base film and the adhesive frame. The film may include openings for fluid flow through the strip. The wicking collection medium layer may include a material such as foam, lattice, fiber, or a combination thereof, and functions to capture cellular material when the collection device is in use. A secondary mesh layer may also be incorporated to increase cell capture rates.

[0018] Another aspect of the present invention relates to a cell collection patch for use on the topsheet layer of an absorbent pad. The absorbent pad can include a topsheet that prevents cellular material from reaching the embedded strip. By placing the patch on the topsheet, the physiological fluid can be directly collected without being absorbed and filtered by the upper layer of the pad. The patch is used to collect a cell sample and transport the cells, moist, back to the laboratory for analysis.

[0019] The patch preferably comprises a frame with a surface and edges that allow for safe and comfortable contact with the female vulva and surrounding epidermis. The patch is constructed of a soft, flexible material and may include a wicking layer and a mesh layer. The mesh layer is positioned below the wicking layer to capture additional cells. The mesh size can be adjusted depending on the requirements of the analysis being performed. The patch surface has multiple entry ports. The collection layer captures cells for processing in the laboratory, and the majority of the liquid penetrates into the pad, allowing for extended sample collection times to capture more cellular material.

[0020] Another aspect of the present invention relates to DMS or DBS collection strips that use double-sided medical tape or transfer adhesive to adhere the collection paper to the base film.

[0021] Another aspect of the present invention relates to a method for high speed manufacturing of absorbent pads, such as feminine hygiene pads and incontinence pads, wherein pockets within the pad are formed by zone coating the pad with a hot melt adhesive to secure the nonwoven facing to the pad and form artificial impermeable zone(s) around the pocket. [Brief explanation of the drawings]

[0022] [Figure 1] FIG. 1 is a perspective view of an absorbent pad of the present invention showing notches cut into the periphery and, in this example, an oval and directional arrow printed as an indicator. [Figure 2] 2 is an elevational view of the pad of FIG. 1 with the pull tab of the collection strip extending into the notch; [Figure 3] FIG. 1 is an external view of a sample transport container with a cutout to show part of its interior. [Figure 4] The container has an open lid and a collection strip partially inserted into the container. [Figure 5] FIG. 10 is another view showing the container with the lid open. [Figure 6]1 is an exploded view of an open container with one collection strip placed inside. [Figure 7] FIG. 2 is a cross-sectional view showing the inside of the container. [Figure 8] FIG. 2 is a perspective view showing the inside of the container. [Figure 9A] FIG. 1 shows a tether and a triple lip seal. [Figure 9B] FIG. 10 shows a tether and a triple lip seal. [Figure 10A] FIG. 1 shows a cell collection container for a sample strip that can be filled with a liquid such as a buffer solution and does not require drying. [Figure 10B] FIG. 1 shows a cell collection container for a sample strip that can be filled with a liquid such as a buffer solution and does not require drying. [Figure 10C] FIG. 1 shows a cell collection container for a sample strip that can be filled with a liquid such as a buffer solution and does not require drying. [Figure 10D] FIG. 1 shows a cell collection container for a sample strip that can be filled with a liquid such as a buffer solution and does not require drying. [Figure 11] FIG. 1 shows the appearance of a cell collection container for a collection patch that does not require drying. [Figure 12] FIG. 12 is an exploded view of the container of FIG. [Figure 13] 12 shows the container of FIG. 11 with the lid partially open to expose the interior containing the patch. [Figure 14A] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 14B] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 14C] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 14D] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 15A] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 15B] FIG. 1 shows a second preferred embodiment of a strip sample container. [Figure 16] FIG. 1 is an exploded view of a DMS or DBS collection strip. [Figure 17] FIG. 1 is an exploded view of a plasma collection strip that uses a track-etch membrane as the primary filter and also incorporates DMS or DBS collection. [Figure 18] FIG. 1 is an exploded view of a plasma collection strip that also incorporates DMS or DBS collection and uses a depth filter adhered to a removable layer using double-sided tape or transfer adhesive. [Figure 19] FIG. 10 is an exploded view of a multi-stage plasma filter collection strip that also incorporates DMS or DBS collection and includes a depth pre-filter and track-etch membrane adhered to a removable layer using double-sided tape or transfer adhesive. [Figure 20] FIG. 10 is an exploded view of another multi-stage plasma filter collection strip, which also incorporates DMS or DBS collection and includes a heat-set depth pre-filter and a track-etch membrane filter adhered to a removable layer. [Figure 21] FIG. 1 is an exploded view of a lateral flow plasma collection strip that also incorporates DMS or DBS collection, has no pre-filter, and has a sample introduction port in a removable layer. [Figure 22] FIG. 1 shows an exploded view of a plasma collection strip with a track-etch membrane pre-filter adhered to a removable layer and a lateral flow collection layer that also incorporates DMS or DBS collection. [Figure 23]An exploded view of a plasma collection strip with a lateral flow collection layer that also incorporates DMS or DBS collection and a depth pre-filter adhered to the removable layer using double-sided tape or transfer adhesive. [Figure 24] An exploded view of another multi-stage plasma filter collection strip, in which a TE membrane pre-filter and an asymmetrical path pre-filter are attached to a removable layer, and which includes a lateral flow collection layer that also incorporates DMS or DBS collection. [Figure 25] FIG. 1 is an exploded view of a cell collection strip designed to slide into a strip pocket. [Figure 26] FIG. 1 is an elevation view of a patch-type cell collection device on a pad. [Figure 27] FIG. 27 is an exploded view of the patch-type cell collection device of FIG. 26. [Figure 28A] FIG. 10 shows a DMS or DBS collection strip where the filter paper is attached to the base film using double-sided tape or transfer adhesive. [Figure 28B] FIG. 10 shows a DMS or DBS collection strip where the filter paper is attached to the base film using double-sided tape or transfer adhesive. [Figure 28C] FIG. 10 shows a DMS or DBS collection strip where the filter paper is attached to the base film using double-sided tape or transfer adhesive. [Figure 29] FIG. 1 shows the top of a partially fabricated pad with the top layer removed. [Figure 30] 1 is a structural diagram of a hot melt adhesive slot application nozzle and a cross-sectional view of a pad. [Figure 31A] FIG. 1 shows a portion of a pad and fluid being absorbed directly into the absorbent layer. [Figure 31B] FIG. 10 shows a portion of the pad outside the pocket with adhesive zones where increasing adhesive coverage allows fluid to spread to the top layer of nonwoven, providing a controllable barrier. DETAILED DESCRIPTION OF THE INVENTION

[0023] 1 and 2 show a sanitary napkin (100) of the present invention. The napkin (100) comprises a fluid-permeable topsheet (111) and a fluid-absorbent layer (112), and includes a pocket 104 formed between the topsheet and the fluid-absorbent layer. The pocket is designed to accommodate a removable fluid collection device (113).

[0024] The fluid collection device (113) can be in the form of a semi-rigid collection strip (301) that is inserted into a pad pocket and collects fluid for analysis. The collection strip can include one or more sheets of collection paper (302). The pocket (104) holds the collection strip and prevents the collection paper from moving out of its central position in the vaginal canal. The pocket can be formed by selectively applying a construction adhesive between the sheets that make up the pad.

[0025] As shown, the contour of the pad includes recesses or notches (103) that extend entirely through the pad layers or through portions of the pad to join selected layers of the pad from the top or bottom of the pad. The notches (103) overlap the edges of the fluid-absorbent layer and allow access to the pockets (104) and the strip pull tabs (305) when positioned within the pockets. The notches are formed during pad manufacture in a final die cut using a modified rotary die cutter.

[0026] Preferably, an oval (101) is printed on the top sheet (111) of the sanitary napkin. The oval (101) is positioned directly under the vaginal canal. The oval is sized to match the time it takes the user to fill the oval with fluid and the time it takes for collection onto the collection paper (302) to be complete. The oval (101) can be any circular, linear, or graphical object shape, depending on the requirements of the particular collection strip used with the pad. The oval provides a reference point for the location of the collection paper (302) on the strip, allowing the user to know where to deposit menstrual blood relative to the position of the pad. The oval (101) is sized and shaped to allow a visual estimation of the volume of sample collected on the pad.

[0027] The pad orientation indicator (101) preferably includes the word "FRONT" and an arrow and is printed on the top sheet adjacent to and aligned with the pad notch (103), informing the user that this pad is directional, unlike most standard pads which can be used with either end forward.

[0028] Figures 3 through 13 show containers used to protect samples during transport and storage. Figures 3 through 9B show containers in which samples are dried and stored for laboratory analysis. Figures 10 through 13 show cell collection containers optimized to not require drying during transport but instead maintain moisture.

[0029] As shown in Figures 3 through 9B, the container is formed from injection-molded, mirror-image case halves (203), allowing one part to be used for both halves. Each slot (208) has features (206) designed to guide the strip into position while allowing vapor transfer from the strip to the desiccant through channels designed into the guides (207), enabling efficient drying. The two case halves (203) are held together primarily using pins (205) and, for redundancy, a wrap-around sticker (202).

[0030] The elastomeric lid (201) with triple lip seal (210) allows for easy removal and opening by the user while providing a sufficient seal to reduce the rate of vapor migration from the environment to an acceptable level. Vapor transmission is also reduced by the wraparound sticker (202). The lid (201) is connected to the case by a molded tether (209).

[0031] The sample container contains a molecular sieve desiccant (204) that dries the sample in a consistent and predictable manner, keeping the sample dry during transport and while the strips are processed in the laboratory. The desiccant (204) has sufficient drying power for two strips (301) of any type, allowing the sample to be dried and stored dry for extended periods of time.

[0032] An oxygen absorber (not shown) may be placed in the container, which can further enhance sample preservation by slowing the rate of sample oxidation.

[0033] A poly sticker (202) is wrapped around the case after the container is assembled and serves as a secondary closure method to reduce vapor transmission rate and is also used to label with graphical instructions, warnings, branding, and / or restrictions.

[0034] Figure 3 shows the lid (201), collection strip (301), wraparound sticker (202), case half (203), and desiccant (204). Figure 4 shows the lid (201), collection strip (301), and case half (203). Figure 5 shows the lid (201) and case half (203). Figure 6 shows the collection paper (302), lid (201), case half (203), desiccant (204), pin (205), guide (206), and vapor flow channel (207). Figure 7 shows the desiccant (204), guide (206), and vapor flow channel (207). Figure 8 shows the pin (205), guide (206), and slot (208). Figures 9A and 9B show the tether (209) and triple lip seal (210).

[0035] 10A-10D show another embodiment of a cell sample collection container (211) that can be used for samples that do not require drying. This variation is waterproof and airtight to maintain the condition of the sample. In some cases, the container contains a buffer to suspend the sample. In other cases, the container does not contain a buffer, in which case the sample remains in the same condition as when it was collected. In either case, the sample container can be used for transporting and storing the sample.

[0036] As shown in these figures, the container body (211) is an injection molded part designed to protect and maintain the integrity of the sample. It is molded to contain the minimum amount of buffer needed to maintain sample quality.

[0037] The container lid (212) is airtight and waterproof, preventing ingress and egress. An optional extraction insert (213) is used in the laboratory when removing the strip from the container. The insert has a compression feature (215) to "squeeze" the collected material (214) when the strip is removed.

[0038] Figures 10A-10C show the container body (211), extraction insert (213), container lid 212, cell collection strip 214, collection strip foam, and compression feature 215 of the extraction insert (see Figure 10C). Figure 10D shows the compression feature (215) of the extraction insert, which "squeezes" the foam during removal, allowing the sample to be forced out of the material and into the liquid.

[0039] 11, 12, and 13 show another embodiment of a cell collection sample container 216 for a collection patch 402 that does not require drying. The container is designed to be stored and shipped in a vapor barrier pouch 217. The container and pouch combination is designed to maintain the sample in its as-collected state for extended periods of time during transport.

[0040] The container 216 includes a container body 219, which is an injection molded part whose primary function is to protect the sample. The surface on which the patch 402 rests is constructed with a number of spacer pegs 220 that hold the sample away from flat surfaces, maintaining the integrity of the sample during storage and transport.

[0041] The container lid (218) is made of an elastomeric material and tightly seals against the exterior of the container body (219), and the lid also has spacer pegs (220) to prevent the patch from contacting a flat surface.

[0042] A collection / storage pouch 217 can be provided to maintain sample moisture and cell viability. The cell sample container 216 is stored and transported in the moisture-proof pouch 217.

[0043] Figure 11 shows the sample collection container and moisture-proof pouch 217 for the cell patch 216. Figure 12 shows the cell sample container lid 218, cell sample container body 219, and spacer pegs 220. Figure 13 shows the cell sample container lid 218, cell sample container body 219, spacer pegs 220, and cell collection patch 402.

[0044] Figures 14A-14D and 15A-15B show another embodiment of a strip sample container for sample storage and drying, which can be molded as a unitary structure for manufacturing and assembly efficiency.

[0045] The case (221) is molded as a single piece and is therefore deeply drawn on both longitudinal sides. One drawing creates the strip cavity (228), and the other creates the desiccant cavity (223). The strip cavity is molded with the feature (226) shown in Figure 15A to prevent the area of ​​the collection paper where the sample resides from contacting the interior of the case. To allow vapor transfer from the collection paper to the desiccant, the case is molded with a series of slots (227), as shown in Figure 15B. These slots (227) are located directly above the collection paper and are small enough to prevent the desiccant from entering the strip cavity.

[0046] The lid 222 is molded as part of the case to the end of the strip cavity using a living hinge, allowing the user easy access to the strip slot. Instead of being molded as a single piece using a living hinge, the lid 222 can be a separate part made of the same or a different plastic that is assembled to the case 221 using a pin, slide mechanism, or other similar mechanism. The lid 222 also serves to seal the interior of the case from the environment using a snap-fit ​​feature 224, which also helps extend the life of the desiccant when not in a moisture-proof pouch.

[0047] During the assembly process, small desiccant balls and, optionally, oxygen absorber packets are loaded into the desiccant cavity 223, which is then sealed within the cavity with foil and / or plastic film 225. This film can be attached using adhesives and / or other techniques such as ultrasonic welding.

[0048] Figure 14A shows the molded case (221) and snap lid (222). Figure 14B shows the snap lid (222) and desiccant cavity (223). Figure 14C shows the open snap lid (222), lid snap feature (224), and desiccant cavity film seal (225). Figure 14D shows the strip slot (228), lid (301), and collection strip (301).

[0049] Figure 15A shows the lid (222), touch prevention feature (226), vapor permeable slot (227), and strip (301). Figure 15B shows slot 227.

[0050] Figures 16 through 28 show various collection strip configurations. Figure 16 shows a DMS or DBS collection strip. To collect a sample, the strip (301) contains a sheet of collection paper (302). The collection paper (302) is attached to a thin plastic base film (303) via a bottom frame (304). The bottom frame (304) is a single-sided medical tape coated with an inert acrylic (or equivalent) medical-grade adhesive. A pull tab (305) is used to insert the strip into the pad during the assembly process and also allows the user to remove the strip (301) from the pad after collection is complete. A unique device identification number (UDI) (not shown) is printed on the back of the strip or printed on a durable sticker that is affixed to the back of the strip during the assembly process. A unique serial number, lot number, and expiration date are also included. The base film (303) also contains multiple punched holes (306) for easy laboratory processing.

[0051] FIG. 16 shows the DMS or DBS collection strip (top) (301), pull tab (305), collection filter paper (302), bottom frame (304), punched holes (306), and base film (303).

[0052] 17 through 25 illustrate collection strips that include sections for filtering red blood cells from menstrual, venous, or capillary blood. The plasma produced by this filter is dehydrated in a sample container to produce a dried menstrual plasma sample (DMPS) when menstrual blood is the source sample matrix, or a dried plasma sample (DPS) when venous or capillary blood is the sample. Separation can be performed using a variety of configurations, including depth filters, lateral flow filters, and / or membrane filters.

[0053] The configurations can be categorized into three generally described groups: strips with through-flow filtration, strips that use a combination of through-flow and side-flow, and strips that use only side-flow filtration.

[0054] As shown in Figures 17 and 18, the through-flow strip uses the plasma collection paper (307) only as a sample receiver. Blood flows directly through the filter onto the collection paper (307). The filter performs the filtration, separating the collection paper from the unfiltered whole blood. This configuration has the advantage of reducing collection time compared to other configurations, as a larger surface area is available for filtering the blood sample. The filter stack can use one or more membranes: track-etched fixed pore size filters and / or irregular tortuous type filters.

[0055] Figure 17 shows a single-stage blood separator with a track-etched membrane. This is one embodiment of a filter for DMPS or DPS strips. The single-layer track-etched membrane (308) is used for filtering menstrual blood samples, venous blood, or capillary blood. The pore size of the membrane can be from 0.05 μm to 2.0 μm.

[0056] The collection paper (307) is sandwiched between a track-etch (TE) membrane (308) and a base film (304), and the TE membrane and film are connected by a medical-grade transfer adhesive or double-sided tape (309), which allows the collection paper to be easily retrieved and dried after peeling or cutting off the membrane after use.

[0057] FIG. 17 shows the DMS or DBS collection paper (302), pull tab (305), bottom frame 304, punched holes (306), base film (303), plasma collection paper (307), track-etch membrane 308, and transfer adhesive (309).

[0058] FIG. 18 shows another embodiment of a plasma system that uses an irregular, tortuous path depth filter, such as Vivid™ by Pall, to perform the blood separation function (310): depth pre-filter (Vivid, IPOC, microglass fiber) strip.

[0059] A caveat to the depth filter is that it must be separated from the collection paper (307) during drying in order to retain a consistent volume of whole blood; otherwise, the plasma sample will be contaminated with hemolysate. To separate the filter, the depth filter is attached to a removable layer of single-sided or double-sided medical tape (311). The depth filter (310) is discarded by the user after collection and before the strip is inserted into a sample container for storage and transport.

[0060] FIG. 18 shows the DMS or DBS collection paper (302), pull tab (305), plasma collection paper (307), depth filter 310, and release laminate (311).

[0061] Figure 19 shows a multi-stage plasma filter stack containing an asymmetrical tortuous path pre-filter (Vivid, IPOC). This asymmetric filter slows the rate at which red blood cells (RBCs) pass through the filter structure, reducing the amount of RBCs that need to be filtered by the TE membrane. This reduces the level of hemolysates in the final dried sample.

[0062] A depth filter placed before the TE membrane in the fluid flow path significantly reduces red blood cell migration onto the collection paper. The release layer consists of a double-layered double-sided tape (311). The upper adhesive layer of the tape is used to attach the depth filter (310), and the lower adhesive layer is used to attach the TE membrane (308). The release layer can also be attached to the bottom frame (304) to seal the plasma collection paper (307) from exposure to whole blood during collection (whether using a pad or directly administering a liquid sample such as menstrual blood, venous blood, or capillary blood).

[0063] To establish a stronger fluid connection between the pre-filter (310) and the TE membrane (308), a PE drain membrane (313) can be included between the pre-filter (310) and the TE membrane (308).

[0064] In an alternative embodiment, a depth pre-filter plus a track-etch membrane primary filter can be used, in which single sided tape (311) is used instead of double sided tape, and the pre-filter can be heat staked (314) to the tape instead of using an adhesive to join the materials.

[0065] Figure 19 shows the DMS collection paper (302), pull tab (305), bottom frame (304), base film (303), plasma collection paper (307), track-etch membrane (308), depth pre-filter (310), peel-off laminate (311), and optional PPE drain membrane (313).

[0066] FIG. 20 shows the DMS or DBS collection paper (302), pull tab (305), bottom frame (304), base film (303), plasma collection paper (307), track-etch membrane (308), depth pre-filter (310), release laminate (311), and heat fixation zone (314).

[0067] (lateral separation configuration) Using Cytiva LF1 (or equivalent) as plasma collection paper provides additional functionality for blood separation. LF1 is composed of microglass fibers and a binder material. As blood flows across the LF1, the glass fibers trap larger red blood cells, preventing them from migrating across the paper as the paper draws blood from the inlet to the other side. LF1 is essentially a whole blood collection device and a lateral flow plasma separator combined into one. The device image below shows the lateral flow separation direction of the LF1 labeled.

[0068] Figure 21 shows a lateral flow only (no pre-filter) configuration. As can be seen in this figure, the plasma separation portion of the strip is a rectangular piece (307) of LF1 (or equivalent), which is shielded from contact with whole blood except for a single entry port (315) by a peel-off laminate (311). The port is shaped to reduce the amount of liquid touching the edge of LF1, preventing unfiltered liquid from passing through the paper and flowing down the edge. The single-sided tape (311) covering LF1 can be peeled off after collection, simplifying processing in the laboratory.

[0069] FIG. 21 shows the DMS or DBS collection paper (302), pull tab (305), bottom frame (304), base film (303), plasma separation collection paper (307), release laminate (311), and whole blood introduction port (315).

[0070] (Track-etch membrane prefilter + lateral flow) To reduce the number of red blood cells entering the inlet port of the lateral flow collection paper (307), a pre-filter can be added to the inlet port (308). In this embodiment, a track-etch membrane (308) is used as the pre-filter.

[0071] As shown in Figure 22, this embodiment is constructed using double-sided tape (317) sandwiched between plastic films (316, 318, and 303). The base film (303) has punched holes (306) underneath the DMS or DBS collection paper (302) to facilitate processing in the laboratory. The DMS or DBS collection paper (302) is secured in place by the punched plastic film (316). The laterally separated plasma collection paper (307) is attached onto the double-sided tape (317) and wrapped in a peelable plastic film (318).

[0072] The entry port of the plasma separator paper (308) is covered with a track-etch membrane (308) for pre-filtering blood. A transfer adhesive (309) bonds and seals the track-etch membrane (308) to a peelable plastic film (318). The release layer (312) is then removed, along with the pre-filter (308), peelable plastic film (318), and transfer adhesive (309) attached to the release layer. This improves sample drying, reduces sample contamination with hemolysate, and allows for easier access to the collection paper, resulting in more efficient laboratory processing.

[0073] FIG. 22 shows the DMS or DBS collection paper (302), pull tab (305), punched holes (306), base film (303), plasma separation collection paper (307), track-etch membrane (308), transfer adhesive (309), release layer (312), introduction port (315), plastic film (DMS or DBS side) (316), double-sided tape (317), and removable plastic film (plasma side) (318).

[0074] (depth prefilter + lateral flow) FIG. 23 shows a configuration in which the depth pre-filter (310) uses a tortuous path to capture red blood cells. The tortuous path allows plasma to reach the bottom of the pre-filter before the red blood cells pass through. The filter may be asymmetric, such as a Vivid™ filter, or homogenous, such as a microglass fiber filter. The lateral separation and collection paper (307) provides an additional tortuous patch for red blood cells as they flow down the paper, effectively separating them from plasma while the strip is wet. The release layer (312) can be removed by the user or laboratory to aid in drying the paper, reduce hemolysate contamination, and facilitate access to the collection paper for processing.

[0075] FIG. 23 shows the DMS or DBS collection paper (302), pull tab (305), bottom frame (304), punched holes (306), base film (303), plasma separation collection paper (307), transfer adhesive (309), depth pre-filter 310, release laminate (311), release layer (312), and introduction port (315).

[0076] (depth prefilter + track-etch membrane prefilter + lateral flow) An alternative embodiment of the strip shown in Figure 23 is not shown, but in this embodiment a TE membrane is placed after the depth pre-filter to provide additional filtering.

[0077] (pre-filter + inertial separator + lateral flow) Another embodiment of the plasma strip shown in FIG. 24 is a plasma strip in which whole blood enters the inlet port (315). The inertial filter (321) uses fluid channels to aid in the pre-filtration of whole blood before it is introduced into the collection paper (307). Multiple fluid traps and bends are provided to trap red blood cells while allowing plasma to pass through. The channel widths vary from micrometers to millimeters. A TE pre-filter (308) is also provided at the inlet of the inertial filter (321) to reduce the amount of red blood cells that must be removed by the inertial filter (321).

[0078] After passing through the inertial filter (321), the fluid enters the inlet port (315) and flows across the plasma separation collection paper (307). After collection is complete, the plastic film (with attached inertial filter, TE membrane, and plastic cover) is cut away at the perforations (320) and discarded for easy access and drying of the paper.

[0079] FIG. 24 shows the DMS or DBS collection paper (302), pull tab (305), punched holes (306), base film (303), plasma separation collection paper (307), track-etch pre-filter (308), introduction port (315), double-sided tape (317), plastic film (inertial pre-filter) (319), tear perforations (320), and inertial pre-filter (321).

[0080] (Cell collection device) Cell Collection with Cell Strips: Unlike strips designed to collect dry samples, such as DMS, DMPS, DBS, and DPS strips, cell strips are not designed to collect and transport samples dry to the laboratory. The purpose of cell strips is to collect live cells and return them intact to the laboratory for analysis. This requires that the collected sample remain moist.

[0081] Figure 25 shows a strip-based cell collection device designed to slide into a strip pocket (104). Similar to other strip designs, the cell collection strip has a base film (303) with a pull tab (305). The acquisition layer is sandwiched between the base film (303) and an adhesive frame (405), and the bottom film is perforated to allow fluid to pass through the strip (407).

[0082] As fluid flows through the strip, cellular material is captured by the wicking layer (404) and collection mesh (403). The wicking layer (404) is a hydrophilic material such as foam or felt, and the mesh (403) has pores with sizes ranging from 10 μm to 100 μm, optimized to collect the cell size of interest. Multiple entry ports (406) are provided in the adhesive frame to maximize the collection area.

[0083] FIG. 25 shows the pull tab (305), base film (303), collection mesh (403), wicking layer (404), adhesive frame 405, introduction port (406), and through-flow port (407).

[0084] Cell collection by patch: Figures 26 and 27 show a patch-type cell collection device. A patch with a pull tab (305) is attached to the surface of the nonwoven top sheet (105) of the pad. This allows the patch to directly capture menstrual blood without it being absorbed or filtered by the nonwoven top layer.

[0085] As shown in these figures, the surface of the frame (408) and the edges of the patch come into contact with the female, and therefore must be constructed using a soft, flexible material that will not irritate the user. The capture layer resembles the strip version of the cell collection device (401), with a wicking layer (404) on top and a mesh layer (403) underneath the wicking layer (404). This embodiment can be used with commercially available sanitary napkins, allowing the napkin to be applied as a patch. As described above, when using a notched pad, the patch pull tap (305) extends into the pad notch (103), preventing blood from adhering to the pad notch. The patch includes multiple entry ports (406), which cover most of the pad surface. The collection layer captures cells to be processed in the laboratory, and the majority of the liquid penetrates the pad, potentially extending sample collection time.

[0086] Figure 26 shows the notch (103), pull tab (305), and nonwoven surface of the pad (105). Figure 27 is an exploded view of the patch collection device, showing the entry port (406), collection mesh (403), wicking layer (404), flow port (407), and frame (408).

[0087] Another embodiment of a DMS or DBS collection strip (with double-sided tape or transfer adhesive) is shown in Figures 28A, 28B, and 28C. In this embodiment, the DMS or DBS collection strip is manufactured using double-sided (DS) tape, which attaches the collection paper to the support film, allowing for efficient manufacturing, optimal size, and maximized collection area.

[0088] The strip consists of a plastic film (303) (made of materials such as PET or PP), double-sided tape (323), and collection paper (302). The DS tape (323) is sandwiched between the collection paper and the plastic base film (303). The strip may or may not have a thin tape film to protect the leading edge of the collection paper (322) to prevent peeling. The plastic film (303) and DS tape (323) have punched holes (306) to facilitate processing of the strip in the laboratory. The front of the strip is narrow and can function as a pull tap (305) that the user uses to remove the strip from the pad.

[0089] Figure 28A shows the collection filter paper (302), base film (303), pull tab (305), and tape (322) for protecting the edge of the collection filter paper. Figure 28B shows the base film (303), pull tab (305), and punched holes (306). Figure 28C shows the collection filter paper (302), base film (303), pull tab (305), punched holes (306), and protective tape (322).

[0090] Another aspect of the present invention relates to a method for rapid manufacturing of absorbent articles, such as feminine hygiene pads, urinary pads, and the like, that include strips for collecting bodily fluids for analysis. More specifically, the method provides a stable opening in one or more end seals of the absorbent article to facilitate the insertion of a semi-rigid component, such as a bodily fluid collection strip used in bodily fluid analysis.

[0091] As previously mentioned, a collection device, such as a semi-rigid strip, is typically inserted through a slit in the top sheet or a gap in the end seal. The end seal is typically formed by adhesive and / or mechanical crimping. In prior art, a portion of the end seal is left unsealed to facilitate an opening for inserting the strip. However, due to the drapeability, i.e., flexibility, of the end seal, this process is difficult and time-consuming. The end seal is typically made very soft and pliable for user comfort.

[0092] High-speed manufacturing requires a better process. The method of the present invention solves this problem by providing an absorbent pad with an area coated with hot melt adhesive, creating an impermeable area around the permeable pocket, and then providing a notch cut to expose the pocket. The notch is created by cutting a small section of the absorbent core to fit the width of the pocket. This stiffens the opening, facilitating insertion of the strip into the pocket.

[0093] Figure 29 shows a top view of the pad during manufacturing, with the top layer removed, showing the pockets formed by the adhesive application areas. Figure 30 shows a schematic diagram of a hot melt adhesive slot application nozzle and a cross-section of the pad. The pockets for placing the collection strips on the pad are created by zone coating the build adhesive used to secure the nonwoven to the pad. This is accomplished using a slot coater with three solenoid-controlled application zones.

[0094] While the pad machine is running, the left and right solenoids are kept open, creating two areas where the adhesive is completely applied. The center solenoid alternates between on and off, creating an adhesive-free area (a pocket for the strip). The length of the pocket is controlled by the length of time the solenoid is closed.

[0095] The nonwoven facing is preferably carded hydroentangled cotton. This process forms the nonwoven structure without the use of chemical binders, resulting in a slightly napped, soft-to-the-touch web. The nonwoven contains a small amount of adhesive that allows the cotton fibers to break through the adhesive film, creating an opening for fluid to pass through and enter the absorbent core of the pad. This can be demonstrated by dropping a dropper of blue food coloring in water onto a section of the pad.

[0096] Figure 31A shows a portion of the pad pocket with fluid absorbed directly into the absorbent layer, while Figure 31B shows a portion of the pad outside the pocket with an adhesive zone that provides a barrier to selectively reduce the rate of absorption into the fluid-absorbing layer of the pad.

[0097] While the present invention has disclosed several preferred embodiments for purposes of illustration, it will be understood that many modifications and variations therein are possible, and the present invention is intended to cover all such modifications and variations which fall within the scope of the present invention as defined by the claims.

Claims

1. 1. An absorbent pad having a peripheral edge, The pad is a fluid permeable top sheet; a fluid-absorbing layer; a fluid-impermeable backsheet; a pocket formed between the topsheet and the absorbent layer; a fluid collection device adapted to be received in the pocket to collect bodily fluids for analysis; Equipped with the collector comprises a body and a pull tab extending from the body of the collector; the top sheet includes a notch extending inward from an edge of the pad to expose the pull tab of the collection device; pad.

2. 1. An absorbent pad having a peripheral edge, The pad is a fluid permeable top sheet; a fluid-absorbing layer; a fluid-impermeable backsheet; a pocket formed between the topsheet and the absorbent layer; a fluid collection device adapted to be received in the pocket to collect bodily fluids for analysis; Equipped with the pad comprises one or more indicators printed on the top sheet centrally below the vaginal canal; one or more of the indicators are sized so that the time it takes a user to fill a shape corresponds to the time it takes to complete fluid collection by the fluid collection device. pad.

3. further comprising a directional indicator on the top sheet near the notch; The directional indicator is configured to inform a user of the correct orientation of the pad during use. The pad of claim 1.

4. 1. A container for transporting a fluid collection device of the type used in an absorbent pad to collect a sample, comprising: The container comprises: a slot adapted to receive the fluid collection device, a desiccant, and a channel connecting the slot and the desiccant, configured to transfer vapor from the fluid collection device to dry the sample during transport; container.

5. 1. A container for transporting a fluid collection device of the type used to administer a sample, comprising: The container comprises: a slot adapted to receive the fluid collection device, a desiccant, and a channel connecting the slot and the desiccant, configured to transfer vapor from the fluid collection device to dry the sample during transport; container.

6. 1. A collection strip for collecting menstrual, venous, capillary, or urinary samples for use within an absorbent pad or by direct administration independent of an absorbent pad, comprising: It comprises a sheet of collecting paper, a thin plastic base film, and a bottom frame; the collecting paper is attached to the thin plastic base film on the bottom frame; the bottom frame comprises single-sided medical tape coated with an inert adhesive; Collection strips.

7. A collection strip for use within an absorbent pad or for collecting and processing menstrual, venous, capillary, or urinary samples by direct administration independent of an absorbent pad, the collection strip incorporating a filter for separating red blood cells from whole blood, resulting in the production of plasma; the collection strip comprises a collection paper and a filter stack; blood flows through the filter stack directly onto the collecting paper, whereby the filter stack filters the blood and isolates the collecting paper from unfiltered blood; Collection strips.

8. Further provided with a base film, the filter comprises a single layer of track-etched membrane, the collecting paper being disposed between the membrane and the base film; 8. The plasma collection strip of claim 6 or 7.

9. The filter comprises a tortuous path depth filter mounted on a removable medical tape layer.

8. The plasma collection strip of claim 6 or 7.

10. The filter includes a lateral blood separation and collection paper with an introduction port formed in a removable layer.

8. The plasma collection strip of claim 6 or 7.

11. The filter includes a depth pre-filter incorporated in a removable layer and a primary filter of a track-etched membrane.

8. The plasma collection strip of claim 6 or 7.

12. The filter includes a track-etch membrane pre-filter incorporated into a removable layer and a lateral blood separation collection paper.

8. The plasma collection strip of claim 6 or 7.

13. The filter includes a tortuous path depth pre-filter incorporated into a removable layer and a lateral blood separation collection paper.

8. The plasma collection strip of claim 6 or 7.

14. The filter incorporates a filter with channels formed in a serpentine path configuration; the tortuous path is formed in a sandwiched layer embedded between the removable layer and a lateral blood separation collection paper; 8. The plasma collection strip of claim 6 or 7.

15. the filter includes a track-etch pre-filter; 15. The plasma collection strip of claim 14.

16. the filter includes a track-etch post-filter; 15. The plasma collection strip of claim 14.

17. 1. A cell collection strip system for use within an absorbent pad to collect a cell sample and return said cells in a hydrated state to a laboratory, comprising: The system comprises: a cell collection wicking medium, including foam, felt, lattice structure material, etc.; A base film; An adhesive frame, Equipped with the cell collection wicking medium is disposed between the base film and the adhesive frame; The film is an opening for fluid to flow through said strip; a wicking medium layer comprising a hydrophilic material for capturing cellular material as the fluid flows through the cell collection strip; Including, Cell collection strip system.

18. A cell collection patch for use within an absorbent pad to return cells to a laboratory in a hydrated state for DNA and slide-based analysis, comprising: The patch comprises a frame having a surface and an edge that contacts the female vulva and epidermis; the surface is comprised of a soft, conformable material, a wicking collection layer including foam, felt, lattice material, etc., and a mesh layer; the mesh layer is positioned below the wicking collection layer; the patch comprises a plurality of entry ports; the collection layer and the mesh layer capture cells being processed in the laboratory; Cell collection patch.

19. 1. A method for rapidly manufacturing absorbent pads, including feminine hygiene pads and urine pads, using a carded hydroentangled cotton nonwoven facing, comprising: The method comprises: creating a pocket in the pad for holding a fluid collection strip used to analyze the fluid; the pocket is formed by zone-coating the pad with a hot melt adhesive to secure a nonwoven facing to the pad, forming an adjustable zone of impermeability around the pocket; The zone coating is realized by a hot melt slot coating machine with left, right and center solenoid controlled application zone sockets; While the coating machine is running, the left and right solenoids are maintained in an open state to form two separate adhesive application areas; a central solenoid of the coating machine is cycled on and off to create an adhesive-free area in the pocket of the strip; The length of the pocket is controlled by the length of time the central solenoid of the device is closed. method.

20. the amount of adhesive applied to the nonwoven facing by the machine is small enough to allow the cotton fibers to break through the adhesive film, creating an entrance for fluid to pass through the adhesive film and into the absorbent core of the pad; 20. The method of claim 19.

Images