EP3067037A1

EP3067037A1 - A safety medical transfer device

Info

Publication number: EP3067037A1
Application number: EP15158271.5A
Authority: EP
Inventors: Mehmet Tunc Tuncel; Hikmet Bayhan
Original assignee: Epsilon Elektronik Sanayi Ve Ticaret AS
Current assignee: Epsilon Elektronik Sanayi Ve Ticaret AS
Priority date: 2015-03-09
Filing date: 2015-03-09
Publication date: 2016-09-14
Anticipated expiration: 2035-03-09
Also published as: EP3067037B1; WO2016142369A1

Abstract

The present invention relates to a medical transfer device (100) for transferring fluids from a vial (10) to another vessel, comprising a piercing device (30) having a main body (33) in a tubular shape, a lock member (36) having at least one flexible member (43), at least one arm (42) for attaching said lock member (36) into the main body (33), at least one protrusion (41) formed on the lock member (36) being guidable in a guiding channel (29) and a guiding window (21) provided at a connection portion (27) of a connector (20), a needle holder (31) having a needle (32) functioning as a first flow path through which a liquid can pass, a first barrier member (37) disposed in said lock member (36) made of an elastic material for opening and closing the first flow path, a connector (20) for attaching to the vial (10), comprising an inner portion having a lumen (99) which functions as a second flow path, at least one elevating member (28) has a portion of, at least partly, helix shape, and a second barrier member (47) disposed in the inner portion and is made of an elastic material for opening and closing the second flow path. Said medical transfer device (100) further comprises, an elevating member follower (35) disposed in the main body (33) for limiting movement of at least one flexible member (43) of the lock member (36) such that an axial movement of the piercing device with respect to the connector (20) is prevented, said elevating member follower (35) being rotatable around a longitudinal axis (A) of the piercing device (33) with respect to the connector (20) and guidable on the elevating member (28).

Description

Technical Field of the Invention

The present invention relates to a transfer device for transferring a substance from one vessel such as a vial or the like to another vessel while avoiding leakage of liquid and/or gas contaminants, more particularly to a medical transfer device comprising a connector for attaching to a vial and a piercing device. The medical transfer device is enhanced with locking arrangements that prevents potential leakage of hazardous drug or vapor concentrations outside said vial and minimizes the risk of users being accidentally exposed to said hazardous content even when an excessive torque is accidentally applied to said medical transfer device.

Background of the Invention

Cancer cells differ from normal cells in many ways that allow them to grow out of control and become invasive. One important difference is that cancer cells are less specialized than normal cells Inhibition of the growth and proliferation of microbes or tumor cells or eliminating them where possible, without damaging the normal cells of the patient or the host with the anti-neoplastic drugs used in cancer treatment is the main principle of the treatment.
Selectivity of anti-neoplastic drugs against cancer cells is low. Because there is no qualitative difference between the malignant cells and normal human cells, the difference is mainly quantitative. Antineoplastic acts to prevent, inhibit or halt the development of a neoplasm (a tumor). Carcinogenic, mutagenic and teratogenic effects of anti-neoplastic drugs were confirmed by clinical studies.
In order to minimize these carcinogenic effects, the amount of medicine should be precisely adjusted according to the patient's weight and length. The dose is adjusted by taking the required amount of liquid medicine from the vessel with the help of an injector and transferred into the infusion bag. If the health staff engaged in the transfer of this drug is exposed to the drug (via respiratory tract or skin) during this process, then user may be exposed to the drug's carcinogenic effects. Transferring of anti-neoplastic drugs form one vessel to another vessel, staff may be exposed to the medical fluid by means of contamination. Such contamination may be vaporized medical fluid or aerosol in the air. The contaminations may contaminate the staff trough their lungs or vaporized medical fluid or aerosol in the air which condensates on the skin to thereafter penetrate the skin of the staff.
Exposure to contaminations like this, on a long term, may cause high concentrations of medicaments in the blood or the human body of the staff. The medical staff engaging in this procedure has a high risk of cancer. Therefore, closed system transfer devices are developed that prevents the contamination of the drug to the medium during the drug transfer. There are many developments and patent documents which allow the transfer without any leaking to the medium. Such transfer devices mainly comprises a piercing device functioning as a first flow path through which liquid can pass and a connector for attaching to the vial having a lumen functions as a second flow path through which liquid can pass. The piercing devices of transfer device require a mating connector or adaptor to enable assembly with a vial to prevent leakage. To enable a firm connection with e.g. piercing devices, medical device connectors, also referred to as medical device adaptors, has been developed. It is known that the connector attached to the vial comprising a neck element with guiding tracks having to establish a good connection with a piercing device. For engagement of the piercing device and the connector, an axial movement and rotation is needed; such turning and axial motion may cause accidentally disconnect of the transfer device, if the user apply force than required.
A prior art publication in the technical field of the present invention may be referred to as US8075550 (B2 ) among others, the document disclosing a piercing member protection device which comprises a locking arrangement with a deformable bias flange, to prevent the turning of a first cylindrical member with respect to a second cylindrical member, the locking arrangement is altered between a locked position and an unlocked position by deforming the deformable bias flange. However, when the needle is in the vial, the user should not rotate the piercing device.
In the prior art, although such devices provide a locking with a vial adapter, if an excessive torque is applied, i.e. rotation movement, to the injector adapter after the needle enters to the vial adapter, able to draw the substance from the vial, the device can be unlocked, causing a possible exposure of the substance in the vial to the medium. Therefore, there is a need for a reliable liquid transfer device that prevents the releasing of the locking position, even if the system is rotated in the wrong direction.

Objects of the Invention

Primary object of the present invention is to provide a medical transfer device which is enhanced with locking arrangements that prevents the escape of hazardous drug or vapor concentrations outside, and minimizes the risk of the user being accidentally exposed when an excessive torque is accidentally applied to said medical transfer device
Another object of the invention is to provide a medical transfer device in which a needle of a piercing device of the medical transfer device is in a position that the user cannot reach.
Another object of the invention is to provide a medical transfer device in which the health of medical staff is protected by preventing the accidental unlocking of the system and contamination of an anti-neoplastic drug to the outside.
Another object of the invention is to provide a simple, easy to use and economically viable medical transfer device for transferring a substance from one vessel such as a vial or the like to another vessel while avoiding leakage of liquid and gas contaminants.

Summary of the invention

The present invention relates to a medical transfer device for transferring fluids from a vial, comprising a piercing device having a main body in a tubular shape a lock member having at least one flexible member, at least one arm for attaching said lock member into the main body, at least one protrusion formed on the lock member being guidable in a guiding channel and a guiding window provided at a connection portion of a connector, a needle holder having a needle functioning as a first flow path through which a liquid can pass, a first barrier member disposed in said lock member made of an elastic material for opening and closing the first flow path, a connector for attaching to the vial, comprising an inner portion having a lumen which functions as a second flow path, at least one elevating member has a portion of, at least partly, helix shape, and a second barrier member disposed in the inner portion and is made of an elastic material for opening and closing the second flow path. Said medical transfer device further comprises, an elevating member follower disposed in the main body for limiting movement of at least one flexible member of the lock member such that an axial movement of the piercing device with respect to the connector is prevented, said elevating member follower being rotatable around a longitudinal axis of the piercing device with respect to the connector and guidable on the elevating member.
Said transfer device includes a first state in which the piercing device and the connector are connected with the at least one protrusion formed in the lock member by sliding in the at least one protrusion guiding channel, and the main body of the piercing device is rotatable around the longitudinal axis (A) of the piercing device with respect to the connector but is not movable in the axial direction while the first flow path is closed by the first barrier member and the second flow path is closed by the second barrier member and the elevating member follower blocks movement of the at least one flexible member;
a second state which is established by the rotating the main body around the longitudinal axis of the piercing device with respect to the connector by guiding at least one protrusion at the guiding window and in which said elevating member follower is elevated along the way of the elevating member such that the at least one flexible member can be stretched when the axial force with respect to the connector is applied.
a third state which is established by moving the piercing device in the axial direction with respect to the connector from the second state, and in which the needle of the needle holder is inserted through the first barrier member and the second barrier member to communicate the first flow path and the second flow path with each other.

Brief Description of the Figures

Accompanying drawings are given solely for the purpose of exemplifying a medical transfer device whose advantages over prior art were outlined above and will be explained in brief hereinafter. The drawings are not meant to delimit the scope of protection as identified in the claims nor should they be referred to alone in an effort to interpret the scope identified in said claims without recourse to the technical disclosure in the description of the present invention.

Fig. 1 demonstrates a perspective view of a connector having suitable grip members for attaching to a vessel such as vial or the like according to the present invention.
Fig. 2 demonstrates a partial perspective view of a medical transfer device attached to a vial according to the present invention.
Fig. 3 demonstrates a cross sectional view of a transfer device with a vial according to the present invention.
Fig. 4 demonstrates an exploded view of a piercing device according to the present invention.
Fig. 5a demonstrates a perspective view of a medical transfer device is in a second state where a main body of a piercing device can be moved in an axial direction with respect to a connector according to the present invention.
Fig. 5b demonstrates a perspective view of a medical transfer device is in a third state where a needle of a piercing device is inserted into a vial according to the present invention.
Fig. 6 demonstrates a perspective view of a piercing device according to the present invention.
Fig. 7 demonstrates a perspective view of a connector according to the present invention.
Fig. 8a demonstrates a partial cross-sectional view of a transfer device which is in a first state according to the present invention.
Fig. 8b demonstrates a partial cross-sectional view of a transfer device which is in a second state according to the present invention.
Fig. 9a demonstrates a partial perspective view of a main body according to the present invention.
Fig. 9b demonstrates a partial perspective view of a main body in which a lock member is guided according to the present invention.
Fig. 9c demonstrates another partial perspective view of a main body in which a lock member is guided by the way of rails of main body according to the present invention.
Fig. 10a demonstrates perspective view of a first embodiment of a needle holder of a transfer device according to the present invention.
Fig. 10b demonstrates a cross sectional view of a first embodiment of a needle holder of a transfer device shown in Fig. 10a
Fig. 11 a demonstrates perspective view of a second embodiment of a needle holder according to the present invention.
Fig. 11b demonstrates a cross sectional view of a second embodiment of a needle holder shown in Fig. 11 a.
Fig. 12a demonstrates a perspective view of a third embodiment of a needle holder of a transfer device where a needle holder is detached according to the present invention.
Fig. 12b demonstrates a perspective view of a third embodiment of a needle holder of a transfer device shown in fig. 12a.
Fig. 13a demonstrates a perspective view of an elevating member follower in a first position, placed on a connector according to the present invention.
Fig. 13b demonstrates a perspective view of an elevating member follower in a second position, guided on a connector according to the present invention.
Fig. 14 demonstrates a partial perspective view of a transfer device where a protrusion is guided in a guiding window according to the present invention.
Fig. 15 demonstrates a cross sectional view of a transfer device shown in Fig. 5b, which is in a third state according to present invention.

Detailed Description of the Invention

The following numerals are used in this detailed description:

10: Vial
11: Neck
20: Connector
21: Guiding window
23: Equalization port
24: Flat portion
25: Grip member
26: Protrusion housing
27: Connection portion
28: Elevating member
29: Protrusion guiding channel
30: Piercing device
31: Needle holder
31a: Needle holder
31b: Needle holder
31c: Needle holder
32: Needle
32a: Needle tip
33: Main body
34: Resilient member
35: Elevating member follower
36: Lock member
37: First barrier member
38: Threaded portion
39: Needle holding groove
41: Protrusion
42: Arm
43: Flexible member
44: Lock member skirt
45: Protrusion of flexible member
46: Holding portion
47: Second barrier member
48: Inclined surface
49: Upper part of elevating means
50: Curved edge
51: Filter
53: Arm protrusion
54: Inner portion
55: Limiting portion
56: Engagement groove
60: Lower portion
70: Upper portion
71: Piercing portion
72: Resilient member needle hole
78: Channel
80: First state
81: Second state
82: Guiding window protrusion
84: Third state
85: Direction of movement
86: Direction of rotation
88: Abutting portion
90: Welding portion
91: Protrusion
92: Outer wall
93: Groove
94: Claw
95: Recess
96: Wing
97: Projection
98: Rail
99: Lumen
100: Transfer device
H: Height difference of the elevating member follower
A: Longitudinal axis of the piercing device

The present invention relates to a transfer device (100) mainly comprising a connector (20) for attaching to a neck (11) of a vessel such as a vial (10) or the like, and a piercing device (30) having a needle (32) which passes through said connector (20) for transferring a substance from the vial (10) to another vessel while avoiding leakage of liquid and gas contaminants.
The connector (20) of the transfer device (100), as shown in Figure 1, is matched with a plurality of grip members (25) integrally with a flat portion (24) of the connector, to the vial (10). Said grip members (25) operate by being fitted onto the neck (11) of the vial (10) with a snap on function. The connector (20) mainly consists of two parts, a lower portion (60) for attaching to the vial, and an upper portion (70) for maintaining secure connection with the piercing device (30). The lower portion (60) and the upper portion (70) is separated with a channel (78) through which the substance, especially liquid, passes. The connection portion (27) of the connector (20) is substantially shaped cylindrically, at least two protrusion housings (26) each positioned, preferably, at the opposite sides along the exterior peripheral of the connection portion (27) and at least two protrusion guiding channel (29) at an other side of the protrusion housing (26) for guiding at least one protrusion (41) provided on a lock member (36). The connector (20) has a lumen (99) in an inner portion of itself, which functions as a second flow path through which liquid can pass, and a second barrier member (47) disposed in an inner portion and made of an elastic material for opening and closing the second flow path.
Said protrusion guiding channels (29) are connected to a transversely formed guiding window (21) formed in the connection portion (27) of the connector (20). Thus two protrusions (41) provided on the lock member (36) pass through the protrusion guiding channel (29) shaped and dimensioned according to the protrusion (41) and reaches down to the transverse guiding window (21) with the help of the axial direction (A) with respect to the connector (20) applied by the user which is called as a first state (80), as can be seen in fig 8a. Rotating the piercing device (30) around a longitudinal axis (A) of the piercing device (30) with respect to the connector (20) guides at least one protrusion (41) at the guiding window (21), and in which an elevating member follower (35) is elevated along the way of at least one elevating member (28) provided in the connector (20) such that at least one flexible member (43) can be stretched backwards when an axial force is applied, which is called as a second state. At this state the piercing device (30) is movable in the axial direction (A) with respect to the connector (20), as can be seen in fig. 8b.
Said transversely formed guiding window (21) has a guiding window protrusion (82) for preventing sliding of said protrusion (41) backwards after rotation of the piercing device (30) with respect to the connector (20). The piercing device (30) has a longitudinal center axis (A) extending in the longitudinal direction of the medical transfer device (100) and in the center of the piercing device (30). The two protrusions (41) are intended to, during connection with the connector (20), be inserted according to the longitudinal axis of the piercing device (30) into the two corresponding protrusion guiding channel (29) which are arranged on the connection portion (27) of the connector (20).
As can be seen in Fig. 3, a preferred embodiment, the needle (32) functioning as a first flow path through which liquid can pass, is kept by a needle holder (31) and then attached to the piercing device (30) by the way of rotation at clockwise direction. Said needle (32) has a mount end and a sharp needle tip (32a), intended for penetration of a human or animal body, or for other medical uses such as the penetration of a pierceable membrane of the vial (20). In fig. 4, a resilient member (34) has a portion of M-like shape for repositioning said elevating member follower (35), placed on an inner portion of the lock member (36). Said resilient member (34) comprises a resilient member needle hole (72) through which the needle pass, and a piercing portion (71) through which the needle pierces when the axial force is applied by the user. Said resilient member (34) shaped as an inwardly oval shaped.
The lock member (36) (an exploded view shown in Figure 4) comprises an inner portion (54) formed as a cylindrical shaped, the flexible members (43) located around the inner portion (54), and two arms (42) for attaching, also preventing rotational movement, to the piercing device (30). At least two protrusions (41) preferably in a cylinder, square or rectangular forms are provided on a lock member skirt (44) forming underside portion of the lock member (36). When the transfer device (100) is in a first state (80), as can be seen in 8a, a limiting portion (55) of the elevating member follower abuts the flexible members (43) for preventing movement of the flexible member (43) such that an axial movement with respect to the connector (20) cannot be applied by a user. If the elevating member follower (35) is heightened by guiding on the helix shaped elevating member (28), said flexible members (43) are released such that a main body (33) of the piercing device (30) can be moved in the axial direction with respect to the connector (20). Referring to Figure 1, at least two grip members (25) are positioned preferably at the opposite side of the connector (20). Said grip members (25) have a space in between, with their inward oval claw shaped structure, attach to the neck (11) of the vial (10) and provides a stable snap on function.
Said protrusion guiding channels (29) are used the piercing device (30) to be locked or unlocked especially shifting between the first (80), a second (81) and a third (84) states, respectively. Firstly, the protrusions (41) are guided downwardly with the direction of movement (85) along the way protrusion guiding channels (29). Referring Figure 8a, in a first state (80), protrusions are advanced only in the guiding window (21) yet and in order to come to the position, to second state (81), shown in Figure 8b, the piercing device (30) and the two protrusions (41) should be rotated axially by the user. Rotation of the piercing device (30) in order to bring the device (100) to the second state (81), the elevating member follower (35) located inside the piercing device (30) is guided on the two substantially symmetrically positioned the elevating members (28). Thus, the transfer device (100) comes to the second state (81) as shown in Figure 8b and the rear part of the flexible member (43) facing to the inner portion of the lock member, is released. Height difference of the elevating member follower (H) during the rotation of the piercing device (30) is shown in Figure 13a-b. Height difference of the elevating member follower (H) can be arranged by the shape of the elevating member (28). As seen in the Figures, the elevating means (28) shaped gradually in a helix form and two curved edges (50) of the elevating member follower (35) advances on an inclined surface (48) of the elevating member (28).
The limiting portion (55) of the elevating member follower (35) is formed as claw shape and located between the flexible members (43) and the inner portion (54). In the first state (80), the limiting portion (55) of the elevating member follower (43) abuts against the flexible member (43) also which lean against an abutting portion (88) of a holding portion (46) of the main body (33). A protrusion of flexible member (45) having an inclined surface helps to be stand firmly when in touch with the abutting portion (88) of the holding portion (46). The flexible member (43) can be stretched backwards when the axial force is applied in the downward direction if the transfer device (100) is brought in to the second state (81).
Fig. 15 demonstrates a cross sectional view of the transfer device (100) which is in a third state. The third state (84) is established by moving the piercing device (30) in the axial direction with respect to the connector (20) from the second state, and in which the needle (32) of the needle holder (31) is inserted through a first barrier member (37) and a second barrier member (47) to communicate the first flow path and the second flow path with each other. When the axial force is applied in order to drive the piercing device (30) in the longitudinal axis (A) of the piercing device (30), the force is transmitted to the abutting portion (88) to which said a claw-like like upper portion of the flexible member (45) abuts. As there is an angled surface between upper portion and the abutting portion (88), axial forces are divided into components, namely the normal force and the resultant force.
In the second state (81), as shown in fig. 8b, of the transfer device, in other words, unlocked position which is provided by releasing the rear part of the flexible member (43) by advancing the elevating member follower (35) on the elevating member (28) is shown in Figure 5a and 8b. In this state, the first barrier member (37) placed under the piercing device (30) and the second corresponding barrier member (47) placed at the upper portion of the connector (20) match and pushes each other and as a result, the protrusions (41) apply a pressure towards the upper base of the guiding window (21). Said barrier member (47) is disposed in the inner portion (54) and made of an elastic material for opening and closing the second flow path, so as to provide for a double membrane coupling after connection with the piercing device (30).
Referring to Figure 6, the piercing device (30) comprises the main body (33) that guides the lock member (36) inside. The holding portion (46) formed in the two opposite portions of the main body (33) for the user to hold and press. Inner side of the holding portion (46) and the claw-like protrusion of the flexible member (45) abut to each other when the device (100) is in the first state (80) for blocking movement of the piercing device in the longitudinal axis (A).
Also as a secondary safety locking mechanism is provided when the device is brought to the third state (84). Said main body (33) has at least two engagement grooves (56) extending vertically with respect the longitudinal axis of the main body. Said engagement grooves (56) are shaped and dimensioned according to the protrusion housing (26) provided on the connector (20), and when the medical transfer device (100) is brought the second state (81), it is placed in the opposite position and as a result of a downwards direction of movement by the user is prevented. Said protrusion housings (26) and corresponding grooves (56) are matched to grip each other when the protrusions (41) are guided at an end of the guiding window (21). When the axial force is applied at the third state (84), as seen in Figure 5b, the protrusion housings (26) and the engagement grooves (56) come to a matched position and a stable fixation is maintained, and the rotation of the piercing device (30) around its own axis is prevented.
As can be seen in figure 7, the elevating member follower (35) advance on the inclined surface of the elevating means (28) and reached an upper part of elevating means (49) on this surface. The important point here is, if the transfer device (100) is not rotated completely, the engagement grooves (56) and the protrusion housings (26) do not position reciprocally and thus the axial force cannot be applied. When the system is brought into the third state (84), the liquid transfer can be maintained. On the other hand when the user wants to unlock the system the piercing device (30) is pulled upwards and then drawn back by rotating backwards inside the guiding window (21) through the protrusion guiding channel (29) in the protrusion (41).
Besides, the elevating member (28) which advances with a certain pitch contains a secondary upper part of elevating means (49). The elevating member (28), at its upper portion, contains a secondary upper part of elevating means which elevates the elevating member follower (35) in a short distance in order to release the rear of the flexible member (43). The elevated elevating member follower (35) as a result of rotation squeezes the resilient member (34) in the axial direction. During the transfer, the resilient member (34) acts as a spring and allows the elevating member follower (35) to be repositioned. Referring Figure 7, the second barrier member overlapping with the first barrier member (37) placed in the piercing device (30), like the first barrier member, can also be produced from thermoplastic elastomer, silicone or thermoplastic polyurethane.
In figure 9a-c, the position of lock member (36) located in the main body (33) of the piercing device (30) is shown. As seen in Figure 9b, at least two arms (42) of the lock member (36) can be slided along the way through rails (98) provided at an inner wall of the main body (33) in the longitudinal direction. Referring to fig. 9b, each pair of rails (98) has at least two projections (97) for engaging with corresponding two arm protrusions (53) provided at the opposite side of the arm (42) for a stable connection.
The connection provided with an injector or a similar structure is arranged with a threaded portion (38) on the upper portion of the needle holder (31), shown in Figure 4. An outer circumferential portion of the threaded portion (38), a plurality of male thread is formed. Said male threads of threaded portion (38) can be screwed into the female thread of a lock adapter portion of a syringe or the like.
In a preferred embodiment, the needle holder (31) contains a cylindrical outer surface and a needle holding groove (39) inside to hold the needle (32). The needle (32) is a standard hollow needle, with a needle tip (32a) on one side and containing a hole for liquid inlet-outlet at the needle tip (32a). Needle (32) is positioned leaktight at the first state (80) between the resilient member (34) and the first barrier member (37).
Different type of needle holders (31 a, 31 b, 31 c) can be used as shown from 10a to 13a. First embodiment of the needle holder (31 a) is shown in Figure 10a and 10b. The fixing of the needle holder (31 a) to the main body (33) can be obtained by welding or gluing methods in this embodiment. When welding is used, the cylindrical form of the needle holder (31 a) is welded to the overlapping upper portion of the main body (33) and thus the welding portion (90) is formed. When attaching the syringe to the threaded portion (38), piercing device (30) or syringe is turned around its own axis.
In Figure 11a and 11b, second embodiment of the needle holder (31 b) is shown. In this embodiment, there are at least two protrusions (91) extending out from the main body (33). Besides, there is an outer wall (92) surrounding these protrusions on the needle holder. In this outer wall (92), continuous opposite protrusion matches with said protrusion (91). During the assembly, claw on the needle holder (31 b) stretches axially and comes to its final position by skipping over the body. Two claw structures keeping the needle holder in its place. As the needle holder is cavernously on the main body, needle holder (31b) can turn 360 degrees on its own axis according to the main body.
In Figure 12a and 12b, a third embodiment of a needle holder (31c) is shown. A plurality of grooves (93) is formed in a circumferential manner at the upper portion of the main body (33) having corresponding protrusion for engagement with claws formed on the lower part of the needle holder (31c). As seen in Figure 12a, cylindrical portion of the needle holder (31 c) and the threaded portion (38) are connected wit at least one supporting wing (96) for enhancing its rigidity. Said a plurality of claw (94) of needle holder (31c) separated with at least one recess (95) from each other. With the grooves (95) in these claws (94), flexibility and a better connection are maintained. In this embodiment, the needle holder can be rotated 360 ° around its own axis. When the needle holder (31c) is attached to the main body (33) relation between said grooves (93) and claws (94) are fitted to each other as can be seen in fig. 12b.
The elevating member follower (35) for limiting movement of at least one flexible member (43) of the lock member (36) such that an axial movement with respect to the connector (20) cannot be applied, being disposed in the piercing device (30) for rotation around the axis of the main body (33) with respect to the connector (20).
To sum up; the first state (80), as can be seen in fig 8a, of the transfer device (100) in which the piercing device (30) and the connector (30) are connected with the at least one protrusion (41) formed on the lock member (36) by sliding in at least one protrusion guiding channel (29) provided at the connection portion (27) of the connector (20), and the piercing device (30) is rotatable around the longitudinal axis (A) with respect to the connector (20) but are not movable in an axial direction while the first flow path is closed by the first barrier member (37) and the second flow path is closed by the second barrier member (47) and the elevating member follower (35) blocks movement of the at least one flexible member (43). a second state (81), as can be seen in fig. 8b, which is established by rotating the piercing device (30) and the lock member (36) around the axis longitudinal axis (A) with respect to the connector (20) by guiding at least one protrusion (41) at the guiding window (21) from the first state, and in which said elevating member follower (35) is elevated along the way of at least one elevating member (28) provided on the connector (20) such that at least one flexible member (43) can be stretched backwards when an axial force is applied, the piercing device (30) is movable in the axial direction with respect to the connector (20). the third state (84), as can be seen in fig. 15, which is established by moving the piercing device (30) in the axial direction with respect to the connector (20) from the second state, and in which the needle (32) of needle holder (31) is inserted through the first barrier member (37) and the second barrier member (47) to communicate the first flow path and the second flow path with each other. As said before at least one engagement groove (56) formed in the main body (33) is coupled with at least one protrusion housing (26) of the connector (20) when transfer device is the third state (84) such that the rotating the piercing device (30) around the longitudinal axis (A) with respect to the connector (20) is prevented.
During closed drug transfer, air equal to the volume of drug drawn from the vial (10) should be sent into the vial and pressure difference created during transfer should be equalized. Accordingly, there is an equalization port (23) used extending out from the connector (20) and a filter (51) is connected to the equalization port (23).

Claims

A transfer device (100) for transferring fluids from a vial (10), comprising:
a piercing device (30) having a main body (33) in a tubular shape, a lock member (36) having at least one flexible member (43), at least one arm (42) for attaching said lock member (36) into the main body (33), at least one protrusion (41) formed on the lock member (36) being guidable in a guiding channel (29) and a guiding window (21) provided at a connection portion (27) of a connector (20),

a needle holder (31) having a needle (32) functioning as a first flow path through which a liquid can pass,

a first barrier member (37) disposed in the lock member (36) made of an elastic material for opening and closing the first flow path,

a connector (20) for attaching to the vial (10), comprising an inner portion having a lumen (99) which functions as a second flow path, at least one elevating member (28) has a portion of, at least partly, helix shape, and a second barrier member (47) disposed in the inner portion and is made of an elastic material for opening and closing the second flow path;

characterized in that; said transfer device (100) further comprises,

an elevating member follower (35) disposed in the main body (33) for limiting movement of the at least one flexible member (43) of the lock member (36) such that an axial movement of the piercing device with respect to the connector (20) is prevented, said elevating member follower (35) being rotatable around a longitudinal axis (A) of the piercing device (30) with respect to the connector (20) and guidable on the elevating member (28).
A transfer device (100) as in Claim 1, characterized in that said transfer device (100) includes a first state (80) in which the piercing device (30) and the connector (20) are connected with the at least one protrusion (41) formed in the lock member (36) by sliding in the at least one protrusion guiding channel (29), and the main body (33) of the piercing device (30) is rotatable around the longitudinal axis (A) of the piercing device (30) with respect to the connector (20) but is not movable in the axial direction while the first flow path is closed by the first barrier member (37) and the second flow path is closed by the second barrier member (47) and the elevating member follower (35) blocks movement of the at least one flexible member (43).
A transfer device (100) as in Claim 2, characterized in that said transfer device (100) includes a second state (81) which is established by the rotating the main body (33) around the longitudinal axis (A) of the piercing device (30) with respect to the connector (20) by guiding at least one protrusion (41) at the guiding window (21) and in which said elevating member follower (35) is elevated along the way of the elevating member (28) such that the at least one flexible member (43) can be stretched when the axial force with respect to the connector (20) is applied.
A transfer device (100) as in Claim 3, characterized in that said transfer device (100) includes a third state (84) which is established by moving the piercing device (30) in the axial direction with respect to the connector (20) from the second state (81), and in which the needle (32) of the needle holder (31) is inserted through the first barrier member (37) and the second barrier member (47) to communicate the first flow path and the second flow path with each other.
A transfer device (100) as in Claim 1, characterized in that said main body (33) comprises at least one engagement groove (56) for coupling with at least one protrusion housing (26) of the connector (20) such that the rotation of the main body (33) is prevented when the transfer device (100) is in the third state (84).
A transfer device (100) as in Claim 1, characterized in that said main body (33) comprises at least two rails (98) in which the lock member (36) is guided.
A transfer device (100) as in Claim 6, characterized in that said at least two rails (98) comprise at least two projections (97) for engaging with corresponding at least one arm protrusion (53).
A transfer device (100) as in Claim 1, characterized in that said elevating member follower (35) has a limiting portion (55) formed on an upper portion of the elevating member follower (35).
A transfer device (100) as in Claim 1, characterized in that further comprises a resilient member (34) has a portion of M-like shape for repositioning said elevating member follower (35).
A transfer device (100) as in Claim 9, characterized in that said resilient member has a resilient member needle hole (72) through which the needle (32) can pass, and a piercing portion (71) through which the needle (32) can pierce when an axial force with respect to the connector (20) is applied.
A transfer device (100) as in Claim 1, characterized in that said at least one flexible member (43) abuts to an abutting portion (88) of a holding portion (46) of the main body (33) when the transfer device (100) is in a first or second state (81, 82).
A transfer device (100) as in Claim 1, characterized in that said needle holder (31) has a treaded portion (38) to be connected, by threaded engagement, to a liquid container in which liquid can be contained.
A transfer device (100) as in Claim 1, characterized in that said transfer device (100) further comprises a needle holder (31a) can be attached to the main body (33) by welding along a welding portion (90).
A transfer device (100) as in Claim 1, characterized in that said transfer device (100) further comprises a needle holder (31b) having an outer wall (92) with at least one protrusion for engaging with at least one protrusion (91) extending outwardly from the main body (33).
A transfer device (100) as in Claim 1, characterized in that said transfer device (100) comprises a needle holder (31c) having at least two projections (94) for engaging with corresponding groove (93) formed on the main body (33).