FLUID TRANSFER DEVICE HAVING A PIERCING MEMBER

Description

Field of the Invention

[0001] The present invention relates to a fluid transferring device having improved safety and functional structure which ensures ease of manufacture. More particularly, the invention relates to an adapter device of the type having a piercing member for transferring of medicaments from one vessel to another with an improved functionality and safety while providing a specially designed spring member that simplifies manufacturing of the device.

Background Art

[0002] Liquid medicaments, prodrugs, biologic samples or diagnosis agents are generally stored in rigid or semi-rigid vessels such as bottles, vials or otherwise in plastic bags, and these sometimes need to be transferred very carefully in order to avoid spillage of the liquid material as well as vapour thereof which can be detrimental for the health of medical stuff as well as the patient. Therefore, it has long been a challenge in the medical device sector to provide functionally improved and safe medical adapters and medication transfer devices with the objective of maximal sealing from the surroundings.

[0003] Due to the large number of vials and connectors available today that have a pierceable septum, there is a continuing need to provide adaptors designed to have access to the said kind of vials and connectors without suffering of the well-known drawbacks. A fluid transfer device of the kind that has a piercing member enclosed in a protection chamber is disclosed in WO 2008/136720 A1 wherein first and second connection parts are rotatably engaged to each other in order to provide safer handling and administration of drugs and other medical substances. This arrangement has several drawbacks in terms of safety, production and use. The device for instance comprises several components slidable along an axis and rotatable in radial direction which apparently increase complexity and production costs. The need to activate the device by movement in both longitudinal and radial directions increases also complexity of using the device, and this would be undesirable for the physician and nursing staff that usually prepare several doses in a day.

[0004] A more simplified device for transferring of medicaments is disclosed in WO 03/086530 A1 wherein the device exhibits a first end and a second end for attachment to a bottle and infusion port, respectively. This device however, is not suitable to be used with a syringe and it further suffers of several drawbacks because the device is still complicated with its telescopically arranged structure and is also lacking of a safety measure against unintentional exposure of the needle outside as well as leakage or spillage of the medical agent after removal of the device from the liquid transfer assembly.

[0005] EP 0 888 794 A2 discloses a fluid transfer device having an access cannula and blunt cannula wherein a spring means is provided for helping to position said access cannula within the passageway of the blunt cannula. The spring means can be a coil spring or can be made of an elastic material which can seal, to a certain extent, surrounding of the cannula. The fluid transfer device is nevertheless insufficient for satisfactory sealing at proximal end where access cannula is operated. As shown in Figure 7, there is provided no locking means at the side of the access cannula in transferring of liquid, for instance from a vial, which can eventually result in spillage and exposure to surroundings the liquid to be transferred.

[0006] To provide a solution to aforesaid problems of conventional devices, US 2013/0006200 A1 for instance discloses a female piercing member protection device for connection with a male connection part in order to avoidance of undesired exposure to and leakage of hazardous medicaments, although the female part is always in need of being used together with the corresponding male part for safety concerns. Because the tip of the piercing member, i.e. the needle, is kept in between barriers of female and male parts in inactivated position, the female part per se is not suitable to be used alone, and therefore is not flexible enough to be used with different varieties of vessels, vials, plastic bags, adapters etc. Moreover, the device is still complicated enough in terms of use and production. The activated position, for instance can only be reached when the outer casing has been turned to a second position, and the connection member is moved along the longitudinal axis (A).

[0007] A well known type of snap-fit like connection for easy mantling and dismantling of a device is disclosed in WO 2009/090627 which involves two bores in different diameters wherein a plurality of resilient leaves are provided in an expanded position within the larger bore, which however are squeezed upon moving into the narrower bore. Connection principles of this fashion are also known in earlier patents such as US 4,895,570 and EP 0 367 549 which all the way suffer at least one of the problems mentioned above.

[0008] WO 96/00053 describes another fluid transfer device comprising a hollow piercing element

[0009] Therefore, there exist a continuing need in prior art to provide fluid transfer devices that have improved safety, and particularly ease of use and manufacturing as well as flexibility to be used with large variety of vessels, adapters, and connectors. The objectives of the current invention are achieved through a fluid transfer device as defined in claim 1 and a kit of parts comprising the said fluid transfer device according to claim 12.

Brief Description of the Figures

[0010] The figures as referred to hereinbelow are mainly for illustrating the basic embodiments, and they should not be construed as limiting the present invention.

Figure 1 shows a cross-sectional view of the fluid transfer device (1) according an embodiment of the present invention.

Figure 2 shows an assembly comprising the fluid transfer device (1) of the present invention, for transferring of a liquid from a vial (300) to an injection device (100) wherein the device (1) is in activated position.

Figures 3a, 3b and 3c show different views of the spring member (11) belonging to the device (1) according to an embodiment of the present invention.

Figure 4 shows a mode of fluid transfer from a vial (300) to an injection device (100) by using an aeration cannula adapter (200) and the fluid transfer device (1) according to the present invention.

Figure 5 shows a proper functioning of the fluid transfer device (1) according to the present invention.

Figure 6 demonstrates safety level in case of a malfunctioning of the fluid transfer device (1) according to this invention.

Figures 7 and 8 show the use of different aeration cannula adapters (200) in combination with the fluid transfer device (1) of the current invention.

Figure 9 shows a further embodiment of the fluid transfer device (1) with clips associated with locking members (5).

Figures 10 and 11 show a different use of the device (1) in combination with an adapter (500) having two inlet ports.

Figure 12 shows a spike adapter (600) that can be used with the device (1) of the present invention.

Figure 13 shows another use involving the device (1) and a spike adapter (700) having two inlet ports for transferring of a medicament from an injection device (100) to a plastic bag (400) and subsequently transferring the same from the plastic bag (400) to another vessel or directly to a patient.

Figure 14 shows a spike adapter as used in Fig. 13 having a port (720) for connection to the device (1) and having another port (710) for connection to the plastic bag (400).

Summary of the Invention

[0011] The present invention relates to a fluid transfer device (1) comprising an outer casing (6), a proximal end (8), a piercing member (3), a pierceable seal (4) arranged against said piercing member (3) and a distal end (D) with a number of locking members (5). Said piercing member (3) that is partially held in a channel (2) extends from the proximal end (8) longitudinally through the distal end (D) to provide a fluid passageway therebetween in an activated position of the device (1).

[0012] The device (1) of the present invention further comprises a spring member (11) made of an elastic material extending from the proximal end (8) longitudinally through the distal end (D) in a manner surrounding the piercing member (3) in fluid tight fashion and forming an inner through channel (22) therein. Said spring member (11) comprises an upper portion (12), a sealing portion (13), and a number of locking members (14) in close proximity to the said distal end (D), wherein said upper portion (12), sealing portion (13), and locking members (14) are integrally molded as a one piece unit. Said upper portion (12) is flexible such that being movable between an activated position (dawn) and deactivated position (up). Said locking members (14) comprise a claw like structure that is tightly squeezed around the surface to be connected in an activated position of the device (1). The locking members (14) preferably comprise a ring shaped protrusion (21) surrounding, in horizontal direction, the said locking members (14).

[0013] The device (1) of the present invention has a hallow inner surface, and is preferably having groove (22) corresponding to the aforesaid protrusion (21). This groove (22) receives the protrusion (21) in a deactivated position of the device (1) as shown in Fig. 1. When the device (1) is engaged, for instance on an adapter (200) as shown in Fig. 2, and is pushed downwardly for activation of the device (1), the protrusion (21) of the locking members (14) dismantles from the corresponding groove (22) causing an inwardly bending of the locking members (14) and providing a squeezing function. In this position upper portion (12) of the spring member (11) becomes loaded such that the device (1) has a double locking by surrounding the corresponding protrusions on another vial, adapter or valve by means of the locking members (5) of the casing (6) and locking members (14) of the spring member (11), whereby said piercing member (3) pierces the pierceable seal (4) and is exposed to the said vial, adapter or valve.

[0014] According to a preferred embodiment of the present invention the piercing member (3) is arranged in a position pricked within the pierceable seal (4) when the device (1) rests in a deactivated position. The proximal end (8) of the device (1) is also configured to make a female connection with for instance an injection device, more particularly with a standard syringe device. Still in a preferred embodiment said flexible upper portion (12) is formed as a bellow which is advantageous for obtaining a more stable flexibility. The sealing portion (13) of the spring member (11) comprises a seat for housing the pierceable seal (4) such that the piercing member (3) is isolated from outside within the through channel (23) of the spring member (11).

Detailed Description of the Invention

[0015] The present invention is disclosed in more detail with reference to different embodiments hereinbelow. The invention is mainly directed to a fluid transfer device (1) in the form of an adapter which can be used for instance as a conduit in between several components known in the art, for instance syringes, vials, bottles, plastic bags, cannulas and various adapters used for transferring of liquids, more preferably of medicaments or any biological liquids from one storage medium to another. The device according to the present invention is particularly suitable for use in transferring of hazardous medicaments or biologic material, exposure to which causes undesirable health risks in medical staff and patients.

[0016] Referring to Fig. 1, the fluid transfer device (1) of the present invention comprises a tubular rigid casing (6) which optionally includes a clips (7) (Fig. 9) for dismantling of the locking members (5) after the transferring operation. Said clips (7) may be preferable as it helps easily to move away another device (e.g. vial, cannula, bottle or any adapter) after usage, and it also prevents unintentional detachment of the device (1) from another vial or adapter.

[0017] The fluid transfer device (1) of the current invention further comprises a proximal end (8) and a distal end (D) that provide fluid tight connection to other devices and vessels. In a preferred embodiment said proximal end (8) is of the type of a female connection part, preferably threaded in order to, for instance fixedly connect to an injection device (100) (e.g. syringe) as shown in Figure 2. However, as those skilled in the art would appreciate, this proximal end (8) may be adapted to make connection to any vial, syringe or adapter such that a fluid tight connection in transfer of fluid is achieved.

[0018] According to the present invention, there is provided a piercing member (3) and a spring member (11) extending longitudinally inside the rigid casing (6). The spring member (11) itself surrounds the piercing member (3) such that it is isolated from casing (6) of the device (1) and is operated within the through channel (23) of the spring member (11). Said spring member (11) mainly comprises an upper portion (12), a sealing portion (13) and a number of locking members (14) preferably in the form of claws. The spring member (11) having the components above is made of an elastic material such as natural rubber, synthetic rubber or thermoplastic elastomer, but more preferably of thermoplastic polyurethane (TPU). The upper portion (12) extending longitudinally inside the casing (6) is preferably formed as a bellow which is found to be the most advantageous configuration for easy and stable movement of the device (1) during activation and deactivation positioning upon another device.

[0019] In one aspect of the present invention, said upper portion (12), sealing portion (13) and the locking members (14) of the spring member (11) are integrally molded to have a one piece structure. This is not only advantageous for ease of manufacturing but also provides a perfectly sealed and safe arrangement during operation and post-operation of the device (1). Referring again to Fig. 1, where the device (1) rests in a deactivated position, the spring member (11) remains unloaded. Tip portion (9) of the piercing member (3), is also secured in deactivated position inside the through channel (23) of the spring member (11). In a preferred embodiment, the tip portion (9) in this position is arranged to be pricked into the pierceable seal (4) that is placed in a sealing seat within the seal portion (13) of the spring member (11). The details of the spring member (11) can be seen in detail in Figures 3a, 3b and 3c.

[0020] The spring member (11) of the current invention has a proximal end (19) having an enlarged width or radius compared to the upper portion (12) that enables fixation in between the needle holder (10) and casing (6) of the fluid transfer device (1). This is preferably the only fixation point of said spring member (11) inside the casing (6) which enables a very easy production procedure and avoidance of complicated components.

[0021] According to the first aspect of the invention mentioned above, the fluid transfer device (1) may for instance be used in transferring of a liquid medicament from a vial (300) to an injection device (100) or vice versa, as shown in Figures 2. In this mode of use, the proximal end (8) of the device (1) can be coupled to the injection device (100) while the distal end (D) is coupled to an adapter (200). These kind of adapters are well known in the art as for instance disclosed in WO 2010/069359 and WO 2013/119823 which primarily function for piercing of an elastic collar of a vial (300) by way of a cannula (201), replacement of the medicament inside the vial (300) with air, and at the same time filtering or isolation of the air and medicament from contaminants. In this instance, the proximal end (8) of the fluid transfer device (1) can be adopted for connection to a tip portion of the conventional syringes which can be used as an injection device (100).

[0022] Referring again to Figure 2 together with Fig. 1, the fluid transfer device (1) of the current invention, when placed on an adapter-vial arrangement, can be easily activated by a simple longitudinal force in which case a top portion or top sealing (204) of the adapter (200) abuts to the sealing portion (13) of the spring member (11) as well as to the pierceable sealing (4) located therein. As the longitudinal force is downwardly applied, the spring member (11), particularly upper portion (12) thereof is loaded and compressed which eventually causes the piercing member (3) to move distally along the pierceable seal (4) and to be exposed through inside of the adapter (200) as shown in Fig. 2. In the meantime, it should be noted that both the locking members (14) of the spring member (11) and locking members (5) of the casing (6) are engaged to corresponding protrusions (202, 203) of the adapter (200) to provide a "double locking". Therefore, a perfectly secured arrangement is provided in a fluid tight manner by applying a force only in "one direction". The flow of the liquid from the vial (300) to the injection device (100) is illustrated in Fig. 4. The white arrows in this figure represent the air flow while the black arrows represent the liquid flow. As shown, the cannula of the adapter (200) includes a liquid passageway (205) and air passageway (206) for transfer of the liquid through the device (1) properly. It is mostly desirable to prevent any contamination to be mixed with the liquid inside the vial (300) via air that is drawn with the adapter (200). For this purpose, an air supply means (207) would be desirable that can provide clean air into the system. The air supply means (207) can be of any type such as a filter type as in Fig. 7, or a receptacle type as shown in Fig. 8 or a combination of both. The receptacle types can be flexible (e.g. bellow) that contain prefilled clean air to be supplied into the vial (300) for purposes of pressure equalizing. A filter type air supply means (207) is particularly preferred as it provides a more compact structure and practical use. The filter can have apertures of 0.1 to 0.7 µm, more particularly of about 0.2 µm which can substantially clean the air from contaminants.

[0023] The device (1) can be deactivated and detached after completion of the fluid transfer similarly by applying an inverse longitudinal force only in one direction. In case a clips (7) arrangement connected to the locking members (5) is used (Fig. 9), the user may easily dismantle said locking members (5) via said clips (7), in which case said device (1) automatically turns into the normal position of Fig. 1, without needing of any other rotational movement, where the piercing member (3) turns into a perfectly secured and sealed position. By virtue of the automatic deactivation and sealing manner as mentioned above, spillage of liquid or vapor is completely eliminated, and further the risk of accidental exposure of the piercing member (3) is also overcome. As may be appreciated by those skilled in the art, medical staff is usually encountered with problems such as unintentional pushing of the syringe's piston or accidentally dropping the same on the ground which frequently causes again spillage of the medicament. These accidental problems are also eliminated because once the device (1) is detached from the connector (200) and deactivated in an automatic manner by retraction of the spring member (11), there becomes no more possible to transfer a fluid through the device (1).

[0024] To elaborate further one of the gists of the invention, namely the one piece spring member (11) having the flexible upper portion (12), sealing portion (13) and locking members (14) integrally molded, reference is made again to Figs. 3a, 3b and 3c showing the spring member (11) in different perspectives. As noted above distal end (D) of the fluid transfer device (1) according to the present invention is configured as a female connection part, and therefore locking members (14) of the spring member (11) are also arranged as a female connection part that provide an additional locking means (i.e. double locking) of the device (1). As exemplified above, the double locking can be realized upon the corresponding protrusions (202, 203) on an adapter or even on a vial. Once the locking is accomplished the spring member (11) itself functions as a seal isolating the piercing member (3) from the external casing (6) and outside.

[0025] Hence, according to another aspect of the present invention the sealing portion (13) of the spring member (11) is provided with a special arrangement as shown in detail with Fig. 3c. This arrangement mainly comprises an outer wall (17) and an inner wall (16) which are concentrically formed and having a spacing (15) therebetween. The spacing (15) as mentioned herein is adapted to receive a corresponding protrusion (203) of an adapter or vial. As may be appreciated by those skilled in the art, locking of an elastic member such as the locking members (14) of the spring member (11) according to this invention to a corresponding protrusion (203) of an adapter or vial could be problematic because the elastic claws would not be rigid enough to grip the said protrusion (203) which would likely result in a malfunction in terms of sealing and locking. The present invention solves this additional problem by a specially arranged locking members (14) as an integral part of the spring member (11), comprising a ring shaped protrusion (21) that is normally accommodated in a corresponding groove (22) of the casing (6). This arrangement advantageously enables the technical effect that once the device (1) is activated and spring member (11) is loaded, the protrusion (21) of the locking members (14) dismantles from the corresponding groove (22) and moves upwardly causing inwardly bending of the locking members (14) such that squeezing around the periphery of a male connection port (e.g. a collar or protrusion; 203) of another device.

[0026] More specifically, once the fluid transfer device (1) is pushed upon an adapter (200) for instance, the longitudinal force causes the spring member (11) to be loaded and moved proximally in the direction of the proximal end (8), where in this instance the locking members (14) of the spring member (11) are squeezed to a certain extent in central direction. A connection of this fashion constitutes a first locking which is also sealing an opening of the said male connection part, whereas the locking members (5) of the casing (6) provides an additional lock function on a corresponding protrusion (202). The latter locking means fixes the overall device (1) to the adapter (200) or where appropriate to a vial (300) such that the loaded spring member (11) does not cause a detachment without intention of the user.

[0027] As a consequence, a perfectly sealed arrangement is achieved through a one piece spring member (11) which can be easily assembled to the casing (6) of the fluid transfer device (1). Unlike the state of the art devices, the device (1) of the current invention provides an excellent safety without needing extra locking means operated by complicated components and movement in different axis (i.e. transversally or radially). The spring member (11) which acts also as a sealing around the piercing member (3) is also advantages even in malfunction of the pierceable seal (4) of the device (1). This is best illustrated in Figures 5 and 6 which show proper and malfunction states of the system, respectively. As can be seen in Fig. 6, the spring member (11) successfully stores the liquid within the through channel (23) without any leakage to the casing (6).

[0028] Although the fluid transfer device (1) of the present invention is described in an exemplary system containing a vial (300), adapter (200) and an injection device (100), it can also be used in other systems, for instance for transferring of liquid medicament from a vial (300) to another vessel such as a plastic bag (400). An adapter (500; 700) with two inlet ports can advantageously be used as shown in Figures 10, 11, 13 and 14 for transferring of a liquid into two different receptacles.

[0029] In a more particular embodiment, a medicament for instance can be transferred from a vial (300) to any receptacle such as a plastic bag as shown in the configuration of Figures 10 and 11. In this arrangement the adapter (500) is adapted to operate with one injection device (100) and two fluid transfer devices (1) according to the present invention. The adapter (500) having two inlets can for instance be connected to the fluid transfer devices (1) via first and second ports (501, 502) with a luer lock connection style from the proximal ends (8) of the devices (1) wherein one of the devices (1) is connected to a vial (300) and the other is adapted to connect to a plastic bag (not shown) via a spike adapter (600). It should be noted that any kind of adapter that is connected to the distal end (D) of the device (1) such as the one mentioned above is needed to have circumferential protrusions (602, 603) in order to achieve a "double locking" connection as identified in foregoing sections. This is simply because the first protrusion (602) is designed to engage with locking members (5) of the casing (6) and the other protrusion (603) is designed to engage with locking members (14) of the spring member (11). In this way, a medicament in a vial (300) can be transferred into another receptacle (e.g. plastic bag) by drawing it firstly into the injection device (100) and then injecting the same through the adapter (500) to another fluid flow way without detachment of the any of the devices within the assembly.

[0030] In another embodiment of the current invention the liquid medicament is transferred from the injection device (100) to a receptacle (400) (e.g. plastic bag) which release the said medicament in a predetermined dosage rate to a patient as shown in Fig. 13. The dashed arrows show the direction of the fluid flow within this assembly. Accordingly a spike adapter (700) with two inlet ports as shown in Fig. 14 is used for this purpose. Said adapter (700) may comprise a cannula (710) that is adapted to engage to a hose of the receptacle (400) while one of the ports (720) is also adapted to engage with the fluid transfer device (1) according to the present invention by way of locking to the protrusions (721, 722) provided circumferentially on the relevant port (720). The other port (730) of the adapter (700) may be adapted to engage with a further port delivering the medicament to the patient.

[0031] As exemplified above in connection with different embodiments, the fluid transfer device (1) according to the present invention can be used with various fluid transfer systems including various components such as injection devices (100), vial adapters (200), adapters with two inlets (500, 700), and spike adapters (600).

[0032] It is therefore an aspect of the present invention to provide a kit of parts comprising;

• a fluid transfer device (1) in accordance with the present invention,
• at least one injection device (100) that is adapted to engage in a fluid tight manner to the proximal end (8) of the fluid transfer device (1), and
• at least one adapter (200, 500, 600, 700) adapted to engage with the fluid transfer device (1).

[0033] According to this aspect, at least one adapter comprises a first circumferential protrusion (202; 602; 721) that is adapted to engage with locking members (5) of the casing (6), and a second circumferential protrusion (203; 603; 722) adapted to be engaged with locking members (14) of the spring member (11) at a distal end (D) of the fluid transfer device (1).

[0034] According to this aspect the kit of parts preferably contains an adapter (500; 700) with two inlet ports at least one port of which is adapted to be engaged in a double locking manner with the fluid transfer device (1) of the present invention.

[0035] Further aspects and variations of the present invention will become apparent to those skilled in the art in view of the foregoing description and appended claims.

Claims

1. A fluid transfer device (1) comprising an outer casing (6), a proximal end (8), a piercing member (3), a pierceable seal (4) arranged against said piercing member (3) and a distal end (D) with a number of locking members (5); said piercing member (3) extending from the proximal end (8) longitudinally through the distal end (D) to provide a fluid passageway therebetween in an activated position of the device (1);
wherein the device (1) further comprises a spring member (11) made of an elastic material extending from the proximal end (8) longitudinally through the distal end (D) in a manner surrounding the piercing member (3) in fluid tight fashion and forming an inner through channel (23) therein, said spring member (11) comprising an upper portion (12), a sealing portion (13), and a number of locking members (14) in close proximity to the said distal end (D), that are integrally molded as a one piece unit; said upper portion (12) being flexible such that being movable between an activated position and deactivated position, and
wherein the device (1) being operable between said activated and deactivated positions, said device (1) being activated by a longitudinal force to load the spring member (11) whereby the device (1) having a double locking by surrounding the corresponding protrusions on another vial, adapter or valve by means of the locking members (5) of the casing (6) and locking members (14) of the spring member (11).

2. A fluid transfer device (1) according to claim 1 wherein the piercing member (3) is arranged in a position pricked within the pierceable seal (4) when the device (1) rests in a deactivated position.

3. A fluid transfer device (1) according to claim 1 wherein the proximal end (8) of the device (1) is configured to make a female connection.

4. A fluid transfer device (1) according to claim 1 wherein said flexible upper portion (12) is formed as a bellow.

5. A fluid transfer device (1) according to claim 1 wherein the sealing portion (13) of the spring member (11) comprises a seat for housing the pierceable seal (4) such that the piercing member (3) is isolated from outside within the through channel (23) of the spring member (11).

6. A fluid transfer device (1) according to claim 1 wherein the sealing portion (13) comprises concentrically formed inner wall (16) and outer wall (17) forming a spacing (15) therebetween.

7. A fluid transfer device (1) according to claim 1 wherein the locking members (14) of the spring member (11) are formed in the shape of claws.

8. A fluid transfer device (1) according to claim 7 wherein the locking members (14) of the spring member (11) comprise ring shaped circumferential protrusion (21) and said outer casing (6) comprising a groove (22) receiving said protrusion (21) whereby said protrusion (21) is dismantled from the corresponding groove (22) in an activated position of the device (1) such that inwardly bending said locking members (14) in order to squeeze the corresponding protrusions on another vial, adapter or valve.

9. A fluid transfer device (1) according to claim 1 wherein the upper portion (12) of the spring member (11) comprises an expanded end portion (19) in order to be restricted between the outer casing (6) and a needle holder (10) for fixation of the spring member (11) within the fluid transfer device (1).

10. A fluid transfer device (1) according to claim 3 wherein proximal end (8) of the device (1) is configured to make a luer locking with an injection device (100).

11. A fluid transfer device (1) according to claim 1 wherein the outer casing (6) comprises a clips (7) associated with the locking members (5).

12. A kit of parts comprising;

- a fluid transfer device (1) according to any of the preceding claims,

- at least one injection device (100) that is adapted to engage in a fluid tight manner to the proximal end (8) of the fluid transfer device (1), and

- at least one adapter (200, 500, 600, 700) adapted to engage with the fluid transfer device (1).

13. A kit of parts according to claim 12 wherein at least one adapter (200, 500, 600, 700) comprises a first circumferential protrusion (202; 602; 721) that is adapted to engage with locking members (5) of the casing (6), and a second circumferential protrusion (203; 603; 722) adapted to be engaged with locking members (14) of the spring member (11) at a distal end (D) of the fluid transfer device (1).

14. A kit of parts according to claim 12 wherein the kit of parts comprises an adapter (500; 700) having two inlet ports, at least one port of which is adapted to be engaged in a double locking manner with the fluid transfer device (1).

15. A kit of parts according to claim 14 wherein the kit of parts comprises a spike adapter (600; 700) adapted to engage with a plastic bag, whereas at least one port of said adapter (600; 700) being adapted to be engaged in a double locking manner with the fluid transfer device (1).

Ansprüche

1. Flüssigkeitsübertragungsvorrichtung (1) mit einem äußeren Gehäuse (6), einem proximalen Ende (8), einem Durchstechelement (3), einer durchstechbaren Dichtung (4), die gegen das Durchstechelement (3) angeordnet ist, und einem distalen Ende (D) mit einer Anzahl von Verriegelungselementen (5); wobei sich das Durchstechelement (3) von dem proximalen Ende (8) in Längsrichtung durch das distale Ende (D) erstreckt, um in einer aktivierten Position der Vorrichtung (1) einen Flüssigkeitsdurchgang dazwischen zu schaffen;
wobei die Vorrichtung (1) ferner ein Federelement (11) aus einem elastischen Material aufweist, das sich in einer das Durchstechelement (3) flüssigkeitsdicht umgebenden Weise von dem proximalen Ende (8) in Längsrichtung durch das distale Ende (D) erstreckt und in seinem Inneren einen inneren Durchgangskanal (23) bildet, wobei das Federelement (11) einen oberen Bereich (12), einen Dichtungsbereich (13) und eine Anzahl von Verriegelungselementen (14) in unmittelbarer Nähe zu dem genannten distalen Ende (D) aufweist, die in Form einer einstückigen Einheit in integraler Weise durch Formen gebildet sind; wobei der obere Bereich (12) flexibel ist, so dass er zwischen einer aktivierten Position und einer deaktivierten Position beweglich ist, und
wobei die Vorrichtung (1) zwischen der aktiviertem und der deaktivierten Position betätigbar ist, wobei die Vorrichtung (1) durch eine Längskraft aktiviert wird, um das Federelement (11) zu spannen, wobei die Vorrichtung (1) eine Doppelverriegelung aufweist, indem sie die entsprechenden Vorsprünge an einem weiteren Fläschchen, Adapter oder Ventil mittels der Verriegelungselemente (5) des Gehäuses (6) und der Verriegelungselemente (14) des Federelements (11) umschließt.

2. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei das Durchstechelement (3) in einer in die durchstechbare Dichtung (4) eingestochenen Position angeordnet ist, wenn sich die Vorrichtung (1) in einer deaktivierten Position befindet.

3. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei das proximale Ende (8) der Vorrichtung (1) zum Herstellen einer aufnehmenden Verbindung ausgebildet ist.

4. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei der flexible obere Bereich (12) als Faltenbalg ausgebildet ist.

5. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei der Dichtungsbereich (13) des Federelements (11) einen Sitz zur derartigen Unterbringung der durchstechbaren Dichtung (4) aufweist, dass das Durchstechelement (3) innerhalb des Durchgangskanals (23) des Federelements (11) von der äußeren Umgebung isoliert ist.

6. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei der Dichtungsbereich (13) in konzentrischer Ausbildung eine Innenwand (16) und eine Außenwand (17) aufweist, die dazwischen einen Abstand (15) bilden.

7. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei die Verriegelungselemente (14) des Federelements (11) in Form von Klauen ausgebildet sind.

8. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 7,
wobei die Verriegelungselemente (14) des Federelements (11) einen ringförmigen umlaufenden Vorsprung (21) aufweisen und das äußere Gehäuse (6) eine den Vorsprung (21) aufnehmende Nut (22) aufweist, wobei der Vorsprung (21) in einer aktivierten Position der Vorrichtung (1) aus der entsprechenden Nut (22) entfernt ist und die Verriegelungselemente (14) dadurch nach innen gebogen sind, um die entsprechenden Vorsprünge an einem weiteren Fläschchen, Adapter oder Ventil mit Druck zu beaufschlagen.

9. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei der obere Bereich (12) des Federelements (11) einen erweiterten Endbereich (19) aufweist, der zur Fixierung des Federelements (11) in der Flüssigkeitsübertragungsvorrichtung (1) zwischen dem äußeren Gehäuse (6) und einem Nadelhalter (10) festgelegt ist.

10. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 3,
wobei das proximale Ende (8) der Vorrichtung (1) zur Herstellung einer Luer-Verriegelung mit einer Injektionsvorrichtung (100) ausgebildet ist.

11. Flüssigkeitsübertragungsvorrichtung (1) nach Anspruch 1,
wobei das äußere Gehäuse (6) Klammern (7) aufweist, die den Verriegelungselementen (5) zugeordnet sind.

12. Teilesatz, aufweisend:

- eine Flüssigkeitsübertragungsvorrichtung (1) nach einem der vorhergehenden Ansprüche,

- mindestens eine Injektionsvorrichtung (100), die dazu ausgebildet ist, in flüssigkeitsdichter Weise mit dem proximalen Ende (8) der Flüssigkeitsübertragungsvorrichtung (1) in Eingriff zu treten, und

- mindestens einen Adapter (200, 500, 600, 700), der zur Ineingriffnahme mit der Flüssigkeitstransfervorrichtung (1) ausgebildet ist.

13. Teilesatz nach Anspruch 12,
wobei mindestens ein Adapter (200, 500, 600, 700) einen ersten umlaufenden Vorsprung aufweist (202; 602; 721) aufweist, der zur Ineingriffnahme mit Verriegelungselementen (5) des Gehäuses (6) ausgebildet ist, sowie einen zweiten umlaufenden Vorsprung (203; 603; 722) aufweist, der zur Ineingriffnahme mit Verriegelungselementen (14) des Federelements (11) an einem distalen Ende (D) der Flüssigkeitsübertragungsvorrichtung (1) ausgebildet ist.

14. Teilesatz nach Anspruch 12,
wobei der Teilesatz einen Adapter (500; 700) mit zwei Einlassöffnungen aufweist, wobei mindestens eine Öffnung davon dazu ausgebildet ist, mit der Flüssigkeitsübertragungsvorrichtung (1) in Doppelverriegelungsweise in Eingriff zu treten.

15. Teilesatz nach Anspruch 14,
wobei der Teilesatz einen Dorn-Adapter (600; 700) aufweist, der zur Ineingriffnahme mit einem Kunststoffbeutel ausgebildet ist, während mindestens eine Öffnung des Adapters (600; 700) dazu ausgebildet ist, mit der Flüssigkeitsübertragungsvorrichtung (1) in Doppelverriegelungsweise in Eingriff zu treten.

Revendications

1. Dispositif de transfert de fluide (1), comprenant une enveloppe externe (6), une extrémité proximale (8), un élément de perçage (3), un joint d'étanchéité à percement (4) agencé contre ledit élément de perçage (3) et une extrémité distale (D) avec plusieurs éléments de verrouillage (5); ledit élément de perçage (3) s'étendant à partir de l'extrémité proximale (8), longitudinalement à travers l'extrémité distale (D), pour établir un passage de fluide entre elles dans une position activée du dispositif (1) ;
dans lequel le dispositif (1) comprend en outre un élément de ressort (11) composé d'un matériau élastique, s'étendant à partir de l'extrémité proximale (8), longitudinalement à travers l'extrémité distale (D), de sorte à entourer l'élément de passage (3) de manière étanche au fluide, et y formant un canal traversant interne (23), ledit élément de ressort (11) comprenant une partie supérieure (12), une partie d'étanchéité (13) et plusieurs éléments de verrouillage (14) à proximité étroite de ladite extrémité distale (D), moulés intégralement sous forme d'une unité d'une seule pièce ; ladite partie supérieure (12) étant flexible, de sorte à pouvoir être déplacée entre une position activé et une position désactivée, et
dans lequel le dispositif (1) peut fonctionner entre lesdites positions activée et désactivée, ledit dispositif (1) étant activé par une force longitudinale pour charger l'élément de ressort (11), le dispositif (1) comportant ainsi un double verrouillage en entourant les saillies correspondantes sur un autre flacon, adaptateur ou soupape, par l'intermédiaire des éléments de verrouillage (5) de l'enveloppe (6) et des éléments de verrouillage (14) de l'élément de ressort (11).

2. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel l'élément de perçage (3) est agencé dans une position piquée dans le joint d'étanchéité à percement (4) lorsque le dispositif (1) reste dans une position désactivée.

3. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel l'extrémité proximale (8) du dispositif (1) est configurée de sorte à établir une connexion femelle.

4. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel ladite partie supérieure flexible (12) a la forme d'un soufflet.

5. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel la partie d'étanchéité (13) de l'élément de ressort (11) comprend un siège pour loger le joint d'étanchéité à percement (4), de sorte que l'élément de perçage (3) est isolé de l'extérieur dans le canal traversant (23) de l'élément de ressort (11).

6. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel la partie d'étanchéité (13) comprend une paroi interne (16) et une paroi externe (17) formées de manière concentrique, formant un espace (15) entre elles.

7. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel les éléments de verrouillage (14) de l'élément de ressort (11) ont la forme de griffes.

8. Dispositif de transfert de fluide (1) selon la revendication 7, dans lequel les éléments de verrouillage (14) de l'élément de ressort (11) comprennent une saillie circonférentielle de forme annulaire (21), ladite enveloppe externe (6) comprenant une rainure (22) recevant ladite saillie (21), ladite saillie (21) étant ainsi démontée de la rainure correspondante (22) dans une position activée du dispositif (1), de sorte à fléchir vers l'intérieur lesdits éléments de verrouillage (14) en vue de presser les saillies correspondantes sur un autre flacon, adaptateur ou soupape.

9. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel la partie supérieure (12) de l'élément de ressort (11) comprend une partie d'extrémité élargie (19) afin de la limiter entre l'enveloppe externe (6) et un porte-aiguille (10) en vue de la fixation de l'élément de ressort (11) dans le dispositif de transfert de fluide (1).

10. Dispositif de transfert de fluide (1) selon la revendication 3, dans lequel l'extrémité proximale (8) du dispositif (1) est configurée de sorte à établir un verrouillage Luer avec un dispositif d'injection (100).

11. Dispositif de transfert de fluide (1) selon la revendication 1, dans lequel l'enveloppe externe (6) comprend des pinces (7) associées aux éléments de verrouillage (5).

12. Kit de pièces, comprenant :

un dispositif de transfert de fluide (1) selon l'une quelconque des revendications précédentes ;

au moins un dispositif d'injection (100), adapté pour s'engager de manière étanche au fluide dans l'extrémité proximale (8) du dispositif de transfert de fluide (1), et

au moins un adaptateur (200, 500, 600, 700) adapté pour s'engager dans le dispositif de transfert de fluide.

13. Kit de pièces selon la revendication 12, dans lequel au moins un adaptateur (200, 500, 600, 700) comprend une première saillie circonférentielle (202 ; 602 ; 721) , adaptée pour s'engager dans des éléments de verrouillage (5) de l'enveloppe (6), et une deuxième saillie circonférentielle (203 ; 603 ; 722), adaptée pour s'engager dans les éléments de verrouillage (14) de l'élément de ressort (11) au niveau d'une extrémité distale (D) du dispositif de transfert de fluide (1).

14. Kit de pièces selon la revendication 12, dans lequel le kit de pièces comprend un adaptateur (500 ; 700) comportant deux orifices d'entrée, au moins un des orifices étant adapté pour s'engager d'une manière à double verrouillage dans le dispositif de transfert de fluide (1).

15. Kit de pièces selon la revendication 14, dans lequel le kit de pièces comprend un adaptateur de perforateur (600 ; 700) adapté pour s'engager dans un sac plastique, au moins un orifice dudit adaptateur (600 ; 700) étant adapté pour s'engager d'une manière à double verrouillage dans le dispositif de transfert de fluide (1).

Drawing