阅读说明：本技术 保障器件联接安全性的装置 (Device for securing connection of components ) 是由 马里诺·克里赫里 拉南·塔沃 于 2018-11-15 设计创作，主要内容包括：本发明公开了一种保障公-母连接安全性的装置,包括：(a)母连接器,其进一步包括固定调节器部分；(b)公连接器；(c)一个或多个锚固凸台；和(d)至少一个可转动的齿轮。(The invention discloses a device for guaranteeing the safety of male-female connection, which comprises: (a) a female connector further comprising a fixed adjuster portion; (b) a male connector; (c) one or more anchoring bosses; and (d) at least one rotatable gear.)

1. An apparatus for securing a male-female connection, comprising:

(a) a female connector further comprising a fixed adjuster portion;

(b) a male connector;

(c) one or more anchoring bosses; and

(d) at least one rotatable gear.

2. The device of claim 1, wherein the rotatable gear comprises or is attached to a hollow portion adapted to receive anchoring bosses provided on opposite sides thereof.

3. The apparatus of claim 2, wherein a slit is formed in the gear such that the hollow portion is provided with an opening, a direction of which changes with rotation of the gear.

4. The apparatus of claim 2, comprising at least one or more sprockets disposed about a periphery of the gear.

5. The device of claim 1, wherein at least one or more steps are formed on the female connector.

6. The device of claim 1, wherein at least one or more steps are formed on the male connector and the steps are adapted to move relative to the gear as the male connector slides within the female connector.

7. The device of claim 5, wherein at least one guide rail or guide is formed inside the female connector.

8. A device as claimed in claim 6, wherein a track is provided between the rail or guide and the step or steps along which the gear can travel longitudinally.

9. The device of claim 1, comprising two each of the anchoring boss, the ladder, and the rotatable gear.

10. The apparatus of claim 1, wherein each of the female connector portion and the male connector is coupled to an element of a fluid delivery system.

11. The apparatus of claim 1, wherein one or both of the female connector portion and the male connector is an integral part of a fluid transfer system component.

12. The device of claim 1, wherein the female connector portion is connected to a syringe.

13. The device of claim 1, wherein the female connector portion connects to a female luer, a male luer, or a luer lock port.

14. The apparatus of claim 1, wherein the female connector portion is connected to a conduit.

15. The device of claim 1, wherein the female connector portion is connected to a spike.

16. The apparatus of claim 1, wherein the male connector is connected to a vial adapter.

17. The device of claim 1, wherein the male connector is connected to a spike.

18. The device of claim 1, wherein the male connector is connected to a female luer, a male luer, or a luer lock port.

19. The apparatus of claim 1, wherein the male connector is connected to a pipe.

20. The device of claim 1, wherein the axis about which the at least one rotatable gear rotates is substantially perpendicular to a plane in which the shafts along which the female and male connectors slide.

21. A component of a fluid delivery system that couples or otherwise connects with the female connector portion of claim 1.

22. A component of a fluid delivery system coupled or otherwise connected to the male connector of claim 1.

23. A drug transfer system comprising the device of claim 1.

24. A syringe adapter comprising the device of claim 1.

25. A duct comprising the apparatus of claim 1.

26. The apparatus of claim 1, wherein the rotatable gear mechanism comprises two steps and a sprocket.

27. The apparatus of claim 1, wherein the rotatable gear mechanism comprises at least one notch adapted to engage a step.

28. The apparatus of claim 1, wherein the rotatable gear mechanism comprises a step adapted to be engaged by two sprockets.

29. The apparatus of claim 1, wherein the rotatable gear mechanism comprises a step adapted to engage with a notch.

30. The device of claim 1, wherein the anchoring boss is disposed on the male connector and the rotatable gear is located on the female connector.

31. The device of claim 1, wherein the anchoring boss is disposed on the female connector and the rotatable gear is located on the male connector.

32. The device of claim 1, wherein the rotatable gear is rotatably attached to a shaft at a radial distance from the gear center axis.

Technical Field

The present invention relates to medical devices. More particularly, the present invention relates to an apparatus and method for securing a physical connection between male and female connectors. More particularly, the present invention relates to component connections in liquid delivery systems.

Background

In many fields, many devices contain various interconnected components. Different types of connections are required for different components and applications of interconnected components. In some applications, the components are interconnected by inserting a protruding portion in one component into a receiving portion in another component. Such a connection is referred to herein as a male-female connection.

In many applications, the male-female connection requires the use of some sort of securing device to keep the components connected to each other and prevent unwanted separation. Common fixing devices include latches, screws, bayonet (bayonet cache), elastic elements, tenons, circlips, and the like. Such connection devices are relatively numerous, particularly in the field of hazardous liquid delivery systems. An exemplary method of securing a male-female connection is disclosed in U.S. patent No.8,196,614, the inventor of which is the same as the present application, which discloses a closed system fluid delivery device for contamination-free delivery of hazardous drugs.

Fig. 1A and 1B generally illustrate the assembly process of the fluid delivery device of U.S. patent No.8,196,614. Shown is that elements 35a at the ends of resilient arms 35 of female connector portion 14 are pressed into the narrow proximal portion of connector portion 14, thereby holding membranes 32 and 17 together and engaged along the direction of longitudinal extension, under the membrane sealing cap of vial adapter (visual adapter) 15, thereby preventing bi-membrane seal adjuster 34 from disengaging from vial adapter 15 when the needle pierces the membrane, thereby preventing leakage.

To understand the present invention, it is important to understand the challenges faced by systems similar to the present invention. First, it is to be understood that: the implementation of the coupling between the male and female connectors, and the displacement of the movable part therein, must be carried out in a specific sequence. If the sequence deviates from the correct sequence, it will result in leakage of the fluid that is desired to be transmitted through the coupling, which may be unacceptable if the fluid contains a harmful and/or potent chemical (e.g., an antineoplastic agent). Secondly, to ensure that the material is transferred safely during the coupling process, the relative movement of the various moving parts in the assembly must be performed smoothly and consistently. It is an object of the present invention to meet this challenge.

This is important to ensure the safety of the male-female connection and, therefore, to increase the level of control over the engagement and disengagement of the male-female connection means and the device, which is not ideal for the devices currently known in the art.

It is therefore another object of the present invention to provide a device for controlling disengagement of a male-female connection.

It is another object of the present invention to provide a device for controlling the engagement and disengagement of a male-female connection that is easy to operate.

It is a further object of the present invention to provide a device for controlling engagement and disengagement of a male-female connection that can be used in systems that include one or more needles as well as needle-free systems.

It is a further object of the present invention to provide a device that can be safely used to transfer fluid between two separate components of a system while avoiding leakage of hazardous liquids, aerosols or vapors into the surrounding atmosphere.

Other objects and advantages of the invention will appear as the description proceeds.

Disclosure of Invention

The invention provides a device for guaranteeing the safety of male-female connection, which comprises:

(a) a female connector including a fixing adjuster section;

(b) a male connector;

(c) one or more anchoring projections (anchoring ridges); and

(d) at least one rotatable gear.

According to an embodiment of the invention, the rotatable gearwheel comprises or has attached a hollow portion (void) adapted to receive anchoring projections arranged on opposite sides thereof. In another embodiment, a slit is formed in the hollow portion, and the hollow portion is provided with an opening whose direction changes with rotation of the gear. In yet another embodiment of the invention, the apparatus comprises at least one or more sprockets (sprockets) disposed around the periphery of the gear.

At least one or more steps (rungs) may be formed on the female connector, or on the male connector, and adapted to move relative to the gear as the male connector slides within the female connector.

According to an embodiment of the invention, at least one guide rail (rail) or guide (guide) is formed inside the female connector. In this embodiment, a track may be provided between the rail or guide and the one or more steps along which the gear may travel longitudinally. In one embodiment of the invention, the apparatus of the invention comprises two each of an anchoring boss, a ladder and a rotatable gear.

Each of the female connector portion and the male connector may be coupled to a component of a fluid delivery system. Alternatively, one or both of the female connector portion and the male connector may be integrated as part of a component of the fluid delivery system. For example, the female connector portion may be connected to a syringe, a female or male luer or luer lock port, tubing, a vial adapter, spike (spike), or any other suitable fluid transfer element.

Similarly, the male connector may connect to a female luer, male luer or luer lock port, tubing, or any other suitable fluid transfer element.

According to an embodiment of the invention, the at least one rotatable gearwheel rotates around an axis which is substantially perpendicular to the plane along which the female connector and the male connector slide.

The invention also includes elements of a fluid delivery system that are coupled (connected) or otherwise connected (connected) to a female connector portion or a male connector.

The present invention also relates to a drug transfer system comprising a device as described herein.

The present invention also provides for syringe adapters, tubing, and all elements of a fluid transfer system, as described herein.

It will be apparent to those skilled in the art that many different mechanisms can be provided in accordance with the present invention without departing from the scope of the invention. For example, the rotatable gear mechanism may comprise two steps and one sprocket, or recesses adapted to engage with the steps, or steps adapted to engage with two sprockets, or steps adapted to engage with recesses, all of which meet the requirements of the present invention and fall within the scope of the present invention.

The anchor boss may be provided on the male connector and the rotary gear may be located on the female connector, or the anchor boss may be provided on the female connector and the rotary gear may be located on the male connector.

According to a further embodiment of the invention, the female connector is provided with a rotatable gear wheel which is rotatably connected to a shaft which is located at a radial distance from the centre of said gear wheel.

All of the above and other features and advantages of the present invention can be realized and attained by the means of the instrumentalities and combinations particularly pointed out in the appended drawings.

Drawings

FIGS. 1A and 1B are schematic views of a drug transfer device in the prior art;

FIG. 2A schematically illustrates a front view of a female connector and its corresponding male connector, according to an embodiment of the present invention;

FIG. 2B schematically illustrates a side view of a female connector and its corresponding male connector according to an embodiment of the invention;

figure 3A schematically illustrates a perspective view of a female connector body according to one embodiment of the present invention;

FIG. 3B is the female connector body of FIG. 3A with one of the exterior walls cut away to show the interior thereof;

FIG. 4 is a perspective view of a fixed adjuster according to an embodiment of the invention;

FIG. 5 is a cut-away perspective view of the female connector body of FIG. 3 with the fixed adjuster of FIG. 4 disposed therein, in accordance with one embodiment of the present invention;

FIGS. 6A-6C are perspective views, partially in section, of a male connector, partially inserted into a female connector in a plurality of sequential positions, according to one embodiment of the invention;

FIG. 7 is a cross-sectional view of the female connector with the regulator manually pushed up for clarity and without the male connector inserted to reveal the pin through the regulator membrane;

fig. 8A and 8B show front and side views, respectively, of a male connector coupled to a vial and a female connector coupled to a syringe in a first position not yet in contact with each other;

FIG. 8C is a cross-sectional view of FIG. 8A;

FIG. 8D is a partial enlarged view of FIG. 8C;

FIG. 8E is a cross-sectional view of FIG. 8B;

FIG. 8F is an enlarged view of a portion of FIG. 8E;

FIG. 9A shows a front cross-sectional view of the male and female connectors of FIG. 8 in a second position in which they are in close proximity but not yet in contact;

fig. 9B is a partially enlarged view of fig. 9A.

Fig. 9C shows a cross-sectional side view of the male and female connectors of fig. 9A in a second position in which they are in close proximity but not yet in contact.

FIG. 9D is a partial enlarged view of FIG. 9C;

FIG. 10A shows a front cross-sectional view of the male and female connectors of FIG. 8 in a third position in which they have been brought into close proximity, their opposing membranes squeezed against each other, thereby preventing leakage of liquid, and the needle has been perforated in both membranes and is located inside the vial;

fig. 10B is a partially enlarged view of fig. 10A.

FIG. 10C shows a side cross-sectional view of the male and female connectors of FIG. 8 in a third position in which they have been brought into close proximity, their opposing membranes squeezed against each other, thereby preventing leakage of liquid, and the needle has been perforated in both membranes and has been positioned inside the vial;

FIG. 10D is a partial enlarged view of FIG. 10C;

FIGS. 11A and 11B schematically illustrate a side view and a front view, respectively, of a male-female connector according to an embodiment of the invention, where the male connector is coupled to a spike and the female connector is coupled to a syringe before the male and female connectors are brought into contact with each other;

FIGS. 12A-C are cross-sectional views of a device according to an embodiment of the present invention showing the male connector coupled to the male luer lock and the female connector coupled to a syringe before, during initial contact and during insertion of the male connector into the female connector, respectively;

13A-E schematically illustrate some alternative gear combinations;

FIG. 14 schematically illustrates an assembly using an alternative gear combination.

Detailed Description

Embodiments of the present invention will now be described herein with reference to the accompanying drawings, which are illustrative only. One skilled in the art will readily recognize from the following description that alternative embodiments of the present invention may be devised with appropriate modification of the structure and method of embodiments, without departing from the principles of the invention.

It should be understood that the fixed adjuster is positioned and movable within the female connector. For the sake of brevity, whenever reference is made to a female connector, this is to be understood as referring to the female element within which the fixed adjuster is displaceable.

Fig. 2A and 2B schematically illustrate front and side views, respectively, of a female connector 201 and a male connector 221 designed without consideration of details, designed to achieve interconnection by inserting a protrusion 222 of the male connector into a receiving portion 202 of the female connector, according to principles of an embodiment of the present invention. As shown in fig. 2A and 2B, an anchor boss 223 is fixedly mounted on the tip (top side) of the projection 222. The function of the bosses (e.g., boss 223) is described below.

Fig. 3A is a perspective view of the main body of the female connector 201 according to an embodiment of the present invention, wherein the interior of the receiving portion 202 is visible through an opening 203 in the proximal side of the connector 201. Fig. 3B is a cut-away perspective view of the female connector 201 of fig. 3A. A ladder 204 including a plurality of rungs (e.g., 205) is formed on the front or back of each of the left and right sides of the interior of the receiving portion 202, and a rail 206 is formed on the side (i.e., the back or front) opposite thereto from each of the left and right sides of the interior of the receiving portion 202. A track, generally indicated by reference numeral 207, is formed between the rail 206 and the ladder 204, along which track the gear wheel can be moved longitudinally if the gear wheel comprises a plurality of chain wheels of a size corresponding to the space between the rungs 205.

Fig. 4 is a perspective view of a fixed adjuster 401 according to an embodiment of the present invention, which includes a rotatable gear 402 rotatably coupled to guides 403 on both sides of a base 407. Each gear 402 includes a plurality of sprockets (e.g., 404) disposed about the periphery of a hollow portion 405, and the gap 406 is formed by removing a portion of the periphery so that the hollow portion can be accessed from a location other than the periphery of the gear.

Fig. 5 is a cut-away perspective view of the female connector 201 with a fixed adjuster 401 in one embodiment of the invention. The guide 403 is located at the track 207 such that the sprocket of each gear 402 is inserted between the rungs 205 of the ladder 204. The actuator 401 moves longitudinally along the track, driving the gear 402 to rotate, as the sprocket is forced to rotate about its axis. Thus, the orientation of the slot 406 relative to the opening 203 changes with longitudinal movement of the actuator 401.

Fig. 6A-6C illustrate perspective views (shown in cross-section) of a male connector's male portion 222 inserted into a receiving portion 202 of a female connector 201, according to an embodiment of the present invention. The width of the boss 223 corresponds to the size of the slit 406 such that the boss 223 can pass through the slit 406 and be received in the hollow 405. The height and depth of the boss 223 correspond to the diameter and depth, respectively, of the hollow 405, so that the gear 402 can rotate freely when the boss 223 is fully present within the hollow 405. Fig. 6A shows the insertion of the boss 223 into the hollow 405 through the slit 406. In this position, rotation of the gear 402 is inhibited because the slot 406 of the gear strikes the boss 223 from the side, and any movement of the entire adjuster 401 is then inhibited. This inhibition of movement facilitates the process of squeezing the elastic membrane, which is performed in parallel with this process stage, as will be described in further detail below with reference to fig. 12A-C. As shown in fig. 6B, when the protruding portion 222 is further inserted into the receiving portion 202, the boss 223 passes completely through the slit 406 and is received within the hollow portion 405. As the protruding portion 222 is further inserted into the receiving portion 202, the gear 402 rotates according to the direction directed by the ladder 204 (i.e., clockwise in the embodiment shown in fig. 6C, as indicated by circular arrow 601). Once the gear 402 starts to rotate, the boss 223 is trapped and locked within the hollow 405 and remains locked throughout the connection and disconnection process. For the above mentioned process of compressing the two elastic membranes, the initial rotation torque of the gear 402 enables the membranes to obtain a precise locking position in a specific, inseparable compression. Further insertion of the projection 222 into the receiving portion 202 causes the locked membrane to be pierced by the securing pin of the female connector.

In the position of the adjuster 401 shown in fig. 6C, the boss cannot clear the hollow 405, and therefore proximal displacement of the projection 222 of the male connector 221 is prevented unless the gear 402 is rotated and the boss 223 is disengaged from the gear. Obviously, the person skilled in the art will understand that: the boss 223 remains within the hollow 405 at any location along the ladder 204 of the gear 402 (as long as the slot 406 is not the opposing opening 203).

When the female connector 201 is disconnected from the male connector 221, the process is reversed: the protruding portion 222 is withdrawn from the receiving portion 202, causing the gear 402 to rotate counterclockwise between the ladders 204 until the boss 223 is opposite the slot 406 and can exit the core 405. In the disconnection process described above, which is carried out in parallel with the extraction process, the needles are first retracted from the membrane, with the projections 223 facing the slits 406 and leaving the hollow portion 405, the membrane being safely detached, so that their surfaces remain clean and free from any residues of liquid (see description of fig. 12AC below).

Figures 5 and 6 show the step 205 on the female part of the assembly. However, it will be apparent to those skilled in the art that: it is also possible to mount the steps on a male part (male connector) of the assembly so that when the female part (female connector) slides on the male part, they move relative to the gear wheel, thereby rotating the gear wheel. Similarly, the position of the boss and gear can be switched by placing the rotating gear on the male component and the boss on the adjuster.

It will be appreciated by those skilled in the art that although a set of two gears and a plurality of steps are provided herein for clarity of presentation, the number of steps may be limited to a small number since the required rotation is small. The actual number of steps used depends on the desired rotation and the size of the various parts and can be readily determined by one skilled in the art.

As used herein, the term "gear" should be considered to have a broad meaning and denote any element adapted to achieve a locking effect by its movement. For an explanation of this concept, reference may be made to fig. 13 (a-E). FIG. 13A is the arrangement used in FIGS. 5 and 6; fig. 13B shows a case where only the gear 130 of two steps (steps 131 and 131') and one sprocket 132 is used; fig. 13C shows the gear 133 with the sprocket replaced by a notch 134, the notch 134 engaging with the step 135; in fig. 13D, the gear 136 is provided with two sprockets (sprockets 137 and 137') that interact with one step 138; fig. 13E shows a gear 130 similar to that of fig. 13B, which interacts with a notch 139. To those skilled in the art, what is shown in FIG. 13 is merely some illustrative example of many possible arrangements.

The above described arrangement provides a valuable solution in equipment with a secure male-female connection, where the engagement or disengagement between the connectors must be tightly controlled, as the connection and disconnection between the male and female connectors requires the gear 402 to be brought to the proximal side of the ladder 204 (e.g. towards the opening 203), thereby defining constraints and precise points of engagement and disengagement of the connectors.

One practical example of such a male-female connection is in a drug transfer system, where toxic substances are transferred from a first container (e.g. a vial) to another container (e.g. a syringe). If the separation between the connectors and/or the needles of the two containers is not controlled, dangerous consequences may result from exposure of the toxic substance.

In the description herein, when referring to a "male connector" or a "female connector", it should be understood to refer to portions of the assembly that participate in the coupling process, regardless of the other system elements to which they are connected. For example, and as will be described further below, the male connector may be coupled to or integrally provided with: a vial, tubing, spike or fluid port (e.g., luer lock), or any other component of a desired fluid delivery system. Similarly, the female connector may be coupled to or integrally provided with: a syringe, infusion tubing, or fluid port, such as a luer lock, may be integrally formed therein.

Additionally, in the illustrative example of an embodiment of the present invention, a syringe coupled to a female connector with two needles is shown. Such a two-needle system is present in a closed system environment, for example as described in US 8,196,614. However, those skilled in the art will appreciate that the present invention is not limited to use with any particular number of needles, and that closed or open systems, for example, using only one needle, may also enjoy the benefits of the present invention and are therefore also intended to be encompassed.

Fig. 7 schematically shows in cross-section a drug transfer system according to a preferred embodiment of the present invention. The female connector 701 is provided with an adjuster 401 which is intentionally pushed up without inserting the male connector 702 in order to show how the needle 703 and the needle 705 (in this particular embodiment, the needle 703 and the needle 705 are part of the connector 701) penetrate the membrane 706.

Fig. 8A and 8B show male connector 801 (which couples with a vial adapter having a vial 802) and female connector 803 (which couples with a syringe 804). When the assembly is shown in the first position, the connectors 801 and 803 are not yet in contact with each other. Fig. 8A is a front view, and fig. 8B is a side view. The front view of fig. 8A can be seen from the sectional view of fig. 8C, while fig. 8D is a partial enlargement of fig. 8C, wherein the relative positions of the regulator 805, the needle 806 and the needle 807, and the membrane 808 can be clearly seen. Referring to the following figures, it should be noted that the membrane 809 of the male connector should be in intimate contact with and press against the membrane 808 of the regulator.

Fig. 8E is a sectional view of fig. 8B, and fig. 8F is a partial enlarged view of fig. 8E, in which the gear 402 of fig. 4 is clearly seen.

Fig. 9A shows a front cross-sectional view (front cross-sectional view) of the male and female connectors of fig. 8 in a second position in which the male and female connectors have been brought into proximity with each other, but their membranes 808 and 809 have not yet been in contact. Fig. 9B is a partially enlarged view of fig. 9A, and the same reference numerals as those of fig. 8D are used in the figure.

Fig. 9C shows a side cross-sectional view of the male and female connectors of fig. 9A in a second position in which the male and female connectors are already in close proximity, but the membranes 808 and 809 are not yet in contact. Fig. 9D is an enlarged partial view of fig. 9C, where the boss 223 can be seen beginning to engage the gear 402.

Fig. 10A shows a front cross-sectional view of the male and female connectors of fig. 8 in a third position in which the male and female connectors have been brought into close proximity such that their opposing membranes 808 and 809 are pressed against each other, thereby preventing liquids with membrane surfaces from contacting each other and the needle penetrating both membranes and being located within the vial. Fig. 10B is a partially enlarged view of fig. 10A. At this point, the male connector 801 is fully received within the regulator 805, inside the female connector 803.

Fig. 10C shows a side cross-sectional view of the male and female connectors of fig. 8 in a third position. In this third position, the male and female connectors are in close proximity, as viewed from the side, such that their opposing membranes 808 and 809 are pressed against each other and the needle penetrates both membranes and is located within the vial. Fig. 10D is an enlarged partial view of fig. 10C, where it can be seen that the boss 223 is now locked within the gear 402. The same is true of the other side of the regulator (not shown).

It should be understood that when referring to the boss 223 being "locked" inside the gear 402, it should not be understood as immovable, as it is sufficient to pull the male connector apart from the female connector, once the male connector and the female connector are pulled apart, the gear 402 will rotate with it as the sprocket 404 moves along the ladder 204, thereby bringing the opening to a lower position; when pulled further apart, the boss 402 may disengage from this position. By "locked position" is meant that when the assembly is in this position and the membranes 808 and 809 are pressed strongly against each other, no accidental release of said pressure occurs. As mentioned above, in order to disengage the parts of the assembly according to the invention, the user must make a positive decision and must take a positive action to pull the assembly apart.

Fig. 11A and 11B schematically illustrate a male-female connector according to an embodiment of the present invention, in which a male connector 801 is coupled to a spike 110 and a female connector 803 is coupled to a syringe 804 before the male and female connectors are brought into contact with each other. Fig. 11A and 11B are side and front views, respectively, of the assembly. The figure shows how the male-female connection assembly can be coupled to different elements of a liquid delivery system, and in this example, the male connector 801 and the spike 110 can be integrally formed.

Fig. 12A-C are cross-sectional views of a male-female connector according to an embodiment of the present invention, wherein the male connector 801 is coupled to the male luer lock 120 and the female connector 803 is coupled to the female luer lock 820, as shown. As shown, they are in three positions: before contact, during initial contact and in a locked position.

Referring to the above figures, when the male connector is introduced into the female connector from the distal side, the boss 223 passes further through the slit 406 into the interior of the hollow part 405 of the gearwheel, while the sealing films 808 and 809 are pressed together, see the above detailed description of fig. 6A-6C. When the adjustor 401 is additionally proximally displaced, one or more needles fixedly attached to the female connector penetrate the second and first sealing membranes 808 and 809, respectively.

The male connector is further inserted into the female connector such that the one or more needles further penetrate the sealing membrane, further deeper, and establish a fluid path through its distal side to the vial 802. Subsequently, continued insertion of the male connector into the female connector causes the adjustor 401 to drive the gear 402 to rotate and displace the guide distally by the force exerted thereon by the male connector.

At the beginning of the connection process, the membrane needs to be first pressed to a certain size and then locked in this compressed state (i.e. kept pressed together) throughout the connection and at all times (i.e. from the beginning of the needle penetration process until the needle is retracted during the last separation process). This two-film connection is based on the following method: the surfaces of the two elastic membranes are pressed together to become almost an elastic septum and then pierced with a needle. Since the pressed membrane surface remains out of liquid contact with the needle, after the needle is retracted and the membrane is separated, the membrane surface remains clean without any residual liquid that could cause injury. The compression of the membranes 808 and 809 is achieved because the regulator 401 is inhibited from pushing deeper into the female connector until the boss 223 has fully traveled into the hollow portion 405 of the gear, as described above. As the boss 223 passes through the slit 406, the membrane 809 of the male connector pushes the membrane 808 of the adjuster, thereby moving the adjuster 401 deeper into the connector, causing the gear 402 to rotate. However, since the slits 406 in the gear 402 hit the boss 223 from the side and cannot rotate until the boss 223 passes completely through the slits 406 into the hollow part 405 of the gear, the rotation is inhibited and hindered. Once the boss 223 is fully within the hollow 405 of the gear, the gear 402 begins to rotate and the adjuster is allowed to lower deeper into the female connector. The two films are sufficiently compressed because, among other things, the distances between the slit 406 and the film 808 and between the lands 223 and the film 809 are determined so that the films 808 and 809 are sufficiently compressed when the lands 223 travel through the slit 406.

As long as the boss 223 is located within the hollow 405 of the gear, the membranes will lock to each other in a constant compressed dimension, with the result that: the one or more needles are securely positioned within the vial so that the substance can be delivered through the needles without the risk of the male and female connectors suddenly disengaging. Since the connection of the female and male connectors is a smooth axial movement for the user, the mechanism described above allows precise control of the following points: a) the film is squeezed and protected; b) the needle may penetrate the node of the membrane; c) a node where the needle is fully retracted from the membrane; d) the membrane may safely separate the nodes.

Although it is very convenient to arrange the gear and ladder in two ways on different sides of the female connector and the regulator, it is also possible to use only a single gear-ladder coupling, but of course also more than two gear-ladder couplings. The invention is therefore not limited to a particular number of these elements.

An alternative embodiment of the invention is shown in fig. 14, in which the female connector 803 is provided with a rotatable gear 402, the rotatable gear 402 being provided on a fixed adjuster (not shown) which, like fig. 5, 6, 8-10 and 12, is freely movable about its central axis. The sprocket of the gear is rotatably connected to a shaft 1400 that is located at a radial distance from the center of the gear 402. The shaft is disposed over a flexible member 1500 that can flex laterally. When the gear 402 engages the anchor projections 223, the anchor projections 223 are pushed further upward into the female connector 803, and the rotatable gear 402 rotates and maintains a coupled state with the anchor projections 223 of the connector 801, only the upper portion of which is shown in the drawing. The bending flexibility of the element 1500 allows the shaft 1400 to be moved slightly sideways by the rotation of the gear 402. It will be appreciated by those skilled in the art that many different mechanical arrangements may be provided in accordance with the present invention to allow the shaft 1400 to move somewhat freely sideways, for example, the element 1500 may be rigid but provided with a slit-shaped window within which the shaft 1400 may move.

It is noted that the device for securing a male-female connection according to the invention can be used in various applications and apparatuses. The present invention is not limited to male-female connections of drug transfer systems and may be used for male-female connections of other devices and apparatuses.

Although embodiments of the present invention have been described above by way of illustration, it should be understood that: the invention may be embodied with many variations, modifications and adaptations, without departing from its scope as defined in the claims.