CN104136055B - The Pu sterile liquid ditch pipe connecting being connected with medicament reservoir is helped in medicine conveying - Google Patents
The Pu sterile liquid ditch pipe connecting being connected with medicament reservoir is helped in medicine conveying Download PDFInfo
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- CN104136055B CN104136055B CN201280041852.4A CN201280041852A CN104136055B CN 104136055 B CN104136055 B CN 104136055B CN 201280041852 A CN201280041852 A CN 201280041852A CN 104136055 B CN104136055 B CN 104136055B
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- Prior art keywords
- liquid channel
- sleeve pipe
- medicament reservoir
- liquid
- seal
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Abstract
The present invention provides a kind of liquid channel connector (300) activated by user, comprises: connect socket (310)；Puncture member (330)；Aseptic sleeve pipe (320)；And medicament reservoir (50), having hoop lid (52), pierceable seal (56), cylinder (58) and plunger seal (60), puncture member (330) is originally maintained in aseptic sleeve pipe (320) and is positioned between connection socket (310) and seal (56).Connect socket (3310) and comprise the inside opening (3310D) being located in connection socket (3310), it is used as current limiter, and puncture member (3330) is connected to one end of inside opening (3310D), liquid conduits (3030) is connected to the other end of inside opening (3310D).A kind of medicine conveying side Pu (10) of the aseptic holding member with integration, comprise housing (12), housing is installed and activates mechanism (14), interposer (200), liquid channel connector described above (300), electric power and control system (400) and be connected to the drive mechanism (100) of medicament reservoir (50).The assembling of the present invention and the method for operation are also provided.
Description
[RELATED APPLICATION of related application]
Subject application is advocated in JIUYUE in 2011 13 days No. 61/534,059 of U.S.'s proposition
The priority of Provisional Application, is incorporated to all the elements of this application case as reference at this.
Technical field
The present invention is about medicine conveying side Pu (drug delivery pump).In more detail, the present invention
It is about the sterile liquid raceway groove being connected with medicament reservoir being activated (user-initiated) by user
Connector, utilize this connector medicine conveying side Pu, operate these devices method and
The method assembling these devices.
Background technology
The parenteral formula of various medicines is administered, that is not via the administration of digestive tract, because very
Many reasons and the medication that necessitates.Can improve with the form of injection system administration and be given
The effect of material and guarantee that original medicine arrives the portion of its wanted administration with effective concentration
Position.Similarly, the undesirable side effect relevant with other dosing way, such as general
Toxicity (systemic toxicity), it is more likely that be administered through parenteral formula and avoid.By keeping away
Open the digestive system of the sufferer belonging to mammal, so that it may avoid due in digestive tract and liver
It is catalyzed the deterioration of the effective ingredient that ferment (catalytic enzyme) is caused and guarantees the medicine of necessity
Measure and arrive target site with desired concentration.
Traditionally, utilize manual operation syringe (syringe) and injection pen (injection pen) to incite somebody to action
The medicine of parenteral formula is defeated gives sufferer.Recently, the parenteral formula of liquid medicine input human body is administered,
By using pin (needle) and the rapid intravenous injection (bolus of reservoir (reservoir)
Injection) dispenser (dispenser) of gravity, is utilized or through skin patch
(transdermal patch) technology and realize.Rapid intravenous injection usually can not suit sufferer completely
Clinical need, and the dosage needed for typically requiring than that time point carried out in this injection is the most single
Dose.The successive administration carried out through gravity feeding system (gravity-feed system), then
It is compromised by activeness and the life style of sufferer, and makes treatment be limited to undue simple flow rate
And it is administered planning (profile).Another kind of form of medication, skin patch, there is it to limit too.
It is just effective that skin patch typically requires specific molecular medicine structure, and through the medicine of skin patch
Thing give with control limited by the strictest.
Transfusion (ambulatory infusion) the side Pu changed has developed the most in order to by liquid
Medicine is defeated gives sufferer.The transfusion planning that these infusion sets can provide complicated is the most complete to reach
The demands such as dosage injection, continuous transfusion and variable administration flow rate.The ability of these transfusions is usual
The effect that can make medicine and treatment more preferably and makes the toxicity for sufferer body system relatively
Low.Current obtainable modifiable infusion set is the most costly, be difficult to do the planning infused with
Prepare and the hugest, the heaviest and the most fragile.Want filling (filling) these devices can
Energy meeting is highly difficult and needs sufferer to hold the accessory needed for medicine to be loaded and filling.These dresses
Put the most usually need special maintenance, safeguard and clean to guarantee its under long-term use all
Normal function and safety can be maintained, and for the supplier of sufferer or health care
The most not there is cost benefit.
Compared to syringe and injection pen, Pump type doser is due to can be day and night the most any
Time can automatically calculate the dosage of medicine and flow to sufferer, therefore significant for sufferer
Ground is more convenient.And, be linked with metabolic sensor (metabolic sensor) or monitor and
During use, side Pu is controlled makes according to metaboilic level that is that sense or that monitor, and suitably
Require time for automatically providing the dosage of suitable liquid medium.Therefore, the administration dress of side Pu type
Put one that the modern medical service of all kinds of medical conditions becoming such as diabetes etc. disposes important
Instrument.
Although Pump type drug-supplying system is made to solve substantial amounts of sufferer demand, but manual operation
Syringe and injection pen because its there is the security features of integration and can the most visually sentence
Whether the situation not being administered and the administration of dosage terminate and still preferably select for be administered.But,
The syringe of manual operation and injection pen can not one size fits all and not for all medicines give with
It is all preferably.Thus, still suffer from for having the adjustable (and/or able to programme of following feature
Sequence) the demand of transfusion system, this feature is: precisely and reliable and can provide clinician
And sufferer one is small-sized, low cost, light weight, the easily parenteral formula of the liquid medicine of use are given
Medicine selects.
Summary of the invention
The present invention provides the container of a kind of aseptic condition being activated and maintaining liquid channel by user
Connector (container connection), a kind of include that this kind be connected with medicament reservoir aseptic
Liquid channel connector medicine conveying side Pu, a kind of method operating these devices and
A kind of method assembling these devices.The liquid channel connector of the present invention provides and can ensure that medicine
Before conveying, the safety feature of the integration of the aseptic condition of the liquid channel in and after.?
In one aspect, this liquid channel maintains the state not being connected with medicament reservoir until user
Activate this connector and this device.In second pattern, this liquid channel with medicament reservoir
Will puncture through component before connection to be maintained at collapsible or compressible and make connection can activate at user
To maintain the aseptic condition of puncture member in the aseptic sleeve pipe (sterile sleeve) of Shi Dacheng.Work as use
Person one activates, and causes the puncture member in liquid channel connector to pierce through the pierceable of medicament reservoir
Seal with connect this liquid channel and flow through this medicine conveying liquid channel and
Enter the internal of user.Therefore, the device of the novelty of the present invention alleviates with the most such
One or more problems that prior art apparatus is relevant.
In the first embodiment, the present invention provides a kind of liquid channel activated by user to connect
Part (fluid pathway connection).This liquid channel connector comprises: connect socket
(connection hub)；Puncture member；Aseptic sleeve pipe；And medicament reservoir, have hoop lid (cap),
Pierceable seal, cylinder (barrel) and plunger seal (plunger seal), wherein, should
Puncture member is originally maintained in this aseptic sleeve pipe and is positioned at this connection socket and this medicament reservoir
Between this pierceable seal.This medicament reservoir can load wants the defeated medicinal liquid given, to use
It is delivered to the internal of user via this liquid channel connector when person activates.This can be pierced
Seal comprises the sealing barrier portion that can be penetrated by this puncture member when user activates
(seal barrier).In at least one embodiment, this puncture member initially ties up to what this can be pierced
Contact or close to this sealing barrier portion in seal and with this sealing barrier portion.This kind of group structure can make
The distance that liquid channel connector has to move to make liquid channel couple together is minimum.This liquid
Bulk channel connector is selectively included the connection seat being attached to this pierceable seal
(connection mount)。
The aseptic sleeve pipe of this liquid channel connector can compress from its initial group structure or fold, or
Person deforms.In at least one implements aspect, this pierceable seal of this sterile sleeve piping
Preformed some (pre-formed aspect) so that both are the assembly formed as one.
This aseptic sleeve pipe can be connected slotting by the socket connector (hub connector) of this aseptic sleeve pipe with this
Joint between the corresponding thimble connector (sleeve connector) of seat and be connected to this connection and insert
Seat.Implementing in aspect at one, this puncture member is through this connection socket and is connected to liquid and leads
Pipe.One or more current limiter (flow restrictor) can be used.The activation machine that user is promoted
The displacement of structure causes this connection socket displacement to make this puncture member penetrate this pierceable sealing
Body.
In another embodiment, the present invention provides (flow restricting) liquid ditch of a kind of current limliting
Pipe connecting, has: puncture member and aseptic sleeve pipe, and wherein, this puncture member initially keeps
In this aseptic sleeve pipe；Medicament reservoir, have hoop lid, pierceable seal, cylinder and
Plunger seal；And connection socket, there is inside opening wherein so that flowing through this connection and inserting
The flowing of the medicinal liquid of seat slows down.This pierceable seal has can be when user activates by this
The sealing barrier portion that puncture member is penetrated.In a preferred embodiment, this puncture member
Initially contact or close to this sealing barrier in seal that this is pierceable and with this sealing barrier portion
Portion.This aseptic sleeve pipe from its initial group structure compression or folding, or can deform.At one relatively
In good embodiment, this aseptic sleeve pipe is the preformed some of this pierceable seal
(pre-formed aspect).This aseptic sleeve pipe can by the socket connector of this aseptic sleeve pipe with should
Connect the joint between the corresponding thimble connector of socket and be connected to this connection socket.This thorn
Wearing component and be connected to one end of the inside opening in this connection socket, it is interior that liquid conduits is connected to this
The other end of portion's opening.In a preferred embodiment, this inside opening can be used as current limiter.
The displacement of the activation mechanism that user is promoted causes this connection socket displacement to make this puncture member
Penetrate this pierceable seal.
In still another embodiment, the present invention provides a kind of aseptic holding member with integration
Medicine conveying side Pu, there is housing and assembly platform, this assembly platform can be installed activation
Mechanism (activation mechanism), interposer, liquid channel connector, electric power and control
System and have the drive mechanism (drive mechanism) of medicament reservoir, this liquid channel connects
Part includes connecting socket, puncture member and aseptic sleeve pipe, and wherein, this medicament reservoir has hoop
Lid, pierceable seal, cylinder and plunger seal, and wherein, this puncture member is
What to be just this connection socket of being maintained in this aseptic sleeve pipe pierceable with this of this medicament reservoir is close
Between envelope body.This medicament reservoir is incorporated with the internal medicinal liquid of user to be delivered to.This can sting
The seal worn has the sealing barrier that can be penetrated by this puncture member when user activates
Portion.In at least one embodiment, this puncture member initially in seal that this is pierceable and
Contact with this sealing barrier portion or close to this sealing barrier portion.This group of structure can make liquid channel even
The distance that fitting has to move to make liquid channel couple together is minimum.User is promoted
The displacement activating mechanism causes this connection socket displacement to make this puncture member penetrate what this can be pierced
Seal.
The embodiment offer of the above-mentioned novelty of the present invention activated by user with medicament reservoir even
The liquid channel connector connect and the medicine utilizing this connector conveying side Pu, can be in operation
Before this device, among and maintain the aseptic condition of this liquid channel afterwards, and can be made this
Device can carry out security control actively.In this specification, unless stated otherwise, otherwise own
" including " or relevant term, such as " comprise ", " by ... constituted ", all referring to " opening
Meaning (inclusively) (may also have in addition to listed assembly) " rather than " meaning of closure
Justice (exclusively) (only listed assembly) ", so an integer specified or the combination of integer
One or more integer do not pointed out or the combination of integer may be comprised.As will be explained below
, embodiments of the present invention can comprise and one or more can it be considered as in the industry of medical treatment device
The extra assembly of standard package.These assemblies and comprise the embodiment of these assemblies,
All in the range of the present invention is attempted to contain, all should be considered as falling within the scope of the present invention by it.
Accompanying drawing explanation
The enforcement aspect of the present invention is by with reference to appended graphic and be described as follows, but the present invention is not
It is limited to this, wherein:
Figure 1A shows have sterile liquid ditch pipe connecting according to one of present invention embodiment
The isometric view at medicine conveying side Pu；
Figure 1B shows the isometric view of the intraware at the medicine conveying side Pu shown in Figure 1A；
Fig. 1 C shows the isometric view of the bottom at the medicine conveying side Pu shown in Figure 1A；
Fig. 2 A show according to one embodiment of the invention is connected with medicament reservoir by user
The isometric view of the liquid channel connector activated；
Fig. 2 B shows the isogonism of the liquid channel connector shown in Fig. 2 A being attached to medicament reservoir
View；
Fig. 3 A show at least one embodiment according to the present invention along longitudinal axis " A " decompose come
The exploded view of liquid channel connector；
Fig. 3 B shows the sectional exploded view of the liquid channel connector shown in Fig. 3 A；
Fig. 4 A display user activate before the liquid ditch being attached to medicament reservoir as shown in Figure 2 B
The profile of pipe connecting；
Fig. 4 B shows and by user liquid channel couples together being attached to as shown in Figure 2 B
The profile of the liquid channel connector of medicament reservoir；
Fig. 5 A show according to an embodiment of the invention connect socket from tip side viewing etc.
Angle view；
Fig. 5 B shows the isometric view from base portion side viewing connecting socket shown in Fig. 5 A；
Fig. 5 C shows the perspective view connecting socket shown in Fig. 5 B；
Fig. 6 A shows watching from tip side of connection socket according to another embodiment of the present invention
Isometric view；
Fig. 6 B shows the isometric view from base portion side viewing connecting socket shown in Fig. 6 A；
Fig. 6 C shows the perspective view connecting socket shown in Fig. 6 B.
Detailed description of the invention
Used below being used illustrates the drive mechanism of the present invention, medicine conveying side Pu or assembly
The term " axially " of any relative position generally mean drive mechanism be preferably located on it (although also
Be not necessarily intended to axial symmetry) the direction of longitudinal axis " A ".Term " radially " with axle " A " just generally means
The direction handed over.Term " base portion side (proximal) ", " rear side ", " rear ", " backward " generally mean
In axial " P " direction.Term " tip side (distal) ", " front side ", " front ", " press direction ",
" forward " generally mean in axial " D " direction.Additionally, it should be appreciated that term " glass " used below
System comprises the material (non-reactive material) being not susceptible to reaction that other is similar, and this is difficult to
The material system reacted is suitable for typically requiring the medical-grade purposes of glass, be to comprise but
It is not limited to some polymer being not susceptible to reaction, such as cyclic olefine copolymer (cyclic olefin
And cyclic olefin polymer (cyclic olefin polymer:COP) copolymer:COC).Term " is moulded
Material " thermoplasticity and thermosetting polymer can be comprised.Thermoplastic polymer can be allowed to the softest by heating
The state of chemical conversion its original, thermosetting polymer is the most not all right.Term " plastics " used below is main
Refer to mouldable thermoplastic polymer, such as: polyethylene and polypropylene or acrylic acid series tree
Fat, mouldable thermoplastic polymer be typically containing such as firming agent, filler, reinforcing agent,
Other composition such as coloring agent and/or plasticiser, and can mould-forming person under heat and pressure.With
Lower term " plastics " used does not comprise glass, the polymer being not susceptible to reaction or elasticity
Body, this kind of elastomer confirmed for can with may and plastics react or probably due to from moulding
Material enters substituent group wherein and is allowed to the purposes that rotten treatment liquid directly contacts.Term is " elastic
Body ", " elastomer ", " elastomeric material " refer mainly to be easily deformed than plastics but authenticated available
It is susceptible to eluviation (leaching) or gas transfer in medical grade liquid and in Room pressure
Crosslinked thermosetting elastomeric polymer (the cross-linked of effect (gas migration) impact
thermosetting rubbery polymer)." liquid (fluid) " refers mainly to liquid, but also can comprise
It is dispersed with the situation of solid suspension in a liquid and gas is dissolved in liquid or and liquid
Be concurrently present in side Pu containing the situation in liquid portion.According to various aspects described herein as and
Embodiment, be directed to it and " suppress component (biasing member) " can be any can store and
The component released energy.The example that can enumerate comprises spring, such as helical spring, compresses or draws
Stretch spring, torque spring, leaf spring, can flexibly compress or belt springy or appoint
What its component with similar function, but it is not limited to this.At least one reality in the present invention
Executing in example, this suppresses component system is spring, and preferably is compression spring.
The device of the novelty of the present invention provides a kind of nothing activated and maintain liquid channel by user
The container connector of bacterium state and a kind of include that this kind be connected with medicament reservoir aseptic
The medicine conveying side Pu of liquid channel connector.These equipment safeties and easily using, and for
For the sufferer of autonomous management attractive in appearance and meet ergonomics.Even if device described herein as has
It it is the unbred user feature that all can activate simply, operate and lock.The present invention it
Novel device provides these gratifying features, has no any of prior art apparatus
The problem met with.The novelty of the present invention medicine conveying side Pu, liquid channel connector, with
And some embodiments of the most each assembly will be further described below with reference to enclose graphic,
Only embodiments of the present invention are not limited to this.
Herein use " side Pu " be used the family of languages attempt comprise can activate time dispensing liquid to user
Various delivery systems.These delivery systems comprise such as injecting systems, transfusion side
Pu, rapid intravenous injection device (bolus injector) etc..Figure 1A to 1C display according to the present invention it
The delivery device (drug delivery device) of the example of at least one embodiment.This medicine is defeated
Device is sent to can be used to manage the internal Drug therapy being administered for user.Such as Figure 1A extremely
Shown in 1C, medicine side Pu 10 comprises side Pu housing 12.Side Pu housing 12 can comprise one or many
Individual can be solidly joined housing sub-assembly so that medicine side the manufacture at Pu, assembling and operation relatively
For easily.For example, medicine side Pu 10 side Pu housing 12 comprise upper shell 12A and under
Housing 12B.This medicine side Pu can comprise activation mechanism 14, positioning indicator 16 and window again
18.Window 18 can be any can to see the transparent of the operation at medicine side Pu or can through it
The face of transmission.As shown in Figure 1B, Pu comprises assembly platform 20 again, sterile liquid is led in medicine side
Pipe 30, there is the drive mechanism 100 of medicament reservoir 50, interposer 200, liquid channel even
Fitting 300 and electric power and control system 400.One or more assemblies at these medicines side Pu can
Modularity can the most first be assembled into independent assembly and be assembled to medicine side Pu the most during fabrication
On the assembly platform 20 of 10.
Side Pu housing 12 all of device assembly is wrapped in the inside and be provided with for by device removing
The mode gone is attached to the instrument of the skin of user.The inside of side Pu housing 12 also protection device
Assembly is to resist the impact of external environment condition.Side Pu housing 12 ties up to size, shape and relevant spy
Be designed on Dian to have very much aesthetic feeling and meet ergonomics, it is possible to be unbred and/or
Physically impaired user can be received easily and operate with.And, side Pu housing 12
Outer surface may utilize and arranges product label and safe instruction etc..It addition, as it has been described above, housing
12 can comprise some for the assembly feeding back to user after providing operation, such as state instruction
Device 16 and window 18.
In at least one embodiment, medicine side Pu 10 is provided with activation mechanism 14, and user makes this
Activate mechanism 14 displacement to cause a sign on to electric power and control system 400.At one
In preferred embodiment, system of this activation mechanism (such as passes upper shell 12A for passing side Pu housing 12
And the opening between lower house 12B) and one of setting beginning button 14, this starts button 14 and electric power
And a control arm 40 of control system 400 contacts.In at least one embodiment, this starts
Button 14 can be a button, in other embodiments, can be on/off switch, one
Any similar activating part in trigger (toggle) or known techniques.Side Pu housing 12 also sets
There are positioning indicator 16 and window 18.In other embodiments, mechanism 14, state are activated
Indicator 16, window 18 and combinations thereof may be provided on upper shell 12A or lower house 12B,
Such as when medicine side Pu 10 is put on the body of the user, user can be seen from the side or operate
To position on.Below, by with reference to other assembly of the present invention and embodiment to be described in more detail
Housing 12.
Pu system of medicine side is configured to when user pressing activates mechanism and activates, and medicine side Pu is just
Beginning action with: liquid channel is inserted user；Make medicament reservoir, liquid channel and nothing
The connector of the needs between bacteria liquid conduit is effective, connection or open-minded；And make to be stored in medicine
Medicinal liquid in container enters user by this liquid channel and the liquid conduits of conveying.
Available one or more release mechanisms matched, such as, prevent too early the swashing at medicine side Pu
Live.For example, in one embodiment, one can be arranged and can match human body (on-body) biography
Sensor 24 (with reference to Fig. 1 C) is used as safety component, with guarantee electric power and control system 400 or
Activate mechanism will not start, unless medicine side Pu 10 be in the state contacted with user.At this
In embodiment, this human body sensor 24 is that be positioned at can the lower house 12B of physical contact with the user
Bottom on.When human body sensor 24 displacement, allow for activating the pressing of mechanism.Therefore, exist
In at least one embodiment, this human body sensor 24 is to be a mechanical release mechanism, example
As one is used for preventing medicine side Pu 10 by activating the mechanical latching device (lock that mechanism 14 is activated
out).In another embodiment, this human body sensor 24 can be the sensing of an electro-mechanical
Device, such as one meeting transmits and allows the signal activated to close to the machinery of electric power and control system 400
Lock device (lock out).In another embodiment, this human body sensor 24 can be an electronic type,
Such as one has the condenser type detecting the activation that tissue just allows electric power and control system 400 only
Or the sensor of impedance type.These embodiments and non-exclusive but can within the scope of the invention profit
The too early sharp reviver at such as medicine side Pu is prevented with the combination of one or more.At one
In preferred embodiment, medicine side Pu 10 is to utilize one or more mechanical human body sensor.
The medicine of the novelty below in reference to the present invention is helped its of Pu by other integrated release mechanism
Its assembly and illustrate.
Electric power and control system:
Electric power and control system 400 comprise each electronic building brick in supply energy drug side Pu
Power supply, one or more feedback mechanism, microcontroller, circuit board, one or more conduction
Connection pad (conductive pad) and one or more interior online (interconnect).Also can comprise
For having usually intellectual in the art obviously in this kind of electronic system
Other assembly commonly used.These one or more feedback mechanisms can comprise such as: such as piezoelectricity is alert
The siren that can send sound of report device (piezo alarm) and/or such as light emitting diode (LED)
Visual indicator.This microcontroller can be such as microprocessor.Electric power and control system 400
Control several device with user interaction and be connected with drive mechanism 100.In one embodiment,
Electric power and control system 400 are connected with control arm 40 identify human body sensor 24 and/or activate
Whether mechanism 14 is activated.Electric power and control system 400 also can be with the states helping Pu housing 12
Indicator 16 connects, this positioning indicator 16 can be allow the transmissive that passes through of light or thoroughly
Bright material, to provide user visual feedback.Electric power and control system 400 are through one
Individual or multiple interior online be connected with drive mechanism 100, to transmit case pointer (status
Indication), such as activate, be administered in and be administered terminate (end-of-dose) give user.This
Case pointer can pass through the tone (such as through sending the siren of sound) and/or thoroughly of audition
The display (visual indicator of such as LED) crossing vision is presented to user.The most real one
Executing in example, the control interface of other inter-module at electric power and control system and medicine side Pu is using
Person activate before equal access failures or couple together.This is the accident preventing medicine side Pu by being intended to
The safety feature of operation, and the most also can maintain in power supply in periods such as storage, transports
Energy.
Electric power and control system 400 can be set to be supplied to make by the most several different case pointers
User.For example, electric power and control system 400 may be designed to: at human body sensor and/or
After trigger mechanism is depressed, if the activation inspection of device does not has mistake, electric power and control system
System 400 just provides the status command signal of a ready to start through positioning indicator 16.Provide
After the status command signal of ready to start, in there is the embodiment of human body sensor of apolegamy, if should
Human body sensor maintains the state of the Body contact with user, electric power and control system 400
Drive mechanism 100 will be supplied electricity to begin through liquid channel connector 300 and sterile liquid
The administration of the Drug therapy of conduit 30.In a preferred embodiment of the present invention, can be by activating
The operation of the user of mechanism 14 directly activates interposer 200 and liquid channel connector
300.In administration process, electric power and control system 400 are to be designed to through positioning indicator 16
One dispensing status command signal is provided.Medicine input the most in control user internal after
And terminate in any extra intermittent time (dwell time) to have guaranteed almost all of dosage the most
Defeated give user after, electric power and control system 400 can pass through positioning indicator 16 and provide one
The status command signal of individual removable (okey-to-remove).User can be by the window of side Pu housing 12
Mouth 18 is watched drive mechanisms and the administration of medicament and is verified independently and can be removed.Additionally, it is electric
Power and control system 400 may be designed to provide one or more alarm through positioning indicator 16
Signal, such as, represent fault or the alarm of operation failure situation.
The medicine side Pu of the novelty of the present invention can use other electric power and control system group structure.Lift
For example, some can be used during being administered to activate and to postpone (activation delay).As it has been described above,
Be selectively included in system group structure this kind postpone, be one for notice use
Person has completed to guarantee before the intermittent time of substantially all of medicament administration the most.Similarly, dress
The activation put may need had pressure (that is pressing) to activate 14 1 sections of mechanism before side Pu is activated
The condition of time.It is administered end signal additionally, system can comprise permission user response and makes medicine
Thing side Pu stops or the parts of power-off.These parts may need also exist for pressing and activate 14 1 sections of mechanism
Time, in case the accident of locking apparatus stops.These parts provide desirable safety integrate with
And easy-to-use characteristic drug side Pu.Activate mechanism and also can integrate another safety component
Prevent the situation of pressing not exclusively (thus side Pu is activated not exclusively).For example, machine will can be activated
Structure and/or electric power and Control System Design become device only activate completely and completely close, to prevent
Activate incomplete situation.Afterwards, other pattern at Pu is helped to insert the medicine together with this novelty right
These parts are described in detail.
Interposer:
Several interposers are used equally in the medicine side Pu of the present invention.In at least one embodiment,
Interposer 200 comprises: have the insertion machine of one or more locking window (lockout window)
Structure shell and be used for be connected to assembly platform and/or side Pu housing (as shown in Figure 1B and 1C)
Base portion.This base portion may be designed to such as with being connected of assembly platform 20: allow this base portion
Bottom allows the direct physical contact of this base portion and user through the hole of assembly platform.At this
Planting in group structure, the bottom of this base portion can comprise one and can get rid of before the use at medicine side Pu 10
Sealing film.This interposer can comprise one or more insertion again and suppress component, a pin
(needle), component, a sleeve pipe (cannula) and a manifold (manifold) are suppressed in a retraction.
This manifold be connectable to sterile liquid conduit 30 make liquid can during being administered by this manifold, should
Sleeve pipe and be flowed into the internal of user.
Use the term of " pin (needle) " to be desirable to contain various pins herein, comprise (but do not limit
In) pin of traditional hollow, the hollow draw point of such as hard and be relatively frequently referred to " the trocar
(trocar) the center pin (core needle) of hard ".In a preferred embodiment, this pin system 27
Number hard sleeve pin, in other embodiments, this pin can be by being suitably inserted into the medicine of wanted administration
Species type and dosing mode (such as subcutaneous injection, intramuscular injection, intradermal injection etc.) to be taken
The pin of any size of sleeve pipe (cannula) used.Sterile buffer set can be used in interposer
(sterile boot).Its base end of this sterile buffer set system is solidly connected to foregoing manifolds, and distal end is affixed
Contractile aseptic Membrane cover to aforementioned base portion.In at least one embodiment, this is aseptic slow
Rush its distal end of set system to be fixed in and be maintained between base portion and interposer shell.This base portion bag
Containing a base portion opening, as will be described below, in interposer operating process, this is inserted
And this sleeve pipe can pass through this base portion opening.This is inserted and the aseptic condition of this sleeve pipe is by the beginning
It is seated in and maintains among the aseptic portion of interposer.In detail, as it has been described above, this is inserted and should
Set piping is maintained among the gnotobasis of manifold and aseptic cushion collar.This base portion of base portion is opened
Mouthful can be closed also by such as sealing film 254 (with reference to Fig. 1 C) and by non-sterile environment
Isolation is outside.
At least one embodiment according to the present invention, interposer be initially by stop pin by locking
In state ready for using, this stop pin is initially that position is in the locking window of interposer shell.
In the group structure initial at this, insert and suppress component and retraction is suppressed component and is all maintained at compression and saves up strength
State.As shown in Figure 1B, stop pin 208 can be straight by user pressing activation mechanism 14
Connect and be allowed to displacement.Any release mechanism, the human body sensor such as matched is released at user
Time 24 (with reference to Fig. 1 C), so that it may pressing activates mechanism 14 makes medicine side Pu start.Activate mechanism
The pressing of 14 can directly make control arm 40 translate or displacement and directly or indirectly make stop pin 208
Remove from its initial position among the locking window 202A of interposer shell 202.Stop pin
208 remove allows insertion to suppress component to stretch out from its initial compression state bullet that saves up strength.Insert
The health driving this pin and this sleeve pipe to enter user stretched by the bullet suppressing component.In the stage of insertion
Finally, it is allowed to retraction is suppressed component and stretched out from its initial state that saves up strength bullet.This retraction is suppressed
The bullet of component is stretched and is made this pin retract, but maintains negotiable liquid between this sleeve pipe and health of user
The state of body.Therefore, interposer can be used to make pin and sleeve pipe enter user, then makes pin
Retract but make sleeve pipe be maintained at for carrying the medicine internal position to user.
Drive mechanism:
Multiple drive mechanism can be utilized to from medicament reservoir conveying internal to user of liquid.
In this embodiment, drive mechanism 100 online in comprising drive mechanism shell, status switch,
And medicament reservoir, this medicament reservoir has hoop lid, pierceable seal, cylinder and post
Plug seal.This medicament reservoir between seal and this plunger seal that this is pierceable
This cylinder in can load medicinal liquid, this medicinal liquid is for helping Pu to carry via interposer and medicine
Internal to user.Seal described herein may utilize a lot of material and constitutes, but one
In preferred embodiment, it is to be made up of one or more elastomers or rubber.This drive mechanism can
Comprise one further and connect seat (connection mount) to guide this liquid channel connector
Puncture member inserts the cylinder 58 locating this medicament reservoir.This drive mechanism 100 can comprise again one or
Component, one or more relieving mechanism and one or more guiding element are suppressed in multiple drivings
(guide), as described below.The function of each assembly of drive mechanism is: make liquid from medicine
Container flows out and via pierceable seal, or is preferably via this liquid channel connector
Puncture member, then by this liquid channel connector, aseptic liquid conduits and insert
Mechanism and be delivered to the internal of user.
In a specific embodiment, drive mechanism 100 uses one or more compression spring to make
For suppressing component.When user makes medicine side Pu activate, electric power and control system 400 are actionable
And directly or indirectly make compression spring discharge from its state saved up strength.Once discharge, compression spring
Just can resist the resistance of plunger seal and plunger is pushed away forward, make medicinal liquid flow from medicament reservoir
Go out.Liquid channel connector 300 or or can lead to before drive mechanism activates afterwards simultaneously
Cross pierceable seal and be connected to medicament reservoir, to allow liquid to flow out from medicament reservoir,
The body of user is entered via liquid channel connector, sterile liquid conduit and interposer
In, thereby it is administered.In at least one embodiment, liquid only flows through the manifold of interposer
And sleeve pipe, administration process thereby and before administration and maintains the aseptic condition of liquid channel.
About these components and function thereof, more detailed description will be done later.
When activating, the assembly of drive mechanism 100 can be used to order about the plunger seal of medicament reservoir
Body toward its tip side to moving axially.Drive mechanism 100 is selectively included one or many
The feature (compliance feature) of individual compliance, this feature makes plunger seal physical ability the most more
It is moved along, such as to guarantee that almost all of medicament is all delivered to user and determines feedback
Contact mechanism (feedback contact mechanism) connects.And, plunger seal
Itself can have some compressibilities (compressibility) with can be conformally from medicament reservoir
Medicinal liquid is released.Drive mechanism 100 similarly can comprise one or more state indicating mechanism,
Such as in online and connection pad, with before the operation of drive mechanism and device, among and afterwards
Measure the state of drive mechanism and let the user know that.Additionally, drive mechanism 100 can comprise one
Individual or multiple release mechanisms, activate anti-locking mechanism the most completely, improve mechanism and device
Safety and availability.More detailed content about drive mechanism 100 will help Pu with reference to medicine
Other component and be described as follows.
Liquid channel connector:
The embodiment of the novelty of the present invention provide can before device operates, among and tie up afterwards
Hold the aseptic condition of liquid channel, and can make device can do the one of security control actively by
The liquid channel connector being connected with medicament reservoir of user activation and one utilize this even
The medicine side Pu connect.In one embodiment, liquid channel connector 300 comprises: sterile liquid
Conduit 30, puncture member 330, connect socket 310 and aseptic sleeve pipe 320, such as Fig. 2 A and
Shown in 2B.This liquid channel connector comprises one or more current limiter (flow the most again
restrictor).When user suitably makes device activate, liquid channel connector 300 connects
To medicament reservoir 50, make liquid can flow out from medicament reservoir and (be probably driving of drive mechanism 100
Make down), entered by liquid channel connector 300, liquid conduits 30 and interposer 200
Enter the internal of user.Being connected between these liquid channel connector 300 with medicament reservoirs 50 can
The pierceable seal 56 (reference of medicament reservoir 50 is penetrated by puncture member 330 (such as pin)
Fig. 3 A, 3B, 4A and 4B) and carry out.The aseptic condition of this connection can be by the nothing having flexibility
Bacterium sleeve pipe 320 is attached and maintains.Activation with interposer 200 substantially simultaneously, medicine
Liquid channel between container 50 and interposer 200 completes and allows medicament to be conveyed into use
Person's is internal.
In at least one embodiment of the present invention, it is by the direct action of user, such as, uses
Person, for activating the pressing of mechanism, makes the puncture member of liquid channel connector penetrate drive mechanism
The pierceable seal of medicament reservoir.For example, drive mechanism itself is connectable to liquid
Bulk channel connector is so that the displacement that activation mechanism starts from the position of its original also can make liquid
Bulk channel connector displacement.In a preferred embodiment, this connection ties up to user pressing activation
Mechanism and order about puncture member and penetrate and set up in the case of pierceable seal.Because liquid ditch
Pipe connecting was not connected to medicament reservoir, so unless user is thought before user activates
Medication otherwise medicinal liquid is wanted to flow out all without from medicament reservoir.The most not only provide user important
Safety feature, also maintains the integrity of medicament reservoir and the aseptic condition of liquid channel simultaneously.?
In this embodiment, can be between hoop lid and the connection socket of liquid channel connector of medicament reservoir
An affixed collapsible or compressible aseptic sleeve pipe.This puncture member can connect raceway groove at liquid
It was held in this aseptic sleeve pipe before needing between medicament reservoir to be connected.This aseptic sleeve pipe can
For swashing with the connection between device and liquid channel connector and medicament reservoir through sterilization processing
The aseptic condition of puncture member and liquid channel is guaranteed before work.
As shown in Figure 2 A, liquid channel connector 300 can be attached to medicament reservoir 50 and utilize
Various known methods fixedly or detachably install the assembly platform 20 to medicine side Pu or shell
Body.This assembly platform can be the parts that can separate with this housing also can be that preform is at this housing
The parts integrally formed with this housing of inner face.In one embodiment, can be by this medicament reservoir 50
Install, connect or be attached to a fixing position of this assembly platform 20 or this housing, with
Time this liquid channel connector 300 installed, connects or is attached to one and move when user
The movable guide 390 that can move when activating mechanism 14.In other embodiments, can be with upper
This medicament reservoir 50 is attached to this movable guide 390, by this liquid ditch by group structure mutually on the contrary that state
Pipe connecting 300 is attached to a fixing position of this assembly platform 20 or this housing.These are two years old
Kind of group structure all can maintain the aseptic condition of liquid channel, for the raceway groove of liquid flowing at user
Want medication and all without even before active activation medicament reservoir and the connection of liquid channel connector
Pick up.Although previous group of structure is preferable, but later group structure may such as use casket at some
The embodiment of the medicament reservoir (cartridge-style drug container) of formula is for relatively needing.
User makes activation mechanism 14 translate or displacement similarly, can make guiding element 390 directly or indirectly
Displacement and make the connection establishment between liquid channel connector and medicament reservoir.Also can pass through
Various different suppress component, comprise compression spring, stretching spring, elastic webbing etc., come such as
Lower user and act on the activating force activated needed for mechanism 14, to help the position of this guiding element 390
Move.
Fig. 2 B shows the liquid helping the housing at Pu, assembly platform and other assembly to separate with medicine
Ditch pipe connecting 300 and medicament reservoir 50.As it has been described above, medicament reservoir 50 can comprise one end tool
Plunger seal 60 other end is had to have the cylinder 58 of hoop lid 52.Liquid channel connector 300
Can install, connect or be attached to the hoop lid 52 of this medicament reservoir 50.At least at initial group structure
In, the distal end system of puncture member 330 be maintained in aseptic sleeve pipe 320 and with medicament reservoir 50
Pierceable seal come close to or in contact with.This puncture member 330 can be various sleeve pipe or conduit,
The pin of such as hard, and available various materials (such as steel) constitute.In at least one embodiment,
Puncture member 330 is the draw point for hard.Aseptic sleeve pipe 320 is to be positioned at medicament reservoir 50 and connect
Compressible or folding film between combination hub 310, it is provided that one wherein can house and pierces through structure
The gnotobasis of part 330.Aseptic sleeve pipe 320 may utilize various compressible or folding material
Constitute, but preferably is synthetic rubber film.Aseptic sleeve pipe 320 for compressing, fold,
Or deform and make two adjacent assemblies to become maintaining the aseptic condition of inside of sleeve pipe in the case of
Must closer to person, can be various different shape or group structure, comprise cone, pyramid,
Oval spherical, avette, spherical, the octahedral bodily form (diamond) etc..Similarly, aseptic sleeve pipe 320
Can have one or more surface pattern, such as, contribute to compressibility or foldability is longitudinally
(axially) and/or the laterally dimpled grain of (radially), convex ridge, trench, organ folding (accordion fold) etc..
These surface patterns can be at equal intervals or unequal interval, and various groups of structures comprise along sterile sleeve
The surface pattern that the inner surface of pipe, outer surface or surfaces externally and internally have.Fig. 2 B shows have edge
The embodiment of the dimpled grain that the external surface peripheral of aseptic sleeve pipe 320 is arranged at equal intervals.
Puncture member 330 is to be maintained in the gnotobasis in aseptic sleeve pipe 320.This asepsis ring
Border is connecting between socket 310 and the hoop lid 52 of medicament reservoir 50.Fig. 3 A shows according to this
The exploded view of the arrangement of the assembly of the liquid channel connector of at least one embodiment of invention, Fig. 3 B
Display sectional exploded view.This two figure comprises some assembly of medicament reservoir, especially can be pierced
Seal 56 and the connection seat 54 that can match, because the two assembly and liquid channel connector
The connection of 300 is relevant.As it can be seen, system makes ferrule interface 320A of aseptic sleeve pipe 320 when assembling
Contact with the seal interface 56A of pierceable seal 56.The interface of these correspondences can be fixed
Connected in location and/or utilization hoop lid 52, as shown in fig. 4 a and 4b, so that aseptic
The distal end of sleeve pipe 320 keeps and is fixed in hoop lid 52, being left of the most aseptic sleeve pipe 320
Part is exposed at outside hoop lid 52.When using these group structures, can be contained in by the connection seat 54 of apolegamy can
In the seal recess 56B of the seal 56 pierced through, it is allowed to be in the aseptic of aseptic sleeve pipe 320
Internal medium in.Or, pierceable seal 56 and aseptic sleeve pipe 320 are for single
Two parts of preformed assembly (that is there is the group formed as one of two or more function
Part).In this group of structure, also with hoop lid 52, this assembly can be maintained at medicament reservoir 50
The position (and being attached to the base end of cylinder 58) of base end.In any one of these embodiments
In, aseptic sleeve pipe 320 can have container connection opening 320B and make puncture member in its tip side
330 can by this connect opening 320B pierce through pierceable seal 56 and with medicament reservoir 50
Set up the connection of flow path.Or, this connection opening 320B is formed as the face closed
And as the pierceable diaphragm seal between liquid channel and medicament reservoir.But, at this
In at least one bright preferred embodiment, pierceable seal 56 has and can be pierced and make medicine
Reservoir is to the sealing barrier portion 56C of liquid channel.An initial position, pierce through structure
The distal end of part 330 can be set as this sealing barrier portion 56C of the seal 56 pierceable with this and connect
Touching or close, such as make this liquid channel connector 300 moves to that to pierce through this pierceable
Seal 56 and make medicament reservoir be communicated to the distance minimum that liquid channel is required.The most real one
Execute in example, the distal end of component 330 can be will puncture through and be set as that at least a part of to thrust this pierceable
The sealing barrier portion 56C of seal 56 but pierce through the most completely, until user activates device
It is allowed to pierce through.When the connection seat 54 of apolegamy is utilized, such as, to guarantee the most positively
Pierce through this pierceable seal 56, puncture member 330 can be made to thrust by this connection seat 54
Puncture member recess 54A.
Aseptic sleeve pipe 320 connects to connect the base end of socket 310.In one embodiment,
It is corresponding with connect socket 310 by the socket connector 320C of aseptic sleeve pipe 320 that this connects system
Thimble connector 310C between joint (engagement) and reach.This joint can be buckle
(snap-fit), interference engagement (inferference fit), screw is coordinated to coordinate (screw fit) or various
Other connecting rod connects.Puncture member 330 is through connecting socket 310 and being maintained at puncture member
In place of connecting hole 310A.As described below, in one embodiment, connecting socket 310 is
It is configured to house the puncture member 330 of bending, so that this puncture member passes and seized on both sides by the arms in thorn
Wear both component hole 310A and conduit connecting hole 310B part.Liquid conduits 30 ties up to this and leads
The base end of this puncture member 330 it is connected at pipe connecting hole 310B.As being familiar with this area skill
The personage of art can will readily appreciate that, available various viscoses or solid or other connection
Method, be such as clasped, interference engagement, screw coordinate, melted engage, welding, Supersonic
Wave soldering meets (ultrasonic welding) etc., carries out connecing of one or more assemblies described herein
Close.Fig. 5 A to 5C display according to one embodiment of the invention be attached with liquid conduits 30 and
The connection socket 310 of puncture member 330.Fig. 5 A and 5B show may pass through connection socket 310
Puncture member 330.Fig. 5 C shows that above-mentioned such as has the bending being connected with liquid conduits 30
Puncture member 330 embodiment in the perspective view of connection socket 310.
Various groups of structures of liquid channel connector described herein are optionally used one or many
Individual current limiter.For example, current limiter is usable between puncture member 330 and liquid conduits 30
Connection in.The present invention medicine side Pu can carry in the range of one have different stickiness and
The medicine of amount.This medicine side Pu can carry by check flow rate (flow velocity) and/or the amount specified
Medicine.In one embodiment, it is to utilize in liquid channel connector and/or sterile liquid conduit
One or more current limiters control drug delivery process.In other embodiments, can be by changing
The assembly becoming liquid flow channel or the geometry of delivery conduit, change drive mechanism pushes medicine
Container makes speed or the combination of above-mentioned means that medicine therein transfers out, and provides
Other flow rate.
In one embodiment of this invention, connect socket itself and can be used as one of liquid channel
Part and be optionally used as current limiter.Fig. 6 A and 6B shows this embodiment,
Wherein connect socket 3310 have be respectively connecting to connect socket 3310 internal holes 3310D (can
Perspective view shown in Fig. 6 C is seen) the puncture member 3330 at two ends and liquid conduits
3030.Therefore, this internal holes 3310D become the some of liquid channel and can be used to limit or
Adjust and flow to interposer 200 from medicament reservoir 50 and be transported to the internal medicinal liquid of user
Liquid stream.For example, this internal holes 3310D can have less than the diameter of liquid conduits 30 straight
Footpath connects the liquid stream of 300 to limit by fluid path.And, internal holes 3310D can
It is constructed so that the length elongation of fluid path flows to user institute to extend medicine from medicament reservoir
The time needed.For example, although the embodiment shown in Fig. 6 C be shown that a straight line and
Short-range internal holes 3310D, but internal holes can be the length so that liquid channel and/or
System is added the roundabout or path of complications in connecting socket of all more flowing restrictions.Logical
Cross and use one or more to be not susceptible to materials (non-reactive material) and/or not of reaction
The polymer easily reacted forms connection socket 3310, to maintain integrity and the liquid of container
The aseptic condition of body path.
With reference to Fig. 4 A and 4B, when user makes activation mechanism 14 (in the direction of solid arrow) position
Moving, puncture member 330 penetrates this pierceable seal 56 (through sealing barrier portion 56C) and beats
Open from medicament reservoir 50 to the liquid channel of liquid channel connector 300.As it has been described above, because
Puncture member 330 is to be maintained in the gnotobasis in aseptic sleeve pipe 320, it is assured that liquid
The aseptic condition of body path.Compressible or folding aseptic sleeve pipe 320 can deform and allow liquid
Bulk channel connector 300 translates or displacement when user activates.Fig. 4 A shows makes aseptic sleeve pipe
320 and pierceable seal 56 be the most independent assembly and cover 52 by binding round it is attached to
One embodiment of the invention of the base end of cylinder 58.But, as it has been described above, aseptic sleeve pipe 320
And pierceable seal 56 can be the integrally formed assembly with two or more function.Also
The connection seat 54 that display can be matched to guide puncture member 330 when activating.In this embodiment,
When aseptic sleeve pipe 320 is by axial compression, it can do deforming radially.But, at other
In embodiment, aseptic sleeve pipe 320 can whole axially fold, the sterile sleeve of such as concertina
Pipe 320.It is be not connected with by keep fluid path before using at user, and maintains liquid
Body path and the aseptic condition of medicament reservoir.The group structure of this novelty also provides and prevents medicine from flowing out directly
Other safety feature wanting medication and active activation to user is to user.
As it has been described above, the aseptic sleeve pipe of liquid channel connector, especially liquid channel connector
The hoop lid of medicament reservoir and/or pierceable sealing can be connected to when user activates this device
Body.Liquid conduits can be connected to this liquid channel connector in one end, and the other end is connected to insertion machine
Structure, makes liquid channel when opening, connect or enabling from medicament reservoir, via liquid channel
The sleeve pipe of connector, liquid conduits, interposer and administrable and a road are through to user
Internal.So just each assembling components of composition liquid channel is completed.Each assembly is available each
Kind of known method sterilizes, and then installs to medicine in fixing or dismountable mode and holds
The assembly platform of device or housing, as shown in Figure 1B.
It is contemplated that use aseptic raceway groove even in the case of in without departing from the spirit and scope of the present invention
The standard package of the apolegamy at fitting 300 or medicine side Pu 10 or change shape (variations).Lift
For example, upper and lower house is selectively included one or more transparent or translucent window
Mouth 18, as shown in Figure 1A, allows user viewing medicine help the operation at Pu 10 or to confirm that medicament is
No supply.Additionally, medicine side Pu 10 can comprise the stickiness paster 26 of the bottom surface being located at housing 12
Or paster cuticula 28.This stickiness paster 26 can be used to medicine is helped Pu 10 paste to user
Health is defeated with the confession carrying out medicament.As the tool usually intellectual of the art can be easily
Understand, this stickiness paster 26 can have for medicine is helped Pu paste to user health it
Paste face.The face of pasting of this stickiness paster 26 can be covered first with paster cuticula 28, etc.
This paster cuticula 28 is just torn off by the Body contact to medicine to be made side Pu 10 with user.Tear
Go this paster cuticula 28 to be got rid of by the sealing film 254 of interposer 200 further, make
Interposer 200 directly facing the health of user to carry out medicine conveying (as shown in Figure 1 C).
It addition, as it has been described above, may optionally utilize various current limiter to adjust liquid channel connector
In the flowing of liquid.
Similarly, can in without departing from the spirit and scope of the present invention in the case of revise liquid ditch
Pipe connecting 300 and one or more assemblies at medicine side Pu 10.For example, as above-mentioned,
It is made up of upper shell 12A and lower house 12B although the housing that medicine is helped Pu 10 is shown as,
But this two assembly is also formed as single integrally formed assembly.Similarly, although by aseptic
It is assembly independently that sleeve pipe 320 is shown as with pierceable seal 56, but also can one
Shape and become the preformed some of this pierceable seal.As it has been described above, it is available
Viscose, solid or material known to other or method are by liquid channel connector and/or medicine
The mutual gluing of one or more assemblies at thing side Pu is together.For example, upper shell and lower casing
Body can be mat viscose or solid or screw is connected, interference engagement, melted engage, weldering
Connect, ultrasound welding etc. and the assembly being separated that is fixed together；Or upper shell and lower casing
Body can be single integrally formed assembly.These standards assembly or change functionally are for this
It is can will readily appreciate that for technical field tool usually intellectual, the most all in the essence of the present invention
In god and scope.
Understand, from above-mentioned explanation, the liquid channel connector herein disclosed and medicine side Pu provides one
Plant and be used for automatically from effective percentage and the maneuverable system of medicament reservoir administration.This of the present invention
The appearance of a kind of aseptic condition being activated and maintaining liquid channel by user is provided in novel device
Device connector and a kind of integration have this sterile liquid ditch pipe connecting being connected with medicament reservoir
Medicine conveying side Pu.These equipment safeties and easily using, and for the disease of autonomous management
For trouble attractive in appearance and meet ergonomics.Even device described herein as is integrated indiscipline
The user feature that all can activate simply, operate and lock.Because fluid path is using
Before person wants medication and be not connected with, thus can maintain liquid channel connector, medicament reservoir,
Medicinal liquid and the aseptic condition of whole device.These features of the present invention provide user to accord with very much
Desired storage, transport and the benefit of safety wanted.It addition, the liquid channel connector of the present invention
And the novel group structure at medicine side Pu also maintains the aseptic shape of fluid path after the operation of device
State.Because the path of the medicinal liquid of circulation maintains aseptic condition completely in device, so only
Some assemblies need to sterilize in the fabrication process.These assemblies comprise drive mechanism medicament reservoir,
Liquid channel connector, sterile liquid conduit and interposer.At least one reality in the present invention
Execute in example, this electric power and control system, this assembly platform, this control arm, this activation mechanism,
Other assembly at this housing and medicine side Pu is not required to sterilization.This is substantially improved device
The assembly cost that manufacturability and reduction are correlated with.Therefore, the device of the present invention is when being completed
It is not required to finally sterilize.The present invention yet a further advantage is that components described herein system designs
Become modularity so that housing and other assembly at such as medicine side Pu can be configured to accept easily
And operate and above-mentioned connect socket 310, connect other the changes various of socket 3310 or assembly
The configuration of shape.
Liquid channel connector 300, medicine conveying side Pu 10 or the group of any independent assembly
Various known material in dress and/or the available known techniques of manufacture and method.For example,
Available various cleanout fluid, such as isopropanol and hexane clean each assembly and/or each device.With
Sample ground, can use various known solid or viscose in the fabrication process.It addition, can be at this
The novel assembly of invention and the manufacture process of device use various known silication and/or lubrication
Liquid and processing procedure.And, known sterilization can be implemented in one or more manufactures and assembling stage
Process the aseptic guaranteeing final products.
This liquid channel connector may utilize various method and assembles.In an assemble method,
This medicament reservoir 50 can be assembled and be filled into the liquid being delivered to user.This medicament reservoir 50
Comprise hoop lid 52, pierceable seal 56, cylinder 58 and plunger seal 60.This can
The seal 56 pierced through can hoop lid 52 and cylinder 58 between fixed engagement to this cylinder 58
Distal end.This cylinder 58 can be from its base end before plunger seal 60 inserts its base end
Medicinal liquid is filled into wherein.The connection seat 54 of apolegamy can be mounted to the seal 56 caning be pierced
Distal end.This connection seat 54 holds at the puncture member medicine to be inserted of this liquid channel connector
The insertion of this puncture member is guided during the cylinder 58 of device 50.Medicament reservoir 50 can be mounted to drive
The distal end of dynamic mechanism shell 130.As it has been described above, aseptic sleeve pipe 320 can be connected to this can
Fixing is maintained by the seal 56 and the utilization hoop lid 52 that pierce through.Connect socket 310, liquid
Conduit 30 and puncture member 330 can fit together then by the socket of aseptic sleeve pipe 320
Joint between adapter 320C with the corresponding thimble connector 310C connecting socket 310 and incite somebody to action
The base end being attached to aseptic sleeve pipe 320, as shown in Figure 4 A.Drive mechanism 100 can be attached
It is connected to the distal end of medicament reservoir 50.Interposer 200 can be assembled and be attached to liquid
The other end of conduit 30.Before being assembled to medicine side Pu 10, drive as it has been described above, this comprises
Motivation structure 100, medicament reservoir 50, liquid channel connector 300, time group of interposer 200
Component (sub-assembly) can sterilize.Some assembly of this sub assembly can be mounted to group
Assembling platform 20 or be directly mounted to the inside of this housing 12, other assembly is then installed to being used for
Guide this guiding element 390 of the activation action of user.
The manufacture method at medicine side Pu comprises: by both liquid channel connector and medicament reservoir (no
Managing it is two separate assemblies or the assembly combined) be attached to medicine side Pu assembling
Platform or the step of housing.This manufacture method comprises again: by drive mechanism, medicament reservoir and
Interposer is attached to this assembly platform or housing.Then, available attachment, preform or pre-
The mode assembled will as aforementioned comprise electric power and control system, activation mechanism and control arm it
Other the assembly at medicine side Pu is installed to this assembly platform or housing.Stickiness paster and paster protect
Film can be attached to the housing table at the medicine side Pu contacted with user during the operation of device
Face.
The method operating this medicine side Pu comprises with purgation step: activated this activation machine by user
Structure；Make control arm displacement to make interposer action；Make guiding element displacement to make liquid channel connect
Part translates；And make electric power and control system action to activate drive mechanism to drive medicinal liquid to flow through
This medicine side Pu, wherein, it is pierceable that the translation of this liquid channel connector makes puncture member penetrate
Seal and make open-minded to the fluid path of liquid channel connector from medicament reservoir.The method
Comprise again: before making activation mechanism activation, touch the step of a human body sensor that can match.
It addition, this operational approach can comprise: make plunger seal flat in drive mechanism and medicament reservoir
In-migration make medicinal liquid flow through this medicament reservoir, this liquid channel connector, sterile liquid conduit and
Interposer and be delivered to the internal of user.This interposer and the operational approach at medicine side Pu
Can refer to Fig. 4 A to 4B and preferably understood, as mentioned above.
All descriptive purposes of this explanation indicate that presently preferred embodiments of the present invention, do not exist
In limiting the present invention to any one embodiment or specific several feature.Can be without departing from this
In the case of the scope of invention for the above-described and the embodiment of icon carries out various change and repaiies
Change.Each patent mentioned in this specification and scientific literature, computer program and algorithm are the most also
Enter in this specification as reference.
Claims (23)
1. the liquid channel connector (300) that a kind is activated by user, including:
Connect socket (310)；
Puncture member (330)；
Aseptic sleeve pipe (320)；And
Medicament reservoir (50), have hoop lid (52), pierceable seal (56), cylinder (58) and
Plunger seal (60),
This medicament reservoir (50) has base end；
This hoop lid (52) is positioned at this base portion of this medicament reservoir (50) with this seal (56) caning be pierced
End；
This aseptic sleeve pipe (320) has base end and distal end；And
The distal end of this aseptic sleeve pipe (320) couples the base end of this medicament reservoir (50),
Wherein, during this puncture member (330) is originally maintained at this aseptic sleeve pipe (320) and be positioned at this company
Between this pierceable seal (56) of combination hub (310) and this medicament reservoir (50).
2. liquid channel connector as claimed in claim 1, wherein, this medicament reservoir (50)
Accommodate medicinal liquid.
3. liquid channel connector as claimed in claim 1, wherein, this pierceable sealing
Body (56) have sealing barrier portion (56C), this sealing barrier portion (56C) when user activates by this
Puncture member (330) penetrates.
4. liquid channel connector as claimed in claim 3, wherein, this puncture member (330)
Initially contact or close in seal (56) that this is pierceable and with this sealing barrier portion (56C).
5. the liquid channel connector as described in any one of Claims 1-4, also includes attachment
Connection seat (54) to this pierceable seal (56).
6. the liquid channel connector as described in any one of Claims 1-4, wherein, this hoop
Lid (52) couples the distal end base end to this medicament reservoir (50) of this aseptic sleeve pipe (320).
7. the liquid channel connector as described in any one of Claims 1-4, wherein, this nothing
Bacterium sleeve pipe (320) is compressible or folding.
8. the liquid channel connector as described in any one of Claims 1-4, wherein, this thorn
Wear component (330) and through this connection socket (310) and be connected to liquid conduits (30).
9. the liquid channel connector as described in any one of Claims 1-4, wherein, this nothing
Bacterium sleeve pipe (320) is the preformed some of this pierceable seal (56).
10. the liquid channel connector as described in any one of Claims 1-4, wherein, should
Aseptic sleeve pipe (320) is connected socket by the socket connector (320C) of this aseptic sleeve pipe (320) with this
(310) the joint between corresponding thimble connector (310C) and be connected to this connection socket
(310)。
The 11. liquid channel connectors as described in any one of Claims 1-4, wherein, use
The displacement of the activation mechanism (14) that person is promoted causes this connection socket (310) displacement to make this pierce through
Component (330) penetrates the seal (56) that this is pierceable.
The 12. liquid channel connectors as described in any one of Claims 1-4, also include one
Or multiple current limiter.
The 13. liquid channel connectors as described in any one of Claims 1-4, wherein, this thorn
Wear component (330), this aseptic sleeve pipe (320) axially aligns with this medicament reservoir (50).
The liquid channel connector (300) of 14. 1 kinds of current limlitings, including:
Puncture member (3330) and aseptic sleeve pipe (320), wherein, this puncture member (3330) is initially protected
Hold in this aseptic sleeve pipe (320)；
Medicament reservoir (50), have hoop lid (52), pierceable seal (56), cylinder (58) and
Plunger seal (60)；And
Connect socket (3310), there is inside opening (3310D) wherein so that flowing through this connection and inserting
The flowing of the medicinal liquid of seat (3310) slows down, and wherein, this aseptic sleeve pipe (320) has base end and end
Top end, and the distal end of this aseptic sleeve pipe (320) couples the base end of this medicament reservoir (50).
15. liquid channel connectors (300) as claimed in claim 14, wherein, this can be pierced
Seal (56) have sealing barrier portion (56C), this sealing barrier portion (56C) user activate
Time penetrated by this puncture member (3330).
16. liquid channel connectors (300) as claimed in claim 15, wherein, this pierces through structure
Part (3330) initially contacts in seal (56) that this is pierceable and with this sealing barrier portion (56C)
Or close to this sealing barrier portion (56C).
The 17. liquid channel connectors (300) as described in any one of claim 14 to 16, wherein,
This aseptic sleeve pipe (320) is compressible or folding.
The 18. liquid channel connectors (300) as described in any one of claim 14 to 16, wherein,
This puncture member (3330) is connected to this inside opening (3310D) in this connection socket (3310)
One end, liquid conduits (3030) is connected to the other end of this inside opening (3310D).
The 19. liquid channel connectors (300) as described in any one of claim 14 to 16, wherein,
This aseptic sleeve pipe (320) is the preformed some of this pierceable seal (56).
The 20. liquid channel connectors (300) as described in any one of claim 14 to 16, wherein,
This aseptic sleeve pipe (320) is connected slotting by the socket connector (320C) of this aseptic sleeve pipe (320) with this
Joint between the corresponding thimble connector (3310C) of seat (3310) and be connected to this connection socket
(3310)。
The 21. liquid channel connectors (300) as described in any one of claim 14 to 16, wherein,
The displacement of the activation mechanism (14) that user is promoted causes this connection socket (3310) displacement to make this
Puncture member (3330) penetrates the seal (56) that this is pierceable.
Medicine conveying side Pu (10) of 22. 1 kinds of aseptic holding members with integration, including:
Housing (12)；And
Assembly platform (20), this assembly platform (20) is provided with activation mechanism (14), interposer
(200), liquid channel connector (300) as described in any one of claim 1 to 21, electric power with
Control system (400) and there is the drive mechanism (100) of medicament reservoir (50).
23. medicines as claimed in claim 22 conveying side Pu (10), when liquid channel connector is
During liquid channel connector as claimed in claim 12, wherein, in this connection socket (3310)
Inside opening (3310D) be used as current limiter, and this puncture member (3330) is connected to inside this
One end of opening (3310D), liquid conduits (3030) is connected to another of this inside opening (3310D)
End.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201161534059P | 2011-09-13 | 2011-09-13 | |
| US61/534,059 | 2011-09-13 | ||
| PCT/US2012/054861 WO2013040032A1 (en) | 2011-09-13 | 2012-09-12 | Sterile fluid pathway connection to drug containers for drug delivery pumps |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN104136055A CN104136055A (en) | 2014-11-05 |
| CN104136055B true CN104136055B (en) | 2016-11-30 |
Family
ID=
Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2077128A1 (en) * | 2005-12-23 | 2009-07-08 | Unomedical A/S | Injection Device |
Patent Citations (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2077128A1 (en) * | 2005-12-23 | 2009-07-08 | Unomedical A/S | Injection Device |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| PB01 | Publication | ||
| SE01 | Entry into force of request for substantive examination | ||
| CB02 | Change of applicant information |
Address after: New South Wales Australia Applicant after: UNITRACT SYRINGE PTY LTD Address before: New South Wales Australia Applicant before: Unitract Syringe Pty Ltd. |
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| GR01 | Patent grant | ||
| CF01 | Termination of patent right due to non-payment of annual fee |
Granted publication date: 20161130 Termination date: 20200912 |