Medical Connecting Device

Abstract

A bottle connector for use in a medical fluid transfer arrangement, the bottle connector having an axial direction and a radial direction and comprising a first part and a second part, the first part comprising a hollow piercing member comprising an inner gas channel and extending in the axial direction beyond the end of the first part. The second part comprises a bottle coupling member, for coupling the bottle connector to a medical bottle. The first and second parts are pre-connected and are concentrically arranged with respect to each other and the bottle connector has a transport configuration with a first, maximum length in which the piercing member is completely located within the bottle connector, and a fluid transfer configuration with a second, minimum length.

Claims

1. A bottle connector for use in a medical fluid transfer arrangement, said bottle connector having an axial direction and a radial direction and comprising: a first generally cylindrical part having a first end a second end, said first generally cylindrical part comprising a hollow piercing member comprising an inner channel, said hollow piercing member extending in said axial direction from an interior portion of said first generally cylindrical part beyond said second end of said first generally cylindrical part; and a second generally cylindrical part connected to the first generally cylindrical part, said second generally cylindrical part having a first end and a second end, said second generally cylindrical part comprising a bottle coupling member, for coupling said bottle connector to a medical bottle, wherein the second generally cylindrical part is releasably locked to the first generally cylindrical part and is transitionable between a transport configuration and a fluid transfer configuration, wherein the second generally cylindrical part is configured to move from an unlocked configuration corresponding to the first and second generally cylindrical parts not being locked together, to the transport configuration, and wherein, when the second generally cylindrical part moves from the unlocked configuration to the transport configuration, the second generally cylindrical part moves along a longitudinal axis without rotation.

2. A bottle connector according to claim 1, wherein the second generally cylindrical part completely shields said hollow piercing member.

3. A bottle connector according to claim 1, wherein, when said bottle connector is in the fluid transfer configuration, at least a portion of said hollow piercing member extends beyond said second end of said first generally cylindrical part.

4. A bottle connector according to claim 1, wherein, when said bottle connector is in the transport configuration, said bottle connector defines a length between said first end of said first generally cylindrical part and said second end of said second generally cylindrical part, and wherein said length is greater than said length of said hollow piercing member so that the hollow piercing member protrudes past the second end of the first generally cylindrical part.

5. A bottle connector according to claim 1, wherein said second part is arranged inside said first part in said radial direction.

6. A bottle connector according to claim 1, wherein said means for interlocking said first part and said second part in said fluid transfer configuration is an irreversible locking arrangement.

7. A bottle connector according to claim 1, wherein said first part carries a barrier member, said barrier member being mounted in a barrier member holder centrally in said first part.

8. A bottle connector according to claim 1, wherein said second part comprises means for connecting said second part to a bottle.

9. A bottle connector according to claim 1, wherein said first part comprises means for connecting said first part to a medical device.

10. A bottle connector according to claim 9, wherein said means for connecting said first part to a medical device comprises a bayonet fitting.

11. A bottle connector according to claim 1, wherein said first and second parts of said bottle connector comprise cooperating guiding members for guiding said piercing member through said sealing member of said bottle at a predetermined angle.

12. A bottle connector according to claim 11, wherein said predetermined angle is 85 to 95.

13. A bottle connector according to claim 1, wherein said bottle connector comprises a pressure equalizing member.

14. A bottle connector according to claim 13, wherein said pressure equalizing member comprises a pressure regulating chamber having a pressure adapting volume and being in fluid communication with said air channel in said piercing member and comprising a filter between said pressure regulating chamber and said air channel in said piercing member.

15. A bottle connector according to claim 1, wherein said piercing member is aligned with a central axis of said bottle connector and is placed along said central axis or not more than 3 mm from said central axis as measured in said radial direction of said bottle connector.

16. A bottle connector according to claim 1, wherein said first generally cylindrical part comprises a first opening and a second opening which are spaced apart in a longitudinal direction of said first generally cylindrical part, wherein said second generally cylindrical part comprises a locking protrusion protruding outward, wherein, with said bottle connector in the transport configuration, said locking protrusion is locked in said first opening, and wherein, with said bottle connector in the fluid transfer configuration, said locking protrusion is locked in said second opening.

17. A bottle connector according to claim 16, wherein when said locking protrusion is released from said first opening by pushing said first part down over said second part to move into said second opening said bottle connector transits from said transport configuration to said fluid transfer configuration.

18. A bottle connector according to claim 16, wherein, when said first and second generally cylindrical parts transition from the transport configuration to the transfer configuration, said locking protrusion deflects inwardly.

19. A bottle connector according to claim 1, wherein said first generally cylindrical part further has an intermediate portion disposed between the first end and the second end; wherein the hollow piercing member further comprises a proximal end and a distal end disposed opposite and distal the proximal end; and wherein the proximal end is disposed at said intermediate portion.

20. A bottle connector according to claim 19, wherein the proximal end of said hollow piercing member is disposed generally midway between the first and second ends of said first generally cylindrical part.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0029] FIG. 1 shows an exploded view of a bottle connector according to the invention;

[0030] FIG. 2a shows a perspective view of a first part of the bottle connector in FIG. 1;

[0031] FIG. 2b shows a perspective view of a second part of the bottle connector in FIG. 1;

[0032] FIG. 3a shows a first cross-sectional view of the bottle connector in FIGS. 1 and 2 in a transport configuration and without a pressure equalizing member;

[0033] FIG. 3b shows a second cross-sectional view of the bottle connector in FIGS. 1 and 2 in a transport configuration and showing a pressure equalizing member;

[0034] FIG. 4a shows a first cross-sectional view of the bottle connector in FIG. 1 in a fluid transfer configuration and without a pressure equalizing member;

[0035] FIG. 4b shows a second cross-sectional view of the bottle connector in FIGS. 1 and 2 in a fluid transfer configuration and showing a pressure equalizing member;

[0036] FIGS. 5a-5c show the bottle connector in FIGS. 1-4 while being applied to a medical bottle; and show an injection device adapted for being connected to the bottle connector in FIGS. 1-4; and

[0037] FIG. 6 shows an example of a medical device that may be used with the bottle connector of FIG. 1.

DESCRIPTION OF THE INVENTION

[0038] FIG. 1 shows a bottle connector 1 according to the invention with the parts separated. The bottle connector 1, as shown in FIG. 1, comprises a first generally cylindrical part 2 with a first end 4 and a second end 5 and a second generally cylindrical part 3 with a first end 5 and a second end 7. The bottle connector further comprises a barrier member 8 and a piercing member. A parabola-shaped gas chamber 10 belonging to a pressure equalizing member 11 is shown to be connected to the first part 2 of the bottle connector 1. Further, parts of the pressure equalizing member 11 are a filter 12, a filter holder 3, and a flexible wall member 14.

[0039] The barrier member 8 is shown to be generally disc-shaped, with a thicker central portion and thinner peripheral portion. The barrier member may be a type of sealing membrane or septum as defined herein.

[0040] When assembled, the pressure equalizing member 11 is arranged to adapt its volume in response to a change in gas pressure. The volume of the pressure equalizing member 11 may be changed by expanding or collapsing the flexible wall member 14. The flexible wall member 14 may be a thin film material, e.g. a thin transparent film that is welded or adhesively attached to the outer rim 5 of the parabola-shaped gas chamber 10 so as to form a gas-tight seal between the parabola-shaped gas chamber 10 and the flexible wall member 14. Any gas passing into the gas container formed between the parabola-shape gas chamber 10 and the flexible wall member 14 will pass through the filter 12 in the filter holder 13. The filter 12 may be any suitable commercially available filter, such as a particulate air filter having a pore size of 0.2 pm. Although the filter holder 13 is shown in FIG. 1 as being separate from the parabola-shaped gas chamber 10, it may be integrally formed with the parabola-shaped gas chamber 10 by a blow moulding or vacuum forming process. If formed as a separate component, it may be attached to the parabola-shaped gas chamber 10 by welding, such as by ultrasonic welding as known in the art. Adhesive attachments or mechanical fittings are also conceivable within the scope of the invention. The filter 12 may be attached to the filter holder 13 by means of adhesive or welding or may be mechanically held, in the filter holder 13.

[0041] The particular pressure equalizing member 11 shown in the figures should not be considered to be limiting to the invention. Accordingly, the pressure equalizing member 11 may take any form as known in the art, including non-closed arrangements, although a closed-chamber pressure equalizing member is highly preferred when handling hazardous substances. One example of a suitable pressure equalizing member is found in International Patent Publication No. WO 2008/153459 A1. The piercing member 9 has an internal channel 16 which is in fluid communication with the pressure equalizing member 11 when the bottle connector 1 is assembled. The internal channel 16 allows gas and air to pass into the volume-changing gas container formed between the parabola-shaped gas chamber 10 and the flexible wall member 14. FIG. 2a shows the first part 2 of the bottle connector 1 in FIG. 1 seen from the second end 5 and with the parts of the pressure equalizing member 11 assembled but without the piercing member 9. The first part 2 of the bottle connector 1 has a generally cylindrical shape with a larger diameter portion 22 at the second end 5 and a smaller diameter portion 23 at the first end 4. The second wider end 5 is adapted for connection with the second part 3 of the bottle connector 1 and the first smaller end 4 is adapted for connection with a medical device. In the example shown in the figures, the medical device is a syringe, as shown in FIG. 6.

[0042] In order to enable coupling between the first part 2 and the second part 3 of the bottle connector 1, the first part is provided with first locking openings 17 arranged opposite each other in the wall of the first part 2 and constituting receiving members or female members of a snaplock arrangement allowing the first and second parts 2, 3 to be releasably locked in the first configuration constituting a transport configuration. The first locking openings 17 are placed at a distance from the edge of the second end 5 of the first part 2, leaving room between the first locking openings 17 and the edge of the first part 2 at the second 3 end for a guiding groove 18.

[0043] A second set of receiving members in the form of second locking openings 19 are arranged at the junction between the larger diameter portion 22 and the smaller diameter portion 23 of the first part 2 of the bottle connector 1. The second locking openings 19 do also form part of the snaplock arrangement between the first and second parts 2, 3 of the bottle connector 1. The second locking openings 19 are used to lock the first and second parts 2, 3 in a second configuration constituting a fluid transfer configuration. Although the shown arrangement with opposing coupling members may be preferred, any coupling arrangement allowing telescopic movement without simultaneous rotation between the first and second parts 2, 3 may be used within the scope of the invention. Accordingly, each part 2, 3 of the bottle connector 1 may comprise one or more coupling members such as 1-6 coupling members. If more than one coupling member is used, the coupling members are preferably symmetrically arranged in the walls of the bottle connector 1. Moreover, the locking arrangement between the parts 2, 3 may comprise any one or more of locking means such as bayonet fittings, stop notches, a stop knobs, a snap locks, etc., as known in the art.

[0044] The first part 2 of the bottle connector 1 further comprises grooves 20 constituting female guiding means for guiding the second part 3 info the first part 2.

[0045] The first part 2 of the bottle connector 1 is further shown to have an intermediate wall 21 between the larger diameter portion 22 at the second end 5 and the smaller diameter portion 23 at the first end 4. A central opening 24 bordered by a circular sealing flange 25 is arranged in the intermediate wall 21. The central opening 24 accommodates both a socket 26 for the piercing member 9 and a channel 27 for an external piercing member, such as a needle in a syringe. The circular sealing flange 25 ascertains that a tight seal is created around the piercing site when the bottle connector 1 is applied to a medical bottle. Alternative sealing arrangements include the use of a small diameter spike having two internal channels for fluid and gas transfer. A further feature of the first part 2 of the bottle connector 1 as shown in FIG. 2a is a female part 28 of a bayonet fitting arranged in the smaller diameter portion 23 of the first part 2 for coupling of a syringe, or similar device to the bottle connector 1. It is to be noted that both the smaller diameter portion 23 of the first part and the bayonet fitting are optional features of a bottle connector in accordance with the invention.

[0046] Depending on the type of medical device to be coupled to the first end 4 of the first part 2, the coupling arrangement at the first end 4 may be different from the bayonet fitting shown in the figures. Accordingly, any type of threaded coupling, bayonet fitting, snap-lock, locking ring, slide fitting, clamp, etc. may be used, as known in the art. Furthermore, more than one locking element of the same or different construction may be used in combination to create a coupling between the bottle connector 1 and a medical device. When the bottle connector 1 has been connected to a first medical device, it can subsequently be connected with a second medical device carrying a piercing member 9. Consequently, the medical device that is connected with the bottle connector 1 at the first end 4 of the first part 2 of the bottle connector 1 may be a piercing device such as a syringe, another connecting device, a needle protection device, etc.

[0047] The second part 3 of the bottle connector 1 is shown in FIG. 2b and is seen from the second end 7 which is the end that is arranged to be remote from the second end 5 of the first part 2 when the bottle connector 1 is assembled. The second part 3 of the bottle connector 1 comprises two oppositely arranged flexible locking tongues 30 each carrying a locking protrusion 31 which are arranged to cooperate with the first locking openings 17 and the second locking openings 19 on the first part 2 of the bottle connector 1 for locking the bottle connector 1 in the transport configuration and the fluid transfer configuration, respectively.

[0048] The second part 3 of the bottle connector 1 further comprises opposing male guiding elements 32 arranged to engage with the guiding grooves 20 on the first part of the bottle connector 1. In the shown embodiment, the male guiding elements 32 together with the locking protrusions 31 also serve to restrict movement of the second part 3 into the first part 2. The dimensioning of the locking protrusions 31 and the guiding elements 32 determines the axial force required to activate the telescopic movement between the first and second parts 2, 3.

[0049] As with the coupling members, the configuration of the guiding means and locking members shown in the figures and described herein should not be considered limiting to the bottle connector 1 of the invention. Accordingly, the arrangement may be reversed so that the grooves are arranged on the second part and the protrusions engaging with the grooves are arranged on the first part. Moreover, the number of guiding arrangements and locking members may be different from the two arrangements shown in the figures, such as 1-5 guiding arrangements and 1-5 locking arrangements. The guiding and locking function may be fulfilled within one and the same arrangement. If more than one guiding/locking arrangement is provided, the guiding arrangements are preferably symmetrically arranged. The first end 6 of the second part 3 has an end wall 33 with an end opening 34. When the bottle connector 1 is in the fluid transfer configuration, the end wall 33 of the second part 3 will be in direct contact with the intermediate wall 21 of the first part 2, prohibiting further axial compressive movement of the parts 2, 3 relative each other. In the fluid transfer configuration, the circular sealing flange 25 on the first part 2 of the bottle connector 1 extends through the end opening 34 in the end wall 33 of the second part 3.

[0050] The second end 7 of the second part 3 is provided with hook elements 35. The hook elements 35 are configured to fit over a bottle neck to keep the bottle connector 1 locked to the bottle, in order to facilitate application of the bottle connector 1 to a bottle, the side wall of the second part 3 of the bottle connector 1 is divided into flexible tongues 36 that can be slightly bent outwardly as the bottle connector 1 is pressed down over a bottle neck. The flexible tongues 38 may be two or more, such as 2-30 flexible tongues. The hook elements 35 are arranged at the free ends of the flexible tongues 36. Alternatively, the side wall of the second part 3 may be provided with slits extending in the axial direction of the second part 3.

[0051] FIGS. 3a and 3b show the bottle connector 1 as it appears in its assembled state in the transport configuration and having an axial direction A and a radial direction R, perpendicular to the axial direction A. The cross-section in FIG. 3a is taken centrally through the bottle connector 1 in a plane through the first locking openings 17 and the second locking openings 19 of the first part 2 of the bottle connector 1. The pressure equalizing member 11 is not seen in FIG. 3a as the view is in a direction away from the piercing member 9 and the pressure equalizing member 11. As the piercing member 9 is placed slightly off-set from the central axis through the bottle connector 1 in a direction towards the pressure equalizing member 11, the piercing member 9 is also not visible in FIG. 3a. The cross-section in FIG. 3b is taken in a plane perpendicular to that in FIG. 3a and extends through the pressure equalizing member 11 and the hollow piercing member 9.

[0052] In the transport configuration shown in FIGS. 3a and 3b, the bottle connector 1 has a maximum length L.sub.1 in the axial direction of the bottle connector 1. The maximum length L.sub.1, is greater than the length L.sub.FP of the first part 2 of the bottle connector 1. As is seen in FIG. 3a, the second part 3 of the bottle connector 1 extends in the axial direction A past the tip 40 of the piercing member 9 so that the piercing member 9 is completely shielded in the radial direction, R when the bottle connector is in the transport configuration even though the tip 40 of the piercing member 9 protrudes slightly past the second end 5 of the first part 2 of the bottle connector 1.

[0053] FIGS. 3a and 3b show the barrier member 8 mounted in a barrier member holder 37 centrally in the first part 2 of the bottle connector 1.

[0054] The first and second parts 2, 3 of the bottle connector 1 are pre-connected by means of the locking protrusions 31 on the flexible locking tongues 30 on the second part 3 being inserted in the first locking openings 17 on the first part 2. The connection between the parts is preferably made so as to prohibit a use from deliberately or accidentally separate the parts 2, 3, but so as to allow deliberate telescopic compression of the parts 2, 3.

[0055] FIGS. 4a and 4b show the bottle connector 1 as it appears in its assembled state in the fluid transfer configuration. The cross-sections in FIG. 4a and FIG. 4b correspond to the cross-sections in FIGS. 3a and 3b.

[0056] In the fluid transfer configuration, the bottle connector 1 has been compressed in the axial direction A, by sliding or pushing the first part 2 of the bottle connector 1 down over the second part 3 of the bottle connector 1 until the first end 8 of the second part 3 of the bottle connector 1 comes into contact with the intermediate wall 21 in the first part 2 of the bottle connector 1 and the locking protrusions 31 on the locking tongues 31 on the second part 3 engage with the second locking openings 19 on the first part 2 of the bottle connector 1. During compression of the bottle connector 1, the guiding grooves 20 on the first part 2 of the bottle connector 1 cooperate with the male guiding elements 5 (protrusions) 32 on the second part of the bottle connector 1 to ensure that the piercing member 9 is guided at a predetermined angle towards and through a bottle stopper. The piercing member 9 is preferably guided at an angle of 90 through the bottle stopper. However, other angles such as an angle of from 85 to 95 are conceivable within the scope of the invention.

[0057] The bottle connector 1 in the fluid transfer configuration has a minimum length L.sub.2, which is shown to be identical to the length L.sub.FP the first part 2 of the bottle connector 1. The minimum length L.sub.2 of the bottle connector 1 need not be equal to the length L.sub.FP of the first part 2 of the bottle connector 1. However, the minimum length L.sub.2 will always be less than the maximum length L.sub.1, of the bottle connector 1.

[0058] FIGS. 5a-c show a bottle connector 1 of the invention in the process of being applied to a medical bottle 41.

[0059] The medical bottle 41 or vial is a small glass bottle with a bottle neck 42 and a bottle opening 43. A rim 44 extends around the bottle opening 43 and serves as a receiving connection means that will cooperate with the hook elements 35 at the ends of the flexible tongues 36 on the second part of the bottle connector 1 when the bottle connector 1 is pushed down over the bottle neck 42. A sealing member 45 is inserted into the bottle neck 42 through the bottle opening 43 in order to keep the fluid 46 that is contained in the medical bottle 41 from escaping out through the bottle opening 43. The sealing member 45 is commonly a rubber stopper which may be penetrated by the piercing member 9 of the bottle connector 1 and by an external piercing member such as a syringe. The interface between the sealing member 45 and the rim 44 at the bottle opening 43 is further sealed by means of a protective foil 47 extending around the bottle opening 43 with a first end portion on the exposed surface of the sealing member 45 and a second end portion beneath the rim 44 around the bottle opening 43. Accordingly, the protective foil 47 is wrapped around an edge portion of the upper part of the medical bottle 41, leaving only a circular piercing area of the sealing member 45 exposed at the center of the sealing member 45.

[0060] The hook elements 35 on the second part 3 of the bottle connector 1 are configured to fit under the rim 44 around the bottle opening 43 in the medical bottle 41 to keep the bottle connector 1 securely locked in position over the bottle opening 43.

[0061] FIG. 5a shows the bottle connector 1 and the medical bottle 41 just before the bottle connector 1 is brought into contact with the bottle 41. The tip 40 of the piercing member 9 can be seen to protrude slightly past the edge of the second end 5 of the first part 2 of the bottle connector 1 but not past the edge of the second end 7 of the second part 3 of the bottle connector.

[0062] FIG. 5b shows the bottle connector 1 and the medical bottle 41 in the process of being pressed down onto the medical bottle 41 but before the hook elements 35 on the flexible tongues at the second end 7 of the second part of the bottle connector 1 have snapped into engagement with the rim 44 at the bottle neck 42.

[0063] While applying the second part 3 of the bottle connector 1 over the bottle neck 42, the bottle connector 1 is kept in the transport configuration by means of the locking protrusions 31 on the locking tongues 30 on the second part 3 of the bottle connector 1 being engaged with the first locking openings 17 in the first part 2 of the bottle connector 2.

[0064] After coupling of the bottle connector 1 to the bottle neck 42, the piercing member 9 on the first part of the bottle connector 1 is brought to penetrate the sealing member 45 in the bottle opening 43 by telescopically sliding or pushing the first part 2 in relation to the second part 3 and bringing the connecting device to assume the fluid transfer configuration shown in FIG. 5c and described in detail in connection with FIGS. 4a and 4b.

[0065] When the bottle connector 1 has been securely fixed to the medical bottle 41 and has been brought into the fluid transfer configuration, the piercing member 9 penetrates all the way through the sealing member 45 in the bottle opening 43 so that air and gas may pass from the medical bottle 41 through the piercing member 9 and further into the pressure equalizing member 11. The two-part telescopic construction of the bottle connector 1 allows safe and controlled handling and application also of bottle connectors having piercing members of comparatively greater length. The pre-connection between the first and second parts of the bottle connector 1 ascertains simple handling of the bottle connector 1 and ascertains proper alignment of the parts and of the piercing member 9.

[0066] FIG. 6 shows an example of a medical device that may be used together with a bottle connector 1 according to the invention. The medical device in FIG. 6 is an injection device 48 adapted for being connected to the bottle connector in FIGS. 1-5 by means of male locking members 49 designed to mate with the female members of the bayonet fitting 28 on the bottle connector 1. The injection device 48 has an internal needle (not visible in FIG. 8) and is provided with a barrier member 50 that will be in close contact with the barrier member 8 in the bottle connector 1 when the injection device 48 is connected to the bottle connector 1, thus creating a double barrier for the internal needle to penetrate before passing down through the sealing member 45 in the medical bottle 41 and further down into the fluid contained in the medical bottle 41.

[0067] Further modifications of the invention within the scope of the claims would be apparent to a skilled person. For instance, the locking and guiding mechanisms disclosed herein may be differently designed and configured without deviating from the invention.