JP5059190B2 - Pressure equalizing device, receptacle, and method - Google Patents

Description

  The present invention relates to a pressure equalizing apparatus that includes a fluid container, that is, a liquid and / or gas container, and is attached to a receptacle such as a vial to enable pressure equalization between the fluid container and the receptacle. The present invention further relates to a receptacle provided with such a pressure equalizing device.

  In the preparation and administration of drugs, care has been taken to minimize or preferably eliminate the risk of exposure to toxic substances by people such as medical and pharmacological personnel. Drugs are often prepared using safety boxes, cabinets, or isolators to reduce the risk of toxic substances leaking into breathable air.

  However, such equipment requires a lot of space, is not portable, and is expensive to install, maintain, and repair.

  Some drugs require dissolution or dilution prior to administration, which involves transferring the solvent from one container to a sealed vial containing the drug in powder or liquid form, for example using a needle. It is included. If there is any pressure difference between the inside of the vial and the surrounding ambient air, the drug will be in a gaseous state or after aerosolization when the needle is withdrawn from the vial and while the needle is inside the vial. There is a risk of being released to the atmosphere with caution.

  This problem can be eliminated or at least minimized by using a pressure equalizing device that can be attached to the vial during drug preparation. The pressure equalizing device includes a gas container that communicates with the inside of the vial, and when injecting or sucking a gas or liquid to or from the vial, ensures that neither a pressure increase nor a vacuum can be generated inside the vial. . The gas container is filled with air that has been cleaned or sterilized prior to use to ensure that the contents of the vial are not contaminated by particles in the air such as dust, pollen, fungi, bacteria, and other undesirable materials.

  It is an object of the present invention to provide an improved pressure equalization apparatus comprising a fluid container, i.e. a liquid and / or gas container, which is attached to a receptacle such as a vial to allow pressure equalization between the fluid container and the receptacle. That is.

  This object is achieved by a pressure equalizing device having the features of claim 1, which provides a fluid container and fluid communication inside or outside the fluid container when the pressure equalizing device is attached to the receptacle. The flow path is arranged as described above. The pressure equalization device is further a fluid inlet that allows fluid to flow into the fluid container through the fluid inlet and prevents fluid from flowing out of the fluid container through the fluid inlet. A fluid inlet including a directional valve is provided. The pressure equalizing apparatus further includes filter storage means arranged so as to be able to filter the fluid flowing into or outside the fluid container when including the filter.

  The pressure equalization device allows the filtered fluid to flow into or out of the receptacle (depending on whether it is temporarily a fluid container or a receptacle that has a high pressure) in the fluid container and the receptacle. Equalize the pressure. The pressure equalization device thereby allows for safe and reliable injection or aspiration of substances inside or outside the receptacle, such as toxic drugs, while at least minimizing the risk of substances contaminating breathable air. Provide a simple closure system that eliminates.

  According to one embodiment of the invention, the filter storage means comprises a removable or non-removable filter. As an example, a filter having a mesh size of 0.2 μm can be used to remove substantially all particles and microorganisms larger than that size. The filter removes particles in gases such as dust, pollen, fungi, or bacteria, thereby eliminating or at least reducing the risk of particles in these gases contaminating the material inside the vial (HEPA). It may be a sterilization or sterilization filter of a particulate air filter such as a filter. It should be noted that the pressure equalizing device may comprise multiple filters of the same type or different types.

According to one embodiment of the present invention, the filter storage means is located upstream or downstream of the one-way valve in the fluid inlet, and when the filter storage means includes a filter, when the fluid flows into the fluid container, Can be filtered. According to another embodiment of the present invention, the filter storage means is located in the flow path, and when the filter storage means includes a filter, the fluid can be filtered when the fluid flows from the fluid container into the receptacle. .
According to another embodiment of the invention, the fluid container is an air container.
According to another embodiment of the invention, the fluid inlet is arranged to communicate with outside air, i.e. non-sterilized air. Since the outside air can be cleaned in the device using a sterilization or sterilization filter in the pressure equalization device, both the sterile environment and the extra equipment must be cleaned to fill the fluid container with the cleaned air. There is no need for a clean air supply. Thus, the pressure equalizing device according to the invention can be filled or replenished with cleaned fluid almost everywhere with a simple method and low cost.

According to another embodiment of the present invention, the fluid container includes a flexible part, such as an air bag, i.e. a part containing a flexible or inflatable material, the volume of that part into the fluid container. It can be increased by drawing the fluid and decreased by sucking the fluid from the fluid container. However, the fluid container may be composed at least in part of a rigid incompressible material.
According to one embodiment of the present invention, the one-way valve is formed integrally with the filter storage means or the filter.

  According to another embodiment of the present invention, the filter storage means is removable from the fluid container.

  According to another embodiment of the present invention, the pressure equalizing device comprises a bayonet coupling for attaching the pressure equalizing device to an injector such as a syringe, a connecting means such as a luer lock or a snap fit mechanism, and / or a receptacle. And connecting means such as a snap-fit mechanism for mounting the pressure equalizing device.

  According to one embodiment of the invention, at least a part of the fluid container is formed integrally with the connecting means, for example from the same material, which can be polyethylene or polypropylene, acrylonitrile butadiene styrene (ABS), polycarbonate, polyester, Or it may be a thermoplastic material such as any other suitable material.

According to another embodiment of the invention, the fluid container is removable from the connecting means.
The invention further relates to a receptacle comprising a pressure equalizing device according to any of the embodiments of the invention.
According to one embodiment of the invention, at least a portion of the pressure equalizing device is integrally formed with at least one component of the receptacle, such as a cap or sealing means.

  The pressure equalizing device according to the present invention is particularly used as a pressure equalizing device during the preparation or administration of drugs, but is not limited thereto.

FIG. 3 shows a pressure equalizing device according to an embodiment of the present invention before being attached to a vial. FIG. 3 shows a pressure equalizing device according to one embodiment of the present invention after attachment to a vial. It is a figure which shows a part of fluid container by 1st embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 2nd embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 2nd embodiment of this invention. It is a figure which shows a part of fluid container by 3rd embodiment of this invention. It is a figure which shows a part of fluid container by 3rd embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 4th embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 4th embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 4th embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 5th embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 5th embodiment of this invention. It is a figure which shows a part of pressure equalization apparatus by 5th embodiment of this invention.

The invention will now be further described by way of non-limiting examples with reference to the following accompanying drawings.
It should be noted that the drawings are not drawn to scale, and the dimensions of certain features are exaggerated for clarity.

  FIG. 1 shows a pressure equalizing device 10 according to one embodiment of the present invention before being attached to a vial 12 containing a solid, liquid, or gaseous pharmaceutical, biological, or veterinary material. The vial 12 is sealed with a cap 14 and / or an elastic stopper or membrane. The pressure equalizing apparatus 10 includes a gas container 16 having a variable volume. The gas container 16 includes a first portion 16a that includes a relatively rigid material such as a plastic parabola coupled to the body of the pressure equalizing device 10, and a thin portion that is airtightly attached to the first portion 16a. And a second portion 16b including a relatively flexible material such as a transparent plastic film.

  For example, the gas container 16 can be designed as a bellows that can be compressed and expanded. Thereby, the volume of the gas container 16 can be increased or decreased. Although the apparatus shown in FIG. 1 includes a partially compressible gas container 16, in another embodiment of the invention, the gas container 16 includes a cylinder and its volume so that the volume of the gas container can be changed. And a piston disposed therein.

  Alternatively, the gas container 16 can be configured by a bellows that can be manually expanded and contracted. The gas container 16 shown in FIG. 1 is shown in a fully expanded state. The thick dotted line in FIG. 2 indicates the position of the flexible portion 16b when the gas container 16 is completely deflated after being discharged.

The gas container 16 may have a volume of 1 cm ³ or less, up to 1 liter or more depending on the use or size of the receptacle, and includes at least one gas inlet 20 including a one-way valve and filter housing means. The pressure equalizing apparatus 10 includes, for example, a connecting means 22 such as a snap-fit mechanism for attaching the pressure equalizing apparatus 10 to the neck of a vial 12 having a diameter of 1 to 4 cm and a volume of 50 cm ^{3. In} this case, the volume of the gas container is Can be 50 cm ³ in fully expanded state.

  The pressure equalizing device 10 can of course be dimensioned for attachment to receptacles of any size and volume. The pressure equalizing device 10 further includes a flow path 18 that is arranged to provide gas communication between the gas container 16 and the interior of the vial 12 when the pressure equalizing device 10 is connected to the vial 12. FIG. 1 further illustrates a syringe 26 that may be used to inject fluid into the vial 12 or to aspirate fluid from the vial 12.

  FIG. 2 shows the pressure equalizing device shown in FIG. 1 after being attached to the vial 12 in a removable or non-removable state and the needle 26a of the syringe 26 being inserted into the vial 12 via the pressure equalizing device 10. 10 is shown. When fluid is injected into or aspirated from the vial 12, gas is transferred from the inside of the vial 12 to the gas container 16 or from the gas container 16 to the vial 12 by the pressure equalizing device flow path 18. This allows the fluid to flow, thereby equalizing the pressure within the vial 12 and the gas container 16, however, no gas can exit the gas container 16.

  As a result, during insertion or withdrawal of the needle 26a from the vial 12, or while the needle 26a is being inserted into the vial 12, any substance inside the vial 12 is in a gaseous state or is subjected to aerosolization to the outside air. The risk of being released is eliminated or at least reduced. Also, the increase in pressure inside the vial 12 causes the vial 12 to deform, which also eliminates the risk of leakage of the vial contents due to, for example, the removal of the vial cap 14 from the vial wall. Reduced.

  FIG. 3 shows an uncompressed portion 16a of the gas container 16 shown in FIGS. The gas container portion 16 a allows a gas to flow into the gas container 16 through the gas inlet 20 and prevents the gas from flowing out of the gas container 16 through the gas inlet 20. A gas inlet 20 including 28 is provided. The gas inlet 20 further includes filter storage means 30 located upstream of the one-way valve 28. The gas inlet 20 is disposed so as to communicate with the outside air.

  When a filter is disposed in the filter storage means 30, the outside air is filtered when flowing into the gas container 16. The filter may be any suitable commercially available filter, such as a particulate air filter with a pore size of 0.2 μm. In the illustrated embodiment, the one-way valve 28 is formed integrally with the filter storage means 30. This integrated unit may or may not be detachable from the gas container 16. The gas container 16 further includes a flow path 18 that provides a gas communication path inside and outside the gas container 16.

  The embodiment illustrated in FIG. 3 includes a unitary one-way valve 28 and filter housing means 30 slidably mounted on a plastic parabola 16a of a gas container. The one-way valve 28 includes an elastic sheath 28a that covers the opening 28b and is disposed so as to expose the opening 28b in the open position. When the pressure outside the gas container 16 exceeds the pressure inside the gas container 16, the unit of the integrated one-way valve 28 and the filter storage means 30 is pushed inward in the radial direction in the direction toward the inside of the gas container 16 and is elastic. The sheath 28a contracts against the stopper 28c, exposes the opening 28b, and allows filtered air to enter the gas container 16.

  On the contrary, when the pressure inside the gas container 16 exceeds the pressure outside the gas container 16, the unit of the integrated one-way valve 28 and the filter storage means 30 is pushed radially outward in the direction toward the outside of the gas container 16. Thus, the elastic sheath 28 a extends to cover the opening 28 b and prevents further gas from entering the gas container 16 through the air inlet 20. The one-way valve 28 has a filter housing means 30 in order to maintain the pressure inside the vial 12 in balance with the pressure outside the vial 12 when the pressure inside the gas container 16 falls below a predetermined pressure such as atmospheric pressure. It arrange | positions so that external air may be drawn in into the gas container 16 from the opening part 28b. Alternatively, the one-way valve 28 can be arranged to be manually opened and closed.

  4 and 5 show a part of the pressure equalizing apparatus 10 according to the second embodiment of the present invention. The pressure equalizing device includes a connecting means 22 for attaching to a receptacle, a connecting means 23 for attaching to an injector such as a syringe, that is, a bayonet coupling part, a plastic parabola 16a, and a flexible part attached to the plastic parabola 16a. And a gas container 16 (not shown). The filter may be placed in the filter housing means 30 for filtering gas entering the gas container 16 via the air inlet 20 (hidden behind the filter housing means 30 in FIGS. 4 and 5).

  The filter storage means 30 is formed integrally with the plastic parabola 16a of the gas container 16 by, for example, blow molding or vacuum forming process, or is formed of the plastic parabola 16a by, for example, continuous welding process such as ultrasonic welding. Mounted on the inner surface. The ultrasonic waves are used to generate internal friction in the plastic and filter storage means 30 of the parabola 16a, thereby heating the parabola 16a and the filter storage means 30. The heated surfaces are then joined by applying pressure. The filter is permanently attached to the filter storage means 30 using ultrasonic welding.

  The filter and filter storage means 30 should be arranged such that the flexible portion is inflated substantially uniformly, and a state in which no excessively extending portion is generated during the expansion is ensured. For example, the filter is not arranged perpendicular to the direction of the incoming air, but is arranged at an angle with respect to the direction of the incoming air, as shown in FIGS. The second filter housing means may be arranged in the flow path so that the fluid passing between the vial 12 and the gas container 16 can be filtered.

  FIG. 6 shows a partial exploded view of a pressure equalizing device 10 according to a third embodiment of the present invention. The gas container 16 includes a parabola 16a and a flexible part 16b including a thin transparent film. The gas container 16 includes an air inlet 20 and a one-way valve 28 is located in the air inlet 20. FIG. 7 shows the pressure equalizing device 10 of FIG. 6 in use. The gas flows into the gas container 16 in the direction of the arrow in FIG. 7, that is, through the opening in the portion 24 of the gas container 16, through the filter 34 through the radial passage, and into the air inlet 20, The gas flows through the one-way valve 28 and flows into the gas container.

  In the illustrated embodiment, the portion 24 including the opening may be removably disposed from the gas container 16 or may be fixedly attached, for example, by gluing or welding. FIG. 7 illustrates that the filter housing means 30 may be located at the mouth of the flow path 18 and / or any other location along the flow path 18 that provides gas communication to the interior or exterior of the gas container. .

  8 to 10 show a part of a pressure equalizing apparatus 10 according to a fourth embodiment of the present invention. The pressure equalizing apparatus 10 includes a gas container including a parabola 16a and means 22 for connecting the pressure equalizing apparatus 10 to a receptor. The gas container 16 may be removable from the connection means 22. The gas container 16 is attached to the connecting means 22 using, for example, a bayonet coupling or any other releasable coupling means. The filter storage means 30 is disposed between the gas container 16 and the connection means 22.

  11 to 13 show a part of a pressure equalizing apparatus 10 according to a fifth embodiment of the present invention. The pressure equalizing apparatus 10 includes a parabola 16a and connection means 23 for attaching the pressure equalizing apparatus 10 to an injector such as a syringe. The parabola 16a is formed integrally with the connecting means 22 and 23 in the illustrated embodiment. The pressure equalizing apparatus 10 includes an insertion portion 36 including a filter storage means 30 and a one-way valve 28. The insert 36 is removably or non-removably attached to the interior of the parabola 16a to facilitate positioning of the one-way valve 28 within the flow path 18 and / or the air inlet 20. Guide means may be provided.

  Other variations of the invention that fall within the scope of the claims will be apparent to those skilled in the art. For example, the gas container may be of any shape and size and may be placed in any suitable position relative to the receptacle when the pressure equalizing device is attached to the receptacle.

Claims (15)

A pressure equalizing device (10) comprising a fluid container (16) and attached to a receptacle (12) such as a vial to allow pressure equalization between the fluid container (16) and the receptacle (12),
A flow path (18) arranged to provide fluid communication to the interior or exterior of the fluid container (16) when the pressure equalization device (10) is attached to the receptacle (12);
A fluid inlet (20) that allows fluid to flow into the fluid container (16) through the fluid inlet (20) and fluid through the fluid inlet (20); (16) a fluid inlet (20) including a one-way valve (28) to prevent flow to the outside;
And a filter storage means (30) arranged so as to be able to filter the fluid flowing into or out of the fluid container (16) when the filter (34) is included. ).   The pressure equalizing device (10) according to claim 1, characterized in that the filter housing means (30) comprises a removable or non-removable filter (34).   The pressure equalizing device (10) according to claim 2, wherein the filter (34) is a sterilization or sterilization filter such as a particulate air filter such as a high performance particulate air (HEPA) filter.   The filter storage means (30) is located upstream or downstream of the one-way valve (28) in the fluid inlet (20), and when the filter storage means (30) includes a filter (34), A pressure equalizing device (10) according to any preceding claim, characterized in that the fluid can be filtered when it flows into the fluid container (16).   The filter storage means (30) is located in the flow path (18), and when the filter storage means (30) includes a filter (34), fluid flows from the fluid container (16) to the receptacle (12). The pressure equalizing device (10) according to any one of claims 1 to 3, characterized in that the fluid can be filtered when it flows into the water.   A pressure equalizing device (10) according to any preceding claim, characterized in that the fluid container (16) is an air container.   A pressure equalizing device (10) according to any preceding claim, characterized in that the fluid inlet (20) is arranged to communicate with outside air.   A pressure equalizing device (10) according to any preceding claim, characterized in that the fluid container (16) comprises a flexible part (16b).   A pressure equalizing device (10) according to any preceding claim, characterized in that the one-way valve (28) is formed integrally with the filter housing means (30) or the filter (34).   A pressure equalizing device (10) according to any preceding claim, characterized in that the filter housing means (30) is removable from the fluid container (16).   Connection means (22) for attaching the pressure equalizing device (10) to the receptacle (12) and / or connecting means (23) for attaching the pressure equalizing device (10) to an injector such as a syringe. A pressure equalizing device (10) according to any preceding claim, characterized in that At least a portion of the fluid container (16a), characterized in that said connection means Ru is integrally formed with the (22, 23), pressure equalizing device according to claim 11 (10).   12. The pressure equalizing device (10) according to claim 11, characterized in that the fluid container (16) is removable from the connecting means (22, 23).   A receptacle comprising the pressure equalizing device (10) according to any one of claims 1 to 13.   15. A receptacle according to claim 14, characterized in that at least a part of the pressure equalizing device (10) is integrally formed with at least one component of the receptacle (12).