WO2017187544A1 - Molded-body filter using ptfe film, and disposable bag or container for medical aspirator using said molded-body filter - Google Patents

Abstract

Provided is a molded-body filter having an air permeability that is at least equivalent to that of PE sintered compact-CMC filters, short-term and long-term waterproofness, and improved bacteria barrier properties. Further provided is a disposable bag or container including the molded-body filter. A porous polytetrafluoroethylene (PTFE) film having a designated structure and pore diameter is used as the filter base material. The filter base material is thermally fused or adhered, via an adhesive, to a three-dimensional component that is internally hollow and has a support part for fixing the film-like filter base material, said support part being provided with a mesh-like rib preventing swelling toward the inner side of the filter base material, such that a molded-body filter is constituted by bonding to the support part so as to preserve the airtightness of the three-dimensional component. The molded-body filter is attached to the discharge port of a disposable bag or container such that internal exhalation and air inside the disposable bag or container definitely passes through when being discharged outside the disposable bag or container.

Description

Molded filter using PTFE film, and disposable bag or container for medical suction device using the same

The present invention is a medical aspirator system, which aspirates a patient's exhaled breath, body endocrine substances and saline, waste liquid such as blood, stores it, discards it when it reaches a certain storage amount, and can be discarded The present invention relates to a bag or a container, and a molded article filter used therefor.

In medical aspirator systems, flexible bags or containers made of plastic film in recent years (here, those formed from films or sheets are referred to as bags, those formed by injection molding or hollow molding are referred to as containers) The patient's exhaled breath, body endocrine substances and saline, waste liquid such as blood (hereinafter referred to as "body endocrine substances") is aspirated and stored, and this bag or container itself when it reaches a certain storage amount There is an increasing type of component parts including bags or containers (hereinafter referred to as “disposable bags etc.”) called disposable “disposable bags” for discarding waste. In this disposable bag, a structurally essential port is a suction port for introducing exhaled breath and body endocrine substances sucked from the patient into the bag, and an opening for exhausting the air in the bag to a rigid container outside the bag. (Patent Document 1). In addition, the opening for exhaustion contains a body endocrine that is aspirated simultaneously with air permeability for transmitting suction (negative pressure) from the external suction pump to the suction catheter inserted into the patient's body. A waterproof filter is also required to prevent filtration through the opening to the suction pump side. At present, a sintered body of high molecular weight polyethylene (PE) is immersed in an aqueous solution of sodium carboxymethylcellulose (CMC) and dried to obtain a function corresponding to these two requirements, ie, two types of cylindrical molded articles Molded articles made of different materials are used as ventilation / waterproof filters (hereinafter referred to as "PE sintered bodies / CMC filters") in the form of blocking the exhaust port.

With regard to this disposable bag and the like, various proposals have been made for the configuration, arrangement and exhaust system of the suction port and the exhaust port mainly for ease of handling at the time of bag disposal and simplification of the entire system structure mainly in Europe and the United States. It is coming. However, the most important point to be technically solved is, in the disposable bag or the like, an opening for exhaustion in order to transmit the suction force (negative pressure) from the suction pump to the suction catheter inserted into the body of the patient or the like. In addition to being required to be breathable, it is waterproof to prevent body endocrine substances etc. sucked through the catheter from being filtered out to the suction pump side from the opening, and also to breathe the body during ventilation. Three points of bacterial barrier properties are required to prevent filtration of bacteria contained in the outside of disposable bags and the like. However, with regard to how to achieve these points at the same time, particularly with regard to the bacterial barrier property to internal breath, it has been extremely important, although it has not been discussed so far.

At present, the above-mentioned PE sintered body / CMC filter is used worldwide as a vent / waterproof filter in the form of blocking the exhaust port. However, the present PE sintered body / CMC filter has a large defect as described in detail below. In comparison with various ideas and shapes and layouts so far, patents and developments and proposals on novel filter materials and molded filters formed using them have hardly been made in the past including Europe and the United States.

First, a basic system of a medical suction device of a general-purpose type currently used will be briefly described. The basic system 100 is usually configured as schematically shown in FIG.
(1) A suction port 11 for connecting a suction catheter 18 for suctioning body endocrine substances and the like of a patient etc., and for discharging the air in the bag from the bag through the filter 12 while preventing water leakage. Disposable plastic bag 110, which is made of flexible plastic and has an exhaust port 13 and is formed so as to be able to store body endocrine such as a patient in this bag 110
(2) A rigid container body 120 having a discharge port 15 / suction port 16 for storing a disposable bag or the like and for reducing the pressure inside, and its lid 122
(3) Aspirator main body 130 for generating a suction force by an electric motor
(4) Suction port for transferring suction force to the catheter 18 (5) Tube 19 for connecting the rigid container main body 120 and the suction main body 130 and a joint for mounting the same (not shown)

The basic system 100 stores the disposable bag 110 of (1) inside the rigid container body 120 of (2), and directly connects the exhaust port 13 of the bag and the suction port 16 on the side of the suction device 130 of (3). Instead of connecting the discharge port 15 of the rigid container and the suction port 16 on the suction device side, the pressure in the rigid container is reduced to reduce the pressure from the exhaust port 13 of the disposable bag etc. There is. The reason for this is that since the bag is expanded under reduced pressure, storage of body endocrine substances etc. is facilitated and at the same time it is simple at the time of removal of the suction bag, and body endocrine substances etc. in the bag are temporarily sintered. Even if it leaks from the body / CMC filter 12, it is a safety measure to store this in a rigid container and prevent it from being absorbed directly by the suction mechanism on the main body side.

By the way, since the disposable bag etc. 110 is 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 breathable / waterproof filter such as disposable bag is attached to the bag In this case, it is also possible to attach or externally attach the exhaust port from the outside of the bag. However, when it is intended to store a disposable bag or the like equipped with a ventilation / waterproof filter as efficiently as possible inside the rigid container body 120, it is usually more efficient to attach the ventilation / waterproof filter inside the bag. . Based on the above basic system, in the example of disposable bag and the like currently performed, a PE sintered body / CMC filter is formed in a molded article of plastic (PP) provided with a pair of suction port and exhaust port to close the exhaust port. The molded product is formed by a method of heat-sealing a plastic bag and a molded product by storing the molded product inside a flexible plastic bag. Such a built-in system is considered reasonable in terms of maximizing the storage capacity of disposable bags etc. and suppressing the cost of forming bags.

The mechanism for suctioning secretions from the patient's body into the disposable bag etc. is as follows. First, the aspirator main body 130 sucks the air in the rigid container from the discharge port 15 of the rigid container main body 120 at a pressure of usually 20 to 35 kPa, and the pressure in the rigid container is reduced. As a result, the disposable bag etc. 110 stored in the rigid container expand due to the pressure difference, and at the same time, the air in the disposable bag etc. is discharged from the exhaust port 13 of the disposable bag etc. 110 through the ventilation filter attached to the same bag. As a result, suction force is generated in the bag 110, whereby the body's endocrinecrine substance and the like of the patient are sucked into the disposable bag and the like 110 through the suction catheter 18.

In “Background technology” of Patent Document 1 (Japanese Patent Publication No. 2015-521069, “waste liquid container device and suction bag unit”), “a suction port (a liquid discharge container device is connected to a suction source and the suction bag is exhausted) ) May be placed in the lid, may be directly connected to the suction bag, and may be placed in a rigid drainage container so that the drainage container is first evacuated and then It is described for the first time that the suction bag located therein is evacuated. And, it is supposed that the deformation of these shapes belongs to the most known.

JP-A-2015-521069 Patent No. 4638347 Patent No. 3204695 Patent No. 2922692 gazette U.S. Pat. No. 4,111,204 JP-A-9-56810

Vacuum suction waste bag member "High-performance filter and vent", Essentra Porous Technologies, 2014 "3786-012 Filter Valve", Vacsax Limited Material Specification, January 2012 Carboxymethylcellulose sodium "serogen" general catalog, Daiichi Kogyo Seiyaku Co., Ltd.

The disposable bag etc. 110 stores the sucked body endocrine etc. in the bag and discards it together with the bag when it reaches a predetermined amount, and the body endocrines sucked and stored in the bag is the filter part It is necessary to prevent leakage from the exhaust port 13 through 12 and contaminating the inside of the rigid container body 120 and also to adversely affect the suction mechanism of the aspirator body 130. Furthermore, when ventilating the discharge port, or even if a body endocrine substance or the like leaks the filter portion, the filter portion must have bacterial barrier property. It goes without saying that it is important whether or not the bacteria contained therein are removed when exhausting through the body exhalation filter or leakage of body endocrine substances and the like. In disposable bags and the like in medical aspirator systems, the most important thing is obviously the air permeability of the filter (molded body) built in or attached to the suction port or exhaust port rather than the shape problem and attachment method of this port. And it is necessary to simultaneously satisfy the difficult functions of waterproofness and bacterial barrier property.

It is obviously difficult to manufacture a filter made of a single material that is required to simultaneously satisfy this inconvenient breathability, waterproofness and bacterial barrier property, and this is why in medical aspirators, Research and development of filters of one type of material have not been performed until now. The current filter is based on the idea that two kinds of materials, ie, a molded article of a polymer and another polymer swelling material, are combined to have an air-permeable function and a waterproof function, respectively. Specifically, the present air-permeable / water-proof filter is made by immersing a porous PE sintered body, which is formed into a desired shape by heat-sealing PE having a small particle size, into a water-soluble CMC solution and Dry to manufacture. The air permeability is derived from the porous nature of the PE sintered body, and the standard opening range is approximately 30 to 50 μm. In order to secure the largest possible surface area and at the same time reduce the risk of breakage etc., this PE sintered body is usually in the shape of a cylinder without one bottom and about 3.7 to 3.9 mm. It is formed thick. On the other hand, the waterproof function is that CMC, which exists in the state of coating individual particle surface of PE sintered body, expands rapidly when it comes in contact with liquid body endocrine etc., and blocks the pores of PE sintered body. It is expressed. For this reason, some companies that manufacture and sell ventilated and waterproof filters in Europe and the United States refer to CMC used for filters as a self-sealing material. In addition, the bacteria / aerosol removal rate in this filter is described as 99.9 to 99.98% in the pamphlet, despite the large pore diameter of the PE sintered body.

However, the first problem with conventional filters is that PE sinter and CMC filters, which are currently used as standard aeration and waterproof filters for medical aspirators in Japan and the world, are fundamentally waterproof for a long time To have a This is due to the ease of water solubility of the CMC responsible for the waterproof function. The second problem is the pore size and bacterial barrier property of the PE sintered body. As mentioned above, this is a concern because the pore diameter of the PE sintered body is larger than the size of the bacteria. The third problem is that the ventilation performance is insufficient.

First, the first problem, that is, the problem of the water solubility of CMC having a waterproof function, 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 is eluted. This phenomenon clearly shows that the mixture of CMC solution and body endocrine products is directly linked to the serious problem that it easily leaks out from the outlet of the disposable bag or the like. In the following, the waterproofing performance required for disposable bags etc. and the waterproofing function of the present PE sintered body / CMC filter are analyzed and compared in detail.

First, there are two sides to the waterproofness required for disposable bags and the like. The first aspect relates to waterproofing for a long time. Although disposable bags after used are stored after being incinerated, due to the waterproofness of the bags, body endocrine substances including bacteria and viruses leak out of the bags during the storage period, resulting in hygiene for the environment and humans etc. It must be absolutely prevented to cause problems. For example, the risk of the disposable disposable bag etc. getting wet due to rain is easily imagined. The second aspect relates to instantaneous waterproofness. The filter is submerged in body endocrine while being aspirated, and instantaneously mist or liquid body endocrine etc. leaks from the filter, passes through the exhaust port 13 and contaminates the suction mechanism in the rigid container and in the aspirator main body. Or to prevent adverse effects. As described above, the PE sintered body / CMC filter can cope with the second instantaneous waterproof function, which has serious problems in long-term waterproofness. Thus, the PE sintered body / CMC filter currently widely used in the world and in Japan lacks waterproofing for a long time.

As the second problem, consider the bacterial barrier property and the pore size of the PE sintered body. The exhaled breath is aspirated into the disposable bag through the inhalation port together with the endocrine secretion etc., while the endocrine secretion etc. is stored in the bag, the exhaled breath passes through the ventilation filter and the aspirator from the rigid container It flows to the body and is finally discharged to the outside. Therefore, the barrier property against bacteria of the ventilation / waterproof filter is the two cases of the barrier property against this body exhalation and the barrier property when body endocrine substances etc. leak out from the ventilation / waterproof filter together with the CMC solution as mentioned above. Exists. It is general to judge the barrier property of the filter to the first exhalation breath using the bacteria aerosol removal rate (JIS L1912) as an index. On the other hand, no established indicator is found in the barrier properties to bacteria when liquid leaks from the filter. However, in any case, it is clear that the size of the bacteria and the size of the pore size of the PE sintered body are crucial. Generally, the size of the bacteria is 0.8 (S. aureus) to 10 μm, whereas the pore diameter in the state where the CMC is coated is unknown, but the pores of the PE sintered body are approximately 30 to 50 μm It is. Therefore, PE sintered body filters are considered to exhibit high barrier property in the bacteria aerosol removal rate test unless their pores have pores of 10 μm or less, but the barrier property in liquid material is essentially to bacteria. It is considered that it does not have a barrier function. And, with PE sintered body / CMC filter, it is not possible to make the pore to 30 to 50 μm or less, due to the limitations of sintering technology and the necessity of securing air permeability of a certain amount (20 L) or more (35 kPa · 16 cm ² ) It is possible. Therefore, it is considered that the present PE sintered body / CMC filter basically has great concern for the bacterial barrier property. In the future, we plan to quickly investigate the bacterial barrier properties of PE sintered bodies and CMC filters.

As the third problem, the ventilation performance of the present PE sintered body / CMC filter will be described. In the current medical suction device, it is generally required that the ventilation filter in the disposable bag or the like have a ventilation flow rate of 20 L / min or more under a suction force (differential pressure) of about 35 kPa. The ventilation flow per unit suction force (1 kPa) and unit area (1 cm ² ) of Non-Patent Document 1 which is a standard PE sintered body and waterproof filter at present is 0.0391 L, and Non-Patent Document 2 has 0.0514 L It has become. For this reason, in order to obtain a predetermined ventilation amount in Non Patent Literatures 1 and 2, filter areas of 14.61 cm ² (3.9 × 3.9 cm) and 11.12 cm ² (3.4 × 3.4 cm), respectively. Is required. On the other hand, the surface area of non-patent documents 1 and 2 which makes a cylindrical product with a standard product is about 16 cm ² . Therefore, with the current PE sintered body / CMC filter, it is difficult to reduce the filter surface area below the current state. In the current medical suction device, in order to reduce the filter area with a given amount of air flow of 20 L / min with a suction force of 35 kPa / min, the air flow rate per unit suction power / unit area is large. Must. The above calculation is premised on that the aeration flow rate is linearly proportional to the unit differential pressure and the unit area. Miniaturization of the filter reduces production costs and increases the design freedom of disposable bags and the like.

The object of the present invention is considered to be relatively safe, with ventilation performance comparable to current products, while solving the problem of long-term waterproofness which is a fundamental defect of current PE sintered body and CMC filters. It is an object of the present invention to provide a molded article filter formed of a porous PTFE film having a bacterial barrier property, and a disposable bag or the like in which the molded article filter is incorporated.

As a result of various trial and error and grooving experiments for the development of a new aeration and waterproof filter, it is thought that this can be realized by a PTFE film molded body filter using a porous polytetrafluoroethylene (PTFE) film The That is, the problem of instantaneous waterproofness and long-term waterproofing can be solved by the hydrophobic performance of the highest PTFE film in plastic materials, and the air permeability contrary to the waterproofness is that the maximum pore diameter of the film is a certain value or more Since air permeability equal to or higher than that of PE sintered body and CMC filter may be obtained, and the size of bacteria is approximately in the range of 0.8 to 10 μm, if the pore diameter can be controlled to 1 μm or less at maximum, In theory, most bacteria should be removable.

In the PTFE film, base molecular weight (for example, standard specific gravity is 2.16 or more or less), presence or absence of copolymerization component, base material shape (round bar, rolling, sheet), stretching method (uniaxial, biaxial) There are various factors that define the physical properties in terms of the stretching ratio, the layer configuration (single layer, multilayer), and other aspects such as the manufacturing method and the configuration. Basically, the air permeability of the PTFE film depends on the draw ratio, and in general, uniaxial stretching forms a fillet (fiber) extending in parallel with the node, and biaxial stretching reduces the node and fillet together. At the same time, it is thought that ventilation and waterproofness are both improved by randomizing the direction of filling. It has been found that proper selection in consideration of the production method and structure thereof is crucial in the selection of the PTFE film. Table 1 summarizes the relationship between single layer / lamination, uniaxial / biaxial, and ventilation / waterproof function.

  Table 1 Types of PTFE film and ventilation and waterproof function

In order to use the PTFE film in a breathable / waterproof filter which is actually incorporated in a disposable bag of a medical aspirator, etc., PTFE integrally achieves the individual requirements of air permeability, waterproofness and maximum pore diameter (bacterial / barrier property) Experiments were conducted to determine if the film was present, and if so, how to balance these at high levels.

As a result of conducting experiments of air permeability assuming a practical medical disposable bag etc. for the PTFE film confirmed to be capable of stable production, there are also large differences in numerical values depending on the stretching method and configuration Although there are some types of appropriately selected types with the maximum pore diameter in the range of 1 to 5 μm, the same area (16 cm ² ) as the current PE sintered body / CMC filter, 35 kPa suction usually required by a medical suction device It was found that an air flow of 24 to 48 L / min can be secured under pressure (differential pressure). From the viewpoint of bacterial barrier, it is desirable that the film pore diameter is up to 0.8 μm, but with a pore diameter of 1 μm, under the suction force (differential pressure) of 35 kPa, 24 L / min with the same area (16 cm ² ) It was actually confirmed that both ventilation and bacterial / barrier measures were compatible.

As waterproofness was found to be based on exactly the same principle as the pressure resistance test of the medical suction device in the past research, the water pressure resistance test of JIS L1912 proved to be of a type in which both aeration, bacteria and barrier properties were confirmed. The PTFE films of the invention were screened based on their water pressure resistance data, and water leakage experiments were carried out using PTFE films having a maximum pore diameter in the range of 0.2 to 5.0 μm. The result was extremely good that no water leak occurred under the suction force (differential pressure) of 35 kPa required for the medical suction device. With a film with a maximum pore diameter of 0.2 μm (thickness 80 μm), there was no water leakage at a suction force (differential pressure) of 65 kPa, but with a film with a pore diameter of 1 μm (thickness 100 μm), a suction force (differential pressure) of 75 kPa Leakage occurred in the Further, with a film having a pore diameter of 5 μm (thickness 100 μm), water leaked after about 1 minute elapsed under a suction force (differential pressure) of about 70 kPa. However, since the differential pressure condition which is the premise of the waterproofness is 35 kPa, and 70 kPa corresponds to a safety factor of 2.0 times, it can be judged that this result also has sufficient waterproofness. Based on these comprehensive results, the maximum pore diameter of the appropriately selected PTFE film is in the range of 1 to 5.0 μm, simultaneously satisfying at a high level the breathability and waterproofness required for disposable bags etc. and the bacterial barrier properties. It has been proved that things are actually obtained. It should be noted that, unlike the CMC film, if there is no problem in instantaneous waterproofing, the PTFE film is waterproofed for a long time without causing any water leakage.

Since it was found that a PTFE film satisfying air permeability, waterproofness, bacteria resistance and barrier properties exists, the same experiment was conducted on a PTFE non-woven fabric (200 μm in thickness) laminated with a PET non-woven fabric as a support. As a result, air permeability is 21.7 L / min under the same area (16 cm ² ), suction force (differential pressure) of 35 kPa, waterproofness is 35 kPa and there is no water leakage, 48.3 kPa will cause water leakage, and even PTFE nonwoven fabric type suction It has been confirmed that there are usable vents and waterproof filters for However, in the case of non-woven fabrics, it is not possible to measure the size of the void, and it is not possible to estimate the bacterial barrier properties of this type.

By appropriately selecting the PTFE film and the PTFE non-woven fabric in this manner, it is basically possible to form a filter having breathability / water resistance and a bacteria / barrier which can be used in a medical aspirator. I found it. Table 2 summarizes the results of the aeration and waterproofing experiments of the PTFE film, the PTFE non-woven fabric, and the PE sintered body / CMC filter.

  Table 2 Experimental results of air permeability and waterproofness of PTFE film

However, in order to form a molded article filter using a PTFE film, the following processing problems are assumed and it was necessary to find a solution. One of the causes of these problems is that the PTFE film is intended to be used alone without laminating a support such as PP or PET non-woven fabric on the PTFE film in order to suppress the production cost of the PTFE filter.
(1) The bonding method of the bonding portion of the three-dimensionally shaped component 200 and the PTFE film 25 serving as an exhaust flow path in the bag shown in FIG. 2A and the airtightness problem (2) For example, when the pressure is reduced to 35 kPa, the PTFE film 25 swells largely inside the three-dimensional shaped part 200. However, the problem of film breakage or airtightness damage at this time

An adhesive can not be used for laminating the PTFE film and the three-dimensional shaped part 200, and both are joined by a method of heat-sealing them, and the airtightness of the heat-sealing part is sufficiently maintained under a reduced pressure of 35 kPa. I was able to confirm it. As another method, the bonding part area of 4 sides can be taken large, and it can also bond with an adhesive. In addition, since the PTFE film is thin, in an actual heat fusion method, a method of directly laminating the PTFE film on a three-dimensional shaped part and heating the hot plate from the upper side of the PTFE film is preferable.

In order to prevent the PTFE film from being greatly expanded inside the three-dimensional shaped part, it is necessary to install support parts consisting of ribs at intervals of about 10 mm in the upper and lower sides of the three-dimensional shaped part opening. In FIG. 2A, grid-like ribs that are orthogonal to each other are displayed, but the shape of the ribs is not limited to this. What is important is that the PTFE film and the rib portion are not heat-sealed in order not to reduce the air permeability. As a result, it was actually confirmed that both the prevention of the deterioration of the air permeability and the prevention of the swelling of the PTFE film can be achieved even when the inside of the disposable bag etc. is depressurized to, for example, 35 kPa.

Through the above progress, we have established a molded filter formed of a very excellent PTFE film to replace the existing PE sintered body / CMC filter.

The following can be mentioned as an effect in the case of using the molded article filter formed from the PTFE film according to the present invention as a breathable / waterproof / bacterial / barrier filter incorporated in a disposable bag or the like.
(1) The aeration / waterproof / bacterial / barrier filter of the present invention is completely waterproof, and is a fundamental defect of the present PE sintered body / CMC filter, which occurs when discarding and storing disposable bags etc. May be prevented from leaking out of the bag, such as mixtures of CMC solution and body endocrine substances.
(2) The aeration / waterproof filter of the present invention, which has a pore diameter of at most 1 μm, can theoretically suppress leakage of most bacteria to the outside of the bag for both internal exhalation and systemic endocrine substances and the like.
(3) The air permeability of the new aeration / waterproof filter of the present invention using a base material having an opening diameter of 5 μm is 0.086 L / 1 kPa · 1 cm ² · 1 min. The air permeability is 0.0514 L / 1 kPa · 1 cm ² · 1 / 1.67 times. This means that the surface area of the aeration and waterproofing filter of the present invention can be reduced to 60% (9.6 cm ² ). That is, the size of the aeration / waterproof filter of the present invention can be reduced as compared with the existing PE sintered body / CMC filter, and therefore, the design of the disposable bag etc. and attachment of the suction port and exhaust port thereto is free. Degree will increase.

FIG. 1 is a schematic block diagram of the basic system of the present medical aspirator. FIG. 2A is a perspective view of a three-dimensional shaped component used in the disposable bag and the like according to the present invention (before bonding of the filter substrate). FIG. 2B is a perspective view of a molded article filter (three-dimensionally shaped component after filter substrate bonding) used for a disposable bag and the like according to the present invention. FIG. 3A is a perspective view of the ventilation component used for the disposable bag etc. based on this invention. FIG. 3B is a perspective view of the ventilation part after attaching a three-dimensional part for use in the disposable bag etc. according to the present invention. FIG. 4A is a perspective view of a flexible bag used for a disposable bag etc. according to the present invention. FIG. 4B is a perspective view of a disposable bag and the like after all of the ventilated part, the three-dimensionally shaped part, and the flexible bag according to the present invention are joined. FIG. 5A is a cross-sectional view showing a disposable bag etc. according to the present invention housed in a rigid container. FIG. 5B is a perspective view showing a rigid container containing the disposable bag and the like according to the present invention in a state in which the lid is opened.

The disposable bag etc. which make the molded part which has the ventilation and waterproof function formed using a PTFE film etc. into the integral product part can manufacture the type with various shape, a function, and a size. Hereinafter, representative embodiments of the present invention will be described.

FIG. 2A shows a three-dimensionally shaped component 200 that heat-seals the PTFE film 25 to the opening 21 later. This shape uses polypropylene (PP) as a raw material and is manufactured by injection molding using a mold. This three-dimensional shaped part has an opening 21 which is a region for heat-sealing a PTFE film or the like, a lattice rib 22 for supporting the PTFE film at the opening, and an internal cavity 23 which is a flow passage of passing air. It has a fitting shape 24 for attachment to the molding shown in FIG. 3A. Note that one side, both sides, four sides, or four sides and a bottom face of a substantially rectangular molded component may be used as the opening. In addition, the shape of the said three-dimensional shaped component can be various things, such as cylindrical shape and disk shape besides a rectangular parallelepiped. The open areas in this example are shown in Table 3.

  Opening area

FIG. 2B shows the molded part 210 in a state in which the PTFE film 25 is heat-sealed to the three-dimensional part. Hereinafter, this molded part 210 is referred to as a "molded 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. In addition, when using a PTFE nonwoven fabric as a support body, the thickness containing PET nonwoven fabric was 300 micrometers or less (pore diameter can not be prescribed).

FIG. 3A shows the appearance of a molded manufactured vent component 300 inscribed in a film bag. The aeration component 300 has a suction port 31 for joining the suction catheter 18 and its cap 32, a mounting shape 33 to a rigid container, and a fitting portion 34 with a fitting shape 24 of the PTFE film heat sealing solid shape component 200, And an exhaust port 35, and a joint portion 36 by heat fusion or the like with a film bag for storing body endocrine products and the like. In addition, a vulcanized rubber is separately used for the outlet 37 of the suction port on the film bag side in order to prevent backflow of body endocrine products etc. stored in the film bag or their mist-like substances back into the suction pipe. Mounting the check valve 38 manufactured.

FIG. 3B shows a composite molded body 310 in which the PTFE filter of FIG. 2B which is heat-sealed is fitted and integrated with the vented part of FIG. 3A in an airtight state. In addition, it is of course possible to perform the integration to maintain the air tightness not by the fitting but by heat fusion of both.

FIG. 4A shows an example of a film bag for storing body endocrine substances and the like. Although the shape of the film bag can be varied, 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 further an adhesive resin. In the embodiment of the present invention, the film bag is composed of three layers, and the thickness is 30 μm for the outer layer (PET), 7 μm for the adhesive resin layer, and 120 μm for the inner layer (LLDPE). Moreover, the internal volume of a present Example is 1300 cc.

FIG. 4B shows a form in which the composite molded body 310 of FIG. 3B is inscribed and airtightly heat-sealed inside the upper end of the film bag of FIG. 4A. In this manner, a final product for a medical suction device configured from the above-described film bag 400 and the integrated composite molded body 310 using the three-dimensional shaped component 210 having the function of ventilation and waterproofing formed using the PTFE film Disposable bag 410 is completed. Although the present embodiment shows an example in which the composite molded body 310 is inscribed in the bag, it may be jointed and joined to the outside of the film bag. Further, the mounting position of the composite molded body 310 to the film bag does not have to be at the upper end of the film bag 400, and may be at four sides of the bag or at a middle position of the side corner portions.

FIGS. 5A and 5B show the finally completed disposable bag attached to the rigid container 500. FIG. FIG. 5B shows an example in which the composite molded body 310 is not a vertical type PTFE film three-dimensional shaped part as shown in FIG. 3B but a horizontal type.

In the above embodiment, a three-dimensional shaped part in which the PTFE film is heat-sealed, that is, a molded, is used in order to use a detour exhaust system in which the rigid container is depressurized by the aspirator body and the interior of disposable bag etc. Although the configuration in which the body filter is incorporated in the disposable bag or the like has been described, the disposable bag or the like may be directly suctioned by the suction device main body to be decompressed. In this case, outside the exhaust port 35 of the ventilating fixture 300, air-tightly install and suction a molded filter formed so that air in the disposable bag or container and exhaled breath of the subject always pass through, and suction The suction tube directly connected to the vessel body may be connected to the outlet side of the filter. Alternatively, the molded product 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 venting part 300 and the inlet of the molded product filter are connected by a suction tube and suctioned from the suction port 16 It is good also as composition. Alternatively, the molded body filter may be provided somewhere on the suction tube.

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

100 Medical aspirator basic system 11 suction port 12 filter 13 exhaust port 16 exhaust port 18 suction port 19 suction catheter 19 catheter 110 disposable bag etc 120, 500 rigid container 122 rigid container lid 130 aspirator main body 200 three-dimensional parts 21 Opening 22 Rib 23 Internal cavity 24 Mating shape 25 PTFE film 210 Molded body filter (three-dimensional shape part joined PTFE film)
300 Ventilation parts 31 Suction port 32 Cap 33 Mounting shape for rigid container 34 Fitting part 35 Exhaust port 36 Joint part 37 Suction port outlet 38 Anti-return valve 310 Integrated molded composite,
400 film bag 410 final disposable bag

Claims (29)

The medical suction system includes a suction port for connecting a catheter for introducing body exhalation and body endocrine substances from a patient or a user, and the above-mentioned body breath and body endocrine substances aspirated from the suction port. It is stored and stored in the space formed by the rigid container main body and its lid which are other components of the medical suction system, storing the body endocrine thing, excluding the suction port and its periphery. A flexible disposable bag or container configured to be removed from the rigid container and discarded when the body endocrine product reaches a predetermined storage volume,
The disposable bag or container is formed of a venting part having an exhaust port configured to pass through whenever air and breath inside the disposable bag or container are discharged out of the disposable bag or container. Have a body
The disposable bag or container is further provided with a molded filter that is joined or connected to the venting part in a gas-tight manner, prevents passage of the body endocrine and allows all of the air and body exhalation to pass.
A disposable bag or container characterized in that the substrate of the molded filter is a porous polytetrafluoroethylene (PTFE) film or a PTFE non-woven fabric. The venting part further comprises an attachment configuration for securing to the suction port and the rigid container and / or the lid portion,
The vent is in gaseous communication with the interior of the rigid container, and when the aspirator body is connected to the rigid container and the rigid container is evacuated, the disposable bag or container is also depressurized through the vent, resulting in the suction A disposable bag or container is used until the body filter is immersed or submerged in the body endocrine in the disposable bag or container while aspirating the body exhalation and body endocrine through the port, until the ventilation function is significantly impaired. The disposable bag or container according to claim 1, wherein the air inhaled into the body and the exhaled breath are configured to be exhausted into the rigid container through the exhaust port. The exhaust port of the venting component is directly connected to the aspirator body via the aspiration tube, whereby the disposable bag or container is depressurized, so that the body exhalation and body endocrine substances are aspirated from the aspiration port. On the other hand, the endocrine system is stored in the disposable bag or container, and the remaining air or exhaled breath is exhausted out of the rigid container through the exhaust port.
In the space formed by the rigid container main body and the lid portion, the molded body filter is in contact with the ventilating part, in contact with the rigid container or the lid portion, or from the exhaust port. The disposable bag or container according to claim 1, mounted in the middle of the suction tube up to the container or the lid. The molded body filter is
A body of a three-dimensionally shaped part attachable to cover the exhaust port and hollow inside;
A support portion for joining the filter base material provided on the three-dimensional shaped part;
A mesh-like rib provided on the support portion for preventing the film-like filter substrate from expanding to the inside;
The disposable bag or container according to claim 2 or 3, further comprising: the filter substrate airtightly bonded to the support. The disposable bag or the like according to any one of claims 1 to 4, wherein the venting part is made of a thermoplastic material containing polypropylene (PP) or polyethylene (PE). The disposable bag or container according to claim 4 or 5, wherein the shape of the three-dimensional shaped part is cylindrical or rectangular. The disposable bag or container according to any one of claims 1 to 6, wherein the support portion is a flat plate having a shape including a circle or a square, and the opening has a structure reinforced by mesh ribs. The disposable bag or container according to any one of claims 1 to 7, wherein the porous PTFE film is a monolayer or multilayer PTFE film produced by uniaxial stretching or biaxial stretching. 9. The disposable bag or container according to claim 8, wherein the porous PTFE film is a monolayer or multilayer PTFE film produced by biaxial stretching. The disposable bag or container according to any one of claims 1 to 9, wherein the maximum pore diameter of the porous PTFE film is in the range of 0.2 to 5 μm. The disposable bag or container according to claim 10, wherein the maximum pore diameter of the porous PTFE film is in the range of 1 to 5 μm. The disposable bag or container according to any one of claims 1 to 11, wherein the PTFE film or the PTFE non-woven fabric is reinforced by laminating a non-woven fabric of polyethylene terephthalate (PET) resin or PP resin on both sides or one side. . The disposable bag or container according to any one of claims 1 to 12, further comprising a molded filter having an air permeability of 20 L or more in an area of 16 cm ² under a differential pressure of 35 kPa. The medical suction system includes a suction port for connecting a catheter for introducing body exhalation and body endocrine substances from a patient or a user, and the above-mentioned body breath and body endocrine substances aspirated from the suction port. It is stored and stored in the space formed by the rigid container main body and its lid which are other components of the medical suction system, storing the body endocrine thing, excluding the suction port and its periphery. It is configured to be removed from the rigid container and discarded when the body endocrine product reaches a predetermined storage amount, and has an exhaust port configured to always pass air and the internal exhalation when discharged to the outside. A shaped filter for use in a flexible disposable bag or container further comprising a shaped part of a venting part, comprising:
The molded body filter is joined or connected to the molded body of the venting part in an airtight manner to prevent passage of the body endocrine and is configured to pass all the air and the body exhalation.
A molded article filter for use in the disposable bag or container, wherein the substrate of the molded article filter is a porous polytetrafluoroethylene (PTFE) film or a PTFE non-woven fabric. The molded body filter is
A body of a three-dimensionally shaped part attachable to cover the exhaust port and hollow inside;
A support portion for joining the filter base material provided on the three-dimensional shaped part;
A mesh-like rib provided on the support portion for preventing the film-like filter substrate from expanding to the inside;
The filter according to claim 14, wherein the filter base is airtightly bonded to the support portion. The filter for use in a disposable bag or container according to claim 14 or 15, wherein the shape of the three-dimensional shaped part is cylindrical or rectangular. The filter according to any one of claims 14 to 16, wherein the support portion is a flat plate having a shape including a circle or a square, and the opening has a structure reinforced by mesh ribs. The filter according to any one of claims 15 to 17, wherein the porous PTFE film is a monolayer or multilayer PTFE film produced by uniaxial stretching or biaxial stretching. . The disposable filter according to claim 18, wherein the porous PTFE film is a monolayer or multilayer PTFE film produced by biaxial stretching. The molded article filter for use in the disposable bag or container according to any one of claims 14 to 19, wherein the maximum pore diameter of the porous PTFE film is in the range of 0.2 to 5 μm. The filter according to claim 20, wherein the maximum pore diameter of the porous PTFE film is in the range of 1 to 5 μm. 22. The disposable according to any one of claims 14 to 21, wherein the PTFE film or the PTFE non-woven fabric is reinforced by laminating a non-woven fabric of polyethylene terephthalate (PET) resin or polypropylene (PP) resin on both sides or one side. Mold filter for bags or containers. A molded article filter for use in a disposable bag or container according to any one of claims 14 to 22, having a permeability of 20 L or more in an area of 16 cm ² under a differential pressure of 35 kPa. A suction port for connecting a suction catheter for suctioning body exhalation and body endocrine substances from a patient or user;
A flexible disposable bag or container for storing the body endocrine substance of the body exhalation and body endocrine substances sucked from the suction port;
A rigid container body for storing the disposable bag or container and its lid;
The disposable bag or container comprising: the suction port; and an air outlet configured to pass through the air in the disposable bag or container and the body exhalation whenever the exhaled breath is discharged out of the disposable bag or container. Moldings of vented parts joined in an airtight manner,
Connected to the outlet of the rigid container in gas communication with the outlet to decompress the interior of the rigid container, thereby evacuating the interior of the disposable bag or container, or directly to the outlet via a suction tube An aspirator body connected to evacuate the interior of the disposable bag or container;
Preventing passage of the body endocrine substance, which is joined to the ventilating part in an airtight state or installed inside the rigid container body via the suction tube connected to the disposable bag or container And a molded body filter having an area of 16 cm ² and an air permeability of at least 20 L and a differential pressure of 35 kPa through which all the air and exhaled breath pass.
The disposable bag or container has a mounting shape and is fixed to the rigid container and / or the lid, and is removed from the rigid container and discarded when the body endocrine matter reaches a predetermined storage amount. Configured and
A medical suction device system characterized in that the substrate of the molded filter is a porous polytetrafluoroethylene (PTFE) film having a maximum pore diameter in the range of 0.2 to 5 μm, or a PTFE non-woven fabric. The medical suction system includes a suction port for connecting a catheter for introducing body exhalation and body endocrine substances from a patient, and the body endocrine substance of the body breath and body endocrine substances aspirated from the suction port The body endocrine that is stored and stored in the space formed by the rigid container body and its lid which are other components of the medical aspirator system, except for the aspiration port and its periphery. A method of manufacturing a flexible disposable bag or container configured to be removed from the rigid container and discarded when a predetermined storage amount is reached,
The suction port portion, an exhaust port for storing the body endocrine product and the like and discharging the remaining exhaled gas directly into the depressurized rigid container or into the aspirator main body, the rigid container body and / or Producing a venting piece having a mounting configuration for securing to the lid by molding a plastic material comprising polypropylene (PP) or polyethylene (PE);
A three-dimensionally shaped component having a hollow inside and provided with a support for fixing a film-like filter substrate, and providing the support with a mesh-like rib for preventing the filter substrate from expanding inward. Manufacturing by molding;
A porous polytetrafluoroethylene (PTFE) film or a PTFE non-woven fabric as the filter substrate is joined to the support portion to maintain the airtightness of the three-dimensional shaped part by heat fusion or adhesion with a pressure-sensitive adhesive, and a molded filter Manufacturing the
Manufacturing the composite molded body by joining the molded body filter so as to cover the exhaust port of the ventilated part so as to maintain airtightness by a method including fitting, heat fusion, and adhesion;
Bonding and integrating the composite molded body to the opening of the flexible film bag for storing the body endocrine product and the like by heat fusion or adhesion so as to maintain airtightness. Method of manufacturing disposable bags or containers. 26. The method for manufacturing a disposable bag or container according to claim 25, wherein the step of integrating inscribes and joins the composite molded body to the inside of the opening of the film bag. 26. The method of manufacturing a disposable bag or container according to claim 25, wherein the step of integrating places the composite molded body in a state of being circumscribed outside the opening of the film bag. The medical suction system includes a suction port for connecting a catheter for introducing body exhalation and body endocrine substances from a patient, and the body endocrine substance of the body breath and body endocrine substances aspirated from the suction port The body endocrine that is stored and stored in the space formed by the rigid container body and its lid which are other components of the medical aspirator system, except for the aspiration port and its periphery. A venting component having an exhaust port configured to be removed from the rigid container and discarded when a predetermined amount of storage is reached, and to be passed whenever air and the body exhalation are discharged to the outside. A method for producing a molded article filter for use in a flexible disposable bag or container further comprising a molded article, comprising:
A three-dimensionally shaped component having a hollow inside and provided with a support for fixing a film-like filter substrate, and providing the support with a mesh-like rib for preventing the filter substrate from expanding inward. , Forming by molding,
As the filter base material, a porous polytetrafluoroethylene (PTFE) film or a PTFE non-woven fabric is joined to the support portion to maintain the airtightness of the three-dimensional shaped part by heat fusion or adhesion with a pressure-sensitive adhesive, and a molded filter Manufacturing a molded body filter for use in the disposable bag or container. The suction port portion, an exhaust port for storing the body endocrine product and the like and discharging the remaining exhaled gas directly into the depressurized rigid container or into the aspirator main body, the rigid container body and / or Making the venting piece having a mounting shape for securing to the lid by molding a plastic material comprising polypropylene (PP) or polyethylene (PE);
29. A disposable bag according to claim 28, further comprising: joining the molded body filter in a gas-tight manner by covering the exhaust port of the ventilating part by a method including fitting, heat fusion, adhesion. Or the manufacturing method of the molded object filter used for a container.

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