Storage bag in continuous outflow system circuit, continuous outflow system circuit, quality management system for continuous outflow system circuit, and quality management method for storage bag in continuous outflow system circuit

Abstract

[Problem] The present invention addresses the following problems. To produce a urine storage bag that, while retaining the sealed structure of a sealed urine storage bag circuit that is a urine collection kit currently in common use, does not require any mechanical or electrical drive or control mechanism, and that has a structure and function, when used as a constituent element in the kit, to serve as a continuous outflow system through the operation of the siphon principle because of the mass and potential energy of urine, pressure and abdominal pressure due to the natural filling and contraction of the urinary bladder, and the structure and function of the bag. To form a urine collection kit by combining members other than the bag with conventional constituent components. To develop a closed siphon-creating bag that, even if there is a first height difference in which the bag is higher than an outflow source or a second height difference in which an inflow tube is lower than an inflow port of the bag, serves as a closed siphon-creating continuous outflow bag circuit in which there is continuous outflow to the urine storage bag. [Solution] A quality management system was constructed by taking as a basis a suction-type closed siphon-creating bag that relies on reduction in initial siphon pressure due to negative pressure resulting from the siphon principle and a shape memory function that is exhibited because of closed format due to the material and shape of the bag, and also due to additional negative pressure. In the system, a conventional urine collection kit is made to function as a continuous outflow system circuit, and a series of procedures and mechanisms are included for quality management of the urine collection kit as a continuous outflow system circuit. Standards were planned and quality was tested in advance to devise a stable and safe continuous outflow system circuit, a closed siphon-creating bag of an engine portion thereof, and a quality management system therefor.

Description

Reservoir bag in continuous outflow system circuit, continuous outflow system circuit, quality control system for continuous outflow system circuit, and quality control method for reservoir bag in continuous outflow system circuit

[0001] The present invention relates to a storage bag for a continuous outflow system circuit, a continuous outflow system circuit, a quality control system for a continuous outflow system circuit, and a quality control method for a storage bag for a continuous outflow system circuit. More specifically, the present invention relates to a storage bag for realizing a continuous outflow system circuit that does not suffer from accumulation or stagnation due to height differences caused by a mismatch between the structure of a conventional closed urine collection bag circuit and actual clinical use conditions.

[0002] The present invention maintains the basic structure of a conventional closed-type outflow circuit with a urine collection bag, but clarifies the conditions under which urine flows from the source of an elastic closed space inside the body through a higher section, overcomes two or more elevation differences, and siphons for continuous outflow to a destination space outside the body. It establishes and confirms the specifications for the urine collection bag itself, and guarantees its quality, so that the urine flows continuously under these conditions. That is, by changing the material, shape, or structure of the urine collection bag itself, it is possible to simplify conventional products, eliminate the need for accessories, and reduce manufacturing costs. Furthermore, by utilizing the environment of the conventional closed-type outflow circuit and the properties and shape of the urine collection bag's vinyl chloride material, it can be applied to a urine collection bag that constitutes a negative-pressure continuous siphoning circuit that prevents backflow, overturning conventional concepts.

[0003] In medical and nursing care settings, a urine collection bag circuit consisting of a urine collection tube and a urine collection bag is connected to an indwelling bladder catheter, commonly known as a Foley catheter. Such urine collection bags are sold individually or as a sterilized set product, commonly referred to as a urinary catheter insertion and urine collection kit (hereinafter referred to as a "urine collection kit"), which is a closed-system urine collection bag circuit. Under the Pharmaceutical and Medical Device Act, a tripartite council consisting of the Ministry of Health, Labor and Welfare's Pharmaceutical and Food Safety Bureau, the Japan Medical Device Association (JFMDA), and the Association of Registered Certification Bodies (ARCB) certifies and approves manufacturers, distributors, and applicable products based on a certification item eligibility checklist. Therefore, products are distributed to the market after being certified under a system in which manufacturers, distributors, and applicable products are individually certified and approved by 11 certification bodies based on a certification item eligibility checklist. However, while indwelling bladder catheters, Foley catheters, are certified as medical devices, the urine collection bag itself is not.

[0004] However, when a urine collection bag is integrated with this Foley catheter to form a "urinary catheter insertion and urine collection kit," it is classified as a medical device under risk category II code 14292000 and sold as a certified product. The urine collection bag alone is not a medical device and does not require certification. Bladder catheters and urine collection kits are medical devices, and when an approved manufacturer places an order, they are manufactured by an approved manufacturer and sold by an approved distributor. The "urine collection tube" and "urine collection bag" are part of the components of the urine collection kit, which is one of the medical devices sold under the legal licensing system.

[0005] However, neither the certified product eligibility checklist nor other certification systems take into consideration the actual clinical and daily use conditions in nursing care, and there are no specific warnings or regulations. In actual use environments and situations, whether the user is bedridden or in a wheelchair, it is common for a Foley catheter or urine collection tube to have a first height difference that is one step higher than the bladder from which the urine flows, and a second height difference that causes the urine collection tube to hang down below the inlet to the urine collection bag.

[0006] As a result, when a conventional "urinary catheter insertion and urine collection kit" (called a "closed urine collection bag circuit") is used, the difference in height causes the patient's urine to stagnate and accumulate, creating dead space and an airlock, preventing urine from flowing from the bladder into the collection bag. As a result, even just having a closed urine collection bag attached for a few days after surgery can cause unprecedented pain. Furthermore, for example, quadriplegics with cervical spinal cord injuries can experience autonomic hyperreflexia due to urinary retention, putting their lives at risk and causing them excruciating daily pain.

[0007] This situation becomes a daily occurrence for patients who are confined to hospital beds after surgery. If this state of urinary retention continues chronically, it can lead to secondary health problems such as pyelonephritis, hydronephrosis, and renal failure, causing further suffering for the patient.

[0008] However, the reality is that, whether it is for acute use after surgery or chronic use for other reasons, whether in the medical care or nursing field, the current situation is such that the mismatch between the product structure and the conditions of use, the gap, and the problems are not fully recognized by either the end users themselves, the middle users in the medical care and nursing field, or the manufacturers and distributors.

[0009] What makes things even more troublesome is that even if users at all levels and manufacturers were aware of the above-mentioned real-world problems, and even if the manufacturers, the nursing field, and end users wanted to somehow correct the above-mentioned problems, the "urine collection kits" and "urinary catheter insertion and urine collection kits" were approved through official channels, sold, distributed on the market, and used daily as everyday products, the manufacturers also have their own economic backgrounds and circumstances regarding their manufacturing costs and sales prices, and furthermore, the actual manufacturers, global companies, have invested capital and built manufacturing lines where manufacturing orders are concentrated, making it difficult to change these manufacturing lines, and as a result, the current situation is such that they are unable to respond promptly and sensitively to end-user feedback.

[0010] In other words, within the certification system, the framework for each manufacturing and distribution has already been firmly established and firmly established, making it difficult for manufacturers, distributors, medical professionals, and actual users to mutually change it; manufacturing, sales, and the market have become firmly established, stable, and fixed.

[0011] Under these circumstances, the inventor, who is also the applicant for the patent, became aware of the problem after being hospitalized twice, devised a way to improve it, revised the structure, and devised a continuous outflow system circuit for the urine collection tube that can maintain continuous outflow even when there is a slight difference in height in two or more places in actual clinical practice, thereby creating an invention and filing a patent application, and obtaining a patent for that patent application (Patent No. 7158792).

[0012] The above patent describes a continuous outflow system circuit that provides an "open drip chamber" in the conventional outflow circuit from the bladder to the storage bag, specifies the conditions for siphoning the outflow circuit, and enables continuous outflow using only the internal pressure from the patient and the potential energy of the urine mass, and is automatically stored in the urine collection bag.

[0013] By publishing the above patent, we asked the public to improve the above problematic situation, but because the device was configured to form an open continuous flow system circuit by providing an "open drip chamber," it became an effort to change the structure and framework of the conventional closed circuit.However, with the above-mentioned certification system in place, it became clear that awareness among manufacturers, manufacturers, and the general public was not yet mature, and even if there was a personal need, it did not become a societal need.

[0014] Therefore, in this patent application, as an improvement measure to make the urine collection kit into a continuous outflow system circuit, the basic structure of the conventional "closed urine collection bag," which is a medical device that has already been certified and is widely used, is not changed, and no intermediate circuit such as the urine collection tube is modified, but the urine collection bag itself, which does not constitute a medical device on its own, is devised and improved. In other words, because it is a closed system, the initial siphoning pressure is reduced more than ever before, and further, a urine collection bag for use in a closed siphoning continuous outflow system that is simple, convenient, and clean for the end user has been devised.

[0015] Patent No. 7158792

[0016] Applicability of intermittent urinary catheters combined with urine collection bags to the generic name Review-related work (1) *Missing numbers from Seq. No. 130 onwards are consultations that have been withdrawn. *Replies to Seq. No. 130 and earlier are also listed if they have been corrected. Consultation contents and responses for FY2021 and FY2022 Pharmaceutical Industry Production Statistics: Ministry of Health, Labour and Welfare (mhlw.go.jp) Pharmaceutical and Medical Device Industry Survey (Medical Device Industry Survey Report): Ministry of Health, Labour and Welfare (mhlw.go.jp) Ministry of Finance Trade Statistics: Trade Statistics of Japan (customs.go.jp) Examples of health administration reports: Ministry of Health, Labour and Welfare (mhlw.go.jp) Medical Device Database: (kikidb.jp) The medical device database is operated by the Medical Information System Development Center, a general incorporated foundation. Search medical device package inserts: Pharmaceuticals and Medical Devices Agency (pmda.go.jp) Pharmaceuticals and Medical Devices Agency (PMDA) Notification No. 0430-1, April 30, 2021, Conformity Checklist for Designated Specially Controlled Medical Devices (Part 19) 314 21-AA04 (September 10, 2021) Patent Publishing, 2003

[0017] The problem that the present invention aims to solve is to provide a storage bag that constitutes a continuous outflow system that does not require any mechanical or electrical drive or control mechanisms, and that, under the law of universal gravitation, can continuously discharge accumulated urine by the mass of urine, its potential energy, the bladder's natural filling and contraction pressure, and abdominal pressure, even if the circuit is somewhat higher than the outflow source, thereby maintaining the natural bladder urination function even in actual clinical settings, and that automatically siphons when a certain amount of urine is stored in the bladder, allowing continuous outflow and complete discharge even if there is a slight difference in elevation along the way.

[0018] More specifically, the objective of the present invention is to eliminate the structural gap between the conditions of actual clinical use and conventional occlusive-type urine collection kits, based on the premise that the urine collection bag does not need to be newly certified as a medical device, without destroying the basic structure and framework that is currently certified and commercialized, and to construct a urine collection kit that will siphon and continuously outflow, even when first and second height differences occur in the outflow system circuit, while maintaining the structure of the conventional "closed-type urine collection bag" and leaving the structural configuration of the conventional urine collection tube intact, simply by changing the urine collection bag.

[0019] Furthermore, in order to create a system circuit with guaranteed quality that allows continuous, forward flow without backflow even under actual on-site conditions of use, and that allows complete flow without retention or accumulation in the bladder or any intermediate circuit, the objective of this invention is to establish a method for verifying its specifications and quality, as well as a system and quality control method for verifying and managing whether or not it can be operated under various fluid properties and bladder functional states.

[0020] In the previous patent (No. 7158792) of the same applicant, a continuous outflow system circuit was constructed by modifying the urine collection tube in the circuit leading to the urine collection bag (urine collection bag), but in the present patent application, a continuous outflow system circuit was realized by modifying and improving the storage bag (urine collection bag) itself, and this is the point of difference from the previous patent (No. 7158792). In other words, the storage (urine collection) bag used in this closed siphon continuous outflow system circuit is a continuous outflow system circuit in which modifications have been made to the storage bag (urine collection bag) itself.

[0021] More specifically, the present invention inherits the concepts of the "minimum required siphoning volume for siphoning Vmin" and "initial siphoning pressure Ps" from the previous patent, but does not adopt the "open drip chamber" from the previous patent. Instead, it adds innovations and improvements to the material, shape and structure of the storage bag (urine collection bag) itself, and is based on the closed environment of the "closed type (a configuration in which the entire system from the bladder, which is the source of outflow, to the storage bag, which is the destination of outflow, is closed to the atmosphere and is not open to the atmosphere)" that is currently commonly used.

[0022] That is, according to one aspect of the present invention, the resistance (peripheral resistance) Rp of the storage bag (urine collection bag) that is the outflow destination, which forms the initial siphoning resistance Rs that is the source of the initial siphoning pressure Ps, is reduced by devising the material, shape, or structure of the storage bag (urine collection bag). Also, according to another aspect of the present invention, the siphon principle and scientific principles related to pressure are used to bring the initial siphoning pressure Ps required for siphoning as close to 0 (zero) as possible by creating a negative pressure in the storage bag (urine collection bag) itself.

[0023] Therefore, the basic function and operation of the present invention are the same as the "Continuous Outflow (Complete Evacuation) System Circuit" of the previous patent. However, the initial siphoning pressure is reduced more than in the previous patent, and the scope of application is expanded while maintaining the "closed" structure currently common in the market. Furthermore, the number of components other than the urine collection bag has been further reduced and simplified, thereby advantageously reducing manufacturing costs. This eliminates the burden, hassle, inconvenience, and financial burden that has been associated with manufacturers, middle-users (medical and nursing care professionals), and end users (the actual wearers). Furthermore, as one of the components of the continuous outflow system circuit as a urine collection kit, it is necessary to verify and test its compliance with various clinical requirements, necessitating the establishment and implementation of a "quality control system."

[0024] From this viewpoint, the invention described in claim 1 is a storage bag in a continuous outflow system circuit that continuously outflows a fluid from an outflow source, which is an expandable and contractible elastic closed space in the body, by siphoning the fluid in the elastic closed space using the siphon principle, and stores the fluid, the continuous outflow system circuit comprising an outflow inductor provided for outflowing the fluid from the outflow source, and an outflow tube for moving the fluid from the outflow inductor to the outflow destination, the storage bag, and the pressure difference between the outflow source and the outflow destination, the storage bag, is defined as P, the resistance of the entire siphoning continuous outflow system circuit is defined as Rall, and the pressure difference between the outflow source and the outflow destination ... pressure difference between the outflow source and the outflow destination, the storage bag, is defined as P, and the resistance of the entire siphoning continuous outflow system circuit is defined as Rall, taking into consideration actual usage environmental conditions. Let Vmin be the specified minimum volume required to generate an initial siphoning pressure Ps as the initial pressure difference for siphoning that overcomes the first height difference H1 and the initial siphoning resistance Rs due to the pipeline resistance in consideration of the clinical arc model condition and starts continuous outflow, let Vo be the volume that fills the elastic closed space within Vmin, let Vloop be the volume that occupies the lumen of the first height difference up to the siphoning boundary where outflow starts after overcoming the peak of the first height difference due to the initial siphoning pressure Ps, let Vhg be the lumen volume of the outflow guide and Vht be the lumen volume of the outflow tube, and further let Vg and Vt be the total lumen volumes of the outflow guide and the outflow tube, respectively, and then the relational equation is and the continuous outflow system circuit is designed to satisfy the siphoning capacity condition defined by the formula and to fill the lumen without any gaps while outflowing, and is configured such that once the pressure difference P exceeds a Ps value that balances with the initial siphoning resistance Rs, siphoning occurs, and even if there is a second height difference H2 generated by the arc after the first height difference H1, outflow continues due to the elasticity of the outflow source and the pressure difference with the storage bag, resulting in complete outflow, and the relationship between the conduit resistance Rg of the outflow guide over the entire length, the conduit resistance Rt of the outflow tube over the entire length, the resistance Rp in the storage bag, the first height difference H1 and the second height difference H2 generated in the outflow tube as clinical arc model conditions taking into account actual use conditions, and the initial siphoning pressure Rs due to the conduit resistance of the outflow tube, and the initial siphoning pressure Ps as the initial pressure difference for siphoning that overcomes the resistance of the first height difference H1 and the second height difference H2 and the initial siphoning pressure Rs and starts continuous outflow is as follows: [Equation 2] Ps≧Rs>Rall=Rg+Rt+Rp. The resistance Rp has a value that generates the initial siphoning pressure Ps so that the above relationship holds.

[0025] The invention described in claim 2 is a storage bag described in claim 1, characterized in that the source of the outflow is the bladder, the fluid is urine, it is configured as a urine collection bag, and the resistance Rp varies depending on the material, shape, or structure of the storage bag body.

[0026] The invention described in claim 3 is a storage bag in a continuous outflow system circuit described in claim 2, characterized in that the urine collection bag body has a completely sealed structure, is made of low-density polyethylene (LDPE), and is formed into a thin bag shape by stacking two urine collection bag body constituent pieces, front and back, in the thickness direction and joining the peripheral parts.

[0027] The invention described in claim 4 is a storage bag in a continuous outflow system circuit described in claim 2, characterized in that it is made of a material that is deformable when an external force is applied and has the rigidity to return to its original shape when the external force is removed after compression, and is formed into an entire cylindrical shape.

[0028] The invention described in claim 5 is a storage bag in a continuous outflow system circuit described in claim 2, which is made of a material that is flexible, elastically deforms when an external force is applied, and has the rigidity to return to its original shape when the external force is removed after deformation, is formed in an overall cylindrical shape, has a bellows portion along the axial direction, is compressible when an external force along the axial direction is applied by the bellows portion, and returns to its original shape when the external force is removed after compression, and is configured to generate negative pressure when returning to its original shape.

[0029] The invention described in claim 6 is a storage bag in a continuous outflow system circuit described in claim 2, characterized in that it is made of synthetic resin, is made of a material that is deformable when an external force is applied, and has the rigidity to return to its original shape when the external force is removed after compression, and is formed into an overall rectangular shape.

[0030] The invention described in claim 7 is a storage bag in a continuous outflow system circuit described in any one of claims 2, 3, 4, 5 or 6, characterized in that the outflow tube is connected to one side end of the upper end to form an inflow section, and an outflow section that can be opened to the atmosphere and can discharge stored urine is provided at the upper side end on the opposite side in the width direction of the inflow section.

[0031] The invention of claim 8 is a reservoir bag in a continuous outflow system circuit according to any one of claims 4, 5 or 6, characterized in that it is made of polyvinyl chloride resin, polypropylene or a shape-memory material.

[0032] The invention of claim 9 is a quality control system for continuous outflow system circuits, characterized in that the continuous outflow system circuit of claim 1 is a product that is actually operated under the clinical arc model conditions at the specified initial siphoning pressure and minimum volume, and is further standard-tested and certified using an initial siphoning pressure measurement method and a simple complete outflow confirmation test method as methods for confirming compliance with the standards of the continuous outflow system circuit, which actually measure and check the initial siphoning pressure.

[0033] The invention described in claim 10 is a quality control system for a continuous outflow system circuit described in claim 9, characterized in that whether or not the fluid is operated under conditions that reflect clinical conditions is managed by a PDCA cycle that includes a reference load test using a reference artificial bladder and reference concentrated glucose, and a load limit confirmation method for confirming the limit.

[0034] The invention of claim 11 is a quality control system for a continuous outflow system circuit of claim 9, characterized in that the standard artificial bladder is designed and manufactured with a margin to allow for a height difference of 20 cm and a duct resistance to be cleared, and the internal pressure becomes 25 cm of water column when filled with 50 ml of the fluid.

[0035] The invention described in claim 12 is a quality control system for a continuous outflow system circuit described in claim 9, in which the fluids flowing through the continuous outflow system circuit are standard artificial urine, standard concentrated diabetes urine, and other artificial urine with clinically encountered properties, and includes a standard compliance confirmation test and load test for the initial siphoning pressure measurement method and the simple complete outflow confirmation test method, as well as a load limit confirmation method for confirming limits.

[0036] The invention described in claim 13 is a quality control system for a continuous outflow system circuit described in claim 9, characterized in that the elements of the initial siphoning resistance, such as the specifications of the standard artificial bladder which is the outflow source, the properties of the standard concentrated glucose which is the fluid, the specified minimum volume Vmin, the tube diameter, the tube length, the tube material, and the tube friction coefficient, can be changed as needed, and compliance with these various conditions and standards can be confirmed as to whether or not the circuit is a continuous outflow system circuit, thereby ensuring quality.

[0037] The invention described in claim 14 is a continuous outflow system circuit described in claim 1, characterized in that a standard confirmation test is conducted using the quality control system of the continuous outflow system circuit described in claim 9 to verify the standard and guarantee the quality regarding whether or not siphoning and continuous outflow are actually possible even under the conditions and environments in which it is actually used on site.

[0038] The invention described in claim 15 is a quality control method for a storage bag used in a continuous outflow system circuit, characterized by evaluating the material, shape, and structure of the storage bag body from the perspective of whether the continuous outflow system circuit described in claim 1 is capable of reducing the initial siphoning pressure Ps under the clinical arc model conditions.

[0039] The storage bag in the continuous outflow system circuit of the present invention is not a medical device on its own, but when used as a bag in a so-called closed urine collection bag circuit, a "urinary catheter / urine collection kit" that is integrated with an indwelling bladder catheter (Foley catheter) and a urine collection tube, it is possible to form a system circuit that allows continuous outflow from the bladder without placing a burden on the user's body by reducing the initial siphoning pressure by using the siphon principle and reducing the fluid resistance of the storage bag, even if the other components are existing products.

[0040] Furthermore, because the present invention is configured to be able to generate negative pressure in the storage bag, it is possible to reduce the initial siphoning pressure in a siphoned continuous outflow system circuit by using negative pressure, thereby reducing peripheral resistance in the storage bag located at the end of the continuous outflow system as much as possible, thereby forming a system circuit that allows urine to continuously outflow from the bladder without imposing a burden on the user's body.Furthermore, because the initial siphoning pressure can be set to negative, by applying the storage bag of the present invention to a urine collection kit that has been sold and used until now, siphoning is possible even when clinical elevation differences occur, and as a result, it is possible to form an engine part of a urine collection kit that allows urine to continuously outflow in a unidirectional, forward laminar flow, full flow state, without backflow, and completely outflow.

[0041] More specifically, when the storage bag of the present invention is used as a closed urine collection bag circuit in a urine collection kit, it exhibits the following effects and benefits: Based on natural scientific principles, conventional accessories such as drip chambers, air filters, and check valves are no longer necessary, further simplifying the system and reducing manufacturing costs. Furthermore, the bag itself is not a medical device, does not require any licenses or permits, is made of commonly available materials and structures, does not require special medical device manufacturing processes, and can be manufactured by any reasonable small or medium-sized enterprise in the city. There is no need to order from a specialized medical device manufacturer of a large global corporation with specialized manufacturing equipment and processes.

[0042] It is a closed system, and allows continuous and complete outflow without backflow, resulting in no residual urine or urinary retention. It has a full laminar flow and is antegrade, allowing for cleaner handling when draining fluid from the bag and reducing the risk of retrograde infection. In other words, there is no stagnation or congestion, and no urinary retention occurs, and there is no subsequent pain, distress, or worry or anxiety about health damage. We can provide safe, secure, high-quality, and appropriate products with quality controlled by our quality management system.

[0043] From a medical perspective, it also makes post-operative management easier, reduces the workload of nurses, enables proper timed urine measurement, eliminates and prevents the wasteful administration of inappropriate diuretics, potassium preparations, cardiac stimulants, etc., and contributes to improving and optimizing the quality of medical care. Even if the user is bedridden, they will no longer have to endure the pain caused by conventional bladder compression and the dreaded autonomic hyperreflexia.

[0044] Accidents such as self-removal of indwelling bladder catheters by elderly people or those with dementia will also be eliminated, and the catheter can be removed after the minimum necessary period, preventing unnecessary invasion and damage to the bladder lining and dysfunction of excretory functions. Early removal allows the patient to be released from restrictions on their activities at an early stage. Early removal of the urine collection kit reduces the burden of medical and nursing care costs. It also reduces the time and effort required by family members and caregivers, reducing the burden of caregiving.

[0045] This device can be used continuously for a long period of time without placing an extra burden on the patient, and allows urination based solely on natural principles for those with urinary retention due to spinal cord injury, cerebral hemorrhage, cerebral infarction, other central nervous system disorders, or peripheral nervous system disorders, or for those who are bedridden and incontinent, contributing to the maintenance and recovery of remaining bladder function.

[0046] The invention described in claim 5 is based on a simple principle that only involves the basic principles of natural science, the siphon principle, and the principle of negative pressure, making it easy to understand and utilize. It is not a particularly complicated principle, and its usage requires only an understanding of the principle of pumping air into a toy swimming pool with a foot air pump. It is at the level of everyday common sense, and no special higher education is required. Even ordinary people and caregivers can use it without having to study nursing or medicine.

[0047] This will enable manufacturers to reduce costs, restore and increase credibility, and fulfill their social responsibility and contribute to society. It will be possible to prevent accidents due to self-extubation, bladder damage, bladder dysfunction, and kidney dysfunction, thereby reducing the unnecessary procedures, processing, and compensation issues that have occurred since the accident occurred. The simple structure allows for manufacturing at the level of small and medium-sized enterprises in Japan, eliminating the need for dependence on large global companies overseas, and as a result, reducing manufacturing costs. The supply of safe and reliable products based on principles and mechanisms based on natural science will allow for clear claims of effectiveness and efficacy.

[0048] Improved simplicity and convenience in the nursing and caregiving fields can reduce the burden of nursing and caregiving. Accurate hourly urine measurement in medical care can prevent misdiagnosis and medical errors and contribute to the realization of high-quality medical care. It can create and provide benefits to three parties: medical device manufacturers, users (medical, nursing, and caregiving fields), and target users (actual users). Because the basic structure of the currently available "closed-type storage bag" does not need to be changed, new certification expertise is not required, and it is easy to overcome legal, economic, industry structural, and certification system challenges for improving and upgrading existing products. As a result, even when commercializing the claimed invention, even small and medium-sized enterprises that are not domestic medical device manufacturers can manufacture the storage bag of the claimed invention without relying on global manufacturers with a virtual monopoly and without new investment, thereby contributing to the promotion of Japan's manufacturing industry at large.

[0049] Because the collection bag (urine collection bag) itself is not a medical device, even if manufacturing is outsourced to a Japanese synthetic resin product manufacturer, the manufacturing technology for conventional products other than the bag can be used as is. Furthermore, both the medical side and the market distributors who accept and use the collection bag (urine collection bag) of the present invention will not feel any discomfort as it is a conventional closed-type product.

[0050] This product will provide relief by solving the various problems users encounter when using urine collection kits, which are generally used worldwide and comprised of closed circuits. It will also provide medical and economic solutions to the increasingly aging and super-aging society that will lead to increasingly serious problems such as spinal cord injury, urinary incontinence, and benign prostatic hyperplasia. It will also represent a major turning point in reducing and eliminating the burden of medical care, nursing care, and caregiving, as well as eliminating the economic burden, and ensuring and maintaining a better quality of life. In other words, it will enable small and medium-sized Japanese companies to replace the current large global manufacturers and supply urine collection kit bags to the world, revitalizing Japanese industry and stimulating the Japanese economy.

[0051] 1 is a diagram showing the conditions and situations of use of a conventional urine collection kit (outflow guide, outflow tube, and storage (urine collection) bag) in clinical practice or daily life based on actual conditions of use. 2 is a diagram showing a practical clinical arc model that illustrates and models the use of a storage (urine collection) bag with reduced peripheral resistance according to the present invention, assuming the conditions of use of the urine collection kit in 1. This is a siphoning confirmation test to confirm whether a urine collection kit product consisting of a urine collection bag and a urine collection tube connected to the urine collection bag can be used in the continuous outflow system circuit according to the present invention, under the conditions of the practical clinical arc model. This is a graph illustratively showing the relationship between the initial siphoning pressure Ps and the storage and outflow of urine produced in the bladder when a conventional urine collection kit is configured as a continuous outflow system circuit using the storage bag in the continuous outflow system circuit according to the present invention. 4(1) shows a schematic diagram illustrating various embodiments of the storage bag in the continuous outflow system circuit of the present invention. FIG. 4(1) shows a urine collection bag constructed by stacking two urine collection bag body components made of LDPE (low density polyethylene) on the front and back in the thickness direction and joining the peripheral edges. FIG. 4(2) shows a urine collection bag formed into a cylindrical shape using polyvinyl chloride as the material. FIG. 4(3) shows a urine collection bag formed into a rectangular shape using polyvinyl chloride as the material. 1 shows one embodiment of a storage bag in a continuous outflow system circuit according to the present invention, which is made of a flexible material that elastically deforms when an external force is applied and returns to its original shape when the external force is removed after deformation; the bag is cylindrical overall and has a bellows section along its axial direction, allowing it to be compressed when an external force is applied along the axial direction by the bellows section; and when the external force is removed after compression, it returns to its original shape. The diagrams show a usage procedure for a foot pump-like configuration in which negative pressure is generated when the storage bag is returned to its original shape; (1) shows the state before use; (2) shows the state in which the urine collection bag has been compressed to generate weak negative pressure; and (3) shows the state in which negative pressure is generated when the urine collection bag returns to its original shape, causing the continuous outflow system circuit, consisting of the outflow guide, outflow tube, and urine collection bag, to become siphonic, allowing urine from the bladder to continuously flow into the urine collection bag.FIG. 1 is an explanatory diagram conceptually showing a quality control system for a continuous outflow system circuit to which a urine collection bag according to the present invention is applied (a quality control system for a closed siphoning (urine collection) bag).

[0052] Below, the storage bag in the continuous outflow system circuit, the continuous outflow system circuit, the quality control system for the continuous outflow system circuit, and the quality control method for the storage bag in the continuous outflow system circuit according to the present invention will be described in detail based on each embodiment, using the example of applying the storage bag to a urine collection bag.

[0053] Before explaining the storage bag of the present invention, we will first explain a continuous outflow system circuit to which the storage bag of the present invention is applied. That is, when using the storage (urine collection) bag of the present invention as a component of a continuous outflow system circuit, it is necessary to confirm its usage limits and conditions depending on the properties of the outflow source. Continuous outflow from the bladder to the urine collection bag will only be possible if the conditions of the quality control system for the continuous outflow system circuit to which the storage bag of the present invention is applied, as shown in Figure 6, are met.

[0054] Furthermore, when the storage (urine collection) bag according to the present invention is used as a medical device in the form of a urine collection kit, which has been commercially available and is in general use, it is necessary to at least conduct a siphoning test on the kit. However, the urine collection bags that have been commercially available and in use do not specify any product specifications or limits.

[0055] That is, depending on the patient's symptoms and the user's physical condition, it is necessary to determine the level of sustained outflow in cases of proteinuria, glucose, hematuria, bacteriuria, etc., and select a product with appropriate performance to suit the user's physical condition and state. In the present invention, negative pressure is generated within the urine collection bag and adjusted, and if necessary, the initial siphoning pressure can be set to a negative pressure. To avoid harm to the user's body, it is generally appropriate to set the initial siphoning pressure as close to 0 cm of water column as possible, even when negative pressure is generated within the urine collection bag. However, depending on the situation, a certain level of negative pressure can be temporarily used. The reserve capacity of the negative pressure is also determined by the bag's material, shape, and volume. Once a "compression negative pressure curve" showing the relationship between the compressibility and the generated negative pressure is created, the initial siphoning pressure can be adjusted to a negative pressure depending on the user's condition, allowing for sustained outflow even with highly viscous fluids (such as urine) due to various causes, greatly expanding the range of uses.

[0056] [Clinical Arc Model as a Prerequisite for Siphonage Confirmation Tests] First, the "clinical arc model as a prerequisite for siphonage confirmation tests" shown in Fig. 1 will be described. Fig. 1(1) is a diagram that schematically illustrates the conditions and situations of use of a conventional urine collection kit (an outflow guide, an outflow tube 11 connected to the outflow guide, and a storage (urine) bag 13) in clinical practice or daily use based on actual conditions of use. Fig. 1(2) is a diagram that schematically illustrates a clinical arc model that, based on the conditions of use of the urine collection kit of Fig. 1(1), uses an open-ended container 15 containing a fluid and a storage (urine) bag according to the present invention (a peripheral resistance-reduced urine collection bag) 14 that is capable of reducing the resistance value (peripheral resistance value) of the initial siphon pressure Rs due to the material, shape, or structure of the bag body.

[0057] As shown in Figure 1 (1), in the actual environment and conditions in which urine collection bags are used in clinical practice, a first height difference (H1) will inevitably occur, in which the outflow guide or outflow tube 11 will be higher than the bladder (or external urethral meatus) 10, and a second height difference (H2) will inevitably occur, in which the flow tube will sag and be lower than the inlet part 27 of the urine collection bag 11.

[0058] Generally, when the storage bag (urine collection bag) 13 is used in bed with a patient or user lying down, it is fastened to a protective fence installed on the side of the bed and positioned below the height of the patient's bladder 10. However, the outflow guide / outflow tube 11 is positioned so that it curves upward in an arc from the height of the patient's bladder 10, creating a first height difference (H1) that reaches a position higher than the bladder. It then descends toward the urine collection bag 13, but hangs below the inflow section 27 of the urine collection bag 13, then descends again in an arc and curves downward, creating a second height difference (H2) that reaches a position lower than the connecting inflow section 27. These height differences (H1 and H2) hinder the natural, continuous outflow of urine from the bladder 10. Therefore, the challenge is how to overcome these height differences (H1 and H2) to allow urine to flow out.

[0059] In FIG. 1, the above-described actual usage situation is modeled, and a first (arc) height difference (H1) and a second (arc) height difference (H2) are defined. Considering the environmental conditions of daily life, it is necessary to assume that the height difference from the external vesical sphincter to the navel is at least 20 cm. Of course, the difference may be greater depending on the individual's body type, but the specified value must also be taken into consideration for both small and large races. In this embodiment, the first height difference (H1) and the second height difference (H2) are provisionally defined as 20 cm. Reference numeral 28 in the figure denotes a fluid discharged from the body (urine in this embodiment).

[0060] [Siphonation Confirmation Test Under Practical Clinical Arc Model Conditions] Figure 2 shows the state of a siphonation confirmation test to confirm whether a urine collection kit product having a urine collection bag (peripheral resistance reduced bag) 14 and a urine collection tube 11 connected to the urine collection bag 14 can be used in the continuous outflow system circuit of the present invention under the practical clinical arc model conditions shown in Figure 1. In this case, (1) in Figure 2 shows the preparation stage in which siphoning has not yet occurred, (2) shows the state in which siphoning has begun, and (3) shows the state in which siphoning has occurred and continuous outflow of urine 28 is possible.

[0061] The siphoning bag circuit to be tested is set to the clinical arc model conditions shown in Figure 1. In this case, the first arc height difference H1 and the second arc height difference H2 are provisionally set to 20 cm. The arc height differences can be changed depending on the purpose and application. The minimum siphoning outflow volume Vmin required for siphoning under atmospheric pressure can be calculated using the following formula: Given that the radius of the outflow (urine collection) tube is r mm, the length of the outflow (urine collection) tube is L m, and the lumen volume of the indwelling bladder catheter is α ml, the minimum siphoning outflow volume Vmin = (r / 10)^2 × 3.14 × L × 100 + α.

[0062] For example, in the case of an existing product currently in use, if the outflow tube has an inner diameter of 8 mm and a length of 1.5 m, and the indwelling bladder catheter has an inner diameter of 6 mm and a length of 40 cm, then Vmin = 0.4 x 0.4 x 3.14 x 1.5 x 100 + 0.3 x 0.3 x 3.14 x 40 = 75.36 + 11.30 ≒ 87 ml. In other words, with the urine collection circuit bag of existing components, it is clear that siphoning and continuous outflow are possible only when a urine volume of 87 ml or more has accumulated in the bladder.

[0063] Based on the above assumptions, a siphoning confirmation test is carried out according to the following procedure: 1) Preparation stage: A fluid equal to or greater than the minimum siphoning outflow volume Vmin is poured into the open-ended container 15 from which the fluid is to flow, and the container is set at a reference height position S where the bottom of the fluid is lower than the apex of the first height difference (H1) of the outflow tube 11.

[0064] 2) Confirmation of siphoning: The fluid enters and raises the open-ended container 15. When the fluid passes the peak of the first height difference (H1) at the outlet 16, the height difference at which the fluid continues to flow downward beyond the peak of the first height difference (H1) is Hs. Immediately after this, the open-ended container 15 is returned to the reference height position S. The distance Hs cm from the reference height S to the bottom of the open-ended container 15 from which the fluid flows when the fluid continues to flow beyond the peak of the arc of the first arc height difference (H1) is the water pressure required for siphoning, i.e., the initial siphoning pressure Ps, where Ps = Hs cm of water column. Furthermore, because there is some resistance in the pipeline, even though it is short, Hs > H1 under atmospheric pressure.

[0065] Even if the open-ended container 15 is returned to the standard height position S, siphoning continues and the fluid continues to flow into the bag. When all the fluid has completely flowed out, the initial siphoning pressure Ps is evaluated as "siphoned bag" siphoning at a water column of Hs cm.

[0066] However, if the urine stops at the second height difference H2 and an air layer forms along the way, the open-ended container 15 from which the urine flows out is raised again higher to overcome the peak of the second height difference, and the urine continues to siphon and flow into the urine collection bag 14. If the urine flows out completely, the bag is evaluated as a "semi-siphoned bag." In this case, the urine collection bag can be made into a siphoned bag by applying negative pressure to the urine collection bag, as described below.

[0067] [Conditions for Outflow Guide and Outflow Tube] In the present invention, the outflow guide (so-called Foley catheter) and outflow tube can be used even if they are products such as conventional "urine collection kits." However, it is desirable that the outflow tube be neither too hard nor too soft. For example, an outflow tube made of a material that can naturally bend, bend, maintain an arc, and not bend to block the lumen when climbing over the side rails of a hospital bed or the handrail of a wheelchair, or when climbing over a slight difference in height, is appropriate.

[0068] The ease of fluid flow varies depending on the characteristics of the outflowing fluid (specific gravity, concentration, viscosity, etc.). For example, caution is required in cases of diabetes, proteinuria, hematuria, bacteriuria, etc., as they can be difficult to flow or prone to blockage. Specifically, a narrow inner diameter increases the resistance of the inner surface of the tubing due to the height difference of the first arc, and the initial siphoning pressure also increases. Therefore, it is preferable to have as large an inner diameter as possible. However, to facilitate siphoning, a smaller inner diameter (i.e., radius) of the outflow tubing is more likely to form a siphon. As shown in Figure 3, once fluid accumulates at the outflow source beyond the minimum siphoning outflow volume specific to that circuit, and the internal pressure of the outflow source exceeds the initial siphoning pressure, siphoning occurs, resulting in continuous and complete outflow in the forward direction.

[0069] [Urine collection bag] Figure 4 (1) shows a conventional, generally widely used, thin, pouch-shaped urine collection bag 17 constructed by stacking two urine collection bag body constituent pieces 29a, 29b made of LDPE (low density polyethylene) on top of each other in the thickness direction and joining the peripheral edge 30; (2) shows a urine collection bag 21 made of polyvinyl chloride and formed into a cylindrical shape overall; and (3) shows a urine collection bag 24 made of polyvinyl chloride and formed into a rectangular parallelepiped overall. All of these are constructed to reduce peripheral resistance caused by the storage bag in a continuous outflow circuit.

[0070] (1) Reducing peripheral resistance in the outflow circuit by changing the material of the urine collection bag. The bag 17 according to the embodiment shown in Figure 4(1) has a fully sealed storage bag body 31 made of low-density polyethylene (LDPE). The body is made by stacking two urine collection bag body components 29a and 29b, one on the front and one on the back, in the thickness direction, and welding the peripheral edge 30 together. Low-density polyethylene (LDPE) is a crystalline thermoplastic resin in which repeating units of ethylene are randomly branched and bonded. It is softer than other polyethylenes and is also called soft polyethylene. Its low crystallization rate, low melting point, and pliable softness are also characteristic of LDPE.

[0071] Therefore, the low-density polyethylene urine collection bag 17 according to this embodiment has the same totally sealed structure as conventionally used urine collection bags, and is formed into a thin bag shape; however, the urine collection bag main body constituent pieces 29a, 29b, which are joined at the periphery to the two front and back pieces, are made of low-density polyethylene (LDPE), and therefore, as described above, it is pliable and soft, and when urine 28 flows in, it tends to flexibly expand in accordance with the amount of urine 28 that flows in. Therefore, it tends to deform in accordance with the flow of urine 28 into the urine collection bag 17, and the fluid resistance generated by the urine 28 can be reduced.

[0072] Conventional urine collection bags are made of polyvinyl chloride (PVC) resin and are shaped like a thin, sealed bag made by bonding two sheets of the same material together, which makes the material hard and less flexible, so even when urine flows in, the void space formed inside follows and deforms, preventing it from expanding significantly.When an outflow tube is connected to such a conventional urine collection bag and a Foley catheter is connected to the outflow tube and placed in the bladder to drain urine, the bag forms a closed circuit with no part open to the atmosphere.

[0073] In conventional urine collection bags, the material is hard and has low elasticity, as described above, so when urine flows in, fluid resistance increases, peripheral resistance throughout the entire circuit increases, and there are also elevation differences and duct resistance along the way, so that normal abdominal pressure and intravesical pressure alone do not allow siphoning, resulting in urine embolism and retention. To improve this situation, in this embodiment, the urine collection bag is formed in a thin bag shape by bonding two urine collection bag body components 29a, 29b together, but the material is changed to low-density polyethylene (LDPE), which is more flexible and expandable. Therefore, in the urine collection bag 17 according to this embodiment, when urine 28 flows in through the inflow portion 18 and is stored, the urine collection bag body 31 deforms appropriately in accordance with the amount of urine 28 stored, thereby reducing fluid resistance due to the urine 28 and, as a result, it is possible to attenuate peripheral resistance in the outflow circuit. Since the shape and structure of the urine collection bag is not changed, but only the material of the urine collection bag body 31 is changed, it is possible to reduce peripheral resistance in the continuous outflow circuit without changing the manufacturing process or the mold for the urine collection bag.

[0074] The urine collection bag 17 according to this embodiment is formed in a vertically elongated rectangular shape when viewed from the side, and the inflow section 18 is formed by connecting the outflow tube 11b to one end of the longitudinal upper end 33, and the discharge section 19, which can be opened to the atmosphere and through which stored urine can be discharged, is provided at the lateral upper end 34 on the opposite side in the width direction of the inflow section 18. A cap 20, which can close the discharge hole, is removably attached to the tip of the discharge section 19.

[0075] In most conventional and currently commercially available urine collection bags, the outlet for draining accumulated urine is located near the bottom end of the urine collection bag. When the outlet is located in such a position, urine accumulates from the bottom of the urine collection bag 13. When a medical professional, nurse, or caregiver drains urine from the urine collection bag 13, they must open the cap of the outlet located at the area where urine has accumulated and drain the urine, which can result in urine contamination on their hands or retrograde infection during the process.

[0076] That is, when urine 28 flows into the urine collection bag 13, it accumulates from the bottom end of the urine collection bag 13. Therefore, even when urine 28 is flowing into the urine collection bag 13, it is common for the urine 28 not to accumulate at the top end, and a caregiver or the like typically drains the urine before it becomes full of urine. Therefore, in this embodiment, as described above, by providing the discharge portion 19 on the side opposite the inlet portion 18 in the width direction and at the upper lateral end 34 of the urine collection bag 17, even if the cap 20 of the discharge portion 19 is opened to drain the urine 28, the urine 28 will not be drained immediately, thereby effectively preventing the caregiver or the like from soiling their hands with urine 28 when draining the urine and from developing a retrograde infection.

[0077] Furthermore, in this embodiment, since the discharge section 19 is provided at the upper lateral end 34 in the longitudinal direction of the urine collection bag 17, the caregiver or other person can easily, quickly, and cleanly discharge the accumulated urine 28 by holding the inlet section 18 of the urine collection bag 17 with one hand, hanging the urine collection bag 17, and gradually lifting the lower part of the urine collection bag 17, which is diagonally opposite to the discharge section 19, and then placing the discharge section 19 downward.

[0078] (2) Reducing peripheral resistance in the outflow circuit by changing the shape of the urine collection bag. A hollow structure is considered to be a structure that can further reduce peripheral resistance compared to the thin, sealed bag-shaped structure in which two front and back sheets are stacked and joined in the thickness direction in the above-mentioned embodiment. If the material is conventional polyvinyl chloride resin, the hardness of the material allows for shape memory, and leaving it hollow reduces peripheral resistance and facilitates inflow. Specific shapes that can be considered include a cylindrical shape and a rectangular parallelepiped shape. This will be explained in detail below.

[0079] (a) Urine storage bag in the shape of a whole cylinder The urine storage bag 21 according to the embodiment shown in Fig. 4(2) is made of synthetic resin, can be deformed when an external force is applied, and has a rigidity that allows it to return to its original shape when the external force is removed after compression. It is formed in the shape of a whole cylinder. On the upper surface part 35, an inflow part 18 to which an outflow tube 11b is connected is formed at one end in the radial direction. On the opposite side in the radial direction of the inflow part 18 and at the upper end 36 of the side circumferential surface, a discharge part 19 that can be opened to the atmosphere and can discharge the stored urine is provided, which is the same as in the case of the urine storage bag 17 according to the above embodiment.

[0080] The urine storage bag 21 according to this embodiment is in the shape of a whole cylinder, and a cylindrical void part 22 with a predetermined diameter and a predetermined depth dimension and a predetermined capacity is formed inside. The capacity of this void part 22 is, when the radius of the bottom surface part 23 is r and the height dimension is h cm, Volume (capacity) = π × r^2 × h. As a result, even when urine 28 flows into the internal void part 22 from the inflow part 18, since it is a void part 22 with a predetermined capacity, the fluid resistance of the urine can be greatly attenuated, and the peripheral resistance in the outflow circuit can be reduced.

[0081] The material of the urine storage bag 21 according to this embodiment is vinyl chloride (PVC). Since vinyl chloride (PVC) has a predetermined hardness as a material, it can be deformed when an external force is applied and has a rigidity that allows it to return to its original shape when the external force is removed after compression. Therefore, the urine storage bag 21 according to this embodiment has a certain level of shape memory that can maintain a predetermined cylindrical shape even when an external force from some external source is applied during actual use. Thus, it can maintain the above capacity of the cylindrical void part 22 formed inside and continue to reduce the peripheral resistance.

[0082] (b) Overall rectangular parallelepiped urine collection bag The urine collection bag 24 according to the embodiment shown in Figure 4 (3) is made of synthetic resin and is made of a material that is rigid enough to be deformed when an external force is applied and to return to its original shape when the external force is removed after compression, and is shaped as an overall rectangular parallelepiped. Similar to the urine collection bag 17 according to the above embodiment, the top surface 35 has an inlet 18 at one end in the width direction to which the outlet tube 11b is connected, and an outlet 19 at an upper lateral end 38 on the opposite side in the width direction of the inlet 18 that can be opened to the atmosphere and through which stored urine can be discharged.

[0083] The urine collection bag 24 according to this embodiment has an overall thin rectangular parallelepiped shape, and has a rectangular parallelepiped void 26 formed therein that has a predetermined width, depth, thickness, and capacity. The capacity of this void 26 is X × Y × Z, where X is the width, Y is the thickness, and Z is the height. As a result, even when urine 28 flows into the internal void 26 from the inflow portion 18, the void 26 has a predetermined capacity, so that the fluid resistance of the urine 28 is significantly attenuated, thereby reducing peripheral resistance in the outflow circuit.

[0084] The urine collection bag 24 according to this embodiment is made of polyvinyl chloride (PVC), as in the previous embodiment. Because PVC has a certain hardness, it can be deformed when an external force is applied, and it has the rigidity to return to its original shape when the external force is removed after compression. Therefore, the urine collection bag 24 according to this embodiment has a certain level of shape memory that allows it to maintain its cylindrical shape even when an external force is applied during actual use. Therefore, the volume of the rectangular parallelepiped cavity 26 formed inside the bag can be maintained, and peripheral resistance can be continuously reduced.

[0085] (c) Cylindrical Urine Collection Bag with a Bellows Section The urine collection bag 32 shown in Figure 5 is made of a flexible material that elastically deforms when an external force is applied and returns to its original shape when the external force is removed. In this embodiment, it is made of vinyl chloride resin, but it may also be made of polypropylene resin. It may also be made of an appropriate shape-memory material such as a shape-memory alloy or shape-memory resin. The urine collection bag 32 is entirely cylindrical, and a bellows section 25 is provided on the urine collection bag body 31 along the axial direction. The bellows section 25 allows compression when an external force is applied along the axial direction, and returns to its original shape when the external force is removed after compression, generating negative pressure during the return to its original shape.

[0086] The arrangement of the inlet portion 18 and the outlet portion 19 is the same as in the above embodiment. That is, the inlet portion 18, to which the outlet tube 11b is connected, is provided at one radial end of the upper surface portion 35, and the outlet portion 19, which can be opened to the atmosphere and can discharge stored urine, is provided at the upper end portion 36 of the lateral peripheral surface on the radial opposite side of the inlet portion 18.

[0087] The urine collection bag 32 according to this embodiment is a hollow cylindrical structure with a bellows structure formed by the bellows portion 25. It is formed as a compressible and recoverable structure that can be easily flattened by axially squeezing it from above, a so-called "foot pump" configuration. Therefore, in the urine collection bag 32 according to this embodiment, as shown in Fig. 5(1), the cap 20 on the discharge portion 19 is removed to open the discharge portion 19. Next, as shown in Fig. 5(2), a force is applied from above to the urine collection bag body 31, compressing and deforming the urine collection bag 32 to form a compressed urine collection bag 39 (32), generating a weak negative pressure. The discharge portion 19 is then closed with the cap 20. Then, as shown in Fig. 5(3), when the force applied to the urine collection bag body 31 is released, the urine collection bag 40 (32) returns to its original shape due to the rigidity of its material. However, since the interior of the urine collection bag body 31 is a closed space, a predetermined amount of negative pressure is generated within the urine collection bag. As a result, the peripheral resistance in the outflow circuit is greatly attenuated, and the initial siphoning pressure Ps can be further reduced compared to the urine collection bags according to the above-described embodiments.

[0088] That is, when actually using the urine collection bag 32, the cap 20 on the outflow section 19 is removed, leaving the discharge section 19 open to the atmosphere, and then the urine collection bag 32 is compressed and flattened by applying force from above to form a urine collection bag 39 (32) in a state in which the air inside the hollow structure urine collection bag has been pushed out, and when the discharge section 19 is closed with the cap 20, the inside of the urine collection bag body 39 (32) is placed in a (weak) negative pressure state.

[0089] In this case, in the continuous outflow circuit system according to this embodiment, as shown in FIG. 2, in a siphoning confirmation test under practical clinical arc model conditions, a negative pressure Pn (cm water pressure) is generated when the system returns to its original shape after being compressed according to the above procedure, and as shown in FIG. 5 (3), because the structure is closed and the space is sealed, a suction force due to the negative pressure also acts on the bladder 10, which is the source of outflow from the urine collection bag 40 (32), reducing the initial siphoning pressure, and the normal initial siphoning pressure Ps is reduced by the negative pressure Pn, resulting in an initial siphoning pressure of Ps-Pn, and continuous outflow is possible even if H1>Hs.

[0090] Furthermore, by constructing the bag as a closed-type urine collection bag similar to conventional products, but using a material with a predetermined strength such as vinyl chloride or polypropylene and forming it into a cylindrical, hollow, bellows-like structure, the bag can be compressed vertically like a bellows or foot pump drum before use to close the outlet 19 and then returned to its original shape, thereby creating a predetermined amount of negative pressure inside, thereby reducing the initial siphoning pressure and the minimum amount of urine siphoned in the continuous outflow circuit system of the present invention. As described above, by forming the bag into a hollow, cylindrical, bellows-like structure and arranging the inlet 18 and outlet 19 so that the inlet 18 is located at one radial end of the top surface 35 and the outlet 19 is located at the radially opposite end of the side circumferential surface 36, there is no need for a drip chamber, a check valve, or an air filter, and the overall structure can be constructed with the minimum necessary components and elements.

[0091] Therefore, if the urine collection bag 32 is set to a negative pressure sufficient to create a -20 cm water column when fully compressed to the state indicated by reference numeral 39 in Figure 5(2), the initial siphoning pressure will not become negative, allowing for safe use for the user. Furthermore, depending on the intended use, even a urine collection bag configured to create a negative pressure of 25 cm or 30 cm water column when compressed can be used effectively depending on the urine characteristics of the user or patient. Furthermore, in this embodiment, the urine collection bag 32 is entirely cylindrical and the bellows section 25 is provided on the urine collection bag body 32. However, with this embodiment, the negative pressure of the bag is easily adjusted. On the other hand, in actual use, when the urine collection bag 32 is installed in a small, limited space, such as when used as a leg bag, a thin, rectangular urine collection bag 24 as shown in Figure 4(c) can be formed with bellows sections provided along the thickness and width directions, allowing for negative pressure to be generated by compressing the bag along the thickness or width direction. Therefore, the specific shape and configuration of the urine collection bag are not limited to the configuration according to this embodiment.

[0092] The relationship between the negative pressure and the initial siphon pressure when the urine collection bag 32 according to this embodiment is in use will be described below with reference to FIG.

[0093] In the pre-use state shown in Figure 5 (1), the cylindrical bag's outlet is open and connected to the Foley catheter and outflow tubing of the outflow guide under practical clinical arc model conditions as a urine collection kit. In this state, the cap 20 is removed from the discharge port 19 of the urine collection bag 32, leaving the internal cavity of the urine collection bag 32 open to the atmosphere and at atmospheric pressure. From this state, the discharge port 19 of the urine collection bag 32 is closed with the cap 20 (or not) and used as is. Note that the urine collection bag 32 must have passed a siphoning confirmation test under the practical clinical arc model in use, and its initial siphoning pressure must be specified. Naturally, if the viscosity of the outflow varies depending on the nature of the urine, such as nephrosis or hematuria, its usability must be determined in advance by clarifying its effective limits in a quality control system.

[0094] 20 + α cm water column > initial siphoning pressure > = 0 cm water column. Figure 5 (2) shows the urine collection bag 39 (32) in a state where the urine collection bag 32 is pressed downward by the bellows portion 25 to a position where the first height difference, minus 20 cm water column, is reached. In this case, the discharge port 19 is closed with the cap 20 after compression. In this case, after compression, the urine collection bag body 31 attempts to return to its original shape due to the rigidity of its material (vinyl chloride in this embodiment). Because the first height difference is set to 20 cm, the initial siphoning pressure should be 20 + α cm water column at atmospheric pressure, even when considering factors such as lumen resistance. This is offset by the negative pressure inside the bag, resulting in a + α cm water column.

[0095] Figure 5 (3) shows a state in which urine 28 accumulates in the bladder 10 in an amount greater than the minimum amount required for siphoning and outflow, and when the initial siphoning pressure is reached, urine 28 continues to flow out of the bladder, filling all of the intermediate circuits and forming a siphon, and urine 28 continues to flow out.

[0096] Initial siphoning pressure < 0 cm water column: This section explains how to use the urine collection bag 35 when urine is viscous and difficult to flow, such as in cases of diabetes, nephrotic syndrome, or bacterial infection. Preparation for use in Figure 5 (1) is the same as in Example 1. Next, the urine collection bag 32 is further compressed with greater force, and then the discharge port 19 is closed with the cap 20 to generate a greater negative pressure according to the viscosity of the urine. In this case, the generated negative pressure is adjusted according to the viscosity of the urine.

[0097] For example, if a urine collection kit is compressed to a certain level, it will result in a -25cm or -30cm water column. The relationship between the degree of compression and negative pressure is confirmed and understood depending on the material and structure of the urine collection bag in the urine collection kit, and a "compression negative pressure curve" is created for each product of the size and shape of the urine collection bag. Since the degree of compression (height) from the initial natural length (height) determines the negative pressure when the outlet is closed, it is necessary to specify in advance as a standard how many centimeters of negative pressure will be achieved when compressed to a certain height. Using this as a guide, the pressure should be adjusted to allow for gentle, sustained outflow without applying too much negative pressure too suddenly. Then, while checking the actual outflow rate, the compression of the bag (i.e., the negative pressure inside the urine collection bag) can be adjusted to achieve a moderate, sustained outflow.

[0098] Figure 6 shows the elements necessary for manufacturing a continuous outflow system circuit, the elements necessary for establishing its standards, and the elements necessary for ensuring its quality. It also shows an overall picture of the quality assurance and quality control system that applies the PDCA cycle to properly manufacture and manage the quality of medical devices. This continuous outflow control system ensures that continuous outflow system circuits are properly manufactured, used, and operated, increasing the convenience of clinical management, providing appropriate medical care, and improving the quality of life for users and their families. To achieve this, it is necessary to consider the reference artificial bladder, reference concentrated diabetes, and clinical loop model conditions. After accurately identifying the current situation, systems thinking based on objectives, goals, and the PDCA cycle is essential.

[0099] The present invention is not limited to the configurations of the above-described embodiments, and modifications and applications are possible as appropriate without departing from the spirit and scope of the present invention. For example, although the present embodiment has been described with reference to an example in which the urine collection bag is made of polyvinyl chloride (PVC), it may also be made of polypropylene. Furthermore, it may also be made of other synthetic resins having a predetermined flexibility and rigidity. Furthermore, it may be made of various shape-memory materials, and the urine collection bag or storage bag may also be made of shape-memory alloys or shape-memory resins. Furthermore, although the above-described embodiment has been described with reference to an example in which the storage bag in the continuous outflow system circuit of the present invention is applied to a urine collection bag that stores urine discharged from the bladder, the present invention is not limited to the above-described embodiments, and may also be applied to cases in which fluid is discharged from a fluid source other than the bladder and stored.

[0100] Depending on the bag's material and shape, cylindrical bellows bags can also be made using shape-memory materials. However, if the bag is simply intended to contain the contents without leaking, a two-ply bag made of low-density polyethylene (LDPE) can be used for continuous flow. However, if the cylindrical structure is desired, polyvinyl chloride (PVC), the same material as conventional bags, can also be used. On the other hand, if a strong negative pressure is required, polypropylene, which is used in various air pumps and foot pump drums, is suitable and can be used. In either case, it is necessary to select a material and shape appropriate for the volume and control of negative pressure. In other words, there is no need to go to the trouble of creating a bellows structure; simply selecting a cylindrical material will suffice. The relationship between the shape, material, and negative pressure must be confirmed.

[0101] The present invention relates to a storage bag in a continuous outflow system circuit, a continuous outflow system circuit, a quality control system for a continuous outflow system circuit, and a quality control method for a storage bag in a continuous outflow system circuit, and therefore has wide industrial applicability.

[0102] 10 Bladder 11 Outflow guide or outflow tube 11a Outflow guide 11b Outflow tube 12 Connecting inlet portion 13 Conventional storage (urine collection) bag 14 Storage (urine collection) bag according to the present invention 15 Open container 16 Outlet 17 Urine collection bag made of low-density polyethylene (LDPE) 18 Inlet portion 19 Outlet portion 20 Cap 21 Urine collection bag (cylindrical) 22 Void portion 23 Bottom portion 24 Urine collection bag (rectangular) 25 Bellows portion 26 Void portion 27 Inlet portion 28 Fluid (urine) 29 Urine collection bag main body constituent piece 30 Peripheral portion 31 Urine collection bag main body 32 Urine collection bag 34 Side upper end portion 35 Top portion 36 Side peripheral upper end portion 37 Top portion 38 Side upper end portion 39 Urine collection bag immediately after compression 40 Urine collection bag during compression release S Standard height position

Claims

1. A storage bag in a continuous outflow system circuit that continuously flows out a fluid from an outflow source, which is an elastic closed space inside the body that can be expanded and contracted, by siphoning the fluid within the elastic closed space using the siphon principle, and stores the fluid, wherein the continuous outflow system circuit comprises an outflow inductor provided for outflowing the fluid from the outflow source, and an outflow tube for moving the fluid from the outflow inductor to the storage bag that is the outflow destination, the pressure difference between the outflow source and the storage bag that is the outflow destination is P, the resistance of the entire siphoning continuous outflow system circuit is Rall, and the specified minimum capacity for generating an initial siphoning pressure Ps as the initial pressure difference for siphoning that overcomes the first height difference H1 of the clinical arc model condition that takes into account the actual usage environment conditions and the initial siphoning resistance Rs due to the pipeline resistance and starts continuous outflow is Vmin, The volume that fills the elastic closed space is Vo, the volume that occupies the lumen of the first height difference H1 up to the siphoning boundary where the initial siphoning pressure Ps exceeds the peak of the first height difference and starts to flow out is Vloop, the lumen volume of the outflow guide is Vhg and the lumen volume of the outflow tube is Vht, and further, the total lumen volumes of the outflow guide and the outflow tube are Vg and Vt, respectively. The relationship between them is given by [Equation 1] and the continuous outflow system circuit is designed to satisfy the siphoning capacity condition defined by the formula and to flow out while filling the lumen without any gaps even during outflow, and is configured to be siphoned once the pressure difference P exceeds a Ps value that balances with the initial siphoning resistance Rs, and to continue to flow out due to the elasticity of the outflow source and the pressure difference with the storage bag, even if there is a second height difference H2 generated by the arc following the first height difference H1, and to completely outflow, and the relationship between the conduit resistance Rg of the outflow guide, the conduit resistance Rt of the entire length of the outflow tube, the resistance Rp in the storage bag, the first height difference H1 and the second height difference H2 generated in the outflow tube as clinical arc model conditions considering actual use conditions, and the initial siphoning pressure Rs due to the conduit resistance of the outflow tube, and the initial siphoning pressure Ps as the initial pressure difference for siphoning that overcomes the resistance of the first height difference H1 and the second height difference H2 and the initial siphoning pressure Rs and starts continuous outflow is as follows: [Mathematical Expression 2] Ps ≧ Rs > Rall = Rg + Rt + Rp, and the resistance Rp has a value that generates the initial siphoning pressure Ps so that the above relationship holds. A storage bag in a continuous outflow system circuit.

2. A storage bag in a continuous outflow system circuit as described in claim 1, characterized in that the outflow source is the bladder and the fluid is urine, the storage bag is configured as a urine collection bag, and the resistance value of the initial siphon pressure Rs is reduced by the material, shape or structure of the urine collection bag body.

3. A storage bag in a continuous outflow system circuit as described in claim 2, characterized in that the urine collection bag body is made of low-density polyethylene (LDPE), and is formed into a thin bag shape by stacking two urine collection bag body constituent pieces on the front and back in the thickness direction and joining the peripheral parts.

4. A storage bag in a continuous outflow system circuit as described in claim 2, characterized in that it is made of a material having a rigidity that allows it to be deformed when an external force is applied and to return to its original shape when the external force is removed after compression, and is formed into an overall cylindrical shape.

5. A storage bag in a continuous outflow system circuit as described in claim 2, which is made of a material that is flexible, elastically deforms when an external force is applied, and has the rigidity to return to its original shape when the external force is removed after deformation, is formed in an overall cylindrical shape, has a bellows section along the axial direction, can be compressed by the bellows section when an external force is applied along the axial direction, and returns to its original shape when the external force is removed after compression, and is configured to generate negative pressure when returning to its original shape.

6. A storage bag in a continuous outflow system circuit as claimed in claim 2, characterized in that it is made of a material having a rigidity such that it can be deformed when an external force is applied and can return to its original shape when the external force is removed after compression, and is formed into an overall rectangular parallelepiped.

7. A storage bag in a continuous outflow system circuit as described in any one of claims 2, 3, 4, 5 or 6, characterized in that the outflow tube is connected to one upper side end to form an inflow section, and a discharge section that can be opened to the atmosphere and can discharge stored urine is provided at the upper lateral end on the opposite side in the width direction of the inflow section.

8. A storage bag in a continuous outflow system circuit according to any one of claims 4, 5 or 6, characterized in that it is made of polyvinyl chloride resin, polypropylene or a shape-memory material.

9. A quality control system for a continuous outflow system circuit, characterized in that the continuous outflow system circuit of claim 1 is a product that is actually operated under the clinical arc model conditions with the initial siphoning pressure and minimum volume set as the standard, and is standard tested and certified by an initial siphoning pressure measurement method and a simple complete outflow confirmation test method as a method for confirming compliance with the standard of the continuous outflow system circuit, which actually measures and checks the initial siphoning pressure.

10. A quality control system for a continuous outflow system circuit as described in claim 9, characterized in that whether or not the fluid is operated under conditions reflecting clinical conditions is managed by a PDCA cycle including a reference load test using a reference artificial bladder and reference concentrated glucose, and a load limit confirmation method for confirming the limit.

11. A quality control system for a continuous outflow system circuit as described in claim 9, characterized in that the reference artificial bladder is designed and manufactured with a margin to allow for a height difference of 20 cm and a piping resistance to be cleared, and the internal pressure when filled with 50 ml of the fluid is 25 cm of water column.

12. The quality control system for the continuous outflow system circuit as described in claim 9, in which the fluids flowing through the continuous outflow system circuit are standard artificial urine, standard concentrated diabetes mellitus, and other artificial urine with clinically encountered properties, and includes a standard conformity confirmation test and load test for the initial siphonage pressure measurement method and the simplified complete outflow confirmation test method, as well as a load limit confirmation method for confirming the limits.

13. A quality control system for a continuous outflow system circuit as described in claim 9, characterized in that the specifications of the standard artificial bladder which is the outflow source, the properties of the standard concentrated glucose which is the fluid, the specified minimum volume Vmin, the tube diameter, the tube length, the tube material, and the initial siphoning resistance elements of the tube friction coefficient, and the first height difference H1 or the second height difference H2 can be changed as necessary, and it is possible to confirm whether or not it is a continuous outflow system circuit based on these various conditions and various specifications, and quality can be guaranteed.

14. The continuous outflow system circuit of claim 1, characterized in that a quality control system for the continuous outflow system circuit of claim 9 is used to carry out a standard confirmation test to verify the standard and guarantee the quality in order to determine whether or not the circuit can actually be siphoned and continuously outflowed under the conditions and environments in which it is actually used at the site.

15. A quality control method for a storage bag used in a continuous outflow system circuit, comprising evaluating the material, shape or structure of the storage bag body from the viewpoint of whether or not the continuous outflow system circuit described in claim 1 is capable of reducing the initial siphonage pressure Ps under the clinical arc model conditions.

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