CN108404261A - Drug mixing arrangement and the method for mixing drug - Google Patents
Drug mixing arrangement and the method for mixing drug Download PDFInfo
- Publication number
- CN108404261A CN108404261A CN201810124577.1A CN201810124577A CN108404261A CN 108404261 A CN108404261 A CN 108404261A CN 201810124577 A CN201810124577 A CN 201810124577A CN 108404261 A CN108404261 A CN 108404261A
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- 229940079593 drug Drugs 0.000 title claims abstract description 108
- 238000002156 mixing Methods 0.000 title claims abstract description 52
- 238000000034 method Methods 0.000 title claims abstract description 21
- 238000007789 sealing Methods 0.000 claims abstract description 37
- 239000012530 fluid Substances 0.000 claims description 31
- 230000007246 mechanism Effects 0.000 claims description 24
- 230000006835 compression Effects 0.000 claims description 16
- 238000007906 compression Methods 0.000 claims description 16
- 238000013519 translation Methods 0.000 claims description 15
- 238000004891 communication Methods 0.000 claims description 11
- 230000008859 change Effects 0.000 claims description 9
- 238000002955 isolation Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 description 12
- 239000007924 injection Substances 0.000 description 12
- 230000014616 translation Effects 0.000 description 7
- 239000000463 material Substances 0.000 description 6
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- 239000011521 glass Substances 0.000 description 3
- 239000004615 ingredient Substances 0.000 description 3
- 239000007788 liquid Substances 0.000 description 3
- 229920001296 polysiloxane Polymers 0.000 description 3
- 230000004888 barrier function Effects 0.000 description 2
- 239000003795 chemical substances by application Substances 0.000 description 2
- 238000000354 decomposition reaction Methods 0.000 description 2
- 230000007812 deficiency Effects 0.000 description 2
- 238000013461 design Methods 0.000 description 2
- 239000003085 diluting agent Substances 0.000 description 2
- 238000006073 displacement reaction Methods 0.000 description 2
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- 239000013536 elastomeric material Substances 0.000 description 2
- 238000000465 moulding Methods 0.000 description 2
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- PEDCQBHIVMGVHV-UHFFFAOYSA-N Glycerine Chemical compound OCC(O)CO PEDCQBHIVMGVHV-UHFFFAOYSA-N 0.000 description 1
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- 239000002904 solvent Substances 0.000 description 1
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- 229920001169 thermoplastic Polymers 0.000 description 1
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/31—Details
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
- A61M2005/2006—Having specific accessories
Landscapes
- Health & Medical Sciences (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Medical Preparation Storing Or Oral Administration Devices (AREA)
Abstract
The present invention is entitled " drug mixing arrangement and the method for mixing drug ".Present invention contemplates a kind of drug mixing arrangements may include shell, the shell has the first chamber comprising the first drug component and provides the second chamber for including the second drug component wherein, and with the sealing structure that selectively first chamber is isolated with the second chamber.The sealing structure may include the first seal member with the first sealed interface and the second seal member with the second sealed interface, wherein the first compressing force can be applied to first seal member and the second seal member so that the sealed interface forms sealing.First compressing force then can be configured to allow for first seal member and second seal member keep at least one degree of freedom relative to each other.
Description
Technical field
Present invention relates generally to automatic injectors and precharging injection syringe, and relate more specifically to compact condition store but
Allow the automatic injector for preparing or mixing various pharmaceutical ingredients before pharmaceutical ingredients are delivered to patient.
Background technology
It has been recognized that if drug is separately stored as dry drug with diluent, the shelf life of drug can significantly prolong
It is long.In addition, these drugs are usually in the in emergency circumstances use of preferred self-administration.However, being related to just before injection
The added burden that dry drug is dissolved in liquid dosages usually requires the step that user executes the multiple troubles of row, and usually because agent
Amount is wrong, accidentally drops, leak, high injection failure rate and other known problem allow process to seem intractable.Thus, it might be useful to have
Wieldy automatic injector or precharging injection syringe device, it is automatic to carry out drug preparation process, while maximum journey being also provided
Degree reduces the platform of user training and user's failure probability.
Currently available system generally includes to design using the barrel type with bypass of fluid.Fluid forces are arrived by activating
It rushes down in blanking barrel, fluid is mixed with other fluid and/or dry drug.It is rushed down in blanking barrel however, problem is present in these,
Wherein bypass can leak or fluid is fallen plunger and escaped with the opposite way round by rushing down.This is it is usually because the pressure in system and need
There are certain pressure release mechanisms to be connected.Plunger is usually not intended to be used as high-pressure sealing ring, since it is desired that they are translated, by
This limitation plunger can be applied to the radial pressure amount on wall, suitably shake off power to obtain.In this way, their offers are sealed in length
It is usually insufficient in period, and if simultaneously non-optimal design can lead to sterility problems.Leakage during this storage caused
Early pollution, while the leakage during injection will reduce Dose accuracy and precision.Therefore, there is not under a constant close
The seal durability of enhancing and extended service life can also be provided in the device of envelope chamber.
Invention described herein provides a solution, tries hard to solve the problems, such as determined above and therefore just durable
Property, sterile, dosage control, precision, accuracy and actuating when system direction degree of freedom improved.
Invention content
It has been recognized that by providing the automatic injection with operable valve between separation and different chambers
Device can overcome the various deficiencies of the prior art, wherein the positive compression power provided between each valve member can enhance sealing completely
Property simultaneously reduces leakage；And therefore keep service life and Dose accuracy.
In order to realize above-mentioned advantageous effect, a kind of drug mixing arrangement may include shell, middle casing are contemplated herein
Include the first chamber comprising the first drug component and include the second chamber of the second drug component, the second drug component is configured
It is mixed at the first component.
Shell, which may also include, is configured to selectively change the dischargeable capacity of first chamber so as to by the first drug component
It is pushed to the first shift mechanism mixed in second chamber.
Then the sealing structure for being configured to that first chamber is isolated with second chamber can be provided, wherein sealing structure can wrap
The first seal member with the first sealed interface is included, the first sealed interface can coordinate against or against the second seal member, the
Two seal members have second sealed interface opposite with the first sealed interface of the first seal member.It then can be by the first compression
Power is applied to the first seal member and the second seal member or therebetween so that sealing interface pair provides sealing force to form sealing.
Then it should be understood that these opposite first sealed interfaces and the second sealed interface can be configured to such side
Formula coordinates or engagement, to keep at least one degree of freedom relative to each other, to allow the valve therefore formed playing on or off
Relative motion under closed state and respective operations.
In some embodiments, the first seal member can be equipped with the outlet or in flow communication that can be used as first chamber
The first hole, and wherein the second seal member can be equipped with the second hole provided with the fluid communication of second chamber, wherein first
Hole and the second hole are optionally aligned.In some such embodiments, degree of freedom may be provided as first selectively
The sliding translation in hole and the alignment of the second hole.Alternatively, degree of freedom may be provided as selectively being directed at the first hole and the second hole
Radial translation.In other such embodiment, degree of freedom can be the axis for being selectively directed at the first hole and the second hole
To rotation.In other such embodiment, degree of freedom can be selectively to put down the first hole and the linear of the second hole alignment
It moves.
In a further embodiment, first chamber can be formed using interior column tube, is configured to carry wherein can provide
The column tube sleeve of interior column tube.In some such embodiments, the first seal member that can be between interior column tube and column tube sleeve
Upper offer upper flange, wherein the second compressing force is provided between column tube sleeve and interior column tube, to compress interior column tube and column tube set
Upper flange between cylinder, to which the first drug component to be sealed in interior column tube.
In some other embodiments, it is possible to provide intermediate support is to accommodate column tube sleeve, wherein passing through centre
Support element provides the second seal member, and wherein by providing one or more protrusions being oriented radially inwards in column tube sleeve
The first compressing force is provided between intermediate support, the top edge of these protrusion bond post pipe sleeve cylinders simultaneously biases column tube sleeve
Into intermediate support, to form the first compressing force.
Then it should be appreciated that in some embodiments, not using single shift mechanism to two chambers, but can
Second shift mechanism of the dischargeable capacity that can be configured to selectively change second chamber is provided.
In other arrangement, drug mixing arrangement can be described as having the device of first chamber and second chamber.It can
The valve seal being arranged between first chamber and second chamber is then provided.The valve seal may include being centered around first chamber
First seal member of the hole setting of middle offer；It is in direct contact the second seal member of the first seal member, second sealing
Part is provided forms the entrance being selectively in fluid communication with second chamber；Various structure members or the energy source of storage can wherein be passed through
Compressing force is provided, which then can make the apparent surface of the first seal member and the second seal member in a sealing manner
It is engaged with each other.
As described above, the sealing of formation can be configured to keep between the first seal member and the second seal member to
Few one degree of freedom so that valve seal is changed by the various translations of the foregoing description between closing and open configuration.
A kind of drug mixed method using above-mentioned apparatus is contemplated herein, wherein in addition to providing described device, the party
Method may also include various steps, such as provide the first drug component to first chamber；The second drug component is provided to second chamber；
A part for mobile compression valve seal, the first hole and the second hole pair that thus the movement will be formed in compressing valve seal
Thus standard forms fluid path between first chamber and second chamber；And by fluid path by the first drug component from
First chamber is displaced in second chamber, so that the first drug component is mixed with the second drug component.
Description of the drawings
Figure 1A to Fig. 1 C shows the perspective exterior view of drug mixing and delivery apparatus, passes through each of the first actuation step
A stage shows various aspects of the invention；
Fig. 2A to Fig. 2 B shows that the drug of Figure 1A to Fig. 1 C mixes by each stage of the second actuating or delivery step
With the side sectional view of delivery apparatus；
Fig. 3 A show the exploded view of the drug mixing and delivery apparatus of Figure 1A to Fig. 1 C, are shown in which to use multiple
Single component；
Fig. 3 B show the exploded view for the mixing sub-component that the selection A of Fig. 3 A is irised out；
Fig. 4 A to Fig. 4 D show in the drug mixing of Figure 1A to Fig. 1 C and delivery apparatus the mixing sub-component that uses and
The side sectional view of delivery components；
Fig. 5 shows the enlarged cross-sectional view in the region for selecting B to iris out shown in Fig. 4 B；
Fig. 6 A to Fig. 6 B show rotary valve and its perspective view of operation principle, can adjust the rotary valve for this paper institutes
Any one embodiment stated；
Fig. 7 A to Fig. 7 B show radial valve and its perspective view of operation principle, and the radial direction valve is adjusted for this paper institutes
Any one embodiment stated；
Fig. 8 shows the decomposition of the alternative embodiment with the drug mixing and delivery apparatus at least selecting electric hybrid module else
Perspective view；
Fig. 9 A to Fig. 9 B show to form each of a part for the alternative electric hybrid module of the mixing of the drug of Fig. 8 and delivery apparatus
The enlarged perspective and decomposition perspective view of a component；
Figure 10 A to Figure 10 B show to form a part for the alternative electric hybrid module of the mixing of the drug of Fig. 8 and delivery apparatus
The side of all parts and horizontal cross；And
Figure 11 A to Figure 11 B show drug mixing and the delivery apparatus for the Fig. 8 for being formed by light axial rotating configurations
The optionally side of all parts of a part for electric hybrid module and horizontal cross.
Specific implementation mode
This application claims the equity of following patent application：The U.S. for being filed on 2 9th, 2017 co-pending is temporarily special
Profit application 62/456,727；It is filed in the Co-pending U.S. Patent Application 15/832,346 on December 5th, 2017；Jointly not
U.S. Patent application 15/034,967 certainly；It is filed in the PCT application PCT/US15/45761 on the 18th of August in 2015；It is filed in
The U.S. Provisional Patent Application on the 13rd of August in 2015 62/204,940；It is filed on 2 27th, 2015 US provisional patent Shens
It please 62/126,011；It is filed on 2 25th, 2015 U.S. Provisional Patent Applications 62/120,792；It is filed in 2015 10
The U.S. Provisional Patent Application 62/061,664 on the moon 8；And it is filed in the U.S. Provisional Patent Application on the 18th of August in 2014
62/038,386, these patents, which are incorporated by reference, to be incorporated herein.
As described above, it has been recognized that there is operable valve between separation and different chambers by providing
Automated injection device can overcome the various deficiencies of the prior art, wherein the positive compression power provided between each valve member can enhance
Sealing integrity simultaneously reduces leakage, and thus keeps service life and Dose accuracy.In order to realize these and other advantageous effect,
Drug mixing arrangement 10 is contemplated herein, and component and embodiment are shown in Fig. 1 to Fig. 7.Drug mixing arrangement 10 can wrap
Shell 12 is included, middle casing 12 includes first chamber and second chamber, and the first chamber and second chamber include to be intended for
The component mixed before delivering.It should be understood that drug mixing arrangement 10 can be activated in the way of various with various states, however,
For exemplary purposes, Figure 1A to Figure 1B show initiate mixing step the first actuating method, middle cover 14 relative to
The rotation of shell 12 is to initiate the mixing of the indoor component of each chamber included in shell.At least in above-mentioned related application
About the detailed description of actuating method.
Fig. 2A to Fig. 2 B shows the side sectional view of drug mixing arrangement 10 by the second delivery step, and Fig. 4 A extremely scheme
4D then shows unmixed, mixing front opening, each stage mixed and ejection state.These views better illustrate
The first chamber 212 being included in column tube 210, wherein the first drug component may include wherein, it is therefore preferable to liquid diluting
The drug suspending components of agent or injectable.
These views also show the second chamber 272 being included in the second column tube 270, and second chamber is configured to contain
It is formulated into the second drug component mixed with the first drug component.It is carried it should also be understood that the second drug component can be used as dry component
For.In addition, second drug component can be also provided in the channel being located between first chamber and second chamber, so as to first
Drug component ensures to mix when being delivered in second chamber from first chamber.
Drug mixing arrangement 10 may also include the first shift mechanism 204 that can be used as plunger offer, wherein the first shifting machine
Structure 204 can be configured to selectively change the dischargeable capacity of first chamber 212, so that the first drug component is pushed to second
It is mixed in chamber.
Then the sealing structure 230 for being configured to that first chamber 212 is isolated with second chamber 272 can be provided, wherein close
Seal structure 230 may include the first seal member 280 with the first sealed interface 234, the first sealed interface can against or it is opposite
Coordinate in the second seal member as shown herein for intermediate support 240, wherein intermediate support includes being used as its inner bottom table
The second sealed interface 244 that face provides.In this way, the first sealed interface of the second sealed interface 244 and the first seal member 280
234 is opposite.First compressing force then can be applied to the first seal member and the second seal member or therebetween so as to sealing connect
Mouth provides sealing force to form sealing.
Then it should be understood that these opposite first sealed interfaces and the second sealed interface can be configured to such side
Formula coordinates or engagement, to keep at least one degree of freedom relative to each other, to allow the valve therefore formed playing on or off
Relative motion under closed state and respective operations.The degree of freedom can be described as being present in the first seal member and the second seal member
Between plane, wherein the first seal member and the second seal member can rotate or radial manner is slided relative to each other.
In some embodiments, the first seal member 280, which can be equipped with, can be used as the outlet of first chamber 212 or is flowed with it
First hole 214 of body connection, and wherein the second seal member 240 can be equipped with and form the be in fluid communication with second chamber 272
Two holes 246, wherein the first hole and the second hole can be selected by the relative motion between the first seal member and the second seal member
Property it is aligned.
In some such embodiments, degree of freedom may be provided as the cunning for being selectively directed at the first hole and the second hole
Dynamic translation.Wherein in some such embodiments, sliding or translation may be provided as the first hole and the second hole selectively
The radial translation of alignment, as shown in Fig. 7 A to Fig. 7 B.In other such embodiment, degree of freedom may be provided as selecting
Property the axial-rotation that is directed at the first hole and the second hole, as shown in Fig. 6 A to Fig. 6 B.
In exemplary implementation scheme shown in this article, first chamber 212 can be formed using interior column tube 210, wherein can
The column tube sleeve 220 for being configured to carry interior column tube 210 is provided.It, can be in interior column tube 210 and column in some such embodiments
Upper flange 284 is provided on the first seal member 280 between pipe sleeve cylinder 220, wherein column tube sleeve 220 and interior column tube 210 it
Between the second compressing force is provided, to compress the upper flange 284 between interior column tube 210 and column tube sleeve 220, to by the first drug
Component is sealed in interior column tube, wherein unique outflow path is through via 214 when being correctly aligned.In some such embodiments
In, column tube sleeve 220 can have one or more protrusions 224 for radially-inwardly biasing or being orientated, these protrusions can be configured to
The top edge of column tube 210 and by column tube biased downward to the inside of column tube sleeve 220 in engagement, therefore formation is by upper flange
284 are interposed in the first compressing force between column tube sleeve 220 and the bottom margin of column tube 220.
It may be provided between column tube sleeve 220 and the internal edge of intermediate support 240 in addition, the first seal member can have
Lower flange 288, wherein the compressing force provided between column tube sleeve 220 and the inside of intermediate support is convex under then can making
Edge 288 is interposed in or presses between the lower edge of column tube sleeve 220 and the inner surface of intermediate support, is then thus provided double
Seal again and prevent fluid compression in interior column tube 210 when be delivered between column tube sleeve 220 and shell 12 or column tube sleeve 220
The inside of shell 12 between intermediate support 240.
In some embodiments, seal member can also be respectively provided with profile or protrusion 290 and 294, can strategically cloth
Set these profiles or protrusion to allow around respective surface deformation and increase sealing reliability and be evenly distributed sealing force, especially
It is realized by being translated against apparent surface's such as column tube inner wall or against the second sealing engagement surface 244.
Then it should be appreciated that in some embodiments, not using single shift mechanism to two chambers, but can
Second shift mechanism 250 of the dischargeable capacity that can be configured to selectively change second chamber is provided.In the embodiment
In, the second shift mechanism 250 is provided as the plunger of the outer lower face surface around intermediate support 240, wherein the second shift mechanism
250 extend in the inner peripheral surface of second chamber 272 and coordinate with it.Intermediate host 240 and plunger 250 can be respectively provided with
Across its hole 246 and 256, this some holes when being aligned with the outlet opening 214 of first chamber 212 together be used as enter second chamber
272 fluid path, to allow fluid flow through they and with may include in the path or be included in second chamber itself
In the second drug component mixing.In this way, the first drug component of mobile offer in the first drug component to second chamber and
The necessary mixing of two drug components.
In this way, drug mixing arrangement 10 can be described as having the device of first chamber and second chamber.214 He of through hole
The selective misalignment in hole 246 is aligned to provide valve.
A kind of drug mixed method using above-mentioned apparatus is contemplated herein, wherein in addition to providing described device, the party
Method may also include various steps, such as provide the first drug component to first chamber；The second drug component is provided to second chamber；
A part for mobile compression valve seal, the first hole and the second hole pair that thus the movement will be formed in compressing valve seal
Thus standard forms fluid path between first chamber and second chamber；And by fluid path by the first drug component from
First chamber is displaced in second chamber, so that the first drug component is mixed with the second drug component.
Fig. 3 A to Fig. 3 B show the exploded view of the automatic injector 10 of at least one embodiment according to the present invention.
The exploded view shows the various internal parts in shell 12 and lid 14.The automatic injector for including electric hybrid module 200 can be provided
10.Drug hybrid system has at least one chamber, for storing at least one drug component, such as wet solvent, diluent or
Suspension.Drug electric hybrid module 200, which can also surround its end set, can accommodate such as dry medicine of at least one second drug component
The second column tube or container 270 of product ingredient, wherein the second column tube is configured for receiving the first drug component.Such as this paper institutes
To show, first chamber and second chamber can be separation and different chambers, have the different separated structures for forming its respective volume, and
And it can be moved relative to each other.
As shown here, first chamber and second chamber can be configured to translate toward and away from one another, relative to each other
It radially slides and is rotated relative to each other along common axis or any combination of them.
Shell may include the energy source 122 preloaded, and energy source is shown here as spring, or can be implemented as compressing
Air chamber, compressed air chamber can be transformed although being not shown by those skilled in the art.Spring can be configured in inner prop
Driving force and reaction force are provided between plug axis 112, and driving force and reaction force are transmitted to mixing group in each stage
The all parts of part 200, will be later discussed.Electric hybrid module 200 may be housed in frame 110, wherein electric hybrid module
200 each individual components can be configured to selectively rotate in shell 12.Spring is also configured to provide one or more
Compressing force to upper flange 284 and lower flange 288 to provide sealing respectively, as described above, concrete mode is will by plunger axis 112
Power is transmitted to top edge or the wheel rim of interior column tube 210 or column tube sleeve 220.
Frame cover 114 can be used that electric hybrid module 200 is maintained in frame, which can be formed separately with frame 110
Or it is integrally formed.Frame cover 114 prevent after delivering or injection electric hybrid module 200 be pushed through frame 110 and completely from
Shell 12 is opened, and reaction force is provided to push the first drug of mixing from second chamber 272 to the extension of spring 122
Component and the second drug component.
Frame cover 114 can also assist in keeping the needle guard when injection needle passes through or pierces through needle guard 314, and providing the needle guard can be
It is sterile that needle 310 is preferably kept in the state of insertion user.Therefore, when pushing down on, the bottom of electric hybrid module 200 is pushed out
And kept by frame cover 114, can pierce needle guard 314 with hour hands 310 and extend beyond shell, so that mixed drug component is passed
It is sent to injection site.
As shown here, needle housing 150 and needle housing can be set between the frame 110 at the dispensing end of shell 12 and shell 12
Spring 154.Needle housing 150 can be used as the trigger of the second delivery step, as shown in Fig. 2A to Fig. 2 B, and needle housing spring 154
It can be configured to axially downwardly bias the improper exposure of needle housing 150 before and after injection so as to lasting limitation needle 310.These functions exist
It is described in more detail in relevant application.
The multiple portions of frame 110 and electric hybrid module 200 can be configured to work as applies axis between lid 14 and shell 12
To being rotated together in shell when torsion, as shown in Figure 1A to Fig. 1 C.Therefore lid 14 can be connected to frame in a manner of radially fixed
Frame 110, the frame are connected to certain components of electric hybrid module 200, and driver interface 118 can also be provided, the driver
Interface is not only connected to the alternative part (being such as connected to inner plunger axis 112) of electric hybrid module 200 in a manner of radially fixed, and
It is rigidly connected to shell 12.In this way, the axial torsion and reaction force being applied between lid and shell can be passed to
In certain components of electric hybrid module 200 and so that these components are activated.
Electric hybrid module may include the inner plunger axis 112 and inner plunger 204 that are used as above-mentioned first shift mechanism together.First
Shift mechanism can be configured to reduce the dischargeable capacity of first chamber, and first chamber initially accommodates the first drug component, i.e. drug
Liquid component.
The plunger is configured to coordinate with the interior column tube 210 for forming first chamber.Interior column tube may be housed in column tube sleeve
In 220, or alternatively, column tube sleeve 220 and interior column tube 210 can be integrally formed by homogenous material.
Column tube sleeve 220 then can coordinate with the rotation valve seal 280 in intermediate support 240.Intermediate supports
Part 240 can have the second shift mechanism 250, that is, the second plunger being coupled, which, which is configured to reduce, is located at the
The dischargeable capacity of second chamber in two column tubes 270.
Second column tube 270 can then have the delivery components 300 that are attached to it, the delivery components may include needle 310 or
Intubation and needle guard 314 or other barriers, the needle guard or other barriers are configured to keep it before delivery components use
Aseptic.
Column tube sleeve can have one or more protrusions extended radially inwardly, these protrusions to correspond to the top of glass column tube
Portion edge.By being inserted into glass column tube and providing downward force or compressing force, wherein the protrusion of the column tube sleeve extended radially inwardly
The top edge of column tube itself will be engaged and maintain compressing force.Compressing force between column tube itself and column tube sleeve can be configured to by
The upper flange of compression seal is sandwiched therebetween, and thus prevents from escaping into column tube and column tube set included in the moistening indoor fluid of chamber
In region between cylinder.In some embodiments, compression seal can further comprise other upward extension, the extension
Extend to the stop part for being used as plunger in the internal cavity of column tube and after injection.It is there are one the upward extension can also have or more
A extension, these extensions can be configured to interact or connect with the respective slot formed on the inner surface of column tube itself
It closes, thus adds another a series of sealing, to prevent the drug being included in from occurring leaking and premature contamination.
It should be appreciated that each hole and/or fluid path can misalignment by various modes, be such as arranged in the sidewall, simultaneously
Axial displacement is placed in bottom end wall and axial twist or radial translation.
Fig. 6 A to Fig. 6 B show the operation principle of the rotation valve seal 400 used in the above-described embodiment.It can shape
At rotary valve, wherein establishing fluid path by making a hole be rotated relative to another hole.It, can in the graphical representation of exemplary
The providing holes 214A in forming the bottom part of column tube of chamber, and across the bottom engagement portion of sealing element 400 setting the
Two hole 246A can be the entrance of the remainder for the fluid channel for leading to another chamber.Fig. 6 A show closed configuration,
The misalignment of two of which hole and there is no be in fluid communication.Fig. 6 B show that open configuration, two of which hole are aligned and establish
It is in fluid communication.It should be appreciated that in order to form better seal, one or both of described component can be by with deformable category
Property material (such as rubber or silicones) formation.In another embodiment, one of component is rubber, the other is firmly
Plastics.In another embodiment, each sealing surfaces at a joint portion by the combination system of duroplasts and elastomeric material
At.
Fig. 7 A to Fig. 7 B show the operation principle of the radial valve seal 500 used in the above-described embodiment.It can shape
Radially valve, wherein establishing fluid path by making a hole be radially slided relative to another hole.In the graphical representation of exemplary
In, can in forming the bottom part of column tube of chamber providing holes 214B, and set across the bottom engagement portion of sealing element 500
The second hole 246B is set, can be the entrance of the remainder for the fluid channel for leading to another chamber.Fig. 7 A show closure
Configuration, the misalignment of two of which hole and there is no be in fluid communication.Fig. 7 B show open configuration, the alignment of two of which hole and
Establish fluid communication.It should be appreciated that in order to form better seal, one or both of described component can be variable by having
Material (such as rubber or silicones) formation of shape attribute.In another embodiment, one of component is rubber, another
It is duroplasts.In another embodiment, each sealing surfaces in an interface by the group of duroplasts and elastomeric material
Conjunction is made.
Fig. 8 to Figure 11 shows the alternative embodiment of drug mixing and delivery apparatus 600, which includes various alternative
Arrangement (i.e. in electric hybrid module 700), to no longer needing at least one seal compression power.In particular, electric hybrid module 700
It may include the column tube sleeve 620 with column tube part 624, column tube part is integrally formed in the inside of set 620, therefore is no longer needed
Separation described in embodiment and different column tubes before wanting.It should be appreciated that the alternative embodiment still includes difference
Two separation formed by column tube 670 and column tube sleeve 620 and different chambers, wherein associated separation and different displacements
Mechanism 604 and 650 is configured to reduce the dischargeable capacity of its respective chamber.
Embodiment more than being similar to, drug mixing and delivery apparatus include valve module 630, which is being closed
It is operated between open position, so that the first drug component to be retained in column tube part 624, thus with positioned at column tube part
Except (i.e. in the second column tube 670) the second drug component mixing.Similarly, can arrange and lead to second chamber entrance or
The outlet 634 that fluid path 654 is selectively aligned is illustrated herein as flowing through the second shift mechanism 650.
For valve module mainly from the formation of the bottom edge surfaces 628 of column tube sleeve 620, which abuts the second shifting machine
The inner surface of the apparent surface of structure 650 or corresponding intermediate support 640.Intermediate support 640 can provide structure to various components
Support and function, including at least carry the second shift mechanism；Various actuation feature portions, such as tab or protrusion operate these spies
It sign portion can open or close valve module；And to column tube sleeve provide structural support, so as at its own between column tube sleeve
And compression seal power is provided between column tube sleeve 620 and the top edge of the second shift mechanism 250, as shown here.
Above-mentioned compressing force can be applied by providing tab or spring 644, these tabs or spring can be biased inwardly so that when
After column tube sleeve is inserted into intermediate support to some compression depth, tab 644 is flexible to central part and to be bonded on column tube set
Column tube sleeve, is thus held against back or the phase of the second shift mechanism 650 by the correspondence antelabium provided on the outer surface of cylinder
To the compression arrangement on surface, or alternatively it is bent to the inner surface of intermediate support (provided that but being not shown) herein.
As shown here, shift mechanism 650 can be by corresponding protrusion, antelabium and/or groove relative to intermediate support
640 are maintained at axial restraint position.In this way, it can be fought and be sealed to respond the compressing force by column tube sleeve 620.The compression
Power then can lead to the apparent surface of column tube sleeve 620 and shift mechanism (especially when exporting 634 and 654 misalignment of channel)
Between form positive sealing force.
In some embodiments, column tube sleeve 620 can be by coating the thermoplastic of molding on glass column tube portion
It is formed.Alternatively, entire column tube sleeve can be formed by the integral structure with the homogeneous material for forming its structure.Similarly,
Two shift mechanisms 650 can be the rubber material that molding is coated on or within intermediate support 640.
It can be moulded using similar cladding in any structure in any embodiment disclosed herein.
It should be appreciated that the plunger or valve member that are discussed in any embodiment of this paper can be by sealing substance shapes appropriate
At such as rubber, silicones or the substantially any substance phase that can be individually customized to the first drug component or the second drug component
The extensible material of appearance.
Claims (20)
1. a kind of drug mixing arrangement, including：
Shell；
First chamber is arranged in the shell, and the first chamber includes the first drug component；
First shift mechanism is configured to selectively change the dischargeable capacity of the first chamber；
Second chamber is arranged in the shell；
Second drug component is arranged in the shell, except the first chamber；
It is characterized in that the drug mixing arrangement includes：
Sealing structure is isolated by the first chamber with the second chamber, and the sealing structure further includes：
The first seal member with the first sealed interface；
The second seal member with the second sealed interface, second sealed interface are described close with first seal member
Sealing-in mouth is opposite；
The first compressing force for being wherein applied to first seal member and second seal member makes the sealed interface
Form sealing；And
Wherein first compressing force allow first seal member and second seal member keep relative to each other to
Few one degree of freedom.
2. drug mixing arrangement according to claim 1, wherein first seal member is provided with and is arranged described
First hole of the communication in first chamber, and wherein described second seal member is provided with and the second chamber
The second hole being in fluid communication is provided.
3. drug mixing arrangement according to claim 2, wherein the degree of freedom be selectively by first hole with
The sliding translation of the second hole alignment.
4. drug mixing arrangement according to claim 2, wherein the degree of freedom be selectively by first hole with
The radial translation of the second hole alignment.
5. drug mixing arrangement according to claim 2, wherein the degree of freedom be selectively by first hole with
The axial-rotation of the second hole alignment.
6. drug mixing arrangement according to claim 2, wherein the degree of freedom be selectively by first hole with
The linear translation of the second hole alignment.
7. drug mixing arrangement according to claim 1, further includes：
Interior column tube forms the first chamber；
Column tube sleeve carries the interior column tube；
Upper flange, on first seal member being arranged between the interior column tube and the column tube sleeve；And
The second compressing force wherein is provided between the column tube sleeve and the interior column tube, to be compressed in the interior column tube and institute
State the upper flange between column tube sleeve.
8. drug mixing arrangement according to claim 7, further includes：
Intermediate support accommodates the column tube sleeve, wherein second seal member includes being arranged in the intermediate support
With the lower flange between the column tube sleeve；And
Wherein in the column tube sleeve and the intermediate support by providing one or more protrusions being oriented radially inwards
Between first compressing force is provided, the protrusion engages the top edge of the column tube sleeve and biases the column tube sleeve
Into the intermediate support, to form first compressing force.
9. drug mixing arrangement according to claim 1 further includes being configured to selectively change the second chamber
Dischargeable capacity the second shift mechanism.
10. a kind of drug mixing arrangement, described device include：
First chamber；
Second chamber；
Valve seal is arranged between the first chamber and the second chamber, it is characterised in that the valve seal also wraps
It includes：
Around the first seal member of the hole arrangement being arranged in the first chamber；
It is in direct contact the second seal member of first seal member, second seal member provides and the second chamber
Form the entrance being selectively in fluid communication；
The compressing force provided between first seal member and the apparent surface of second seal member, so that institute
It states the first seal member and second seal member seals against each other.
It is wherein formed by be sealed between first seal member and second seal member and keeps at least one freedom
Degree, the degree of freedom enable the valve seal to change between closed configuration and opening configuration.
11. drug mixing arrangement according to claim 10, wherein the degree of freedom is radial translation, wherein the radial direction
The entrance pair in the hole in first seal member and second seal member will be selectively arranged in translation
It is accurate.
12. drug mixing arrangement according to claim 10, wherein the degree of freedom is plane translation, wherein the plane
The entrance pair in the hole in first seal member and second seal member will be selectively arranged in translation
It is accurate.
13. drug mixing arrangement according to claim 10, wherein the degree of freedom is axial-rotation, wherein the axial direction
The entrance pair in the hole in first seal member and second seal member will be selectively arranged in rotation
It is accurate.
14. a kind of method of mixing drug, the method includes：
Shell is provided；
First chamber is provided in the shell；
First drug component is provided in the first chamber；
Second chamber is provided in the shell；
Sealing structure is provided between the first chamber and the second chamber, the sealing structure by the first chamber with
Second chamber isolation, it is characterised in that the sealing structure further includes：
First seal member；
Second seal member；And
Wherein described first seal member and second seal member are in first seal member and second sealing
The first compressing force is provided between the apparent surface of part；And
The second drug component is provided, second drug component is arranged in the sealing opposite with first drug component
At structure.
15. according to the method for claim 14, further including：
It provides across the first hole of first seal member, first hole and the outlet stream being arranged in the first chamber
Body is connected to；
It provides across the second hole of second seal member, connects with the fluid of the second chamber wherein second hole is provided
It is logical；And
Degree of freedom is provided between first seal member and the apparent surface of second seal member, the degree of freedom permits
Perhaps the alignment of the selectivity between first hole and second hole.
16. according to the method for claim 15, wherein the degree of freedom is radial translation.
17. according to the method for claim 15, wherein the degree of freedom is axial-rotation.
18. according to the method for claim 14, further including：
Dry drug is provided in the second chamber.
19. according to the method for claim 14, further including：
First shift mechanism of the dischargeable capacity for being configured to selectively change the first chamber is provided；And
Second shift mechanism of the dischargeable capacity for being configured to selectively change the second chamber is provided.
20. a kind of method of mixing drug, the method includes：
The drug mixing arrangement for being wherein disposed with first chamber and second chamber is provided；
It provides in the first drug component to the first chamber；
It provides in the second drug component to the second chamber；
The method, which is further characterized in that, the described method comprises the following steps：
The compression valve seal being arranged between the first chamber and the second chamber is provided；
A part for the mobile compression valve seal, thus the movement will be formed in the compression valve seal first
Hole and the alignment of the second hole, thus form fluid path between the first chamber and the second chamber；And
First drug component is displaced to from the first chamber in the second chamber by the fluid path, thus
So that first drug component is mixed with second drug component.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201762456727P | 2017-02-09 | 2017-02-09 | |
| US62/456,727 | 2017-02-09 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN108404261A true CN108404261A (en) | 2018-08-17 |
| CN108404261B CN108404261B (en) | 2021-06-04 |
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Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN201810124577.1A Active CN108404261B (en) | 2017-02-09 | 2018-02-07 | Medicine mixing device and method for mixing medicines |
Country Status (3)
| Country | Link |
|---|---|
| CN (1) | CN108404261B (en) |
| AU (1) | AU2018200957B2 (en) |
| CA (1) | CA2994386A1 (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113905709A (en) * | 2019-05-03 | 2022-01-07 | 詹森生物科技公司 | Cryogenic vial and vial assembly |
| US11771841B2 (en) | 2020-12-23 | 2023-10-03 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
| USD1029245S1 (en) | 2022-06-22 | 2024-05-28 | Tolmar International Limited | Syringe connector |
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| CN101010111A (en) * | 2004-07-04 | 2007-08-01 | M.L.I.S.工程有限公司 | A syringe assembly |
| WO2015177082A1 (en) * | 2014-05-19 | 2015-11-26 | Medicom Innovation Partner A/S | A medical cartridge comprising a one way valve |
| WO2016028817A2 (en) * | 2014-08-18 | 2016-02-25 | Windgap Medical, Inc | Portable drug mixing and delivery device and associated methods |
| CN105407943A (en) * | 2013-03-15 | 2016-03-16 | 温德加普医疗股份有限公司 | Portable drug mixing and delivery system and method |
| CN106039480A (en) * | 2016-08-04 | 2016-10-26 | 山东威高集团医用高分子制品股份有限公司 | Pre-filled syringe for continuous treatment |
| WO2017009072A1 (en) * | 2015-07-10 | 2017-01-19 | Novo Nordisk A/S | Pressure based event detection |
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- 2018-02-07 CN CN201810124577.1A patent/CN108404261B/en active Active
- 2018-02-08 AU AU2018200957A patent/AU2018200957B2/en active Active
- 2018-02-08 CA CA2994386A patent/CA2994386A1/en active Pending
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| CN101010111A (en) * | 2004-07-04 | 2007-08-01 | M.L.I.S.工程有限公司 | A syringe assembly |
| CN105407943A (en) * | 2013-03-15 | 2016-03-16 | 温德加普医疗股份有限公司 | Portable drug mixing and delivery system and method |
| WO2015177082A1 (en) * | 2014-05-19 | 2015-11-26 | Medicom Innovation Partner A/S | A medical cartridge comprising a one way valve |
| WO2016028817A2 (en) * | 2014-08-18 | 2016-02-25 | Windgap Medical, Inc | Portable drug mixing and delivery device and associated methods |
| WO2017009072A1 (en) * | 2015-07-10 | 2017-01-19 | Novo Nordisk A/S | Pressure based event detection |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113905709A (en) * | 2019-05-03 | 2022-01-07 | 詹森生物科技公司 | Cryogenic vial and vial assembly |
| US11771841B2 (en) | 2020-12-23 | 2023-10-03 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
| US11931559B2 (en) | 2020-12-23 | 2024-03-19 | Tolmar International Limited | Systems and methods for mixing syringe valve assemblies |
| USD1029245S1 (en) | 2022-06-22 | 2024-05-28 | Tolmar International Limited | Syringe connector |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2994386A1 (en) | 2018-08-09 |
| AU2018200957B2 (en) | 2021-09-16 |
| AU2018200957A1 (en) | 2018-08-23 |
| CN108404261B (en) | 2021-06-04 |
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