TW201406418A - Dual-chamber mixing device for syringe and assembly method thereof, and syringe using the same and its method of manufacturing and operation - Google Patents

Abstract

The present invention discloses a dual-chamber mixing device for a syringe and its assembly method, and a syringe using the same and its manufacturing and operation method. The dual-chamber mixing device comprises an outer barrel and an inner barrel concentrically arranged to form an outer chamber, the inner barrel having an inner chamber. A mixing plunger is slidably arranged in the outer chamber. A seal located in the outer chamber is axially movable, in response to depression of the mixing plunger, from a first position in sealing engagement with one or more apertures in the inner barrel to a second position between the apertures and vents in the outer barrel, thereby allowing the depression of the mixing plunger to force a first mixed substance from the outer chamber through the apertures to be mixed with a second mixed substance in the inner chamber. The mixed substance in the inner barrel is then delivered by the syringe, followed by the needle retraction.

Description

Double chamber mixing device for syringe and combination method thereof and syringe using double chamber mixing device and manufacturing and operating method thereof

The invention relates to a double chamber mixing device for a syringe and a combination method thereof, a syringe using the double chamber mixing device and a manufacturing method thereof, in particular to a double chamber mixing device for a syringe, capable of storing, mixing and Inject one or more drug substances.

Conventional syringes include a mixer for mixing the materials that can be delivered prior to injection, for example, allowing a diluent to be added to the dried, lyophilized, dehydrated or powdered activating material prior to use, especially for those that are in aqueous form. It is very beneficial that the stored material will reduce or damage its activation.

Most syringe mixers utilize a continuous chamber, wherein the syringe includes a barrel having a first proximal chamber and a second end chamber separated by a membrane or elastomeric seal, such syringe utilizing A splitter section of the barrel causes the liquid of the proximal chamber to bypass the separation membrane to mix with the liquid or powder within the end chamber.

Some hybrid syringes utilize a concentric cartridge configuration, however, such concentric cartridge mixing syringes have so far required complex components and diverse user manipulation steps or other particular nuances to make them different in manufacturing, assembly or operation. For example, some conventional in-line cartridge mixing syringes require that the concentric inner and outer cylinders are mutually rotatable, and that one or more sealing rings have a passage means therein, the inner and outer cylinders must be rotated to make the inner cylinder The channel means for aligning a hole with a seal, the channel means of the seal comprising an opening extending through the seal ring and a groove extending longitudinally from the opening extending from the radiation, such a configuration providing the groove a slot connecting the outer cylinder and the radially extending opening, and the radially extending opening selectively connects the groove and the bore of the inner cylinder, such that liquid enters the inner cylinder from the outer cylinder to mix the liquid with the inner cylinder A substance, such a structure requires complex components and difficult handling conditions to allow the user to operate the device.

Other concentric cylinder designs are located within a barrel with a retractable inner and outer tubular member having a coaxial iliac axis, the outer tubular member and the barrel forming a cavity for storing a liquid, the outer tubular member having a a liquid passageway for allowing the liquid to flow from the chamber into the inner tubular member, the inner tubular member being provided with a seal near one end of the injection port, the seal having a bore therein, the inner tubular member receiving the end of the piston and thereon Elastomeric seals, therefore, the mixing syringe requires three tubular elements and an inner and outer concentric chamber inside the third cylinder.

There are many complications in the use of a mixing syringe with a center cylinder. In addition to the above, a mixing syringe using a concentric cylinder must meet several factors, such as maintaining container hygiene, component seal interaction, ventilation requirements, and internal force distribution. Some dual chamber injection chambers have concentric inner and outer barrels forming an annular space for containing a liquid and utilizing one or more holes between the inner and outer barrels to cause a liquid from the ring a space that flows into the inner cylinder to mix the liquid with a substance in the inner cylinder, and a lowering of a piston slidable within the inner cylinder forces the liquid to flow from the annular space into the inner cylinder, the annular Spaces are provided with spaced first and second sealing strips in the vicinity of the inner cylinder. The position of the sealing strip can govern the sanitation of the liquid passage, the distribution of internal forces, and the ventilation. For example, the sealing strips are initially located above the holes. Forming a sealed annular volume for the first liquid element, because of the arrangement, when the piston is lowered, the hole must serve as an outlet to allow air in the annular space to pass through the hole Discharged to the second sealing strip, the space must be sterile, such outlet requirements can be difficult and require additional components and processing steps to be vacuumed into the inner chamber to remove air from the outer chamber And at the end of the outer cylinder below the second seal.

In general, conventional mixing devices including concentric cylinders are complicated in construction and require that the inner and outer cylinders be aligned with one or more holes to allow a liquid to flow from one chamber to the other, making fabrication easy and mixing. In terms of the operation of the device, strict constraints on different hygiene, sealing and export arrangements are used.

It is an object of the present invention to provide a dual chamber mixing device and/or a syringe comprising the dual chamber mixing device to improve one or more of the problems of conventional mixing devices and/or syringes, as described above.

One aspect of the present invention provides a dual chamber mixing device for a syringe, the dual chamber mixing device comprising: an outer cylinder and an inner cylinder in substantially coaxial relationship, the dual chamber mixing device capable of including a plurality of mixed substances, wherein at least a first mixture is located in an outer chamber between the outer cylinder and the inner cylinder, and at least a second mixture is located in an inner chamber of the inner cylinder, the inner cylinder including one or more liquid passages The first mixture is passed from the outer chamber therethrough to the inner chamber of the inner cylinder for mixing with the second mixture; one or more vents are in communication with the outer chamber; and at least one seal a member located within the outer chamber, the seal being axially movable, moving from a first position of the one or more liquid passage sealing cartridges of the inner barrel to at least partially in the one or more a second position between the fluid passage and the one or more vents. Suitably, the inner cylinder and the outer cylinder are non-rotatable with each other.

The one or more liquid passages comprise a plurality of holes, holes, bores, ports, passages or conduits, the shape, configuration, configuration and/or number of which are not limited. Preferably, the liquid passage comprises a plurality of holes, The hole is a radial bore (ie perpendicular to the axis of the barrel), an angular aperture (ie, at an angle to the axis of the barrel), helical (eg, as it passes through the thickness of the barrel wall becomes a An angular radial path) or any other structure, the number and arrangement, spacing and arrangement of the holes can be adjusted to the desired mixing characteristics, as such, the parameters of the holes are assigned to facilitate the desired Mix, dilute and other liquid flow characteristics of the mixing syringe.

Suitably, the dual chamber mixing device further includes a mixing piston axially moving within the outer chamber between the outer barrel and the inner barrel to facilitate entry of the at least first mixed substance into the inner chamber of the inner barrel And facilitating axial movement of the seal from a first position of the one or more liquid passage sealing cartridges of the inner cylinder to at least partially in the one or more liquid passages and the venting opening Between the second positions, the mixing piston has one or more extensions, such as fingers and/or thumb extensions, that are easy to handle or aesthetically pleasing.

Preferably, the liquid mixing device comprises a plurality of seals. Preferably, the plurality of seals comprise a proximal seal and an end seal. In a preferred embodiment, the plurality of seals include a proximal seal that is snapped, coupled, coupled, secured to the mixing piston and slidable within the outer chamber; the end initially in a first position The seal and the one or more liquid passage seals of the inner barrel slide to a second position at least partially between the one or more liquid passages and the venting opening, the shaft of the mixing piston Movement of the proximal seal that engages, engages, connects, and secures the mixing piston to the movement, such movement being transferred to the first mixture within the outer chamber, and similarly, to the end seal, Thus, the axial movement of the mixing piston indirectly (not necessarily in direct contact) promotes axial movement of the end seal to the second position.

Preferably, when the mixing piston and the end seal slide within the outer chamber, the one or more vents are operable to facilitate air exiting the outer chamber to the atmosphere, the one or one The above venting holes may be integrally formed in the barrel, or a hole cover may be mounted or fixed to the inner and/or outer tube. In any embodiment, a catheter, a hole, a porous membrane, a foldable element or the like may be used. Similarly, in at least one embodiment, the aperture cover is a plastic aperture cover including one or more aperture conduits that close the outer chamber at the end of the outer cylinder when the mixing piston is lowered and The movement of the end seal allows air to pass through the one or more bore conduits to the atmosphere.

In an embodiment, the dual chamber mixing device further includes a removable safety cover. Preferably, the removable safety cover prevents unnecessary movement of the end seal prior to use (eg, during transport), the removable safety cover including a plurality of protrusions that can be inserted into separate vents to be adjacent or Contact the end seal.

The dual chamber mixing device further includes a barrel extension mounted to the outer barrel or integrally formed with the outer barrel, the barrel extension may include a finger flange or a finger flange or a finger attached thereto .

The dual chamber mixing device further includes a mixing piston lock, and in one embodiment, the elements of the mixing piston and the barrel extension are collapsible to form the hybrid piston lock, in a particular embodiment, The hybrid piston lock prevents the mixing piston from moving from the outer chamber during use. In a particular embodiment, the hybrid piston lock prevents proximal movement of the mixing piston after mixing.

The first and second mixed substances may comprise one or more liquids or one or more solids, and the first mixed substance located in the outer chamber is a liquid, and the liquid is activating liquid or a drug A non-activating liquid of the drug, such as a diluent, the second mixture in the inner chamber being an activated solid of a drug or an activated or non-activated liquid of a drug.

In one embodiment, the inner chamber includes a drug-activated solid and the outer chamber includes a non-activated diluent of a drug, such as water, from which the diluent passes from the outer chamber. Entry into the inner chamber promotes mixing with the activated solid of the drug, and the interaction of the diluent with the activated solid of the drug allows the activated solids of the drug to be reconstituted for subsequent delivery to the patient for injection.

In another embodiment, the inner chamber includes a drug-activated solid and the outer chamber includes a drug-activated liquid through which the liquid enters the inner chamber through the one or more apertures To promote mixing with the activated solid of the drug in the lumen, the interaction of the active liquid of the drug with the activated solid of the drug allows the activated solids of the drug to be reconstituted for subsequent delivery to the patient for injection.

In another embodiment, the inner chamber includes a first drug activating liquid and the outer chamber includes a second drug activating liquid through which the first drug activating liquid passes through the one or more fluid passages Entering the inner chamber from the outer chamber promotes mixing of the activating liquid of the first drug with the activating liquid of the second drug, the mutual influence of the activating liquid of the first drug and the activating liquid of the second drug making the drug The activated liquid can be mixed for injection on the patient for subsequent delivery.

Thus, the dual chamber mixing device facilitates storage of the various drug substances in the outer chamber and the inner chamber, thereby maintaining the stability and efficacy of the drug substance during transport and extending the period of storage.

Another aspect of the present invention provides a syringe comprising a delivery piston, an injection needle and a dual chamber mixing device of the above, which can be used for storing, transporting, mixing and injecting one or more mixed substances to a patient, as follows Further described, the syringe further includes a safety feature that retracts the needle after use to prevent unnecessary needle sticking or reuse of the syringe.

Suitably, the delivery piston can slide within the inner barrel of the mixing device to facilitate delivery of the mixed mass to the user, patient or recipient.

In a preferred form, the syringe is a retractable syringe comprising a retractable injection needle. Suitably, the delivery piston can be snapped with the injection needle to facilitate retraction of the injection needle. Suitably, a biasing member facilitates retraction of the needle, such as an elastic member capable of storing and releasing energy to facilitate retraction of the needle, the retractable syringe including any retracted structure and the mixing device described herein The needle retraction configuration of the PCT publications WO2006/119570, WO2006/108243, WO2009/003234, WO2011/075760.

According to an embodiment, the injector includes a transfer piston including a biasing member, a piston member, a piston housing and one or more lock members, wherein the piston member and the piston housing operate together Releasably maintaining the biasing member in an initially energized state, the syringe further comprising an injection needle assembly including the retractable injection needle, wherein the retractable injection needle includes a cannula and An injection needle can be stuck with the piston member.

Preferably, a piston seal is mounted to the piston member to be engaged with the injection needle.

Preferably, the needle assembly further includes an injection needle seal to hold the retractable injection needle, wherein the retractable injection needle cannula passes the injection needle seal to deliver the mixed substance or mixture To the user, patient or other recipient.

In at least one embodiment, the dual chamber mixing device includes a release ring, suitably located at a proximal end of the mixing piston (in other words, opposite the end, snapped or joined, connected or Fixed to the first or proximal seal), the release ring can be a separate component or a component of the hybrid piston integrally formed. In a preferred embodiment, the release ring is the smaller diameter of the mixing piston a portion of the proximal end, the retractable syringe and the injection needle being snapped, the release ring being actuatable to retract the needle, and once the needle is retracted, the piston member and the piston housing are disengaged to allow the elasticity Extending from its initial energized state, the piston housing substantially contacts or connects the release ring when the piston member is axially moved toward the most proximal direction by the release of the resilient member, thereby retracting the release ring The cannula and the injection needle.

Suitably, the retractable syringe includes one or more lock systems for the transfer piston, in an embodiment of the lock system, the piston housing of the transfer piston includes a lock member that is retracted at the injection needle The lock member can then be latched with the release ring of the mixing piston to prevent or prevent further movement of the transfer piston relative to the release ring. In another embodiment of the lock system, the piston housing includes a clip. After the piston member is retracted, the cartridge clamps the piston member and the needle of the needle.

In at least one embodiment of the invention, the retractable syringe includes a retractable structure substantially as described in WO 2011/075760 and the modification of the release ring of the hybrid piston described above.

Another aspect of the present invention provides a method of combining a dual chamber mixing apparatus, the method comprising the steps of:

(i) axially aligning an outer cylinder on an inner cylinder, the inner cylinder having one or more holes communicating with the inner chamber of the inner cylinder, the inner cylinder and the outer cylinder being axially aligned to form a An outer chamber, wherein the outer chamber has one or more venting holes in fluid communication with the one or more holes located distally;

(ii) inserting a seal into the outer chamber and sealing the cartridge with the one or more holes.

In one embodiment, the method further includes, prior to the step (i), securing a hole cover having one or more vents to a portion of the inner tube at the distal end of the one or more hole. Preferably, the end of the outer cylinder is fixed to the hole cover.

Preferably, the method further comprises inserting an injection needle assembly into the inner chamber at the distal end of the one or more apertures.

Another aspect of the present invention provides a method of making a syringe, the method comprising the steps of:

(i) providing a first mixture in an outer chamber of the dual chamber mixing device, inserting a first or proximal seal into the outer chamber of the dual chamber mixing device to contact the first mixture ;

(ii) providing a second mixture in an interior of the dual chamber mixing device;

(iii) inserting a transfer piston into the inner cylinder, wherein the transfer piston is one or more holes closest to the inner cylinder;

(iv) installing a mixing piston within the outer chamber, wherein the mixing piston contacts the first or proximal seal.

Another aspect of the present invention provides a method of operating a syringe comprising a dual chamber mixing device, the method comprising the steps of:

(i) operating a mixing piston of the dual chamber mixing device to mix a plurality of materials;

(ii) operating a transfer piston to deliver the material mixed in step (i) to a recipient.

In at least one embodiment, the method of operating a syringe comprising a dual chamber mixing device further comprises the steps of:

(iii) actuating an injection retraction mechanism to retract an injection needle into the syringe. Preferably, the retraction of the retraction structure of the needle occurs after all of the substance has been delivered to the recipient.

Referring to FIGS. 1A and 1B, an embodiment of a dual chamber mixing device 100 includes an inner cylinder 110; the inner cylinder 110 includes an inner cylinder wall 111 and an inner chamber 112; and an outer cylinder 120. The outer cylinder 120 includes an outer cylinder wall 121; a mixing piston 130; an outer chamber 140 is formed between the inner cylinder wall 111 of the inner cylinder 110 and the outer cylinder wall 121 of the outer cylinder 120. The inner cylinder 110 and the outer cylinder 120 can be made of different materials, including plastic and glass, but are preferably made of glass, and the inner cylinder 110 and the outer cylinder 120 are substantially concentric, so that The inner cylinder 110 and the outer cylinder 120 substantially maintain a common central longitudinal axis, and the inner cylinder 110 and the outer cylinder 120 are not mutually rotatable relative to each other.

An outer cylinder extension 150 includes finger grips 151A, B for assisting the user in gripping, the outer cylinder extension 150 may be integrally formed in the outer cylinder 120 or a separate component is secured to the outer cylinder 120, the outer cylinder The extension 150 further includes an inner lip 152 and a lock ring 153, the function of which is described in more detail below.

Typically, the outer chamber 140 includes a liquid material and the inner chamber 112 includes a solid material that can be mixed within the inner chamber 112 to form a mixed substance injection, however, In at least one embodiment, both the outer chamber 140 and the inner chamber 112 touch the liquid substance.

In the embodiment shown in the first A and the first B, the outer cylinder 120 is shorter than the inner cylinder 110. This structure provides some advantages, for example, allowing a thermal conversion sleeve (not shown) to be directly placed around the circumference. Touching a portion of the inner cylinder 110, such that the liquid material 112 in the inner chamber is lyophilized in situ, during or after the manufacture of the dual chamber mixing device 100, allowing a liquid substance to be filled and then lyophilized The liquid substance becomes a powder.

In another implementation, the inner barrel 110 and the outer barrel 120 are substantially similar in length, and this embodiment may be more aesthetically pleasing or provide an additional volume by the outer chamber 140 in the outer chamber 140. A first or proximal seal 160 and a second or end seal 170 are slidably disposed therein.

The outer cylinder 120 further includes a hole cover 123. The hole cover 123 includes a plurality of ventilation holes 122. A ventilation space 142 is disposed between the ventilation hole 122 and the second or end seal 170 because the substance does not touch the hole. A venting space 142, which may be non-sterile and open to the atmosphere, is configured to enable the second or end seal 170 to be displaced toward the plurality of vents 122 during operation of the mixing step. Opening one or more apertures 114 thereby allowing liquid to pass from the outer chamber to the inner chamber from the outer chamber 140 to the inner chamber 112 due to the displaced position of the second or distal seal 170 The fluid pathway remains sterile.

The mixing piston 130 includes a button 131 and a cylindrical shaft 132 that is slidably axially movable within the outer chamber 140. The mixing piston 130 further includes spring projections 133A, B located The cylindrical shaft 132 is deflected outward from the cylindrical shaft 132, and when the mixing piston 130 is inserted into the outer chamber 140 of the dual chamber mixing device 100, the spring projections 133A, B are moved outward ( Deviating against the double chamber mixing device 100, the spring projections 133A, B prevent the mixing piston 130 from moving from the outer chamber 140, which will be described in detail below, the mixing piston 130 further including a locking projection 134A, B (134B not visible) are located on the cylindrical shaft 132, deflected outwardly from the cylindrical shaft 132, and the locking projections 134A, B are outwardly deflected and the inner lip 152 of the outer cylinder extension 150 The cassette, after the mixing is completed, facilitates locking the mixing device 130 from the closest movement.

The mixing piston 130 further includes a release ring 136 located at a proximal end (closest to the user) of the cylindrical shaft 132. The release ring 136 can be a separate component or an integrally formed component of the mixing piston 130. In the preferred embodiment, the release ring 136 is a portion of the proximal end of the smaller diameter of the mixing piston 130. The function of the release ring 136 will be described in detail below.

The first or proximal seal 160 is an end 135 of the cylindrical shaft 132 that contacts the mixing piston 130, the second or end seal 170 being positioned within the outer chamber 140 away from the first or proximal seal The first or proximal seal 160 is axially slidable within the outer chamber 140 through the contact and movement of the cylindrical shaft 132 of the mixing piston 130, as indicated by the first circle B, The aperture 114 in the inner cylinder wall 111 provides a flow path for allowing flow from the outer chamber 140 into the inner chamber 112, initially the second or end seal 170 is sealed with the aperture 114 (ie, Cover the hole 114; compare the first figure A with the first figure B).

In the embodiment shown in the second figure, a safety cover 180 is movably mounted to a bracket 125 of the outer cylinder 20, the full security cover including a ring body 182 and a projection 181 which passes through the respective Vents 122 (not shown in the second figure) to abut or contact the end seal 170 to prevent undesired movement of the end seal 170, such as a change in air pressure during transport or the user's carelessness of the mixing piston 130 prior to operation The movement.

Referring to Figures 3 through 4 and Figures 8 through 11, the mixing device is a component of a retractable syringe 100 that includes a delivery piston 200 and a retractable needle Assembly 400, the transfer piston 200 is axially slid within the inner chamber 112 of the inner barrel 110 of the dual chamber mixing device 100 to deliver the liquid contents of the inner barrel 110 and subsequently retract the retractable The injection needle assembly 400 is returned.

The transfer piston 200 includes a piston member 210 having a shaft 211, a ring projection 212 and a sealing jaw 216. In this embodiment, a threaded projection 217 is engaged with the piston seal 800. A threaded recess 820 further includes an injection needle catch 810.

The transfer piston 200 further includes a piston housing 220 having an elongated body portion 221 and a base portion 225, a head portion 222 and a lock member 227.

A control rod 230 is releasably coupled to the piston member 210. The control rod 230 includes a button 231, an arm portion 232 and a shaft 233. The transfer piston 200 further includes a compression spring 270 mounted to the piston member 210 and the piston. Between the outer casings 220, the annular projection 212 of the piston member 210 and the base portion 225 of the piston housing 220 are sandwiched in an initially compressed state. In at least one embodiment, the lever 230 is releasably coupled to the piston member 210 through the shaft 233, and the shaft 233 is releasably coupled to the piston through a frangible joint 234 (as shown in FIG. 10). The lever 234 is also releasably latching the piston housing 220 to hold the spring 270 in the initial compressed state of the ring projection 212 of the piston member 210 and the piston in the extension body. Between the bases 225 of the outer casing 220. Initially, a projection 235 of the arm portion 232 abuts against the edge 229 of the piston housing 220 to retain and prevent axial movement of the lever 230 relative to the piston housing 220, however, the arm portion 232 of the lever 230 is Elastically flexing and moving in the direction of the solid arrow of the fourth figure allows the lever 230 to be disengaged from the piston housing 220 to facilitate decompression of the spring 270, as described in detail below.

The needle assembly 400 includes a cannula 410, an injection needle 420, a fixture 300, an injection needle seal 430, and a pusher 600.

For operation of the dual chamber mixing device 100, reference is made to the description of Figures A, B, V and VI, in which the outer chamber 140 includes a liquid material and the inner chamber 112 includes a solid material. The liquid substance and the solid substance may be mixed in the inner chamber 112 to form a mixed liquid substance for injection. As shown in the fifth figure, the safety cover 180 (as shown in the second figure) has been externally The barrel 120 is removed to allow movement of the second or end seal 170 within the outer chamber 140.

Initially the second or end seal 170 covers the aperture 114 of the inner cylinder wall 111 to prevent liquid from flowing from the outer chamber 140 into the inner chamber 112, the mixing piston 130 decreasing toward the solid arrow (toward the dotted arrow) The needle 400 moves axially) forcing the first or proximal seal 160 in the outer chamber 140 to exit the second end seal 170 (ie, toward the retractable needle 400), thereby opening the The aperture 114 allows liquid to be transferred from the outer chamber 140 to the chamber 112.

As shown in the sixth figure, the lowering of the mixing piston 130 in the direction of the dashed arrow forces further movement of the first or proximal seal 160 within the outer chamber 140 from the outer chamber. 140 flows into the inner chamber 112 until the first or proximal seal 160 strikes the second or end seal 170, the seals 160 and 170 reaching the end of the outer chamber 140 stroke, the The second or end seal 170 will contact the aperture cover 123, in this position, and any seal 160 or seals 160, 170 that seal the cassette with the aperture 114 may partially engage the aperture 114. The cartridge is sealed, the latter being possible, for example, when liquid flows from the outer chamber 140 to the inner chamber 112 without the need for the second or end seal 170 to completely cover the aperture 114.

At this point, the liquid transfer from the outer chamber 140 to the inner chamber 112 is complete and the mixing piston 130 cannot be withdrawn from the outer chamber 140 because the hybrid piston rod shaft 132 (outwardly deflected) The locking projections 134A, B and the inner lip 152 of the outer cylinder extension 150 are latched to form a lock to prevent the proximal end of the mixing piston 130 from moving (toward the directional) beyond this point, and the mixing is locked after the mixing The piston 130 is beneficial for guiding the force of the delivery piston 200 to inject the liquid substance through the injection needle 400, instead of flowing the liquid substance back to the outer chamber 140, or by the first or proximal seal 160 and the hole The final positioning of the 114 seals is achieved, as such, the complete axial movement of the mixing piston 130 and/or the jamming of the mixing piston 130 and one or more pawls of the outer cylinder 120 can undo the transfer. The piston 200, or a lock configuration of the inner cylinder 110, enables the transfer piston to be axially lowered, thus providing the user with the loading Ensure proper injection procedures, prior to injection into the patient, the drug can be mixed or restored.

The venting space 142 between the second or end seal 170 and the venting opening 122 never contacts any material within the dual chamber mixing device 100, so there is no need to maintain sterility maintaining the venting space 142 area. The space 142 may be filled with air, and when the mixing piston 130 is lowered and the axial movement of the second or end seal 170, the annular space between the outer cylinder 120 and the inner cylinder 110 and the venting opening 122 and the The second or end seals 170 are removed. Further, because the second or end seals 170 initially cover the holes 114 in the inner cylinder wall 111 of the inner cylinder 110, the dual chamber mixing device 100 During use, the fluid passage between the outer chamber 140 and the inner chamber 112 is maintained as sterile, only the second or end seal 170 may contact the outer barrel 120 and the inner barrel 110 non-sterilely. Part because the liquid has flowed from the outer chamber 140 into the inner chamber 112 and is not exposed to non-sterile Part.

The syringe 1000 is a "closed system" indicating that the fluid passage has no outlet other than injection of the injection needle, and therefore, the delivery piston 200 can move in the proximal chamber (toward the user) in the inner chamber 110 to react to the mixing. The end of the device 130 moves because the end movement of the mixing device 130 forces liquid to flow from the outer chamber 140 into the inner chamber 112 and increases the pressure and/or volume of liquid within the inner chamber 112 because of a hard The needle sleeve 119 still covers the retractable needle 400. In addition to forcing the transfer piston 200 in the proximal direction of the outer barrel 120, there is no room for volume expansion, which is a satisfactory reaction because it A visual and tactile indication is provided to the user indicating that the mixing is complete and the injection can be initiated.

Once the mixing of the contents in the inner chamber 112 is completed, the syringe 1000 is ready for use, the hard needle hub 119 is removed, the cannula 410 of the needle 400 is inserted into a recipient and the delivery piston 200 is depressed To deliver the mixed liquid contents of the inner chamber 112 to the recipient, standard medical practice, such as a syringe shaking by hand to further promote mixing of the substance, and/or the syringe eliminates any residual air prior to injection, during injection needle insertion and The liquid contents can be executed prior to injection.

In at least one embodiment of the invention, the retraction of the injection needle is substantially similar to that described in WO2011/075760, which will be briefly described below with reference to Figures 7 through IX, when the liquid contents are delivered, The transfer piston 200 is axially moved through the inner cylinder 110 toward the solid arrow of the seventh figure. As shown in the eighth figure, the piston seal 800 abuts against the injection needle seal 430 and then abuts against the push. Element 600, further, a pusher element ring 610 radially outwardly moves the hook ends 321A, B of the arms 320A, B of the fixture 300 as indicated by the direction of the solid arrow in the eighth figure, the needle 420 Disengaging the fastener 300 to release the retractable needle 400 and then retracting, at this point, the recess 810 of a piston seal 800 is jammed with a portion 425 of the retractable needle body 420 and A recess 860 receives the liquid end 412 of the cannula 410 such that the retractable injection needle 400 is effectively coupled to the piston member 21 0.

As shown in the ninth figure, in order to retract the retractable injection needle 400 at the delivery end of the liquid contents, the compression spring 270 must be relieved of pressure by the piston member 210 from the piston housing 220, the release ring 136 promoting Such disengagement, because the piston member 210 and the piston housing 220 are substantially completely lowered (ie, axially moved toward the direction indicated by the dashed arrow) to inject liquid from the inner chamber 110, one or both Contacting the release ring 136, via such contact, the release ring 136 radially outwardly moves the arm 32 (in the direction of the solid arrow) and out of the edge 229 of the piston housing 220, this disengagement allowing the compression spring 270 to be released The pressure and the ring protrusion 212 of the piston member 210 are used to retract the piston member 210 and the control rod 230 coupled thereto, and the piston member 210 coupled to the injection needle 420 and the cannula 410 transmits the When the compression of the spring 270 is axially moved in the closest direction, the piston Casing 220 remains in contact or substantially connected to the release ring 136, the cannula 410 is retracted and thereby the needle 420.

Suitably, the retractable syringe 1000 includes one or more lock systems for the transfer piston 200, as shown in the tenth diagram, in an embodiment of the lock system, the piston housing of the transfer piston 200 210 includes a lock member 227 that includes an edge 228 that latches the bottom surface 137 of the release ring 136 after the needle is retracted to prevent or prevent further movement of the transfer piston 200 relative to the release ring 136, such as As shown in the figure, therefore, in addition to initially assisting the retraction of the needle, the secondary function of the release ring 136 is to lock the delivery piston 200 after the first use to prevent reuse.

As shown in the tenth figure, after the other or more locking systems of the transfer piston 200 are retracted, a clip 224 of the piston housing 220 and a locking groove 219 of the piston member 210 together form a lock system. The piston member 210 and the piston housing 220 are locked and the movement of the piston member 210 relative to the piston housing 220 is prevented.

At the end of the piston member 210 and the retractable injection needle 410 retracted, the lever 230 is selectively disengaged from the piston member 210 at the frangible joint 234 and is manually retractable from the retractable The syringe 1000 is removed and discarded as "clean" waste, such that there is little portion of the piston member 210 that extends out of the syringe, forcing the transfer piston 200 to retract into the inner barrel 110, and Attempting to re-engage the needle with the needle (as shown), as shown in the tenth figure, the frangible joint 234 may be located along the piston member 210 in the closest direction when the syringe is in the retracted position. One point of the head 222 is randomly locked to prevent reuse.

Another variation of the dual chamber mixing device 100 is contemplated. In another embodiment of the rigid needle hub 119, a perforated needle sleeve can include a first protective member and a second protective member. The first and second protection members are slidingly latched, and when the protective member is slid open to an unfolded state, the opening is present when the first and second protective members are in a locked and retracted state. No opening is allowed through the needle end, however, when the first and second protective members are in a stuck but unfolded state (ie, sliding along an axis), air is allowed to pass through the needle, The patient is not exposed to the risk of exposure, and if so desired, the needle can be used to change the amount of air and/or pressure within the inner chamber 112 from which the liquid enters according to the liquid. The displacement of the inner chamber 112.

In another embodiment, the lowered end of the mixing piston 130 can be locked to the outer cylinder 120 via the inter-fitted pawl configuration (not shown) at a point in the axial direction of the end of the mixing piston 130. To prevent subsequent axial movement in the proximal direction, these interfitting pawls can be used with or as an alternative to the locking projections 134A, B described above.

In another embodiment, the outer cylinder extension 150 may include a pawl configuration (not shown) that mates with the outer cylinder 120 that the mixing piston 130 is engaged with, depending on the complete axis of the mixing device toward the end direction. Move to.

In another embodiment, the outer chamber 140 can be divided (ie, including a plurality of compartments), such as at least one frangible or porous membrane, wall, seal, or the like, each compartment containing A different liquid or solid material, the reduction of the mixing piston 130 promotes mixing of each of the different liquid or solid materials, additionally or alternatively, the inner chamber 112 can also be divided, each compartment containing A different liquid or solid material, therefore, the mixing device 100 can include two or more substances for mixed injection.

The mixing device described above and the syringe disclosed herein provide an efficient and easy to operate system for mixing a variety of species prior to delivery by the syringe, without the need to rotate the inner and outer barrels to open or align the liquid route prior to use, unlike prior The conventional mixing device described provides an appropriate outlet for the positioning of the end seal relative to the through hole in the outer barrel and the bore of the inner barrel while maintaining the contents of the mixing device sterile, in contrast to the conventional mixing device previously described.

The dual chamber mixing device 100, the retractable syringe 1000 or other individual components may be cleaned using some known materials and conventional methods, such as some known clean liquids, isopropanol and hexane. Components and/or devices may be used in the manufacture of known adhesives or glues. In addition, these novel components and devices may be used in the manufacture of known deuterated liquids and processing, the bore of the inner cylinder. Known drilling or perforating methods can be used, such as mechanical or laser drilling, and, in addition, manufacturing or combination stages, known aseptic processes can be used to ensure that the final product is sterile.

In an embodiment, the method of combining the dual chamber mixing device comprises the following steps:

(i) securing a hole cover having one or more venting holes to an end of an inner cylinder, wherein the inner cylinder has one or more holes therethrough, the hole cover being fixed away from the one or one The above holes;

(ii) axially aligning an outer cylinder over the inner cylinder and connecting the end of the outer cylinder to the orifice cover, wherein the diameter of the outer cylinder is larger than the diameter of the inner cylinder, and the two cylinders are aligned so that two An annular space between the cylinders forms an outer chamber;

(iii) inserting an end seal into the outer chamber and positioning the end seal with the one or more holes to seal the cassette; and

(iv) inserting an injection needle assembly into the inner chamber such that the injection needle assembly is remote from the aperture.

As described above, one or more elements of the dual chamber mixing device are secured to one another using a glue or adhesive, one or more of which are integral, one or more elements of the dual chamber mixing device, For example, the hole cover may be a separate component fixed to the inner cylinder and the outer cylinder with an adhesive, or the hole cover is pre-formed at the end of the outer cylinder, and the outer cylinder is adhered to the inner cylinder. The elements are sterile, separately or together, and may be sterilized when combined or combined in a sterile environment, one or more of which may be deuterated before or after combination.

A dual chamber mixing device can be used as an element of a mixing syringe. In one embodiment, a method of manufacturing a syringe having a mixing device includes the following steps:

(i) at least partially filling the first liquid substance in the outer chamber, inserting a proximal seal into the outer chamber to contact the first liquid substance;

(ii) at least partially filling the second liquid substance in the inner chamber, inserting a transfer piston into the inner chamber, wherein the transfer piston is the one closest to the inner tube;

(iii) installing a mixing piston within the outer chamber, wherein the mixing piston abuts against the proximal seal.

Using some conventional filling process and equipment to achieve the filling step of the syringe manufacturing process, in one embodiment, the second liquid material can be filled as a second liquid substance to be lyophilized in situ using certain cylinder thermal transfer equipment The injection needle assembly, the delivery piston and other components described in the manufacturing and assembly process can be as described above, or use some of the approximate elements that achieve the same function of these elements.

The description of the present invention is intended to be illustrative of the preferred embodiments of the invention, and is not intended to

The patents, scientific documents, computer programs and calculations mentioned in the specification are collectively incorporated into the references.

(100). . . Double chamber mixing device

(110). . . Inner cylinder

(111). . . Inner wall

(112). . . Inner chamber

(114). . . hole

(119). . . Needle sleeve

(120). . . Outer tube

(121). . . Outer wall

(122). . . Vents

(123). . . Hole cover

(125). . . bracket

(130). . . Hybrid piston

(131). . . Button

(132). . . Cylinder shaft

(133A). . . Spring projection

(133B). . . Spring projection

(134A). . . Locking piece

(134B). . . Locking piece

(135). . . End

(136). . . Release ring

(137). . . Bottom

(140). . . Outer chamber

(142). . . Ventilation space

(150). . . Outer tube extension

(151A). . . Finger handle

(151B). . . Finger handle

(152). . . Inner lip

(153). . . Lock ring

(160). . . First or proximal seal

(170). . . Second or end seal

(180). . . Safety cover

(181). . . Ring body

(182). . . Projection

(1000). . . syringe

(200). . . Transfer piston

(210). . . Piston parts

(211). . . Shaft

(212). . . Ring projection

(216). . . Sealed card

(217). . . Threaded projection

(219). . . Lock slot

(220). . . Piston housing

(221). . . Extended body

(222). . . head

(224). . . clip

(225). . . Base

(227). . . Lock

(228). . . edge

(229). . . edge

(230). . . Controller

(231). . . Button

(232). . . Arm

(233). . . axis

(234). . . Joint

(235). . . Protruding

(270). . . spring

(300). . . Fastener

(320A). . . Arm

(320B). . . Arm

(321A). . . Hook end

(321B). . . Hook end

(400). . . Injection needle assembly

(410). . . Intubation

(412). . . Liquid end

(420). . . Injection needle

(425). . . Part

(430). . . Injection needle seal

(600). . . Projection element

(610). . . Push element ring

(800). . . Piston seal

(810). . . Injection needle

(810). . . Recess

(820). . . Thread groove

Figure A is a side view of one embodiment of a mixing device.

The first B diagram shows a side view of an embodiment of a mixing device and the end seal is moved to reveal a liquid passage opening.

The second figure shows an embodiment of a mixing device further comprising a security cover mounted.

Figure 3A shows an embodiment of a retractable syringe including a mixing device.

Figure 3B is an exploded view of one embodiment of a retractable syringe including a mixing device.

The fourth figure is a cross-sectional view of one embodiment of a delivery piston of a retractable syringe.

The fifth figure shows an embodiment of a retractable syringe that includes a mixing device after the safety cap is removed before a mixing piston of the mixing device is lowered.

The sixth figure shows an embodiment of a retractable syringe comprising a mixing device after a mixing piston of the mixing device is lowered.

The seventh figure shows an embodiment of a retractable syringe comprising a mixing device after the delivery piston is lowered.

The eighth figure shows an embodiment of an injection needle assembly being held by a transfer piston cartridge prior to retraction.

The ninth diagram shows a release ring that is detached from the inside of a piston from the outside of a piston to facilitate spring decompression and retraction of the needle.

The tenth figure shows a lock system that retracts the syringe.

(100). . . Double chamber mixing device

(110). . . Inner cylinder

(111). . . Inner wall

(112). . . Inner chamber

(120). . . Outer tube

(121). . . Outer wall

(122). . . Vents

(123). . . Hole cover

(125). . . bracket

(130). . . Hybrid piston

(131). . . Button

(132). . . Cylinder shaft

(133A). . . Spring projection

(133B). . . Spring projection

(134A). . . Locking piece

(135). . . End

(136). . . Release ring

(140). . . Outer chamber

(142). . . Ventilation space

(150). . . Outer tube extension

(151A). . . Finger handle

(151B). . . Finger handle

(152). . . Inner lip

(153). . . Lock ring

(160). . . First or proximal seal

(170). . . Second or end seal

Claims (25)

A dual chamber mixing device for a syringe, the dual chamber mixing device comprising:
An outer cylinder and an inner cylinder are substantially in a coaxial relationship, and the dual chamber mixing device can include a plurality of mixed materials, wherein at least one first mixed substance is located in an outer chamber between the outer cylinder and the inner cylinder, at least one a second mixed substance is located in an inner chamber of the inner cylinder, the inner cylinder including one or more liquid passages through which the first mixed substance can pass into the inner chamber of the inner cylinder And the second mixture is mixed; one or more venting holes are in communication with the outer chamber; and at least one sealing member is located in the outer chamber, the sealing member is axially movable from the one of the inner cylinder Or a first position of the one or more liquid passage sealing cassettes moved to a second position at least partially between the one or more liquid passages and the one or more venting holes. A double chamber mixing device for a syringe according to claim 1, wherein the inner cylinder and the outer cylinder are concentric. A dual chamber mixing apparatus for a syringe according to claim 1, wherein the one or more liquid passages comprise a plurality of holes in an inner cylinder wall of the inner cylinder. A double chamber mixing device for a syringe according to claim 1, further comprising a mixing piston axially moving within the outer chamber between the outer cylinder and the inner cylinder. The dual chamber mixing device of the syringe of claim 4, further comprising a proximal seal that is snapped, coupled, coupled, secured to the mixing piston and slidable within the outer chamber. The dual chamber mixing device of the syringe of claim 5, wherein the at least one sealing member of the one or more liquid passage sealing cartridges of the inner cylinder is an end seal, the mixing The axial movement of the piston indirectly facilitates axial movement of the tip seal to intermediate the second position or at least partially between the one or more liquid passages and the one or more vents. A dual chamber mixing device for a syringe according to claim 6 wherein the axial movement of the mixing piston facilitates entry of the at least first mixed substance into the inner chamber of the inner barrel. A dual chamber mixing device for a syringe according to claim 4, wherein the one or more vents are operable to facilitate air from the mixing piston as it slides within the outer chamber The outer chamber goes out to the atmosphere. A double chamber mixing device for a syringe according to claim 5, further comprising a removable safety cover having a plurality of protrusions adapted to be inserted into the respective vents to contact or contact the end seals . A dual chamber mixing device for a syringe according to claim 5, further comprising a mixing piston lock for preventing movement of the mixing piston from the outer chamber of the mixing device. A dual chamber mixing device for a syringe according to claim 1, wherein the first mixture contained in the outer chamber comprises one or more liquids. A double chamber mixing device for a syringe according to claim 11, wherein the liquid is an active liquid of a drug or a non-activated liquid of a drug. The dual chamber mixing device of the syringe of claim 11, wherein the second mixture contained in the inner chamber comprises one or more active liquids of the drug or one or more Activate the liquid. A double-chamber mixing device for a syringe according to claim 13, wherein the inner chamber comprises a drug-activated solid and the outer chamber comprises a drug-activated liquid or a drug-inactivated liquid. The passage of the liquid from the outer chamber into the inner chamber through the one or more liquid passages facilitates mixing of the liquid with the activated solids of the medicament. The double-chamber mixing device for a syringe according to claim 13, wherein the inner chamber includes a first drug activating liquid and the outer chamber includes a second drug activating liquid, whereby the first The activation liquid of the drug enters the inner chamber from the outer chamber through the one or more liquid passages to promote mixing of the activating liquid of the first drug with the activating liquid of the second drug. A syringe comprising a delivery piston, an injection needle and a dual chamber mixing device of the syringe of claim 1. The syringe of claim 16 is a retractable syringe comprising a retractable injection needle. The syringe of claim 17, wherein the delivery piston is engageable with the injection needle to facilitate retraction of the injection needle. The syringe of claim 18, wherein the retraction is facilitated by a biasing member. The syringe of claim 19, wherein the transfer piston comprises the biasing member, wherein the biasing member is a spring, a piston member, a piston housing and one or more lock members, the piston Cooperating with the piston housing to releaseably maintain the biasing member in an initially energized state, the syringe further comprising an injection needle assembly including the retractable injection needle, wherein the retractable needle The injection needle includes a cannula and an injection needle that can be engaged with the piston member. A combination method of a double chamber mixing device for a syringe according to the first aspect of the invention, comprising the following steps:
(i) axially aligning an outer cylinder on an inner cylinder, the inner cylinder having one or more holes communicating with the inner chamber of the inner cylinder, the inner cylinder and the outer cylinder being axially aligned to form a An outer chamber, wherein the outer chamber has one or more venting holes in fluid communication with the one or more holes located distally;
(ii) inserting a seal into the outer chamber and sealing the cassette with the one or more holes. The method for assembling a double chamber mixing device for a syringe according to claim 21, further comprising the following steps:
(a) prior to step (i), securing a hole cover having one or more venting holes to a portion of the inner cylinder, the inner cylinder being at the distal end of the one or more holes;
(b) prior to step (ii), the end of the outer barrel is secured to the aperture cover; and (c) inserting an injection needle assembly into the inner chamber at the distal end of the one or more apertures. A method of manufacturing a syringe according to item 16 of the patent application, comprising the steps of:
(i) providing a first mixture in an outer chamber of the mixing device, inserting a first or proximal seal into the outer chamber of the mixing device to contact the first mixture;
(ii) providing a second mixture in an interior of the mixing device;
(iii) inserting a transfer piston into the inner cylinder, wherein the transfer piston is one or more holes closest to the inner cylinder; and (iv) installing a mixing piston in the outer chamber, wherein the mixing piston contacts the First or proximal seal. A method of operating a syringe according to item 16 of the patent application, comprising the steps of:
(i) operating a mixing piston of the mixing device to mix a plurality of materials; and (ii) operating a transfer piston to deliver the material mixed in step (i) to a recipient. The method of claim 24, further comprising the steps of:
(iii) actuating an injection retraction mechanism to retract an injection needle into the syringe.