CN108355194A - Equipment for distributing fluid - Google Patents

Equipment for distributing fluid Download PDF

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Publication number
CN108355194A
CN108355194A CN201810153852.2A CN201810153852A CN108355194A CN 108355194 A CN108355194 A CN 108355194A CN 201810153852 A CN201810153852 A CN 201810153852A CN 108355194 A CN108355194 A CN 108355194A
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CN
China
Prior art keywords
fluid
pump
volume
pumping
liquid storage
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201810153852.2A
Other languages
Chinese (zh)
Other versions
CN108355194B (en
Inventor
迪安·卡门
拉里·B·格雷
拉塞尔·H·比维斯
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Deka Products LP
Original Assignee
Deka Products LP
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Filing date
Publication date
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Publication of CN108355194A publication Critical patent/CN108355194A/en
Application granted granted Critical
Publication of CN108355194B publication Critical patent/CN108355194B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

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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
    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142—Pressure infusion, e.g. using pumps
    • A61M5/14212—Pumping with an aspiration and an expulsion action
    • A61M5/14216—Reciprocating piston type
    • A—HUMAN NECESSITIES
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    • A61B5/0002—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network
    • A61B5/0015—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system
    • A61B5/0024—Remote monitoring of patients using telemetry, e.g. transmission of vital signals via a communication network characterised by features of the telemetry system for multiple sensor units attached to the patient, e.g. using a body or personal area network
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    • A61B5/68—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient
    • A61B5/6801—Arrangements of detecting, measuring or recording means, e.g. sensors, in relation to patient specially adapted to be attached to or worn on the body surface
    • A61B5/683—Means for maintaining contact with the body
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    • A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A—HUMAN NECESSITIES
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    • A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/162—Needle sets, i.e. connections by puncture between reservoir and tube ; Connections between reservoir and tube
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    • A—HUMAN NECESSITIES
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    • A61M5/168—Means for controlling media flow to the body or for metering media to the body, e.g. drip meters, counters ; Monitoring media flow to the body
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    • A—HUMAN NECESSITIES
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    • G—PHYSICS
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    • G01F—MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
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    • G05D7/0641—Control of flow characterised by the use of electric means specially adapted for fluid materials characterised by the type of regulator means by action on throttling means using a plurality of throttling means
    • G05D7/0647—Control of flow characterised by the use of electric means specially adapted for fluid materials characterised by the type of regulator means by action on throttling means using a plurality of throttling means the plurality of throttling means being arranged in series
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Abstract

The present invention relates to a kind of equipment for distributing fluid, the equipment includes：Shell, the size of the shell are used to be attached to the body of patient；Liquid storage device, the liquid storage device is for keeping the medical fluid being enclosed in the shell；Pump, the pump can be connected to positioned at the downstream of the liquid storage device with the reservoir fluid, and the pump is closed in the shell；And allocation component, the allocation component is located at the downstream of the pump, and can be in fluid communication with the pump；It is characterized in that, the allocation component has sensor, the parameter measured for determining the volume of the therapeutic reagent to leaving the allocation component repeatedly, or determine the function of the volume for the therapeutic reagent for leaving the allocation component.

Description

Equipment for distributing fluid
Divisional application
The application is the divisional application of No. 201410309548.4 Chinese invention application.No. 201410309548.4 Chinese invention application is No. 200780007306.8 Chinese invention application (international application no PCT/US2007/003587) Divisional application and its applying date be on 2 9th, 2007, it is entitled " peripheral system ".No. 200780007306.8 The applying date of China's application is on 2 9th, 2007, entitled " peripheral system ".
Technical field
Invention relates generally to a kind of binder for medical device and peripheral system and methods, more particularly to use In the equipment of distribution fluid.
Background technology
Due to malabsorption, liver metabolism or other medicines kinetic factor, much have potential value includes biology The drug or compound for learning product are not orally active.Additionally, some therapeutic compounds, although they can pass through Oral absorption is sometimes required that and is so frequently administered, so that patient is difficult to keep expected plan.In these cases, it often adopts With or can use parenteral delivery.
Drug conveys and effective parenteral route of other fluids and compound conveying, such as is subcutaneously injected, muscle note It penetrates and intravenous (IV) is administered, skin is pierced including the use of needle or lancet.Insulin is number with ten million diabetic One example of the treatment fluid voluntarily injected.The user of user's parenteral delivery drug will benefit from one kind can be at one section Drug/compound wears device needed for period automatic conveying.
For this purpose, making efforts to the portable device design for therapeutant controlled release.Known this device tool There are liquid storage device, such as cylindrantherae, syringe or medicine bag, and electronically controlled.These devices adversely have multiple lack Point, including failure rate.The size, weight and cost for reducing these devices be also presently, there are problem.
Invention content
In one embodiment of the invention, the equipment for distributing medical fluid includes：Shell, the shell Size is used to be attached to the body of patient；Liquid storage device, the liquid storage device are used for the medical fluid to being enclosed in the shell It is kept；Pump, the pump can be connected to positioned at the downstream of the liquid storage device with the reservoir fluid, and described Pump is closed in the shell；And allocation component, the allocation component are located at the downstream of the pump, and can with it is described Pump is in fluid communication；Wherein, the allocation component has sensor, for determining the treatment to leaving the allocation component repeatedly The parameter that the volume of reagent measures, or determine the function of the volume for the therapeutic reagent for leaving the allocation component.
In another embodiment of the invention, the equipment for distributing fluid includes：The shell of patch size；Pump, it is described Pump is disposed in the shell, and the pump has pump discharge；Allocation component, the allocation component also are disposed on the shell In, the allocation component includes distribution cavity, and there is the distribution cavity distribution entrance and distribution to export, wherein the distribution entrance It is attached to the pump discharge, the allocation component has sensor, for determining the stream to leaving the distribution cavity repeatedly The parameter that body volume measures, or determine the function for the fluid volume for leaving the distribution cavity；And limited flow resistance, institute State the outlet that limited flow resistance is attached to the distribution cavity, wherein the limited flow resistance is passive flow resistance, the passive flow resistance Including crooked route, wherein the shell includes single use portion, and it includes the crooked route that the single use portion, which has, Integral fluid path.
In one embodiment of the invention, a kind of transponder system is provided for controlling medical device.This system May include transponder and user interface.The transponder may include circuit, (i) be used on given range from least one It is a wear medical device receive signal, (ii) be used on given range to can wear medical device emit signal, (iii) For in the wide range more than the given range, received letter to be emitted to the user interface positioned far from patient Number, and (iv) be used in the wide range from user interface receive signal.The user interface may include circuit, (i) it is used to receive signal from transponder, and (ii) is used to emit signal to transponder.The medical device can be matched Wear or transplant device.
In some embodiments, the circuit of user interface can also be provided for directly receiving letter from can wear device Number and directly emit signal to device can be worn.Believe moreover, the circuit of transponder may be adapted to receive from multiple medical devices Number.
In some embodiments, the transponder may include with one or more in lower component：For recording Memory, the processor for analyzing received data about malfunction existence of data are received, and for notifying Alarm existing for user malfunction state.The malfunction may include that following event occurs, wherein transponder with can match The distance for wearing medical device separation is more than given range.
In one embodiment of the invention, the pump for the patch size that transponder is suitable for being worn on control targe body, from And to the under test body trandfer fluid.In this embodiment, transponder can have circuit, (i) be used on given range from Pump receives signal, and received signal contains number related with the fluid volume by pump conveying and related with alarm state According to, and (ii) be used on the wide range more than the given range to for monitoring trandfer fluid volume and alarm The interface Transmission received signal of state.The circuit of this transponder can also provide in wide range from described Interface control signal, it is described control signal contain is useful for control pump control information, and on given range to Pump emits the control signal.
This transponder can have the characteristic above with regard to transponder described in transponder system.In addition to or Substitute for wherein transponder occurs and can wear medical device detach at a distance from be more than the event of given range with alarm Device, transponder can also include the alarm for detecting flowing blocking or bubble in pump.
In another embodiment of the invention, binder patch system is provided for adhering to object to human body.It is this viscous It may include two sets of binder components to tie agent patch system.It is each in the first set component with three or more components A component includes that binder material sets to be attached to body when applying pressure around middle section at least one side Set the component.Similarly, in second set of component with three or more components, each component is at least one Include binder material on side, to be attached to body when applying pressure, the component is set around middle section.First Set component is spaced in the space provided between first set component with second set of component of permission and is attached to body, and second Set component is spaced to allow first set component not so that being detached from from body in the case that second set of component is detached from.
In one embodiment of binder patch system, at least one component is perforated to allow to be easy to will be described Component is torn.The component is torn the stimulation that can mitigate in following skin.Moreover, the middle section is suitable for admittedly Surely medical device can be worn.The binder patch can be semicircular.The binder patch may include peelable lining Pad.The component of the binder patch system can be linked to middle section using fiber.The component of first set can have There is the first color and second set of component there can be the second color different from the first color.
This binder patch system can be used by following methods and object is attached to human body, the method packet Include following steps：There is provided the first set component with three or more components, (as noted above, each of which component exists Including binder material to be attached to body when the pressure is exerted at least on side, the portion is set around middle section Part)；First set component is attached to body to the slot milling between each component, to remain to the object Body；There is provided second set of component with three or more components, (each of which component includes binder at least one side The component is arranged to be attached to body when the pressure is exerted, around middle section in material)；Between first set component Second set of component is attached to body in space, to which object is remained to body using second set of component；And by second Set component is attached to after body, and first set component is removed from body.
The object being attached can be the pump for pumping treatment fluid to body by skin.The casing of this pump can be worn Skin is crossed to allow through skin from the pump trandfer fluid.In the preferred embodiment of the method, when second set of component quilt When being attached to body and when first set component is removed from body, described sleeve pipe is not moved and is kept across skin.
Similarly, the object being attached can be for the probe by the parameter in skin measurement body.This probe Skin can be passed through.In the preferred embodiment of this method, when second set of component is attached to body and when first set portion When part is removed from body, the probe is not moved and is kept across skin.
The object being concatenated in this binder patch system can be equipped with air duct, attached to work as the object Air is allowed to flow to body below the object when body.
A kind of alternative bonding system for adhering to from object to human body includes central unit, which is suitable for solid Wearable object and can have binder material to be attached to body when applying pressure at least one side surely, it is described can It further includes multiple peripheral components to substitute bonding system, each component include binder material at least one side to It is attached to body when applying pressure, wherein fibrous connector is provided for each peripheral components being connected to center Component.In a preferred embodiment, the fibrous connector is elastic.
In one embodiment of the invention, a kind of method for using treatment liquid filling liquid storage device is provided.It is this Method may include providing a kind of packing station, and the packing station has for keeping liquid storage device to be in inclined substantially rigid Packing station base portion, and it is attached to the packing station cap of the substantially rigid of packing station base portion.The packing station cap, which has, to be used for The filling hole of fluid is received from syringe.The packing station cap and packing station base portion limit a constant volume, to prevent pair The liquid storage device is excessively filled.This method further includes that liquid storage device is placed in the packing station, is closed on the liquid storage device The packing station cap applies the syringe containing treatment liquid to filling hole, and by the filling hole by treatment liquid It is injected into liquid storage device from syringe.In a preferred embodiment, any sky in the liquid storage device after injecting step is removed Gas.Window can be located in the packing station cap, to check the amount of liquid in liquid storage device.Institute can be passed through by comparing It states the liquid level and fluid-level indicia that window views and estimates amount of liquid.
In one embodiment of the invention, base station is provided for the delivery device of patch size, wherein the delivery device Including single use portion and reusable part, and the single use portion and reusable part can via with it is described can be again It is connected to each other with the associated link mechanism in part.The base station includes for keeping the reusable of the delivery device Partial receiver, the receiver include the component for mutually cooperating with the link mechanism of reusable part.The base station Can also include for the charger to the accumulator charging in reusable part.The base station can also be included in independent Communication interface between computer and reusable part, to reusable part upload information or from its download information.
The aspects of the invention be not intended to it is exclusive and when with appended claims and attached drawing be combined into Those of ordinary skill in the art should be readily appreciated that other feature, aspect and the advantage of the present invention when row is read.
Description of the drawings
The preceding feature of the present invention will be more readily understood by reference to following detailed description in refer to the attached drawing, wherein：
Fig. 1 describes the patient with patch and wireless handheld user's interface unit；
Fig. 2A is the skeleton diagram of the fluid delivery device with feedback control；
Fig. 2 B are the skeleton diagrams of the fluid delivery device with feedback control and liquid storage device；
Fig. 3 is the skeleton diagram of the fluid delivery device with non-pressurised liquid storage device；
Fig. 4 A-4C are the summary sectional views of the various embodiments of current limiter；
Fig. 5 is shown and the concatenated elastic allocation component of current limiter；
Fig. 6 shows the allocation component with measurement chamber and sensor；
Fig. 7 shows the allocation component with measurement chamber and sensor with distribution spring；
Fig. 8 shows the section view with the allocation component of alternative acoustic path；
Fig. 9 shows the schematic illustration of allocation component；
Figure 10 shows the diaphragm spring for elastic variable volume dispensing chamber；
Figure 11 A show the dynamics distribution of exemplary base fluid conveying；
Figure 11 B show the dynamics distribution of exemplary pill fluid conveying；
Figure 11 C show to represent the dynamics data of normal fluid conveying；
Figure 11 D-11F show to represent the dynamics data of various malfunctions；
Figure 12 shows the flow chart of the sensing and reaction process of fluid delivery device embodiment；
Figure 13 shows the block diagram of the flowline with Pressure-creating components；
Figure 14 shows the block diagram of the flowline with valve pump；
Figure 15 A-15D show the skeleton diagram of pumping mechanism；
Figure 16 shows the skeleton diagram of pumping mechanism；
Figure 17, which is briefly showed, to be regarded with the section of the embodiment including shape memory actuator of multiple pumping modes Figure；
Figure 18 is briefly showed including two shape memory actuators and can be with the embodiment of multiple pumping modes Section view；
Figure 19 briefly shows the section view of the embodiment of the shape memory actuator including different length；
Figure 20 A-20B briefly show the embodiment for attachment shape memory actuator；
Figure 21 A-21B briefly show the embodiment for shape memory actuator to be attached to pumping mechanism；
Figure 22 and 23 shows the pumping mechanism using finger；
Figure 24 shows the pumping mechanism using rotation protrusion；
Figure 25 shows the pumping mechanism using plunger and plunger barrel；
Figure 26 shows the view of the shape memory actuator in swelling state；
Figure 27 shows the view of the shape memory actuator in contraction state；
Figure 28 shows the view of the pump using plunger and plunger barrel and the shape memory motor with lever；
Figure 29 is shown using plunger and the pump of plunger barrel and the view of shape memory motor；
Figure 30 shows the pumping devices using plunger and plunger barrel and the shape memory horse with conducting wire in plunger axis The view reached；
Figure 31 shows the flowline embodiment with sundstrand pump and liquid storage device；
Figure 32 briefly shows the section view of the valve pump in rest position；
Figure 33 briefly shows the section view of the valve pump of Figure 32 in an intermediate position；
Figure 34 briefly shows the section view of the valve pump of Figure 32 in actuated position；
Figure 35 briefly shows the section view of the pumping diaphragm for valve pump；
Figure 36 shows the perspective view of the diaphragm spring for pumping diaphragm；
Figure 37 briefly shows the section view of valve pump and shape memory wire actuator using lever；
Figure 38 briefly shows the section view of the embodiment including the valve pump using elastic Cylindrical Buckling；
Figure 39 briefly shows the section including the embodiment with elastomeric element and the valve pump buckling of rigid strutting piece and regards Figure；
Figure 40 is schematically shown in the section of valve pump in resting state in of the flexible partition upstream with diaphragm spring View；
Figure 41 briefly shows the section view of the valve pump of Figure 40 in intermediate state；
Figure 42 briefly shows the section view of the valve pump of Figure 40 in actuating state；
Figure 43 is schematically shown in the section view of valve pump of the flexible partition upstream with diaphragm spring, wherein it is flexible every Film is circumferentially attached to active force and applies component；
Figure 44 is schematically shown in the section view of valve pump of the flexible partition upstream with diaphragm spring, it includes being used for The rigid ball of transmitting forces；
Figure 45 briefly shows the section view of the embodiment including the valve pump with elastic pump blade；
The section that Figure 46 briefly shows the embodiment of the elastic pump blade including the alternative form for valve pump regards Figure；
Figure 47 briefly shows the section view of the embodiment of the valve pump including applying component with multiple active forces；
Figure 48 briefly show in rest or fill pattern include bell crank lever driving valve pump and bias current valve pump Send mechanism；
Figure 49 briefly shows the pumping mechanism of Figure 48 in actuating state.
Figure 50 is briefly showed according to embodiments of the present invention with raised valve seat and bias current valve in the closed position Section view；
Figure 51 briefly shows the section view of the bias current valve of Figure 50 in an open position；
Figure 52, which is briefly showed according to embodiments of the present invention, does not have raised valve seat and bias current valve in an open position Section view；
Figure 53 briefly shows the section view of the bias current valve of Figure 52 in the closed position；'
Figure 54 briefly shows the active force acted on according to embodiments of the present invention on the poppet near valve export；
Figure 55 is briefly showed with detailed view and is acted on the poppet near valve inlet according to embodiments of the present invention Active force；
Figure 56 briefly shows the bias current valve according to embodiments of the present invention with adjustable Opening pressure；
Figure 57 and 58 shows the skeleton diagram of the flowline using non-pressurised liquid storage device；
Figure 59 A-59E show the skeleton diagram of the flowing of the fluid in fluid delivery device；
Figure 60 A-60D show the decomposition skeleton diagram of the flowing of the fluid in fluid delivery device；
Figure 61 A-61C show the skeleton diagram of the flowing of the fluid in fluid delivery device；
Figure 62 A and 62B show the skeleton diagram of individual devices；
Figure 63 A-63C show the section skeleton diagram of device embodiments；
Figure 64 A-64D show the section skeleton diagram of device embodiments；
Figure 65 A-65B are shown connected to the section skeleton diagram of the embodiment of the delivery device of flowline；
Figure 66 A-66D are shown the section skeleton diagram of the sequence in liquid storage device inserter instrument；
Figure 67 A-67F show the skeleton diagram of the embodiment of fluid delivery device；
Figure 68 is attached to the skeleton diagram of one embodiment of the portable pump embodiment of the device of patient；
Figure 69 A-69B show the schematic illustration on the downside of the shell of device；
Figure 70-70D are the views for being depicted in available various components in fluid delivery device embodiment；
Figure 71 briefly shows the component that can be assembled to form the fluid delivery device according to device embodiments；
Figure 72 shows the side view for the fluid delivery device that there is acoustic volume to measure component；
Figure 73 shows the printed circuit board measured for acoustic volume；
Figure 74 shows the pictorial view of device embodiments；
Figure 75 shows the illustrated section view of the embodiment of fluid delivery device；
Figure 76 shows the decomposition diagram view of the embodiment of fluid delivery device；
Figure 77 shows the decomposition view that can be assembled to form the component of one embodiment of fluid delivery device；
Figure 78 shows the decomposition view of the embodiment of fluid delivery device；
Figure 79 shows the top view of the base portion of one embodiment of fluid delivery device；
Figure 80 shows the downside at the top of one embodiment of fluid delivery device；
Figure 81 A-81C show the sequence of the process for indicating to clamp liquid storage device 20 between top and base portion；
Figure 82 shows the decomposition vertical view of device；
Figure 83 shows the decomposition view of the bottom of one embodiment of device, and there is shown with fluid path component, bottom shells Body and diaphragm and binder；
Figure 84 shows the bottom view of base portion, and there is shown with the bottom views of fluid path component；
Figure 85 A-85D show decomposition, exploded and the non-decomposition view of device embodiments；
Figure 86 A show there is delivery device and the infusion of analyte sensor that is connected and sensor module it is general Sketch map；
Figure 86 B are shown with the decomposition view of infusion and sensor module as shown in Figure 86 A for introducing needle；
Figure 87 A-87E show that the embodiment of infusion and sensor module is inserted into sequence in device；
Figure 88 A-88B show one embodiment in the inserter device being infused in the sequence with sensor module；
Figure 88 C-88D show the partial sectional view of the inserter of Figure 88 A-88B；
Figure 89 A show the front view of one embodiment of the inserter device for being inserted into infusion and sensor module；
Figure 89 B show the rearview of the inserter instrument of Figure 89 A；
Figure 90 is shown for being infused and the perspective view of one embodiment of the cylindrantherae of sensor module；
Figure 91 A-91C show the front perspective view and side perspective of the inserter device for being inserted into infusion and sensor module Figure；
Figure 92 A-92F briefly show the time series of one embodiment for operating inserter mechanism；
Figure 92 G show the inserter mechanism with brake component (catch) and compression spring lever in a closed position；
Figure 92 H show the inserter mechanism with brake component and compression spring lever in the open position；
Figure 93 A-93C show the time series for inserting the cannula into fluid delivery device base portion；
Figure 94 A-94C show the sequential for inserting the cannula into base portion when casing is consistently connected to flowline Sequence；
Figure 95 shows the top view of the binder patch for keeping fluid delivery device；
Figure 96 is schematically shown in the section view of the fluid delivery device below binder patch；
Figure 97 shows the perspective view of two overlapping binder patches for keeping fluid delivery device；
Figure 98 shows the top view of two semicircle binder patch portions；
Figure 99 shows to keep the perspective view of two semicircle binder patch portions of fluid delivery device；
Figure 100 shows the perspective view of the semicircle binder patch portion removed by patient；
Figure 101 shows the perspective view for the fluid delivery device for investing patient using multiple binder components and tether；
Figure 102 A show the fixture for assembly device；
Figure 102 B show the base portion of the fluid delivery device with the keyhole for being inserted into fixture；
Figure 102 C show the section view of the fluid delivery device using fixture assembling；
Figure 103 A show the perspective view of the cam guide for assembling fluid delivery device；
Figure 103 B show the top view of the cam guide of Figure 103 A；
Figure 103 C show the perspective view of the clamp pin for assembling fluid delivery device；
Figure 103 D show the embodiment of the fluid delivery device assembled using clamp pin and cam guide；
Figure 104 shows the section view for collapsing liquid storage device according to one embodiment；
Figure 105 shows the perspective view of the liquid storage device of Figure 104；
Figure 106 A-106C show to be used to diaphragm being fixed to end cap to form a system of liquid storage device according to one embodiment Row step；
Figure 107 shows the liquid storage device packing station according to one embodiment；
Figure 108 A-108B are shown in the implementation for opening the liquid storage device packing station in (108A) and closing position (108B) Example；
Figure 109 A show one embodiment of the data acquisition and control scheme of the embodiment for fluid delivery system Block diagram；
Figure 109 B show one embodiment of the data acquisition and control scheme of the embodiment for fluid delivery system Block diagram
Figure 110 A show to describe the flow chart of the operation of the fluid delivery device according to one embodiment；
Figure 110 B show to describe the flow chart of the operation of the fluid delivery device according to one embodiment；
Figure 111 shows the block diagram of the user interface and fluid conveying member communicated wirelessly to each other；
Figure 112 shows that data flow view, the view show the use of the intermediary transceiver according to one embodiment；
Figure 113 shows the block diagram of the intermediary transceiver according to one embodiment；
Figure 114 shows the data flow view that general patient interface is used for according to one embodiment；
Figure 115 show according to the non-disposable part of the fluid delivery device in decoupled state of one embodiment and Battery charger；
Figure 116 shows the non-disposable of the fluid delivery device of Figure 115 in mated condition according to one embodiment Part and battery charger；And
Figure 117 is to describe the process for measuring the liquid volume conveyed in pump stroke according to embodiments of the present invention Flow chart.
It should be appreciated that above figure and the element described wherein may not according to consistent ratio or in any proportion It draws.
Specific implementation mode
Definition.As used in this explanation and appended claims, term below will contain with what is illustrated Justice, unless the context requires otherwise：
" the user's input " of device, which includes device user or other operators, can be used for any of control device function Mechanism.User's input may include mechanical device (such as switching, press button), the wireless interface for being communicated with remote controllers (such as RF, infrared), acoustic interface (such as with speech recognition), computer network interface (such as USB port) and other The interface of type.
Related " button " is inputted with user, such as what is be discussed below so-called " inject button (bolus Button) ", can be able to carry out any kind of user input of required function, and be not limited to press button.
" alarm " includes any mechanism that can be used for sending out alarm to user or third party.Alarm can wrap Include audible alarm (such as loud speaker, buzzer, speech synthesizer), visual alarm (such as LED, LCD screen), tactile police Report device (such as vibrating elements), wireless signal (such as wireless transmission for remote controllers either keeper) or other Mechanism.Can alarm simultaneously, synchronously or sequentially occur using multiple mechanisms, including spare mechanism is (for example, two Different audio frequency sirens) or complementary means (for example, audio frequency siren, tactile alarm and wireless alarm).
" fluid " means the substance that can be flowed by flowline, such as liquid.
" impedance " means device or flowline for the obstruction of the fluid stream flowed therethrough.
" wetting " description forms the component being in direct contact during normal fluid conveying operations with fluid.Because fluid is not It is limited to liquid, " wetting " component not necessarily becomes to moisten.
" patient " includes receiving fluid or in other ways from the fluid delivery device of the part as medical treatment Receive people or the animal of fluid.
" casing " means can be to the disposable device of patient's infusion.Casing as used herein can refer to Traditional casing or needle.
" analyte sensor " means can determine any sensor that there is analyte in patients.Analyte senses The embodiment of device includes but not limited to that can determine any viral, parasitic, bacterium or chemical analyte Existing sensor.Term analyte includes glucose.Analyte sensor can be with other structures in fluid delivery device It part (for example, controller in non-disposable part) and/or is communicated with remote controllers.
" allocation component sensor " means the mechanism for determining the fluid volume present in dispensed chambers.
" sharp object " means to pierce through or expose animal skin, in particular any object of the skin of people.Sharply Object may include casing, casing inserter instrument, analyte sensor or analyte sensor inserter instrument.For example, in cylindrantherae In can respectively provide or can provide together multiple sharp objects.
" disposable " refers to the component for it is contemplated that used in the fixed time period, being then dropped and replacing, device, portion Divide or other similar.
" non-disposable " refers to the reusable part for being intended to have the unlimited use age.
" patch size " means sufficiently small size, so that being utilized during the substance contained in conveying the device Such as binder or belt can be fixed to patient skin and be worn as medical device.It is small to may be used as The medical device of graft belongs to the range of this definition.
" usually existing limited flow resistance " means in the conventional process of fluid conveying, that is, when there is no error conditions Existing limited flow resistance when (for example, blocking).
" passive " impedance is during pumping circulation not by the impedance of Active control.
" acoustic volume measurement " means to use for example described in United States Patent (USP) No.5,349,852 and 5,641,892 The quantitative measurment of the related volume of acoustic technique and technology described here.
" temperature sensor " include for measuring temperature and to controller transmit temperature information any mechanism.The device Part may include the one or more temperature for measuring such as skin temperature, AVS temperature, environment temperature and fluid temperature (F.T.) Sensor.
Device described here, pumping mechanism, system and method embodiment be related to such fluid conveying, it is described Fluid conveying includes pumping and fluid volume measures and the actuating and control of fluid conveying.The embodiment of the device includes Portable or non-portable device for fluid conveying.Some embodiments of the device include disposable base portion and Non-disposable top.The device includes that wherein delivery device is inserted by base portion and is directly entered the reality of patient's body Apply example.These device embodiments are patch pump device (patch pump device).Can use binder, belt or its Patch pump is attached to patient by its appropriate device.Binder can have the peelable band of protectiveness, the band that can make With before be removed to expose binder.
However, in other embodiments, fluid delivery device is the portable device that wherein pipeline is connected to flowline Part.Usually, pipeline is connected to by patient by casing.
In some embodiments for wherein using disposable base portion and non-disposable top, base portion includes wetted portion Part, and part included in non-disposable top is usually non-wetted component.
The various embodiments of pumping mechanism include upstream inlet valve, pumping actuation component, lower exit valve and movable part Part.In some embodiments, pumping actuation component and valve downstream function are realized using identity unit.Pumping mechanism passes through stream Fluid is pumped into outlet by dynamic pipeline from liquid storage device.Pumping mechanism is usually used together with non-pressurised liquid storage device, however, this hair Bright range is without being limited thereto.
In one embodiment of fluid delivery system, the device includes analyte sensor shell.Analyte senses Device is introduced into patient's body by the analyte sensor shell of device base portion.In these embodiments, also by device base portion Shroud introduce delivery device.In these embodiments, the device is worn as patch pump by user.
The system generally includes controller, and the controller may include wireless transceiver.Therefore, by wireless Controller device can fully or partly control the device.Controller device can be by radio communication from analysis Object sensor and/or fluid delivery device receive information.Patient or third party can use controller device control stream Body conveys the function of device.
In one embodiment of fluid delivery device, the device is insulin pump and the analyte sensor It is blood glucose sensor.Receive with the volume of insulin of the conveying number of pump stroke (or during certain time) and The controller of the related information of blood glucose data contributes to user to be programmed the actuating time table of the pump machanism.
It is described herein illustrative allocation component and volume sensing device.Allocation component includes at least one microphone And loudspeaker.The component determines the stereomutation in dispensed chambers to determine pumped fluid volume.Volume senses data It is used for determining the state of fluid delivery device.Therefore, various controls may rely on volume sensing data.
In an embodiment of the present invention, user conveys device via user interface fluid, so that fluid conveying Device trandfer fluid in a suitable manner.In one embodiment, user interface is the independence that can be wirelessly communicated with the patch Hand held consumer interface module.The patch can be disposable, or partly disposable.
As described above, the example of use of the device embodiments is for conveying insulin to diabetic, still Other purposes include conveying any fluid.Fluid includes the analgestic for pain patients, the chemotherapy for cancer patient And the enzyme for arteries in metabolic disorder patients.Various treatment fluids may include small molecule, natural prodcuts, peptide, protein, Nucleic acid, carbohydrate, nano granule suspension and the related acceptable carrier molecule in terms of materia medica.Treatment Bioactive molecule can be modified to improve the stability in conveying device (for example, by the poly- second two of peptide or protein Refine (PEGylated)).Although illustrative examples here describe drug delivery application, embodiment can be used for other Using including the examination for measuring (such as miniature laboratory technique application and capillary chromatography) for the analysis of highoutput The liquid of agent distributes.For purpose described below, term " therapeutic agent " or " fluid " are employed interchangeably, however, at it In its embodiment, any fluid as described above can be used.Therefore, the device and explanation for including herein are not limited to treat Purposes.
Exemplary embodiments include the liquid storage device for keeping fluid to supply.In the situation of insulin, liquid storage device can be by It is advantageously set to the size supplied with the insulin that can keep being enough to convey in one day or more days.For example, liquid storage device About 1 insulin for arriving 2ml can be accommodated.For about 90% potential user, 2ml insulin cartridges can correspond to Supply in about 3 days.In other embodiments, liquid storage device can have any size or shape and can be adapted to accommodate Any amount of insulin or other fluids.In some embodiments, the size and shape of liquid storage device are suitable for holding with liquid storage device The fluid type received is related.Fluid reservoirs can have eccentric or irregular shape and/or can be locked to The installation of defence mistake uses.
Some embodiments of fluid delivery device are used suitable for diabetic, therefore, in these embodiments, device Part conveys the insulin for supplementing or replacing patient's beta Cell of islet.Embodiment suitable for insulin conveying attempts to pass through The fluid conveying of foundation level is provided and injects horizontal conveying and simulates pancreas effect.It is used by using wireless hand-held Family interface can be set foundation level by patient or another party, inject horizontal and timing.Additionally, it can respond integrated Either the output of external analyte sensor (such as glucose monitors part or blood glucose sensor) and trigger or Person adjusts basis and/or injects level.In some embodiments it is possible to use the regulation button being located on fluid delivery device Either other input units are injected by patient or third party's triggering.In a further embodiment, it injects or foundation level energy It is enough to be programmed or manage by the user interface on fluid delivery device.
According to an exemplary embodiment of the present, Fig. 1 shows to wear fluid delivery device 10 and hold for monitoring and adjusting Save the patient 12 of the wireless subscriber interface component 14 of the operation of fluid delivery device 10.User's interface unit 14 generally includes (such as LCD is shown equipment for input information (such as touch screen or keypad) and for transmitting from information to user Device, loud speaker or vibration alarm device).Fluid delivery device is general sufficiently small and light, to be kept cosily in a few days It is attached to patient.
In Fig. 1, fluid delivery device 10 is illustrated as on the arm for being worn on patient 12.In other embodiments, fluid Conveying device 10 can be worn at the other positions with patient, and patient body being capable of advantageous land productivity at these locations With transported specialized fluids.For example, fluid can be advantageously transported to patient abdomen region, lumbar region, leg or its Its position.
Referring now to Fig. 2A, the generalized schematic of fluid delivery device 10 is shown, which has from allocation component 120 To the feedback loop 360 of pump 16.Pump 16 pumps fluid to allocation component 120；Fluid is then by including current limliting Device 340 and the spout assembly of output section 17 leave.The output section generally includes casing and leads to patient.Allocation component 120 may include the variable volume dispensed chambers and at least one microphone and loudspeaker of elasticity, for measure with The related parameter of stream that time passes through the output section.Feedback loop 360 allows to based on the duplicate measurements carried out by sensor And adjust the operation of pump 16.Current limiter 340 is formed between allocation component 120 and the output section of flowline 5010 High impedance.Current limiter 340 may, for example, be a part for narrower bore pipe or micro-pipe.
Referring now to Fig. 2 B, in one embodiment, fluid is pumped into allocation component by pump 16 from liquid storage device 20 120。
Referring now to Figure 3, showing the block diagram of another embodiment using fluid mechanics principle.The connection storage of flowline 310 Liquid device 20, pump 16, allocation component 120 and spout assembly 17.Spout assembly 17 may include high impedance current limiter 340 and delivery device 5010, such as casing.The output of current limiter 340 is sent to delivery device 5010, to be conveyed to patient. Current limiter 340 has flow resistance more higher than the part positioned at 120 upstream of allocation component of flowline 310.Therefore, pumping group The case where part 16 can leave spout assembly 17 than fluid quickly pumps fluid into allocation component 120.Allocation component 120 may include the variable volume dispensed chambers 122 with elastic wall.In embodiment given below, elastic wall be every Film.The example of diaphragm material includes silicones, NITRILE and with for needed for playing a role as described herein Any other material of elasticity and characteristic.Additionally, other structures can be used for identical purpose.When due to pump 16 When acting on and receiving fluid supply, membrane elastic will allow chamber 122 to expand first and then provide driving allocation component 120 fluid contents reach the discharge pressure needed for patient by current limiter 340.When equipped with proper sensors (under Face describes the example) when, allocation component 120 can measure the fluid stream by variable volume dispensed chambers 122 and can lead to Cross feedback loop 360 provide feedback with control pump 16 pumping or be partially filled with dispensed chambers 122 timing and/or Thus rate conveys required dosage with required rate to patient.
Referring again to FIGS. 3, additionally, 340 anti-fluid flow of current limiter is more than regulation flow rate.In turn, because passing through pumping Component 16, allocation component 120 and current limiter 340 reciprocation and complete pressurized fluid conveying, therefore can use non-pressurised Liquid storage device 20.
Referring still to Fig. 3, feedback loop 360 may include controller 501.Controller 501 may include processor and be used for Pump 16 is activated to pump the control circuit of fluid to allocation component 120.Controller 501 is from can be with allocation component 120 Integrally formed sensor repeatedly receives parameter related with fluid stream, and using the state modulator pump 16 with Realize the desired flowing by output section.For example, controller 501 can adjust actuating timing or the journey of pump 16 Degree either injects the basis needed for flow rate and/or conveying with the basis needed for realization or injects intergal dose.It is pumped determining When the timing sent or degree, controller 501 can use sensor output (not shown) with the rate of estimating of fluid stream, Integrated flux or the two (and a lot of other amounts), and be then based on the estimation and determine compensation behavior appropriate. In various embodiments, can pulsedly it be pumped, it can be with 10-9It rises per pulse to any between microlitre every pulse Rate is conveyed.It can be by conveying multiple pulses come optimized integration or bolus dose.It (is shown below and describes The example on basis and bolus dose).
Using the non-pressurised liquid storage device 20 that can collapse of part can advantageously prevent when the fluid in liquid storage device is exhausted Air is accumulated in liquid storage device.Liquid storage device 20 can be connected to flowline 310 by diaphragm (not shown).In ventilation liquid storage Air accumulation can prevent fluid from being flowed out from liquid storage device 20 in device, especially contain in liquid storage device when system is angled such that Fluid and the diaphragm of liquid storage device 20 between intervene air packet when.During it can such as wear the normal operating of device, it is desirable to be System is inclined by.Figure 104-106C depict the various embodiments and view of one embodiment of liquid storage device.Additionally, below Including to liquid storage device further instruction.
Referring now to Fig. 4 A-4C, the various embodiments of current limiter 340 are shown.Referring now to Fig. 4 A, current limiter is molding Runner 340, it can be the molded indentation (not shown) in base portion.In one embodiment, the section of molded flow channels 340 Substantially 0.009 inch.In this embodiment, current limiter 340 is molded into equipment.Referring now to Fig. 4 B, as current limiter Alternate embodiments micro-pipe 340 is shown.In one embodiment, micro-pipe has substantially 0.009 inch of internal diameter.Molding stream Road and micro-pipe are using the long path with small internal diameter or section to give flow resistance.Referring now to Fig. 4 C, show as limit Flow the accurate orifice plate of device 340.In one embodiment, accurate orifice plate is the plate for having laser drill.In alternate embodiments In, any flow resistance device being known in the art or method can be used.And have the function of to be typically considered to The prior art fluid transport system that the active downstream valve of unlimited flow resistance is formed in meaning is different, and current limiter 340 forms current limiting Resistance.From possible sometimes due to the prior art systems for blocking and being obstructed are different, impedance of the invention is also in normal condition It is existing.Due to the finiteness of flow resistance, in the embodiment including dispensed chambers 122, even if when dispensed chambers 122 expand When, fluid may also be revealed by exporting.
Fig. 5-8 briefly shows the section view of the illustrative examples of allocation component 120.It should be understood that being used for other mesh The fluid conveying of (such as industrial process) belong to the scope of the invention, and be only example with the explanation that concrete term provides Mode.As shown in figure 5, allocation component 120 may include variable volume dispensed chambers 122 and sensor 550.Variable volume Dispensed chambers 122 include elasticity distribution diaphragm 125, it allows chamber 122 swollen according to the fluid stream of disengaging allocation component 120 Swollen and contraction.In certain embodiments of the present invention, as will be discussed further herein, variable volume dispensed chambers 122 can To be separated from other elements of allocation component 120.The bullet for allowing chamber 122 to expand and shrink is shown using double-headed arrow Property distribution diaphragm 125 concept.Measurement chamber 122 has been believed to comprise that utilize arrow 112 to specify in Figure 5 has fluid Flow a part for the circuit 110 of feature.Either the position of the termination of circuit 110 or characteristic do not limit such as institute fluid stream 112 The scope of the present invention that attached claim is distinctly claimed.Compared to the fluid when pumped component 16 is pumped into chamber 122 The case where into chamber 122, current limiter 340 is so that fluid more slowly leaves dispensed chambers 122.As a result, when fluid supplies Be fed it is fashionable, dispensed chambers 122 expand and be pressurized.The distribution diaphragm 125 deformed due to the expansion of dispensed chambers 122 Providing conveying metered volume makes it reach the active force needed for spout assembly 17 by current limiter 340.As begged for above By sensor 550 repeatedly measures can be with the relevant parameter of volume of resilient dispensing chamber 122, such as displacement or heat Mechanics variable or capacity.The cubing generated by sensor 550 can be used for by feedback loop control pump to Dispensed chambers 122 pump timing and the rate of fluid, to which fluid stream appropriate is transported to spout assembly 17 and subsequent Pipeline, and thus for example it is transported to patient.It is (more detailed below that such as acoustic volume sensing may be used in sensor 550 Carefully describe) either other methods (optics or the capacitive character, as other for determining volume or volume relevant parameter Example).Acoustic volume measuring technique is to authorize the DEKA Products Limited United States Patent (USP) No.5 of Partnership, 575,310 and 5,755,683 and submitted on April 5th, 2006 it is entitled " for flow control cubing side Method ", Serial No. No.60/789, the theme of 243 co-pending Provisional U.S. Patent Application, they are by reference side Formula and be bonded to here.Fluid volume sensing can be carried out in nanoliter range using the embodiment, therefore contributes to height Accurately and precisely monitoring and conveying.Other alternative technologies for measuring fluid stream can also be used；For example, being based on The method of Doppler (Doppler)；Use Hall (Hall) effect sensor combined with leaf valve or flapper valve；Make With strain beam (for example, with compliant member in fluid chamber in relation to the flexure for sensing compliant member)；Use utilization The capacitive sensing of plate；Or the time-of-flight method (thermal time of flight method) of heat.
Referring now to Fig. 6 to 9, show that wherein sensor utilizes the embodiment of acoustic volume sensing (AVS) technology.First Discussion with reference to the embodiment described in figs. 6 and 7.Allocation component 120 have sensor, it include reference chamber 127 and The variable volume that fixed volume chamber 129 is connected to by port 128 measures chamber 121.Although can utilize such as the institutes of Fig. 6 and 7 The reference chamber 127 shown implements the present invention, but in certain other embodiments of the present invention, does not provide reference space.It answers The understanding, it is " fixed " that space 129 is referred to herein as term, but its reality on acoustics firing time scale Volume can slightly change, such as when being referred to as the region of fixed space 129 using speaker diaphragm driving.Fluid passes through bullet Property dispensed chambers 122 flow to input unit 123 from pump 16, and flow out exit passageway 124.Since high downstream hinders Anti-, when fluid enters dispensed chambers 122, distribution diaphragm 125 is expanded into variable volume chamber 121.Printing can be arranged in Electronic building brick on circuit board 126 has loudspeaker 1202, sensing microphone 1203 and reference microphone 1201, for measuring With gas (being usually air) relevant parameters,acoustic in variable volume chamber 121, cavity volume is by distribution diaphragm 125 Position restriction.The sound wave incuded by loudspeaker 134 advances to variable volume chamber via port 128 by fixed volume chamber 129 Room 121；Sound wave also advances to reference chamber 127.It, can when distribution diaphragm 125 is moved with fluid stream by flowline Volume of air in volume 121 changes, and causes its acoustic characteristic that related change occurs, this can utilize loudspeaker It is detected with microphone 1203.For identical acoustic excitation, reference microphone 1201 can detect the sound in fixed reference space 127 Learn characteristic.These reference measurements for example can be used to eliminate inexactness and resist the inaccurate of common schema in acoustic excitation True property and other mistakes.Can by comparing variable volume chamber 121 measure volume and variable volume chamber 121 just The volume of beginning volume and the determining fluid being shifted.Because the total measurement (volume) of dispensed chambers 122 and variable volume chamber 121 is kept It is constant, additionally it is possible to estimate the absolute volume of dispensed chambers 122.
Embodiment shown in Fig. 6 utilizes the distribution diaphragm 125 of intrinsic elasticity, and the embodiment shown in Fig. 7 utilizes elasticity point With spring 130, the elasticity distribution spring 130 increases the elasticity of dispensed chambers 122 simultaneously when being combined with distribution diaphragm 125 And it can allow using than in the embodiment shown in fig. 5 by point of desired distribution diaphragm more compliant (that is, more low elasticity) With diaphragm 125.Distribution spring 130, which is usually positioned on the side opposite with dispensed chambers 122 of diaphragm 125, to be adjacent to Distribute diaphragm 125.
Alternatively, in order to reduce the background noise from microphone, loudspeaker 1202 and sensing microphone 1203 can be with It is connected to variable volume chamber 121 via the port of separation.It is such as briefly showed in Fig. 8, loudspeaker 1202 is via loudspeaker Port 6020 is acoustically coupled in the fixation loudspeaker space 6000 of variable volume chamber 121 and generates pressure wave.Pressure wave from Loudspeaker 1202 advances to variable volume chamber 121 and then in sensed microphone by loudspeaker ports 6020 Pass through microphone port 6010 before 1203 records.Loudspeaker ports 6020 may include having flared hole 6030 Line segments 6040.Flared hole 6030 is used to form sound wave edge to all axial paths of line segments 6040 Its even length advanced.For example, line segments 6040 can be with the geometry of cylinder, such as column body or vertical circle The geometry of cylinder.Similar flared hole can also abut line segments to limit microphone port 6010.With figure 6 is different with 7 AVS sensors, and in the embodiment in fig. 8, the pressure wave advanced from loudspeaker 1202, which does not have, reaches sensing wheat The directapath of gram wind 1203.It is therefore prevented that the pressure wave from loudspeaker 1202 is not first passing around variable volume 121 In the case of directly impact sensing microphone 1203.Therefore microphone receives the background signal of reduction and realizes preferably Signal/noise ratio.Additionally, can include upper shelf 6050 in any one of the embodiment of Fig. 6-8, to be advantageously reduced The volume of reference chamber 127.
In the embodiment being further described, sensor and the measurement chamber of allocation component will can be conveniently separated Part, to which dispensed chambers are dismountable and disposable.In this case, dispensed chambers are located at the disposable portion of patch In point, and sensor is located in reusable part.Dispensed chambers can be distributed diaphragm (such as conduct in figure 6 by elastic fluid Shown in 122 and 124) it defines.Alternatively, as in the figure 7, dispensed chambers 122 can be defined by submissive diaphragm 125.Herein In situation, distribution spring 130 can be used in assigning elasticity in dispensed chambers 122.When 122 quilt of sensor 550 and dispensed chambers When being placed in together, distribution spring 130 covers submissive distribution diaphragm 125.It distributes spring 130 and distribution diaphragm 125 can be alternately It is used, as the single part for limiting dispensed chambers 122.
As shown in figure 9, showing the alternate embodiments of allocation component.In the embodiment for the allocation component 120 that Fig. 9 describes In, variable volume measures chamber 121 and shares compliant wall with dispensed chambers 122 (here depicted as submissive diaphragm 125).128 sound of port It learns ground and is coupled to fixed volume chamber 129 by chamber 121 is measured, abutted by the acoustics that label 1290 totally marks to be formed Region.Compressible fluid (being usually air or another gas) filling acoustics neighboring region 1290 and driven member 1214 excitations, the driving part 1214 itself are driven by actuator 1216.Driving part 1214 can be the diaphragm of loud speaker, Such as the diaphragm of hearing additional loudspeaker, in the loudspeaker, actuator 1216 is, for example, voice coil solenoid or piezoelectricity member Part.In the scope of the invention, driving part 1214 can also be coextensive (coextensive) with actuator 1216, such as When driving part 1214 itself can be piezoelectric element.Driving part 1214 can be contained in Drive Module 1212, The Drive Module can contain reference space 1220 on the side of the separate fixed space 129 of driving part 1214.So And reference space 1220 is not generally used in the practice of the present invention.
Reference microphone 1208 is illustrated as when signal microphone 1209 is acoustically coupled to measure chamber 121 and fixation 129 acoustic connection of space.The volume of measured zone 121 can be located at by one or more microphones 1208,1209 based on it Pressure change (alternatively, equally, acoustic signal) that corresponding position in acoustics neighboring region 1290 measures and the electricity provided Subsignal is determined.It can be by exciting phase to be compared with acoustics the response phase at one or more microphones Or be compared with the response phase at the position of another microphone, to execute phase measurement.It is based on by processor 1210 Phase and/or amplitude measurement as discussed below determine the volume of measured zone 121 and conclude therefrom that dispensed chambers 122 volume, the processor obtain electric power from power supply 1211, and the power supply is representatively shown as accumulator.
In order to accurately convey the therapeutic reagent of small quantity, it is expected that being conveyed in each pump stroke small but very accurate The amount of metering.However, if the fluid of micro volume, metering process are pumped by circuit 110 during each pump stroke It is required that high resolution ratio.Therefore, according to an embodiment of the invention, by sensor 550 at least 10 nanoliters of resolution measurement The change of volume.0.01% of the vacant volume for measured zone 121 may be implemented in some embodiments of the invention The measurement of resolution ratio.According to other embodiments of the present invention, sensor 550 provides the resolution ratio better than 13 nanoliters.However other In embodiment, sensor 550 provides the resolution ratio better than 15 nanoliters, and in a further embodiment, provides better than 20 nanoliters Resolution ratio.In this case, the total measurement (volume) of acoustics neighboring region 1290 can be less than 130 μ l, also, in other implementations In example, it is less than 10 μ l.
According to various embodiments of the present invention, it can use to dispensed chambers 122 and subsequent variable volume chamber The first modeling of the volume response of 121 (here, being referred to as " metric space "), the first modeling is based on defeated due to entering Enter the fluid filling dispensed chambers of the pumped volume in portion 123 and carries out.Although other models belong to the scope of the invention, It is the dispensed chambers that the model that may be used will be responsive to pumped incoming fluid and the outlet with fixed flow resistance Fluid volume expression in 122
For baseline volume VBWith by peak displacement VDThe sum of exponential damping volume of characterization, to metering during measurement Cavity volume is characterized as being the function of time t, as follows：
It is surveyed in order to enable the parametrization of modeling exponential damping (or other function models) is fitted to a series of acoustics It measures, such as the response derivation for the system described in Fig. 6 to 9 is as follows.In order to be modeled to response, the feature of port 128 exists In length l and diameter d.The pressure and volume of ideal adiabatic gas can pass through PVγ=K is associated, and wherein K is as at the beginning of system The constant that beginning state limits.
Ideal adiabatic gas law can be by according to average pressure P and volume V and small on those pressure Time-varying disturbs p (t) v (t) and states：
(P+p(t))(V+v(t))γ=K
The equation differential is obtained：
Alternatively, simplification obtains：
If acoustic stress level is more much smaller than environmental pressure, the equation can be further simplified for：
Using perfect gas law, P=ρ RT, and it is provided into following result instead of pressure：
It can be according to speed of soundIt is written as：
Moreover, the acoustic impedance about certain volume is defined as：
According to a group model, it is assumed that all fluids in port essentially as axially reciprocal rigidity Cylinder and in the case of moving, acoustical ports are modeled.It is assumed that all fluids in channel (port 128) are with identical Rate is advanced, it is assumed that the channel has constant cross-section, and enters and leaves caused by the fluid in channel " end effect " quilt Ignore.
It is assumed thatThe laminar flow friction of form, acts on the rubbing action on flowing material in the channel Power can be written as：
Then second-order differential equation can be write out for the fluid dynamics in channel：
Alternatively, according to volume flow rate：
Then the acoustic impedance in channel can be written as：
Using the volume and port dynamics being defined above, acoustic volume can be described by following equation system Sensing system (wherein index k represents loud speaker, and r represents resonator)：
According to identical agreement,And
In addition,
If p2More than p1, then volume tend to accelerate along positive direction.
Equation number is reduced (by p0It is considered as input), and substitute into
A structure is provided using these equatioies
Or
These equatioies can also be expressed in the form of transmission function." intersecting loud speaker (cross-speaker) " transmits letter Number, p1/p0For：
Or
Wherein：
And
Similarly, " cross system " transmission function of the measurement based on the either end to port 128 is p2/p0, under Formula provides：
Use the volume estimation of cross system phase
Similarly, using same principle, it is easy to derive transmission function, using fixed volume chamber 129 via port 128 The pressure in pressure representative fixed volume chamber 129 in the variable volume chamber 121 coupled therewith.Particularly, the transmission Function is：
In any case above-mentioned, system resonance frequency can be expressed as variable volume V2Function：
Because all other parameters are all known, therefore for example can calculate variable volume V based on resonant frequency2, But derive V2Other methods it may be advantageous, and further describe in this application.It is not constant in the equation A parameter be speed of sound a, it can be calculated based on related temperature and either be derived or survey in other ways Amount.
As described, various strategies may be used to inquire the system, to derive volume V2.According to the present invention Some embodiments, the system is excited with single-frequency by driving part 1214, while monitoring one or more converter The response of (microphone 1208 and 1209, Fig. 9).The response is captured as complex signal, keeps the amplitude and phase of pressure change Position.Advantageously, resonance of the single query frequency close to system in mid-stroke, this is because it is thus achieved that for The maximum phase in the entire scope of chamber with volume is emptied to change.
It can be with the response of correction signal microphone 1208, to eliminate due to excitation loudspeaker 1202 (being shown in Fig. 6) or drive Common-mode effect caused by the characteristic of the dependent Frequency of dynamic component 1214 (being shown in Fig. 9).Complex ratio as microphone signal (complex ratio) and obtain correction signal can be expressed as mi, wherein the continuous time sample of index i representation signals This.
Similar to second-order mechanical Helmholz resonance device (Helmholtz resonator), the table in the form of transmission function It reaches, the signal can be represented as：
Here, normalization variable be introduced into, to maintain related parameter be located at order unit in terms of calculating it is useful Dynamics range in.Final expression formula is expressed by real and imaginary parts divided by common denominator.Obtain the ratio of real part μ and imaginary part ν Rate, (that is, phase cotangent),
Error may be defined as：
Wherein N and D respectively represents the molecule and denominator of the model.
If minimizing the error about each model parameter, best fit is realized.Any side may be used Method fitted model parameters.In one embodiment of the invention, minimum value is found using gradient descent method：
For each specific application of the present invention, the interval of each continued time domain sample is obtained, and for being fitted Model in Time Domain parameter and the skip number that samples are advantageously optimized by.When fluid is with slow but relative constant rate stream When dynamic, such as in basal insulin conveying, it has been found that from the period of the τ of τ/3 to 3 sample be effective.In another pole It holds in situation, when conveying the relatively large fluid injected, in the time scale of exponential decay time constant, fluid may be only It is present in the short term in allocation space 122.In this case, it is adopted on the shorter period of characteristic decay time Sample.
According to a preferred embodiment of the invention, based on the cross system phase measurement carried out with single stimulating frequency, according to The fluid volume distributed by allocation space 122 is determined to the fitting of the model of volume versus time.Moreover, in the first of pump stroke During initial portion, with reference to the flow chart shown in figure 117, it is combined progress preliminary surveying with measurement agreement and is operated with calibration system, As described in the present like that.The metering process totally marked by label 1170 is advantageously saved computer resource and is reduced Thus power consumption extends and is charging or replacing the usage time between power supply 1211 (being shown in Fig. 9), while passing through frequency calibration Provide the accuracy of measurement required by trandfer fluid in such a way that every stroke has above-mentioned resolution ratio.
Before each pump stroke or when it starts 1171, or in both cases, processor 1210 starts The self calibration phase 1172 of AVS systems.Without measuring until the electronic transient caused by activating pump has significantly been decayed. In step 1173, with a series of frequency, microphone and speaker gain are set, and driving part 1214 is activated, Wherein five substantially closer to adjacent acoustical area 1290 (or referred to herein as " acoustic chamber ") resonance of generally use Frequency.The frequency within the scope of 6-8kHz is usually used, but the scope of the invention is belonged to using any frequency.Each When the actuating of a successive frequencies starts, in the period of substantially 5ms in, data acquisition is delayed by, until acoustics transition declines substantially Subtract.
For the duration of substantially 64 infrasonics cycle, following gathered data：To by temperature sensing in step 1174 The temperature reading sampling that device 132 (Figure 70 B are shown) provides, and signal microphone 1209 is relative to reference microphone 1208 The real and imaginary parts of the ratio of output signal indicated with ρ and ι are sampled respectively.In order to describe the purpose of AVS systems, signal Complex ratio or microphone signal can be referred to as " letter relative to other functional combinations of the benchmark herein Number ".
Based on the measurement under each frequency carried out in the period of each frequency substantially 200ms, for each Signal real and imaginary parts under a frequency each and a cell mean and variance are derived for temperature reading. The analysis of these numerical value is allowed in step 1175 to determine whether error is located in prescribed limit.Abnormal transmission function Can exemplary system failure, the failure include but not limited to advantageously microphone or other sensors, loud speaker, conversion Failure, bad acoustic seal, excessive environmental noise in device, electronic device, mechanical component, fluid inlet and excess impact And vibration.Additionally, functional dependencies of the phase angle of signal as frequency function are determined in step 1176.Signal Phase angle, i.e. the arc tangent of its imaginary part and real part ratio is used as phase measurement, however within the scope of the present invention Any phase measurement can be used.The letter can be derived by the fitting of a polynomial of phase and frequency or in other ways Number dependence.In step 1177, it is based on the fitting of a polynomial, or in other ways, under cubing frequency really Phase bit carries out cubing to the slope of frequency.Additionally, and importantly, the abnormal slope of phase versus frequency shows It is intended in the fluid contained in dispensed chambers 122 that there are bubbles.
For the following section of each pump stroke, driving part 1214 is activated substantially under single-frequency, thus at this The gas in acoustics neighboring region 1290 is acoustically excited under frequency.In the regulation sampling interval recycled at substantially 64, one As be collected relative to the signal data of the output signal complex ratio of reference microphone 1208 based on signal microphone 1209 and Equalization.The real and imaginary parts and temperature data of the signal are recorded for each sampling interval.Based on by sampling and The data of acquisition, are fitted Model in Time Domain.In various embodiments of the invention, as described above, using gradient decline side Method, to make fitted model parameters during each pump stroke, you can the baseline volume V of volume 121B, peak value position Move VDAnd minimizing the error in die-away time τ, thus the fluid volume conveyed by dispensed chambers 122 is provided.
Referring now to Figure 10, distribution spring 130 can have and the spiral or fan shape of diaphragm complementation and can be with With multiple spiral grooves 131.The embodiment of spring as shown can apply substantially uniform active force on diaphragm.It is this Substantially uniform active force contributes to diaphragm to keep generally concave shape when inflated.Groove 131 allows air freely By spring, therefore most of air are not trapped between spring and diaphragm.
Referring now to Figure 11 A and 11B, for representative basis conveying pulse (Figure 11 A) and conveying is injected for typical case 122 row of slave dispensed chambers that (Figure 11 B) shows the kinetic measurement of the volume of dispensed chambers 122 (shown in Fig. 5) and calculated The example of the cumulative volume gone out.Such as from Figure 11 A as it can be seen that actuating pump 16 causes dispensed chambers 122 in about 2 second time Interior from about 0 to about 1.5 μ l expansions, as measured by acoustic volume sensor 550.Notice resilient dispensing chamber 122 Contract and its fluid is discharged from chamber 122 by high impedance output in the period of about 30 seconds, wherein exponential damping is dynamic Mechanical relationship was by about 6 seconds half-life period (t1/2) characterization.It is calculated from distribution cavity from using the measurement carried out by sensor 550 The cumulative volume that room 122 exports, and it is also noted that it exponentially rises to about 1.5 μ l.It can be found that high impedance output Delay is introduced between actuating pump group part and the most of displacement fluid of conveying.It can be considered that the elasticity applied by dispensed chambers 122 The t of active force and the impedance level of output selection system1/2Characteristic.In various embodiments, time constant can change with It economizes on electricity and eliminates drifting problem.Time constant may, for example, be t1/2=2 seconds or t1/c=2 seconds.
Figure 11 B show to be distributed using the dynamics for injecting fluid conveying of fluid delivery device 10.It is quickly successive big No. about 29 times pump actuating (that is, pulse) moves on to from fluid source by fluid in resilient dispensing chamber 122, therefore causes by acoustics body Corresponding change occurs for the parameter that product measurement sensor 550 measures.It can be noted that the volume of dispensed chambers 122 at first About 1.5 μ l are expanded into pump pulse, which is similar to the numerical value observed in Figure 11 A.Shorter than realizing distribution group Under other pulsation pumping under the pulse spacing in discharge required period completely of part 120,122 volume of dispensed chambers is into one Step expansion；The expansion reaches about 6 μ l of maximum.After about 85 seconds pump surging stop and find the volume of chamber 122 with Exponential damping kinetics relation and reduce, to be discharged completely contained by it with about 30 seconds time after stopping pumping Fluid.The t finally discharged for this1/2It is essentially identical with being conveyed for basis shown in Figure 11 A.It notices and is calculated Accumulation export volume during pumping with substantial linear dynamic behavior increase and when stop pump when reach stable water It is flat.
It in described system, therefore, can be with by cubing rather than by pressure measurement detection failure state Failure is determined in several seconds.Figure 11 C-11F show that the sensor 550 of Fig. 5-7 detects various types of malfunctions.With reference to Fig. 5-7 describes all explanations about Figure 11 C-11F.
Figure 11 C show that 550 the output phase of sensor about pumping pulse is for the power of time in normal operating state Credit cloth.As a contrast, Figure 11 D show the expected results that 120 downstream of allocation component blocks；Sensor 550 is rapidly visited Measure increased (or undiminished) volume of the fluid in dispensed chambers 122.
Low volume state is shown in Figure 11 E-11F.In Figure 11 E, reach substantially maximum sensor signal, then For too fast decaying；The state can illustrate the internal leakage in pump 16, flowline 310 or allocation component 120.Figure 11 F Dynamics distribution with low peak volume signals and can represent failure of pump, vacant liquid storage device 20 or be located at distribution cavity The blocking of 122 upstream of room.Dispensed chambers 122 can also illustrate asking in flowline 310 in response to the delayed expansion of pump actuating Topic.Sensor 550 is also possible to that the bubble in fluid can be detected.Alarm can be activated in response to the detection of malfunction.
Figure 12 shows to describe the flow of the cycle of acoustic volume sensing and compensation (control ring 360 for corresponding to Fig. 2A -3) Figure.Sensor can be measured based on the amplitude of the circulation change in the variable volume chamber 121 induced by pumping circulation from device The Fluid Volume that part 10 distributes.For example, sensor 550 can repeat to obtain resonance variable volume chamber 121 and reference space chamber 127 acoustical frequency spectrum (step 2611) and the parameter for maintaining to pump each pulse, the parameter are updated to combine The volume of gas in variable volume chamber 121 reduces.Correspondingly, the parameter expression being updated comes into dispensed chambers 122 In the net flow scale of construction.When between the pulses exist fully delay when, into the fluid in dispensed chambers 122 be substantially equal to by The volume that device 10 distributes.Alternatively, sensor 550 being capable of gas body of the duplicate measurements in variable volume chamber 121 Product increases, to determine the amount distributed by device (if there is adequately delay between the pulses).Acoustical frequency spectrum and enquiry form In model frequency spectrum compare, which can correspond to bubble, without bubble or the gas with varying dimensions Any one or all (steps 2621) of the dispensed chambers 122 of bubble.Enquiry form can contain to be obtained by testing , using model determine or according to working experience determine data.Enquiry form, which can have to represent to contain, changes gas The data of bubble and/or representative about the normal condition of multiple degrees of expansion of dispensed chambers 122.If frequency spectrum and newer total Be fitted proper flow model (step 2631), then obtain another acoustical frequency spectrum and the repetitive cycling at step 2611.Such as Fruit frequency spectrum and/or newer summation are not fitted proper flow model, it is determined that there are low or blocking flowing (steps 2641).Numerical value or less than the newer summation of the two, variable volume chamber 121 is either set by using less than prediction Constant over range volume can illustrate it is low or block flowing.If detecting low or blocking flow regime, Alarm will be triggered (step 2671).Alarm may include audible signal, vibration or both.If do not found Low or block flow regime, then the device determines whether the frequency spectrum is fitted corresponding to having in dispensed chambers 122 Model (the step 2661) of the state of bubble.If it is determined that there are bubble, then it may include alarm and/or compensation behavior to start Reaction, the compensation behavior may include interim increasing pump rate (step 2651) and described circulating in step 2611 Place starts again at.If it is determined that bubble is not present, then alarm is triggered to illustrate not determined malfunction (step 2671).The embodiment of the present invention can also utilize such as in co-pending U.S. patent application serial no No.60/789,243 The bubble detection using AVS technologies of disclosure, the patent application are bonded to here by reference.
Fluid is actuated to allocation component 120 by the pump 16 of Fig. 2A -3 from liquid storage device 20.When use is according to Fig. 6-7 Allocation component when, it is not necessary to using high-precision pump, because be supplied to by allocation component 120 pump 16 feedback permission base Pump 16 is adjusted in the accurate measurement by delivered volume.Each pumping pulse can have sufficiently low volume to permit Perhaps feedback is based on accurately to be compensated.Therefore many different 16 schemes of pump can be used.Pumping is described below The various possible embodiments of component 16.
Figure 13 and 14 roughly shows replacing for some components in fluid delivery device according to the ... of the embodiment of the present invention For embodiment.Figure 13 shows the flowline 310 with pump 16, and the flowline, which has, is located at upstream one-way valve Pumping element 2100 between 21 and downstream one-way valve 22.Pumping element 2100 can use actuator so that flowline One part deforms, to generate pressure in flowline 310.Upstream one-way valve 21 inhibits from 2100 direction of pumping element The refluence of fluid source (not shown), and downstream one-way valve 22 inhibits falling from volume sensing chamber 120 to pumping element 2100 Stream.As a result, fluid is driven along the direction of spout assembly 17, the spout assembly is logical including high impedance in one embodiment Road.
In the alternate embodiments shown in Figure 14, the function of pumping element is executed by combined valve pump 2200, that is, Pressure is generated in flowline 310 and upstream one-way valve 21.Therefore, the pump 16 in Figure 14 embodiments is by two A component is formed, that is, combined valve pump 2200 and downstream one-way valve 22, not for three components in Figure 13 embodiments.It can To use the other embodiments of pump 16.The combination of valve and pump function can be by various machines in valve pump 2200 Structure realizes that some of them are described below with reference to Figure 15 A-16 and 22-56.
In many embodiments being described below, for inlet valve 21 poppet, for outlet valve 22 poppet with And directly or indirectly (for example, such as in Figure 50-56) is connected to pumping actuation component 54 with flowline 310, to Each of these elements can form various Fluid pressures or react for various Fluid pressures.Such as above Pointed, upstream and downstream valve (being referred to as inlet and outlet valve here) is check valve.In other types of check valve In, the valve can be volcano valve (volcano), flapper valve, check-valves or duckbill valve, or be exported towards device The other types of valve of bias current.It is the U. S. application No.5,178,182 for authorizing Dean L.Kamen on January 12nd, 1993 In disclose the example of volcano valve, which combines herein by reference.
In the embodiment shown in Figure 15 A-15D, pump includes inlet valve 21 and outlet valve 22, wherein each Valve includes that (for each valve, movable part is diaphragm 2356 for fluid inlet, fluid outlet and movable part One part).Pump further includes pumping element 2100.Pumping element is located on 21 downstream of inlet valve and outlet valve 22 Trip.In the following description, outlet valve is since closed position, that is, fluid is without flow through outlet valve.However, being carried when fluid When for enough pressure, by applying pressure on the poppet 9221 of diaphragm and outlet valve to open valve so that fluid pressure Power opens the outlet valve, and then fluid can flow through outlet valve 22.Single mechanical action not only blocked pump inlet but also into And be forced through under the meaning of pump discharge flowing, the embodiment of Figure 15 A to 15D is considered combined valve pump (as schemed Object 2200 in 14).
This pumping installations has the opposite side that movable part and wetting line components are separated into flexible barrier diaphragm 2356 The advantages of.As a result, movable part can in reusable component and wetted portions (flowline 310) can be located at it is primary In property component.
In the preferred embodiment of pumping mechanism, fluid source is non-pressurized reservoir.At the movable part of inlet valve In open position and in pumping chamber, there are pressure when negative pressure, existed from liquid storage device towards inlet valve aspiration fluid Difference.The diaphragm in pumping chamber can be utilized is resiliently formed the negative pressure.In an alternate embodiments, it can be built in Spring in diaphragm can be used for assisting rebounding for the diaphragm in pumping chamber.Non-pressurised liquid storage device can collapse, Its volume is reduced to be collapsed accordingly when from liquid storage device aspiration fluid, in liquid storage device.As a result, preventing in liquid storage device Form negative pressure or air.
In the preferred embodiment of pumping mechanism, after inlet valve closing, pressure is applied to pumping chamber with from pump Send chamber towards outlet valve actuating fluid.The pressure formed by pumping motion opens outlet valve and fluid is allowed to flow through The fluid outlet of mouth valve.
Movable part can be any part that can be played a role as described above.In some embodiments, it moves Component is flexible partition or elasticity pumping film.In other embodiments, movable part is spherical rigid structure or can Prevent fluid from another object of the opening outflow in fluid path.
In practice, pumping mechanism can be perfused before the use.Therefore, pumping mechanism is followed by multiple strokes Air is discharged from flowline in ring, until most of or all air in flowline is discharged.Because pumping Fluid volume that exterior thereto has but between valve is small, therefore many pumping mechanisms disclosed herein have The ability of " from being perfused ".When pump actuates the air in pump chambers, it basically forms enough pressure to pass through outlet valve.With Therefore backward stroke afterwards can form enough negative pressure so that pumping from liquid storage device pumping liquid.If " dead " appearance of pump Product is too big, then the air in pumping chamber cannot form enough pressure to be escaped from outlet valve.As a result, pump may stop Operation.
Figure 15 A-15D, 16 and 22-56 show multiple embodiments of pumping mechanism.Referring now to Figure 15 A-15D, show to pump One embodiment for sending mechanism, with multiple steps in example pumping procedure：1. fluid is by inlet valve 21 (such as Figure 15 B institutes Show)；2. inlet valve closes (as shown in figure 15 c)；With 3. when Fluid pressure opens outlet valve 22 54 direction of pumping actuation component Downstream actuating fluid and flow it through fluid outlet (as shown in figure 15d).
The pumping mechanism of Figure 15 A-15D includes movable part, the movable part be in this embodiment it is flexible every One part of film 2356.Inlet valve and outlet valve include the poppet 9221,9222 as valve blockage device.Poppet 9221,9222 and pump actuating member 54 each include spring 8002,8004,8006.Pump plate 8000 is attached to pump actuating Component 54 and import poppet 9221 and as the terminal of its respective spring 8004,8002.
Term " poppet " applies pressure to influence diaphragm position for indicating towards movable part (that is, diaphragm) Component.Although other designs can be used, it is described below and is carried using the spring loads of structure and principle with mechanical advantage Some particular examples of lift valve valve (in conjunction with Figure 50-56).However, mechanism in addition to a poppet can be used in executing phase Congenerous.In Figure 15 B-15D, inlet valve 21 includes fluid inlet and fluid outlet, a part for diaphragm 2356, Yi Jiti Lift valve 9221.Outlet valve 22 includes fluid inlet, fluid outlet, a part for diaphragm and poppet 9222.
In the embodiment shown in Figure 15 A-15D, by that can be rigid or have certain flexibility (preferably soft Degree is less than diaphragm 2356) structure (object 9310 in Figure 15 A) limit fluid path 310.As shown in fig. 15, shell knot Structure 9310 defines valve chamber 9321,9322 and pumping chamber 2350；These three all chambers are respectively positioned on fluid path In 310.
Referring now to Figure 15 B-15D, inlet valve 21, outlet valve 22 and pump element 2100 all have fluid inlet and fluid Outlet.Pumping actuation component 54 has the pumping chamber 2350 that fluid flows here after leaving inlet valve.Pumping actuation Component 54 applies pressure on diaphragm 2356, and normal pressure is formed in flowline.
As shown in Figure 15 B-15D (and similar for the valve seat 4070 for outlet valve shown in Figure 50-56), works as diaphragm When not activated by the poppet of inlet valve 9221, the valve seat 9121 in inlet valve 21 is preferably separated with diaphragm 2356.
Flowline 310 is locally limited by diaphragm 2356.In this embodiment, diaphragm 2356 is by the one of pumping mechanism A little parts are detached with fluid.Therefore, flowline 310 is wetted and pumping actuation device 54 and valve poppet 9221,9222 It is not wetted.However, the alternate embodiments of pump need not include the diaphragm 2356 contacted with flowline 310.Phase Instead, different movable parts can be used for valve and/or pump.In a further embodiment, flowline 310 is only Some parts are detached with pumping mechanism, therefore locally soak pump.
Import poppet 9221 includes end 8018, which indicates the import of the membrane portions of contact flow pipeline 310 The surface region of poppet.Pumping actuation component 54 includes the end 8012 of the membrane portions of contact flow pipeline 310.Equally Ground, outlet poppet 22 include the end 8022 of the membrane portions of contact flow pipeline 310.The end 8018 of valve poppet, 8022 apply pressure, blocking or the corresponding portion for opening flow path 310 on its corresponding region of diaphragm 2356.Pressure The end 8012 of actuating member also applies pressure on the corresponding region of diaphragm, so as to cause the stream of flowline 310 is passed through It is dynamic.
Pumping actuation component 54 is surrounded by plunger bias spring 8004.Plunger bias spring 8004, which has, is located at pump plate 8000 and the terminal at 8014 and also keep pumping actuation component support construction.
Import poppet 21 promotes valve spring 8002 by import and surrounds, but in alternative embodiments, import poppet Itself it is elasticity and therefore the function of spring is provided.Import promoted valve spring 8002 have be located at pump plate 8000 at And the terminal close to the end 8018 of import poppet 9221.
Outlet poppet 9222 promotes valve spring 8006 by passive outlet and surrounds.Outlet, which promotes valve spring 8006, has position The terminal of valve plate 8024 and the lip convex 8020 of the end of close outlet poppet 9222 are promoted in outlet.
In each case, spring 8002,8004,8006 terminated before corresponding end and do not interfere contact every The surface region 8018,8012,8022 of film 2356.
In a preferred embodiment, fluid pumping devices further include as temperature changes at least one shape memory of shape Actuator 278 (for example, conductive shapes memory alloy wires).Heater can be utilized, or more conveniently by application electric current And change the temperature of shape memory actuator.Figure 15 B-15D show tool, and there are one the embodiments of shape memory actuator 278, so And (being described below) may exist more than one shape memory actuator 278 in other embodiments.Implement at one In example, shape memory actuator is to utilize the shape memory wire of nickel/titanium alloys construction, such as NITINOLTMOrHowever, in other embodiments, it is possible to use any device of power, such as helical can be acted Pipe.In certain embodiments, shape memory actuator 278 is with about 0.003 inch of diameter and about 1.5 inches Length.However, in other embodiments, shape memory actuator 278 can be by any alloy that heat can be utilized to shrink Be made (and expand can by alloy apply active force to by the mechanism of alloy tensile to initial length assist into Row, i.e. spring, but this mechanism is not essential), to activate pumping machine like that in embodiment as described herein Structure.In certain embodiments, the diameter of shape memory actuator 278 can be from 0.001 inch to required any diameter simultaneously And length can be required any length.In general, diameter is bigger, obtainable contraction power is higher.However, for adding Electric current required by thermal wire will usually increase with diameter.Therefore, the diameter of marmem 278, length and component It can influence for activating the electric current needed for pumping mechanism.It is unrelated with the length of shape memory actuator 278, actuation force Constant.Increasing for actuation force can be generated by increasing the diameter of shape memory actuator 278.
Shape memory actuator 278 is connected to pump plate 8000 by connector 8008.Description connects in greater detail below Connect device 8008.Shape memory actuator 278 is connected to fluid pumping devices by terminal connector 8010.According to wherein using The device or system of pumping mechanism, terminal link position will change.Terminal connector is described in greater detail below 8010。
Figure 15 B-15D show the flowline 310 being poured as discussed above and pumping mechanism.Referring now to figure 15B, inlet valve 21 is opened, and pumping actuation component 54 is not pressed on diaphragm 2356.Outlet valve 22 is in the closed position In.Shape memory actuator 278 is in expanding position.In the configuration, fluid by from liquid storage device (not shown) be drawn into Mouth 21 fluid inlet of valve.Although (being shown as the protuberance in the diaphragm in inlet valve region, aspiration fluid can in this step To cause diaphragm to be recessed or diaphragm does not deform).When import poppet is in an open position, fluid can be from fluid Inlet flow is to fluid outlet and enters pumping chamber 2350.At this point, outlet poppet end 8022 be compressed tightly against every On film 2356 and seal outlet valve 22.
Below with reference to Figure 15 C, electric current has been applied to shape memory actuator 278, and shape memory actuator is from opening Beginning length is shunk towards required final lengths.The contraction of shape memory actuator 278 pulls pump plate towards flowline 310 8000.Import poppet 9221 and pumping actuation component 54 are each connected to pumping plate 8000.The movement of plate 8000 is towards diaphragm 2356 pull import poppet 9221 and pumping actuation component 54.As shown in figure 15 c, import poppet end 8018 is secured Ground is pressed on diaphragm 2356, by diaphragm seal to valve seat 9121 and closes inlet valve 21.(movement of import poppet can Actuate in import valve cavity room, i.e. the small amount of fluid in object 9321 in Figure 15 A flow through inlet valve 21 fluid inlet or Person's fluid outlet.)
Simultaneously, pumping actuation component 54 starts its path towards pumping chamber 2350.During the process, when into Mouth promotes (at this point, import poppet end 8018 is pressed securely onto flowline 310) when valve spring 8002 is compressed, pump Plate 8000 and pumping actuation component 54 continue to advance towards flowline 310.Import, which promotes valve spring 8002, allows pump plate 8000 As pump actuating member 54 continues to move towards flowline 310, even if when import poppet 9221 is no longer able to advance.
Referring now to Figure 15 D, pumping actuation component 54 is pressed onto the region on pumping chamber 2350 of diaphragm 2356 simultaneously And fluid is pumped, to increase the pressure of the fluid in pumping chamber 2350.Poppet end 8022 is exported to keep securely It is pressed in (under the auxiliary that outlet promotes valve spring 8006) on diaphragm 2356, to seal the fluid inlet and stream of outlet valve 22 Body exports, until the pressure of the fluid flowed out from pumping chamber 2350 forces outlet valve 22 to be opened.When reaching enough pressure, Fluid is left by the fluid outlet of outlet valve 22, therefore overcomes the pressure that outlet valve 22 applies diaphragm 2356.Work as flowing When stopping, passive spring 8006 forces outlet valve 22 to be closed.
During driving stroke, pump actuating member spring 8004 is loaded.Finally, pump actuating member spring 8004 will be drawn Dynamic pump actuating member 54 is far from diaphragm 2356.As a result, during relaxation stroke, spring 8004 will pump actuating member 54 and pumping Plate 8000 returns to the slack position of Figure 15 C；Energy can also be provided for backward stroke by loading import promotion valve spring 8002 Amount.When pumping plate 8000 is close to its slack position, it engages the end cap of import poppet 9221 to lift import poppet And it is pulled away from pedestal, to open inlet valve 21.Actuating member spring 8004 is pumped during backward stroke to be also unloaded.
When reach wherein import promoted valve spring 8002 be in the threshold values of 8000 phase same level of pump plate apart from when, will be sharp Pump plate 8000 is unloaded with pump actuating member spring 8004.Elastic diaphragm 2356 in pumping chamber 2350 by back to it Starting position.This forms negative pressure, and when inlet valve is opened, fluid will be flow to by the fluid inlet of inlet valve Body is exported and is flowed towards pumping chamber 2350.Therefore, pumping mechanism will now be in state as shown in fig. 15b.
When activating pump by applying electric current to shape memory actuator 278 every time, repetition is retouched about Figure 15 B-15D The whole pump sequences stated.
So-called diaphragm includes diaphragm 2356 herein, can be by that can generate necessary characteristic to as herein Any elastic material to play a role as description is made.Additionally, diaphragm material may include biocompatible material, from Without hindering the operation of pump or reducing the therapeutic value of fluid.A variety of biocompatible elastic materials may be appropriate, packet Include nitrile and silicones.However, different treatment fluid components may require selecting different elastic materials.
Above-mentioned pumping mechanism can be described according to length of stroke various embodiments as described herein.Determine punching A kind of mode of Cheng Changdu is using shape memory actuated during the cycle that shape memory actuator is shunk and is expanded Total variation of device length.The difference will determine the total distance that pump rod is advanced and it is thus determined that outflow inlet plenum 2354 and Flow to pumping chamber 2350, outlet chamber 2352 and the fluid total volume for finally flowing out outlet chamber 2352.Determine length of stroke Another way be pump plate 8000 travel distance.For pratial stroke, pump plate 8000 will be not up to it maximum advance away from From.In one embodiment, either micro- stroke is continuously enabled following system initialization in a manner of continuous or rule from storage the stroke of very little Liquid device pump microlitre volume fluid to export.For example, micro- stroke can shift the pump chamber less than 20%, 10% or 1% The volume of room 2350.
Figure 16 shows the modification of the pumping mechanism embodiment shown in Figure 15 B.In figure 16, using two different shapes Longer one and shorter one of memory actuator-.Figure 16 shows the embodiment of pumping mechanism shown in Figure 15 B, wherein shape Shape muscle wire 278 is tensioned around pulley 286 and splits into longer strand and shorter strand.Public affairs as negative terminal Junction can be located at the position that longer and shorter strand divides altogether.Utilize two alternative paths any or two Circuit that is a and realizing allows to adjust pump action power and/or length of stroke.In alternative embodiments, material piece, such as Kevlar materials extend to active force plate 8000 around pulley from common junction, and the shape memory wires of two separation from Common junction extends to its corresponding support element.By using two conducting wires with different length, these embodiments provide Pumping mode and exhaust mode as be described below.
About using shape memory actuator variable to change stroke, for the shape memory actuator of given length, stroke Number dependent on variable：1. the total time of energization/heating；2. total voltage；With the diameter of 3. shape memory actuators.Scheming Some various embodiments are shown in 17-19.However, in some embodiments it is possible to keeping length, conduction time and voltage While change stroke.These embodiments include multiple shape memory actuators on a shape memory wire (see Figure 19) With multiple switch (see Figure 17).It as discussed above, also can be by changing stroke needed for any one or the acquisition of multiple variables Length.
Additionally, the timing of shape memory actuated heating or energization can be changed to control stroke.Shape memory causes Dynamic device can be considered as a pulse by heating every time.Such as the factor of pulse frequency, pulse duration and length of stroke can be with Influence the amount of the fluid conveyed in certain time.
Figure 17-19 additionally describes the embodiment of the pump with fluid pumping pattern and exhaust mode.When being caused When dynamic, the compression that exhaust mode applies application and/or increase displacement that component is applied with active force enhancing by active force is rushed Journey.Exhaust mode can be activated based on the related situation in pump with air or understanding.For example, Can when pipeline is attached to liquid storage device, when by sensor, either sensor device detects bubble or when passing through When sensor or sensor device detect insufficient flow, exhaust mode is activated.Alternatively, described two patterns can be used It is selected between shifting smaller and large volume of fluid in the pumping pulse to giving.
Referring now to Figure 17, briefly showing being activated using shape memory actuator 278 and there are multiple operation modes Pump.When pumping chamber 2350 is filled fluid, pump is operated with fluid pumping pattern.It is pumped in fluid During pattern, electric current flows between negative electricity lead 2960 and positive electrical lead 2961, causes alloy shape memory actuator 278 Resistance heating and thus lead to phase change and power stroke.In one embodiment, pumping mechanism be perfused during or Person when suspect in pumping chamber 2350 there are when bubble 2950, exhaust mode is activated and electric current is along in negative electricity lead The path flowing that length extends between 2960 and positive electrical lead 2965；The result is that with higher active force compression stroke and The displacement that active force applies component 2320 should be enough air 2950 being displaced to pump discharge 2370 from pumping chamber 2350. In alternate embodiments, positive and negative lead can overturn.
Referring now to Figure 18, briefly showing the alternative pumping of the shape memory actuator 278 with multiple equal lengths Component.Other actuator for example can be used to increase the actuating pressure on pumping chamber 2350, to eliminate flowline, pump Send blocking or bubble of the chamber either in other regions of pumping mechanism.Other actuator can also be to any pump feeder Part provides spare.Single shape memory actuator can generate enough active forces to eliminate bubble from pumping chamber. Additionally, in the embodiment shown in Figure 18, according to the length of the second shape memory actuator, return spring in addition may It is necessary.
When liquid storage device is attached to the flowline with pump first, the pumping mechanism (object in Figure 13-14 Part 16) usually it is filled with air.Due to various reasons, air can also enter pumping mechanism in the normal operation period.Because empty Gas is more easily compressed than fluid, so if there are large quantity of air in flowline, application, which has, to be enough to shift fluid The compression stroke of length may be not enough to generate enough pressure, with the Opening pressure of customer service pumping mechanism check valve.Phase Ying Di, pumping mechanism may stop operation.However, during perfusion or working as in pump harmlessly in the presence of a small amount of empty When gas, it may be desirable to force air through pipeline.Therefore, the embodiment shown in Figure 18 can be used in generating volume in this case Outer active force.
Figure 19 briefly shows the alternative pump 16 with multiple shape memory actuators.The first, shorter shape Memory actuator 2975 has the first electrical lead 2976 and the second electrical lead 2977.Shorter actuator 2975 can generate foot To shift the compression stroke of the fluid in pumping chamber 2350；Shorter shape is used during normal fluid pumping mode operates Shape memory alloys actuator 2975.When illustrating exhaust mode or requiring larger pumped fluid volume, can pass through It is longer using second along the actuator length transmission electric current being placed between the first electrical lead 2973 and the second electrical lead 2972 Shape memory alloy actuator 2970.It is included between the first electrical lead 2972 and the second electrical lead 2971 by being formed Short circuit of power path, longer shape memory alloy actuator 2970 are also used as grasping for fluid pumping pattern The standby actuator of work.Shorter shape memory actuator 2975 can be also used for changing stroke capacity in the fluid of reduction Preferably control is provided under volumetric rate.The multi-modal actuator of Figure 17-19 is not limited to the pumping element shown in and is used together, But can be used together with any one of the various embodiments of pumping mechanism described herein, the embodiment includes making With those of fluid pumping devices as be described below and use those of valve pump as be described below.Therefore, By the way that required length of stroke can be formed to length shapes memory actuator energization/heating of length of stroke needed for offer.
Referring now to Figure 20 A and 20B, each shows one embodiment for attachment shape memory actuator.This A little different embodiments can be used in any mechanism or device for wherein using shape memory actuator 278 described here In part.With reference to figure 20A and Figure 20 B, shape memory actuator 278 is fed in grommet 280.Then grommet 280 is attached to portion Part 284.Although only showing two embodiments of the attachment pattern, various other patterns are used in other embodiments. Other patterns that grommet is attached to a part or any fixed position can be used.
Referring now to Figure 21 A and 21B, show to be attached the shape memory actuator 278 for pumping mechanism 16 two show Example property embodiment.In each of these embodiments, shape memory actuator 278 is designed to rotate around pulley 286. With reference to figure 21A, shape memory actuator 278 is attached to the preferably part 288 made of KEVLAR materials grommet 280.Shape One end of shape memory actuator 278 is illustrated as being attached to component 284 by positioning screw device 289.Referring now to figure An end of 21B, shape memory actuator are illustrated as being attached to component 284 by grommet 280.
The various embodiments of pumping mechanism shown here.Pumping mechanism may include inlet valve, pumping actuation component and Outlet valve.As discussed above, different types of check valve can be used in alternate embodiments.Although Figure 15 A-15D are shown Skeleton diagram show one embodiment, attached drawing below shows alternate embodiments.
Referring now to Figure 22 and Figure 23, the side view and section of one part of pumping mechanism are shown.In this embodiment, Pumping actuation component is pumping elongate finger member part 32.When active force is applied in finger 32, finger 32 is depressed removable Dynamic component and the internal volume for reducing flowline.
The part of pumping mechanism in Figure 22 and 23 only shows pumping chamber.When with the check valve (object 21 in Figure 13 With it is 22) combined when, to movable part 23 apply deforming force, force fluid towards spout assembly (not shown) flow. As depicted in figures 22 and 23, finger 32 is point to concentrate active force, but in other embodiments, finger 32 can be Flat or any other suitable shape.Spring 31 is used for relative to elastomeric element 23 towards retracted position biasing fingers 32, in the case of no applications active force finger 32 return to retreat, decompressed position.As shown in figure 23, motor It can be used for active force being applied in finger 23.However, in other embodiments, using shape memory actuator.Respectively The motor of type is appropriate, including motor and piezo-electric motor.
With reference to figure 22 and 23, by preventing movable part 23 from offing normal in response to applying active force by finger 32, only It returns device 33 and limits the potentially traveling of finger 32, support movable part 23, and ensure to reduce flowline or pumping chamber Volume.As shown in figure 22, backstop 33 can advantageously have the shape complementary with elastomeric element 23.In various embodiments In, pump 16 may include that either the crank lever or crank are driven by a motor lever on one end, and Elasticity of compression component 23 at the other end.
Referring now to Figure 24, another embodiment of a pumping actuation component shown partially about pump.Motor Or shape memory actuator (not shown) applies rotating force to the protrusion 42 of one group of connection.These protrusions 42 are used as pump It send actuating member and sequentially applies active force to movable part 23.Correspondingly, active force intermittent pulse is applied to removable Dynamic component 23.Backstop 33, as shown, can advance in shell 44 and upward towards elastomeric element 23 by spring 46 Bias.
Referring now to Figure 25, the active force with pumping actuation component (being plunger here) 54 in plunger barrel 52 is shown Apply the embodiment of component.Motor causes plunger 54 alternately to retract and be inserted into plunger barrel.When plunger 54 is retracted, negative pressure Fluid is drawn into from liquid storage device (not shown) in channel 51 and inner cavity 56 by power.When plunger 54 is inserted into, (not with check valve Showing) the increased pressure that is combined drives fluid towards allocation component (not shown).Inner cavity 56 connects via interface channel 58 The volume of channel 51 and plunger tube inner chamber 56 is connected to as the reeve of plunger 54 acts and reduces, thus actuating fluid passes through Flowline 310.
Figure 26 and 27 shows another embodiment, and wherein pumping actuation component is plunger 54.Force application assembly and including Shape memory actuated 278 linear actuators drives plunger 54.In fig. 26, shape memory wire 278 is in low temperature, expansion In state and it is attached to the first support element 241 and plunger attachment end cap 244.End cap 244 is then sequentially attached to biasing spring 243, the biasing spring is sequentially attached to the second support element 242.When conducting wire 278 is in swelling state, biasing spring 243 In relaxed state.Figure 27 show shape memory actuator 278 due to guiding line 278 apply electric current and simultaneously heat and be in In contraction state.When deflated, active force is applied on end cap 244, so as to cause the insertion campaign of plunger 54 and corresponding Pump action.In contraction state, biasing spring 243 is in high potential energy state.When stopping applying electric field, Nitinol Conducting wire 278 is cooling again and expands, to allow biasing spring 243 that plunger 54 is retreated state back to it.Such as Figure 21 A- Shown in 21B, shape memory actuator 278 can surround one or more pulleys and wind.
Figure 28-30 shows various embodiments, wherein forming pumping chamber by using the compression of shape memory actuator 278 Movable part pumping actuation component 54 realize pumping.Pumping chamber is defined by check valve 21,22.Figure 28 is shown Wherein pumping actuation component is the embodiment of the pumping mechanism of the plunger 54 in plunger barrel 52.The mechanism further include lever 273, Fulcrum 274 and shape memory actuator 278.Shape memory actuator 278 is maintained in shell 298 and at one End is attached to conductive support 279 and is attached to the plus end 275 of lever 273 in the other end.Lever 273 then sequentially exists It is attached to fulcrum 274 at its center and is attached to plunger 54 at the second end.Apply electric current to cause electric current flowing logical Terminal 275, shape memory actuator 278 and conductive support 279 are crossed, shape memory actuator 278 is thus caused to be received Contracting causes lever 273 to be shunk back around the pivot of fulcrum 274 and the effective of plunger 54.Power-off allows cooling shape memory actuator 278, allow it to expand.Return spring 276 is acted on via lever 273, and plunger 54 is returned to the insertion position in plunger barrel 52 It sets.Return spring 276 is maintained in shell 277.O-ring 281 prevents fluid from being revealed from 52 component of plunger 54- plunger barrels. It the insertion of plunger 54 and shrinks back and causes fluid along the orientation by two check-valves (the first check valve 21 and the second check valve 22) Determining direction flows through flowline.Any backflow preventer part appropriate can be used, it includes check valve, non-return Valve, duckbilled valve, flapper valve and volcano valve.
Figure 29 shows there is plunger 54, plunger barrel 52 and the force application assembly for including shape memory actuator 278 Pumping mechanism another embodiment.However, the embodiment unlike shown in Figure 28, which does not include lever.Shape is remembered Recall actuator 278 to be maintained in shell 298 and be attached to conductive support 279 an end and in the other end lead to It crosses contact 275 and is attached to plunger end cap 244.Plunger end cap 244 is attached to plunger 54.Once applying abundance by contact 275 Electric current, then shape memory actuator 278 shrink.This contraction causes the pulling on plunger end cap 244, to realize column Plug 54 is inserted into plunger barrel 52.Power-off allows cooling shape memory actuator 278, it is thus allowed to expand.When conducting wire expands When, return spring 276 plays a role so that plunger 54 to be returned to the retracted position in plunger barrel 52.Return spring 276 is kept In shell 277.O-ring 281 prevents fluid from being revealed from 52 component of plunger 54- plunger barrels.The insertion of plunger 54 and shrinking back causes Fluid flows through flowline along the direction determined by orienting the first check valve 21 and the second check valve 22.
Referring now to Figure 30, the embodiment of the pumping devices using plunger 54 and plunger barrel 52 is shown.In the embodiment In, form is the shape memory actuator 278 of the conducting wire in the axis in plunger 54 for applying active force on plunger. Shape memory actuator 278 extends to support base from plunger end cap 272 by the axis in plunger 54 and by channel 58 299.O-ring 281 and 282 sealed plungers 54, plunger barrel 52 and channel 58.Apply to the first lead 258 and the second lead 257 Electric current causes shape memory actuator 278 to heat, this causes shape memory actuator 278 to shrink.Shape memory actuator 278 Contraction down force is applied on plunger end cap 272, which is enough to overcome return spring 276 Thus upward biasing force drives plunger 54 to enter in the inner cavity 290 of plunger barrel 52.The expansion of shape memory actuator 278 is permitted Perhaps plunger 54 is returned to retracted position by return spring 276.The insertion of plunger 54 and shrinking back causes fluid along by orientation the One check valve 21 and the second check valve 22 and determine direction flow through flowline.
Figure 31 shows the alternate embodiments of pumping mechanism.Pumping actuation component combination liquid storage device and pumping mechanism The component 101 of function.Under the order of controller 501, motor 25 drives plunger 102 to form pressure in liquid storage device 104, Thus the first check valve 106 is forced a fluid through.Bullet of the fluid subsequently into the volume sensing component 120 with sensor 550 Property dispensed chambers 122, and it flow to spout assembly 17.It may include optional second check valve 107.Via controller 501 Feedback control between sensor 550 and motor 25 ensures that required fluid flow to patient.First check valve 106 is used for The elastic acting force due to the dispensed chambers 122 of volume sensing component 120 is prevented when chamber is filled and is expanded and makes stream Body reverse flow.Second check valve 107 is for preventing fluid from spout assembly 17 or 12 reverse flow of patient to distribution cavity In room 122.In this embodiment, sensor 550 can detect the volume in dispensed chambers 122 immediately.
Figure 32-34 briefly shows the section view of combined valve pump 2200.Figure 32, which shows to have to be located at before actuation, to stop It has a rest the collection chamber 2345 of position and the valve pump 2200 of pumping chamber 2350；Figure 33 shows to be in during compression stroke and cause Valve pump 2200 in dynamic state；And Figure 34 shows the pump in actuating state at the end of compression stroke.Pump inlet 2310 with the upstream fluid fluid communication of such as liquid storage device and are connected to the first end in channel 2360.Channel 2360 exists Collection chamber 2345 is connected at the second end, the collection chamber and 2390 fluid of fenestra being placed in elasticity pumping film 2340 Connection.Collection chamber 2345 by elasticity pumping film 2340 and pumps diaphragm 2330 by elasticity on the second side on the first side It defines.In a variety of materials, pumping diaphragm 2330 can be made of latex or silica gel.Pump is led in the downstream side of fenestra 2390 Send chamber 2350.During charge pump and between actuation cycle, fluid is advanced through pump from the fluid source of such as liquid storage device Then import 2310, channel 2360, collection chamber 2345 and fenestra 2390 reach pumping chamber 2350.Check valve 22 prevents Fluid leaves pumping chamber 2350 via pump discharge 2370, until and unless sufficient Fluid pressure is applied to check valve On 22 so that until check valve 22 is opened.In Figure 32, pumping actuation component 2320 is shown in rest position, and And elasticity pumping diaphragm 2330 is shown in the relaxation construction with minimal surface region, thus maximises collecting chamber The volume of room 2345.Although in this embodiment, pumping actuation component is illustrated as spherical shape, in other embodiments, pumping causes Dynamic component can activate and apply sufficient active force to elasticity pumping diaphragm 2330 to appoint to activate pumping mechanism What actuating member.
Such as from Figure 33 as it can be seen that when during compression stroke activate pumping actuation component 2320 when, pumping actuation component 2320 It advances initially towards the fenestra 2390 of elasticity pumping film 2340 and dilatational elasticity pumps diaphragm 2330, so as to cause having received Collect the reverse flow of fluids in collection chamber 2345.Later in active force applies stroke, as shown in figure 34, pumping actuation component 2320 will in a sealing fashion send elasticity pumping diaphragm 2330 to fenestra 2390.For auxiliary seal, pumping actuation component 2320 can have the shape with the shape complementation of fenestra 2390.For example, pumping actuation component 2320 can be it is spherical or Taper and fenestra 2390 can be cylindricality through-hole.Apply this stage of stroke in active force, from pumping chamber 2350 Refluence will be suppressed.Pumping actuation component 2320, which continues on, will make elasticity pumping film 2340 deform and increase pumping chamber Pressure in 2350, while continuing to seal fenestra 2390 to prevent from flowing backwards from pumping chamber 2350.When in pumping chamber 2350 When pressure applies sufficient Fluid pressure to check valve 22, fluid will flow through pump discharge 2370 from pumping chamber 2350.It is returning During backward stroke, pumping actuation component 2320, elasticity pumping diaphragm 2330 and elasticity pumping film 2340 are shown back to Figure 32 Slack position.During backward stroke, the internal pressure of pumping chamber 2350 and collection chamber 2345 will decline, this will lead to Inducing fluid is crossed to flow through pump inlet 2310 and channel 2360 from fluid source and promote again to fill out valve pump 2200 It fills.
Referring now to Figure 35, the outline section view of one embodiment of elasticity pumping film 2340 is shown.Diaphragm ontology 2515 can be by the elastomeric materials of such as silica gel.Can also include diaphragm spring 2510 with to flexible or be bullet The ontology 2515 of property assigns elasticity.Diaphragm spring 2510 can be embedded in elasticity pumping film 2340 or close to elasticity pumping film 2340 and arrange.The example of one embodiment of diaphragm spring 2510 is shown in FIG. 36.It includes conformable material that can use Diaphragm ontology 2515 and diaphragm spring 2510 including elastic material combination；As a result, pumping film 2340 is when contact High sealing characteristic will be presented simultaneously when being pumped the elasticity pumping diaphragm 2330 of actuating member (being not shown, see Figure 32-34) deformation And also there is high flexibility.Valve seat 2517 can surround fenestra 2390 and position.Valve seat 2517 may be used as elasticity pumping The receiver of the deformed part of diaphragm 2330.Active force, which applies component 2320, can be such that pumping diaphragm 2330 deforms, so as to cause Diaphragm 2330 deforms and contacts valve seat 2517 in a sealing fashion.If applying enough active forces, valve seat can elasticity change Shape is to ensure thoroughly to seal to prevent reverse flow of fluids.Depth of section and the section of valve seat 2517 usually can differently be selected The ratio of width makes it match with flowing environment.
Referring now to Figure 36, the example of the diaphragm spring 2510 in the pumping film 2340 for Figure 35 is shown.External anchor ring 2520 pass through at least three elastic arms 2530 with internal anchor ring 2540 connects.The center of internal anchor ring 2540 has spring eye 2550, the spring eye can be directed at the fenestra 2390 of pumping film 2340 as shown in figure 35.
Referring now to Figure 37, show a skeleton diagram, the skeleton diagram with including pumping actuation component 2320, actuator and The force application assembly of lever 273 shows that the section for the valve pump 2200 being shown in front in Figure 32-34 regards combinedly Figure.When being encouraged by the actuator of such as shape memory actuator 278, lever 273 is pivoted around fulcrum 274 to start compression Stroke.Hammer body 2630 is protruded from lever 273.During compression stroke, hammer body 2630 contacts the pumping actuation component of sphering 2320, cause pumping actuation component to be advanced in the gap of support construction 2660, and pumping actuation component 2320 is pressed to Elasticity pumping diaphragm 2330, until pumping actuation component 2320 is remained in a sealing fashion in elasticity pumping film 2340 Fenestra 2390.When lever 273 continues on, pumping actuation component 2320 causes to pump the deformation of film 2340.When enough stream When body pressure is applied on check valve 22, check valve 22 is opened.This permission fluid is flowed through from pumping chamber 2350 to be pumped out Mouth 2370.When shape memory actuator 278 cools down, the elasticity of pumping film 2340 and the elasticity of pumping diaphragm 2330 will cause Lever 273 returns to the starting position determined by lever stop part 2650 and lever brake component 2640.Alternatively, return bullet Spring (not shown) can be used for lever 273 returning to starting position.Although illustrated as sphere, but active force applies component 2320 can be alternatively the raised or other appropriate form of piston, lever 273.
Figure 38 briefly shows the section view of the embodiment of the valve pump using elastic Cylindrical Buckling 2670.In a reality It applies in example, elastic Cylindrical Buckling is made of rubber, but in other embodiments, it can be made of any elastic material.Column Shape buckling 2670 has central corridor 2675, and multiple resilient radial fins 2672 against 2673 sealing arrangement of shell.Into Enter the fluid of pump inlet 2310 by channel 2360 and is collected in the region of 22 upstream of check valve：Collection chamber 2345, the central corridor 2675 and pumping chamber 2350 of Cylindrical Buckling 2670.Pumping chamber by central corridor 2675 with Couple to the mode that collection chamber 2345 is in fluid communication.During pumping mechanism compression stroke, pumping actuation component 2320 is to bullet Property pumping diaphragm 2330 apply active force, make its deformation, until elasticity pumping diaphragm 2330 is hermetically remained to cylindricality and bends The valve seat 2680 of song 2670；Thus the refluence from collection chamber 2345 to pump inlet 2310 is prevented.Pumping actuation component 2320 It continues on and Cylindrical Buckling 2670 is caused to deform；Pressure in pumping chamber 2350 is increased up when being enough to open check valve 22 Until.Then fluid can flow through pump discharge 2370.
Pumping actuation component 2320 is illustrated as spherical shape in Figure 38.However in other embodiments, pumping actuation component 2320 can be any shape that can be played a role as described above.
Referring now to Figure 39, the Cylindrical Buckling 2670 using elastic part 2680 and rigid cylindrical support element 2690 is shown The alternate embodiments of (being shown in Figure 38).Similar to the Cylindrical Buckling 2680 of Figure 38, the elastic portion subpackage of Cylindrical Buckling 2670 Include the valve seat 2680 that central corridor 2675 is sealed when applying active force by pumping actuation component 2320.Therefore, Cylindrical Buckling 2670 elastic part 2680 is deformed to transmit pressure to pumping chamber 2350.
Figure 40-44 is schematically shown in the section view of the alternate embodiments of valve pump in various actuating states.Figure 40- 44 valve pump 2200 has flexible sheet spring 6100 and elastic packing diaphragm 6120, they are played together similar to figure The function of elasticity pumping 2340 function of film of valve pump 2200 shown in 32-34.Figure 40 shows the valve pump in resting state 2200.In resting state, fluid can flow to the top 2346 of collection chamber 2345 from import 2360, pass through diaphragm bullet In hole 6110 and the lower part 2347 of entrance collection chamber 2345 in spring 6100.Fluid, which may then continue with, passes through sealing One or more opening 6130 in diaphragm 6120 and entrance pumping chamber 2350.Under low-pressure state, by unidirectional Valve 22 prevents fluid from further flowing.Spring diaphragm 6100 and sealing diaphragm 6120 can be by elasticity, biocompatible materials Construction.Spring diaphragm 6100 can have than sealing 6120 higher elasticity of diaphragm.For example, spring diaphragm 6100 can be soft Property biologically inert plastic disks and to seal diaphragm 6120 can be silicones or Fluorosilicone elastomers.
Figure 41 and 42 shows the valve pump 2200 in two centres, partial actuation state.Pumping actuation component 2320 So that pumping diaphragm 2330 is deformed and be forced through collection chamber 2345 and be pressed against spring diaphragm 6100, spring diaphragm is then suitable It is secondary to deform and be forced to be pressed against sealing diaphragm 6120.This point in compression stroke passes through the hole of spring diaphragm 6100 6110, either by sealing opening 6130 in diaphragm 6120 or being suppressed by the refluence of the two.Seal diaphragm Opening 6130 allows to form sealing between spring diaphragm 6100 and sealing diaphragm 6120 relative to the offset of spring eye 6100. In some embodiments, which, which can utilize, pumps in filled chamber elasticity between diaphragm 2330 and spring diaphragm 6100 Backup seal is supplemented (for example, the embodiment of Figure 43-44 lacks this backup seal).Around the week of spring fenestra 6110 Valve seat is may be used as to convex ridge (not shown) to reinforce the sealing.
Referring now to Figure 42, continuing on for pumping actuation component 2320 causes to pump diaphragm 2330, spring diaphragm 6100 It is further deformed with sealing diaphragm 6120.It is forced unidirectionally as a result, the fluid in pumping chamber 2350 is compressed up to Fluid pressure Valve 22 is opened；Further compression causes fluid to pass through 2370 outflow of outlet.
The alternate embodiments of the valve pump 2200 of Figure 40-42 are briefly showed in Figure 43.In this embodiment, it pumps Actuating member 2320 passes through elasticity pumping diaphragm 2330.Diaphragm 2330 is pumped in along 2320 length of pumping actuation component The periphery of pumping actuation component 2320 is hermetically attached at point.When activated, diaphragm spring hole 6110 only sealed every Film 6120 seals to prevent backflow；Elasticity pumping diaphragm 2330 will not contact hole 6110.It is shown in FIG. 44 shown in Figure 40 The alternate embodiments of device.
Referring now to Figure 45, the section view of the alternate embodiments of combined valve pump 2200 is shown.It is shape memory actuated 278 actuating compression stroke of device, to cause elastic pump blade 2710 to lift (lever) around fulcrum 274, this causes elastic pumping Diaphragm 2330 deforms.Elastic pump blade 2710 and elasticity pumping diaphragm 2330 are to shallow region 2730 and deeper region 2740 Step pumping chamber 2720 in fluid apply pressure.Early interim in compression stroke, pump blade 2710 causes elastic pumping Diaphragm 2330 blocks the channel 2360 that pump inlet 2310 is connected to step pumping chamber 2720.When compression stroke continues, make The fluid being firmly applied in step pumping chamber 2720, until the Fluid pressure in step pumping chamber 2720 is sufficiently high To open check valve 22.Fluid is then departed from pump discharge 2370.Pump blade 2710 can be in whole or in part by such as rubber Elastomeric materials.In some embodiments, elastic material includes non-resilient side's bolt (spline).Alternatively, at some In embodiment, elasticity is applied by Hookean region 2750, therefore, Hookean region 2750 is the pump blade in these embodiments 2710 only elastic part.In these embodiments, Hookean region 2750 contacts the bottom of step pumping chamber 2720. The elasticity of pump blade 2710 allows the compression stroke after the base portion 2780 that pumping vanes 2710 contact shallow region 2730 to continue. Pump blade 2710 is returned to starting position by return spring (not shown) during backward stroke.
Referring now to Figure 46, the section view of the alternate embodiments of pumping mechanism is shown.The embodiment includes that elasticity pumps Blade 2710.Elastic pump blade 2710 includes the Hookean region 2830 that elasticity is provided to pump blade 2710.Hookean region 2830 will Pumping actuation component 2820 is attached to pump blade 2810.When valve pump (not shown) is used together, the elasticity pump leaf of Figure 42 Piece 2710 will block intake channel (be not shown, 2360) and then be shown as being bent at flexible region 2830 in Figure 45 with Allow active force apply component 2820 to step pumping chamber (be not shown, the fluid in being shown as 2720) in Figure 45 apply into The pressure of one step.Active force applies component 2820 can be all by the elastomeric materials of such as rubber.However, alternative In embodiment, the region for only contacting pumping chamber (not shown) bottom is made of elastic material.Elastic pump blade 2710 exists It will be back to its relaxed shape during backward stroke.
Referring now to Figure 47, the section view of another embodiment of pumping mechanism is shown.The pumping mechanism is illustrated as it Middle lever is in the actuating intermediate stage, and wherein inlet valve 2941 is closed.Pumping mechanism includes flowline 2930, in the reality Apply movable part 2330,2941 poppet 2940 of inlet valve, pumping actuation component 2942, pumping chamber for diaphragm in example 2350 and outlet valve 22.Inlet valve 2941 and pumping actuation component 2942 each by by return spring 276 around simultaneously And the shape memory actuator 278 for being connected to lever 273 activates.Lever 273 activates inlet valve 2941 and pumping actuation component 2942.Lever 273 includes being attached to be articulated with fulcrum 274 and the Rocket/projectile of the lever 273 that terminates at valve actuation hammer body 2946 Spring component 2910.Spring members 2910 can be bending.Spring members 2910 are far from lever 273 and towards inlet valve The position of 2941 ground bias valve actuation hammer bodies 2946.Lever 273 has the pump actuating hammer for not being attached to spring members 2910 Body 2948, and neighbouring pumping actuation component 2942 positions.
Electric current causes the contraction of shape memory actuator 278 and lever 273 is pivoted around fulcrum 274.It is described to pivot valve Door actuating hammer body 2946 is placed in the position for forcing inlet valve 2941 to be closed.When shape memory actuator 278 continues to shrink, Lever 273 continues to pivot and pump actuating hammer body 2948 and presses to pumping chamber 2350 by actuating member 2942 is pumped, even if when into one When step compresses elongated spring members 2910.When realizing enough pressure, Fluid pressure opens outlet valve 22, and fluid passes through The valve flows out.
During relaxation stroke, return spring 276 unloads and lever 273 is returned to starting position, and release pumping causes Dynamic component 2942.Inlet valve 2941 is opened.The elasticity of pumping chamber 2350 causes pumping chamber 2350 to be refilled with.
Referring now to Figure 48 and 49, they briefly show wherein pumping mechanism using crank throw 7200 and by valve pump The section of 2200 embodiments being combined with bias current valve.Crank throw 7200 will be generated by linearity configuration memory actuator 278 Active force is transformed into lateral pump action power.Figure 48 shows that the mechanism is in and rests or be refilled in pattern, and schemes 49 show that the mechanism is in actuating state.The contraction of actuator 278 causes crank throw 7200 to rotate and press around axis 7210 Active force is leaned against to apply on component 2320.This driving elastic diaphragm 7220 is sealed in elasticity pumping film 2340 and from pump chamber Room 2350 is towards 122 actuating fluid of dispensed chambers.Return spring 276 is cooperated with return spring support element 7221 to discharge pumping Active force causes pumping chamber 2350 to expand and from 20 aspiration fluid of liquid storage device.Referring still to Figure 48 and 49, it is also shown that partially Valve 4000 is flowed, it has valve spring 4010, poppet or plunger 4020.
In some embodiments of above-mentioned pumping mechanism, one or more aspect that following valve operation illustrates is It is relevant.Referring now to Figure 50, the example of pent bias current valve 4000 is shown.Valve spring 4010 is in poppet 4020 Valve member 4060 hermetically to be pressed to the valve seat 4070 of the terminal hole around valve export 4040 by upper application active force. Valve seat 4070 may include circumferential raised portion to improve leakproofness.As explained below with reference to Figure 54-55, pass through elasticity The back pressure that the effect of allocation component is formed should be not enough to cause the refluence by bias current valve 4000.As shown in figure 51, work as pump When sending component is activated, it should generate enough pressure so that diaphragm 4060 and poppet 4020 are detached from from valve seat 4070, thus Allow fluid to be flowed from valve inlet 4030, by inlet plenum 4050 and flows to valve export 4040.Figure 52-53 is shown Alternative valve with the valve seat 4070 without circumferential raised portion.
Referring now to Figure 54 and 55, the signal that flow forward and refluence how are distinguished to exemplary bias current valve is shown.Figure 54 outlines represent the valve being in the closed position.Export proximate valves of the back pressure in 4040 to elastomeric valves diaphragm 4060 The smaller area of seat 4070 applies active force and therefore can not remove poppet 4020.Referring now to Figure 55, the figure is general Slightly show the valve during pumping actuation component actuation.The pressure of pumped fluid is neighbouring in being more than for diaphragm 4060 In applying active force on the region in the region of valve seat.As a result, inlet pressure has the mechanical advantage of bigger so that poppet 4020 are detached from valve seat, and in response to the action of pumping actuation component flow forward are occurred immediately.Therefore, for shifting Critical pressure needed for poppet 4020 is lower than in the export in import.Correspondingly, with fluid inlet and fluid outlet The spring bias active force and size of associated active force applying zone may be selected such that flowing substantially along forwards To.
Referring now to Figure 56, the section view of adjustable bias current valve 4130 is shown, the valve is to be similar in Figure 50 Bias current valve principle operation, but allow adjust open valve necessary to pressure, i.e., " Opening pressure " is (in some realities Apply in example, can from 0.2 to 20 pound per square inch or " psi ").It is adjusted and is opened by torsional spring tensioning screw 4090 Pressure is opened, thus the volume that the rotation changes recess portion 4080 changes spring to compress or decompress valve spring 4010 4010 biasing forces.Valve spring 4010 is towards 4060 biased piston 4100 of valve member to be actuated to valve seat.Plunger 4100 play the fixed function power poppet for being similar to bias current valve (4020 and 4000 are respectively shown as in Figure 50-53) Active force applies function.Compression valve spring 4010 will increase its biasing force, thus increase Opening pressure.On the contrary, decompression Spring 4010 will reduce its biasing force and correlation Opening pressure.Valve spring 4010 surrounds the axis of plunger 4100 coaxially It positions and applies its biasing force on plunger 4100.In some embodiments, the axis of plunger 4100 can be shorter than valve Door spring 4010 and recess portion 4080 length, to allow it in response to the increased Fluid pressure in fluid inlet 4030 And it freely shifts.Plunger 4100 can have functions necessary any size as needed.Such as in the reality of Figure 50-53 It applies in example, wetted portions can be located in single use portion 2610 and active force application component (for example, plunger and spring) can To be located in reusable part 2620.Operating principle is also similar；In fluid inlet 4030 more relative to outlet 4040 Big mechanical advantage is more favorable for flow forward rather than refluence.Alternatively, plunger 4100 can be elevated valve (in Figure 50- It is illustrated as 4020) substituting in 55.In some embodiments, it may be desirable to eliminate raised valve seat；In these embodiments, column Plug can be the spherical another shape that can either concentrate active force.
Bias current valve 4000 substantially mitigates or prevents the refluence for entering pumping chamber 2350 from dispensed chambers 122.Such as In Figure 50-56,4010 bias poppet of valve spring or plunger 4040 by diaphragm 7220 to press to valve seat 4070, side Formula to provide mechanical advantage by the flow forward of line 310.The work(of diaphragm 2330 and valve member is pumped by performance Can, diaphragm 7220 allows flowline 310, pumping chamber 2350 and pumping film 2340 to be located in a component (for example, primary Property part 2610) and the rest part of pumping mechanism be located at second, in removable member (for example, reusable part 2620). By disposing more durable and expensive component in reusable part 2620, economy and convenience may be implemented.
Pumping mechanism described in various embodiments above can be used in various devices to pump fluid.As one Exemplary embodiment, the pumping mechanism described in Figure 59 A-59E, Figure 60 A-60D and Figure 60 A-60C will be described as integrating In fluid pumping devices.
With reference to figure 57 and 58, the alternative way illustrated for fluid is shown.They are two skeleton diagrams, wherein liquid storage Device 20 and pump 16 are coupled to allocation component 120.In the embodiment shown in Figure 57, liquid storage device and pump quilt It is serially linked to arrive allocation component 120.In the embodiment shown in Figure 58, shunt line 150 couples from the output of pump 16 And return to liquid storage device 20.Because most of fluid of pump 16 is exported is returned to liquid storage device via shunt line 150 20, so pump 16 can include the various pumping mechanisms 16 that can not play Figure 57 illustrated embodiment required functions.Cause This, in some embodiments for wherein using big volume pumping mechanism, shunt line 150 can be assigned to big volume pumping mechanism Small volume is functional.Check valve 21 and 22 is oriented with the same direction and is included to prevent undesirable time Stream.
Referring now to Figure 59, the fluid skeleton diagram of one embodiment of fluid pumping devices is shown.In this embodiment, Fluid, which is located at, to be connected in the liquid storage device 20 of flowline 310.Flowline 310 is connected to pumping mechanism 16, by diaphragm 2356 Separation.Fluid is pumped into delivery device or casing 5010 to be conveyed to patient by current limiter 340.It should be appreciated that defeated One part of liquid device or casing 5010 not instead of device itself, is attached to patient so as to trandfer fluid.Below It includes delivery device or casing 5010 to be described more fully system embodiment and they.
Referring now to Figure 59 B, the alternate embodiments of skeleton diagram shown in Figure 59 A are shown.In Figure 59 A illustrated embodiments, Fluid is pumped through current limiter 340 then by casing 5010.However, in Figure 59 B, fluid is not pumped through current limliting Device；But fluid is pumped through the casing 5010 with same impedance.
In Figure 59 A and 59B, in one embodiment, the fluid body of patient is pumped into using pump stroke rough calculation Product.Length of stroke will provide the rough estimate of volume to being pumped into patient.
Referring now to Figure 59 C, the fluid skeleton diagram of one embodiment of fluid pumping devices is shown.In this embodiment, Fluid, which is located at, to be connected to by partition 6270 in the liquid storage device 20 of flowline 310.Flowline 310 connects with pumping mechanism 16 It is logical, it is detached by diaphragm 2356.Fluid is pumped into variable volume delivery chamber 122 and is then reached by current limiter 340 Casing 5010 is to be conveyed to patient.
Using including acoustic volume as described above sensing (AVS) component, variable volume delivery chamber 122 and distribution bullet The allocation component 120 of spring 130 determines conveyed fluid volume.Similar to pumping mechanism, diaphragm 2356 forms variable capacity integral With chamber 122.Diaphragm by material identical with the diaphragm 2356 in pumping mechanism 16 (being described in detail above) (alternatively, In some embodiments, different materials) it is made.AVS components are described more elaborately above.
Referring now to Figure 59 D, the alternate embodiments of Figure 59 C illustrated embodiments are shown, in this embodiment, variable Current limiter is not present between volume delivery chamber 122 and casing 5010.Referring now to Figure 59 E, Figure 59 C illustrated embodiments are shown Alternate embodiments, the embodiment carry alternative pumping mechanism 16.
Referring now to Figure 59 A-59E, liquid storage device 20 can be any fluid source, including but not limited to syringe, can collapse Liquid storage device medicine bag, vial, glass medicine bottle (glass vile) or can safely accommodate any of transported fluid Other containers.Partition 6270 is the tie point between flowline 310 and liquid storage device 20.It describes in greater detail below The various embodiments of partition 6270 and liquid storage device 20.
Fluid delivery device embodiment shown in Figure 59 A-59E can be used in conveying any kind of fluid.Additionally, The embodiment can be used as one, two or three independent mating part.Referring now to Figure 60 A-60D, close It is illustrated as being separated into multiple mating parts in the identical embodiment of Figure 59 A-59D descriptions.Part X includes moveable part and portion It includes flowline 310 and diaphragm 2356 to divide Y.In some embodiments of this design, part Y is single use portion and portion It is non-single use portion to divide X.Part X is simultaneously not directly contacted with fluid, and only part Y is the part for having wetting zones.Above In embodiment, liquid storage device 20 can have any size, and be integrated into disposable unit either independent one Secondary property component.In any embodiment, liquid storage device 20 can be re-filled.Liquid storage device 20 is integrated into disposably wherein In embodiment in the Y of part, liquid storage device 20 can be manufactured into filled with fluid, or pass through partition by patient or user 6270 fill liquid storage device 20 using syringe.In wherein liquid storage device 20 is the embodiment of independent component, liquid storage device 20 It can be manufactured into filled with fluid, alternatively, patient or user (are not shown, below by being used as liquid storage device load device Be described more fully) a part partition 6270 using syringe (not shown) filling liquid storage device 20 or by every Piece 6270 manually uses syringe to fill liquid storage device 20.The further of the process in relation to filling liquid storage device 20 is described below Details.
Although describing various embodiments about Figure 59 A-59E and Figure 60 A-60D, pumping mechanism can be Herein as any pumping mechanism either alternate embodiments with similar functions and feature of embodiment description.Example Such as, referring now to Figure 61 A, the embodiment similar with shown in Figure 59 A is shown to have the representative mould including pumping mechanism 16 Block.This is to show, any pumping mechanism 16 that is described here or similarly playing a role can be used in described In fluid pumping devices.Similarly, Figure 61 B and Figure 61 C are the generations of the system for the embodiment for respectively including Figure 59 B and Figure 59 C Table.
The outline of above-mentioned fluid pumping devices can be realized in the device that patient can use.There are multiple embodiments. The device can be independent device or be integrated into another device.The device can have any size or shape Shape.The device can be portable or non-portable.Term " portable " means that patient can tie up the clothing in body Carry in bag region or in other ways the device.Term " non-portable " means that the device is located in health institution Or in family, in addition to this, patient cannot bring the device to their the mobile virtually any locations of institute.This explanation Rest part will pay close attention to portable device as exemplary embodiment.
About portable device, the device can be carried by patient-worn or by patient.Patient-worn institute wherein In the embodiment for stating device, for the purpose of this explanation, call it as " patch pump ".When patient carries the device, in order to The purpose of this explanation calls it as " portable pump ".
Following explanation can be suitable for the various embodiments about patch pump embodiment or portable pump embodiment. In various embodiments, which includes shell, pumping mechanism, flowline, movable part, liquid storage device, power supply and Wei Chu Manage device.In various embodiments, allocation component, such as the volume sensing device including AVS components is wrapped in some embodiments It includes in the device.Moreover, embodiment can also include current limiter, but this does not give description in following figure, because Flowline be illustrated as it is uniform, with simplify illustrate.For the purpose of the explanation, when including allocation component, exemplary reality It will includes AVS components to apply example.Although AVS components are preferred embodiments, in other embodiments, other types can be used Volume sensing device.However, in some embodiments, volume sensing device is not used, but, liquid storage device itself will determine The volume of the fluid conveyed, or conveyed volume is roughly determined suitable for pump stroke.It should be appreciated that shown here as Outline device be intended to illustrate in the device some change.The embodiment represented by these skeleton diagrams each may be used also Including sensor housing, vibrating motor, antenna, radio device or the other components described about Figure 70-70D.Therefore, These descriptions are not intended to limit the component but to illustrate various components how interrelated in the devices.
Referring now to Figure 62 A, the skeleton diagram of individual devices 10 is shown.Shell 10 can have any shape or size And it is adapted to desired use.For example, when the device is used as patch, the device will be sufficiently compact so that energy itself It is enough to be worn.When the device is used as portable pump, the device is correspondingly used sufficiently compact.One In a little embodiments, shell is made of plastics, and in some embodiments, and plastics are the modelings of any injection-molded fluid compatible Material, such as makrolon.In other embodiments, shell is made of the combination of aluminium or titanium and plastics or any other material, The material is lightweight and durable in some embodiments.Other material can include but is not limited to rubber, steel, Titanium and its alloy.As shown in Figure 62 A, device 10 can have required any size or required shape.
Figure 62 A -69B are the skeleton diagrams for showing representative embodiment.Exact Design depends on several factors, including but not It is limited to device size, power limit and desired use.Therefore, Figure 62 A -69B are intended to the various features and possibility of outlines device Combination, however, those of ordinary skill in the art are readily able to design and implement practical devices.As example, it is described below And device embodiments are shown.However, these embodiments are not intended to limit, and it is intended to example.
Referring now to Figure 62 B, about surface-mounted device, in some embodiments, shell 10 includes insert region form 342. The form allows have a position with patient, and delivery device or casing (not shown) are inserted into simultaneously quilt at the position See.Shown here as 5030 region of shroud of device 10.Form 342 is not by can be made of transparent any material, including but not It is limited to plastics.Although form 342 is illustrated as being in a specific location on the device with concrete shape at one, regard Window 342 can be integrated in any housing embodiments in required any position.
Referring now to Figure 63 A, device 10 is shown.Liquid storage device 20 is shown connected to flowline 310, and flowline is right After be connected to pumping mechanism 16.Allocation component 120 is shown connected to flowline 310.Pumping mechanism 16 and allocation component 120 are detached by diaphragm 2356 with flowline 310.Shroud 5030 is located at the downstream of cubing device.Shape memory causes Dynamic device 278 is shown connected to pumping mechanism 16.Microprocessor and power supply on printed circuit board 13 or accumulator 15 It is included.Also flow resistance as described above can be realized between allocation component 120 and shroud 5030.
Referring now to Figure 63 B, show that similar device 10 as shown in Figure 63 A does not include only in this embodiment Allocation component.In this embodiment, the fluid volume conveyed will depend on pump stroke (number and length), liquid storage device 20 (to hold Product and time), both or previously with respect to any other method described in monitoring institute trandfer fluid volume.
Referring now to Figure 63 C, similar device 10 as shown in Figure 63 B is shown, only device 10 includes dispensed chambers 122 and sensor housing 5022.
Referring now to Figure 64 A, one embodiment of patch pump device 10 is shown.Device of the embodiment shown in based on Figure 63 A The embodiment of part 10.In this embodiment, patch pump device 10 is divided into two parts：Top X and base portion Y.Top X contains Pumping mechanism 16, allocation component 120 (it is optional, but is shown as exemplary embodiment), power supply 15 and Wei Chu Manage device and printed circuit board 13.They are non-wetted elements, that is, they are simultaneously not directly contacted with fluid.Base portion Y contains flowing Pipeline 310 and diaphragm 2356.When liquid storage device 20 is built in the device, liquid storage device is also contained on base portion Y.So And in wherein liquid storage device 20 is the embodiment of independent component, liquid storage device 20 is connected to flow duct when fully assembled Line (see Figure 66 A-66D and refers to their explanation), without being built in the device.
Patch pump device further includes shroud 5030.This is the region covered where pipeline 5031.One of flowline 310 Point, set pipeline 5031 allows casing (or other delivery devices) to receive fluid and to patient's (not shown) trandfer fluid.
Referring now to Figure 65 A, in some embodiments, casing 5010 is plugged directly into patient's body by shell 5030. Casing 5010 is connected to the partition (not shown) that set pipeline 5031 is connected to casing 5010.
Referring now to Figure 65 B, in other embodiments, using be inserted into external member (including casing and pipeline, in Figure 65 B not It shows, object 5033 and 5010) is shown as in Figure 64 B；Therefore, being inserted into the pipeline 5033 of external member will connect on one end Casing (not shown) is connected to set pipeline 5030 and on the opposed end of pipeline.
Referring again to Figure 64 A, in use, the internal liquid storage device 20 containing fluid is (as described above, be molded into base portion Y In it is either independent and be attached to base portion Y) be connected to flowline 310.Microprocessor on printed circuit board 13 is sent Signal, the current start stroke to activate pumping mechanism 16 and by being applied to shape memory actuator 278.Fluid is from storage Liquid device 20 flow to allocation component 120 or AVS components in flowline 310.Here, determine fluid in AVS chambers Exact volume and force fluid out AVS chambers, flow to set pipeline 5031 and shroud 5030.
Referring now to Figure 64 B, device shown in Figure 64 A is shown connected to insertion external member, that is, pipeline 5033 and casing 5010.In Figure 64 C, the base portion Y of device is illustrated as being attached to the body of patient 12 using binder patch or gasket 3100 Body.It is noted that in this embodiment, element 3100 can be gasket either patch.However, as in greater detail below Description, object 3100 is referred to as patch, and object 3220 is referred to as gasket.Object is used just to concise purpose 3100；However, in some embodiments, using gasket, therefore object 3220 will be appropriate in those situations.
It is inserted by shroud 5030 so that the casing 5010 for being cooperated to set pipeline 5031 using casing partition 5060 is inserted into In 12 body of patient.However, as above with regard to shown in Fig. 2 B and described, base portion Y can be by including pipeline 5033 and set The insertion external member of pipe 5010 and be fluidly attached to patient.In Figure 64 B and 64C, base portion Y can plug-in-sleeve 5010 it It is preceding or be attached to patient later.Referring again to Fig. 2 C, casing 5010 will be direct if after being inserted into 12 body of patient Fluid is received from device without setting pipeline with infusion (shown in Figure 64 B).Base portion Y is before or after plug-in-sleeve 5010 It is attached to patient 12 using binder patch 3100.Referring now to Figure 64 D, it has been inserted into 12 body of patient in casing 5010 Afterwards, the top X of device 10 is attached to the base portion Y of device 10 in turn.
As described below, binder patch can have many embodiments, and in some cases, the patch Piece is placed on the top of device.Therefore, the patch shown in these embodiments is only one embodiment.As described above, Gasket will be placed in position identical with the patch in Figure 64 A-64D if you are using.
Referring now to Figure 66 A-66D, in this embodiment, liquid storage device 20 is illustrated as the component of separation.As shown in Figure 66 A, Base portion Y includes the liquid storage device cavity 2645 for having partition needle 6272.As shown in Figure 66 B, liquid storage device 20 is first positioned in top storage In liquid device cavity 2640.At this point, liquid storage device 20 is not attached to device.Now, with reference to figure 66C, when top, X is placed in base portion When on Y, liquid storage device 20 is sandwiched in base portion liquid storage device cavity 2645.As shown in Figure 66 D, by the way that top is attached to base portion Y And partition needle 6272 is pushed into the partition 6270 of liquid storage device 20 by the active force formed, which connects liquid storage device 20 It is connected to the flowline 310 of base portion Y.
Referring now to Figure 67 A-F, show Figure 64 A, 64C and 66A-66D illustrated embodiments alternate embodiments.At this In a little alternate embodiments, in addition to shroud 5030, base portion Y includes sensor housing 5022.Referring now to Figure 69 A-69B, sensing Device shell 5022 and shroud 5030 include the outlet reached on the downside of base portion Y, and 5022 and 5030 are respectively shown as in Figure 69 A. Embodiment shown in Figure 69 B depictions 69A, wherein sharp object are protruded by shell.Sensor housing accommodates sensor.One In a little embodiments, sensor is analyte sensor.The analyte sensed includes blood-glucose, but in other implementations In example, which can be required any kind of analyte sensor.
Referring now to Figure 67 B, base portion Y is shown located on the body of patient 12.Sensor 5020 is illustrated as having passed through base Portion's Y sensor housings 5022 are inserted into 12 body of patient.Referring now to Figure 67 C, in some embodiments, casing 5010 and biography Sensor 5020 is simultaneously inserted by their corresponding shells (5030 and 5022) and is entered in 12 body of patient.Join below Figure 67 D are examined, base portion Y is illustrated as using casing 5010 and is attached by being attached to both sensors 5020 of patient 12 by base portion Y To patient.
Referring now to Figure 67 E, base portion Y is illustrated as the casing 5010 for being attached to patient 12 and being inserted by shroud 5030. In the embodiment, sensor housing 5022 is shown without sensor.However, sensor 5020 is illustrated as in another location In middle 12 body of insertion patient.It is still, disclosed below with prison therefore, it is not required to sensor 5020 is inserted by base portion Y Depending on blood-glucose with the related embodiment of insulin is pumped by casing can implement by this method.It additionally, can be with This mode implement in response to or be related to the related other embodiments of the fluids administration of analyte level.
Referring now to Figure 67 F, the device 10 with sensor 5020 and casing 5010 by base portion Y is illustrated as at it It is upper that there is top X.Again, in the embodiment shown in Figure 66 A-66D, once top X is placed on base portion Y, then liquid storage device 20 It is fluidly connected to flowline 310.
Referring now to Figure 68, one embodiment of the portable pump embodiment of device 10 is shown.In the device 10, packet Patient 12 must be connected to by the flowline in device 10 by including the insertion external member of casing 5010 and pipeline 5033.Therefore, casing 5010 are directly connected to patient 12 not over portable pump device 10 in this embodiment.Additionally, although the embodiment It can play as below in relation to the function described in analyte sensor and fluid pump, but sensor 5020 will be similar to that figure The embodiment of sensor 5020 shown in 5F and positioned at portable pump device 10 outside.
Referring now to Figure 70-70D, the patch pump and portable pump embodiment that are described additionally contain allocation component Various components (can be in Application Example), and the embodiment for including AVS components, the various components of allocation component Including at least one microphone, temperature sensor, at least one loud speaker, variable volume dispensed chambers, variable volume chamber, Port and reference chamber.In some embodiments, which contains one or more in following device：Vibrator horse Up to (also, in those embodiments, motor driver), antenna, radio device, skin temperature transducer, button is injected, And in some embodiments, one or more other button.In some embodiments, the antenna is a quarter Wavelength-tracking antenna.In other embodiments antenna can be half-wavelength or quarter-wave tracking, dipole, monopole or Person's loop antenna.The radio device is 2.4GHz radio devices in some embodiments, but in other embodiments In, the radio device is 400MHz radio devices.In a further embodiment, the radio device can be appointed The radio device of what frequency.Therefore, in some embodiments, the device include intensity be enough with several away from the device The radio device of receiver communication in foot distance.In some embodiments, the device includes the second wireless Denso It sets.In some embodiments, second radio device can be special remote radio, for example, 433 or 900MHz radio devices, alternatively, in some embodiments, there is any frequency in ISM band or other frequency bands, It is not shown in Figure 70-70D, the device contains screen and/or user interface in some embodiments.
Two kinds of type of device can be suitable for the explanation of these components and its various embodiments below, and in turn can Enough various embodiments for being suitable for describing about each type of device.Referring now to Figure 67 F, just to illustrative purpose, set Pipe 5010 and sensor 5020 have been inserted into device 10.Moreover, with reference to figure 70-70D, (some of them are not for various components Must be included in all embodiments) it is illustrated as the electrical connection that outline represents those components.Therefore Figure 70-70D are represented The various elements that can be included in the device.According to size requirement, power limit, purposes and preference and other variables, These elements can be mixed and matched.Figure 70 shows the relationship of Figure 70 A-70D.
The device contains at least one microprocessor 271.The microprocessor can at least be handled so that described The microprocessor of any speed of various electrical connections necessary to device operation.In some embodiments, the device contains more In one microprocessor, as shown in Figure 70 A-70B, the device is shown to have two microprocessors 271.
Microprocessor 271 (or in some embodiments, multi-microprocessor) is connected to main printed circuit board (under Wen Zhong, " PCB " refer to term " printed circuit board ") 13.It is that the power supply of accumulator 15 is connected to master in some embodiments PCB 13.In one embodiment, accumulator 15 is the lithium polymer storage battery that can be recharged.In other embodiments, The accumulator can be any kind of replaceable accumulator or rechargeable storage battery.
In some embodiments, the device includes the radio device 370 for being connected to main PCB 13.Radio device 370 are communicated using antenna 3580 with remote controllers 3470.Therefore communication between device 10 and remote controllers 3470 is Wireless.
In some embodiments, the device contains vibrating motor 3210.Vibrating motor 3210 is connected to 13 horse of main PCB Up to the motor driver 3211 on driver 3211.
Some embodiments include injecting button 3213.Inject button 3213 by user to can by rubber or it is any its Press-button structure 3213 made of its suitable material applies active force and plays a role.The force actuation is attached to main PCB 13 On inject button switch 3214 inject press-button actuated.The actuating of switch 3214 is single to inject, will the specific predetermined body of signal Long-pending fluid will be fed to patient.After button 3213 is injected in user's pressing, in some embodiments, device 10 will produce Raw alarm (for example, activate vibrating motor 3210 and/or send signal to remote controllers) to user to illustrate 3213 quilt of button Pressing.Then user needs to inject and should be conveyed for example, by press push button 3213 confirming.In a further embodiment, far Range controller 3470 inquires that user injects and conveyed to confirm.
Similar inquiry/response sequence can be used for various embodiments to test and report patient's response.For example, The device can be configured as by generating alarm (for example, the sense of hearing and/or haptic alerts) and patient being waited for respond (example Such as, button 3213 is activated) and test patient's response.In different time (for example, every five minutes) or it can ought detect example Such as via the anomaly analysis object level of analyte sensor monitoring or via the abnormal physical temperature of temperature sensor monitors State when execute this test.If patient does not provide appropriate response in the given time, reusable part can be to remote Range controller or keeper send alarm.For device fault or it is other due to and may become to lose consciousness or For the patient of person's incapacitation, this test and report may be especially valuable.
(reference figuration memory actuator is in some embodiments NITINOL to NITINOL circuits on main PCB 13 Strand) 278 to NITINOL connectors provide electric current.As shown in Figure 67 F and Figure 70 A, which can include two NITINOL Connector 278 (and two NITINOL strands).However, as described above, in some embodiments, which includes one NITINOL connectors (and a NITINOL strand).
In some embodiments, which includes temperature sensor 3216 shown in Figure 70 B.Temperature sensor 3216 In on the downside of base portion Y and sensing the skin temperature of patient.Skin temperature transducer 3216 is connected to the letter represented by 3217 Number adjuster.As shown in Figure 70 B, Signal Regulation 3217 is represented as a box, however the device includes multiple as needed Signal conditioner, each filters unlike signal.In the following, AVS temperature sensors 132, AVS microphones 133 and analyte Sensor 5020 is each connected to the signal conditioner represented in as 3217 a box.
AVS loud speakers 134 are connected to the loudspeaker drive 135 on main PCB 13.AVS loud speakers 134 are implemented at one It is hearing additional loudspeaker in example.However, in other embodiments, (loud speaker containing voice coil carries electromagnetism to loud speaker 134 The magnet of coil) it is piezoelectric speaker (being shown in Figure 50, represent one embodiment of the device).
Referring still to Figure 70-70D, in some embodiments, antenna 3580 has special PCB 3581, the special PCB right After be connected to main PCB 13.Moreover, in some embodiments, AVS microphones 133 each all have and be connected to main PCB 13 Special PCB 1332,1333.Conventional method, such as flexible circuit or conducting wire can be used, various PCB are connected to master PCB 13。
With reference to figure 67F, for the purpose of illustration, device 10 is shown as exemplary embodiment.However, the layout of various pieces It can change, and many embodiments are shown below.However, other alternate embodiments are not shown, but can It is determined based on size, power and purposes.
According to alternate embodiments, single use portion 2610 may include liquid storage device 20 and optionally include accumulator. Liquid storage device 20 can form one with single use portion or otherwise be connected to single use portion.Accumulator can be For the device main either unique power supply or can be backup power supply, and can be used for reusable portion Point and/or single use portion on electronic device provide electric power.Liquid storage device 20 and accumulator are generally required to regularly replace, institute To include that can provide a user this increased side for being carried out at the same time replacement in single use portion 2610 by the two components Just property.Additionally, by replacing accumulator when replacing liquid storage device every time, user can be more difficult so that exhaustion of the accumulators.
Single use portion 2610 can include additionally or alternately processor, which can be used for, example Such as, (for example, failure of the master controller in reusable part) continues the operations of certain devices in the situation to break down, To generate alarm in the situation to break down, or to reusable part provide status information.About status information, processing Device can keep tracking single use portion operation history and various characteristics and reserved state information so as to disposable It is accessed by user, fluid delivery device 10 and/or user interface 14 during the installation of part 2610.For example, processor can be deposited It stores up with shelf life, maximum exposure or operation temperature, manufacturer, for related states such as the safety distribution limitations for the treatment of. If the device determine these positioning indicators any one is unacceptable, the device can be refused to pumping group Part and allocation component power and illustrate single use portion unusable to user.Processor can by reusable part or Storage battery power supply in single use portion.
More generally, which can be configured as via bar code reader, or via RFID technique from any one Secondary property part (including for example, single use portion 2610 and any Disposable artifact as used herein, such as fluid reservoirs, Accumulator either sharp cylindrantherae or each sharp component), for example, from the processor being placed in single use portion, obtain Status information.If the device detects single use portion, there are problems (for example, the invalid model for reusable part Number or fluid are expired), then the device can take remedial action, e.g., for example, prevent or terminate device operation and Generate appropriate alarm.
Other component can be included in some embodiments.For example, alternate fault can be used to detect and notice machine Structure.Audible alarm may be used in the device.The loudspeaker 1202 of sensor 550 can be used for audible alarm, Huo Zheling Outer loud speaker may include loudspeaker and be used for audible alarm.Device vibrating mechanism 3210 can also be used as alarm Device.If detecting the system failure for requiring to pay close attention at once, two alarms can be activated.Additionally, Ke Yizuo To use chargeable storage or ultracapacitor to the backup of main accumulator.If any accumulator is unable to work Make, then controller can activate one or more alarm, to send out at least one notice of accumulator failure.
Alarm can also be used to illustrate device correctly to work to user.For example, user may be about in the specific period Inject conveying and to the device programming.User may expect to know that programmed conveying correctly carries out.Processor can make With vibrating motor or audio sound to illustrate successfully to program conveying.It therefore, can in some embodiments of the device Use some mechanisms with either user provides affirmative or negative feedback to patient.
Microphone can be used for detecting the shortage of any abnormal vibrations or normal vibration, and trigger alarm state. In various embodiments, the microphone of acoustic volume sensing system can be used for executing this monitoring, or may include independent Microphone for this monitoring.Also it is able to carry out cyclic check, to check expected pump vibration by using microphone Determine that the device is operating.If microphone detects incorrect vibration, or if correct vibration is not detected It arrives, then can activate alarm.
Referring now to Figure 71, the various components of device 10 are briefly showed.In one embodiment of device 10, top X with Base portion Y cooperations and liquid storage device 20 are sandwiched between the X and base portion Y of top.Clamping force allows liquid storage device partition 6272 and base Portion Y is matched.In some embodiments, delivery device 5010 and analyte sensor 5020 be inserted by base portion Y and Into in patient's (not shown) body.
In many embodiments, base portion Y and liquid storage device 20 are single use portions and top X is non-single use portion.It is defeated Liquid device 5010 and analyte sensor are also all disposable.
As previously discussed, patch pump device can be disposable in whole or in part.Figure 72 shows to have primary The embodiment of the fluid delivery device 10 of property and non-disposable part.In this embodiment, single use portion Y contains and fluid The component being in direct contact, including liquid storage device 20, pump the (not shown), (distribution of variable volume dispensed chambers 122 can be collapsed The part of component 120 being located on the X of top) and current limiter (not shown), and liquid storage device is connected to variable volume The fluid path (not shown) and check valve (not shown) of the pumping mechanism of dispensed chambers 122.Additionally, single use portion Y packets Include liquid storage device cavity 2645.
Reusable part X includes the element of allocation component 120, in addition to the variable volume distribution on single use portion Y Chamber 122.In some embodiments, allocation component 120 is AVS components.AVS components have been described in detail above.Referring now to Figure 73, Integrated Acoustic volume-measuring sensors are shown to be on PCB.
Referring now to Figure 74, device 10 shown in Figure 49 are shown.Base portion single use portion Y includes liquid storage device cavity 2645. The non-disposable part X in top includes accumulator 15 and allocation component 120.Microphone 133 and diaphragm spring 130 are shown.One In a little embodiments, allocation component 120 includes more than one microphone.Although running through this explanation, each microphone is claimed Make 133, but this does not illustrate microphone always identical.In some embodiments, microphone is identical, in other implementations In example, microphone is different.
In Figure 74, the non-disposable part X in top further includes main PCB 13, vibrating motor 3210 and pumping actuation component 54.Top, non-disposable part X include AVS components or allocation component 120.In Figure 74, microphone 133 is shown.Top, Non-disposable part X further includes the storage that can be used for the electronics on non-disposable part and/or single use portion Battery 15.In some embodiments, which is rechargeable.It can be carried out again by the method being described below Charging.Single use portion Y includes having flowline (not shown) and the wetting component of pump.In Figure 74, only pump Send plunger 54 it can be seen that.This embodiment of device 10 can further include above-mentioned many elements, including but not limited to flow Resistance, flexible partition, shroud and sensor housing.Any pumping mechanism can be used.
Referring now to Figure 75, wherein it can be seen that showing device 10 in another view of more multicomponent.In Figure 75, Device 10 is shown to have including coiling micro-pipe current limiter 340 and connects import 21 and the flowline 310 of 22 valves of outlet Base portion single use portion Y.Pumping actuation component 54 is also shown.Top X includes 3210, two main PCB 13, vibrating motor Mikes Wind 133, loud speaker 134, reference chamber 127 and fixed volume chamber 129.Accumulator 15 is also shown.Because for current limiter The 340 very small diameters of selection, may cause flowline 310 block (for example, due in treat fluid protein gather Close), it is thus possible to it is expected using the longer pipeline of the length with larger diameter.However, in order in the shell of patch size Packaging has greater length of pipeline, it may be necessary to be bent pipeline to form crooked route, such as coiling or it is snakelike.
Referring now to Figure 76, the decomposition view of device 10 shown in Figure 72,74 and 75 is shown.Top, non-disposable part X is illustrated as detaching with base portion single use portion Y.In practice, liquid storage device (not shown) will be placed in top X and base portion Y portion Between.Once top X and base portion Y are assembled to form device 10, then liquid storage device will be connected to flowline 310.
Referring now to Figure 77, show include the device 10 of disposable base portion Y and non-disposable top X section another reality Apply the decomposition view of example.Further include liquid storage device 20, keeps the binder 3100 and bridge joint of delivery device 5010 and sensor 5020 5040 equipment.The device 10 includes the trace and domed shape of more sphering.Accumulator 15 and main PCB 13 are shown located on top On portion X.Base portion Y includes liquid storage device cavity 2645.Binder 3100 is shown in two-piece type embodiment.Bridge joint 5040 is for leading to It crosses base portion Y and is inserted into delivery device 5010 and sensor 5020.Liquid storage device 20 is shown to have irregular shape, however, other In embodiment, liquid storage device 20 can have any shape according to required fluid displacement and can change size.In device 10 In the embodiment, non-wetted component, which is located in the non-disposable part X in top and soaks component, is located at base portion single use portion Y In.
When assembled, device 10 can be attached to together using binder middle section (not shown).It is alternative Ground, device 10 can use any one of many embodiments described here for locking embodiment with machinery side Formula is locked into together.Although some embodiments are described below here, many other embodiments are apparent , and when device shape changes, in many situations, lockset will also change.
Referring now to Figure 78, the decomposition view of another embodiment of device 10 is shown.The non-disposable part X in top is base This domed shape, however, protrusion Xl is illustrated as accommodating the mechanism in the X of top.Therefore, device shape can change and can Including polyp portion (polyps) and protrusion, scrobicula and other textured features, to be suitable for the various designs of the device.
Liquid storage device 20, delivery device 5010 and sensor 5020 are shown.Delivery device 5010 and sensor 5020 can lead to Base portion Y is crossed to be inserted into and enter in patient's (not shown) body.Base portion Y is illustrated as having binder 3100 or gasket below 3220.In practice, binder 3100 or gasket 3220 can be attached to skin and base portion Y first.Then, infusion apparatus Part 5010 and sensor 5020 (are not shown, are illustrated as 5020 and 5010) in Figure 79 by the way that base portion Y is inserted into the patient. Then by first by liquid storage device 20 be placed in top X in then be sandwiched in top X and base portion Y between, alternatively, liquid storage device 20 is set It is sandwiched in liquid storage device cavity 2645 and then between the X and base portion Y of top, liquid storage device 20 is placed in liquid storage device cavity 2645 In.Either type can be used.Final result be liquid storage device 20 by partition (showing with being reversed) on liquid storage device 20 and every Piece needle (is not shown, sees the flowline (not shown) 6272) being connected in base portion Y.Then, by using bonding Agent, or by mechanically being clipped together top X and base portion Y using lockset 654 fixed top X in this embodiment To base portion Y.
Base portion Y includes those of wetted component.Base portion Y is disposable.Top X includes non-wetted component.Top X It is non-disposable.Referring now to Figure 79, base portion Y includes variable volume dispensed chambers 122, inlet valve 21 and outlet valve 22 With pumping chamber 2350.As shown in the drawing, those elements are illustrated as the diaphragm in region of the covering as chamber or valve.Therefore, Base portion Y includes diaphragm, which firmly holds wetting zones, therefore, maintains the non-profit such as in the (not shown) of top Wet zone.As shown in Figure 79, sensor 5020 and delivery device 5010 have been inserted into their corresponding shells and have passed through base Portion Y reaches patient's (not shown).Base portion Y is shown to have liquid storage device cavity 2645, but connection liquid storage device is needed (not show Go out), to which the flowline from liquid storage device to chamber and to delivery device is connected.
Referring now to Figure 80, the top X of the device is shown.Top X includes those non-wetted components, including, as schemed institute Show, temperature sensor 3216, diaphragm spring 130, inlet valve poppet 21 and outlet valve poppet 22 and pumping actuation component 54.Top Y further includes recess portion 2640 to accommodate liquid storage device (not shown).
Referring now to Figure 81 A-81C, the process for clamping liquid storage device 20 between X and base portion Y at the top of being shown in is shown Sequence.As shown in Figure 81 A, the liquid storage device 20 outside the X and top X of top is shown.Liquid storage device includes partition 6270.Top X packets Include liquid storage device recess portion 2640.In the following, as shown in Figure 81 B, prepare top to be clamped together with base portion Y.Referring now to Figure 81 C, liquid storage device 20 are placed in base portion Y, wherein partition it is lateral under.Partition by with the partition needle with casing in base portion Y (not shown) connects and liquid storage device is connected to flowline (not shown).In alternative embodiments, liquid storage device can wrap Needle rather than partition with casing are included, and fluid path may include the reservoir interface with partition, rather than with set The needle of pipe.
Below with reference to Figure 82, show that top X, one embodiment of wherein pumping mechanism 16 are decomposed.16 quilt of pumping mechanism It is assembled in the pumping mechanism shell 18 in the X of top.The lockset for also showing that base portion Y and clipping together top X and base portion Y 654 part.
Referring now to Figure 83, base portion Y is shown, wherein using fluid path component 166 as the diaphragm decomposed from base portion Y 2356.This illustrates that in some embodiments of device, fluid path component 166 is to be inserted into base portion Y and utilize diaphragm 2356 individual components clamped.In the figure it also shows that binder or gasket 3100/3220 in some embodiments wrap Include the hole for delivery device and sensor (not shown).Referring now to Figure 84, the bottom view of base portion Y is shown.Fluid road The bottom of diameter component 166.
Referring now to Figure 85 A and 85B, another embodiment of device is shown.It is in this embodiment and non-disposable Top X includes injecting button 654.Liquid storage device 20 is shown with decomposition view, however, in one embodiment, liquid storage device 20 is interior It is placed in base portion Y.In another embodiment, liquid storage device 20 is removable and using similar to above with regard to device Process described in another embodiment is placed in liquid storage device cavity 2645.
Base portion Y is wetted portions that are disposable and including device 10.Sensor 5020, casing 5010, variable volume Dispensed chambers 122, inlet valve region 21, outlet valve region 22 and pumping chamber 2350.Capacity distribution chamber, inlet valve region 21, outlet valve region 22 and pumping chamber 2354 are covered by diaphragm material, the diaphragm material can have single diaphragm or The form of person's difference diaphragm.
Device 10 is clipped together using the locking mechanism 654 on top X and base portion Y.Referring now to Figure 85 C-85D, device Part 10 is the retaining mechanism 654 being shown in open position (Figure 85 C) and clamping or closed position (Figure 85 D).Also It can be seen that injecting button 3213 as described in greater detail above.
Lid (not shown) can be provided in any one of the device embodiments, be moved with working as liquid storage device It removes and base portion substitutes liquid storage device and top when being connected to patient.The lid will be free of electric member and therefore can moisten It is used in state.However, in some cases, liquid storage device can be removed without the use of any lid.
Casing and inserter
Figure 86 A briefly show the representative embodiment of infusion and sensor module 5040, and the component is including that can be set The delivery device and analyte sensor including sensor probe 5025 and sensor base 5023 of pipe or needle 5010. Bridge joint 5070 is securely joined with infusion casing 5010 and analyte sensor base portion 5023.Delivery device 5010 on upside by Partition 5060 defines, and the partition allows fluid to be supplied to patient from fluid source flow and by delivery device 5010.It passes Sensor base portion 5023 is the part for being not inserted into patient's body of analyte sensor.In one embodiment, base portion 5023 contains It is useful for the electric contact of blood-glucose electrochemical analysis.Probe 5025 is protruded from the base portion 5023 of analyte sensor 5020.
Referring now to Figure 86 B, in this embodiment, delivery device 5010 is to be introduced into patient's body using introducing needle 5240 Interior casing.When being inserted into patient's body, it is introduced into needle 5240 and is located in casing 5010.Casing 5010 is being inserted into patient's body After interior, introduce needle 5240 be removed and partition 5060 sealed relative to fluid source, device described here some In embodiment, the fluid source is flowline.In some embodiments, sensor probe 5025 is related to needle 5072 is introduced Connection, this helps skin penetrating, to be inserted into sensor probe 5025.When sensor probe 5025 is inserted into patient's body, sensing Device introduces needle 5072 in some embodiments at least partly around sensor probe 5025.
In other embodiments, delivery device 5010 is needle and need not introduce needle 5240.In these embodiments, Delivery device 5010 is inserted into patient's body and partition 5060 seals fluid source.
In Figure 86 A and 86B, when delivery device 5010 and sensor probe 5025 are fitted when ranking, active force quilt It is applied to bridge joint 5070.This forces delivery device 5010 and sensor probe 5025 to enter patient's body.Once being located at patient's body It is interior, then through hole actuation of release 5052, to detach delivery device 5010 and partition 5060, and by sensor base 5023 detach with bridge joint 5070.With reference to figure 86B, which use needle 5240 and 5072 is introduced, they are usually after the insertion It remains and is attached to bridge joint 5070.
The bridge joint can be made of any material requested including plastics.Casing can be any set in this field Pipe.Partition 5060 can be made of rubber or plastics and with any design that can generate required function.It is defeated wherein Liquid device is in the embodiment of needle, and any needle can be used.It is introduced into the embodiment of needle wherein using, any needle, needle Device or introduction means can be used.
Infusion and sensor module require to apply active force, to be inserted into patient's body.Moreover, infusion and sensor Component is required from infusion and sensor module release delivery device and sensor.Therefore, active force and release member can be by hands It activates dynamicly, that is, the personnel of these functions are executed, alternatively, inserter instrument can be used to correctly activate the component.It is existing With reference to figure 87A-87E, the example of the inserter that can be operated in a manual manner 5011 is shown.Delivery device 5010 and biography Sensor 5023 is bridged 5070 holdings.Inserter 5011 includes the lid for both delivery device 5010 and sensor 5023 5012.As shown in Figure 87 B-87E, using inserter 5011, delivery device 5010 and sensor 5023 are inserted into the device 10 In.Although Figure 87 A show the sharp object being exposed, in some embodiments, lid 5012 is complete before insertion process Encapsulate sharp object.
Inserter 5011 can be manually actuated, but can be also bonded in another inserter device, so as to Using mechanical advantage.Referring now to Figure 88 A-88B, one embodiment of inserter device 5013 be used to be similar to Figure 87 A- The equipment of inserter 5012 shown in 87E.The mechanism of inserter device 5013 is shown in Figure 88 C-88D.Actuation lever 5014 is released Putting spring (as shown in Figure 88 C-88D) or providing allows inserter 5012 to be inserted into another machinery in device (not shown) Advantage.Inserter 5012 therefore will release delivery device 5010 and sensor 5023 and be inserted into device 5012 can by from Inserter device 5013 removes and inserter device 5013 is re-filled or inserter device 5013 and inserter 5012 can be discarded.
Various inserter instrument are described herein.However, in other embodiments, different inserter instrument has been used, or Person's delivery device and sensor are manually introduced.
May include that the feature for being automatically inserted into device is fixed to sensor module 5040 for that will be infused.For example, scheming The pin of automatic inserter instrument can be received by being illustrated as 5052 release member in 86A-86B.With reference to figure 89A and 89B, show automatic The representative embodiment of inserter 5100.As shown in the front view of Figure 89 A, inserter 5100, which is included in, is inserted into cylindrantherae recess portion The pin 5130 advanced in pin slit 5140 in 5120.In practice, infusion and sensor module (be not shown, in Figure 86 A and It is shown as 5040) being pressed into cylindrantherae recess portion 5120 in 86B, pin 5130 is caused to be inserted into the hole in infusion and sensor module (being illustrated as 5052 in Figure 86 A and 86B).As shown in the rearview of Figure 89 B, cocking lever 5145 be used to be ready for insertion into device 5100 to discharge.Then shroud and sensor that inserter 5100 is held skin or is aligned on base portion (not shown) It shell and is released by depression of trigger 5110.Upon release, pin 5130 is advanced in their slit 5140, by This forces delivery device and sensor (being not shown) to enter patient's body.The limitation of inserter footing 5160 infusion and sensor Component travels downwardly.Inserter automatically can also introduce needle from infusion and sensor module retraction and (be not shown, see figure 86B)。
Before distributing to terminal user, infusion and sensor module can be preloaded in inserter 5100.Such as figure Shown in 90, in other embodiments, cylindrantherae 5080 can be used for protecting user and protect to be illustrated as in Figure 86 A and 86B The sharp object kept in 5040 component.It is defeated in cylindrantherae embodiment 5080 with reference to figure 90 and Figure 86 A-86B and Figure 89 A Liquid and sensor module 5040 are embedded in cylindrantherae 5080.Cylindrantherae 5080 is installed in cylindrantherae recess portion 5120.Pin 5130 can be with Through hole 5052 protrudes and enters in the groove 5090 in cylindrantherae 5080.After activating inserter 5100, in 5080 court of cylindrantherae When advancing to patient, pin is advanced in groove 5090 to be inserted into sharp object.Cylindrantherae 5080 can be by constructed of rigid materials.
Referring now to Figure 91 A-91C, multiple views of the embodiment of the inserter mechanism for inserter are shown, such as It is illustrated as one of 5100 in Figure 89 A and 89B.Figure 91 A show the perspective view of one embodiment of inserter mechanism, Figure 91 B Front view is shown, and Figure 91 C show side view.Inserter 5100 has cocking lever 5145, it connects via compression spring connecting rod 5350 It is connected to hammer body compression spring sliding block 5330, and for compression spring sliding block 5330 to be moved to load situation.Power spring 5390 is by hammer body Compression spring sliding block 5330 is connected to trigger 5110, also, when pressurised, provides and is inserted into delivery device or infusion and sensing Down force necessary to device assembly (not shown).Triggering hammer body 5340 be placed in the lower section of hammer body compression spring sliding block 5330 with And between a pair of compression spring connecting rod 5350；It triggers hammer body 5340 and transmits and discharged from power spring 5390 when depression of trigger 5110 Kinetic energy.Energized triggering hammer body 5340 impacts underlying cylindrantherae bolt 5380.Cylindrantherae bolt 5380 is coupled to appearance The cartridge case housing 5370 of cylindrantherae is received, for example, showing one of them in Figure 90.Cylindrantherae bolt 5380 is also placed in return spring Cartridge case housing 5350 is returned to retracted position on 5360 top.
Figure 92 A-92F are briefly showed has the type with reference to described in figure 91A-91C for tilting (cock) and release The time series of inserter 5100.Figure 92 A show that inserter 5100 is in rest position.Reduction compression spring lever (it is not shown, See Figure 91 A, 5145) cause hammer body compression spring sliding block 5330 to reduce and engages triggering hammer body 5340.Figure 92 B show hammer body compression spring Sliding block 5330 is in the position reduced, it engages triggering hammer body 5340 in this position.It increases cocking lever and causes hammer body pressure Spring sliding block 5330 and hammer body 5340 are raised, therefore compression power spring 5390；As a result position is shown in Figure 92 C.Ensureing phase After being properly positioned inserter 5100 for base portion (not shown) and/or patient skin, trigger is depressed, thus to issuing Send triggering hammer body 5340；Figure 92 D show to be in triggering hammer body 5340 in transit.As shown in Figure 92 E, triggering hammer body 5340 rushes Cylindrantherae bolt 5380 is hit, it is caused to travel downwardly, is inserted in the one or more needles kept in cartridge case housing (not shown), and And compression retracteding position spring 5360.Figure 92 F show return spring 5360 be in upwards actuate cylindrantherae bolt 5380 during；This Cartridge case housing and cylindrantherae (not shown) wherein included and used any associated introducing needle is caused to retreat.
Referring now to Figure 93 A-93C, show for delivery device (that is, casing or needle 5010) to be inserted into and fix To one embodiment of the time series in base portion Y.Figure 93 A are shown with the lock feature 5210 for being located at 5030 top of shroud Base portion Y.When being inserted into delivery device or casing 5010, base portion Y is generally against the skin positioning of patient 5220.Figure 93 B show Go out to force casing 5010 to pass through the shroud 5030 in base portion Y.In the figure, using needle 5240 is introduced, it (does not show through partition Go out) and coaxially positioned in casing 5010；The sharp point for introducing needle 5240 occurs from the top (not shown) of casing 5010 To pierce through patient 5220.During plug-in-sleeve 5010, elastic locking feature 5210 is pushed to side.Figure 93 C show casing 5010 are fully inserted by the shroud 5030 of base portion Y, and wherein cannula tip is fully inserted into 5220 body of patient.Introduce needle 5240 have been removed and partition 5060 is relative to fluid source or flowline (not shown) self sealss.Elastic locking Thus 5210 abutment sleeve 5010 of feature prevents casing 5010 from being moved relative to base portion Y.Although Figure 93 A-93C show casing 5010, but can use the lock feature 5210 for showing and describing in Figure 93 A-93C and method will be defeated shown in Figure 86 B Liquid and sensor module are inserted into.
Referring now to Figure 92 G-92H, to inserter, such as that is used together shown in Figure 91 A-92F Insertion cylindrantherae screw bolt locking mechanism be illustrated as 5100.Cylindrantherae screw bolt locking mechanism can be used as interlocking, to prevent from working as mechanism quilt Unexpected release when tilting.Retaining mechanism includes brake component 5420, the brake component when being bonded in brake component recess portion 5410 5420 prevent cylindrantherae bolt 5380 from moving downward.As shown in Figure 92 G, when compression spring lever 5145 is in the closed position, compression spring Lever 5145 contacts brake component lever 5440, to rotation brake part 5420 and brake component 5420 is prevented to be inserted into brake component In recess portion 5410.The brake component spring 5430 being placed between brake component 5420 and brake component spring support 5450 is in compression In position.Cylindrantherae bolt 5380 and triggering hammer body 5340 move freely.As shown in Figure 92 H, when compression spring lever 5145 rotates to When in down position, brake component lever 5440 is released, and thus allows brake component spring 5430 that brake component 5420 is forced to be inserted into (brake component 5420 is shown located in recess portion here, but 5410) recess portion described in Figure 92 G is illustrated as in recess portion；Thus Prevent moving downward for cylindrantherae bolt 5380.Brake component 5420 is returned to unlocked positioning by the return of compression spring lever 5145 in turn It sets.Then cylindrantherae bolt 5380 freely moves downward in trigger process.
Referring now to Figure 94 A-94C, shows casing 5010 being cooperated to base portion Y and form fluid with flowline 310 One embodiment of the process of connection, middle sleeve are the traditional sleeves that requirement introduces needle (as shown in Figure 86 B).Figure 94 A are shown There are two the section views of the casing 5010 of partition (introducing needle partition 5062 and flowline partition 5270) for tool.Introduce needle every The middle empty needle of 5062 seal guide sleeve pipe 5010 of piece (is not shown, is illustrated as access 5,280 5290) in Figure 94 B.Casing draws Enter needle 5240 and be shown located on to introduce 5062 top of needle partition and just before being inserted into and introducing needle 5240.
Referring now to Figure 94 B, introduces needle 5240 and be illustrated as being inserted by introducing needle partition 5062.User is by casing 5010 It is cooperated in base portion Y, the base portion has towards upper rigid hollow needle 5290.Casing 5010 is being inserted into base portion Y mid-terms Between, it introduces needle 5240 and pierces through flowline partition 5270, be in fluid communication with being formed between flowline 310 and access 5280. If base portion Y is maintained as against patient's (not shown) during casing 5010 is inserted into base portion Y, with patient skin Be pierced about the same time time forms fluid communication between flowline 310 and access 5280.Referring now to figure 94C shows the casing being fully inserted into base portion Y 5010, is flowed wherein introducing needle and being removed and formed with flowline 310 Body is connected to.
In alternative embodiments, the vibrating motor assisted transfusion device and/or biography by cooperating with fluid delivery device The insertion of sensor.Simultaneously, vibrating motor can be activated for insertion with delivery device and/or sensor.
Binder
Referring now to Figure 95, show for the object of such as fluid delivery device 10 to be fixed to patient's (not shown) skin The top perspective of one embodiment of the binder patch 3100 of skin.Although binder patch 3100 is illustrated as current shape Shape, but other shapes can be used.Any binder patch that can firmly hold fluid delivery device can be used 3100。
Fluid delivery device 10 is securely held in the binder that patient skin is attached to by binder component 3111 Below the middle section 3130 of patch 3100.
These binder components 3111 are scattered with radial pattern from middle section 3130 and by 3121 phases of intermediate region Mutually interval.The radial arrangement of binder component 3111 allows that device 10 is attached to patient with fast way.In some embodiments In, middle section 3130 covers whole devices 10, however, in other embodiments, the one of 3130 covering device 10 of middle section Part.Middle section 3130 can also include interlocking attachment feature (not shown), can be special by the complementary interlocking of device 10 (not shown) is levied to support.In alternative embodiments, device 10 is attached in (example on the top of middle section 3130 securely Such as, pass through binder or interlock feature).
It is that binder patch 3100 is generally flat and be made of polymer flake or fabric.Binder patch 3100 can be supplied with the binder adhered on side, and by the release liner of for example peelable plastic sheet Protection, binder will be arrived more loosely and be attached to the release liner compared with patch 3100.The liner can be single Serialgram, or can be divided into the multiple regions that can be removed respectively.
In an exemplary embodiment, it can be removed for the liner of middle section 3130 and be used for binder without removing The liner of component 3111.In order to use binder patch 3100, user removes the liner of middle section 3130 and by device 10 The binder of middle section newly exposed is pressed to so that device 10 is attached to middle section 3130.User is then by the device Part is placed on skin again, is removed and is padded from binder component 3111, binder component is attached to skin, and utilize Other component repeats attaching process.User can adhere to all binder components 3111 or only some components, and Other binder component 3111 is saved to be used at another day.Because the binder commonly used in being attached to skin only exists It keeps being attached securely in a couple of days, therefore one group of binder component 3111 (for example, every 3 to 5 days) is used in not same date By extend device 10 keep be attached to securely skin time and reduce again using the device when frequently involve when Between, cost and sense of discomfort.Different small pieces can have the label of such as different colours or number, various with instruction attachment The appropriate time of binder component 3111.Binder component 3111 may include perforation, make its relative to middle section 3130 more Add fragility, to which binder component used can be removed after usage.It discusses and is used for above with reference to Figure 79-83 Extend so that device 10 keeps the other embodiment of the duration of attachment.
Figure 96 briefly shows the section view of fluid delivery device 10, wherein the casing 5010 being inserted into is protected securely It holds below binder patch 3100.Gasket 3220 can be included between device 10 and patient skin 3250 and permit Perhaps air flow to skin.The air flowing of skin can be increased to by including access 3230 in gasket 3220.Also may be used With by using separately multiple pads or by using high porosity material construction gasket 3220 formed access 3230. Therefore, gasket 3220 can have any shape and size, and in some embodiments, gasket 3220 is by multiple separation Piece is constituted.Gasket 3220 can be attached to the downside of device 10 during manufacture, or can be attached to device by user 10.Alternatively, gasket 3220 can be loosely placed on skin before using binder patch 3100 by user.Pad Piece 3220 may include conformable material, such as porous polymer foam.
Figure 97 shows the embodiment of the present invention, uses first binder patch 3100 and other binder patch 3300 by device (not shown) to be fixed to patient.First, device (not shown) is positioned to use and utilize to use piece The binder patch 3100 of shape-binder component 3111 is fixed to patient skin (not shown).Middle section 3130 can position In (as shown) in the top device or it is fixed below it.After long or short a period of time, positioning the Two binder patches 3300, so that its middle section is located on the top of first binder patch 3100, and second bonds The binder component 3320 of agent patch is fixed in the intermediate region between the binder component 3111 of first binder patch To patient skin.Weak section can be provided so that the patch 3100 removed with early stage places is related loose or is not required to The binder component 3111 wanted.
Referring now to Figure 98 and 99, show that wherein binder patch 3100 has been divided at least two smaller binders The embodiment of patch.In these embodiments, binder patch 3100 is divided into two binder patches 3410 and 3420, Each all has the binder component 3111 around 3430 radial arrangement of central void.Two 3410 Hes of binder patch 3420 each transform into about 180 ° of semicircle, but other configurations can be used, such as：Each is unfolded 120 ° Three patches or each 90 ° of four patches are unfolded.In some embodiments, binder can include being more than four Patch.In accordance with the formula of 360 °/n, wherein n is patch number for configuration about the description of these embodiments.But other In embodiment, according to the shape of device, the not applicable formula being illustrated and described herein.In a further embodiment, described Patch can also cover the range more than 360 °, and therefore be folded.
As shown in the perspective view of Figure 99, since there are central voids (to be not shown, shown in Figure 98), middle section 3130 have the form of the thin strip for the periphery attachment positioning along device 10.Two patches 3410 and 3420 are together Device 10 is attached to skin (not shown) securely.As in reference to the embodiment described in figure 95, particularly when providing access When 3230, air can flow between binder component 3111 and below device 10.
Figure 100 shows to include to extend using multiple binder patches so that device 10 remains attached to before the removal The perspective view of the embodiment of the time of patient's (not shown).When device 10 is held in place (or by remaining binder patch 3410 and/or pass through user) when, one in multiple portions binder gasket 3420 is removed.Removed binder patch Then 3420 are substituted by new replacement binder patch (not shown).Substituting binder patch can be with the gasket that is removed 3420 is identical or can have binder component 3111, which be located in alternative configuration to allow to glue The new skin being attached between the region covered before by binder patch 3420.Then it can replace in a similar way Remaining binder patch 3410.Such as the label of color code can serve to indicate that binder patch used the time.Patch Piece can also have color change mechanism to expire with the probable life for indicating them.The dicoration of such as image and design Pattern can be included on patch.
Figure 101 briefly shows plurality of binder component 3111 and is attached to patient 12 and also via tether 3730 It is connected to the embodiment in annular central region 3130.Tether 3730 can be fiber or rope and can be elasticity with Mitigate the movement that device 10 is carried out in response to the movement of patient 12.It is also added for binder component using tether 3730 Available selection for 3111 skin site.
Binder for embodiment described in Figure 95-101 can be used for any effective and peace on patient skin Full binder.However, in one embodiment, binder used is 3M product identifications 9915, light and shade weaving lace (value spunlace) medical treatment non-woven tape.
It clamps and locks
Figure 102 A-102C briefly show a kind of for clamping or being locked to the top of fluid delivery device and base portion Mechanism together.Referring initially to Figure 102 A, the front view of fixture 6410 is shown.Figure 102 B are shown with for two fixtures The base portion Y of keyhole 6440；Corresponding keyhole may also be included in that in the (not shown) of top.Referring now to Figure 102 C, top X It can be aligned with base portion Y and fixture 6410 (can be not shown by keyhole, be illustrated as 6440) being inserted into Figure 102 B.With 90 ° of rolling clamps 6410 cause mast 6430 to be moved in latched position.Cam lever 6400 is depressed, engages and is hinged to folder The cam 6415 for having pin 6420, to push top X.As a result, top X and base portion Y are maintained at cam using clamping force Between 6415 and mast 6430.Cam lever 6400 is increased, releases clamping force, and fixture 6410 can rotate 90 ° and retract with allow separate top X and base portion Y.In some embodiments, lever may be used as the protection for top X Lid.
Alternate embodiments for clipping together the multiple portions of the device are shown in Figure 103 A-103D.Figure 103A shows the perspective view of cam guide 6500 and Figure 103 B show top view.Cam guide 6500 has keyhole 6440 and inclined surface 6510.Figure 103 C show the cam-follower 6520 with central pin 6540, and wherein end 6560 is An end portion is attached and bar 6550 is attached to opposed end.As shown in the section view of Figure 103 D, cam-follower (does not show Going out, shown in Figure 103 C) keyhole that can be inserted into top X, base portion Y and cam guide 6500 (is not shown, is shown in In Figure 103 C) in.The movement for being attached to the lever 6530 of central pin 6540 causes cam-follower (to be not shown, be shown in Figure 103 C In) rotation, this causes bar 6550 (to be not shown along inclined surface, be shown as 6510) advancing in Figure 103 C and thus will revolve Transfer to the effect for being firmly converted into clamping base portion Y and top X securely between cam-follower end 6560 and bar 6550 Power.
Liquid storage device
The exemplary embodiment for collapsing liquid storage device for keeping fluid is shown in Figure 104-106C.Storage can be collapsed Liquid utensil has at least one portion being recessed when fluid exits or wall, thus middle inside it to keep environmental pressure.Big In most embodiments, salable port (for example, partition) is included in liquid storage device.The port allows to flow using syringe Body fills the liquid storage device and is additionally operable to be connected to flowline without leakage.Alternatively, adapter can be used for by Liquid storage device is connected to flowline.Alternatively, as above with reference to shown in Figure 71, needle can it is associated with liquid storage device and Partition can be associated with the terminal of flowline.Liquid storage device can be by fluid compatible that is known and including in liquid storage device Plastic material construction, even for the very short duration.In some embodiments, liquid storage device can collapse completely, That is, liquid storage device does not include any rigid body surface.
Referring now to Figure 104, the section view of liquid storage device 20 is shown.In rigid reservoir body 6200 and flexible liquid storage The cavity 2645 for keeping certain volume fluid is formed between device diaphragm 6330.6330 surrounding cavity 2645 of flexible partition Periphery is hermetically attached, to accommodate fluid in cavity 2645.Flexible partition 6330 assigns crushability to liquid storage device 20； When pumping fluid from cavity 2645, it is deformed inward.
Partition 6270 is seated against from the neck 6240 that ontology 6200 extends.Partition 6270 is used as cavity 2645 and flowing Interface between pipeline.In some devices, flowline terminates at needle (not shown).In these embodiments, the needle It is inserted through partition 6270, to lead to 6280 part of needle cavity room of cavity 2645.By the way that partition 6270 is located in end cap Between 6250 and flange (not shown), 6270 position of partition can be maintained, and wherein the flange is formed in needle cavity room 6280 Inner wall 6281 and end cap drilling 6282 engaging portion at.Frictional fit can be utilized to keep end cap in end cap drilling 6282 6250.When being inserted into end cap 6250, its position is limited by the wall 6261 of end cap drilling 6282.End cap 6250 near The part of nearly partition 6270 can have central hole, to allow needle to be inserted by end cap 6250 and enter partition 6270 In.Alternatively, end cap 6250 can be schematically shown.
Figure 105 shows that the perspective view inside liquid storage device 20 can be collapsed.Edge 6230 allows to be attached flexible reservoir membrane, The diaphragm can be attached by welding, clamping, attachment or other proper methods, to form Fluid Sealing.May include preventing Protection structure 6290 prevents needle from entering in cavity to allow fluid to flow to cavity 2645 or flowed out from cavity 2645, by This prevents it from may pierce through reservoir membrane.
Figure 106 A-106C show that partition 6270 is hermetically attached by the alternate embodiments of liquid storage device, wherein end cap 6250 To the wall 6320 of liquid storage device.Wall 6320 can be constructed for example by flexible flake, such as PVC, silicones, polyethylene, Huo Zheyou ACLAR film configurations.In some embodiments, wall 6320 can be thin by the thermoformable polyethylene formed using ACLAR films Piece constructs.Flexible flake and fluid compatible.The wall may be attached to stiff case, such as can be by folding and welding The end for connecing plastic tab is formed by a part for flexible plastic pouch.Figure 106 A show to be sealed to via round fin 6350 The end cap 6250 of wall 6320.Partition 6270 can be inserted from 6250 pivoted frame 6340 outstanding of end cap.Pivoted frame 6340 can be by The material construction of rigidity, such as low density polyethylene (LDPE) can be deformed but are at room temperature at high temperature.Referring now to figure 106B, hot press 6310 either be used to melt or be bent on partition 6270 for another equipment or process of fusing Pivoted frame 6340.Referring now to Figure 106 C, partition 6270 is illustrated as being fixed to end cap 6250.
Certain fluids are for storage state sensitivity.For example, insulin usually stores in transportational process in its vial It is stable to a certain extent, but may be unstable when the certain plastics of Long Term Contact.In some embodiments, it stores up Liquid device 20 is by this constructed in plastic material.In this case, it is possible to just utilize fluid to fill liquid storage device 20 before the use, to There is contact in short period of time in fluid and plastics.
Liquid storage device packing station
Referring now to Figure 107, the liquid storage device packing station 7000 for being filled liquid storage device 20 using fluid is shown.Fluid can To be extracted out from its original container using syringe 7040 and be introduced into liquid storage device 20 by using packing station 7000.It fills out Fill the packing station base that station 7000 may include the substantially rigid for the packing station lid 7020 that substantially rigid is hinged to via hinge 7030 Portion 7010.Correspondingly, standing 7000 can be opened and closed to receive and keep liquid storage device 20.It is attached to syringe 7040 Needle 7050 may then pass through the filling hole 7060 in lid 7020 and be inserted into across liquid storage device partition 6270.Because filling out It fills station lid 7020 to be rigid, so it, which is construed as limiting the traveling of syringe 7040 and therefore controls needle 7050, penetrates storage Depth in liquid device 20, to prevent from piercing through the downside of liquid storage device 20.When being supported on the surface, supporting leg 7070 will stand 7000 It is maintained in obliquity.It 7000 is inclined by because standing, when fluid is entered from the injection of syringe 7040 in liquid storage device 20 When, air will tend towards partition 6270 and rise.The injection of the desired amount of fluid is entered into it in liquid storage device 20 in syringe 7040 Afterwards, syringe 7040 can be used to remove any surplus air in liquid storage device 20.Because of packing station base portion 7010 and lid 7020 are rigid, so flexible reservoir 20 generally can not be extended to more than fixed volume and prevent to 20 mistake of liquid storage device Degree filling.Base portion 7010 and lid 7020 can be locked into using fastener together or heavy lid can be used for further Prevent liquid storage device excessively expansion and excessively filling.
Referring now to Figure 108 A and 108B, the alternate embodiments of liquid storage device packing station 7000 are shown.In the embodiment In, liquid storage device (not shown) is placed in the space between lid 7020 and base portion 7010.Hinge 7030 is attached lid 7020 and base portion 7010.As shown in Figure 108 B, liquid storage device (not shown) is internally positioned, and syringe (not shown) needle (not shown) is inserted into It fills in hole 7060.Filling hole 7060 is directly connected to the partition (not shown) of liquid storage device.Form 7021 is to be injected into The fluid volume of liquid storage device indicates flowline.
Fluid delivery system generally includes fluid delivery device and external user interface, but in some embodiments, it is complete Complete or partial internal user interface is included in device.The device can be any device described here Or its modification.
Figure 109 A show the flow of the data acquisition and control scheme of the exemplary embodiment for fluid delivery system Figure.Patient or health worker utilize external user interface 14, the external user interface 14 be usually base station either independently of Fluid delivery device 10 and accommodate handheld unit.In some embodiments, user interface 14 and computer, portable radiotelephone Phone, personal digital assistant or other consumer's devices are integrated.User's interface unit can be via radio frequency emissions (for example, via LF, RF either standard wireless protocol such as " bluetooth ") carries out continuous or interval with fluid delivery device 10 Data communication, but also can via data cable, optics connection or other proper datas connect and connect.It uses outside Family interface 14 is communicated with processor 1504 with input control parameter, such as weight, fluid dosage range or other data, and And reception state and function renewal, for example there is due to blocking flowing, leakage, empty liquid storage device, bad accumulator status, needs Any wrong shape caused by the either residual fluid total amount or unverified Disposable artifact repairing, is expired, being conveyed State.Interface 14 can be by phone, Email, pager, instant message or other appropriate communication medias to patient monitoring people Or Medical Technologist transmits error signal.Liquid storage device actuator 1519 includes actuator 1518 and liquid storage device 1520.Point Distribution assembly 120 transmits data related with the flowing by flowline to processor 1504.Processor 1504 uses flowing number According to the action for adjusting actuator 1518, it is substantially required that the flowing for being originated from liquid storage device pump group part 1519, which is increased or decreased, Dosage and timing.Optionally, the feedback controller 1506 of processor 1504 can receive and liquid storage device pump group part 1519 Related data are operated with acquisition mode, such as open either short trouble or actuator temperature.
Figure 109 B show the alternate embodiments of the flow chart in Figure 102 A.In this embodiment, allocation component/sensing The shortage of device eliminates the feedback based on fluid volume.
Referring now to Figure 110 A, a reality of the overall operation of the fluid delivery device in fluid delivery system is shown Apply the flow chart of example.User is using switch or from external user interface activation system (step 2800).System is silent by loading Recognize numerical value and be initialised, operating system test (step 2810) and obtain variable element, for example, needed for basis and inject agent Amount.Can user interface be used by user, that is, using the touch screen on such as user interface entering apparatus or by from Memory loads preserved parameter, to select variable element (step 2820).Based on estimated or calibration fluid conveying The performance of device come calculate actuator timing (step 2830).Allocation component is activated when fluid delivery device activates beginning (step 2840).Allocation component data collection 2835 is continued by activating and conveying.During operation, allocation component provides Data, the data allow determine had passed through within one or more period dispensed chambers fluid cumulative volume and Flow rate.Fluid delivery device is activated to cause fluid flows to move pipeline and enter dispensed chambers (step 2840).Drug with Given pace flow to patient from dispensed chambers, which is determined by outlet impedance, and in some embodiments, by diaphragm The active force and (step 2860) is determined by the active force of pump application that spring applies.Stop if there is user Interruption, low flow regime are determined based on estimated accumulation flowing or using the detection of other reservoir volume sensor Liquid storage device, which is any portion of empty situation either system, has any other alert action or with user-defined Any other alert action, then system will stop and notify user's (step 2870).If there is no user's stop signal, Liquid storage device is empty determination or another alarm indicator, then checked to determine whether due to practical and required flow rate it Between deviation or due to user change needed for flow rate and need adjust actuator timing (step 2880).If you do not need into Row is adjusted, then the process return to step 2840.If necessary to adjust, then the process return to step 2830.Referring now to figure 110B shows the flow chart of another embodiment of the fluid delivery device overall operation in fluid delivery system.In the embodiment In, the decision for adjusting actuating timing is made based on variation input by user or another feedback.In this embodiment, do not include Allocation component with the sensor for determining volume；Therefore it is adjusted based on alternative feedback mechanism.
Wireless communication
Referring now to Figure 111, show in fluid delivery system using coil for induction charging and wireless communication The layout of embodiment.As previously mentioned, user's interface unit 14 can be used with the hand-held wirelessly communicated with fluid delivery device 10 The form of family interface module 14 is implemented.Secondary coil (i.e. solenoid) 3560 can be used in fluid delivery device 10, as With the wireless transceiver antenna that wireless controller 3580 is combined.Secondary coil 3560 is also used as secondary transformer, uses It charges at least partly to device accumulator 3150 in combination with battery charging circuit 3540.In this embodiment, it uses Family interface module 14 contains the primary coil 3490 for being useful for coupling energy to induction mode secondary coil 3560.Work as user When interface module 14 is close to fluid delivery device 10, primary coil 3490 encourages secondary coil 3560.Energized two level line 3560 pairs of battery charging circuits 3540 of circle are powered, and are charged with the accumulator 3150 in fluid delivery device 10.In some realities It applies in example, primary coil 3490 also serves as antenna to emit in combination with wireless controller 3470 and from fluid delivery device 10 receive information.
Referring now to Figure 112, some embodiments include remote radio communication (for example, 20- in fluid delivery device 10 200 feet or it is farther) hardware.It therefore, can be with remotely monitor fluid delivery device 10.
Referring still to Figure 112, usually by patient carry intermediary transceiver 6600 be capable of providing telecommunication the advantages of, The size, weight and power consumption of fluid delivery device 10 are not increased simultaneously.As shown in the data flow diagram of Figure 112, fluid can be worn Data are emitted to intermediary transceiver 6600 using short distance hardware and related software or receive from it number by conveying device 10 According to.For example, device 10 can be equipped to emits data in substantially 3-10 feet of distance.Then intermediary transceiver 6600 The data can be received and use remote hardware and software to 14 transfer of the user's interface unit data.Intermediary transceiver 6600 can also connect suspension control signal and to these signals of 10 transfer of device from user's interface unit 14.Optionally, Yong Hujie Mouthful component 14 can also can be with 10 direct communication of fluid delivery device in range.This direct communication can by with It is set to and occurs over just when intermediary transceiver 6600 is not detected or alternatively in user's interface unit 14 and fluid conveying Device be in each other in range whenever.
The data of many types can be emitted by this method, including but not limited to：
Data related with pump actuating timing and cubing and other data from allocation component can be launched To intermediary transceiver 6600 and by transmitted in sequence to user's interface unit 14；
Alarm signal can be emitted to fluid delivery device 10 and can be launched from fluid delivery device 10；
It can be from user interface 14 to intermediary transceiver 6600 and from intermediary transceiver 6600 to fluid delivery device 10 Emit to confirm the signal of data receiver；
It can be emitted from user's interface unit 14 to fluid delivery device 10 for changing device using intermediary transceiver 6600 The control signal of the operating parameter of part 10.
Referring now to Figure 113, the plan view of the specific embodiment of intermediary transceiver 6600 is shown.Short range transceiver 6610 It is communicated with neighbouring fluid delivery device.The short range transceiver and intermediary transceiver 6600 of device can use many agreements One or more agreement and the known tranmitting frequency (such as radio frequency emissions) for short range communication are led to Letter.The data that intermediary transceiver 6600 receives are transported to can store number in memory 6620 (for example, flash chip) According to microprocessor 6630, and retrieve data as needed.Microprocessor 6630 is further attached to user interface into line number According to the remote transceiver 6640 of communication.For example, intermediary transceiver 6600 and user's interface unit can be grasped according to bluetooth standard Make, the bluetooth standard is the radio frequency using about 2.45MHz and can be grasped in the distance up to about 30 feet The spread spectrum protocol of work.Zigbee standards are operated in the ISM band of about 2.4GHz, 915MHz and 868MHz Alternative standard.However, it is possible to use any wireless communication.
Optionally, microprocessor 6630 analyze received data with detect fault condition related with the device or Person's maintenance needs.Some examples of malfunction include but not limited to：
More than setting limitation when interim lack the data being received；
Lack the data reception acknowledgement signal from device or user's interface unit；
The overflow of device memory 6620 or nearly overflow situation；
Low-power；
The cubing of excessively high, too low or incorrect timing is received from fluid delivery device 10.
Based on the accident analysis, microprocessor 6630 can trigger alarm 6650 (for example, bell or buzzer).It is micro- Processor 6630 can also be to remote device communications and warning system state.Remote device can be, for example, using long-range transceiver It is 6640 user's interface unit, defeated using the fluid delivery device 10 or user's interface unit and fluid of close range transceiver Send both devices.When receiving alarm signal, then user's interface unit can believe alarm via longer distance Number it is relayed to Medical Technologist's either patient monitoring people (for example, by pager or phone or other communication means).
Power supply 6670 can be rechargeable, and can store enough energy to operate continuously a period of time, example Such as, at least ten hour.However, the operating time will be based on purposes and device changes.The size of fluid delivery device can be reduced To which it can easily be carried in pocket, wallet, briefcase, knapsack etc..One embodiment of device includes for bearing The device of conventional impact or overflow.May include other feature in some embodiments, it is including but not limited to decorative Feature such as can play video game, send and receive instant message, viewing digital video, listen to music etc. it is a wide range of Any one of the ability of consumer electronic devices.May include that third party controls in one day a period of time or institute Cancel or limit the use of this function during having time.Alternatively, the device can as far as possible it is small and simple, and And it is used only for repeating short distance signal apart from upper longer.For example, memory and analysis ability can be removed.
Referring now to Figure 114, the data flow diagram for system embodiment is shown.Intermediary transceiver 6600 is illustrated as using Make general patient interface, the general patient interface and multiple devices carry out short-range communication and by the letters from those devices Breath via being relayed to and one or more relevant user interface of those devices over long distances.The example of device include can wear, Portable or inside medical device, including fluid delivery system, glucose sensor, with integrated strain transducer Knee joint, the tool electron probe of pill form, defibrillator, pacemaker and other treatment conveying devices worn.Cause For different types of device and the device from different manufacturers can utilize different short-range communication standard and frequency, So intermediary transceiver 6600 may include supporting the hardware of multiple agreements (for example, mutiple antennas and circuit) and software.
Battery charger
Referring now to Figure 115 and 116.One embodiment 7100 for the equipment to battery recharge is shown.Scheming In 15, the top of fluid delivery device 2620, non-disposable part are illustrated as the base portion from fluid delivery device, disposable portion Disjunction is opened.Battery charger 7100 is used to charge to the accumulator (not shown) in top 2620.In Figure 116, top 2620 are shown located on battery charger 7100.Lockset 6530 is shown as being closed, and top 2620 is connected to accumulator Charger 7100.Therefore, it is additionally operable to connect at top 2620 for top 2620 to be connected to the lockset 6530 of base portion (not shown) It is connected to battery charger 7100.Docking can form directly electrically connected, or can utilize inductively transfer electrical power. Moreover, in some embodiments of system, patient is using the multiple non-disposable parts 2620 rotated；That is, when using second A pair non-disposable part 2620 is charged when non-disposable part (not shown).
Various embodiments described here include the element of different type and configuration, e.g., such as pump construction, pump actuating Device, volume sensor, current limiter, liquid storage device (and reservoir interface), sharp inserter, shell, locking mechanism, Yong Hujie Mouth, built-in (on-board) peripheral hardware (such as controller, processor, power supply, network interface, sensor) and other peripheral hardware (examples Such as, handheld remote controller, base station, transponder, packing station).It should be noted that alternate embodiments can combine these yuan The various combinations of part.Thus, for example, with reference to one embodiment describe pump configuration (for example, showing and retouching with reference to figure 15-15D The pump stated) it can be with the pump actuators of various configurations (for example, single shape memory actuator, tool with single operation pattern There are many single shape memory actuator of operation mode, identical sizes or various sizes of multiple shape memory actuated Device) any one of be used together, and can be used for that there are other elements various combinations (or be not present other members Part) and/or various current limiters any type current limiter device.
In turn, although describing various embodiments herein with reference to non-pressurised liquid storage device, it is pointed out that in certain implementations Pressurized reservoir can be used in example or under certain states (for example, during perfusion and/or exhaust).Particularly, such as The retraction for the pump actuating member 54 for showing and describing with reference to figure 15A-15D is followed, pressurized reservoir can be in order to filling pump chamber Room.
Additionally, although describing various embodiments herein with reference to the pump motor being placed in the reusable part of shell, It should be noted that pump and/or pump motor alternatively for example can be located at disposable portion together with the various components of contact fluid In point.Such as about some in other motors described here, the motor being placed in single use portion may include one or The multiple shape memory actuators of person.
It should be noted that include division header for convenience, and they are not intended to limit the scope of the invention.
In various embodiments, what is disclosed herein includes for controlling and measuring fluid flowing and in correlation The method that those of communication operation is established between component can be used as computer program product to realize, the product to it is suitable When controller or other computer systems (referred to herein generally as " computer system ") be used together.This realization May include sequence of computer instructions, which is fixed on tangible medium, such as computer-readable medium It (such as magnetic disc, CD-ROM, ROM, EPROM, EEPROM either hard disk) or can be via being for example connected to net by medium The modem of the communication adapter of network or other interface devices and be transferred in computer system.The medium can be with Be tangible medium (such as optics either analog communication line) or using wireless technology (such as microwave, it is infrared or its Its lift-off technology) realize medium.The institute described in front about the system herein may be implemented in sequence of computer instructions Need functionality.Those skilled in the art should understand that this computer instruction can be programmed with a variety of programming languages, for very A variety of computer architectures or operating system.
In turn, this instruction can be stored in any storage component part, such as semiconductor, magnetic, light or other In storage component part, and any communication technology (such as optics, infrared, acoustics, radio, microwave or other can be used Lift-off technology) it is launched.It is expected that this computer program product can be as with subsidiary printing or electronic literature (example Such as, shrink-wrap software) removable media and distribute, using computer system preload (such as system ROM, EPROM, EEPROM are either on hard disk) or it is public by server or electronics via network (such as internet or WWW) Accuse board distribution.Certainly, some embodiments of the present invention can be with the shape of software (such as computer program product) and hardware combinations Formula is implemented.Other embodiment of the present invention is all as hardware or substantially with the shape of software (such as computer program product) Formula is implemented.
It should be noted that the size listed herein, size and number are exemplary, and the present invention is by no means restricted to This.In an exemplary embodiment of the present invention, the length of the fluid delivery device of patch size can be substantially 6.35cm (~ 2.5 inches), width substantially 3.8cm (~1.5 inches) and height substantially 1.9cm (~0.75 inch), still, together Sample, these sizes are only exemplary, and different embodiment sizes can be changed on a large scale.
Although the principle of the present invention has been described herein, those skilled in the art should understand that the explanation is only logical It crosses way of example to provide, rather than as limitation of the scope of the invention.In addition to the exemplary implementation being illustrated and described herein Example, in the scope of the invention it is also contemplated that other implementations.It is considered belonging to by the modifications and substitutions that those of ordinary skill in the art make In the scope of the present invention.

Claims (24)

1. a kind of equipment for distributing medical fluid, the equipment include：
Shell, the size of the shell are used to be attached to the body of patient；
Liquid storage device, the liquid storage device is for keeping the medical fluid being enclosed in the shell；
Pump, the pump can be connected to positioned at the downstream of the liquid storage device with the reservoir fluid, and the pump is sealed It closes in the shell；And
Allocation component, the allocation component is located at the downstream of the pump, and can be in fluid communication with the pump；
It is characterized in that, the allocation component has sensor, the treatment for leaving the allocation component is tried for determining repeatedly The parameter that the volume of agent measures, or determine the function of the volume for the therapeutic reagent for leaving the allocation component.
2. equipment according to claim 1, wherein the equipment further includes control ring, and the control ring is attached to institute Sensor and the pump are stated, the excitation feelings for adjusting the pump during proper flow state based on measured parameter Condition.
3. equipment according to claim 2, wherein the excitation situation for adjusting the pump includes to time of pumped hair, pump At least one in the rate of excitation and the degree of pumped hair is controlled.
4. equipment according to claim 2, wherein the control ring further includes controller.
5. equipment according to claim 4, wherein the controller is arranged to estimate stream based on identified parameter Add up at least one in liquid stream present in the flow velocity of body and the distribution cavity.
6. equipment according to claim 5, wherein the controller is arranged to determine compensation row based on the estimation For.
7. equipment according to claim 1, wherein the sensor is one of optical sensor and capacitive sensor.
8. equipment according to claim 1, wherein the sensor is acoustic volume sensor.
9. equipment according to claim 8, wherein the acoustic volume sensor includes loudspeaker, the loudspeaker quilt Generation of the arrangement for acoustic volume sensing and audible alarm.
10. equipment according to claim 8, wherein the acoustic volume sensor includes microphone, the microphone quilt Arrangement senses and monitors the operation of pump for acoustic volume.
11. equipment according to claim 8 further includes electronic building brick, the electronic building brick includes loudspeaker and sensing wheat At least one of gram wind and reference microphone.
12. equipment according to claim 11, wherein the electronic building brick is arranged on a printed circuit.
13. equipment according to claim 8, further includes：
Acoustic energy source, the acoustic energy source excite the gas in acoustics neighboring region for acoustically, thus Acoustic responses are wherein generated, the region includes the subregion for being attached to the distribution cavity, to the volume of the distribution cavity Change so that the volume of the subregion also changes；And
Processor.
14. equipment according to claim 13, wherein the sensor includes the first acoustic transducer, first sound It learns converter to be installed at the first position in the acoustics neighboring region, for generating telecommunications based on the acoustic responses Number；And
The processor is attached to first acoustic transducer and benchmark, and is arranged to execution flows and determines step, uses In determining amount related with the change of the volume of the subregion based on the acoustic responses.
15. equipment according to claim 14, wherein the acoustic transducer is arranged to only excite institute with single-frequency Gas is stated, and there is certain phase relation relative to the benchmark by the electric signal that first acoustic transducer generates； And
The processor is arranged to by determining the volume with the subregion based on the time-evolution of the phase relation The relevant amount of change, so that it is determined that the liquid stream.
16. equipment according to claim 13, wherein the sensor can sense the blocking in the allocation component downstream Situation.
17. a kind of equipment for distributing fluid, the equipment include：
The shell of patch size；
Pump, the pump are disposed in the shell, and the pump has pump discharge；
Allocation component, the allocation component also are disposed in the shell, and the allocation component includes distribution cavity, the distribution cavity It is exported with distribution entrance and distribution, wherein the distribution entrance is attached to the pump discharge, and the allocation component, which has, to be passed Sensor for the determining parameter measured to the fluid volume for leaving the distribution cavity repeatedly, or determines and leaves described point The function of fluid volume with chamber；And
Limited flow resistance, the limited flow resistance are attached to the outlet of the distribution cavity,
Wherein, the limited flow resistance is passive flow resistance, which is characterized in that the passive flow resistance includes crooked route, wherein described Shell includes single use portion, and the single use portion is with the integral fluid path for including the crooked route.
18. equipment according to claim 17, wherein the crooked route includes coiling pipeline.
19. equipment according to claim 18, wherein the coiling pipeline includes at least two bendings.
20. equipment according to claim 17, wherein the crooked route has snakelike.
21. equipment according to claim 17, wherein there is the shell full-size, the length in the path to be more than The full-size.
22. equipment according to claim 17, wherein the path includes effective diameter, and the effective diameter is selected For the viscosity based on the fluid scheduled resistance is provided at least one in density.
23. equipment according to claim 17, wherein the length and internal diameter in the path are selected as being based on the fluid Viscosity and density at least one of scheduled resistance is provided.
24. a kind of system for being measured by the flowing of the assigned fluid of pipeline, the system comprises：
Driving part, the driving part with single-frequency for only acoustically exciting the gas in acoustics neighboring region Body, to generate the relevant acoustic responses of variation with the volume of the subregion of the acoustics neighboring region, the subregion The variation of volume is caused by the fluid in the region for the volume for being attached to the subregion；
First microphone, first microphone is installed at the first position in the acoustics neighboring region, and is arranged To generate electric signal based on the acoustic responses；
Processor, the processor are attached to first microphone；
It is characterized in that, the system also includes second microphone, the second microphone is installed in the acoustics adjacent area The second place in domain, for generating the electric signal for constituting benchmark, wherein the electric signal of first microphone is relative to institute The benchmark for stating second microphone has certain phase relation；And
Wherein, the processor is also coupled to the second microphone, and is arranged to the electricity based on first microphone Signal determines and the relevant amount of the change of the volume of the subregion relative to the time-evolution of the phase relation of the benchmark.
CN201810153852.2A 2006-02-09 2007-02-09 Apparatus for dispensing a fluid Active CN108355194B (en)

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US77231306P 2006-02-09 2006-02-09
US60/772,313 2006-02-09
US78924306P 2006-04-05 2006-04-05
US60/789,243 2006-04-05
US79318806P 2006-04-19 2006-04-19
US60/793,188 2006-04-19
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CN2007800073354A Active CN101394879B (en) 2006-02-09 2007-02-09 pumping fluid delivery systems and methods using force application assembly
CN202110103821.8A Active CN112933332B (en) 2006-02-09 2007-02-09 Fluid delivery system
CN201910389649.XA Pending CN110251773A (en) 2006-02-09 2007-02-09 Use the pumping fluid delivery systems and method of force application assembly
CN201810153852.2A Active CN108355194B (en) 2006-02-09 2007-02-09 Apparatus for dispensing a fluid
CN201710219706.0A Active CN107440681B (en) 2006-02-09 2007-02-09 Device for dispensing a fluid
CNA2007800073068A Pending CN101394878A (en) 2006-02-09 2007-02-09 Peripheral systems
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CN202110103821.8A Active CN112933332B (en) 2006-02-09 2007-02-09 Fluid delivery system
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CN112933332A (en) 2021-06-11
CN107440681B (en) 2021-08-17
CN110251773A (en) 2019-09-20
CN101400391B (en) 2014-02-12
CN101400391A (en) 2009-04-01
CN101394879A (en) 2009-03-25
CN101394879B (en) 2012-02-22
CN108355194B (en) 2021-02-12
CN101394878A (en) 2009-03-25
CN101405043B (en) 2012-01-04
CN112933332B (en) 2022-09-06
CN107440681A (en) 2017-12-08

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