JP2022010088A - Disposable bag for medical suction instrument, or virus collecting filer for container - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a molding filter for preventing the passage of bacteria and viruses, which is used for a flexible disposable bag or container manufactured to be capable of sucking in a patient's internal secretions and the like, storing it and disposing of it when its amount reaches a constant storage amount.

SOLUTION: A molding filter is constituted to prevent the passage of internal secretions capable of including bacteria and viruses and permit the passage of all of air and internal aspirated air. A base material for the molding filter is porous polytetrafluoroethylene (PTFE) film or a PTFE nonwoven fabric.

SELECTED DRAWING: Figure 2B

COPYRIGHT: (C)2022,JPO&INPIT

Description

The present invention claims the priority of PCT / JP2016 / 063148 "a molded filter using a PTFE film and a disposable bag or container for a medical aspirator using the same".

The present invention exhausts the patient's internal exhaled breath through a bag or container in a medical aspirator system, and at the same time sucks and stores body secretions and waste liquids such as physiological saline and blood, which is a constant storage amount. The present invention relates to a disposable bag or container that discards the bag or container itself when the amount reaches, a molded body filter used therein, and a secondary filter installed downstream of the bag or container.

In medical aspirator systems, in recent years, flexible bags or containers made of plastic film (here, those formed from film or sheet are referred to as bags, those formed by injection molding or hollow molding are referred to as containers). Inhales the patient's body exhaled breath, body secretions, physiological saline, blood and other waste liquids (hereinafter referred to as "body secretions, etc."), stores them, and when the storage amount reaches a certain level, this bag or container itself. There is an increasing number of models whose components are bags or containers (hereinafter referred to as "disposable bags, etc.") that can be disposed of and are called "disposable bags". In this disposable bag, a suction port for guiding exhaled breath and internal secretions sucked from the patient into the bag, and an opening for discharging the air inside the bag to a rigid container outside the bag, that is, an exhaust port are structurally indispensable. (Patent Document 1). In addition, the opening for exhaust is ventilated to transmit the suction force (negative pressure) from the external suction pump to the suction catheter that is inserted into the patient's body, as well as the aspirated body secretions. A waterproof filter (hereinafter referred to as "primary filter") is also required to prevent the filter from flowing out from the opening to the suction pump side. At present, in order to fulfill the functions of meeting these two requirements, a sintered body of high molecular weight polyethylene (PE) is immersed in an aqueous solution of sodium carboxymethyl cellulose (CMC) and dried into a cylindrical molded product, that is, two types. Molded products made of different materials are used as a ventilation / waterproof filter (hereinafter referred to as "PE sintered body / CMC filter") in a form of closing the exhaust port.

The ventilation / waterproof filter in the entire medical aspirator system is usually only the primary filter installed in disposable bags, etc., but in some cases, mist such as internal secretions may pass through the primary filter and the suction pump. In order to prevent accidents that contaminate the system, a secondary filter that complements the primary filter may be installed after the disposable bag or the like. For example, in Patent Document 1, an example in which an independent filter component (hereinafter referred to as "secondary filter") is used for a connecting hose connecting a suction bottle main body downstream of an exhaust portion of a waste bag and a suction bottle (rigid container). Is disclosed. At present, only the above-mentioned PE sintered body / CMC filter can be used as this primary filter. However, this PE sintered body / CMC filter has major defects as described in detail below. Despite this, compared to various ideas and patents related to shape and arrangement, developments and proposals regarding new filter materials and filters formed using them have been mostly made in the past, including in Europe and the United States. It hasn't come.

First, the basic system of a general-purpose type of medical aspirator currently used will be briefly described. The basic system 100 usually has a configuration as schematically shown in FIG.
(1) A suction port 11 to which a suction catheter 18 for sucking internal secretions of a patient or the like is connected, and an air inside the bag to be discharged to the outside of the bag through a filter 12 while preventing water leakage. Disposable bag, etc. made of flexible plastic, which is provided with an exhaust port 13 and is formed so that internal secretions of patients and the like can be stored in the bag 110.
(2) A rigid container main body 120 having a discharge port 15 / suction port 16 for storing a disposable bag or the like and depressurizing the inside, and a lid portion 122 thereof.
(3) Aspirator body 130 that generates suction force by an electric motor
(4) Suction port that transmits suction force to the catheter 18 (5) A tube 19 that connects the rigid container body 120 and the suction device body 130, a joint for attaching the tube 19 and the like (not shown).

The basic system 100 stores the disposable bag and the like 110 of (1) inside the rigid container main body 120 of (2), and directly connects the exhaust port 13 of the bag and the suction port 16 on the suction port main body 130 side of (3). Instead, a so-called detour exhaust method is adopted in which the discharge port 15 of the rigid container and the suction port 16 on the suction device side are connected, and the inside of the rigid container is depressurized to exhaust air from the exhaust port 13 of a disposable bag or the like. There is. The reason for this is that since the bag expands under reduced pressure, it is easy to store internal secretions, etc., and at the same time, it is easy to remove the suction bag, and if the internal secretions in the bag are PE sintered. Even if it leaks from the body / CMC filter 12, it is a safety measure to store it in a rigid container and prevent it from being directly absorbed by the suction mechanism on the main body side.

By the way, since the disposable bag and the like 110 are stored inside the rigid container main body 120 and the suction port 16 on the suction device main body side is connected to the rigid container discharge port 15, a ventilation / waterproof filter such as a disposable bag is attached to the bag. In that case, it is also possible to attach it from the outside of the bag so as to close the exhaust port, that is, to install it externally. However, when trying to store a disposable bag or the like equipped with a ventilation / waterproof filter inside the rigid container body 120 as efficiently as possible, it is usually more efficient to attach this ventilation / waterproof filter inside the bag. .. Based on the above basic system, in the current example of a disposable bag or the like, a PE sintered body / CMC filter is attached to a plastic (PP) molded product having a pair of suction port and exhaust port, and the exhaust port is closed. It is formed by a method of heat-sealing the plastic bag and the molded product in such a form that the molded product is stored inside a flexible plastic bag. Such a built-in method is considered to be rational in terms of maximizing the capacity of disposable bags and the like and suppressing the cost of forming bags.

The mechanism for sucking secretions from the patient's body into a disposable bag or the like is as follows. First, the suction device main body 130 sucks the air in the rigid container from the discharge port 15 of the rigid container main body 120 at a normal speed of 20 to 35 kPa, and the inside of the rigid container is depressurized. As a result, the disposable bag or the like 110 stored in the rigid container expands due to the pressure difference, and at the same time, the air in the disposable bag or the like is released from the exhaust port 13 of the disposable bag or the like 110 via the ventilation filter attached to the bag. It is discharged, and as a result, a suction force is generated in the bag 110, whereby the body secretions of the patient and the like are sucked into the disposable bag and the like 110 through the suction catheter 18.

The "background technique" of Patent Document 2 (Japanese Patent Laid-Open No. 2015-52169, "Waste Liquid Container Device and Suction Bag Unit") includes "suction port (connecting the drainage container device to a suction source and exhausting the inside of the suction bag". ) May be placed in the lid, may be directly connected to the suction bag, or may be placed in a rigid drainage container, so that the drainage container is first exhausted and then. For the first time, the suction bag located in it is exhausted. " And it is said that most of these deformations of the shape belong to the public knowledge.

Utility Model Registration No. 32033434 Japanese Patent Publication No. 2015-52169 Japanese Patent No. 4638347 Japanese Patent No. 3204695 Japanese Patent No. 2922692 U.S. Pat. No. 4,111,204 Japanese Unexamined Patent Publication No. 9-56810

Vacuum suction waste bag material "high performance filter vent", Essentra Porous Technologies, 2014 "3786-012 Filter Valve", Vacsax Limited Material Specification, January 2012 Carboxymethyl Cellulose Natrum "Selogen" General Catalog, Dai-ichi Kogyo Seiyaku Co., Ltd. Morse Mask Series Catalog, Ace International Japan Co., Ltd.

For disposable bags, etc., various proposals have been made regarding the form, arrangement, and exhaust method of the suction port and exhaust port, mainly for the purpose of ease of handling when disposing of the bag and simplification of the overall system structure, mainly in Europe and the United States. ing. However, the most important point to be solved technically is a suction catheter that inserts the suction force (negative pressure) from the suction pump into the body of the patient or the like as a function required for the primary filter in a disposable bag or the like. The opening for exhaust is required to be breathable in order to transmit to, and at the same time, it is waterproof to prevent internal secretions and the like sucked through the catheter from being filtered out from the opening to the suction pump side. It is required to have three points of sex and, moreover, a pathogenic bacterium barrier property that prevents bacteria and viruses (hereinafter collectively referred to as "pathogenic bacterium") contained in the exhaled body from being filtered out to the outside of a disposable bag or the like at the time of ventilation. That is. However, in the past, the main interest in the above filter was to efficiently achieve both breathability and waterproofness, which are functional elements for operating the entire medical suction device system, and the pathogen barrier property of exhaust gas was described above. Simultaneous fulfillment of the three functions was technically extremely difficult, so it has been neglected. Therefore, the pathogen barrier property against exhaled breath in the body has not been discussed much so far. However, it is a very big risk that it should not be left unattended because it is released to the surrounding environment, and the pathogen barrier property is an important issue for which countermeasures should be considered beyond the ventilation and waterproof function of the filter. ..

The disposable bag, etc. 110 stores the sucked internal secretions, etc. in the bag and discards the entire bag when the amount reaches a predetermined amount, and the internal secretions, etc. sucked and stored in the bag are the filter unit. It is necessary to prevent leakage from the exhaust port 13 through the 12 and contaminating the inside of the rigid container main body 120, and this from adversely affecting the suction mechanism of the suction device main body 130. Further, the filter section must have a pathogen barrier property as described above even when the filter section is ventilated or when a secretion in the body leaks out from the filter section. Needless to say, it is important whether or not the pathogens contained therein are removed when the body exhaled air is exhausted through the filter or the body secretions are leaked. The most important thing in a disposable bag etc. in a medical suction device system is obviously not the shape problem of the suction port or the exhaust port or the mounting method, but rather the filter (molded body) built in or externally attached to the suction port or the exhaust port, as described above. In addition, it is necessary to simultaneously satisfy the difficult-to-parallel functions of breathability, waterproofness, and pathogen barrier property.

It is obviously difficult to manufacture a filter that is required to satisfy the breathability, waterproofness, and pathogen barrier property that are difficult to stand side by side at the same time with one material. Research and development of filters for various materials has been rarely done in the past. Currently, filters are based on the idea of combining two types of materials, namely polymer moldings and other polymer swelling materials, each of which has a ventilation function and a waterproof function. Specifically, in the current ventilation / waterproof filter, a porous PE sintered body formed by heat-sealing a small particle size PE into a desired shape is immersed in a water-soluble CMC solution, and this is used. Manufactured by drying. The air permeability is derived from the porosity of the PE sintered body, and the standard opening range is approximately 30 to 50 μm. In order to secure as large a surface area as possible and at the same time reduce the risk of breakage, this PE sintered body is usually cylindrical with no bottom surface on one side and has a size of about 3.7 to 3.9 mm. It is formed thick. On the other hand, the waterproof function is due to the fact that the CMC, which exists in a state of coating the surface of each particle of the PE sintered body, rapidly expands when it comes into contact with a liquid body secretion or the like and closes the opening of the PE sintered body. Express. For this reason, some companies that manufacture and sell ventilation / waterproof filters in Europe and the United States call the CMC used for the filter a self-sealing material. Further, the bacterial aerosol removal rate in this filter is described as 99.9 to 99.98% on the pamphlet even though the opening diameter of the PE sintered body is large.

However, the first problem with PE sintered body / CMC filters, which are currently used as standard ventilation / waterproof filters for medical suction devices in Japan and around the world, is that they have a fundamental defect in long-term waterproofness. That is. This is due to the water-soluble problem of CMC, which has a waterproof function. The second problem is the pore size of the PE sintered body and the barrier property of pathogens. This is because the size of the bacterium is in the range of 0.8 to 10.0 μm and the size of the virus is in the range of 0.02 to 1.0 μm, but as described above, the opening diameter of the PE sintered body is larger than the size of the bacterium as well as the virus. It is a concern because it is much larger.

First, the problem of water solubility of CMC, which is responsible for the waterproof function, which is the first problem, will be described. When the PE sintered body / CMC filter is immersed in tap water for about 24 hours, it is easily observed that a considerable amount of liquefied CMC elutes. This phenomenon clearly shows that a mixture of CMC solution and body secretions is directly linked to the serious problem of easily leaking out from the outlet of a disposable bag or the like. In the following, the waterproof performance required for disposable bags and the like and the waterproof function of the current PE sintered body / CMC filter will be analyzed and compared in detail.

First, there are two aspects to the waterproofness required for disposable bags and the like. The first aspect concerns long-term waterproofness. Disposable bags, etc. after use are incinerated after storage, but due to a defect in the waterproofness of the bag, internal secretions containing bacteria and viruses leak out of the bag during the storage period, and it is hygienic for the environment and humans. It must be absolutely prevented from causing problems. For example, it is easy to imagine the danger that a disposable disposable bag or the like will get wet with rain. The second aspect concerns instantaneous waterproofness. The filter is submerged in internal secretions during suction, and mist-like or liquid internal secretions momentarily leak from the filter, contaminating the suction mechanism inside the rigid container and further inside the suction device through the exhaust port 13. Or it must be prevented from having an adverse effect. As already mentioned, the PE sintered body / CMC filter can handle the second instantaneous waterproof function, which has a serious problem in long-term waterproofness. As described above, the PE sintered body / CMC filter widely used in the world and Japan at present lacks waterproofness for a long time.

As a second problem, consider the problem of the pathogen barrier property and the pore size of the PE sintered body. Internal exhaled breath is sucked into a disposable bag, etc. from the suction port together with internal secretions, etc., and the internal exhalation, etc. is stored in the bag, while internal exhaled breath passes through a ventilation filter and is sucked from a rigid container. It flows to the main body and is finally discharged to the outside. Therefore, there are two cases of the barrier property against pathogens of the ventilation / waterproof filter: the barrier property against the exhaled breath in the body and the barrier property when the body secretions leak from the ventilation waterproof filter together with the CMC solution or alone as described above. Exists. The barrier property of the filter to the first exhaled breath is generally judged by using the bacterial aerosol removal rate (bacterial droplet collection efficiency test, JIS L1912) and the virus droplet collection efficiency test (JIS L1912 compliant) as indicators. be. On the other hand, there is no established index for the barrier property against pathogens when the liquid material leaks from the filter. However, in any case, it is clear that the size of the pathogen and the size of the pore size of the PE sintered body are crucial. Generally, the size of bacteria is 0.8 (Staphylococcus aureus) to 10 μm, whereas the opening diameter in the CMC-coated state is unknown, but the pores of the PE sintered body are approximately 30 to 50 μm. Is. Therefore, the PE sintered body filter is said to exhibit high barrier properties in the bacterial aerosol removal rate test unless the pores are made into pores of 10 μm or less, but the barrier properties in the liquid material are essentially bacteria. And it is considered that it does not have a barrier function against viruses (pathogens). In the PE sintered body / CMC filter, it is difficult to reduce the pore size to 30 to 50 μm or less due to the limitation of sintering technology and the necessity of ensuring the air permeability of a certain amount or more. Therefore, it must be said that the current PE sintered body / CMC filter basically has a great concern about the barrier property against bacteria and viruses (pathogens).

Next, the ventilation performance of the disposable bag and the like will be described. In the current medical suction device, the ventilation filter in the disposable bag etc. has a ventilation flow rate of 20 L / min or more with a suction force of 60 kPa or more (under differential pressure) with a high suction pressure and high flow rate type (JIST72081-1). : 2012 Electric suction device-Safety requirements Article 59, Paragraph 5) In addition, a low suction pressure / low flow rate type with a suction pressure of 20 kPa or less has an air flow rate of 0.5 to 10 L / min (Article 59, Paragraph 7). Will be done. The current standard PE sintered body / waterproof filter, non-patent document 1, unit suction force (1 kPa), air flow rate per unit area (1 cm ² ) is 0.0391 L, and non-patent document 2 is 0.0514 L. It has become. Therefore, in order to obtain a predetermined air volume in Non-Patent Documents 1 and 2, the filter area is 14.61 cm ² (3.9 × 3.9 cm) and 11.12 cm ² (3.4 × 3.4 cm), respectively. Is required. The surface area of Non-Patent Documents 1 and 2 which are cylindrical in the standard product is about 16 cm ² . It is considered that this is because the surface area of the current PE sintered body / CMC filter is set so as to be compatible with the high suction pressure / high flow rate type.

An object of the present invention is to solve the problem of long-term waterproofness, which is a fundamental defect of the current PE sintered body / CMC filter, and at the same time, to have a ventilation performance comparable to that of the current product, and a bacterial and virus (pathogenic bacteria) barrier. It is an object of the present invention to provide a molded product filter formed of a porous PTFE film (including a non-woven fabric as a support) having a property and a charged non-woven fabric, and a disposable bag containing or externally provided with the molded product filter.

(PTFE film molded body filter)
As a result of various trials and errors and exploration experiments for the development of a new ventilation / waterproof filter, a new filter with bacterial barrier properties has been realized by a PTFE film molded body filter using a porous polytetrafluoroethylene (PTFE) film. I came up with the idea that it could be done. That is, the problem of instantaneous waterproofing and long-term waterproofing can be solved by the hydrophobic performance of the highest PTFE film among plastic materials, and the breathability that contradicts waterproofing is as long as the maximum pore diameter of the film is above a certain level. There is a possibility that air permeability equal to or higher than that of PE sintered body / CMC filter can be obtained, and since the size of bacteria is generally in the range of 0.8 to 10 μm, if the pore diameter can be controlled to a maximum of 1 μm or less, In theory, most bacteria should be able to be removed.

The PTFE film has a molecular weight of the base material (for example, whether the standard specific gravity is 2.16 or more or less), the presence or absence of a copolymerization component, the shape of the base material (round bar / rolling, sheet), and the stretching method (uniaxial or biaxial). There are various factors that determine the physical properties in terms of the drawing ratio, the layer structure (single layer, multilayer), the manufacturing method, the structure, and the like. Basically, the air permeability of the PTFE film depends on the draw ratio, and in general, uniaxial stretching forms a node (nodule) and a filible (fiber) extending in parallel from the node, and biaxial stretching reduces both the node and the filible. At the same time, it is thought that the breathability and waterproofness are improved by randomizing the fibrous direction. It was found that it is crucial to select a PTFE film in consideration of these manufacturing methods and structures. Table 1 summarizes the relationship between single layer / laminated, uniaxial / biaxial and ventilation / waterproof functions.

In order to actually use the PTFE film in the ventilation / waterproof filter built into the disposable bag of a medical aspirator, etc., PTFE that integrally achieves the individual requirements of air permeability, waterproofness and maximum pore size (bacterial barrier property). Experiments were conducted on whether or not the film was present, and if so, how to balance these at a high level.

As a result of conducting a breathability experiment assuming a practical medical disposable bag etc. for the PTFE film confirmed to be stable in production, there is also a large difference in the numerical value depending on the stretching method and composition. JIST72081: 2012 Electric Aspirator-Safe, with the same area (16 cm ² ) as the current PE sintered body / CMC filter, with a maximum pore diameter in the range of 1 to 5 μm, although there is an appropriately selected type. It was confirmed that the necessary and sufficient aeration amount specified by the high suction pressure / high flow rate type specified by the requirements and the low suction pressure / low flow rate type can be obtained.

As for waterproofness, it was found in the past research that the water pressure resistance test of JIS L1912 is based on exactly the same principle as the decompression test of medical aspirators, so it was confirmed that both ventilation, bacteria and barrier properties are compatible. The PTFE film of No. 1 was screened from the water pressure resistance data, and a water leakage experiment was carried out with the PTFE film having a maximum pore diameter in the range of 0.2 to 5.0 μm. The result was extremely good that no water leakage occurred under the suction force (differential pressure) of 35 kPa. A film with a maximum pore diameter of 0.2 μm (thickness 80 μm) had a suction force (differential pressure) of 65 kPa and no water leakage, but a film with a pore diameter of 1 μm (thickness 100 μm) had a suction force (differential pressure) of 75 kPa. Leakage occurred in. Further, in a film having a pore diameter of 5 μm (thickness 100 μm), water leaked after about 1 minute under a suction force (differential pressure) of about 70 kPa. However, the differential pressure condition that is a prerequisite for waterproofness is 60 kPa or less for the low suction pressure / low flow rate type and the medium suction pressure type, and it can be judged from this result that the waterproofness is sufficient. From these comprehensive results, it is actually the case that the maximum pore diameter of the appropriately selected PTFE film is in the range of 1 to 5.0 μm and simultaneously satisfies the breathability, waterproofness and bacterial barrier property required for disposable bags and the like. Proved to be obtained in. Unlike CMC, PTFE film is waterproof for a long period of time and no water leakage occurs if there is no problem with instantaneous waterproofing.

Since it was found that some PTFE films satisfy the air permeability, waterproofness, bacteria, and barrier properties, a similar experiment was conducted on a PTFE non-woven fabric (thickness 200 μm) laminated with a PET non-woven fabric as a support. As a result, the air permeability is 21.7 L / min under the same area (16 cm ² ) and suction force (differential pressure) of 35 kPa, the waterproof property is 35 kPa and no water leakage, and 48.3 kPa causes water leakage. It was confirmed that there is a usable ventilation / waterproof filter for the vessel. However, it is not possible to measure the size of voids with non-woven fabrics, and it is not possible to infer the bacterial barrier properties of this type.

By appropriately selecting the PTFE film and the PTFE non-woven fabric in this way, it is basically possible to form a filter having breathability, waterproofness, and bacterial barrier property that can be used in a medical suction device. I found. Table 2 summarizes the results of ventilation and waterproof experiments for PTFE film, PTFE non-woven fabric, PE sintered body, and CMC filter.

However, in order to form a molded filter using a PTFE film, the following processing problems are further assumed, and it is necessary to find a solution to the problems. These become particularly difficult when a support such as PP or PET non-woven fabric is not laminated on the PTFE film and the PTFE film is to be used alone.
(1) Problems of joining method and airtightness between the three-dimensional shape component 200 which is the flow path of the exhaust in the bag shown in FIG. 2A and the bonded portion of the PTFE film 25 (2) The inside of the bag is sucked from the suction device main body. For example, when the pressure is reduced to 35 kPa, the PTFE film 25 greatly swells inside the three-dimensional shape component 200, but there is a problem of film tearing and airtightness damage at this time.

An adhesive cannot be used to bond the PTFE film and the three-dimensional shape component 200, and the two are bonded by a heat-sealing method, and it is an experiment that the airtightness of the heat-sealed part is sufficiently maintained under a reduced pressure of 35 kPa. I was able to confirm it at. As another method, it is also possible to take a large area of the bonded portion on the four sides and bond them with an adhesive. Since the PTFE film is thin, in the actual heat fusion method, a method in which the PTFE film is directly laminated on the three-dimensional shaped component and the hot plate is heated from above the PTFE film is preferable.

In order to prevent the PTFE film from swelling greatly inside the three-dimensional shape component, it is necessary to install support portions made of ribs at intervals of about 10 mm above and below the opening of the three-dimensional shape component. In FIG. 2A, grid-like ribs that are orthogonal to each other in the vertical and horizontal directions are displayed, but the rib shape is not limited to this. What is important is that the PTFE film and the rib portion are not heat-sealed so as not to deteriorate the air permeability. As a result, it was actually confirmed that even when the inside of the disposable bag or the like is decompressed to, for example, 35 kPa, both prevention of deterioration of air permeability and prevention of swelling of the PTFE film can be achieved.

(Filter with virus barrier property)
As described above, even with a PTFE film or a laminated film of PTFE and a non-woven fabric, if the pore diameter is 1 μm or less, it is possible that the effects of bacterial barrier property and further virus barrier property are partially exhibited, but breathability. Is impaired. However, it is crucial that the ventilation / waterproof filter has a bacterial barrier property to a virus barrier property, and it is absolutely clear to establish a true medical waste bag. It is a task that must be done. Therefore, on the premise of a technically established PTFE film molded filter, we investigated a new method that can remove viruses other than the manipulation of pore size.

Dust collection filters used in chemical factories are classified into general filters, medium- and high-performance filters, and ultra-high-performance filters according to the collection efficiency. The ultra-high-performance filters have a target particle size of 0.3 μm or less (HEPA), 0. The purpose is to remove dust of 1 μm or less (ULPA). Non-woven fabric and glass filter paper are used as materials.

The collection mechanism of the filter is classified as follows. (A) Sieve, (b) Inertial collision, (c) Obstruction, (d) Diffusion, (e) Static electricity. (A) Sieve occurs with a pore diameter of the filter material, (c) Blocking occurs with a particle diameter of 0.1 μm or more, and particles along the air flow come into contact with the surface of the filter material and are collected. Is. The diffusion of (d) occurs when the target particle size is 0.5 μm or less, and is the collection accompanying the Brownian motion of the particles. The static electricity of (e) is a mechanism in which particles having a target particle diameter of 0.05 to 1.0 μm are collected by the Coulomb force of the static electricity of the filter material.

By the way, the size of the virus is in the range of 0.02 (norovirus) to 1.0 μm. The following three directions can be considered as a measure for imparting a pathogen barrier property to a filter based on the above-mentioned PTFE film or a laminated film of PTFE and a non-woven fabric.
(1) The maximum pore diameter of the PTFE film used as a sieve is minimized.
(2) Static electricity is applied to the PTFE film and its Coulomb force is used.
(3) Static electricity is applied (or a charged non-woven fabric is laminated) to the non-woven fabric side of the laminated film of PTFE and the non-woven fabric, and the Coulomb force is used.

When the PTFE film is used as a ventilation / waterproof filter, as detailed in [0025] to [0026], it is necessary to satisfy a certain level of ventilation performance and waterproof performance at the same time, and the maximum pore diameter range is set to 0 from this aspect. It is difficult to make it less than 2 to 1.0 μm. Moreover, even if the pore size of 0.2 μm is utilized, it cannot always be considered to be sufficient from the viewpoint of the pathogen barrier property. In the method of applying static electricity to the PTFE film itself, the hydrophobicity of the PTFE film is lost by applying static electricity and the waterproof property is impaired, and when the PTFE film comes into contact with water such as drainage in the body, it is applied. It is meaningless because the static electricity generated is attenuated and the function of collecting viruses is lost. Therefore, these methods are not effective.

The method of applying static electricity (or laminating a charged non-woven fabric) to the non-woven fabric side of the laminated film is theoretically sufficiently possible, and it is presumed that there is no great difficulty in manufacturing a molded filter. went. With a laminated film of PTFE film and non-woven fabric, the PTFE side is made to function as a sieve, static electricity is applied to the non-woven fabric side (or charged non-woven fabric is laminated), and Coulomb force is given to the above-mentioned filter collection mechanism. A mechanism that combines (a) and (e) is constructed. The Coulomb force of static electricity alone can adsorb a considerable part of the virus size of 0.05 to 1.0 μm, and (b) inertial collision collection and (d) diffusion collection due to Brownian motion. Taken together, an effective barrier against pathogenic bacteria in the virus size range of 1 μm or less can be expected at the exhaust port of the waste bag. In this case, the important condition is that the non-woven fabric to which static electricity is applied does not come into contact with water such as drainage in the body, and conversely, the PTFE film side that exhibits waterproofness comes into contact with water such as drainage in the body. It is to arrange the laminated film.

As the charged nonwoven fabric, a method in which a nonwoven fabric is manufactured from an engineering plastic such as polypropylene resin (PP) or nylon 66 resin as a raw material and charged by a corona discharge method or a hydrocharging method is generally used. The amount of charge is preferably 2.0 × ^10-10 coulomb / cm ² or more in terms of surface charge density. Further, as the manufacturing method, the melt blown method is desirable because an ultrafine fiber diameter can be obtained and it can be manufactured thinly, but the spunbond method is also possible. The PP melt blown method charged non-woven fabric has a thickness of 0.12 to 0.40 mm, a basis weight of 10 to 40 g / g · m ² , and a breathability of 40 cc / cm ² / s for a basis weight of 20 g and 20 cc / cm ² / s for a 40 g basis. Types like are being produced.

Using such a charged non-woven fabric, a laminated film of PTFE film / PP non-woven fabric (support) / PP melt blown method charged non-woven fabric and the current PE sintered body / CMC, and a laminate of the PTFE film / PP non-woven fabric (support) of the present invention. A comparative experiment was carried out between the bacterial droplet collection efficiency (BFE: Bacterial Filtation Efficiency) and the virus droplet collection efficiency (VFE: Virus Filtration Efficiency) of the film. The results are shown in Table 3.

As can be seen from Table 3, a clear difference of about 12% in BEF and about 9% in VFE was observed between the PE sintered body / CMC laminated filter and the PTFE film / PP non-woven fabric laminated filter. It was also found that even with a PTFE film / PP non-woven fabric laminated filter, higher BFE and VFE than expected can be obtained. On the other hand, the difference between the PTFE film / PP non-woven fabric laminated filter and the PTFE film / PP non-woven fabric / charged non-woven fabric laminated filter could not be accurately quantified due to the detection limit of the measured measurements. However, it is known that a mask using an electrostatic charge filter can remove even 0.1 μm particles and reduces the infectivity of the virus by 99.9999% (Non-Patent Document 4). Therefore, although the quantitative difference is unknown from Table 3, by using the PTFE film / PP non-woven fabric / charged non-woven fabric laminated filter for the disposable bag of the present invention, infectious and toxic such as influenza virus and norovirus in particular. It can be expected to have the effect of removing high-grade viruses.

The following are the effects of the present invention when a molded filter formed of a PTFE film is used as a ventilation / waterproof / bacterial / virus (pathogenic) barrier filter built in a disposable bag or the like.
(1) The ventilation / waterproof / pathogen barrier filter of the present invention has complete waterproofness, and is a fundamental defect of the current PE sintered body / CMC filter. It is possible to suppress the leakage of a mixture of CMC solution and body secretions to the outside of the bag, which is a concern.
(2) The laminated filter of PTFE film / PP non-woven fabric and PTFE film / PP non-woven fabric / charged non-woven fabric showed extremely excellent pathogenic fungus barrier property as compared with PE sintered body / CMC filter. In particular, the PTFE film / PP non-woven fabric / charged non-woven fabric laminated filter can be expected to have a high pathogen barrier property not only against bacteria but also against highly infectious viruses. This makes it possible to provide a disposable bag having higher safety for the environment around the patient and human beings.

FIG. 1 is a schematic configuration diagram of a basic system of a current medical aspirator. FIG. 2A is a perspective view of a three-dimensional shape component used in a disposable bag or the like according to the present invention (before joining the filter base material). FIG. 2B is a perspective view of a molded body filter (three-dimensional shaped component after joining the filter base material) used for the disposable bag or the like according to the present invention. FIG. 3A is a perspective view of a ventilation component used in a disposable bag or the like according to the present invention. FIG. 3B is a perspective view of a ventilation component after mounting a three-dimensional shape component used for the disposable bag or the like according to the present invention. FIG. 4A is a perspective view of a flexible bag used for a disposable bag or the like according to the present invention. FIG. 4B is a perspective view of a disposable bag or the like after all the ventilation parts, the three-dimensional shape parts, and the flexible bag are joined according to the present invention. FIG. 5A is a cross-sectional view showing a state in which the disposable bag or the like according to the present invention is housed in a rigid container. FIG. 5B is a perspective view showing a state in which the lid of the rigid container containing the disposable bag or the like according to the present invention is opened.

Disposable bags and the like, whose integrated product is a molded part having a ventilation / waterproof function formed by using a PTFE film or the like, can be manufactured in various shapes, functions, and sizes. Hereinafter, typical embodiments of the present invention are shown.

FIG. 2A is a three-dimensional shape component 200 in which the PTFE film 25 is later heat-sealed into the opening 21. This shape is made from polypropylene (PP) by injection molding using a mold. The three-dimensional shape component includes an opening 21 which is a region for heat-sealing the PTFE film and the like, a grid-like rib 22 for supporting the PTFE film at the opening, and an internal cavity 23 which is a flow path for air to pass through. It has a fitting shape 24 for mounting on the molded body shown in FIG. 3A. It should be noted that one side, both sides, four side surfaces or four side surfaces + bottom surface of a substantially rectangular parallelepiped molded part may be used as an opening. The shape of the three-dimensional component can be various, such as a cylinder or a disk, in addition to the rectangular parallelepiped. Table 4 shows the opening area in this embodiment.

FIG. 2B shows a molded part 210 in a state where a PTFE film or a laminated 25 of a PTFE film, a PP non-woven fabric, and a charged non-woven fabric is heat-sealed to the three-dimensional shaped part. Hereinafter, this molded part 210 is referred to as a “molded body filter”. The thickness of the PTFE film used in this example is in the range of 50 to 200 μm, and the maximum pore diameter is in the range of 0.2 to 5 μm. When the PTFE non-woven fabric was used for the support, the thickness including the PET non-woven fabric was set to 300 μm or less (the pore diameter cannot be specified).

FIG. 3A shows the appearance of a molded air vent component 300 inscribed in a film bag. The ventilation component 300 includes a suction port 31 for joining the suction catheter 18, a cap 32 thereof, a mounting shape 33 to a rigid container, and a fitting portion 34 with the fitting shape 24 of the PTFE film heat-sealed three-dimensional shape component 200. It also includes an exhaust port 35, and a joint portion 36 by heat fusion with a film bag for storing internal secretions and the like. Further, in order to prevent internal secretions and the like stored in the film bag or mist-like substances thereof from flowing back in the suction pipe, vulcanized rubber is separately used at the outlet 37 of the suction port on the film bag side. Install the check valve 38 to be manufactured.

FIG. 3B shows a composite molded body 310 in which a molded body filter 210 obtained by heat-sealing the PTFE film of FIG. 2B is fitted and integrated with the ventilation component of FIG. 3A in a state of maintaining airtightness. Of course, this integration for maintaining airtightness can be performed not by fitting but by heat fusion of both.

FIG. 4A shows an example of a film bag for storing body secretions and the like. The shape of the film bag can be various, but it is necessary that the finally formed integrated disposable bag can be efficiently stored in the rigid container shown in FIGS. 5A and 5B. The film bag is generally formed by multilayer inflation molding using linear polyethylene (LLDPE), polyethylene terephthalate (PET) resin, and / or nylon resin (NY), and an adhesive resin. In the embodiment of the present invention, the film bag is composed of three layers, and the thickness is an outer layer (PET): 30 μm, an adhesive resin layer: 7 μm, and an inner layer (LLDPE): 120 μm. The internal volume of this embodiment is 1300 cc.

FIG. 4B shows a form in which the composite molded body 310 of FIG. 3B is inscribed inside the upper end of the film bag of FIG. 4A and airtightly fused. In this way, the integrated composite molded body 310 using the three-dimensional shaped component 210 having a ventilation / waterproof function formed by using the PTFE film and the final film bag 400 for a medical aspirator. Disposable bag 410 is completed. Although this embodiment shows an example in which the composite molded body 310 is inscribed in the bag, it may be circumscribed in the outside of the film bag and joined. Further, the position of attaching the composite molded body 310 to the film bag does not have to be the upper end portion of the film bag 400, and may be a position at four sides of the bag or at a position higher than the middle stage of the side corner portion.

5A and 5B show a state in which the finally completed disposable bag is attached to the rigid container 500. Note that FIG. 5B shows an example in which the composite molded body 310 is equipped with a horizontal type instead of a vertical type PTFE film three-dimensional shape component as shown in FIG. 3B.

In the above embodiment, since a detour exhaust system is used in which the rigid container is decompressed by the suction device main body and the inside of the disposable bag or the like is depressurized through the ventilation component, the three-dimensional shape component in which the PTFE film is heat-sealed, that is, molded. Although the configuration in which the body filter is built in the disposable bag or the like has been described, the disposable bag or the like may be directly sucked by the suction device body to reduce the pressure. In this case, a molded body filter having a structure that allows air and internal exhaled air in the disposable bag or container to pass through is attached to the outside of the exhaust port 35 of the ventilation equipment 300 while maintaining airtightness, and the suction device main body. A suction tube directly connected to the filter may be connected to the outlet side of the molded body filter. Alternatively, a molded body filter is provided in contact with the inside of the discharge port 15 of the rigid container or its lid, and the exhaust port 35 of the ventilation component 300 and the inlet of the molded body filter are connected by a suction tube and sucked from the suction port 16. It may be configured. Alternatively, a molded filter may be provided somewhere in the middle of the suction tube.

The above embodiment shows a filter (primary filter) in which the aspirated body secretions are attached to a disposable bag or container, but as yet another embodiment, the PTFE film, PP non-woven fabric or PTFE film according to the present invention. -A molded body filter containing a laminated filter of PP non-woven fabric and charged non-woven fabric may be used as a secondary filter connected to the downstream of the disposable bag or container. That is, the molded body filter may be connected between the rigid container 120 of FIG. 1 and the catheter 18 connecting the suction device main body 130 so as to maintain airtightness from the outside air. This makes it possible to realize a higher pathogen barrier property.

Although the above description has been made for Examples, it will be apparent to those skilled in the art that the present invention is not limited thereto and various modifications and modifications can be made within the scope of the spirit of the present invention and the appended claims. ..

100 Basic system of medical suction device 11 Suction port 12 Filter 13 Exhaust port 15 Suction port 16 Suction port 18 Suction catheter 19 Catheter 110 Disposable bag, etc. 120, 500 Rigid container 122 Rigid container lid 130 Aspirator body 200 Three-dimensional shape parts 21 Opening 22 Rib 23 Internal cavity 24 Fitting shape 25 PTFE film 210 Molded body filter (three-dimensional shape part to which PTFE film is joined)
300 Ventilation parts 31 Suction port 32 Cap 33 Mounting shape to rigid container 34 Fitting part 35 Exhaust port 36 Joint part 37 Suction port outlet 38 Backflow prevention valve 310 Integrated composite molded body,
400 Film Bag 410 Final Disposable Bag

Claims (12)

In a medical aspirator system, a suction port for connecting a suction catheter for introducing a suction catheter for introducing a body breath and a body secretion from a patient or a user is provided, and among the body breath and the body secretion sucked from the suction port. The internal secretions are stored and stored in a space formed by a rigid container body and its lid, which are other components of the medical suction device system, except for the suction port and its peripheral parts. An exhaust port configured to be removed from the rigid container and discarded when the internal secretion reaches a predetermined amount, and to pass through the air and the internal exhaled breath when they are discharged to the outside. A molded body filter used in a flexible disposable bag or container further comprising a molded body of a ventilated component.
The molded body filter is joined or coupled to the molded body of the aerated component in an airtight manner to prevent the passage of the body secretions containing bacteria and viruses, and all of the air and the body exhaled air are removed. Configured to pass,
A molded body filter used in the disposable bag or container, which comprises a porous polytetrafluoroethylene (PTFE) film or a PTFE non-woven fabric as a base material of the molded body filter, for preventing the passage of bacteria and viruses. .. The disposable bag according to claim 1, wherein the filter base material of the molded body filter is a laminated body in which a charged non-woven fabric is further arranged on a surface of the PTFE film or the PTFE non-woven fabric downstream of the flow of exhaled air in the body. Or a molded filter used for containers to prevent the passage of bacteria and viruses. The molded body filter
The main body of the three-dimensional part that can be attached so as to cover the exhaust port and has a hollow inside,
A support portion for joining the filter base material provided on the three-dimensional shape component and a support portion.
A mesh-like rib provided on the support portion to prevent inward swelling of the film-like filter base material, and
A molded filter used in the disposable bag or container according to claim 1 or 2, which comprises the filter base material bonded to the support portion in an airtight manner to prevent the passage of bacteria and viruses. The molded filter used for the disposable bag or container according to claim 3, wherein the three-dimensional component has a cylindrical shape or a rectangular parallelepiped shape to prevent the passage of bacteria and viruses. The bacterial virus used in the disposable bag or container according to claim 3 or 4, wherein the support portion is a flat plate having a shape including a circular shape or a square shape, and the opening portion has a structure reinforced by a mesh-like rib. Molded filter that prevents the passage of virus. The virus used in the disposable bag or container according to any one of claims 3 to 5, wherein the porous PTFE film is a single-layer or multi-layer PTFE film produced by uniaxial or biaxial stretching. A molded filter that prevents the passage of viruses. The molded filter for preventing the passage of bacteria and viruses used in the disposable bag or container according to claim 6, wherein the porous PTFE film is a single-layer or multi-layer PTFE film produced by biaxial stretching. A molded body for preventing the passage of bacteria and viruses used in the disposable bag or container according to any one of claims 1 to 7, wherein the maximum pore diameter of the porous PTFE film is in the range of 0.2 to 5 μm. filter. The molded filter used in the disposable bag or container according to claim 8, wherein the maximum pore diameter of the porous PTFE film is in the range of 1 to 5 μm, to prevent the passage of bacteria and viruses. The passage of bacteria virus used in the disposable bag or container according to any one of claims 1 to 9, wherein the PTFE film or PTFE non-woven fabric is reinforced by laminating a resin non-woven fabric on both sides or one side. Molded filter to prevent. In a medical aspirator system, a suction port for connecting a suction catheter for introducing a suction catheter for introducing a body breath and a body secretion from a patient is provided, and the body secretion of the body breath and the body secretion sucked from the suction port is provided. The body that stores objects and is stored and stored in a space formed by a rigid container body and its lid, which are other components of the medical suction device system, except for the suction port and its peripheral parts. A ventilation component with an exhaust port configured to remove the endocrine from the rigid container and dispose of it when it reaches a predetermined amount of storage, and to ensure that air and the exhaled body pass through when it is discharged to the outside. A method for manufacturing a molded body filter used for a flexible disposable bag or container further equipped with the molded body of the above.
A three-dimensional component having a hollow inside, provided with a support portion for fixing a film-shaped filter base material, and provided with a mesh-like rib on the support portion to prevent inward swelling of the filter base material. , The process of making by molding,
As the filter base material, a porous polytetrafluoroethylene (PTFE) film or PTFE non-woven fabric, a laminate of PTFE film / PP non-woven fabric, or a laminate of PTFE film / PP non-woven fabric / charged non-woven fabric is heat-sealed or adhered with an adhesive. A method for manufacturing a molded body filter used for the disposable bag or container, which comprises a step of joining to the support portion to manufacture a molded body filter so as to maintain the airtightness of the three-dimensional shape component. The suction port portion, an exhaust port for storing the internal secretions and the like, and exhausting the remaining exhaled air directly into the decompressed rigid container or directly to the suction device main body, and the rigid container main body and / or A step of manufacturing the ventilation component having a mounting shape for fixing to the lid portion by molding a plastic material containing polypropylene (PP) or polyethylene (PE), and
The disposable bag according to claim 11, further comprising a step of joining the molded body filter so as to cover the exhaust port of the ventilation component and maintain airtightness by a method including fitting, heat fusion, and adhesion. Alternatively, a method for manufacturing a molded filter used for a container.

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