EP4691446A1 - Bag assembly for administering an active compound to a patient and set of bag assemblies - Google Patents
Bag assembly for administering an active compound to a patient and set of bag assembliesInfo
- Publication number
- EP4691446A1 EP4691446A1 EP24193523.8A EP24193523A EP4691446A1 EP 4691446 A1 EP4691446 A1 EP 4691446A1 EP 24193523 A EP24193523 A EP 24193523A EP 4691446 A1 EP4691446 A1 EP 4691446A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- chamber
- bag assembly
- application line
- bag
- active compound
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/05—Containers specially adapted for medical or pharmaceutical purposes for collecting, storing or administering blood, plasma or medical fluids ; Infusion or perfusion containers
- A61J1/10—Bag-type containers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
- A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
- A61J1/14—Details; Accessories therefor
- A61J1/1462—Containers with provisions for hanging, e.g. integral adaptations of the container
Definitions
- the invention is directed to a bag assembly for administering an active compound to a patient.
- the bag assembly comprises a chamber for the active compound. In an application orientation the chamber has an upper end and a lower end.
- a hanging interface configured for hanging the bag assembly on a stand is located adjacent to the upper end and an opening of the chamber is located at the lower end.
- the invention is further directed to a set of such bag assemblies.
- Such bag assemblies may be used for various types of treatments for the patient. Typical treatments include but are not limited to using such bag assemblies for administering one or more of an oncological active compound, a glucose solution, an antibiotic solution or a sodium chloride solution to the patient. When doing so, the bag assembly usually is hung on a stand using the hanging interface of the bag assembly. Consequently, the bag assembly may be held at a well-defined position at a vertical level above the point at which the active compound reaches the patient. Thus, administering the active compound to the patient may be driven or at least supported by gravity.
- the problem to be solved by the present invention is to further improve such bag assemblies. Especially, the handling of such bag assemblies shall be enhanced.
- the problem is solved by a bag assembly for administering an active compound to a patient.
- the bag assembly comprises a chamber for the active compound.
- the chamber In an application orientation the chamber has an upper end and a lower end.
- a hanging interface configured for hanging the NB:TOP bag assembly on a stand is located adjacent to the upper end and an opening of the chamber is located at the lower end. The opening is configured for withdrawing active compound from the chamber.
- at least a lower portion of the chamber arranged adj acent to the lower end is narrowing towards the lower end.
- an application line is connected to the opening and a distance between a free end of the application line and the hanging interface is 40 cm to 70 cm if the application line is extended in parallel to a direction extending from the upper end to the lower end.
- the opening is fluidically connected to the chamber.
- any interruption of a delimitation of the chamber e.g. a welding surrounding the chamber, which is configured for withdrawing active compound qualifies as an opening.
- the welding may connect two plastic films forming the chamber. Consequently, the opening may be used as an outlet opening, i.e. active compound may be transferred from the chamber into the application line via the opening.
- the connection between the application line and the opening or chamber may be permanent.
- the application line is welded or bonded to the chamber.
- the application line may be directly connected to the chamber. This means that the application line may be connected to the chamber without intermediate parts. It is also possible to connect the application line to the chamber via an intermediate part.
- the application line may have the form of a hose or tubing.
- the application line is mechanically flexible. This facilitates connecting the free end of the application line.
- the free end of the application line is connectable to another application line in a so-called piggyback setup.
- a piggyback setup typically comprises a primary bag connected to a primary application line, wherein the primary application line comprises a patient-sided port to be connected to a patient and a lateral port.
- the lateral port may be formed as a Y-port or a manifold.
- the primary bag and/or the primary application line may be filled with an infusion solution.
- the infusion solution may be light and non-toxic.
- the active compound may be mixed with the infusion solution in the primary application line.
- the downstream portion of the primary application line i.e. the portion of the primary application line after the side-port or manifold, may be cleaned of the active compound previously administered from the container connected to the lateral port by flushing the primary application line with the solution contained in the primary container.
- a suitable connector may be provided at the free end of the application line and the Y-port or manifold of the primary application line may comprise a counterpart-connector. Due to the fact that the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm, handling of the bag assembly is simple.
- the distance of 40 cm to 70 cm corresponds to a usual distance between a stand-sided hanging interface and the Y-port or manifold of the primary application line.
- This allows flexibility in the height placement of the bag in regard to the counterpart-connector of the primary application line while avoiding a unconveniently long tubing.
- the bag assembly may be hung on the stand-sided hanging interface for administering the active compound to the patient.
- the stand-sided hanging interface usually is provided at head-level of a standing person. Consequently, the stand-sided hanging interface is easily reachable by a person handling the bag assembly.
- the fact that the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm has the effect, that a position of the stand-sided hanging interface and/or a position of the Y-port or manifold of the primary application line does not at all need to be altered or does only need to be altered slightly when changing the bag assembly.
- the exact distance between the free end of the application line and the hanging interface may be chosen as a function of the specific application of the bag assembly.
- the distance between the free end of the application line and the hanging interface may be 50 cm to 60 cm.
- the distance between the free end of the application line and the hanging interface may amount to 51 cm, 52 cm, 53 cm, 54 cm or 55 cm.
- the hanging interface of the bag assembly is formed by an edge or surface of the bag assembly which is configured for contacting the stand-sided hanging interface.
- the bag assembly according to the present invention, at least a lower portion of the chamber arranged adjacent to the lower end is narrowing towards the lower end.
- This narrowing geometry has the effect that completely or almost completely emptying the chamber is facilitated.
- the bag assembly is less likely to locally form corners, folds and/or depressions withholding the active compound, i.e. blocking the active compound from leaving the chamber towards the patient.
- the chamber may be completely or almost completely emptied with the aid of gravity only. This leads to an efficient use of the active compound since less volume of the active compound is wasted, i.e. not administered to the patient.
- the narrowing geometry of the chamber may be seen best when looking at the chamber along a direction perpendicular to a height direction of the bag assembly being defined by a direction extending from the upper end to the lower end. This may be done if the bag assembly is hanging on a stand and/or if the bag assembly is lying on a substantially horizontal surface.
- the bag assembly according to the present invention may be configured for an intravenous, parenteral, or intrathecal application of the active compound, e.g., by providing an adequate connector at the free end of the application line, for instance one of the connectors described in ISO 80369 series of standards, such as a Luer or an NRFit connector.
- At least the lower portion of the chamber is tapering towards the lower end.
- at least the lower portion of the chamber is narrowing towards the lower end, wherein the narrowing portion has the form of a taper. This comes back to the lower portion of the chamber narrowing in a continuous and uniform manner.
- emptying of the chamber is facilitated to a particularly large extent. Consequently the handling of the bag assembly is particularly facilitated since particularly little attention may be paid to a potentially remaining volume of active compound in the chamber.
- a tapering angle may be 140 degrees or less. This means that faces or edges of the lower portion of the chamber tapering towards the lower end enclose an angle of 140° or less. It has been found that an angle of 140° or less has the effect that the chamber may be emptied with high reliability.
- tapering angle examples include 120°, 125°, 130° and 135°.
- the chamber is tapering towards the lower end.
- the entire chamber is tapering.
- the chamber has a substantially triangular or trapezoidal form if emptied and put into a flat state. In its application orientation the chamber forms a taper over its entire height if filled. It is particularly easy to empty such a chamber completely or nearly completely.
- this configuration is advantageous when producing bag assemblies from plastic films.
- chambers having a substantially triangular or trapezoidal form if emptied and put into a flat state reduce the amount of material that needs to be cut off. This is due to the fact that such shapes may be arranged on a plastic film in a staggered or regularly offset and/or alternatingly inverted manner. Consequently, less material needs to be wasted.
- an upper portion of the chamber arranged adjacent to the upper end has a substantially constant width.
- this portion is substantially cylindrical, wherein a cylinder or a cylindrical form is to be understood as a general cylinder or a form of a general cylinder.
- cylinders having a substantially elliptical base surface are included.
- the cylindrical form of the upper portion relates to a fully or partially filled state of the chamber.
- having an upper portion of the chamber having a substantially constant width or being substantially cylindrical allows for a large volume of the chamber while still allowing for compact dimensions of the bag assembly.
- an upper portion of the chamber arranged adjacent to the upper end may be narrowing towards the upper end.
- both the upper portion and the lower portion of the chamber are narrowing.
- the chamber has a substantially rhombic shape if flattened. This shape may also be called a diamond shape or a lozenge shape.
- a narrowing upper portion is advantageous when producing bag assemblies from plastic films.
- having both an upper portion of the chamber and a lower portion of the chamber narrowing reduces the amount of material that needs to be cut off. This is due to the fact that rhombic shapes may be arranged on a plastic film in a staggered or regularly offset manner. Consequently, less material needs to be wasted.
- the rhombic shape may prevent trapping solution, active compound or air in "pockets" in the upper section of the bag when it collapses. This further improves the withdrawal or drainage of solution or active compound.
- the opening of the chamber is provided by an interruption of a contour seal of a bottom portion of the chamber.
- the application line may be welded to the chamber in that an outer surface of the application line is welded to an inner surface of the films or foils forming the bag.
- the application line is directly welded to the films or foils, i.e. without intermediate parts. This configuration is structurally simple and operationally reliable.
- a bottom portion of the chamber is delimited by a bottom part, wherein the opening of the chamber is provided on the bottom part and wherein a stiffness of the bottom part is higher than a stiffness of a material delimiting the remaining portions of the chamber.
- the bottom portion may be a portion of the lower portion, especially the lowest portion of the lower portion.
- the bottom part may be shaped like a taper or funnel.
- the bottom part may be a part separate from the remaining parts delimiting the chamber, e.g. an injection molded component. In this case, the bottom part is joined to the remaining parts delimiting the chamber during production of the bag assembly.
- a comparatively high stiffness of the bottom part may be achieved by choosing different materials for the bottom part and for the remaining parts delimiting the chamber.
- the bottom part and the remaining parts delimiting the chamber may be formed integrally.
- the comparatively high stiffness of the bottom part may be achieved by a geometric property of the bottom part such as a comparatively large wall thickness. The increased stiffness of the bottom part further facilitates handling of the bag assembly.
- the bottom part comprises the opening which is configured for withdrawing active compound
- the bottom part may as well be called a port or base port.
- the bag assembly may comprise a valve for selectively filling a product into the chamber and/or for selectively withdrawing a product from the chamber, wherein the valve is arranged in the lower portion and/or on the bottom part.
- the valve may be separate from the opening and the application line. This means that the valve is not directly connected to the opening or the application line but rather is located as a distance from the opening or the application line.
- the valve is a so-called normally-closed valve. Consequently, in the absence of an activation of the valve, the valve separates an interior of the chamber from a surrounding of the bag assembly. Only when actuated, the valve fluidically connects the interior of the chamber with an exterior of the bag assembly.
- the valve may be used for selectively withdrawing active compound from the chamber. Since the valve is arranged in the lower portion and/or on the bottom part, the valve is easily accessible. If the valve is arranged on the bottom part, the comparatively high stiffness of the bottom part facilitates a precise operation of the valve.
- the valve is a diaphragm valve.
- a valve is structurally simple and reliable in operation.
- the valve may be a so-called Luer-activated valve or may be configured to be compatible with a mating Luer connector, e.g. Luer slip or Luer lock as described in ISO 80369-7 standard.
- the valve is compliant or compatible with other connection types such as those described in the ISO 80369 series of standards, e.g. ISO 80369-6, and ISO 18250 series of standards.
- the bag assembly further comprises a ventilation port for allowing a gas to enter the chamber.
- the ventilation port is arranged in the lower portion and/or on the bottom part. Allowing gas to enter the chamber via such a ventilation port may support the administration of active compound.
- the gas may be air, preferably purified, e.g. filtered, air. This is especially the case for bag assemblies being comparatively rigid and, thus, having at least a certain mechanical resistance with respect to a collapse of the bag assembly.
- Arranging the ventilation port in the lower portion and/or on the bottom part allows for a reliable operation of the ventilation port since a risk that the ventilation port is blocked or inhibited, e.g. by a portion of the chamber collapsing, is comparatively low at these places.
- the chamber may be delimited by a transparent material and/or by a UV protection layer.
- Transparent material has the advantage that a filling level of active compound is visible to the human eye. Moreover, transparent material facilitates inspection of the active compound, e.g. in quality control. In this case, impurities of the active components may be spotted.
- the UV protection layer may protect the active compound from UV radiation and, thus, from degradation due to exposure to UV radiation. In doing so, a high quality of the active compound may be ensured over a comparatively long time.
- the application line has a length of 50 cm or less, preferably of 35 cm or less. It is understood that the length of the application line needs to be compatible with the distance between the free end of the application line and the hanging interface. In this context, the chamber always needs to have a certain extension bigger than zero. It has been found that an application line having a length of 50 cm or less, preferably of 35 cm or less, is highly convenient when attaching or detaching the free end to or from a lateral port of a primary application line, e.g. a Y-port or manifold. In a preferred example, the length of the application line is 32 cm.
- the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm if the application line is extended in parallel to a direction extending from the upper end to the lower end.
- the application line and the chamber are formed integrally.
- the application line and the bottom part may be formed as one single part.
- the application line may be directly connected to the chamber.
- the connection may be realized by welding or bonding the application line and the chamber.
- forming the application line and the chamber integrally results in a permanent connection of the application line and the chamber. This facilitates the production of the chamber and the application line which is essentially due to the fact that no assembly of the chamber and the application line is necessary after the connection step. This is also advantageous if both the chamber and the application line need to be kept sterile.
- the chamber may have a volume of 20 ml to 1000 ml. Preferably, the volume is 20ml to 500ml. More preferably, the volume is 20ml to 250 ml. It is noted that even though the volume of the chamber may differ, the distance between the free end of the application line and the hanging interface may stay the same. Consequently, the effects and advantages which have been explained in connection with the distance between the free end of the application line and the hanging interface apply independent from the volume of the chamber. Put otherwise, these effects and advantages may be achieved for any volume between 20 ml and 1000 ml.
- Example volumes of the chamber include but are not limited to 50 ml, 100 ml, 250 ml, 500 ml, 700 ml, and 1000 ml. These volumes correspond to standard volumes used in different kinds of known treatments. Consequently, the bag assembly according to the present invention is well-suitable for being used in these known treatments. As has been explained before, the bag assembly according to the present invention may be handled with particular ease.
- the chamber and/or the application line may be at least partially filled with at least one of an active compound, especially an oncological active compound and/or an antibiotic solution and/or a glucose solution and/or a sodium chloride solution.
- the chamber and/or the application line may be completely filled or partially filled.
- the volume of the chamber i.e. its maximum volume capacity, is 700 ml and the volume of the active compound amounts to 50 ml, 100 ml, 250 ml or 500 ml.
- a set of bag assemblies comprising at least two bag assemblies according to the invention.
- a distance between the free end of the application line and the hanging interface is the same for all bag assemblies of the set.
- a volume of the chamber of the at least two bag assemblies of the set is different.
- the bag assemblies of the set have chambers with different volumes. Consequently, all bag assemblies of the set may be used for treating a patient, wherein a distance between a stand-sided hanging interface and the free end of the application line may be the same for all bag assemblies.
- Such a set of bag assemblies may also be called a family or portfolio of bag assemblies.
- a piggyback setup typically comprises a primary bag connected to a primary application line, wherein the primary application line comprises a patient-sided port to be connected to a patient and a lateral port.
- the lateral port may be formed as a Y-port or a manifold.
- the primary bag and/or the primary application line may be filled with an infusion solution.
- the infusion solution may be light and non-toxic.
- the downstream portion of the primary application line i.e. the portion of the primary application line after the side-port or manifold, may be cleaned of the active compound previously administered from the container connected to the lateral port by flushing the primary application line with the solution contained in the primary container.
- a suitable connector may be provided at the free end of the application line and the Y-port or manifold of the primary application line may comprise a counterpart-connector.
- Figure 1 shows a patient P during a treatment with an active compound 10.
- the patient P is lying on a bed 12.
- the active compound 10 is administered to the patient P using a bag assembly 14.
- the active compound 10 is not provided directly to the patient P but via a so-called piggyback setup.
- a patient-sided port 15 is provided at a free end of the primary administration line 13 and this patient-sided port 15 is connected to the patient.
- the primary administration line 13 additionally comprises a lateral port 17 located between the free end of the primary application line 13 and the primary bag 11.
- the active compound 10 provided in the bag assembly 14 is provided at the lateral port 17 as will be explained in more detail further below.
- FIG. 1 shows the bag assembly 14 in more detail.
- the bag assembly 14 is essentially formed from two plastic films which are locally joint to one another such that a chamber 18 for the active compound 10 is formed between the two plastic films.
- the plastic films from which the bag assembly 14 is made are transparent and comprise a UV protection layer. Consequently, the chamber 18 is delimited by a transparent material and by a UV protection layer.
- the chamber 18 is filled with the active compound 10 which may be any one of an oncological active compound, a glucose solution, an antibiotic solution and a sodium chloride solution.
- the active compound 10 may be any one of an oncological active compound, a glucose solution, an antibiotic solution and a sodium chloride solution.
- the chamber has a volume of 1000 ml.
- the chamber 18 has an upper end 18a and a lower end 18b.
- the bag assembly 14 comprises a hanging interface 20.
- the hanging interface 20 is formed by an upper edge of an opening 22 formed in the two plastic films from which the bag assembly 14 is made.
- the hanging interface 20 is configured for hanging the bag assembly 14 on the stand 16.
- the stand 16 comprises a stand-sided hanging interface 24 which in the example of Figure 1 is bar-shaped.
- the stand-sided hanging interface 24 may be hook-shaped or may have any shape that is suitable for hanging the bag assembly 14.
- the hanging interface 20 is located adjacent to the upper end 18a of the chamber 18.
- an opening 26 is provided.
- the opening 26 is fluidically connected to the chamber 18 such that the active compound 10 may leave the chamber 18 via the opening 26. Since the opening 26 is provided at the lower end 18b, the active compound 10 may leave the chamber 18 via the opening 26 simply due to gravity.
- the bag assembly 14 comprises an application line 28.
- One end of the application line 28 is connected to the opening 26.
- the application line 28 and the chamber 18 are formed integrally.
- connection port 30 is fluidically connected to the lateral port 17 of the primary administration line.
- connection port 30 comprises a connector interface and the lateral port 17 comprises a corresponding counter-connector interface that may be coupled to the connector interface.
- a bottom portion of the chamber 18 is delimited by a bottom part 32 which is integrally formed with the remaining parts of the bag assembly 14.
- a mechanical stiffness of the bottom part 32 is higher than a stiffness of the material delimiting the remaining portions of the chamber 18.
- the opening 26 is provided on the bottom part 32. Consequently, the application line 28 is connected to the bottom part 32.
- the application line 28 has a length LL of 32 cm.
- a distance LB between the free end of the application line 28 and the hanging interface 20 is 52 cm if the application line is extended in parallel to a direction extending from the upper end 18a to the lower end 18b.
- a tapering angle A is approximately 120° in the example shown in Figure 2 .
- an upper portion of the chamber 18 arranged adjacent to the upper end 18a has a substantially constant width. This means that the upper portion is substantially cylindrical or substantially ellipsoidal if in the completely filled state.
- the bag assembly 14 has the advantage that its handling is easy. This means that, due to the distance LB, the free end of the application line 28 is always available in a space where it can be easily connected to the lateral port 17.
- FIG 3 shows another example of the bag assembly 14 which may be used for administering the active compound 10 to the patient P in a situation as shown in Figure 1 .
- the bag assembly 14 which may be used for administering the active compound 10 to the patient P in a situation as shown in Figure 1 .
- the bottom part 32 has a different shape as compared to the example of Figure 2 . This is due to the fact that the bag assembly 14 according to Figure 3 comprises a valve 38 for selectively filling a product into the chamber 18 and for selectively withdrawing a product from the chamber 18.
- the valve 38 is arranged on the bottom part 32. It is noted that the valve 38 is separate from the opening 26 and the application line 28.
- valve 38 may even be located outside the bottom part 32, as a separate access.
- the valve 38 is a diaphragm valve which is compatible with a Luer lock connector or a Luer lock fitting. Consequently, a product, such as another active compound, may be filled into the chamber 18 via the valve 38 using a syringe with a Luer lock tip.
- the diaphragm valve can alternatively be compatible with other connectors or fittings such as NRFit or others.
- Figure 4 shows a further example of a bag assembly 14 which may as well be used for administering the active compound 10 to the patient P in a situation as shown in Figure 1 .
- a bag assembly 14 which may as well be used for administering the active compound 10 to the patient P in a situation as shown in Figure 1 .
- the tapering angle of the upper portion and the tapering angle A of the lower portion are equal. Consequently, when seen along a direction substantially perpendicular to a direction extending from the upper end 18a to the lower end 18b, the bag assembly 14 has a substantially rhombic shape when flattened.
- the tapering angle A is roughly the 85°.
- the bag assembly 14 according to Figure 4 comprises a valve 38 as has been explained in connection with the example of Figure 3 .
- the bag assembly 14 according to Figure 4 comprises a ventilation port 40 which is also provided on the bottom part 32.
- the ventilation port 40 allows a gas, in the present example ambient air, to enter the chamber 18. This facilitates the administering of the active compound 10 since a volume increment of air may enter the chamber 18 if a volume increment of active compound 10 is leaving the chamber 18 via the opening 26. Consequently, active compound 10 may be provided to the patient P without the need to deform the bag assembly 14.
- a gas in the present example ambient air
- the active compound 10 can substantially entirely be conducted through the application line 28 and be delivered to the patient P, while a minimum amount of solution, i.e. active compound 10, is trapped in the chamber 18 and/or in the application line 28 down to the lateral port 17, at least.
- the bag assemblies 14 as shown in Figures 2 to 4 may form part of a set of bag assemblies 14.
- the set is characterized in that bag assemblies 14 forming part of the set have chambers 18 of different volumes. However, at the same time the distance LB between the free end of the application line 28 and the hanging interface 20 is the same for all bag assemblies 14 of the set.
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- Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Hematology (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
A bag assembly (14) for administering an active compound (10) to a patient is shown. The bag assembly (14) comprises a chamber (18) for the active compound (10). In an application orientation, the chamber (18) has an upper end (18a) and a lower end (18b). A hanging interface (20) is located adjacent to the upper end (18a). The hanging interface (20) is configured for hanging the bag assembly (14) on a stand. Moreover, at least a lower portion of the chamber (18) arranged adjacent to the lower end (18b) is narrowing towards the lower end (18b) and an opening (26) of the chamber (18) is located at the lower end (18b). An application line (28) is connected to the opening (26) and a distance (LB) between a free end of the application line (28) and the hanging interface (20) is 40 cm to 70 cm if the application line (28) is extended in parallel to a direction extending from the upper end (18a) to the lower end (18b). Additionally, a set of such bag assemblies (14) is disclosed. A distance (LB) between a free end of the application line (28) and the hanging interface (20) is the same for all bag assemblies (14) of the set.
Description
- The invention is directed to a bag assembly for administering an active compound to a patient. The bag assembly comprises a chamber for the active compound. In an application orientation the chamber has an upper end and a lower end. A hanging interface configured for hanging the bag assembly on a stand is located adjacent to the upper end and an opening of the chamber is located at the lower end.
- The invention is further directed to a set of such bag assemblies.
- Such bag assemblies may be used for various types of treatments for the patient. Typical treatments include but are not limited to using such bag assemblies for administering one or more of an oncological active compound, a glucose solution, an antibiotic solution or a sodium chloride solution to the patient. When doing so, the bag assembly usually is hung on a stand using the hanging interface of the bag assembly. Consequently, the bag assembly may be held at a well-defined position at a vertical level above the point at which the active compound reaches the patient. Thus, administering the active compound to the patient may be driven or at least supported by gravity.
- The problem to be solved by the present invention is to further improve such bag assemblies. Especially, the handling of such bag assemblies shall be enhanced.
- The problem is solved by a bag assembly for administering an active compound to a patient. The bag assembly comprises a chamber for the active compound. In an application orientation the chamber has an upper end and a lower end. A hanging interface configured for hanging the NB:TOP bag assembly on a stand is located adjacent to the upper end and an opening of the chamber is located at the lower end. The opening is configured for withdrawing active compound from the chamber. Moreover, at least a lower portion of the chamber arranged adj acent to the lower end is narrowing towards the lower end. Additionally, an application line is connected to the opening and a distance between a free end of the application line and the hanging interface is 40 cm to 70 cm if the application line is extended in parallel to a direction extending from the upper end to the lower end. The opening is fluidically connected to the chamber. In this context, any interruption of a delimitation of the chamber, e.g. a welding surrounding the chamber, which is configured for withdrawing active compound qualifies as an opening. Here, the welding may connect two plastic films forming the chamber. Consequently, the opening may be used as an outlet opening, i.e. active compound may be transferred from the chamber into the application line via the opening. The connection between the application line and the opening or chamber may be permanent. In an example, the application line is welded or bonded to the chamber. Moreover, the application line may be directly connected to the chamber. This means that the application line may be connected to the chamber without intermediate parts. It is also possible to connect the application line to the chamber via an intermediate part. The application line may have the form of a hose or tubing. Thus, the application line is mechanically flexible. This facilitates connecting the free end of the application line. Preferably, the free end of the application line is connectable to another application line in a so-called piggyback setup. A piggyback setup typically comprises a primary bag connected to a primary application line, wherein the primary application line comprises a patient-sided port to be connected to a patient and a lateral port. The lateral port may be formed as a Y-port or a manifold. The primary bag and/or the primary application line may be filled with an infusion solution. The infusion solution may be light and non-toxic. Thus, by connecting the free end of the application line to another application line in a so-called piggyback setup, the active compound may be mixed with the infusion solution in the primary application line. Additionally or alternatively, the downstream portion of the primary application line, i.e. the portion of the primary application line after the side-port or manifold, may be cleaned of the active compound previously administered from the container connected to the lateral port by flushing the primary application line with the solution contained in the primary container. In order to do so, a suitable connector may be provided at the free end of the application line and the Y-port or manifold of the primary application line may comprise a counterpart-connector. Due to the fact that the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm, handling of the bag assembly is simple. This is due to the fact that the distance of 40 cm to 70 cm corresponds to a usual distance between a stand-sided hanging interface and the Y-port or manifold of the primary application line. This allows flexibility in the height placement of the bag in regard to the counterpart-connector of the primary application line while avoiding a unconveniently long tubing. In this context, the bag assembly may be hung on the stand-sided hanging interface for administering the active compound to the patient. The stand-sided hanging interface usually is provided at head-level of a standing person. Consequently, the stand-sided hanging interface is easily reachable by a person handling the bag assembly. Consequently, the fact that the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm has the effect, that a position of the stand-sided hanging interface and/or a position of the Y-port or manifold of the primary application line does not at all need to be altered or does only need to be altered slightly when changing the bag assembly.
- It is noted that the exact distance between the free end of the application line and the hanging interface may be chosen as a function of the specific application of the bag assembly. In an example, the distance between the free end of the application line and the hanging interface may be 50 cm to 60 cm. In particular, the distance between the free end of the application line and the hanging interface may amount to 51 cm, 52 cm, 53 cm, 54 cm or 55 cm.
- In the context of the present invention, the hanging interface of the bag assembly is formed by an edge or surface of the bag assembly which is configured for contacting the stand-sided hanging interface.
- Furthermore, in the bag assembly according to the present invention, at least a lower portion of the chamber arranged adjacent to the lower end is narrowing towards the lower end. This narrowing geometry has the effect that completely or almost completely emptying the chamber is facilitated. In more detail, due to the narrowing geometry, the bag assembly is less likely to locally form corners, folds and/or depressions withholding the active compound, i.e. blocking the active compound from leaving the chamber towards the patient. Thus, the chamber may be completely or almost completely emptied with the aid of gravity only. This leads to an efficient use of the active compound since less volume of the active compound is wasted, i.e. not administered to the patient. This can lead to undermedication, especially if a weight-adjusted dose of active compound is to be administered to a specific patient. Additionally, the fact that just a small volume of active compound or no active compound at all remains in the bag assembly after the treatment facilitates handling of the bag assembly. This is especially due to the fact that a person handling the bag assembly after the treatment needs to pay less attention or no attention at all to the potentially remaining volume of active compound.
- It is noted that the narrowing geometry of the chamber may be seen best when looking at the chamber along a direction perpendicular to a height direction of the bag assembly being defined by a direction extending from the upper end to the lower end. This may be done if the bag assembly is hanging on a stand and/or if the bag assembly is lying on a substantially horizontal surface.
- The bag assembly according to the present invention may be configured for an intravenous, parenteral, or intrathecal application of the active compound, e.g., by providing an adequate connector at the free end of the application line, for instance one of the connectors described in ISO 80369 series of standards, such as a Luer or an NRFit connector.
- According to an embodiment, at least the lower portion of the chamber is tapering towards the lower end. Thus, at least the lower portion of the chamber is narrowing towards the lower end, wherein the narrowing portion has the form of a taper. This comes back to the lower portion of the chamber narrowing in a continuous and uniform manner. Thus, emptying of the chamber is facilitated to a particularly large extent. Consequently the handling of the bag assembly is particularly facilitated since particularly little attention may be paid to a potentially remaining volume of active compound in the chamber.
- A tapering angle may be 140 degrees or less. This means that faces or edges of the lower portion of the chamber tapering towards the lower end enclose an angle of 140° or less. It has been found that an angle of 140° or less has the effect that the chamber may be emptied with high reliability.
- Further examples of the tapering angle include 120°, 125°, 130° and 135°. The above-mentioned effects apply mutatis mutandis.
- In an example, the chamber is tapering towards the lower end. In other words, the entire chamber is tapering. In this case, the chamber has a substantially triangular or trapezoidal form if emptied and put into a flat state. In its application orientation the chamber forms a taper over its entire height if filled. It is particularly easy to empty such a chamber completely or nearly completely. Thus, such a chamber leads to an efficient use of active compound and to particularly easy handling of the bag assembly. Moreover, this configuration is advantageous when producing bag assemblies from plastic films. In this context, chambers having a substantially triangular or trapezoidal form if emptied and put into a flat state, reduce the amount of material that needs to be cut off. This is due to the fact that such shapes may be arranged on a plastic film in a staggered or regularly offset and/or alternatingly inverted manner. Consequently, less material needs to be wasted.
- According to an alternative, an upper portion of the chamber arranged adjacent to the upper end has a substantially constant width. Thus, in a filled state this portion is substantially cylindrical, wherein a cylinder or a cylindrical form is to be understood as a general cylinder or a form of a general cylinder. This includes circular cylinders, but is not limited to circular cylinders. For example, also cylinders having a substantially elliptical base surface are included. It is noted that the cylindrical form of the upper portion relates to a fully or partially filled state of the chamber. In this context, having an upper portion of the chamber having a substantially constant width or being substantially cylindrical allows for a large volume of the chamber while still allowing for compact dimensions of the bag assembly.
- According to another alternative, an upper portion of the chamber arranged adjacent to the upper end may be narrowing towards the upper end. Thus, in this example, both the upper portion and the lower portion of the chamber are narrowing. In a preferred example, the chamber has a substantially rhombic shape if flattened. This shape may also be called a diamond shape or a lozenge shape. A narrowing upper portion is advantageous when producing bag assemblies from plastic films. In this context, having both an upper portion of the chamber and a lower portion of the chamber narrowing reduces the amount of material that needs to be cut off. This is due to the fact that rhombic shapes may be arranged on a plastic film in a staggered or regularly offset manner. Consequently, less material needs to be wasted. Moreover, the rhombic shape may prevent trapping solution, active compound or air in "pockets" in the upper section of the bag when it collapses. This further improves the withdrawal or drainage of solution or active compound.
- In an example, the opening of the chamber is provided by an interruption of a contour seal of a bottom portion of the chamber. In this case, the application line may be welded to the chamber in that an outer surface of the application line is welded to an inner surface of the films or foils forming the bag. Preferably, the application line is directly welded to the films or foils, i.e. without intermediate parts. This configuration is structurally simple and operationally reliable.
- In a further example, a bottom portion of the chamber is delimited by a bottom part, wherein the opening of the chamber is provided on the bottom part and wherein a stiffness of the bottom part is higher than a stiffness of a material delimiting the remaining portions of the chamber. In this context, the bottom portion may be a portion of the lower portion, especially the lowest portion of the lower portion. In a case in which the lower portion is tapering, the bottom part may be shaped like a taper or funnel. In this context, the bottom part may be a part separate from the remaining parts delimiting the chamber, e.g. an injection molded component. In this case, the bottom part is joined to the remaining parts delimiting the chamber during production of the bag assembly. In this example, a comparatively high stiffness of the bottom part may be achieved by choosing different materials for the bottom part and for the remaining parts delimiting the chamber. Alternatively, the bottom part and the remaining parts delimiting the chamber may be formed integrally. In both alternatives, the comparatively high stiffness of the bottom part may be achieved by a geometric property of the bottom part such as a comparatively large wall thickness. The increased stiffness of the bottom part further facilitates handling of the bag assembly.
- Since the bottom part comprises the opening which is configured for withdrawing active compound, the bottom part may as well be called a port or base port.
- The bag assembly may comprise a valve for selectively filling a product into the chamber and/or for selectively withdrawing a product from the chamber, wherein the valve is arranged in the lower portion and/or on the bottom part. The valve may be separate from the opening and the application line. This means that the valve is not directly connected to the opening or the application line but rather is located as a distance from the opening or the application line. Preferably, the valve is a so-called normally-closed valve. Consequently, in the absence of an activation of the valve, the valve separates an interior of the chamber from a surrounding of the bag assembly. Only when actuated, the valve fluidically connects the interior of the chamber with an exterior of the bag assembly. This may be used for adding a supplementary active compound to the active compound already present in the chamber. The supplementary active compound may be a medication. Alternatively, the valve may be used for selectively withdrawing active compound from the chamber. Since the valve is arranged in the lower portion and/or on the bottom part, the valve is easily accessible. If the valve is arranged on the bottom part, the comparatively high stiffness of the bottom part facilitates a precise operation of the valve.
- According to an example, the valve is a diaphragm valve. Such a valve is structurally simple and reliable in operation. The valve may be a so-called Luer-activated valve or may be configured to be compatible with a mating Luer connector, e.g. Luer slip or Luer lock as described in ISO 80369-7 standard. According to another example, the valve is compliant or compatible with other connection types such as those described in the ISO 80369 series of standards, e.g. ISO 80369-6, and ISO 18250 series of standards.
- In an embodiment, the bag assembly further comprises a ventilation port for allowing a gas to enter the chamber. The ventilation port is arranged in the lower portion and/or on the bottom part. Allowing gas to enter the chamber via such a ventilation port may support the administration of active compound. The gas may be air, preferably purified, e.g. filtered, air. This is especially the case for bag assemblies being comparatively rigid and, thus, having at least a certain mechanical resistance with respect to a collapse of the bag assembly. Arranging the ventilation port in the lower portion and/or on the bottom part allows for a reliable operation of the ventilation port since a risk that the ventilation port is blocked or inhibited, e.g. by a portion of the chamber collapsing, is comparatively low at these places.
- The chamber may be delimited by a transparent material and/or by a UV protection layer. Transparent material has the advantage that a filling level of active compound is visible to the human eye. Moreover, transparent material facilitates inspection of the active compound, e.g. in quality control. In this case, impurities of the active components may be spotted. The UV protection layer may protect the active compound from UV radiation and, thus, from degradation due to exposure to UV radiation. In doing so, a high quality of the active compound may be ensured over a comparatively long time.
- In an example, the application line has a length of 50 cm or less, preferably of 35 cm or less. It is understood that the length of the application line needs to be compatible with the distance between the free end of the application line and the hanging interface. In this context, the chamber always needs to have a certain extension bigger than zero. It has been found that an application line having a length of 50 cm or less, preferably of 35 cm or less, is highly convenient when attaching or detaching the free end to or from a lateral port of a primary application line, e.g. a Y-port or manifold. In a preferred example, the length of the application line is 32 cm.
- It is understood that according to the present invention, the distance between the free end of the application line and the hanging interface is 40 cm to 70 cm if the application line is extended in parallel to a direction extending from the upper end to the lower end.
- According to an embodiment, the application line and the chamber are formed integrally. In case there is a bottom part, the application line and the bottom part may be formed as one single part. In case there is no bottom part, the application line may be directly connected to the chamber. In both cases, the connection may be realized by welding or bonding the application line and the chamber. In summary, forming the application line and the chamber integrally results in a permanent connection of the application line and the chamber. This facilitates the production of the chamber and the application line which is essentially due to the fact that no assembly of the chamber and the application line is necessary after the connection step. This is also advantageous if both the chamber and the application line need to be kept sterile.
- The chamber may have a volume of 20 ml to 1000 ml. Preferably, the volume is 20ml to 500ml. More preferably, the volume is 20ml to 250 ml. It is noted that even though the volume of the chamber may differ, the distance between the free end of the application line and the hanging interface may stay the same. Consequently, the effects and advantages which have been explained in connection with the distance between the free end of the application line and the hanging interface apply independent from the volume of the chamber. Put otherwise, these effects and advantages may be achieved for any volume between 20 ml and 1000 ml. Example volumes of the chamber include but are not limited to 50 ml, 100 ml, 250 ml, 500 ml, 700 ml, and 1000 ml. These volumes correspond to standard volumes used in different kinds of known treatments. Consequently, the bag assembly according to the present invention is well-suitable for being used in these known treatments. As has been explained before, the bag assembly according to the present invention may be handled with particular ease.
- The chamber and/or the application line may be at least partially filled with at least one of an active compound, especially an oncological active compound and/or an antibiotic solution and/or a glucose solution and/or a sodium chloride solution. In this context, the chamber and/or the application line may be completely filled or partially filled. In an example, the volume of the chamber, i.e. its maximum volume capacity, is 700 ml and the volume of the active compound amounts to 50 ml, 100 ml, 250 ml or 500 ml. Providing the active component in the chamber and/or the application line makes the bag assembly ready for being used for treating a patient. This means that the preparation of the bag assembly for being used in this treatment is facilitated.
- The problem is additionally solved by a set of bag assemblies comprising at least two bag assemblies according to the invention. A distance between the free end of the application line and the hanging interface is the same for all bag assemblies of the set. Moreover, a volume of the chamber of the at least two bag assemblies of the set is different. In other words, for all bag assemblies of the set, the distance between the free end of the application line and the hanging interface is equal. At the same time, the bag assemblies of the set have chambers with different volumes. Consequently, all bag assemblies of the set may be used for treating a patient, wherein a distance between a stand-sided hanging interface and the free end of the application line may be the same for all bag assemblies. Such a set of bag assemblies may also be called a family or portfolio of bag assemblies. They do not necessarily need to be sold together. As has been mentioned above, the free ends of the application lines may be connectable to another application line in a so-called piggyback setup. A piggyback setup typically comprises a primary bag connected to a primary application line, wherein the primary application line comprises a patient-sided port to be connected to a patient and a lateral port. The lateral port may be formed as a Y-port or a manifold. The primary bag and/or the primary application line may be filled with an infusion solution. The infusion solution may be light and non-toxic. Thus, by connecting the free end of the application line to another application line in a so-called piggyback setup, the active compound may be mixed with the infusion solution in the primary application line. Additionally or alternatively, the downstream portion of the primary application line, i.e. the portion of the primary application line after the side-port or manifold, may be cleaned of the active compound previously administered from the container connected to the lateral port by flushing the primary application line with the solution contained in the primary container. In order to do so, a suitable connector may be provided at the free end of the application line and the Y-port or manifold of the primary application line may comprise a counterpart-connector. Thus, when using different bag assemblies of the set, no adjustment activities need to be performed in respect of the stand-sided hanging interface and/or the location of the lateral port of the primary application line.
- These and other aspects of the present invention will become apparent from and elucidated with reference to the examples described in the following with reference to the drawings.
- Figure 1
- shows a bag assembly according to the invention out of a set according to the invention while being used for administering an active compound to a patient,
- Figure 2
- shows the bag assembly of
Figure 1 in a separate representation, - Figure 3
- shows a bag assembly according to another embodiment of the present invention,
- Figure 4
- shows a bag assembly according to still another embodiment of the present invention, and
- Figure 5
- shows a set of bag assemblies according to the invention.
- The Figures are merely schematic representations and serve only to illustrate examples of the disclosure. Identical or equivalent elements are in principle provided with the same reference signs.
-
Figure 1 shows a patient P during a treatment with an active compound 10. - In the present example, the patient P is lying on a bed 12.
- The active compound 10 is administered to the patient P using a bag assembly 14.
- The bag assembly 14 is hung on a stand 16.
- However, the active compound 10 is not provided directly to the patient P but via a so-called piggyback setup. This means that an infusion solution is provided to the patient P using a primary bag 11 via a primary administration line 13. A patient-sided port 15 is provided at a free end of the primary administration line 13 and this patient-sided port 15 is connected to the patient.
- The primary administration line 13 additionally comprises a lateral port 17 located between the free end of the primary application line 13 and the primary bag 11.
- The active compound 10 provided in the bag assembly 14 is provided at the lateral port 17 as will be explained in more detail further below.
-
Figure 2 shows the bag assembly 14 in more detail. - The bag assembly 14 is essentially formed from two plastic films which are locally joint to one another such that a chamber 18 for the active compound 10 is formed between the two plastic films.
- The plastic films from which the bag assembly 14 is made are transparent and comprise a UV protection layer. Consequently, the chamber 18 is delimited by a transparent material and by a UV protection layer.
- In the present example, the chamber 18 is filled with the active compound 10 which may be any one of an oncological active compound, a glucose solution, an antibiotic solution and a sodium chloride solution.
- In the example, the chamber has a volume of 1000 ml.
- In an application orientation of the bag assembly 14 which corresponds to the orientation of the bag assembly 14 as shown in
Figures 1 and 2 , the chamber 18 has an upper end 18a and a lower end 18b. - Moreover, the bag assembly 14 comprises a hanging interface 20. In the present example, the hanging interface 20 is formed by an upper edge of an opening 22 formed in the two plastic films from which the bag assembly 14 is made.
- The hanging interface 20 is configured for hanging the bag assembly 14 on the stand 16. To this end, the stand 16 comprises a stand-sided hanging interface 24 which in the example of
Figure 1 is bar-shaped. In other examples, the stand-sided hanging interface 24 may be hook-shaped or may have any shape that is suitable for hanging the bag assembly 14. - The hanging interface 20 is located adjacent to the upper end 18a of the chamber 18.
- At the lower end 18b of the chamber 18, an opening 26 is provided. The opening 26 is fluidically connected to the chamber 18 such that the active compound 10 may leave the chamber 18 via the opening 26. Since the opening 26 is provided at the lower end 18b, the active compound 10 may leave the chamber 18 via the opening 26 simply due to gravity.
- Furthermore, the bag assembly 14 comprises an application line 28.
- One end of the application line 28 is connected to the opening 26. In the example of
Figure 2 , the application line 28 and the chamber 18 are formed integrally. - At its free end, i.e. at the end remote from the opening 26, the application line 28 comprises a connection port 30. The connection port 30 is fluidically connected to the lateral port 17 of the primary administration line. To this end, the connection port 30 comprises a connector interface and the lateral port 17 comprises a corresponding counter-connector interface that may be coupled to the connector interface.
- In the present example, a bottom portion of the chamber 18 is delimited by a bottom part 32 which is integrally formed with the remaining parts of the bag assembly 14.
- However, a mechanical stiffness of the bottom part 32 is higher than a stiffness of the material delimiting the remaining portions of the chamber 18.
- In the present example this is achieved because a wall-thickness of the bottom part 32 is increased with respect to the remaining portions delimiting the chamber 18.
- The opening 26 is provided on the bottom part 32. Consequently, the application line 28 is connected to the bottom part 32.
- In the example of
Figure 2 , the application line 28 has a length LL of 32 cm. - A distance LB between the free end of the application line 28 and the hanging interface 20 is 52 cm if the application line is extended in parallel to a direction extending from the upper end 18a to the lower end 18b.
- As far as the shape of the chamber 18 is concerned, a lower portion of the chamber 18 is tapering towards the lower end 18b. A tapering angle A is approximately 120° in the example shown in
Figure 2 . - In contrast thereto, an upper portion of the chamber 18 arranged adjacent to the upper end 18a has a substantially constant width. This means that the upper portion is substantially cylindrical or substantially ellipsoidal if in the completely filled state.
- The bag assembly 14 has the advantage that its handling is easy. This means that, due to the distance LB, the free end of the application line 28 is always available in a space where it can be easily connected to the lateral port 17.
- It is noted that this effect, of course is only available once the position and height of the stand-sided hanging interface 24 has been adjusted accordingly.
-
Figure 3 shows another example of the bag assembly 14 which may be used for administering the active compound 10 to the patient P in a situation as shown inFigure 1 . In the following, only the differences with respect to the example ofFigure 2 will be explained. Otherwise, reference is made to the above explanations. - The differences relate to the bottom part 32. In the example of
Figure 3 , the bottom part 32 has a different shape as compared to the example ofFigure 2 . This is due to the fact that the bag assembly 14 according toFigure 3 comprises a valve 38 for selectively filling a product into the chamber 18 and for selectively withdrawing a product from the chamber 18. - The valve 38 is arranged on the bottom part 32. It is noted that the valve 38 is separate from the opening 26 and the application line 28.
- According to a non-represented alternative, the valve 38 may even be located outside the bottom part 32, as a separate access.
- In the present example, the valve 38 is a diaphragm valve which is compatible with a Luer lock connector or a Luer lock fitting. Consequently, a product, such as another active compound, may be filled into the chamber 18 via the valve 38 using a syringe with a Luer lock tip. The diaphragm valve can alternatively be compatible with other connectors or fittings such as NRFit or others.
-
Figure 4 shows a further example of a bag assembly 14 which may as well be used for administering the active compound 10 to the patient P in a situation as shown inFigure 1 . As before, only the differences with respect to the previous examples will be explained. Otherwise, reference is made to the above explanations. - In contrast to the examples of
Figures 2 and3 , now also an upper portion of the chamber 18 arranged adjacent to the upper end 18a is narrowing towards the upper end 18a of the chamber 18. More precisely, the upper portion of the chamber 18 is tapering towards the upper end 18a. - The tapering angle of the upper portion and the tapering angle A of the lower portion are equal. Consequently, when seen along a direction substantially perpendicular to a direction extending from the upper end 18a to the lower end 18b, the bag assembly 14 has a substantially rhombic shape when flattened.
- In the example of
Figure 4 , the tapering angle A is roughly the 85°. - The bag assembly 14 according to
Figure 4 comprises a valve 38 as has been explained in connection with the example ofFigure 3 . - Additionally, the bag assembly 14 according to
Figure 4 comprises a ventilation port 40 which is also provided on the bottom part 32. - The ventilation port 40 allows a gas, in the present example ambient air, to enter the chamber 18. This facilitates the administering of the active compound 10 since a volume increment of air may enter the chamber 18 if a volume increment of active compound 10 is leaving the chamber 18 via the opening 26. Consequently, active compound 10 may be provided to the patient P without the need to deform the bag assembly 14.
- Furthermore, when a sufficient amount of air is present in the bag assembly, or let in the bag assembly 14, the active compound 10 can substantially entirely be conducted through the application line 28 and be delivered to the patient P, while a minimum amount of solution, i.e. active compound 10, is trapped in the chamber 18 and/or in the application line 28 down to the lateral port 17, at least.
- The bag assemblies 14 as shown in
Figures 2 to 4 may form part of a set of bag assemblies 14. - Such a set is schematically represented in
Figure 5 . - The set is characterized in that bag assemblies 14 forming part of the set have chambers 18 of different volumes. However, at the same time the distance LB between the free end of the application line 28 and the hanging interface 20 is the same for all bag assemblies 14 of the set.
- This has the advantage that for each bag assembly 14 forming part of the set, the free end of the application line 28 will be located approximately at the same position if the different bag assemblies 14 forming part of the set are hung on the stand 16 using the stand-sided hanging interface 24 and the hanging interface 20.
- Consequently, when using bag assemblies 14 forming part of the set and having chambers 18 of different volumes, the stand 16 does not need to be adjusted. Still, the free ends of the application lines 28 will always be in the same position.
-
- 10
- active compound
- 11
- primary bag
- 12
- bed
- 13
- primary administration line
- 14
- bag assembly
- 15
- patient-sided port
- 16
- stand
- 17
- lateral port
- 18
- chamber
- 18a
- upper end of the chamber
- 18b
- lower end of the chamber
- 20
- hanging interface
- 22
- opening
- 24
- stand-sided hanging interface
- 26
- opening
- 28
- application line
- 30
- connection port
- 32
- bottom part
- 36
- connection line
- 38
- valve
- 40
- ventilation port
- A
- tapering angle
- LL
- length of the application line
- LB
- distance between a free end of the application line and a hanging interface
- P
- patient
Claims (15)
- A bag assembly (14) for administering an active compound (10) to a patient (P), the bag assembly (14) comprising a chamber (18) for the active compound (10),wherein in an application orientation the chamber (18) has an upper end (18a) and a lower end (18b),wherein a hanging interface (20) configured for hanging the bag assembly (14) on a stand (16) is located adjacent to the upper end (18a),wherein an opening (26) of the chamber (18) is located at the lower end (18b), wherein the opening (26) is configured for withdrawing active compound (10) from the chamber (18),wherein at least a lower portion of the chamber (18) arranged adjacent to the lower end (18b) is narrowing towards the lower end (18b),wherein an application line (28) is connected to the opening (26), andwherein a distance (LB) between a free end of the application line (28) and the hanging interface (20) is 40 cm to 70 cm if the application line (28) is extended in parallel to a direction extending from the upper end (18a) to the lower end (18b).
- The bag assembly (14) of claim 1, wherein at least the lower portion of the chamber (18) is tapering towards the lower end (18b).
- The bag assembly (14) of claim 2, wherein a tapering angle (A) is 140 degrees or less.
- The bag assembly (14) of claim 2 or 3, wherein the chamber (18) is tapering towards the lower end (18b).
- The bag assembly (14) of any one of the preceding claims, wherein an upper portion of the chamber (18) arranged adjacent to the upper end (18a) has a substantially constant width.
- The bag assembly (14) of any one of claims 1 to 3, wherein an upper portion of the chamber (18) arranged adjacent to the upper end (18a) is narrowing towards the upper end (18a).
- The bag assembly (14) of any one of the preceding claims, wherein a bottom portion of the chamber (18) is delimited by a bottom part (32), wherein the opening (26) of the chamber (18) is provided on the bottom part (32) and wherein a stiffness of the bottom part (32) is higher than a stiffness of a material delimiting the remaining portions of the chamber (18).
- The bag assembly (14) of any one of the preceding claims, further comprising a valve (38) for selectively filling a product into the chamber (18) and/or for selectively withdrawing a product from the chamber (18), wherein the valve (38) is arranged in the lower portion and/or on the bottom part (32).
- The bag assembly (14) of any one of the preceding claims, further comprising a ventilation port (40) for allowing a gas to enter the chamber (18), wherein the ventilation port (40) is arranged in the lower portion and/or on the bottom part (32).
- The bag assembly (14) of any one of the preceding claims, wherein the chamber (18) is delimited by a transparent material and/or by a UV protection layer.
- The bag assembly (14) of any one of the preceding claims, wherein the application line (28) has a length (LL) of 50 cm or less, preferably of 35 cm or less.
- The bag assembly (14) of any one of the preceding claims, wherein the application line (28) and the chamber (18) are formed integrally.
- The bag assembly (14) of any one of the preceding claims, wherein the chamber (18) has a volume of 20 ml to 1000 ml.
- The bag assembly (14) of any one of the preceding claims, wherein the chamber (18) and/or the application line (28) is at least partially filled with an active compound (10), especially an oncological active compound and/or an antibiotic solution and/or a glucose solution and/or a sodium chloride solution.
- A set of bag assemblies (14) comprising at least two bag assemblies (14) according to any one of the preceding claims, wherein a distance (LB) between a free end of the application line (28) and the hanging interface (20) is the same for all bag assemblies (14) of the set and wherein a volume of the chamber (18) of the at least two bag assemblies (14) of the set is different.
Priority Applications (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP24193523.8A EP4691446A1 (en) | 2024-08-08 | 2024-08-08 | Bag assembly for administering an active compound to a patient and set of bag assemblies |
| PCT/IB2025/057913 WO2026033376A1 (en) | 2024-08-08 | 2025-08-04 | Bag assembly for administering an active compound to a patient and set of bag assemblies |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP24193523.8A EP4691446A1 (en) | 2024-08-08 | 2024-08-08 | Bag assembly for administering an active compound to a patient and set of bag assemblies |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP4691446A1 true EP4691446A1 (en) | 2026-02-11 |
Family
ID=92295657
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP24193523.8A Pending EP4691446A1 (en) | 2024-08-08 | 2024-08-08 | Bag assembly for administering an active compound to a patient and set of bag assemblies |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP4691446A1 (en) |
| WO (1) | WO2026033376A1 (en) |
Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5738671A (en) * | 1996-07-30 | 1998-04-14 | Bracco Diagnostics Inc. | Flexible plastic container for the containment and delivery of diagnostic contrast media and parenteral drug formulations |
| US20210093758A1 (en) * | 2019-09-30 | 2021-04-01 | Hackensack Meridian Health, Inc. | Blood collection and infusion container for autotransfusion |
-
2024
- 2024-08-08 EP EP24193523.8A patent/EP4691446A1/en active Pending
-
2025
- 2025-08-04 WO PCT/IB2025/057913 patent/WO2026033376A1/en active Pending
Patent Citations (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5738671A (en) * | 1996-07-30 | 1998-04-14 | Bracco Diagnostics Inc. | Flexible plastic container for the containment and delivery of diagnostic contrast media and parenteral drug formulations |
| US20210093758A1 (en) * | 2019-09-30 | 2021-04-01 | Hackensack Meridian Health, Inc. | Blood collection and infusion container for autotransfusion |
Also Published As
| Publication number | Publication date |
|---|---|
| WO2026033376A1 (en) | 2026-02-12 |
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