Disposal pouches for biowaste such as immunoassay waste

Abstract

A waste pouch for biowaste from a blood analyzer, a cassette including the waste pouch, and a blood analyzer including the waste pouch or the cassette are provided. The waste pouch includes a bag, a vent hole on the top surface of the bag as a gas outlet, and an opening for receiving liquid waste and gaseous waste. The waste pouch includes beads of highly absorbent polymer contained in the bag.

Description

[Technical Field]

[0001] The present invention provides a waste pouch for biowaste from a blood analyzer, a cassette including the waste pouch, and a blood analyzer including the waste pouch or the cassette. The waste pouch includes a bag, a vent hole on the top surface of the bag as a gas outlet, and an opening for receiving liquid waste and gaseous waste. The waste pouch includes a bead-shaped superabsorbent polymer contained in the bag. [Background technology]

[0002] Blood analysis machines are widely used in the medical field to analyze various properties of human blood. (For convenience, blood analysis machines will be referred to herein as "blood analyzers." However, it should be understood that the present invention is not limited to blood analyzers, but can be used in the fields of urine, mucus, spinal fluid, and sperm analyzers.) A blood sample is drawn from a patient, and the blood is transferred to the blood analyzer. The blood analyzer is then used to determine the levels of certain components found in the blood (e.g., blood gases and blood electrolytes).

[0003] After the blood sample analysis by the blood analyzer is completed, the waste blood is transferred to a waste container. The blood analyzer uses liquids for analysis, conditioning, and cleaning the blood analyzer after analyzing the blood sample. These liquids are also transferred to the waste container. Gas is also used to clean the blood analyzer, and this gas is also transferred to the waste container.

[0004] Therefore, large volumes of liquids and gases may be transferred to the waste container. If not handled properly, the liquids and gases may spill, leak, or cause "bulging" within the waste container. The waste container should be capable of managing the waste liquids and gases. For hygienic reasons, the waste container should also be disposable and replaceable, and should comply with hazardous waste regulations. Blood and blood components may also clot after analysis, thereby increasing the risk of blockage of the inlet and / or outlet of the waste container.

[0005] Known waste containers consist of open molded plastic trays, which may not be sufficient to prevent spills and leaks. Other known solutions include waste bags that stand upright within the device, which is undesirable from the standpoint of fluid flow and the ability to replace the waste bag. WO9743988A1 describes a waste bag for a portable blood analyzer. WO2016 / 096845 describes another device that facilitates waste disposal. Summary of the Invention [Problem to be solved by the invention]

[0006] Therefore, there is a need for a disposable, lightweight, and compact waste container for a portable hematology analyzer that can manage large volumes of liquid and gas volumes while substantially preventing spillage and / or leakage of waste fluids. Importantly, the waste container should effectively retain waste liquids while effectively releasing gases to avoid clogging. It is an object of the present invention to provide such a waste container. [Means for solving the problem]

[0007] The inventors have discovered that it is possible to achieve effective waste storage and effective ventilation of a waste pouch for a blood analyzer while avoiding blockage or clogging of the vent hole and waste inlet opening. Accordingly, a waste pouch for biowaste from a blood analyzer is provided, the waste pouch comprising a bag formed of a liquid- and gas-impermeable membrane material, the bag having opposing upper and lower surfaces, the waste pouch further comprising a vent hole on the upper surface of the bag for a gas outlet, the vent hole being covered with a gas-permeable and liquid-impermeable membrane, the waste pouch further comprising an opening for receiving liquid waste and gaseous waste, and the waste pouch comprising a superabsorbent polymer contained in the bag, the superabsorbent polymer having a bead shape.

[0008] Also provided is a disposable cassette for a hematology analyzer comprising the disposal pouch described herein. Also provided is an immunoassay analyzer comprising the cassette described herein or the disposal pouch described herein.

[0009] Other aspects of the invention are described in the following figures and specification, and in the appended claims. The present technology is illustrated in the accompanying drawings. [Brief explanation of the drawings]

[0010] [Figure 1] FIG. 1 is a perspective view of one embodiment of a disposal pouch according to the present invention. [Figure 2] FIG. 2 is a perspective view of one embodiment of a cassette according to the present invention, including a disposal pouch. [Figure 3] FIG. 3 is a schematic diagram showing a bead of superabsorbent polymer and how it may contact a membrane. [Figure 4] FIG. 4 is a photograph of a full waste pouch with blood and assay buffer. DETAILED DESCRIPTION OF THE INVENTION

[0011] As noted above, the present invention relates to a disposal pouch for biowaste from a blood binding analyzer. Typically, biowaste from a hematology analyzer is a mixture of blood and blood components such as plasma, various calibration fluids, calibration and cleaning fluids, and gases. These components can enter the waste pouch in various orders and combinations, making liquid containment and gas separation important.

[0012] The disposal pouch is made of a bag made of a liquid- and gas-impermeable membrane material, allowing liquid and gas waste to be handled hygienically. The maximum capacity of the bag is usually 500 to 2,000 milliliters, and preferably 800 to 1,200 milliliters.

[0013] Those skilled in the art are familiar with suitable liquid- and gas-impermeable membrane materials and techniques for forming the pouch. Suitable liquid- and gas-impermeable materials are polymeric membranes, such as polyethylene (PE) membranes or polypropylene (PP) membranes, which may be single-layered or multi-layered, or may be laminates of different layers. To achieve maximum gas impermeability, the polymeric membrane is preferably covered with, for example, a metal layer. The pouch may be formed by cutting, folding, gluing, or welding (e.g., heat welding) the membrane material as needed. The configuration and material of such a pouch allow the disposal pouch to expand during use as needed, while also being disassembled and / or foldable before use to reduce its space footprint.

[0014] The bag has an upper surface and a lower surface that face each other. In a preferred embodiment shown in Fig. 1, the bag is made of the upper and lower surfaces that face each other, and the opposing upper and lower surfaces are sealed to each other at their respective peripheries. That is, the bag is formed by two films of material that are joined to each other at their respective edges.

[0015] From the viewpoint of ease of manufacturing, it is preferable that the upper and lower surfaces of the bag have essentially the same shape. Therefore, the bag can have a first extension in the XY plane, and the upper and lower surfaces have approximately the same geometric shape in the XY plane. The disposal pouch further includes an opening for receiving liquid waste and gaseous waste. Preferably, the opening of the disposal pouch for liquid waste and gaseous waste is provided in the sealed portion between the upper and lower surfaces or adjacent to the sealed portion. By arranging it in this manner, the opening is raised from the lower surface of the bag—as the bag expands when liquid and gas enter the bag. As a result, liquids can easily flow out of the opening, and the opening is less likely to become blocked.

[0016] The opening for admitting liquid and gaseous waste may include a valve positioned to allow liquid waste to enter the pouch through the opening while substantially preventing liquid waste from exiting the pouch through the opening. Preferably, as shown in FIG. 1 , the opening may include one or more connecting elements. In this manner, the waste pouch is reversibly secured to a corresponding element of the waste tubing of the blood analyzer when inserted into a predetermined position and released when removed from the predetermined position. The connecting element of the waste pouch opening may be secured to a corresponding element of the waste tubing to form a liquid-tight connection. Suitable connecting elements may be push-fit or bayonet-fit connecting elements.

[0017] Preferably, no openings for receiving liquid and gaseous waste are provided on the upper surface of the bag, in which case the valve and openings are spaced apart from each other. Preferably, the disposal pouch has no internal obstructions or walls, i.e., the disposal pouch is defined only by the upper and lower surfaces of the bag. Specifically, the disposal pouch has no internal obstructions or walls disposed in the gas path between the opening and the valve, allowing waste liquid and gas to flow unimpeded between the opening and the valve. This arrangement allows waste to flow freely within the disposal pouch.

[0018] As described above, the disposal pouch further includes a valve on the top surface of the bag for gas outlet. The valve is covered with a gas-permeable, liquid-impermeable membrane. A suitable gas-permeable, liquid-impermeable membrane is a hydrophobic membrane such as a polytetrafluoroethylene membrane or a fluorinated membrane. The disposal pouch may include two or more valves, each covered with a gas-permeable, liquid-impermeable membrane.

[0019] [Table 1]

[0020] While gas-permeable, liquid-impermeable membranes prevent liquids from escaping the disposal pouch, they can become clogged or blocked when exposed to liquid, solid, and semi-solid waste. A blocked membrane can prevent gas from escaping the disposal pouch and cause undesirable expansion of the disposal pouch.

[0021] Preferably, the valve is located approximately in the center of the top surface of the bag. The "center" of the top surface is defined as the point as far away as possible in all directions from the opposite ends of the top surface. Having the valve in this location allows the disposal pouch to expand to its fullest extent, with the valve at the topmost position creating a "doming" effect.

[0022] The disposal pouch comprises a superabsorbent polymer housed in a bag, the superabsorbent polymer having a bead shape. Superabsorbent polymers (SAPs) are known in the field of personal hygiene products and can absorb 200 to 300 times their own weight in liquid water. Suitable superabsorbent polymers can be selected from polyacrylic acid (PAA), poly(methacrylic acid) (PMA), and esters of polyacrylic acid or poly(methacrylic acid), as well as copolymers or block copolymers thereof. Polyacrylamide is also suitable, either alone or as a copolymer or block copolymer. Those skilled in the art may select superabsorbent polymers according to, for example, molecular weight or degree of crosslinking to optimize properties such as swelling.

[0023] Isolating the liquid waste in a superabsorbent polymer reduces the risk of blood spills and exposure to human-derived materials. Furthermore, the superabsorbent polymer bead shape allows it to move relatively freely within the disposal pouch and absorb liquid as needed. The superabsorbent polymer beads themselves, for example, are roughly spherical, which minimizes the contact area with the gas-permeable, liquid-impermeable membrane. Therefore, the membrane does not sink in the liquid, maintaining its breathability. This is shown diagrammatically in Figure 3.

[0024] In this way, clumping of the superabsorbent polymer (and the resulting blockage of the opening and / or vent of the disposal pouch) can be avoided. Superabsorbent polymer beads have the advantage that they can easily pass through each other within the disposal pouch.

[0025] The superabsorbent polymer beads are preferably generally spherical. The superabsorbent polymer beads may have any three-dimensional geometric shape, including, but not limited to, spheres, hemispheres, ellipsoids, and / or polyhedra, or a combination of shapes. Preferably, the superabsorbent polymer beads have at least one curved surface.

[0026] This allows the superabsorbent polymer beads to pass each other smoothly within the disposal pouch, minimizing the contact area with the membrane. It is preferable that there is low surface friction between the beads and between the beads and the disposal pouch, so that the beads will flow easily (i.e., freely) within the disposal pouch in both dry and wet conditions and will tend to avoid clogging or obstructing the opening of the disposal pouch.

[0027] Suitably, the superabsorbent polymer beads have an average particle size - in the dry state - of 2.0 to 3.5 mm, preferably 2.5 to 3.0 mm. A suitable supplier of superabsorbent polymer beads is Demi Corporation.

[0028] Also provided is a disposable cassette for a blood analyzer that includes the waste pouch described herein. The cassette is shown schematically in Figure 2 and has the general shape of a "drawer" designed to be inserted into and removed from the bottom of the blood analyzer.

[0029] The disposable cassette may be formed as a single piece of molded plastic or may be formed from joined (welded or glued) plastic elements. Typically, disposable cassettes are provided as a sealed unit (i.e., the cassette cannot be opened without being destroyed, as the base, walls and lid are joined together).

[0030] The cassette has a generally planar bottom, at least one sidewall (e.g., two, three, or four sidewalls), and a generally planar lid that together define a substantially closed volume comprising the waste pouch with the waste pouch vent positioned furthest from the bottom of the cassette.

[0031] Similar to the waste pouches, the cassette may also include one or more, preferably two to nine, buffer pouches. The buffer pouches contain buffers necessary to perform an assay on the analyzer. Thus, buffers for the analyzer are provided by the cassette. If the analyzer is an immunoassay analyzer, the buffer pouches are assay buffer pouches. By providing the buffer pouches in the cassette, a closed system is achieved, including the buffer pouches and the waste collection waste pouch. This means that the user never comes into direct contact with the reagents, used sample, or used reagents.

[0032] Preferably, the disposal pouch has an internal volume equal to or greater than the total internal volume of all buffer pouches provided in the cassette so that all used assay buffer can be accommodated in the disposal pouch. In the embodiment shown in Figure 2, the waste pouch at least partially encases the buffer pouch within the cassette such that a first portion of the waste pouch is located between the buffer pouch and the cassette lid and a second portion of the waste pouch is located between the assay buffer pouch and the bottom of the cassette. The waste pouch's vent hole is preferably located in the first portion of the waste pouch, and the waste pouch's opening is preferably located in the second portion of the waste pouch. This allows the openings for liquid waste and gaseous waste to be located at the bottom of the cassette, i.e., closest to the bottom, and the vent hole to be located at the top. In one form, the blood analyzer is an immunoassay analyzer. Accordingly, the present invention provides an immunoassay analyzer comprising a cassette as defined herein or a waste pouch as defined herein.

[0033] DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic perspective view of a disposal pouch 10 according to the present invention. The disposal pouch 10 includes a bag 12 made of a liquid- and gas-impermeable membrane material. As shown, the bag 12 has opposing upper and lower surfaces 12a and 12b. The upper and lower surfaces 12a and 12b are joined together via a seal 21, i.e., a sealed edge. In the embodiment of FIG. 1, only the upper and lower surfaces are shown. A vent 14 is located on the upper surface of the bag and is covered by a gas-permeable, liquid-impermeable membrane 16. An opening 18 is positioned to receive liquid and gaseous waste into the disposal pouch 10. The disposal pouch includes beads of superabsorbent polymer 20 housed in the bag. Disposal pouch (10) in FIG. 1 is shown in a folded configuration suitable for storage within cassette (100).

[0034] Figure 2 is a diagram of a cassette 100 according to the present invention (with the lid removed for clarity). The top of Figure 2 shows how the disposal pouch 10 is folded around the buffer pouch 110. In this case, two buffer pouches 110 are shown. The bottom of Figure 2 shows the unfolded configuration, showing how the disposal pouch 10 "wraps" around the buffer pouch 110.

[0035] Figure 3 is a hypothetical image showing how superabsorbent polymer beads (20) form spaces between them and the gas-permeable, liquid-impermeable membrane (16). Gas can thus travel through channels between each bead and between the beads and the membrane.

[0036] Figure 4 is a photograph of a waste pouch (10) filled with a liquid-impermeable membrane (16) and superabsorbent polymer beads (20, 20a) containing blood and assay buffer. A small dot (30) inside the membrane (16; the disk is welded to the pouch) indicates minimal blockage. Thus, the photograph shows that the membrane (16) still retains ample breathability. [Example]

[0037] Bead size test Test Procedure 1. Demi superabsorbent polymer beads were placed inside a clear, folded disposal pouch and prepared for use in this study. 2. A 1.2 liter mixture of assay buffer and blood was prepared and poured into the assay buffer pouch of each solution pack in a ratio of 120 (assay buffer):1 (blood). 3. A solution pack with a folded waste pouch and an assay buffer pouch was prepared for use in the test. 4. To test each solution pack, a test stand was assembled using the following steps: a. 4.5 milliliters of liquid was withdrawn from the assay buffer pouch in 4 seconds 35 times per day for a total of 7 days. b. All of the liquid extracted in step (a) was poured into the disposal pouch at the same rate and frequency as in step (a). At the end of operation in step (a), the liquid pouring was stopped. 5. After step 4, the waste pouch was carefully removed from the solution pack with the breathable membrane side facing up. The liquid absorbent material was visually inspected for condition and performance. 6. Place the waste pouch over the beaker with the vent membrane side facing up. 7. A small cross cut was made in the bottom of each tested disposal pouch and the disposal pouches were left for 24 hours to allow any residual liquid to drain. 8. After step 7, the weight of the liquid that flowed out of the disposal pouch was measured and recorded.

[0038] [Table 2]

[0039] The superabsorbent polymer beads are found to perform well compared to superabsorbent polymer powders and absorbent pads (such as those used to package fresh meat). No blockage of the breathable membrane was observed with the superabsorbent polymers of the present invention.

[0040] The present invention has been described with reference to a number of embodiments. Those skilled in the art will be able to combine elements of different embodiments as needed. All documents cited herein are incorporated by reference.

Claims

1. A waste pouch (10) for biowaste from a blood analyzer, comprising: The disposal pouch (10) comprises a bag (12) formed from a liquid and gas impermeable membrane material; The bag body (12) has an upper surface (12a) and a lower surface (12b) facing each other, The disposal pouch (10) further comprises a vent hole (14) on the upper surface of the bag body as an outlet for gas, the vent hole (14) being covered with a gas-permeable, liquid-impermeable membrane (16); The waste pouch (10) further comprises an opening (18) for receiving liquid waste and gaseous waste; The disposal pouch (10) comprises a superabsorbent polymer (20) contained in the bag (12); The disposal pouch is characterized in that the highly absorbent polymer has the shape of beads (20a).

2. 2. The disposal pouch (10) according to claim 1, wherein the bag body (12) comprises an upper surface (12a) and a lower surface (12b) that face each other, and the opposing upper surface (12a) and lower surface (12b) are sealed to each other at their respective peripheral edges.

3. 3. A disposal pouch (10) according to claim 2, characterized in that the openings (18) for liquid and gaseous waste are provided in the seal (21) between the upper surface (12a) and the lower surface (12b) or adjacent to the seal (21).

4. 4. The disposal pouch (10) according to claim 1, wherein the bag body (12) has a first extension in the XY plane, and the upper surface (12a) and the lower surface (12b) have substantially the same geometric shape in the XY plane.

5. 5. A disposal pouch (10) according to any one of claims 1 to 4, characterized in that the superabsorbent polymer beads (20a) have at least one curved surface and are preferably substantially spherical.

6. 6. A disposal pouch (10) according to any one of claims 1 to 5, characterized in that the highly absorbent polymer beads (20a) have an average particle size - in the dry state - of 2.0 to 3.5 mm, preferably 2.5 to 3.0 mm.

7. 7. A disposal pouch (10) according to any one of claims 1 to 6, characterized in that the superabsorbent polymer beads (20a) are free-flowing within the disposal pouch (10).

8. 8. A disposal pouch (10) according to any one of claims 1 to 7, characterized in that the opening (18) for receiving liquid and gaseous waste comprises a valve arranged to allow liquid waste to enter the pouch through the opening (18) while substantially preventing liquid waste from exiting the pouch through the opening (18).

9. 9. A disposal pouch (10) according to any one of claims 1 to 8, characterized in that the opening (18) for receiving liquid waste and gaseous waste is not located on the upper surface (12a) of the bag (12).

10. 10. The disposal pouch (10) according to any one of claims 1 to 9, wherein the vent hole (14) is located approximately in the center of the upper surface (12a) of the bag body (12).

11. A disposable cassette (100) for a hematology analyzer, characterized in that the cassette comprises a disposal pouch (10) according to any one of claims 1 to 10.

12. 12. The cassette (100) of claim 11, comprising a generally planar bottom, at least one side wall, and a generally planar lid, the bottom, the at least one side wall, and the lid defining a substantially closed volume comprising the disposal pouch (10), the vent hole (14) of the disposal pouch (10) being located at a position furthest from the bottom of the cassette (100).

13. 13. A cassette (100) according to any of claims 11 and 12, further comprising one or more buffer pouches (110), preferably between two and nine in number.

14. 14. A cassette (100) according to any one of claims 11 to 13, wherein the waste pouch (10) has an internal volume equal to or greater than the total internal volume of all buffer pouches (110) in the cassette (100).

15. An immunoassay analyzer comprising a cassette (100) according to any one of claims 10 to 14 or a disposal pouch (10) according to any one of claims 1 to 10.

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