巴西专利BR112012011423B1 online liquid drug medical device for use with a saline source and a medical container for reconstit

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专利摘要:
IN-LINE LIQUID DRUG MEDICAL DEVICES WITH LINEAR DISPLACABLE FLOW CONTROL MEMBER The present invention relates to an in-line liquid drug medical device having a longitudinal geometric axis of the device, a housing with a displaceable sliding flow control member linear, displaceable across a transverse hole from a first flow control position to establish flow communication between a first pair of orifices for liquid drug reconstitution purposes to a second flow position to establish flow communication between a second pair of orifices for liquid drug delivery purposes, and a manually operated actuation mechanism to apply a linear displacement force to urge the flow control member to slide along the hole from its first flow control position to your second flow control position.
公开号:BR112012011423B1
申请号:R112012011423-9
申请日:2010-11-04
公开日:2020-10-13
发明作者:Nimrod Lev；Igor Denenburg；Moshe Gilboa
申请人:Medimop Medical Projects Ltd；
IPC主号:

专利说明:

Field of invention
[001] The present invention relates to in-line liquid drug medical devices for purposes of reconstitution and liquid drug delivery. Background of the invention
[002] The US Patent commonly granted 6,238,372, entitled Fluid Control Device illustrates and describes a fluid control device for use with a syringe and at least one medical container. The fluid control device includes a first orifice, a second orifice for receiving the syringe, a third orifice including an adapter having a fluid conduit member extended into the medical container when attached to it and a flow control member selectively disposable from a first flow control position enabling a flow path between a first pair of two orifices and the second flow control position enabling a flow path between a second pair of two orifices. The flow control member is coupled to one of the holes for manipulation between its flow control positions.
[003] PCT International Application commonly assigned No. PCT / IL2005Z 000376, entitled Liquid Drug Medical Devices and published under PCT International Publication No. WO 2005/105014 illustrates and describes a liquid drug medical device for reconstitution and administration purposes. liquid drug, a vial adapter with elastomer tubing and a needle guard removal device. The liquid drug medical device has a longitudinal geometric axis and is intended for use with a saline source and a medical container. The liquid drug medical device includes a body member having a first fluid connection port with the saline source and a flow control member mounted with rotation on the body member around a geometrical axis of codirectional rotation with the longitudinal geometric axis. The flow control member has a first main flow duct and a second main flow duct substantially in parallel and not coaxial with the axis of rotation and respectively ending in a second orifice, and a third orifice for delivering the liquid drug. The liquid drug medical device further includes a manually rotating adapter having a fluid conduit member with a proximal end in flow communication with the second orifice and a distal end extended into the medical container in its attachment to the adapter, and coupled to the adapter. flow control member to rotate it between a first flow control position to connect the first orifice to the second orifice, and a second flow control position to connect the first orifice to the third orifice.
[004] PCT International Application commonly assigned No. PCT / US2008 / 070024, entitled Medicament Mixing and Injection Apparatus and published under PCT International Publication No. WO 2009/038860 illustrates and describes a mixing and injection apparatus including a needle and a needle base, syringe holder and mixing chamber latch assembly including a needle chamber surrounding the needle and a first liquid duct portion, sealed from the needle chamber and a latch portion of the mixing chamber including a second portion of liquid conduit communicating with the first portion of liquid conduit and configured for communication with a mixing chamber. The syringe fastener and needle base are configured to allow liquid communication between the inside of the syringe and the first liquid line portion when the syringe fastener and needle base are in the first engagement orientation relative and to allow liquid communication between the inside of the syringe and the needle when the syringe holding element and the needle base are in the second relative engagement orientation, axially separated from the first relative orientation along the injection axis. Summary of the invention
[005] The present invention is directed to medical liquid drug devices for use with a physiological fluid source and a medical container for purposes of reconstitution and liquid drug administration.
[006] The in-line liquid drug medical device includes a housing having a longitudinal device axis and a bottle adapter removably attached to the housing and separable from it along a codirectional separation line with the device's geometric axis. The housing has three orifices, a first orifice to which the source of physiological fluid is connected, a second orifice that leads to the medical container and a third orifice that is fitted with a drug dispenser, such as a needle, an atomizer and so on. onwards.
[007] The in-line liquid drug medical device includes a manually operated actuation mechanism to apply a linear displacement force to a flow control member accommodated with a seal inside a hole in the housing to slide the flow control member to the along the hole in a direction transverse to the geometric axis of the device from a first initial flow control position for liquid drug reconstitution purposes to a second subsequent flow control position for liquid drug delivery purposes. The first flow control position allows flow communication between the first orifice and the second orifice for purposes of reconstituting the liquid drug. The second flow control position allows flow communication between the first orifice and the third orifice adapted with a drug dispenser, such as a needle, an atomizer, and so on, for liquid drug delivery purposes. The first and third holes are preferably coaxial to facilitate more intuitive use of the device.
[008] The actuation mechanism has an initial liquid drug reconstitution position corresponding to the first flow control position of the flow control member and a subsequent liquid drug delivery position corresponding to the second flow control position of the flow control member. flow control member. One type of actuation mechanism uses a manual radial actuation force having a component to provide a linear displacement force to the flow control member. Another type of actuation mechanism uses a manual linear actuation force to provide a linear displacement force to a flow control member. Actuation mechanisms are preferably integrally formed with vial adapters for removal together with vial adapters in separating them from a housing after reconstitution of the liquid drug and before the administration of the liquid drug.
[009] Alternatively, the mechanisms of action can be fully formed with the accommodations. Brief description of the drawings
[0010] In order to understand the invention and to see how it can be carried out in practice, preferred modalities will now be described, by means of non-limiting examples only, with reference to accompanying drawings in which similar parts are numbered the same and in which are:
[0011] figure 1 is an illustrated representation of a syringe, vial and an in-line liquid drug medical device having a rotary actuation mechanism and a linear displaceable sliding flow control member,
[0012] figure 2 is a bottom perspective view of the device in figure 1,
[0013] figure 3A is a partially exploded view of the device in figure 1,
[0014] figure 3B is a partially exploded view of another embodiment of the device in figure 1 with an integral bottle adapter,
[0015] figure 4A is a top perspective view of the flow control member of the device of figure 1,
[0016] figure 4B is a bottom perspective view of the flow control member of the device of figure 1,
[0017] figures 5A and 5B are longitudinal sections of the device in figure 1 along lines AA and BB, respectively, in figure 1 showing its actuation mechanism in an initial liquid drug reconstitution position and its flow control member in a first flow control position for liquid drug reconstitution purposes,
[0018] figure 5C is similar to figure 5A showing the separation distances S1 and S2 between opposite internal surfaces of the actuation mechanism in relation to its geometric axis of rotation,
[0019] figure 5D is a cross section of the device in figure 1 along line C-C in figure 5C showing the separation distances S1 and S2 between opposite internal surfaces of the actuation mechanism in relation to its geometric axis of rotation,
[0020] figure 6A is a longitudinal section of the device in figure 1 along line AA in figure 1 showing its actuation mechanism in a subsequent liquid drug delivery position and its flow control member in a second flow position. flow control for liquid drug delivery purposes,
[0021] figure 6B is a cross-section of the device in figure 1 along the CC line in figure 6A showing its actuation mechanism in its subsequent liquid drug delivery position and its flow control member in its second position flow control for liquid drug delivery purposes,
[0022] figure 6C is a longitudinal section of the device in figure 1 along the BB line in figure 1 showing its actuation mechanism in its liquid drug delivery position and its flow control member in its second control position flow for liquid drug delivery purposes,
[0023] figures 7A to 7G show the use of the device of figure 1 for purposes of reconstitution and administration of liquid drug,
[0024] figure 8 is an illustrated representation of a syringe, vial and in-line liquid drug medical device having an actuation mechanism with an actuator similar to a spring leaf and a linear displaceable sliding flow control member,
[0025] figure 9 is a bottom perspective view of the device in figure 8,
[0026] figure 10 is a partially exploded view of the device in figure 8,
[0027] figure 11 is a top perspective view of the flow control member of the device of figure 8,
[0028] figure 12 is a longitudinal section of the device in figure 8 along the DD line in figure 8 showing its actuation mechanism in an initial liquid drug reconstitution position and its flow control member in a first position of flow control for liquid drug reconstitution purposes,
[0029] figure 13 is a longitudinal section of the device in figure 8 along the line DD in figure 8 showing its flow control member in a second flow control position for purposes of liquid drug administration subsequent to the performance of the its mechanism of action,
[0030] figures 14A to 14H show the use of the device of figure 8 for purposes of reconstitution and administration of liquid drug,
[0031] figure 15 is an illustrated representation of another embodiment of the device of figure 8 including a linear displaceable sliding flow control member in a first flow control position for liquid drug reconstitution purposes,
[0032] figure 16 is a longitudinal section of the device in figure 15 along line E-E in figure 15 and
[0033] figure 17 is an illustrated representation of yet another embodiment of the device of figure 8 with a bottle adapter having an elliptically formed stem and stem tip with a stem tip cavity. Detailed description of preferred embodiments of the invention In-line liquid medical medical device including a manually operated rotary actuation mechanism and a linear displaceable sliding flow control member
[0034] Figure 1 shows a syringe 10 constituting a source of physiological fluid, a vial 20 constituting a medicinal container and an in-line liquid drug medical device 100 for use with syringe 10 and vial 20. Syringe 10 includes a cylinder 11 with a plunger 12 and a male Luer lock connector 13. Syringe 10 can be formed with other types of connectors. The vial 20 includes an open top bottle 21 sealed by a vial stopper 22 capped with a metal tape 23 or other suitable buffer material. Vial 20 contains a powdered or liquid drug 24. Syringe 10 typically contains diluent to reconstitute the contents of vial 24.
[0035] Figures 2 to 6 show the in-line liquid drug medical device 100 having a longitudinal geometric axis of the device 101 and including a housing 102 and a vial adapter 103 removably coupled to the housing 102 and separable from it along a codirectional separation line with the geometric axis of the device 101. The housing 102 includes a generally cylindrical body 104 coaxial with the geometric axis of the device 101 and having a syringe orifice 108 at one end and an orifice delivery tube 109 in its opposite end. The body 104 includes a hollow hole 106 having a geometric axis of the hole 107 transversely directed to the geometric axis of the device 101, a proximal end of the hole 106A and a distal end of the hole 106B. Body 104 includes a threaded intermediate section 112 with surrounding fixing threads at circumference 112A. An annular hand glove 111 coaxially aligned with the geometric axis of the device 101 is secured in the intermediate section 112 by two opposite fixing walls 118 to allow a user to hold the housing 102 accordingly during use. Sleeve 111 includes a sleeve opening 111A to allow access to syringe port 108.
[0036] The syringe orifice 108 constitutes a first orifice in flow communication with the hole 106. The syringe orifice 108 is designed for the syringe connector 13 and is co-directional with the geometric axis of the device 101 and, preferably , coax with him. The syringe orifice 108 is typically in the form of a female Luer connector designed to receive a male Luer lock connector from the syringe. The orifice delivery tube 109 is generally cylindrical in shape and is coaxially aligned with the geometric axis of the device 101. Orifice delivery tube 109 includes a second orifice 113 and a third orifice 114, both in flow communication with the bore. 106. The second orifice 113 and the third orifice 114 are co-directional with the geometric axis of the device 101 and the third orifice 114 is preferably coaxial with it. The third orifice 114 is preferably fitted with a needle 116 for purposes of administering the liquid drug. The second orifice 113 is preferably recessed with respect to the third orifice 114, thereby forming an annular cavity 117 for removably coupling the vial adapter 103 in housing 102.
[0037] Device 100 includes a linear displaceable sliding flow control member (FCM) 120 accommodated with seal in hole 106 to establish flow communication between syringe orifice 108 and second orifice 113 in a first flow control position flow for liquid drug reconstitution purposes, and between syringe port 108 and third port 114 in a second flow control position for liquid drug delivery purposes. The flow control member 120 is generally cylindrical in shape and has a peripheral cylindrical surface 121 with a semicircular peripheral flow channel 122 and a longitudinally directed flow switch 123, a blind hole 124, a proximal end of the FCM 126 and a distal end of FCM 127.
[0038] A proximal round protrusion 128 extends beyond the proximal end of the FCM 126 and serves as a contact surface to apply a radial actuating force RAF against it to provide a linear displacement force LDF to propel the flow control member 120 along hole 106. In the first flow control position, flow control member 120 is sealed with hole 106 with the proximal round protrusion 128 projecting substantially out of the proximal end of hole 106A (see figures 5A -5D). In the second flow control position, the proximal round protrusion 128 is substantially inserted fully into the proximal end of hole 106A (see figures 6A-6C).
[0039] The longitudinally directed flow switch 123 is dimensioned so that it is in flow communication with the first orifice 108 when the flow control member 120 is in both its first flow control position and its - second flow control position. Flow channel 122 is arranged towards the proximal end of FCM 126 and extends around the circumference of a proximal end of channel 122A in flow communication with flow switch 123 to a distal end of channel 122B. In the first flow control position, the distal end of channel 122B is in flow communication with the second hole 113 (see figure 5A), and in the second flow control position, the distal end of channel 122B is in flow communication. with the third hole 114 (see figure 6A).
[0040] The bottle adapter 103 includes a skirt 130 with an upper surface 131 and flexible hanging members 132 for fitting fit on the bottle 20. The bottle adapter 103 includes an elongated upright stem 133 and ends at a stem end portion circular 134 having a stem cavity 135 formed for accommodation in housing 102. The stem cavity 135 includes an upper body cavity section 135A for rotation with the generally cylindrical body 104 and a lower distribution tube cavity section in cylindrical shape 135B to adjust with rotation in the tube of orifice 109.
[0041] The stem 133 includes an annular manifold support 136 at a distal end of the lower manifold cavity section 135B for coupling in circumference with annular cavity 117. A fluid conduit 137 that is coaxial with the shaft geometry of device 101 has a proximal end 137A in the annular delivery tube holder 136 for sealed flow communication with the second orifice 113 in the vial adapter 103 coupling in housing 102. Fluid conduit 137 fluidly connects to a distal end 137B in a coaxial cannula 141 through a fluid interconnecting conduit 137C. The drilling cannula 141 serves to pierce the stopper of the vial 22 at its positive insertion in the vial adapter 103, and extends slightly beyond so that with the inversion of vial 20, almost all of its contents 24 can be aspirated from it through the perforation cannula 141 for syringe 10. Rod 133 also includes a blind hole in needle 138 for receiving needle 116 in the coupling of vial adapter 103 in housing 102.
[0042] In a first embodiment, as shown in figure 3A, the stem 133 has a circumferential rim 139 along a lower section to engage a coupler 142 that secures the stem 133 to the upper surface 131. In another embodiment, as shown in 3B, a device 100A similar to device 100 includes an integrally embedded vial adapter 103A which is removably coupled to housing 102.
[0043] Vial adapter 103 is threaded into housing 102 by means of a pair of opposing fixing members 143 extending upwardly from the end portion of the codirectional stem 134 and on opposite sides of the device 101 geometric axis. fasteners 143 each have a perpendicular projection tooth 144 for engaging the fastening threads 112A. When the bottle adapter 103 is rotated with respect to housing 102 around a axis of rotation 146 coaxial with the device axis 101, the bottle adapter 103 detaches from housing 102 and is separable from it along a line of codirectional separation with the geometric axis of the device 101.
[0044] Vial adapter 103 is integrally formed with a manually operated rotary actuation mechanism 150 to apply a radial actuation force RAF to provide a linear displacement force LDF to slide the flow control member 120 along hole 106 from your first flow control position to your second flow control position. The actuation mechanism 150 is made using a semicircular internal flesh surface 151 of the stem end portion 134 to abut against the proximal round protrusion 128 when the vial adapter 103 is separated with rotation of the housing 102. The actuation mechanism 150 has an initial liquid drug reconstitution position corresponding to the first flow control position of the flow control member 120 when the bottle adapter 103 is threaded in housing 102 and a subsequent liquid drug delivery position corresponding to the second position flow control member of the flow control member 120 when the bottle adapter 103 is separable from the housing 102. The internal cam surface 151 defines a separation (S) relative to the axis of rotation 146. The internal cam surface 151 has a maximum separation S1 in the liquid drug reconstitution position of the actuation mechanism 150 and a minimum separation ima S2 in the liquid drug delivery position of the actuation mechanism 150. The separation S2 is smaller than the separation S1, such that the bottle adapter 103 is unscrewed from the housing 102, the internal cam surface 151 applies a force of radial actuation RAF against protrusion 128 having a component to impart a linear displacement force (LDF) to the flow control member 120 to slide it along hole 106 from its first flow control position to its second flow control position. The rod end portion 134 has an outer surface 134A with a uniform radius relative to the axis of rotation 146, such that its wall thickness increases from its thinnest where the inner flesh surface 151 abuts the control member of flow 120 in the reconstitution position of the liquid drug of the actuation mechanism to its thickest where the internal meat surface 151 leans against the flow control member 120 in the position of administration of the liquid drug of the actuation mechanism.
[0045] The operation of device 100 can be better explained by reference to figures 5A - 5D and figures 6A - 6C.
[0046] Figures 5A - 5D show the actuation mechanism 150 in its initial liquid drug reconstitution position and the flow control member 120 in its first flow control position. The bottle adapter 103 is threaded into housing 102 and the flow control member 120 protrudes from the proximal end of hole 106A with the proximal round protrusion 128 touching the inner flesh surface 151.
[0047] Figures 6A - 6C show the actuation mechanism 150 in its subsequent liquid drug delivery position and the flow control member 120 in its second flow control position after half a turn unscrewing the bottle adapter 103 from the housing 102. The radial actuating force RAF is continuously applied to the flow control member 120 by the internal cam surface 151 having a continuously decreasing separation S from the geometric axis of rotation 146 to grant the linear displacement force LDF to slide the flow control member 120 to its second flow control position. Teeth 144 fully disengage from the fastening threads 112A in the liquid drug delivery position of the actuation mechanism when the flow control member 120 is in the second flow control position at which point the bottle adapter 103 is separable from housing 102 .
[0048] The use of the online liquid drug medical device 100 for reconstitution and administration of the liquid drug is shown in figures 7A to 7G as follows:
[0049] Figure 7A shows the device 100 in its first initial flow control position for reconstitution of the liquid drug and a user mounting the device 100 in a vial 20, as indicated by the arrow M.
[0050] Figure 7B shows the user bringing syringe 10 towards device 100, as indicated by arrow N and screwing syringe 10 onto device 100, as indicated by arrow O.
[0051] Figure 7C shows the user injecting the contents of the syringe into vial 20, as indicated by the arrow P. The user shakes the assembly to reconstitute the liquid drug.
[0052] Figure 7D shows the user inverting the assembly and aspirating the contents of the reconstituted liquid drug into the syringe 10, as indicated by the arrow Q.
[0053] Figure 7E shows the user rotating the vial adapter 103 to the subsequent liquid drug delivery position to slide the flow control member 120 to its second subsequent flow control position, as indicated by the arrow R Optionally, for this step and the following steps, the user inverts the assembly, so that syringe 10 is above vial 20.
[0054] Figure 7F shows the user screwing the bottle adapter 103 of the housing 102, as indicated by the arrow S to expose the needle 116, thus enabling the administration of the liquid drug (see figure 7G). The user discards the bottle adapter 103 with the used bottle 20. In-line liquid medical medical devices including a manually operated actuation mechanism with an actuator such as a spring leaf and a linear displaceable sliding flow control member
[0055] Figure 8 shows syringe 10, vial 20 and an in-line liquid drug medical device 200 for use with syringe 10 and vial 20.
[0056] Figures 9 to 13 show the in-line liquid pharmaceutical medical device 200 which has a longitudinal geometric axis of the device 201 and includes a housing 202 and a vial adapter 203 removably coupled in the housing 202 and separable from it along of a codirectional separation line with the geometric axis of the device 201. The housing 202 includes a generally cylindrical central body 204 with a hollow hole 206 having a geometric axis of the hole 207 transversely directed to the geometric axis of the device 201 and having a proximal end 206A and a distal end 206B.
[0057] The housing 202 includes a syringe orifice 208 constituting a first orifice in flow communication with hole 206 and an orifice distribution tube 209 on opposite sides of the central body 204. The syringe orifice 208 is codirectional with the axis device 201 and preferably coaxial with it. The orifice dispensing tube 209 includes a pair of opposing and parallel main surfaces 211 co-directional with the geometric axis of hole 207 and a pair of opposing minority end surfaces 212 for securing vial adapter 203 in housing 202. The tube orifice distribution system 209 includes the second orifice 213 and the third orifice 214, both in flow communication with the hole 206. The second orifice 213 and the third orifice 214 are co-directional with the geometric axis of the device 201 and the third orifice 214 is preferably coaxial with it. The center of the second orifice 213 is displaced from the geometric axis of the device 201 by a length L. The third orifice 214 is preferably fitted with a needle 216. The second orifice 213 is preferably lowered with respect to the third orifice 214, thereby forming a cavity 217 for sealing the bottle adapter 203 in the housing 202.
[0058] Housing 202 includes a flow control member 218 for linear sliding movement along hole 206 from a first initial flow control position to establish flow communication between the first orifice 208 and the second orifice 213 for a second subsequent flow control position to establish flow communication between the first orifice 208 and the third orifice 214. Hole 206 has a uniform cross section along it, except its distal end 206B which is formed with a platform 219 on the side of the delivery tube of the orifice 209 to act as a stopper to stop the linear sliding movement of the flow control member 218 in its second flow control position. The platform can be formed on the side of the syringe orifice 208.
[0059] The flow control member 218 has a proximal end 218A and a distal end 218B and a peripheral cylindrical surface 221. The flow control member 218 is shaped and sized to seal the insert in the hollow hole 206 and is longer than the same, such that its proximal end 218A protrudes from the proximal end 206A in its first flow control position (see figure 12) and its distal end 218B protrudes from the distal end 206B in its second flow control position ( see figure 13).
[0060] The flow control member 218 includes a flow channel 222 codirectional with the geometric axis of the device 201 and disposed towards the proximal end 218A. The flow channel 222 has a proximal end 223 and a distal end 224. The peripheral surface 221 is formed with a longitudinally directed flow switch 226 and a second longitudinally directed switch 227 on the side opposite the flow switch 226. The switch 227 is it faces the orifice distribution tube 209 and is located towards the distal end 218B and defines a contact surface 228 for contact against the stopper 219 to stop the flow control member 218 in its second flow control position.
[0061] The bottle adapter 203 includes a skirt 230 with an upper surface 231 and flexible hanging members 232 to fit the bottle 20. The bottle adapter 203 includes an elongated upright stem 233 ending at a forked tip 234 with a pair of opposite and parallel separate internal surfaces 236 for adjusting friction on the main surfaces 211 of the orifice distribution tube 209. The stem 233 includes a fluid conduit 237 with a proximal end 237A for sealing insertion in cavity 217 for sealed flow communication with the second orifice 213 in the coupling of the vial adapter 203 to the housing 202. The fluid conduit 237 ends at the distal end 237B fluidly connecting with a pointed cannula 241. The stem 233 also includes a needle blind hole 238 to receive the needle 216 in the coupling of the vial adapter 203 to the housing 202.
[0062] The bottle adapter 203 is integrally formed with a manually operated actuation mechanism 250 to apply a linear actuation force LAF to provide a linear displacement force LDF to slide the flow control member 218 along hole 206 a from your first flow control position to your second flow control position. The actuation mechanism 250 is in the form of an actuator such as a manually operated upright spring sheet 251 attached to the base of the stem 233 and having a free end 252 disposed opposite the proximal end 218A of the flow control member. Actuator 251 has a pin 253 for sliding insertion in a recess 254 formed at the proximal end 218A of the flow control member. The actuator 251 is preferably flexed flexibly from an initial position juxtaposed against the flow control member 218. The actuating mechanism 250 is preferably designed such that pin 253 slides freely from recess 254 when released after being released. be used to urge the flow control member 218 to its second flow control position to revert to its initial vertical position.
[0063] The use of the in-line liquid drug medical device 200 for reconstitution and administration of the liquid drug as shown in figures 14A to 14H is as follows:
[0064] Figure 14A shows the device 200 in its first initial flow control position for reconstitution of the liquid drug and a user assembling the device 200 in a vial 20, as indicated by the arrow M.
[0065] Figure 14B shows the user bringing syringe 10 closer to device 200, as indicated by arrow N and screwing syringe 10 onto device 200, as indicated by arrow O.
[0066] Figure 14C shows the user injecting the contents of the syringe into vial 20, as indicated by the arrow P. The user shakes the assembly to reconstitute the liquid drug.
[0067] Figure 14D shows the user inverting the assembly and aspirating the contents of the reconstituted liquid drug into the syringe 10, as indicated by the arrow Q.
[0068] Figure 14E shows the user tightening the hand operated actuator 239 to urge the flow control member 218 to its second subsequent flow control position in which the syringe orifice 208 is in flow communication with the third orifice 214, as indicated by the arrow R.
[0069] Figure 14F shows the user releasing the hand operated actuator 251, which reverts to its pre-pressed position, as indicated by the arrow S. Optionally, for this step and the following steps, the user inverts the assembly, so that syringe 10 is on top and vial 20 is on the bottom.
[0070] Figure 14G shows the user pulling the bottle adapter 203 with the used bottle 20 from the housing 202 to expose the needle 216, as indicated by the arrow T, thus allowing the administration of the liquid drug (see figure 14H).
[0071] Figures 15 and 16 show an in-line liquid drug medical device 200A similar in construction to device 200 and, therefore, similar parts are numbered the same. The device 200A differs from the device 200 in that the first 200A includes an engaging mechanism 256 in which the free end 252 is formed with an annular flange 257 for engaging the proximal end 218A.
[0072] Figure 17 shows an in-line liquid drug medical device 200B similar in construction and operation to device 200 and, therefore, similar parts are numbered the same. The device 200B differs from the device 200 in that the first 200B includes an elliptically formed stem 258 and stem tip 259 with a stem cavity 261, and a hole 206 that is cylindrically formed and includes a key protrusion 262 extended therethrough. engages a groove 263 in the flow control member 218. The keyed protrusion 262 and the groove 263 are configured to prevent rotation of the flow control member 218 inside hole 206.
[0073] Although the invention has been described with respect to a limited number of modalities, it will be found that many variations, modifications and other applications of the invention can be made within the scope of the appended claims.

权利要求:
Claims (9)
[0001]
1. In-line liquid drug medical device (100, 200, 200A, 200B) for use with a saline source and a medical container for reconstitution and administration of a liquid drug, the device having a longitudinal geometric axis of the device (101 ), and comprising: (a) a housing (102, 202) having a first orifice (108, 208) for connecting fluid to the saline source, a second orifice (113, 213) for connecting fluid to the container medicinal, a third orifice (114, 214) for administering the liquid drug and a bore (106, 206); (b) a linear displaceable sliding flow control member (120, 218); (c) a manually operated actuation mechanism (150, 250); and (d) a vial adapter (103, 203) for fitting fit the medical container and including a fluid duct member (137, 237) with a proximal end (137A, 237A) in flow communication with said second orifice (113, 213) and a distal end (137B, 237B) in flow communication with a drilling cannula (141, 241) extended into the medical container in its attachment to said vial adapter (103, 203), and said bottle adapter (103, 203) being removably attached to said housing (102, 202) along a codirectional separation line with the geometric axis of the device (101,201), characterized by the fact that: the hole ( 106, 206) is disposed transversely with respect to the geometric axis of the device (101,201) and in flow communication with said first orifice (108, 208), said second orifice (113, 213) and said third orifice (114, 214); the linear displaceable sliding flow control member (120, 218) is displaceable along said hole (106, 206) from a first flow control position to establish flow communication between said first orifice (108, 208) and said second orifice (113, 213) for purposes of reconstituting the liquid drug to a second flow control position to establish flow communication between said first orifice (108, 208) and said third orifice (114 , 214) for liquid drug delivery purposes; and the manually operated actuation mechanism (150, 250) having an initial liquid drug reconstitution position corresponding to said first flow control position and a subsequent liquid drug delivery position corresponding to said second flow control position, said actuation mechanism (150, 250) applying a linear displacement force to urge said flow control member (120, 218) to slide along said hole (106, 206) from said first control position flow to said second flow control position in manual actuation of said actuation mechanism (150, 250) from said initial liquid drug reconstitution position to said liquid drug delivery position.
[0002]
2. Device according to claim 1, characterized by the fact that said actuation mechanism (150) rotates around a geometric axis of rotation (146) codirectional with the geometric axis of the device (101) and has a surface inner flesh (151) leaning against said flow control member (120), said inner flesh surface (151) has a first separation S1 relative to said geometric axis of rotation (146) in said drug reconstitution position liquid and a second separation S2 relative to said geometric axis of rotation (146) in said position of administration of the liquid drug where said second separation S2 is smaller than said first separation S1, with which the manual actuation of said actuation mechanism (150), from said liquid drug reconstitution position to said liquid drug delivery position, applies a radial actuation force to grant said linear displacement force.
[0003]
3. Device according to claim 2, characterized by the fact that said bottle adapter (103) is separable with rotation of said housing (102) and said rotational separation simultaneously activates said actuation mechanism (150) of said liquid drug reconstitution position for said liquid drug delivery position.
[0004]
4. Device according to claim 2, characterized by the fact that said geometric axis of rotation (146) is coaxial with the geometric axis of the device (101).
[0005]
5. Device, according to claim 1, characterized by the fact that said actuation mechanism (250) includes a manually pressed actuator (251), with which the manual actuation of said actuation mechanism applies a linear actuation force to grant said linear displacement force.
[0006]
6. Device according to claim 5, characterized by the fact that said manually pressed actuator (251) has a configuration like a spring leaf including a first end flexibly mounted on said bottle adapter (203) and a second free end (252) to urge said flow control member (218) from said first flow control position to said second flow control position.
[0007]
Device according to any one of claims 1 to 6, characterized in that said flow control member (120, 218) includes a peripheral cylindrical surface (121, 221) with a longitudinal flow switch (123 , 226) in flow communication with said first orifice (108, 208) in said first flow control position and in said second flow control position, and a flow channel (122, 222) to establish the communication of flow between said flow switch (123, 226) and said second orifice (113, 213) at said first flow control position, and said flow switch (123, 226) and said third orifice (114, 214) in said second flow control position.
[0008]
8. Device according to claim 7, characterized in that said flow channel (122, 222) is a lumen extended through said flow control member (120, 218).
[0009]
9. Device according to claim 7, characterized in that said flow channel (122, 222) is a semicircular flow channel on said peripheral cylindrical surface.

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公开号 | 公开日 | 专利标题

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同族专利:

公开号 | 公开日

US20150020920A1|2015-01-22|

EP2490648A1|2012-08-29|

IN2012DN03347A|2015-10-23|

IL202070D0|2010-06-16|

US8979792B2|2015-03-17|

IL219609D0|2012-07-31|

JP5356609B2|2013-12-04|

DK2490648T3|2014-07-07|

BR112012011423A2|2016-05-03|

US9132063B2|2015-09-15|

CN102596146A|2012-07-18|

JP2013510634A|2013-03-28|

CN102596146B|2014-07-23|

EP2490648B1|2014-05-07|

US20120323172A1|2012-12-20|

IL219609A|2015-08-31|

WO2011058548A1|2011-05-19|

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法律状态:
2019-01-08| B06F| Objections, documents and/or translations needed after an examination request according art. 34 industrial property law|

2020-01-21| B06U| Preliminary requirement: requests with searches performed by other patent offices: suspension of the patent application procedure|

2020-05-19| B09A| Decision: intention to grant|

2020-10-13| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 04/11/2010, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

IL20207009A|IL202070D0|2009-11-12|2009-11-12|Inline liquid drug medical device|

IL202070|2009-11-12|

PCT/IL2010/000915|WO2011058548A1|2009-11-12|2010-11-04|Inline liquid drug medical devices with linear displaceable sliding flow control member|

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