WO2021201789A1

WO2021201789A1 - Drug delivery apparatus with closed transfer system

Info

Publication number: WO2021201789A1
Application number: PCT/TR2020/050267
Authority: WO
Inventors: Emre ANSAL; Erdem ANSAL
Original assignee: Ansal Maki̇na İthalat İhracaat Pazarlama Li̇mi̇ted Şi̇rketi̇
Priority date: 2020-04-03
Filing date: 2020-04-03
Publication date: 2021-10-07

Abstract

The invention relates to a delivery apparatus (10) consisting of a perforating element (12) comprising a fluid channel (121) so as to provide fluid transfer between a vial and an injection element and an air channel (122) and a body (11) having an air filter channel (111) which is configured with a sufficiently narrow channel connection angle (x) relative to the extending axis of the fluid flow occuring in said fluid channel (121) so as to provide pressure balance in the vial.

Description

DRUG DELIVERY APPARATUS WITH CLOSED TRANSFER SYSTEM

Technical Field

The invention relates to a delivery apparatus which performs drug delivery with the closed transfer system from the vials (medicament bottles) used for medical purposes.

The invention particularly relates to a drug delivery apparatus with an increased number of uses which performs delivery with a perforating element.

State of the Art

The drug bottles used for the packaging of drugs suitable for injection to prevent their contact with the external environment and to protect them from harmful factors are called vials. The mouth of the vials is covered with rubber plugs. Therefore apparatuses by which drug delivery is performed with the closed transfer system for receiving drug from the vials are used. These apparatuses are the vial adapters which allow perforation of the rubber plugs and to pull out the drug from the vial.

The vial adapters used in the present applications consist of; a perforating tip with one air jole on one end and a luer lock port on the other end and a body seated on the vial. There is also an air filter hole on the adapter body such that it is connected at an angle perpendicular to the flow direction in the body. When the drug is pulled out from the vial; while the fluid in the vial is pulled out through the fluid hole, the air entering through the air filtre hole is filled into the vial from the air hole so as to provide pressure compensation. Therefore, the pressure required for pulling out the fluid from the vial is created. The applications encountered in relation with the present applications are listed herein below.

The application No TR2017/02158 relates to the vial adapters which adjust the pressure. The vial adapter mentioned in said application comprises; a housing element, a connection element which is configured to connect the adapter to a vial, a regulator channel and an extractor channel formed in the housing element. The extractor channel is configured to facilitate pulling out the fluid from the vial when the adapter is connected with the vial. The regulator channel is configured to facilitate the flow of a regulatory fluid for compensating the changes in the volume of a medical fluid in the vial. In some embodiments, an expansion element is arranged on the housing element and it is configured such that it will expand and narrow according to the changes in the colume of the medical fluid within the vial.

The application No TR2019/04734 relates to a closed drug delivery system. In said system in the mentioned application, a one-way selective valve positioned paralel to the filter in the air channel is used so as to prevent fluid inlet from the syringes connected to the tool. In addition to this, the embodiment comprises components which are configured to prevent the rubber plug of the drug vials from tearing.

The application No CA2715894 (A1) relates to a vial adapter. Said vial adapter comprises; a body section, a penetrating section which protrudes from the body section and places in the vial by means of perforating the sealing member, an interface section which can be connected to a syringe or another medical tool and is supported by the body section. Also it comprises an air filter hole in the vial adapter so as to allow air to be filled in during the removal of the fluid in the vial.

The application No WO2015195844 (A1) relates to a pressure balancing vial adapter. Said vial adapters comprises one or more access channels which is in connection with the fluid included within the connection interface. The adapter also has a perforating element which has a regulation comprisinf a first and a second regulator inlet. Said regulator inlets comprise a filter so as to filter the fluids entering or exiting into/from the adapter. In addition to this, valves are positioned between the regulator inlets and the perforating element.

The application No US2013053814 (A1) relates to an adapter which is used to connect an vial and a syringe-like element. The adapter comprises a perforating element that has a filtering mechanism and a channel configuration located on a shaft so as to provide fluid flow. There is a branched channel and an air channel on said shaft so as to provide fluid flow.

In the embodiments of the adapter used currently, a filter is attached to the air filter hole so as to prevent air entering from the vial through the external environment from causing contamination. However, this filter gets wet by its contact with the fluid after the first or the second usage since the air filter hole is combined with the body at a right angle and it gets blocked thus it prevents the passage of the air. This prevents fluid delivery through the vial. In the applications, the fluid holes in the adapters are in circular forms and their diameters are generally 1 -1 ,5 mm. These diameter values allow the flow rate of the fluid to be increased up to a determined point. In case the fluid flow is relatively slow, it can lead to shortening the duration of blocking of the air filter. In this direction, it is necesarry to replace saaaid adapter configurations with new ones after 1 or 2 uses. Therefore, their usage creates extra cost.

As a result due to the abovementioned disadvantages and the insufficiency of the current solutions regarding the subject matter, a development is required to be made in the relevant technical field.

Brief Description of the Invention

The present invention is related to a delivery operating with a closed transfer system which enables transferring the medicament from vials into an injection tool which fulfils the abovementioned requirements, eliminates all disadvantages and brings some additional advantages.

The main aim of the invention is to provide a delivery apparatus with extended economic life.

An aim of the invention is to provide a delivery apparatus with reduced usage costs.

Another aim of the invention is to provide a delivery apparatus which provides faster delivery compared to its equivalents.

In order to fulfil the abovementioned aims, the invention relates to a delivery apparatus consisting of a perforating element comprising a fluid channel so as to provide fluid transfer between a vial and an injection element and an air channel and a body comprising an air filter channel having a filter so as to provide pressure balancewithin the vial. Accordingly, said delivery apparatus comprises a sufficiently narrow channel connection angle relative to the extending axis of the fluid flow occuring in said fluid channel of said air filter channel so as to reduce the blocking time of said filter by getting wet. In order to fulfil the aims of the invention, said fluid channel comprises a section to increase the channel cross-sectional area so as to increase the fluid flow rate.

In order to fulfil the aims of the invention, said fluid channel section is preferably configured in a semi-circular form.

The structural and characteristic features of the present invention will be understood clearly by the following drawings and the detailed description made with reference to these drawings and therefore the evaluation shall be made by taking these figures and the detailed description into consideration.

Figures Clarifying the Invention

Figure 1 is a side view of the inventive delivery apparatus.

Figure 2 is another side view of the inventive delivery apparatus.

Figure 3 is a bottom view of the inventive delivery apparatus.

Figure 4 is a schematic view of the usage of the inventive delivery apparatus.

The figures must be scaled and the details which are not necesarry for understanding the present invetion may be neglected. Moreover, the elements that are at least substantially identical or have at least substantially identical functions are shown by the same number.

Description of the References

10 Delivery apparatus

11 Body

111 Air Filter Channel

12 Perforating element

121 Fluid Channel

122 Air Channel

13 Luer Locking Port

20 Vial

21 Plug 30 Injection tool 31 Piston x: Channel connection angle Q: Blocked area

Detailed Description of the Invention

In this detailed description, the preferred embodiments of the inventive drug delivery apparatus with closed transfer system (10) is described only for clarifying the subject matter in a manner such that no limiting effect is created.

The delivery apparatus (10) whose side views are given from different angles in Figure 1 and Figure 2 is used for transferring the fluid contained in a vial (20) into an injection tool (30). The delivery apparatus (10) consists of; a body (11) provided on the vial (20), a perforating element (12) which is configured along said body (11), extends out of the body (11) and is located in the plug (21) of the vial (20) and a luer locking port (13) which provides a secure connection to the injection tool (30) configured following the body (11) in a closed system.

Said perforating element (12) has a fluid channel (121) which provides transferring the fluid which extends such that it passes though the body (11) and the luer locking port (13) and an air channel (122) which provides air compensation during the fluid transfer. Said air channel (122) is also connected with an air filter channel (111) which enables air transfer into the vial (20) extending out of the body. Also a filter is positioned (not shown in the figure) in said air filter channel (111).

Said air filter channel (111) provides the required air inlet so as to create the pressure balance while receiving fluid from the vial (20). A filter (which is not included in the invention) is also used for preventing contamination during this air inlet. The contact of this filter with the fluid which escapes from said fluid channel (121) leads to its blockage by its deterioration. In the inventive delivery apparatus (10), the air filter channel (111) is configured such that it forms a narrow channel connection angle (X) with the extension axis of the fluid flow. Since the channel connection angle (x) of the air filter channel (111) is configured to be an acute angle instead of a right angle, fluid escape into the air filter channel (111) is prevented to some extent. Therefore, the blocking period of the filter after getting wet and thus the usage duration of the delivery apparatus is increased and the cost of usage is reduced. The fluid channel (121) enables the transfer of the fluid into the injection tool (30) after it is drawn from the vial (20). The section of the fluid channel (121) is in the form of semi-circle “D” as can be seen in Figure 3. The cross sectional area of the fluid channel (121) is increased with this cross section compared to the circular cross section. This condition increases the fluid passage rate through the fluid channel (121). The increase in fluid transfer rate decreases the fluid risk which will block the filter by means of escaping from the air filter channel (111).

The fluid and air flow performed by the injection tool (30) according to the direction of its piston (31) movement, during the use of the delivery apparatus (10) is seen in Figure 4. In the case of A, the piston (31) is pulled upwards so as to draw fluid into the injection tool (30) from the vial (20) and thus the upward movement of the fluid in the fluid channel (121) and the transfer of the air into the vial (20) through the air channel (122) is realized. The risk of fluid escaping into the air channel (122) is very low in this process. In the case B, the piston (31) is pressed down such that the fluid in the injection tool (30) is injected at high speed and thus the downward movement of the fluid in the fluid channel (121) and the upward transfer of the air in the air channel (122) are realized. The fluid escape into the air filter channel (111) during this application can be tolerated to a certain level by means of the narrow channel connection angle (x) thus the blocked area (Q) formed. The volume of the blocked area (Q) is determined as 48.09 mm³ and the volume of the fluid channel (121) is determined as 2.82 mm³ by the volume calculation made over the 3D model so as to determine the effect of the blocked area (Q). In other words, volume of the blocked area (Q) is approximately 17 times more than the air channel (122) volume where the fluid escape is realized. Since the fluid which escapes through the air channel (122) in the air filter channels placed at right angle is not collected in a blocked area, it moves towards the air filter directly. In case of a possible fluid escape in the embodiment of the inventive delivery apparatus (10), the volume of the blocked area (Q) is at a level which substantially prevents the filter blockage.

Claims

1. Delivery apparatus (10) consisting of a perforating element (12) comprising a fluid channel (121) so as to provide fluid transfer between a vial and an injection element and an air channel (122) and a body (11) comprising an air filter channel (111) having a filter so as to provide pressure balancewithin the vial, characterized in that; said air filter channel (111) comprises a sufficiently narrow channel connection angle (X) relative to the extending axis of the fluid flow occurring in said fluid channel (121) so as to reduce the blocking time of said filter by getting wet.

2. Delivery apparatus (10) according to claim 1 , characterized in that; said fluid channel (121) comprises a section to increase the channel cross-sectional area so as to increase the fluid flow rate. 3. Delivery apparatus (10) according to claim 2, characterized in that; said fluid channel

(121) section is preferably configured in a semi-circular form.