Connector system for medical fluid administration

Abstract

A connector system for medical fluid administration has a female connection member, which can act as an access port for a container of medical fluid, and a male connection member, for accessing the container of medical fluid. The female connection member defines a sheath for receiving a portion of the male connection member and this sheath is spanned at one end by a septum, which acts to close the container of medical fluid. A lumen is defined through the male connection member to allow passage of fluid therethrough. The septum has a central region and a peripheral region, the central region being of substantially greater thickness than the peripheral region. The male connection member comprises means for rupturing the peripheral region of the septum when it is received in the female connection member to form a connection.

Claims

1. A female connection member for a system for medical fluid administration, the female connection member defining a sheath for receiving a distal portion of a male connection member, a distal end of the sheath being spanned by a septum having a central region and a peripheral region, in which the central region of the septum is formed from material having a substantially greater thickness than a peripheral region of the septum surrounding the central region, the female connection member being configured to receive a male connection member having a body comprising a distal portion terminating in a distal end and a proximal portion terminating in a proximal end, a lumen being defined through the body for the passage of liquid from the distal end to the proximal end, in which the distal end of the male connection member comprises means for rupturing the peripheral region of the septum when the male connection member is received in the female connection member to form a connection, in which the female connection member comprises a retaining means for retaining the central region of the septum after the peripheral region of the septum has been ruptured by receiving the male connection member, and the female connection member defines a keyway for receiving a key extending from the distal portion of the male connection member, such that the female connection member can only receive the distal portion of the male connection member to form a connection when the key is aligned with the keyway.

2. A female connection member according to claim 1, in which the central region of the septum is formed from material having a thickness that is between 1.5 and 400 times thicker than material forming the peripheral region of the septum surrounding the central region.

3. A female connection member according to claim 1, in which the material forming the central region has a thickness of between 1 mm and 3 mm.

4. A female connection member according to claim 1, in which the distal end of the sheath is substantially circular in cross-section and has an internal diameter of between 8 mm and 15 mm.

5. A female connection member according to claim 1, in which the retaining means comprises a portion of material configured to connect the female connection member with the central region of the septum after the peripheral region of the septum has been ruptured.

6. A female connection member according to claim 1, in which the retaining means forms a hinge.

7. A female connection member according to claim 1, in which the retaining means comprises a portion of material extending radially between the distal end of the sheath and the central region of the septum, optionally in which the retaining means comprises a lug, flange or tab which projects longitudinally from the distal end of the sheath and in which the portion of material extends radially from the lug, flange or tab to connect with the central region of the septum.

8. A female connection member according to claim 1, in which the female connection member is configured to be disrupted over a portion of the circumference of the peripheral region so that the remaining non-ruptured portion of the peripheral region acts to retain the central portion of the septum, while still allowing a fluidic connection to be formed.

9. A female connection member according to claim 1, in which the keyway extends circumferentially around the female connection member for allowing the male connection member, when received in the female connection member, to rotate relative to the female connection member, the key extending from a distal portion of the male connection member interfering with the female connection member to restrict the rotation to a predetermined angle.

10. A female connection member according to claim 1, comprising a substantially annular flange extending radially outwards from the sheath enabling the female connection member to span an opening in a medical fluid container.

11. A female connection member according to claim 1, in which the female connection member forms an access port into a medical fluid container.

12. A female connection member for a system for medical fluid administration, the female connection member defining a sheath for receiving a distal portion of a male connection member, a distal end of the sheath being spanned by a septum having a central region and a peripheral region, in which the central region of the septum is formed from material having a substantially greater thickness than a peripheral region of the septum surrounding the central region, the female connection member being configured to receive a male connection member having a body comprising a distal portion terminating in a distal end and a proximal portion terminating in a proximal end, a lumen being defined through the body for the passage of liquid from the distal end to the proximal end, in which the distal end of the male connection member comprises means for rupturing the peripheral region of the septum when the male connection member is received in the female connection member to form a connection, in which the female connection member comprises a retaining means for retaining the central region of the septum after the peripheral region of the septum has been ruptured by receiving the male connection member, and the peripheral region of the septum does not form a complete ring around the central region, but extends around the central region sufficiently to result in a catastrophic failure around the periphery of the septum in preference to a puncture through the central region of the septum.

Description

SPECIFIC EMBODIMENTS OF THE INVENTION

(1) Specific embodiments of various aspects of the invention will now be disclosed with reference to figures in which;

(2) FIG. 1 illustrates a plan view of a first embodiment of a female connection member for a connector system for medical fluid administration;

(3) FIG. 2 illustrates a cross section of the female connection member of FIG. 1;

(4) FIG. 3 illustrates the female connection member of FIG. 1 when used as an access port for a medical vial;

(5) FIG. 4 illustrates a plan view of a second embodiment of a female connection member for a connector system for medical fluid administration;

(6) FIG. 5 illustrates a cross section of the female connection member of FIG. 4;

(7) FIG. 6 illustrates the female connection member of FIG. 4 when used as an access port for a medical bottle;

(8) FIG. 7 illustrates a plan view of a third embodiment of a female connection member for a connector system for medical fluid administration;

(9) FIG. 8 illustrates a cross section of the female connection member of FIG. 7;

(10) FIG. 9 illustrates the female connection member of FIG. 7 when used as an access port for a collapsible medical fluid bag;

(11) FIG. 10 is a perspective illustration of a first embodiment of a male connection member for a connector system for medical fluid administration that is compatible with any of the female connection members illustrated in FIGS. 1 to 9;

(12) FIG. 11 is a side view of the connector of FIG. 10;

(13) FIG. 12 is a front view of the connector of FIG. 10;

(14) FIG. 13 is a bottom view of the connector of FIG. 10;

(15) FIG. 14 illustrates a plan view of a connection made by the male connection member of FIG. 10 in engagement with the female connection member of FIG. 1;

(16) FIG. 15 is a sectional view of the connection made in FIG. 14;

(17) FIG. 16 is a perspective view of a fourth embodiment of a female connection member for a connector system for medical fluid administration;

(18) FIG. 17 is a plan view of the female connection member of FIG. 16;

(19) FIG. 18 is a cross-sectional view of the female connection member of FIG. 16;

(20) FIG. 19 is a perspective view of a second embodiment of a male connection member for connection with the female connection member of FIG. 16 in a connector system for medical fluid administration;

(21) FIG. 20 is a plan view of the male connection member of FIG. 19 from the distal end showing a plan view of offset projections and a key associated with the proximal portion of the male connection member;

(22) FIG. 21 illustrates a cross-sectional side view of the connector system for medical fluid administration comprising a female connection member as illustrated in FIG. 16 and a male connection member as illustrated in FIG. 19;

(23) FIG. 22 illustrates a cross-sectional side view of the connection system illustrated in FIG. 21 after a connection has been made.

(24) FIGS. 1 and 2 illustrate a first embodiment of a female connector or female connection member 10. The female connection member 10 may be used as a component in an embodiment of a connector system for medical fluid administration.

(25) The female connection member 10 has a body 20 formed from a single moulding of polypropylene. The body 20 defines a sheath 30 having a substantially circular cross section. A proximal end of the sheath 31 defines an opening for receiving a male connection member and a distal end of the sheath 32 is spanned by a septum 40. An annular flange 50 extends radially outwards from an uppermost or proximal end of the sheath.

(26) The septum 40 comprises two distinct portions. A central region or central portion 41 formed from a thick section of polypropylene and a peripheral region or peripheral portion 42 formed from a thin section of polypropylene. The internal diameter of the sheath at its proximal end is slightly greater than the internal diameter of the sheath at its distal end 32 resulting in a tapering of 1.5 degrees to the walls of the sheath. The polypropylene at the thickened central portion of the septum 41 has a thickness of 1.9 mm. The polypropylene at the peripheral thinner portion 42 has a thickness of 0.25 mm. The locating flange 50 has an annular ridge 55 on it's underside for facilitating sealing against a rubber washer or grommet.

(27) FIG. 3 illustrates the female connection member of FIGS. 1 and 2 located in a vial of medical fluid 60. The glass rim 62 of the vial 60 has an outer diameter of 20 mm. A rubber washer or grommet 70 fits into the neck of the vial 60 and provides a seat for the flange 50 of the female connection member 10. In order to locate the female connection member 10 within the neck of the vial and in order to provide a liquid tight seal, the flange 50 of the connection member 10 is compressed against the rubber washer 70 by an aluminium over-seal 80.

(28) The aluminum over-seal 80 compresses the flange 50 into the rubber washer 70 and the annular ridge 55 on the under side of the flange 50 grips the rubber washer 70 providing additional seal competence. The female connection member 10 is provided with a removable seal 90 that is ultrasonically welded to a circumferential rim 25 of the sheath. This seal 90 prevents contamination to the inner surfaces of the sheath. It is noted that any known method of hermetically affixing a foil or cover to produce such a seal could be used.

(29) The female connection member thus provides a closure for the vial 60 that prevents unwanted egress of fluid contained within the vial. Containers for medical fluid administration come in different sizes. It is possible to adapt a female connector member according to the invention such that it can be used to close different dimensions of medical administration containers.

(30) FIGS. 4, 5 and 6 illustrate a second embodiment of a female connector or female connection member 100. The female connection member 100 may be used as a component in an embodiment of a connector system for medical fluid administration.

(31) The female connection member 100 of FIGS. 4, 5, and 6 is designed to act as a closure for a large fluid container. The sheath and septum of the female connection member are constructed and dimensioned as disclosed for the embodiment illustrated in FIGS. 1, 2 and 3. The connection member has been adapted, however, in that a radially extending flange 150 extends for a diameter of 32 mm (rather than 20 mm as described above). Furthermore, the flange incorporates two concentric annular ridges 155 and 156.

(32) FIG. 6 shows how this female connector 100 is used as an access port for a medical fluid container. A rubber T-section washer 170 fits within a standard 32 mm neck of the container 160. The 32 mm diameter flange 150 is compressed against the rubber T-section washer 170 by an aluminum over-seal 180. In the configuration shown, the two annular ridges 155 and 156 dig into the rubber T-section washer 170 in order to improve the competence of the seal.

(33) FIGS. 7, 8 and 9 illustrate a third embodiment of a female connector or female connection member 200. The female connection member 200 may be used as a component in an embodiment of a connector system for medical fluid administration.

(34) The dimensions of the sheath and septum are identical to the connection member described in relation to FIGS. 1 and 2. In the case of the connection member 200 of FIGS. 7 and 8, a flange is provided having an annular rim 251 designed to facilitate connection by adhesion or welding to a polypropylene infusion bag 260.

(35) FIG. 9 illustrates the female connection member 200 as an access port for a polypropylene infusion bag 260.

(36) The three different examples of a female connection member 10, 100, 200 described above have common dimensions of a sheath for receiving a male connection member and a septum spanning a distal portion of the sheath. All three female connection members may be accessed by a common male connection member.

(37) FIGS. 10, 11 and 12 illustrate a first embodiment of a male connector or male connection member 300. The male connection member 300 may be used as a component in an embodiment of a connector system for medical fluid administration.

(38) The male connection member 300 has a proximal portion 310 and a distal portion 320. A lumen 315 is defined centrally through the male connection member with openings at the proximal portion, in order to allow connection to a tube, and at the distal end 321 of the distal portion 320, to allow liquid to pass through the connector.

(39) An annular flange 330 extends radially outwards from the male connection member between the distal portion 320 and the proximal portion 310. The distal portion of the connector 320 has a substantially circular cross section and is tapered at 1.5 degrees such that the distal end of the distal portion has a slightly narrower diameter than a proximal end of the distal portion adjacent the flange 330.

(40) A pair of longitudinally extending flanges 340, 350 extend from opposite sides of the proximal portion 310 of the male connection member.

(41) The distal end 321 of the connection member comprises a pair of projections 360, 370 that project from an end surface 391. The projections 360, 370 are sculpted such that they project to the greatest degree at the radially outer-most point of the distal end 321 of the connection member, and incline inwards towards the centrally defined lumen. Furthermore, the end surface 391 of the distal end 321 of the connection member is dished such that there is an incline from the circumference 390 towards the centrally defined lumen 315.

(42) Each of the projections 360, 370 is tipped with a tooth 375, 365. The cutting edge of each tooth 375, 365 is oriented to face the opposite circumferential direction to the other, i.e. the cutting edge of tooth 365 faces circumferentially clockwise and the cutting edge of tooth 375 faces a circumferentially anti-clockwise.

(43) A complete connector or connector system for medical fluid administration according to a specific embodiment will comprise both a male connection member and a female connection member as described above. FIG. 14 illustrates a plan view of a male connection member when coupled to a female connection member as described in FIGS. 1 and 2. FIG. 15 is a cutaway along the line indicated in FIG. 14 with FIG. 15 showing a tube or conduit 311 coupled to the proximal end of the male connection member.

(44) In order to form a connection between a male connection member and a female connection member, for example to allow fluid contained within a vial to pass into a fluid administration set, then the male connection member must be inserted into the female connection member. The distal portion of the male connection member is dimensioned to mate with and provide an interference seal with the internal surface of the sheath of the female connection member. The taper of 1.5 degrees in the sheath is mirrored in the taper of the male connection member and this taper allows the connection member to be inserted its full length into the sheath before a seal is made.

(45) Once inserted into the sheath, contact is made between the terminal teeth 365, 375 of the male connection member and the peripheral region of the septum 42. As the material forming this region of the septum is thin, the application of a small amount of pressure to the male connection member both forms a seal with the walls of the sheath and causes the terminating teeth to penetrate the peripheral region of the septum. By simultaneously twisting the male connection member and pushing the male connection member further into the sheath, the septum is ruptured to allow communication between the lumen 315 of the male connection member and the contents if the container.

(46) When the male connection member is twisted the terminal teeth 365, 375 catastrophically disrupt the thin peripheral region of the septum 42. As the male connection member is forced further into the septum the inclined projections or castellations 360, 370 engage with the thickened region in the center of the septum and tilt this thickened region, thereby providing greater stress to the remaining portion of peripheral region of the septum and further aiding the catastrophic rupture of the septum.

(47) FIGS. 16 to 18 illustrate a fourth embodiment of a female connector or female connection member 1010. The female connection member 1010 may be used as a component in an embodiment of a connector system for medical fluid administration. The female connection member 1010 of FIGS. 16 to 18 incorporates a keyway 1011 for receiving a key defined in a male connection member.

(48) FIGS. 19 and 20 illustrate a second embodiment of a male connection member 1200. The male connection member 1200 may be used as a component in an embodiment of a connector system for medical fluid administration. The male connection member 1200 comprises a key 1211 for engaging with a keyway of a female connection member.

(49) The second embodiment of a male connection member 1200 is preferably used for coupling with the female connection member 1010 of FIGS. 16 to 19 in a connector system according to a specific embodiment of the invention.

(50) With reference to FIGS. 16 to 18, the female connection member 1010 has a body 1020 formed from an injection-moulded polypropylene. The body 1020 defines a sheath 1030 having a substantially circular cross-section. A proximal end of the sheath defines an opening for receiving a male connection member, and a distal end of the sheath is spanned by a septum 1040. An annular flange 1050 extends radially outwards from an uppermost or proximal end of the sheath.

(51) The septum comprises a central region or central portion 1041 formed from a thick section of polypropylene and a peripheral section or peripheral portion 1042 formed from a thin section of polypropylene. The central portion 1041 has a thickness of 1.80 mm and the peripheral portion has a thickness of 0.25 mm. The length of the female connection member from the radial flange 1050 to the distal end of the sheath is 14.75 mm.

(52) The body 1020 of the female connection member at its proximal end defines a keyway that extends downwardly into an upper portion of the sheath 1030. The keyway 1011 extends around 170° of an upper portion of the circumference. The keyway extends to a depth of 5 mm from the proximal end of the sheath 1030.

(53) The female connection member 1010 may be used as an access port, for example as an access port to an infusion bag or bottle as illustrated in relation to other specific embodiments of the invention.

(54) FIGS. 19 and 20 illustrate a male connector or male connection member 1200 for connecting with the female connection member 1010 in a connector system for medical fluid administration according to an embodiment of the invention.

(55) The male connection member has a proximal portion 1210 and distal portion 1220. The male connection member 1200 further comprises a lumen 1215, an annular flange 1230, a pair of longitudinally extending flanges 1240, 1250, and a pair of projections 1260, 1270.

(56) The male connection member 1200 of FIGS. 19 and 20 further comprises a key 1211 formed from a section of material that extends radially outward from the distal portion 1220. The key is a portion of material defined and extending from the proximal portion of the male connection member that has a length of 5 mm, a width of 2.5 mm, and a thickness of 1 mm. The key 1211 acts to prevent the proximal portion 1220 of the male connection member 1200 from being inserted into a female connection member that is otherwise dimensioned to make a sound connection but is lacking a keyway to receive the key.

(57) The projections 1260, 1270 are not circumferentially-evenly-spaced on the distal end of the male connection member. Rather than being directly opposing the second projection (i.e. having an angular separation of 180° from the second projection), the first projection 1260 has an angular separation of 170° from the second projection 1270.

(58) In order to form a connection, the male connection member 1200 is inserted into the female connection member 1010. The male connection member 1200 cannot be inserted into the female connection member 1010 until the male connection member is oriented such that the key 1211 on the distal portion of the male connection member is aligned with the keyway 1011 defined in the female connection member 1010. The distal portion 1220 of the male connection member 1200 is dimensioned to mate within an inner surface of the sheath 1030 of the female connection member 1010. At a point of near maximum insertion of the male connection member into the female connection member the projections 1260, 1270 engage with the peripheral portion 1042 of the septum and pierce it. The male connection member 1200 is then twisted within the female connection member 1010. The extent of this twisting is restricted, however, by the interaction of the key 1211 on the male connection member 1200 and the keyway 1011 on the female connection member 1010. By twisting the male connection member anticlockwise until the key abuts a first end-point 1006 of the keyway 1011 and then clockwise until the key abuts a second end-point 1005 of the keyway, the projections cut through a portion of the peripheral portion of the septum. If the keyways allow a 170° rotation of the male connection member and the projections are offset by an angle of 170°, the full range of twisting of the male connection member within the female connection member will result in 340° of the peripheral regional of the septum being ruptured. The remaining 20° that is not ruptured acts as a retaining hinge that retains the central portion 1041 in connection with the female connection member 1010 after a connection has been made.

(59) The keyway may allow a greater or lesser angular rotation than 170°. For example, the keyway may allow a 175° rotation or a 180° rotation or a 185° rotation. As long as the two projections 1260 and 1270 are offset by a small degree, it is possible to rotate the male connection member within the female connection member through a defined angle and cut or rupture the peripheral portion of the septum for a substantial, but not entire, portion of its circumference, thereby leaving a portion of the peripheral region of the septum to connect the central portion of the septum with the female connection member after a connection has been made.

(60) FIG. 21 illustrates the use of a female connection as illustrated in FIGS. 16 to 18 as an access port in a vial of medical fluid 1060, a male connection member 1200 as illustrated in FIGS. 19 and 20 is arranged such that its distal portion 1220 is partially inserted into the sheath of the female connection member 1010. The male connection member 1200 in the illustrated orientation cannot fully connect with the female connection member, as the male connection member is oriented such that the key 1211 is not aligned with the keyway 1011 defined in the female connection member.

(61) FIG. 22 illustrates the male connection member 1200 in the correct orientation, such that the key 1211 and keyway 1011 are in alignment allowing a connection to be made.

(62) In summary, any one of the specific embodiments of female connection members described above would be unsuitable for forming a connection with a standard giving spike or with a hypodermic needle. The thickened central portion of the septum for each of these female connection members is designed to prevent the accidental insertion of a hypodermic needle or giving spike. Were a healthcare professional to angle a hypodermic needle such that was able to penetrate through the thinner peripheral region of the septum, then this region of the septum would not grip the needle to form a competent seal. If a healthcare professional forces either a hypodermic needle or a giving spike into the thickened portion of the septum, then a catastrophic failure of the entire septum would occur at its outer-most annular region forming a leak that prevents a competent connection being made.

(63) In the specific embodiments, the dimensions of the sheath of the female connection members are sufficiently wide to prevent an interference seal being formed with the body of a standard giving spike. Thus, a healthcare professional cannot accidentally form a competent connection to a medical fluid container closed by a female connection member according to an embodiment of the invention.

(64) The specific embodiments of a male connection member described above are uniquely adapted for forming a connection with one or more of the described female connection members. Furthermore, the male connection members of the specific embodiments could not accidentally form a connection with a medical bottle or vial containing fluid closed with a standard rubber septum. The male connection members specifically described are highly unlikely to penetrate a standard rubber septum for closing a vial, and even if they did, this penetration would not allow a seal to be formed by which passage of fluid within the vial could pass into the lumen at the central portion of the male connection member.

(65) Furthermore, the male connection members specifically described above are dimensioned such that they do not physically fit into the standard ports usually used for allowing access to a standard universal giving spike. Thus, it should not be possible for a healthcare professional to accidentally connect a conduit or administration set terminating in a male connection member according to an embodiment of the invention with a medical container fitted with standard closures.

(66) Both the male connection member and the female connection member of a connector system according to an embodiment of the invention are designed to be compatible with each other, but not with other commonly used medical fluid connection members.