TWI564047B - Double chamber mixing device for syringe and combination method thereof and syringe using double chamber mixing device and manufacturing method thereof - Google Patents

Description

Double chamber mixing device for syringe and combination method thereof and syringe using double chamber mixing device and manufacturing 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 passage means for aligning a hole with a seal, the passage means of the seal including an opening extending through the seal ring and from the projection a groove extending longitudinally of the opening, such that the groove joins the outer cylinder and the radially extending opening, and the radially extending opening selectively joins the groove and the bore of the inner cylinder to make a liquid From the outer cylinder entering the inner cylinder mixing the liquid with a substance of the inner cylinder, such a structure requires complicated components and difficult handling conditions for the user to operate the apparatus.

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 associated with 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, interaction of component seals, 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 in the holes. Forming a sealed annular volume on the first liquid element. Because of such a configuration, when the piston is lowered, the hole must serve as an outlet through which the air of the annular space is discharged to the second sealing tape. The space must be sterile, such export requirements can be difficult and require additional components and processing steps to be loaded into the inner chamber under vacuum to remove air from the outer chamber and below the second seal The end of the outer cylinder.

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 The piece is located in the outer chamber, the seal is axially Moving from a first position of the one or more liquid passage sealing cartridges of the inner barrel to at least partially between the one or more liquid passages and the one or more venting holes a second position. 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 comprise a proximal seal card Trussing, engaging, connecting, securing to the mixing piston and slidable within the outer chamber; the end seal initially in a first position slides with the one or more liquid passage seals of the inner barrel to at least Partially in a second position between the one or more liquid passages and the venting opening, the axial movement of the mixing piston causes the proximal seal to be snapped, coupled, connected, and secured to the mixing piston Movement, such movement is transferred to the first mixture in the outer chamber, and likewise to the end seal, whereby the axial movement of the mixing piston indirectly (not necessarily in direct contact) promotes the end seal The axial direction moves 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 active liquid of the drug and the activation of the drug The interaction of the bodies allows the activated solids of the drug to be reconstituted for subsequent delivery to the patient.

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 the needle Retracted, the retractable syringe includes any retracted structure that cooperates with the mixing device described herein, such as the injection needles of PCT Publication Nos. WO2006/119570, WO2006/108243, WO2009/003234, WO2011/075760 Back to construction.

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 are snapped, the release ring can be retracted by the injection needle, After the needle is retracted, the piston member and the piston housing are disengaged to allow the elastic member to extend from its initial energized state, and when the piston member is axially moved toward the closest direction through the release of the elastic member The piston housing is still substantially in contact with or attached to the release ring, thereby retracting 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 over an inner cylinder having one or more inner cylinders a bore communicating with the inner chamber of the inner cylinder, the axial alignment of the inner cylinder and the outer cylinder forming an outer chamber, wherein the outer chamber has one or more venting holes and the distal end of the one or More than one aperture is in fluid communication; (ii) a seal is inserted into the outer chamber to seal the cartridge with the one or more apertures.

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, a first or proximal end a seal is inserted into the outer chamber of the dual chamber mixing device to contact the first mixture; (ii) a second mixture is disposed in an inner chamber of the dual chamber mixing device; (iii) a transfer is performed a piston is inserted into the inner cylinder, wherein the transfer piston is one or more holes closest to the inner cylinder; and (iv) a mixing piston is mounted in the outer chamber, wherein the mixing piston contacts the first or proximal seal Pieces.

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 operation includes a dual chamber mixing device The method of the syringe further includes the step 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, the outer chamber 140 and the inner chamber 112 Both 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 slidingly axially within the outer chamber 140 Movable, the mixing piston 130 further includes spring projections 133A, B located on the cylindrical shaft 132, deflected outwardly from the cylindrical shaft 132, when the mixing piston 130 is inserted into the dual chamber mixing device 100 When the outer chamber 140 is closed, the spring projections 133A, B are moved outwardly (biased against), and the dual chamber mixing device 100 is combined, the spring projections 133A, B preventing the mixing piston 130 from the outer chamber 140 moves, as will be described in more detail below, the mixing piston 130 further includes locking tabs 134A, B (not visible to 134B) on the cylindrical shaft 132, deflected outwardly from the cylindrical shaft 132, the locking projection The outward deflection of 134A, B is jammed with the inner lip 152 of the outer barrel extension 150, facilitating locking of the mixing device 130 from the closest movement after mixing is complete.

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 shown in FIG. On the inner cylinder wall 111 The aperture 114 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, the aperture 114 is covered; For the first figure A and 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 safety cover including a ring body 182 and a projection 181 that passes through separate ventilation Aperture 122 (not shown in the second figure) abuts or contacts the end seal 170 to prevent the end seal 170 from unintentionally moving, such as a change in air pressure during transport or the user's carelessness of the mixing piston 130 prior to operation. mobile.

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, which The piston housing 220 has an elongated body 221 and a base 225, a head 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 at the inner end of the outer chamber 140 to move the second or distal seal 170 (ie, toward the retractable needle 400), This opening of the aperture 114 allows liquid to be transferred from the outer chamber 140 to the chamber 112.

As shown in the sixth diagram, the lowering of the mixing piston 130 in the direction of the dashed arrow forces the first or proximal seal 160 in the outer chamber 140 to move further, leaving the unfinished liquid from the outer chamber 140. Flowing into the inner chamber 112 until the first or proximal seal 160 touches the second or end seal 170, the seals 160 and 170 can reach the end of the outer chamber 140 stroke, the second Or where the end seal 170 will touch the aperture cover 123, in this position, not the seal 160 is sealed (or covered) with the aperture 114, ie both seals 160, 170 can The aperture 114 partially seals the cassette, the latter being possible, for example, when liquid flows from the outer chamber 140 It is not necessary for the inner chamber 112 to have the second or end seal 170 completely refrain from covering 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 protrusions 134A, B and the inner lip 152 of the outer cylinder extending portion 150 are latched to form a lock to prevent the proximal end of the mixing piston 130 from moving (toward the directional person) beyond this point, and the mixing is locked after mixing The piston 130 is beneficial for guiding the force of the delivery piston 200 through the injection needle 400 to inject the liquid substance, rather than forcing the liquid substance to flow back to the outer chamber 140, or by the first or proximal seal 160 The hole 114 seals the final positioning of the cassette, and likewise, the full axial movement of the mixing piston 130 and/or the jamming of the mixing piston 130 and one or more pawls of the outer barrel 120 can be unlocked. The transfer piston 200 or a lock configuration of the inner cylinder 110 is configured to enable the transfer piston to be axially depressed, thereby providing a user with the device to ensure proper injection procedures, and the drug can be reconstituted or prior to injection into the patient. mixing.

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, thus eliminating the need to maintain sterility in the venting space 142 area, which venting space 142 may be filled with air, when the mixing piston 130 is depressed 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 between each other, again, Because the second or end seal 170 initially covers the hole 114 in the inner cylinder wall 111 of the inner cylinder 110, the outer chamber 140 and the inner chamber 112 are used during use of the dual chamber mixing device 100. The liquid passage therebetween is still maintained sterile, and only the second or end seal 170 may contact the outer barrel 120 and the non-sterile portion of the inner barrel 110 because liquid has flowed from the outer chamber 140. The inner chamber 112 does not come into contact with the non-sterile portion.

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 facilitate mixing of the substance, and/or the syringe eliminates any residue prior to injection. Air can be performed both before the injection needle is inserted and the liquid contents are injected.

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 210.

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, the disengagement allowing the compression bomb The spring 270 releases the pressure and pushes the ring protrusion 212 of the piston member 210 to retract the piston member 210 and the control rod 230 coupled thereto, when the piston member is coupled to the injection needle 420 and the cannula 410 When the compression of the spring 270 is axially moved toward the most proximal direction, the piston housing 220 remains substantially in contact with or coupled to the release ring 136, thereby retracting the cannula 410 and the injection 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. As a result, there is almost no part of the piston member 210 extending out of the syringe, forcing the transfer piston 200 to retreat into the inner cylinder 110, and attempting to re-engage with the injection needle (as shown), such as the tenth As shown, when the syringe is in the retracted position, the frangible joint 234 can be located at a point that extends beyond the head 222 in the most proximal direction along the piston member 210 and is optionally locked for 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 can include the hybrid The pawl configuration (not shown) in which the outer cylinders 120 of the piston 130 are engaged with each other is moved in a completely axial direction toward the end direction of the mixing device.

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 perforation methods can be used, such as mechanical or laser drilling, and, Known aseptic procedures can be used in the manufacturing or combination stage to ensure that the final product is sterile.

In one embodiment, a method of combining the dual chamber mixing apparatus includes the steps of: (i) securing a hole cover having one or more venting holes to an end of an inner cylinder, wherein the inner cylinder has a Or one or more apertures therethrough, the aperture cover being remotely secured to the one or more apertures; (ii) axially aligning an outer cylinder over the inner cylinder and attaching the end of the outer cylinder to the a hole cover, wherein the diameter of the outer cylinder is larger than the diameter of the inner cylinder, and the two cylinders are aligned such that the annular space between the two cylinders forms an outer chamber; (iii) an end seal is inserted into the outer chamber and Positioning the end seal with the one or more aperture sealing tabs; and (iv) inserting an injection needle assembly into the inner chamber such that the 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 double chamber mixing device can be used as a hybrid syringe Element, in one embodiment, a method of manufacturing a syringe having a mixing device comprising the steps of: (i) at least partially filling a first liquid substance within the outer chamber, and inserting a proximal seal into the outer chamber Contacting 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; and 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 tube

(111)‧‧‧ Inner wall

(112)‧‧‧ inner chamber

(114)‧‧‧ holes

(119)‧‧‧Injection needle sets

(120)‧‧‧Outer tube

(121)‧‧‧Outer wall

(122)‧‧‧ Ventilation holes

(123)‧‧‧ hole cover

(125)‧‧‧ bracket

(130)‧‧‧ Mixed Piston

(131)‧‧‧ button

(132)‧‧‧Cylinder shaft

(133A)‧‧‧Spring projections

(133B)‧‧‧Spring projections

(134A)‧‧‧Locks

(134B)‧‧‧Locks

(135) ‧ ‧ end

(136)‧‧‧ release ring

(137)‧‧‧ bottom

(140) ‧ ‧ outer chamber

(142)‧‧‧ Ventilation space

(150) ‧‧‧Outer tube extension

(151A)‧‧‧ Finger grip

(151B)‧‧‧ Finger grip

(152) ‧ ‧ inner lip

(153)‧‧‧Lock ring

(160)‧‧‧First or near-end seals

(170)‧‧‧Second or end seals

(180) ‧‧‧Safety cover

(181)‧‧‧Act

(182)‧‧‧

(1000)‧‧‧Syringe

(200)‧‧‧Transport piston

(210)‧‧‧ piston parts

(211)‧‧‧ shaft

(212) ‧‧‧ ring projections

(216)‧‧‧ Sealed card parts

(217)‧‧‧Threaded projections

(219)‧‧‧Lock slot

(220)‧‧‧Piston housing

(221) ‧ ‧ extended body

(222) ‧ ‧ head

(224) ‧‧‧clip

(225) ‧ ‧ base

(227) ‧‧‧Locks

(228) ‧‧‧ edge

(229) ‧‧‧ edge

(230)‧‧‧Control lever

(231)‧‧‧ button

(232)‧‧‧ Arms

(233)‧‧‧Axis

(234) ‧‧‧ joints

(235) ‧‧‧Protruding

(270) ‧ ‧ spring

(300) ‧‧‧Fixed parts

(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 seals

(600)‧‧‧Rejective elements

(610)‧‧‧Rejection element ring

(800)‧‧‧ piston seals

(810)‧‧‧Injection needles

(810)‧‧‧ recess

(820)‧‧‧Threaded grooves

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 tube

(111)‧‧‧ Inner wall

(112)‧‧‧ inner chamber

(120)‧‧‧Outer tube

(121)‧‧‧Outer wall

(122)‧‧‧ Ventilation holes

(123)‧‧‧ hole cover

(125)‧‧‧ bracket

(130)‧‧‧ Mixed Piston

(131)‧‧‧ button

(132)‧‧‧Cylinder shaft

(133A)‧‧‧Spring projections

(133B)‧‧‧Spring projections

(134A)‧‧‧Locks

(135) ‧ ‧ end

(136)‧‧‧ release ring

(140) ‧ ‧ outer chamber

(142)‧‧‧ Ventilation space

(150) ‧‧‧Outer tube extension

(151A)‧‧‧ Finger grip

(151B)‧‧‧ Finger grip

(152) ‧ ‧ inner lip

(153)‧‧‧Lock ring

(160)‧‧‧First or near-end seals

(170)‧‧‧Second or end seals

Claims (23)

A double-chamber mixing device for a syringe, the double-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 one first mixed substance is located An outer chamber between the outer cylinder and the inner cylinder, at least one second mixture is located in an inner chamber of the inner cylinder, the inner cylinder including one or more liquid passages for the first mixture to The outer chamber can enter the inner chamber of the inner cylinder through the fluid passage to be mixed with the second mixture; one or more vent holes communicate with the outer chamber; and at least one seal is located outside the outer chamber The chamber is axially movable from a first position to a second position in the chamber, the seal sealingly engaging the one or more liquid passages of the inner barrel in the first position, the seal being at the first The two locations are at least partially between the one or more liquid passages and the one or more vents. 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. Double chamber mixing of the syringe as described in claim 4 The device further includes a proximal sealing tab that is 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 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 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. The dual chamber mixing device of the syringe of claim 1, wherein the first mixture contained in the outer chamber comprises a 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 transfer piston, an injection needle and a dual chamber mixing device of the syringe of claim 1 wherein the transfer piston is at least partially coaxially slidably moved in the mixing device. The syringe of claim 16, which is a retractable syringe, the 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 when the delivery piston is engaged with the injection needle, the retraction is facilitated by a pressure-reducing 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 method for assembling a double-chamber mixing device for a syringe according to the first aspect of the invention, comprising the steps of: (i) axially aligning an outer cylinder on an inner cylinder, the inner cylinder having one or one The upper aperture is in communication with the inner chamber of the inner cylinder, the axial alignment of the inner cylinder and the outer cylinder forming an outer chamber, wherein the outer chamber has one or more venting holes and the distal end of the one Or more than one hole is in fluid communication; (ii) inserting a seal into the outer chamber and sealing the cartridge with the one or more holes. The method of assembling a double chamber mixing device for a syringe according to claim 21, further comprising the steps of: (a) fixing a hole cover having one or more vent holes before the step (i) a portion of the inner cylinder that is tied to the one or one More than one distal end of the hole; and (b) prior to step (ii), the end of the outer barrel is secured to the safety cover. A method of manufacturing a syringe according to claim 16 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 mixing; The outer chamber in the device contacts the first mixture; (ii) a second mixture is disposed in an interior of the mixing device; (iii) a transfer piston is inserted into the inner tube, wherein the transfer piston is One or more holes that are closest to the inner barrel; and (iv) a mixing piston is mounted within the outer chamber, wherein the mixing piston contacts the first or proximal seal.