CN101394879A - Pumping fluid delivery systems and methods using force application assembly - Google Patents

Abstract

A method of dispensing a therapeutic fluid from a line includes providing an inlet line connectable to an upstream fluid source. The inlet line is in downstream fluid communication with a pumping chamber. The pumping chamber has a pump outlet. The method also includes actuating a force application assembly so as to restrict retrograde flow of fluid through the inlet while pressurizing the pumping chamber to urge flow through the pump outlet. A corresponding system employs the method.

Description

Use the pumping fluid delivery systems and the method for force application assembly

Technical field

The application relates in general to a kind of pumping fluid delivery systems and method of using force application assembly.

Background technology

Because malabsorption, liver metabolism or other medicines kinetic factor, it is not orally active that the medicine that comprises biological product of potential value or chemical compound are much arranged.Additionally, some treat chemical compound, though they can pass through oral absorption, require administration so frequently sometimes, so that the patient are difficult to keep the expection plan.In these cases, often adopt or can adopt parenteral delivery.

Effective parenteral path of the conveying of drug delivery and other fluid and chemical compound, for example subcutaneous injection, intramuscular injection and intravenous (IV) administration comprises and utilizes pin or lancet thorn transdermal.Insulin is the fluidic example of treatment that number is injected voluntarily with ten million diabetics.The user of parenteral delivery medicine will benefit from a kind of can be at the device worn of one section required medicine/chemical compound of automatic transport in period.

For this reason, the portable device design that is used for the treatment of the thing controlled release is made efforts.Known this device has reservoir, for example cartridge case, syringe or medicated bag, and controlled in the electronics mode.These devices have a plurality of shortcomings unfriendly, comprise fault rate.Reducing these size of devices, weight and cost also is a difficult problem that exists at present.

Summary of the invention

In one embodiment, the invention provides and a kind ofly distribute the fluidic method of treatment from pipeline.Described method comprises provides the inlet line that can be connected to the upstream flow body source.Described inlet line is in downstream and pumping chamber in fluid communication.Described pumping chamber has pump discharge.Described method also comprises the brake function force applying assembly, thereby flows backwards by import when pressurization pumping chamber limit fluid when actuating the stream through pump discharge.

In related embodiment, activate described force application assembly and comprise that the use force application assembly flows backwards with restriction in single mechanical action and pressurization pumping chamber at the stroke during the driving stroke.In another related embodiment, the travel limits of the given degree of described active force actuating assembly flows backwards, and the stroke of the higher degree described pumping chamber that pressurizes.

In another related embodiment, activate described force application assembly and comprise by stopping up described inlet line and limit refluence towards fluid source.Alternately or additionally, described method also comprise by use place passive valve between dispensed chambers and the pumping chamber prevent fluid from the dispensed chambers reverse flow to the pumping chamber.

Alternatively, activate described force application assembly and comprise the use shape memory actuator.Also alternatively, use described shape memory actuator to be included in induction (induce) phase change in the shape memory wire, to center on pulley to force application assembly transfer function power.

In yet another embodiment, described method also comprises the mobile relevant parameter of measuring with by described pipeline; And regulate the operation of pump based on measured parameter.Alternatively, measure the stereomutation that comprises the elastomeric chamber of determining to place pumping chamber downstream with mobile relevant parameter by described pipeline.Alternatively, measure described parameter and comprise the measurement of use acoustic volume.

In yet another embodiment, the crooked flow resistance that is positioned at described elastomeric chamber downstream supplied be enough to cause elastomeric chamber in response to pumping expansible flow resistance.

Alternately or additionally, described method also comprise cause fluid by crooked flow resistance conduit from the pump discharge flow further downstream.Described conduit can have various forms.It can have at least two elbows.It can coil.It can have serpentine shaped.Alternatively, described conduit has at least one length and the internal diameter selected for predetermined impedance is provided based on fluidic viscosity and density.Alternatively, described catheter diameter is enough big, thereby prevents because fluid flow produces obstruction by conduit.

In yet another embodiment, described inlet line, pumping chamber, pump discharge and force application assembly are encapsulated in the housing of patch size, and activate described force application assembly and comprise that the processor that uses in the housing activates to cause force application assembly.

Alternatively, described housing has full-size, and described conduit has greater than described maximum sized length.

In yet another embodiment, activating described force application assembly comprises and uses shape memory actuator to respond to.Alternatively, use shape memory actuator to comprise use, and each power path provide different actuation forces by one in a plurality of power paths with different length of shape memory actuator.

In yet another embodiment, described force application assembly has and is used in normal mode of actuating the normal running that flows through pump discharge and the fill-up mode that is used to pour into the pumping chamber.In this embodiment, use shape memory actuator to be included in to use short circuit footpath of shape memory actuator during the force application assembly normal mode and during the force application assembly fill-up mode, use shape memory actuator than the long circuit footpath.

In yet another embodiment, described force application assembly is operated with the basic schema and the pattern of injecting at least, and when being in basic schema, described pumping chamber is with basic speed output fluid.When being in when injecting pattern, described pumping chamber is to inject speed output fluid greater than described basic speed.During the basic schema of force application assembly, use short shape memory actuator, and during the pattern of injecting of force application assembly, use long shape memory actuator.

In yet another embodiment, activating described force application assembly comprises and uses a plurality of shape memory actuators to respond to.Alternatively, using a plurality of shape memory actuators to comprise utilizes them that standby operation is provided.Alternatively, the shape memory actuator that uses a plurality of shape memory actuators to comprise to use different numbers is to provide different actuation force, length of stroke or the two.Alternatively, use a plurality of shape memory actuators to comprise the shape memory actuator of at least two kinds of different lengths of use.

In yet another embodiment, described force application assembly has and is used in normal mode of actuating the normal running that flows through pump discharge and the fill-up mode that is used to pour into the pumping chamber.In this embodiment, use a plurality of shape memory actuators to be included in to use short shape memory actuator during the normal mode of force application assembly and during the fill-up mode of force application assembly, use long shape memory actuator.

Alternatively, use a plurality of shape memory actuators to comprise the shape memory actuator of at least two kinds of different sizes of use.

In another embodiment, the invention provides a kind of system that is used for pumping fluid by pipeline.In this embodiment, described system comprises the pumping chamber, and this pumping chamber has, and the import that is communicated with the fluid source fluid to provide can be provided, and pump discharge.Described system also comprises the force application assembly that is suitable for providing to the pumping chamber compression stroke.In this embodiment, when from the pumping chamber to the pump discharge force fluid, described compression stroke limits from the refluence generation of pumping chamber by import for fluid.

Alternatively, described force application assembly is coupled to imported valve actuator and pump actuator, thereby when pump actuator makes fluid described compression stroke when the pumping chamber is forced into pump discharge activate the imported valve that is connected between import and the fluid source, to close described valve.

Alternatively, described force application assembly comprises plate, and this plate is connected to valve actuator, pump actuator and motor, is used to coordinate the operation of valve actuator and pump actuator.Alternatively, described motor comprises shape memory actuator.Also alternatively, described motor comprises at least one pulley, and it adapts to the reuse part but described pulley is used for folding described shape memory actuator.Alternatively, described force application assembly comprises motor.

In another related embodiment, described motor comprises shape memory actuator.Alternatively, described shape memory actuator is electrically connected, thereby a plurality of power paths with different length by shape memory actuator are provided, and each power path provides different actuation forces.Alternatively, described force application assembly has normal mode that is used for the described pumping chamber of operation under normal pumping state and the fill-up mode that is used to pour into described pumping chamber; In this case, use long power path at the short power path that uses shape memory actuator during the normal mode of force application assembly during the fill-up mode at force application assembly.

In another related embodiment, described motor comprises a plurality of shape memory actuators.Alternatively, described a plurality of shape memory actuator provides the standby operation of force application assembly.Alternatively, the shape memory actuator of the different numbers actuation force that is used to provide different, length of stroke or the two.Alternatively, described a plurality of shape memory actuator comprises the shape memory actuator with at least two kinds of different lengths.Alternatively, described force application assembly has normal mode that is used for operation pumping chamber under normal pumping state and the fill-up mode that is used to pour into the pumping chamber; In this case, use long shape memory actuator using short shape memory actuator during the normal mode of force application assembly during the fill-up mode at force application assembly.

In another related embodiment, described a plurality of shape memory actuators comprise the shape memory actuator with at least two kinds of different sizes.

Another related embodiment additionally comprises and the placed in-line downstream of pump discharge allocation component.In this embodiment, described allocation component comprises the elasticity dispensed chambers.Alternatively, described embodiment also comprises the pick off that is used to measure with mobile relevant parameter by described pipeline.Alternatively, described pumping chamber, import, outlet and active force actuating assembly are the members that size is suitable for the FLUID TRANSPORTATION device worn as paster.

In another related embodiment, described system additionally comprises the high impedance conduit of the bending that is positioned at the allocation component downstream.Described conduit can accomplished in various ways.It can have at least two elbows.It can coil.It can have serpentine shaped.Alternatively, described conduit has at least one length and the internal diameter selected for predetermined impedance is provided based on fluidic viscosity and density.Alternatively, described catheter diameter is enough big, thereby prevents because treatment liquid causes obstruction by pipe flow.

In another related embodiment, described system also comprises passive valve, and this passive valve is used to force the one-way flow towards output.Alternatively, described passive valve is positioned at pumping chamber downstream.Alternatively, described passive valve is positioned at the allocation component upstream.

In another related embodiment, at least one part of described pipeline and disposable member form one, but and described force application assembly and detachable reuse member formation one, but and the described reuse member of the adjacency of the diaphragm material on the described disposable member.Alternatively, described diaphragm material covers the zone of qualification pumping chamber, imported valve and passive valve in the described pipeline, thereby forces to carry out one-way flow towards output.Alternatively, described force application assembly causes that metamorphosis power puts on each the regional diaphragm material that covers the qualification valve, to realize valve closing.Alternatively, described force application assembly causes that metamorphosis power puts on the diaphragm material that covers the zone that limits the pumping chamber, to realize from pumping chamber force fluid.

In another related embodiment, compression pumping chamber with actuate by export flow before, described force application assembly is realized inlet seal.Alternatively, described active force applies parts and comprises inlet seal parts and the pump pressure parts that contract.Described active force applies the driver part that parts can comprise the actuated pump compression member and activate the inlet seal parts.In order to activate the inlet seal parts, driver part can the compression seal spring, thereby constantly loads Packing spring, even contract parts when applying pump action power on the pumping chamber when pump pressure.

In yet another embodiment, described system comprises also and activates the contract driver part of parts of inlet seal parts and pump pressure that described inlet seal parts comprise the Packing spring between the one support member of driver part and seal member.Described inlet seal parts slidably are arranged in the opening of driver part.The described pump pressure parts that contract comprise return spring between distally compression member support member and driver part.In this embodiment, during driving stroke, even when the time towards pumping chamber driving pump compression member, when driver part when the axle of seal member slides, described driver part compression seal spring is to transmit activation force via the all-in-one-piece support member to seal member.

In another related embodiment, even contract parts when applying pump action power on the pumping chamber when pump pressure, described Packing spring also is compressed.

Alternatively, described compression member also comprises the distally stop, and this distally stop is by limiting backward stroke with contacting of described support member.Alternatively, described seal member comprises the nearside extension, and described nearside extension extends beyond the opening of driver part, thereby during backward stroke, driver part engages and makes described extension displacement to allow to flow through import.

In another related embodiment, described force application assembly is activated by shape memory actuator.Alternatively, described passive valve comprises lift valve, and this lift valve utilizes the lift valve biasing spring and is biased on the barrier film of seating.Alternatively, described mechanical dominance helps lift valve is promoted.

In another embodiment, the invention provides a kind of valve that is used for one-way flow.In this embodiment, described valve comprises: have the first of import and outlet, described outlet has the valve seat along circumferential setting; Have active force and apply the second portion of parts; And the barrier film that separates first and second parts.In this embodiment, described active force applies parts and applies biasing force, thereby barrier film is remained against valve seat with sealing means, to limit towards outlet or flowing from outlet, unless the fluid pressure in import or outlet is enough to overcome described biasing force, makes described barrier film break away from described valve seat thus and form and pass through flowing of described valve.Also in this embodiment, when barrier film is remained to valve seat with sealing means, downstream fluid than outlet, the membranous bigger zone of upstream fluid contact of import, give bigger mechanical dominance for upstream fluid thus and cause valve response in the lower pressure of import department and outlet elevated pressures and open, and promote from import and to the one-way flow of outlet.

In another related embodiment, be the reuse part but described first is single use portion and described second portion.Alternatively, described active force applies parts and also comprises spring and lift valve.Alternatively, described valve also comprises the mechanism that is used for the regulating spring active force.

These aspects of the present invention be not be intended to exclusiveness and those of ordinary skills' easy to understand further feature of the present invention, aspect and advantage when reading when combining with claims and accompanying drawing.

Description of drawings

By with reference to following detailed description, incite somebody to action easy to understand aforementioned feature of the present invention more with reference to the accompanying drawings, wherein:

Fig. 1 describes to have the patient of paster and wireless handheld user's interface unit;

Fig. 2 A is the skeleton diagram with FLUID TRANSPORTATION device of feedback control;

Fig. 2 B is the skeleton diagram with FLUID TRANSPORTATION device of feedback control and reservoir;

Fig. 3 is the skeleton diagram with FLUID TRANSPORTATION device of non-pressurised reservoir;

Fig. 4 A-4C is the summary sectional view of the various embodiment of current limiter;

Fig. 5 illustrates and the placed in-line elasticity allocation component of current limiter;

Fig. 6 illustrates the allocation component with measurement chamber and pick off;

Fig. 7 illustrates to have band and distributes the measurement chamber of spring and the allocation component of pick off;

Fig. 8 illustrates the cross sectional view of the allocation component with alternative acoustic path;

Fig. 9 illustrates the schematic illustration of allocation component;

Figure 10 illustrates the diaphragm spring that is used for elastic variable volume dispensed chambers;

Figure 11 A illustrates the kinetics distribution that exemplary base fluids is carried;

The kinetics that Figure 11 B illustrates exemplary pill FLUID TRANSPORTATION distributes;

Figure 11 C illustrates the dynamics data of representing normal fluid to carry;

Figure 11 D-11F illustrates the dynamics data of the various malfunctions of representative;

Figure 12 illustrates the sensing of FLUID TRANSPORTATION device embodiment and the flow chart of course of reaction;

Figure 13 illustrates the block diagram of the flowline with pressure generation component;

Figure 14 illustrates the block diagram of the flowline with valve pump;

Figure 15 A-15D illustrates the skeleton diagram of pumping mechanism;

Figure 16 illustrates the skeleton diagram of pumping mechanism;

Figure 17 briefly shows the cross sectional view of the embodiment that comprises shape memory actuator that can have a plurality of pumping patterns;

Figure 18 briefly shows and comprises two shape memory actuators and can have the cross sectional view of the embodiment of a plurality of pumping patterns;

Figure 19 briefly shows the cross sectional view of the embodiment of the shape memory actuator that comprises different length;

Figure 20 A-20B briefly shows the embodiment that is used for attachment shape memory actuator;

Figure 21 A-21B briefly shows the embodiment that is used for shape memory actuator is attached to pumping mechanism;

Figure 22 and 23 illustrates the pumping mechanism that adopts finger;

Figure 24 illustrates the pumping mechanism that adopts the rotation projection;

Figure 25 illustrates the pumping mechanism that adopts plunger and plunger barrel;

Figure 26 illustrates the view of the shape memory actuator that is in swelling state;

Figure 27 illustrates the view of the shape memory actuator that is in contraction state;

Figure 28 illustrates and adopts plunger and the pump of plunger barrel and the view with shape memory motor of lever;

Figure 29 illustrates and adopts plunger and the pump of plunger barrel and the view of shape memory motor;

Figure 30 illustrates and adopts plunger and the pumping device of plunger barrel and the view that has the shape memory motor of lead in plunger axis;

Figure 31 illustrates the flowline embodiment with sundstrand pump and reservoir;

Figure 32 briefly shows the cross sectional view of the valve pump that is in rest position;

Figure 33 briefly shows the cross sectional view of the valve pump of the Figure 32 that mediates;

Figure 34 briefly shows the cross sectional view of the valve pump of the Figure 32 that is in actuated position;

Figure 35 briefly shows the diaphragm-operated cross sectional view of the pumping that is used for the valve pump;

Figure 36 illustrates the perspective view that is used for the diaphragm-operated diaphragm spring of pumping;

Figure 37 briefly shows the valve pump of employing lever and the cross sectional view of shape memory line actuator;

Figure 38 briefly shows the cross sectional view of the embodiment that comprises the valve pump that adopts elasticity cylindricality flexing;

Figure 39 briefly shows the cross sectional view of the embodiment that comprises the valve pump flexing with elastomeric element and rigid strutting piece;

Figure 40 is schematically shown in the cross sectional view that is in the valve pump in the state of resting that the flexible partition upstream has diaphragm spring;

Figure 41 briefly shows the cross sectional view of valve pump of Figure 40 of the state of mediating;

Figure 42 briefly shows the cross sectional view of the valve pump of the Figure 40 that is in actuating state;

Figure 43 is schematically shown in the cross sectional view that the flexible partition upstream has the valve pump of diaphragm spring, and wherein flexible partition circumferentially is attached to active force and applies parts;

Figure 44 is schematically shown in the cross sectional view that the flexible partition upstream has the valve pump of diaphragm spring, and it comprises the rigid ball that is used for transfer function power;

Figure 45 briefly shows the cross sectional view of the embodiment that comprises the valve pump with elasticity pump blade;

Figure 46 briefly shows the cross sectional view of the embodiment of the elasticity pump blade that comprises the alternative form that is used for the valve pump;

Figure 47 briefly shows and comprises having the cross sectional view of embodiment that a plurality of active forces apply the valve pump of parts;

Figure 48 briefly shows to be in and rests or the bell crank lever that comprises of fill pattern drives the pumping mechanism of valve pump and bias current valve;

Figure 49 briefly shows the pumping mechanism of the Figure 48 that is in actuating state.

Figure 50 briefly shows the cross sectional view that has the valve seat and the bias current valve in the closed position of rising according to the embodiment of the invention;

Figure 51 briefly shows the cross sectional view of the bias current valve of the Figure 50 that is shown in an open position;

Figure 52 briefly shows according to the embodiment of the invention does not have the valve seat of rising and the cross sectional view of the bias current valve that is shown in an open position;

Figure 53 briefly shows the cross sectional view of the bias current valve of Figure 52 in the closed position; '

Figure 54 briefly shows according to the embodiment of the invention and acts on active force near the valve export the lift valve;

Figure 55 briefly shows according to the embodiment of the invention with detailed view and acts on active force near the valve inlet the lift valve;

Figure 56 briefly shows the bias current valve that has the scalable opening pressure according to the embodiment of the invention;

Figure 57 and 58 illustrates the skeleton diagram of the flowline of utilizing non-pressurised reservoir;

Figure 59 A-59E is illustrated in the skeleton diagram of the fluid flow in the FLUID TRANSPORTATION device;

Figure 60 A-60D is illustrated in the decomposition skeleton diagram of the fluid flow in the FLUID TRANSPORTATION device;

Figure 61 A-61C is illustrated in the skeleton diagram of the fluid flow in the FLUID TRANSPORTATION device;

Figure 62 A and 62B illustrate the skeleton diagram of individual devices;

Figure 63 A-63C illustrates the cross section skeleton diagram of device embodiment;

Figure 64 A-64D illustrates the cross section skeleton diagram of device embodiment;

Figure 65 A-65B illustrates the cross section skeleton diagram of the embodiment of the delivery device that is connected to flowline;

Figure 66 A-66D illustrates the cross section skeleton diagram that reservoir is inserted the sequence in the device;

Figure 67 A-67F illustrates the skeleton diagram of the embodiment of FLUID TRANSPORTATION device;

Figure 68 is the skeleton diagram of an embodiment of portable pump embodiment that is connected to patient's device;

Figure 69 A-69B illustrates the schematic illustration of the housing downside of device;

Figure 70-70D is the view that is depicted in available various members among the FLUID TRANSPORTATION device embodiment;

Figure 71 briefly shows the member that can be assembled to form according to the FLUID TRANSPORTATION device of device embodiment;

Figure 72 illustrates has the side view that acoustic volume is measured the FLUID TRANSPORTATION device of member;

Figure 73 illustrates and is used for the printed circuit board (PCB) that acoustic volume is measured;

Figure 74 illustrates the pictorial view of device embodiment;

Figure 75 illustrates the illustrated section view of the embodiment of FLUID TRANSPORTATION device;

Figure 76 illustrates the decomposition pictorial view of the embodiment of FLUID TRANSPORTATION device;

Figure 77 illustrates the decomposition view of the member of an embodiment that can be assembled to form the FLUID TRANSPORTATION device;

Figure 78 illustrates the decomposition view of the embodiment of FLUID TRANSPORTATION device;

Figure 79 illustrates the top view of base portion of an embodiment of FLUID TRANSPORTATION device;

Figure 80 illustrates the downside at top of an embodiment of FLUID TRANSPORTATION device;

Figure 81 A-81C illustrates and is used to be illustrated in the sequence of clamping the process of reservoir 20 between top and the base portion;

Figure 82 illustrates the decomposition vertical view of device;

Figure 83 illustrates the decomposition view of bottom of an embodiment of device, the assembly of fluid path shown in it, bottom shell and barrier film and binding agent;

Figure 84 illustrates the bottom view of base portion, the bottom view of the assembly of fluid path shown in it;

Figure 85 A-85D illustrates decomposition, exploded and the non-decomposition view of device embodiment;

Figure 86 A illustrates the transfusion of the analyte sensor that has delivery device and connected and the skeleton diagram of sensor cluster;

Figure 86 B illustrates has the transfusion shown in Figure 86 A of introducing pin and the decomposition view of sensor cluster;

Figure 87 A-87E illustrates transfusion and the embodiment of sensor cluster and is inserted into sequence in the device;

Figure 88 A-88B is illustrated in an embodiment of the inserter device in the transfusion and the sequence of sensor cluster;

Figure 88 C-88D illustrates the partial sectional view of the inserter of Figure 88 A-88B;

Figure 89 A illustrates the front view of an embodiment of the inserter device that is used to insert transfusion and sensor cluster;

Figure 89 B illustrates the rearview of the insertion device of Figure 89 A;

Figure 90 illustrates and is used to infuse and the perspective view of an embodiment of the cartridge case of sensor cluster;

Figure 91 A-91C illustrates the front perspective view and the side perspective view of the inserter device that is used to insert transfusion and sensor cluster;

Figure 92 A-92F briefly shows the time series of an embodiment who is used to operate inserter mechanism;

Figure 92 G is illustrated in the inserter mechanism with brake component (catch) and stage clip lever in the closed position;

Figure 92 H is illustrated in the inserter mechanism with brake component and stage clip lever in the open position;

Figure 93 A-93C illustrates the time series that is used for sleeve pipe is inserted FLUID TRANSPORTATION device base portion;

Figure 94 A-94C illustrates the time series that is used for when sleeve pipe as one man is connected to flowline sleeve pipe being inserted base portion;

Figure 95 illustrates the top view of the binding agent paster that is used to keep the FLUID TRANSPORTATION device;

Figure 96 is schematically shown in the cross sectional view of the FLUID TRANSPORTATION device below the binding agent paster;

Figure 97 illustrates the perspective view of two overlapping binding agent pasters that are used to keep the FLUID TRANSPORTATION device;

Figure 98 illustrates the top view of two semicircle binding agent paster parts;

Figure 99 illustrates the perspective view of two semicircle binding agent paster parts that keep the FLUID TRANSPORTATION device;

Figure 100 illustrates the perspective view of the semicircle binding agent paster part that is removed by the patient;

Figure 101 illustrates the perspective view that uses a plurality of binding agent parts and tether and invest patient's FLUID TRANSPORTATION device;

Figure 102 A illustrates the anchor clamps that are used for assembly device;

Figure 102 B illustrates the base portion of the FLUID TRANSPORTATION device with the keyhole that is used to insert anchor clamps;

Figure 102 C illustrates the cross sectional view of the FLUID TRANSPORTATION device that utilizes the anchor clamps assembling;

Figure 103 A illustrates the perspective view of the cam guide that is used to assemble the FLUID TRANSPORTATION device;

Figure 103 B illustrates the top view of the cam guide of Figure 103 A;

Figure 103 C illustrates the perspective view of the clamp pin that is used to assemble the FLUID TRANSPORTATION device;

Figure 103 D illustrates the embodiment of the FLUID TRANSPORTATION device that uses clamp pin and cam guide assembling;

Figure 104 illustrates the cross sectional view according to the subsided reservoir of an embodiment;

Figure 105 illustrates the perspective view of the reservoir of Figure 104;

Figure 106 A-106C illustrates according to an embodiment and is used for barrier film is fixed to end cap to form the series of steps of reservoir;

Figure 107 illustrates according to the reservoir of an embodiment and fills the station;

Figure 108 A-108B illustrates and is in the embodiment that opens (108A) and close the reservoir filling station in (108B) position;

Figure 109 A illustrates the data acquisition of the embodiment that is used for fluid delivery system and the block diagram of an embodiment of control scheme;

Figure 109 B illustrates the data acquisition of the embodiment that is used for fluid delivery system and the block diagram of an embodiment of control scheme

Figure 110 A illustrates the flow chart of description according to the operation of the FLUID TRANSPORTATION device of an embodiment;

Figure 110 B illustrates the flow chart of description according to the operation of the FLUID TRANSPORTATION device of an embodiment;

Figure 111 illustrates the user interface of mutual radio communication and the block diagram of FLUID TRANSPORTATION member;

Figure 112 illustrates the data flow view, and described view illustrates the use according to the intermediary transceiver of an embodiment;

Figure 113 illustrates the block diagram according to the intermediary transceiver of an embodiment;

Figure 114 illustrates the data flow view that is used for general patient interface according to an embodiment;

Figure 115 illustrates non-once part and the battery charger according to the FLUID TRANSPORTATION device of the decoupling zero state that is in of an embodiment;

Figure 116 illustrates non-once part and the battery charger according to the FLUID TRANSPORTATION device of Figure 115 that is in mated condition of an embodiment; And

Figure 117 is a flow chart of describing to be used for measuring according to the embodiment of the invention process of the liquid volume of carrying at pump stroke.

The element that should be appreciated that above figure and describe therein may not be according to the ratio of unanimity or with any scale.

The specific embodiment

Definition.As employed in this explanation and claims, following term will have the implication of being illustrated, unless context requires in addition:

" user's input " of device comprises that device user or other operator can be used for any mechanism of control device function.User input can comprise machinery (for example switch, press button), be used for the interface of wave point (for example RF, infrared), acoustic interface (for example having speech recognition), computer network interface (for example USB port) and other type of communicating by letter with remote controllers.

Import relevant " button " with the user, so-called " the injecting button (bolus button) " that for example is discussed below can be the user's input that can carry out any kind of required function, and be not limited to press button.

" siren " comprises can be used for any mechanism of giving the alarm to user or third party.Siren can comprise audible alarm (for example speaker, buzzer, speech synthesizer), visual alarm (for example LED, LCD screen), haptic alerts device (for example vibrating elements), wireless signal (for example at remote controllers or keeper wireless transmit) or other mechanism.Can side by side, synchronously or sequentially use a plurality of mechanisms that alarm takes place, comprise standby mechanism (for example, two different audio alert devices) or complementary means (for example, audio alert device, haptic alerts device and wireless alarm).

" fluid " means and can pass through the mobile material of flowline, for example liquid.

" impedance " means device or the flowline obstruction for the fluid stream that therefrom flows through.

" moistening " forms the member that directly contacts with fluid during being described in the normal fluid conveying operations.Because fluid is not limited to liquid, " moistening " member is not necessarily to become moistening.

" patient " comprises from the FLUID TRANSPORTATION device as the part of medical care and receives fluid or otherwise receive fluidic people or animal.

" sleeve pipe " means and can inculcate fluidic disposable device to the patient.Can refer to traditional sleeve pipe or pin as the sleeve pipe that uses here.

" analyte sensor " means any pick off that can determine to exist analyte in the patient.The embodiment of analyte sensor includes but not limited to determine the pick off of the existence of any viral, parasitic, antibacterial or chemical analyte.Term analyte comprises glucose.Analyte sensor can be communicated by letter with other member in the FLUID TRANSPORTATION device (for example, the controller in the non-once part) and/or with remote controllers.

" allocation component pick off " means the mechanism that is used for determining the fluid volume that exists in dispensed chambers.

" sharp object " means and can pierce through or expose animal skin, in particular any object of people's skin.Sharp object can comprise that sleeve pipe, cover tube inserter spare, analyte sensor or analyte sensor insert device.For example, in cartridge case, can provide respectively or a plurality of sharp objects can be provided together.

" disposable " refers to be expected in the fixed time period and uses, and the parts that are dropped then and change, device, part or other are similar.

" non-once " but refer to and be intended to have the reuse part of not limitting the use age.

" patch size " means enough little size, so that for example utilize binding agent or belt can be fixed to patient skin between the matter era that contains in carrying described device and worn as medical device.Little of the scope that can belong to this definition as the medical device of graft.

" the limited flow resistance that exists usually " means in the conventional process of FLUID TRANSPORTATION, that is, and and the limited flow resistance that when not having error condition (for example, stopping up), exists.

" passive " impedance is the impedance that is not subjected to active control during pumping circulation.

" acoustic volume measurement " means use for example in U.S. Patent No. 5,349, the quantitative measurement of the relevant volume of acoustic technique of describing in 852 and 5,641,892 and the technology here described.

" temperature sensor " comprises any mechanism that is used to measure temperature and transmits temperature information to controller.This device can comprise and is used to measure for example one or more temperature sensors of skin temperature, AVS temperature, ambient temperature and fluid temperature (F.T.).

Here the embodiment of the device of Miao Shuing, pumping mechanism, system and method relates to such FLUID TRANSPORTATION, and described FLUID TRANSPORTATION comprises that pumping and fluid volume are measured and the actuating and the control of FLUID TRANSPORTATION.The embodiment of described device comprises the portable or non-portable device that is used for FLUID TRANSPORTATION.Some embodiment of described device comprise the top of disposable base portion and non-once.Described device comprises that wherein the intravital embodiment of patient is inserted and directly entered to delivery device by base portion.These devices embodiment is patch pump device (patch pump device).Can use binding agent, belt or other appropriate device that patch pump is attached to the patient.Binding agent can have the peelable band of protectiveness, and described band can be removed to expose binding agent before using.

Yet in other embodiments, the FLUID TRANSPORTATION device is that wherein pipeline is connected to the portable device of flowline.Usually, by sleeve pipe pipeline is connected to the patient.

Use therein among some embodiment at disposable base portion and non-once top, base portion comprises wetted parts, but not included part is generally non-wetted part in the disposable top.

The various embodiment of pumping mechanism comprise upstream inlet valve, pumping actuated components, lower exit valve and movable part.In certain embodiments, use identity unit to realize pumping actuated components and valve downstream function.Pumping mechanism is pumped into outlet with fluid from reservoir by flowline.Pumping mechanism uses with non-pressurised reservoir usually, yet the scope of the invention is not limited thereto.

In an embodiment of fluid delivery system, described device comprises the analyte sensor housing.Analyte sensor is introduced in patient's body by the analyte sensor housing of device base portion.In these embodiments, also introduce delivery device by the shroud of device base portion.In these embodiments, described device is worn by the user as patch pump.

Described system usually comprises controller, and described controller can comprise wireless transceiver.Therefore, can be fully by the wireless controller device or partly control described device.Controller device can receive information from analyte sensor and/or FLUID TRANSPORTATION device by radio communication.Patient or third party can use the function of described controller device control FLUID TRANSPORTATION device.

In an embodiment of FLUID TRANSPORTATION device, described device is that insulin pump and described analyte sensor are the blood-glucose pick offs.The controller that receives the information relevant with blood glucose data with the volume of insulin (the perhaps number of pump stroke during certain hour) of carrying helps the user that the actuating time table of described pump machanism is programmed.

Exemplary allocation component and volume sensing device are here described.Allocation component comprises at least one mike and microphone.Described assembly is determined the fluid volume of stereomutation to determine to be pumped in the dispensed chambers.The volume sense data is used to determine the state of FLUID TRANSPORTATION device.Therefore, various controls can depend on the volume sense data.

In an embodiment of the present invention, the user carries device via the user interface fluid, thereby makes FLUID TRANSPORTATION device conveyance fluid in a suitable manner.In one embodiment, user interface be can with the independently hand-held user's interface unit of described paster radio communication.Described paster can be disposable, and is perhaps partly disposable.

As mentioned above, the exemplary purposes of described device embodiment is to be used for carrying insulin to diabetics, carries any fluid but other purposes comprises.Fluid comprises the analgesics that is used for pain patients, the enzyme that is used for cancer patient's chemotherapy and is used for the metabolism disorder patient.Various treatment fluids can comprise micromolecule, natural prodcuts, peptide, protein, nucleic acid, carbohydrate, nano granule suspension and relevant acceptable carrier molecule aspect materia medica.The stability (for example, by peptide or proteinic Pegylation (PEGization)) that the therapeutic activity molecule can be modified and carry in the device to improve.Though the illustrative examples is here described drug delivery and used, embodiment can be used to other and use, and comprises that the liquid of the reagent of the analysis to measure (for example miniature laboratory technique is used and capillary chromatography) that is used for highoutput distributes.For the purpose that the following describes, term " therapeutic agent " or " fluid " are used interchangeably, yet, in other embodiments, can use aforesaid any fluid.Therefore, the device and the explanation that here comprise are not limited to therapeutic use.

Exemplary embodiments comprises the reservoir that is used to keep the fluid supply.In the situation of insulin, reservoir can be made as easily has the size that can keep being enough to the insulin supply of carrying in a day or many days.For example, reservoir can hold about 1 to 2ml insulin.Potential user for about 90%, the 2ml insulin cartridge can be corresponding to about 3 days supply.In other embodiments, reservoir can have virtually any size or shape and can be suitable for holding any amount of insulin or other fluid.In certain embodiments, the size and dimension of reservoir is relevant with the fluid type that reservoir is suitable for holding.Thereby fluid reservoirs can have eccentric or irregular shape and/or can be locked wrong installation of defence or use.

Some embodiment of FLUID TRANSPORTATION device are applicable to that diabetics uses, and therefore, in these embodiments, device is carried the insulin that is used for replenishing or changing patient's beta Cell of islet.Be applicable to that the embodiment that insulin is carried attempts to simulate the pancreas effect by FLUID TRANSPORTATION that foundation level is provided and the conveying of injecting level.By using the wireless hand-held user interface to set foundation level, injecting level and timing by patient or the opposing party.Additionally, can respond the output of analyte sensor (for example glucose monitors part or blood-glucose pick off) one or outside and trigger or regulate the basis and/or inject level.In certain embodiments, can use the regulation button or other input equipment that are positioned on the FLUID TRANSPORTATION device to inject by patient or third party's triggering.In a further embodiment, inject or foundation level can be programmed or manage by the user interface that is positioned on the FLUID TRANSPORTATION device.

According to an exemplary embodiment of the present, Fig. 1 illustrates to wear FLUID TRANSPORTATION device 10 and grip and is used to monitor the patient 12 of wireless subscriber interface assembly 14 who carries the operation of device 10 with regulated fluid.User's interface unit 14 usually comprises the equipment (for example LCD display, speaker or vibration alarm device) that is used for input information (for example touch screen or keypad) and is used for the information of transmitting to the user.The FLUID TRANSPORTATION device is general enough little and light, thereby keeps cosily being attached to the patient in a few days.

In Fig. 1, FLUID TRANSPORTATION device 10 is illustrated as being worn on patient 12 the arm.In other embodiments, FLUID TRANSPORTATION device 10 can be worn on patient other position on one's body, can advantageously utilize the special fluid that is transferred at these position patient bodies.For example, fluid can advantageously be transported to patient's abdomen area, lumbar region, lower limb or other position.

With reference now to Fig. 2 A,, the generalized schematic of FLUID TRANSPORTATION device 10 is shown, this device has from allocation component 120 to pump 16 feedback loop 360.Pump 16 is to allocation component 120 pumping fluids; Fluid leaves by the spout assembly 17 that comprises current limiter 340 and efferent then.Described efferent usually comprises sleeve pipe and leads to the patient.Allocation component 120 can comprise elastic variable volume dispensed chambers and at least one mike and microphone, be used to measure with along with the time by the relevant parameter of the stream of described efferent.Feedback loop 360 makes and can regulate the operation of pump 16 based on the repeated measure of being undertaken by pick off.Current limiter 340 forms high impedance between the efferent of allocation component 120 and flowline 5010.Current limiter 340 can for example be the part of narrow hole pipe or microtubule.

With reference now to Fig. 2 B,, in one embodiment, pump 16 is pumped into allocation component 120 with fluid from reservoir 20.

With reference now to Fig. 3,, the block diagram of another embodiment that adopts fluid mechanics principle is shown.Flowline 310 connects reservoir 20, pump 16, allocation component 120 and spout assembly 17.Spout assembly 17 can comprise high impedance current limiter 340 and delivery device 5010, for example sleeve pipe.The output of current limiter 340 is sent to delivery device 5010, so that flow to the patient.Current limiter 340 has the higher flow resistance of part that is positioned at allocation component 120 upstreams than flowline 310.Therefore, pump 16 can pump fluid in the allocation component 120 quickly than the situation that fluid can leave spout assembly 17.Allocation component 120 can comprise the variable volume dispensed chambers 122 with elastic wall.Among the embodiment that provides below, elastic wall is a barrier film.The example of diaphragm material comprises silicones, NITRILE and has and is used for as any other material of described required elasticity that plays a role and characteristic here.Additionally, other structure can be used for identical purpose.When the effect owing to pump 16 receives the fluid supply, barrier film elasticity will allow chamber 122 at first to expand and provide the fluid contents that drives allocation component 120 to arrive the required discharge pressure of patients through current limiter 340 then.When being equipped with proper sensors (being described below the example), allocation component 120 can be measured the fluid stream by variable volume dispensed chambers 122 and can provide feedback with 16 pumpings of control pump sending component or partly fill the timing and/or the speed of dispensed chambers 122 by feedback loop 360, carries required dosage with desired rate to the patient thus.

Refer again to Fig. 3, additionally, current limiter 340 prevents that fluid stream from surpassing the regulation flow rate.And then, carry because finish pressure fluid by the reciprocal action of pump 16, allocation component 120 and current limiter 340, therefore can adopt non-pressurised reservoir 20.

Still with reference to figure 3, feedback loop 360 can comprise controller 501.Controller 501 can comprise processor and be used for actuated pump sending component 16 with the control circuit to allocation component 120 pumping fluids.Controller 501 be from can repeatedly receiving and the relevant parameter of fluid stream with the integrally formed pick off of allocation component 120, and uses this parameter control pump sending component 16 to flow by the desired of efferent realizing.For example, the actuating that controller 501 can be regulated pump 16 regularly or degree, to realize required basis or to inject flow rate and/or carry required basis or inject accumulated dose.When the timing of determining pumping or degree, controller 501 can use the output (not shown) of pick off with the speed of estimating of fluid stream, integrated flux or the two (and much other amounts), and determines the suitable compensation behavior based on described estimation then.In various embodiments, can carry out pumping pulsedly, they can be with 10 ^-9Rising every pulse carries to any speed between the every pulse of microlitre.Can realize basis or bolus dose by carrying a plurality of pulses.(illustrating and describe the example of basis and bolus dose below).

Use the local non-pressurised reservoir 20 that can subside advantageously to prevent from when the fluid in the reservoir exhausts, in reservoir, to accumulate air.Reservoir 20 can be connected to flowline 310 by the barrier film (not shown).Flow out from reservoir 20 at the tired fluid that can prevent of ventilation reservoir hollow QI-mass, particularly be tilted when making between the barrier film of the fluid that in reservoir, contains and reservoir 20 intervention air bag when system.As during can wearing the normal running of device, wish that system is tilted.Figure 104-106C has described various embodiment and the view of an embodiment of reservoir.Additionally, comprise below the reservoir further instruction.

With reference now to Fig. 4 A-4C,, the various embodiment of current limiter 340 is shown.With reference now to Fig. 4 A,, current limiter is molded runner 340, and it can be the molded indentation (not shown) in base portion.In one embodiment, the cross section of molded runner 340 is roughly 0.009 inch.In this embodiment, current limiter 340 is molded in the equipment.With reference now to Fig. 4 B,, microtubule 340 is shown as the alternate embodiments of current limiter.In one embodiment, microtubule has roughly 0.009 inch internal diameter.Molded runner and microtubule all use the long path with little internal diameter or cross section to give flow resistance.With reference now to Fig. 4 C,, shows accurate orifice plate as current limiter 340.In one embodiment, accurately orifice plate is the plate with laser drill.In alternate embodiments, can use any flow resistance device or the method that are known in the art.Usually to be considered on functional meaning to form the prior art fluid delivery system of active downstream valve of unlimited flow resistance different with having possibility, and current limiter 340 is formed with the current limliting resistance.The prior art systems that is hindered owing to stop up when having is different, and impedance of the present invention also exists when normal condition.Because the finiteness of flow resistance, in the embodiment that comprises dispensed chambers 122, even when dispensed chambers 122 expands, fluid also may be revealed by outlet.

Fig. 5-8 briefly shows the cross sectional view of the illustrative examples of allocation component 120.Should be appreciated that the FLUID TRANSPORTATION that is used for other purpose (for example industrial process) belongs to the scope of the invention, and only be way of example with the explanation that concrete term provides.As shown in Figure 5, allocation component 120 can comprise variable volume dispensed chambers 122 and pick off 550.Variable volume dispensed chambers 122 comprises elasticity distribution diaphragm 125, and its allows chamber 122 to expand according to the fluid stream that passes in and out allocation component 120 and shrinks.In certain embodiments of the present invention, as will ground being discussed further here, variable volume dispensed chambers 122 can be separated by other element from allocation component 120.Utilize double-headed arrow to show the notion that permission chamber 122 expands and the elasticity of contraction is distributed diaphragm 125.Measurement chamber 122 has been believed to comprise and has utilized arrow 112 specified parts with circuit 110 of fluid flow characteristics in Fig. 5.The position or the characteristic of the termination of fluid stream 112 or circuit 110 all do not limit the scope of the present invention that explicitly calls for protection as claims.Than the situation that fluid when being pumped assembly 16 and being pumped into chamber 122 enters chamber 122, current limiter 340 makes fluid leave dispensed chambers 122 more lentamente.As a result, when the fluid supply entered, dispensed chambers 122 expanded and is pressurized.The distribution diaphragm 125 that is out of shape owing to the expansion of dispensed chambers 122 provides the conveying and metering volume to make it arrive the required active force of spout assembly 17 through current limiter 340.As discussed above, repeatedly measure can the parameter relevant with the volume of elasticity dispensed chambers 122, for example displacement or thermodynamic variable or capacity for pick off 550.The cubing that produces by pick off 550 can be used for by timing and the speed of feedback loop control pump sending component to dispensed chambers 122 pumping fluids, thereby suitable fluid stream is transported to spout assembly 17 and pipeline subsequently, and for example is transported to the patient thus.Pick off 550 can adopt acoustic volume sensing for example (describing in further detail below) or be used for determining other method (optics or capacitive character are as other example) of volume or volume relevant parameter.The acoustic volume measuring technique is the U.S. Patent No. 5 of authorizing DEKA ProductsLimited Partnership, 575,310 and 5,755,683 and the exercise question submitted on April 5th, 2006 be No.60/789 for the volume measuring method of control " be used for flow ", series number, the theme of 243 the interim U.S. Patent application of common pending trial, they all are bonded to here by reference.Utilize this embodiment to carry out the fluid volume sensing in the scope of liter receiving, therefore help pin-point accuracy and accurately monitor and conveying.Also can use other the alternative technology that is used to measure fluid stream; For example, based on Doppler (Doppler's) method; Hall (Hall) effect sensor that use and leaf valve or flapper valve are combined; Use strain beam (for example, relevant with the compliant member in the fluid chamber) to be used for the deflection of sensing compliant member; Use utilizes the capacitive sensing of plate; Perhaps Re time-of-flight method (thermal time offlight method).

With reference now to Fig. 6 to 9,, the embodiment that pick off wherein utilizes acoustic volume sensing (AVS) technology is shown.Discussion at first is with reference to the embodiment that describes in Fig. 6 and 7.Allocation component 120 has pick off, and it comprises reference chamber 127 and the variable volume measurement chamber 121 that is connected to fixed volume chamber 129 by port one 28.Though can utilize the reference chamber 127 shown in Fig. 6 and 7 to implement the present invention, in some other embodiment of the present invention, not provide reference space.Should be appreciated that space 129 b referred to as " fixed " here as term, but its actual volume can change a little on acoustics firing time yardstick, as when utilizing speaker diaphragm driving to be known as fixed space 129 regional.Fluid flow to input part 123 by elasticity dispensed chambers 122 from pump 16, and flows out exit passageway 124.Because high downstream impedance when fluid enters dispensed chambers 122, distributes diaphragm 125 to expand in the variable volume chamber 121.The electronic building brick that can be arranged on the printed circuit board (PCB) 126 has microphone 1202, sensing mike 1203 and benchmark mike 1201, be used for measuring the relevant parameters,acoustic of gas (being generally air) with variable volume chamber 121, cavity volume is limited by the position of distributing diaphragm 125.Advance to variable volume chamber 121 via port one 28 by fixed volume chamber 129 by microphone 134 induced sound waves; Sound wave also advances to reference chamber 127.When distribution diaphragm 125 was mobile along with the fluid flow via flow line, the volume of air in the variable volume chamber 121 changed, and caused that its acoustic characteristic takes place by relevant the change, and this can utilize microphone and mike 1203 detections.For identical acoustic excitation, benchmark mike 1201 can be surveyed the acoustic characteristic in fixed reference space 127.Inaccuracy and other mistake that these reference measurements can for example be used for eliminating inexactness and resist the acoustic excitation common schema.The measurement volume that can be by variable volume chamber 121 relatively and the original volume of variable volume chamber 121 are determined the fluidic volume that is shifted.Because the total measurement (volume) of dispensed chambers 122 and variable volume chamber 121 remains unchanged, can also estimate the absolute volume of dispensed chambers 122.

Embodiment shown in Fig. 6 utilizes intrinsic elastic distribution diaphragm 125, and the embodiment shown in Fig. 7 utilizes elasticity to distribute spring 130, described elasticity distributes spring 130 when with 125 combinations of distribution diaphragm, increased the elasticity of dispensed chambers 122 and can allow to use distribution diaphragm 125 than the distribution diaphragm that will require in the embodiment shown in fig. 5 submissiveer (that is, more low elasticity).Be adjacent on the side relative of distributing that spring 130 usually is positioned in diaphragm 125 and distribute diaphragm 125 with dispensed chambers 122.

Alternately, in order to reduce the background noise from mike, microphone 1202 and sensing mike 1203 can be connected to variable volume chamber 121 via isolating port.As in Fig. 8, briefly showing, microphone 1202 via loudspeaker ports 6020 acoustics be coupled in the fixedly microphone space 6000 of variable volume chamber 121 and produce pressure wave.Pressure wave advances to variable volume chamber 121 and passed through microphone port 6010 then before sensed mike 1203 records by loudspeaker ports 6020 from microphone 1202.Loudspeaker ports 6020 can comprise the pipeline part 6040 with flared hole 6030.Flared hole 6030 is used for all axial path of pipeline part 6040 are formed sound wave along its even length of advancing.For example, pipeline part 6040 can have the geometry of cylinder, for example column body or upright cylindrical geometry.Similar flared hole also can be in abutting connection with the pipeline part to limit microphone port 6010.Different with the AVS pick off of Fig. 6 and 7, in the embodiment of Fig. 8, the pressure wave of advancing from microphone 1202 does not have the directapath that arrives sensing mike 1203.Therefore, prevent from first directly do not impacting sensing mike 1203 under the process situation of variable volume 121 from the pressure wave of microphone 1202.Therefore mike receives the background signal of reduction and has realized the better letter/ratio of making an uproar.Additionally, can in any one of the embodiment of Fig. 6-8, comprise shelf 6050, thereby advantageously reduce the volume of reference chamber 127.

In the embodiment that will be further described, can separate pick off and measurement chamber's part of allocation component easily, thereby dispensed chambers is dismountable and disposable.In this case, dispensed chambers is arranged in the single use portion of paster, but and pick off is arranged in the reuse part.Dispensed chambers can by elastic fluid distribute diaphragm (as among Fig. 6 as shown in 122 and 124) define.Alternately, as in Fig. 7, dispensed chambers 122 can be defined by submissive diaphragm 125.In this case, distribute spring 130 to can be used on dispensed chambers 122 and give elasticity.When pick off 550 and dispensed chambers 122 are placed in a time-out, distribute spring 130 to cover submissive distribution diaphragm 125.Distribute spring 130 and distribute diaphragm 125 alternately to be used, as the single part that limits dispensed chambers 122.

The alternate embodiments of allocation component is shown as shown in Figure 9.In the embodiment of the allocation component 120 that Fig. 9 describes, variable volume is measured chamber 121 and is shared compliant wall (being shown submissive diaphragm 125 here) with dispensed chambers 122.Port one 28 acoustics ground will be measured chamber 121 and be coupled to fixed volume chamber 129, thereby form the acoustics neighboring region by label 1290 overall marks.Compressible fluid (being generally air or another gas) is filled acoustics neighboring region 1290 and is driven parts 1214 and excites, and this driver part 1214 is driven by actuator 1216 itself.Driver part 1214 can be the diaphragm of speaker, the diaphragm of audition additional loudspeaker for example, and in this speaker, actuator 1216 for example is voice coil loudspeaker voice coil solenoid or piezoelectric element.In the scope of the invention, driver part 1214 can also be coextensive (coextensive) with actuator 1216, for example when driver part 1214 self can be piezoelectric element.Driver part 1214 can be contained in the Drive Module 1212, and this Drive Module can contain reference space 1220 on the side away from fixed space 129 of driver part 1214.Yet, in the present invention's practice, generally do not adopt reference space 1220.

Benchmark mike 1208 be illustrated as when signal mike 1209 acoustics be coupled to when measuring chamber 121 and fixed space 129 acoustic connection.The volume of measured zone 121 can by one or more the pressure measured based on its corresponding position that is arranged in acoustics neighboring region 1290 of multi-microphone 1208,1209 change (perhaps, equivalently, acoustic signal) and the electronic signal that provides is determined.Can by with one or more the multi-microphone place response phase and acoustics excites phase place to compare or compare with response phase in the position of another mike, come excute phase to measure.By processor 1210 based on phase place and/or as discussed below amplitude measurement determine the volume of measured zone 121 and the volume of inferring dispensed chambers 122 thus, described processor obtains electric power from power supply 1211, and described power supply is shown accumulator typically.

In order accurately to carry the treatment reagent of small quantity, be desirably in and carry the little still amount of very accurate metering in each pump stroke.Yet if pass through the fluid of the small volume of circuit 110 pumpings during each pump stroke, metering process requires high resolution.Therefore, according to embodiments of the invention, receive the volumetrical change of resolution measurement that rises with at least 10 by pick off 550.Can realize measurement in some embodiments of the invention for vacant volumetrical 0.01% resolution of measured zone 121.According to other embodiments of the present invention, pick off 550 provides and is better than 13 and receives the resolution that rises.Yet in other embodiments, pick off 550 provides and is better than 15 and receives the resolution that rises, and in a further embodiment, provides to be better than 20 and to receive the resolution that rises.In this case, the total measurement (volume) of acoustics neighboring region 1290 can be less than 130 μ l, and, in other embodiments, less than 10 μ l.

According to various embodiments of the present invention; can use (here dispensed chambers 122 and variable volume chamber 121 subsequently; also can be called " metric space ") the modeling formerly of volume response, this modeling formerly is based on carrying out owing to the fluid filled dispensed chambers that is pumped volume that enters input part 123.Though other model belongs to the scope of the invention, a model that can adopt will be expressed as baseline volume V in response to incoming fluid that is pumped and the fluid volume that has in the dispensed chambers 122 of the fixedly outlet of flow resistance _BWith by peak displacement V _DThe exponential damping volume sum that characterizes, thus the measurement chamber's volume during measuring is characterized as being the function of time t, as follows:

$V=V_D\exp \left(\frac{-t}{\mathrm{\τ}}\right)+V_B|$

In order to make the parametrization of modeling exponential damping (perhaps other function model) be fit to a series of acoustic measurement, the response of the system of for example describing in Fig. 6 to 9 is derived as follows.For modeling is carried out in response, port one 28 is characterised in that length 1 and diameter d.The pressure and the volume of desirable adiabatic gas can pass through PV ^γ=K is associated, and wherein K is the constant that is limited by system initial state.

Desirable adiabatic gas law can become disturbance p (t) v (t) statement by according to average pressure P and volume V and little on those pressure the time:

(P+p(t))(v+v(t)) ^γ＝K

These branches that decline are obtained:

$\stackrel{.}{p}\left(t\right){(V+v\left(t\right))}^{\mathrm{\γ}}+\mathrm{\γ}{(V+v\left(t\right))}^{\mathrm{\γ}-1}(P+p\left(t\right))\stackrel{.}{v}\left(t\right)=0|$

Perhaps, simplification obtains:

$\stackrel{.}{p}\left(t\right)+\mathrm{\γ}\frac{P+p\left(t\right)}{V+v\left(t\right)}\stackrel{.}{v}\left(t\right)=0|$

If the acoustic stress level is more much smaller than ambient pressure, then described equation can further be reduced to:

$\stackrel{.}{p}\left(t\right)+\frac{\mathrm{\γP}}{V}\stackrel{.}{v}\left(t\right)=0$

Use perfect gas law, P=ρ RT, and it is replaced pressure and provide following result:

$\stackrel{.}{p}\left(t\right)+\frac{\mathrm{\γPT\ρ}}{V}\stackrel{.}{v}\left(t\right)=0|$

Can be according to speed of sound $a=\sqrt{\mathrm{\γRT}}|$ It is written as:

$\stackrel{.}{p}\left(t\right)+\frac{\mathrm{\ρ}{a}^2}{V}\stackrel{.}{v}\left(t\right)=0$

And, be defined as about the acoustic impedance of certain volume:

$Z_v=\frac{p\left(t\right)}{\stackrel{.}{v}\left(t\right)}=\frac{1}{\left(\frac{V}{\mathrm{\ρ}{a}^2}\right)s}=-\frac{\mathrm{\ρ}{a}^2}{V}\·\frac{1}{s}|$

According to a group model, at supposition all fluids in the port in fact as reciprocal rigidity cylinder and under the mobile situation, acoustical ports is carried out modeling along axial direction.Suppose that all fluids in the passage (port one 28) advance with the phase same rate, suppose that described passage has constant cross-section, and enter and leave " end effect " that the fluid of passage causes and be left in the basket.

Suppose and be $\mathrm{\Δp}=\mathrm{R\ρ}\stackrel{.}{v}|$ The laminar flow friction of form, the friction force that acts on the flowing material in the described passage can be written as:

$F=\mathrm{R\ρ}{A}^2\stackrel{.}{x}.$

Can write out the second-order differential equation for the hydrodynamics in the passage then:

$\mathrm{\ρLA}\stackrel{..}{x}=\mathrm{\ΔpA}-\mathrm{R\ρ}{A}^2\stackrel{.}{x}|$

Perhaps, according to volume flow rate:

$\stackrel{..}{v}=-\frac{\mathrm{RA}}{L}\stackrel{.}{v}+\mathrm{\Δ\ρ}\frac{A}{\mathrm{\ρL}}$

The acoustic impedance of passage can be written as then:

$Z_p=\frac{\mathrm{\Δp}}{\stackrel{.}{v}}=\frac{\mathrm{\ρL}}{A}{(s+\frac{\mathrm{RA}}{L})}_{:}$

Use the volume and the port kinetics of definition in the above, can describe acoustic volume sensing system (wherein index k is represented speaker, and r represents resonator) by following equation system:

${\stackrel{.}{p}}_0-\frac{{\mathrm{\ρa}}^2}{V_0}{\stackrel{.}{v}}_k=0$

According to identical agreement, ${\stackrel{.}{v}}_k>0\&DoubleRightArrow;{\stackrel{.}{p}}_1<0|$ And ${\stackrel{.}{v}}_r>0\&DoubleRightArrow;{\stackrel{.}{p}}_1>0,$

${\stackrel{.}{p}}_1+\frac{{\mathrm{\&rho;a}}^2}{V_1}({\stackrel{.}{v}}_k-{\stackrel{.}{v}}_r)=0|$

In addition, ${\stackrel{.}{v}}_r>0\&DoubleRightArrow;{\stackrel{.}{p}}_2<0|$

${\stackrel{.}{p}}_2+\frac{{\mathrm{\&rho;a}}^2}{V_2}{\stackrel{.}{v}}_r=0$

If p ₂Greater than p ₁, then volume is tending towards quickening along positive direction.

${\stackrel{..}{v}}_r=-\frac{\mathrm{RA}}{L}{\stackrel{.}{v}}_r+\frac{A}{\mathrm{\&rho;L}}(p_2-p_1).$

Reduce the equation number (with p ₀Be considered as input), and substitution

${\stackrel{.}{v}}_k=\frac{{\mathrm{<figure-callout\; id="0"\; label="V"\; filenames="A200780007335E01241.png,A200780007335E01251.png"\; state="\{\{state\}\}">V</figure-callout>}}_0}{{\mathrm{\&rho;a}}^2}{\stackrel{.}{p}}_0,$

${\stackrel{.}{p}}_1+\frac{V_0}{V_1}{\stackrel{.}{p}}_0-\frac{{\mathrm{\&rho;a}}^2}{V_1}{\stackrel{.}{v}}_r=0$

${\stackrel{.}{p}}_2+\frac{{\mathrm{\&rho;a}}^2}{V_2}{\stackrel{.}{v}}_r=0$

${\stackrel{..}{v}}_r=-\frac{\mathrm{RA}}{L}{\stackrel{.}{v}}_r+\frac{A}{\mathrm{\&rho;L}}{p}_1-\frac{A}{\mathrm{\&rho;<figure-callout\; id="2"\; label="L\; p"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">L</figure-callout>}}{p}_{}{}_2$

Use these equatioies to provide a structure

$\left.\begin{array}{c}\frac{{\mathrm{\&rho;a}}^2}{V_2}{\stackrel{.}{v}}_r=\frac{V_1}{{\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2}\&CenterDot;\left(\frac{{\mathrm{\&rho;a}}^2}{V_1}{\stackrel{.}{v}}_r\right)=\frac{V_1}{V_2}{\stackrel{.}{p}}_1+\frac{V_0}{V_2}{\stackrel{.}{p}}_0\\ {\stackrel{.}{p}}_2+\frac{V_0}{V_2}{\stackrel{.}{p}}_0+\frac{V_1}{V_2}{\stackrel{.}{p}}_1=0\end{array}\right|$

$\begin{array}{c}{V}_0{\stackrel{.}{p}}_0+V_1{\stackrel{.}{p}}_1=-V_2{\stackrel{.}{p}}_2|\\ -\frac{V_0{\stackrel{.}{p}}_0+V_1{\stackrel{.}{p}}_1}{{\stackrel{.}{p}}_2}={\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2,|\end{array}$

Perhaps

$\left.\begin{array}{c}{V}_0{\mathrm{<figure-callout\; id="0"\; label="p"\; filenames="A200780007335E01241.png,A200780007335E01251.png"\; state="\{\{state\}\}">p</figure-callout>}}_0+V_1{\mathrm{<figure-callout\; id="1"\; label="p"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">p</figure-callout>}}_1=-V_2{p}_2\\ -\frac{V_0{\mathrm{<figure-callout\; id="0"\; label="p"\; filenames="A200780007335E01241.png,A200780007335E01251.png"\; state="\{\{state\}\}">p</figure-callout>}}_0+V_1{p}_1}{{\mathrm{<figure-callout\; id="2"\; label="p"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">p</figure-callout>}}_2}={\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2\end{array}\right|$

These equatioies also can be with the formal representation of transfer function." intersection speaker (cross-speaker) " transfer function, p ₁/ p ₀For:

$\left.\begin{array}{c}s\&CenterDot;{\mathrm{<figure-callout\; id="1"\; label="p"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">p</figure-callout>}}_1+\frac{V_0}{V_1}s\&CenterDot;p_0-\frac{{\mathrm{\&rho;a}}^2}{V_1}s\&CenterDot;v_r=0\\ s\&CenterDot;{\mathrm{<figure-callout\; id="2"\; label="p"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">p</figure-callout>}}_2+\frac{{\mathrm{\&rho;a}}^2}{V_2}s\&CenterDot;v_r=0\\ {\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">s</figure-callout>}}^2\&CenterDot;v_r=-\frac{\mathrm{RA}}{L}s\&CenterDot;v_r-\frac{A}{\mathrm{\&rho;<figure-callout\; id="1"\; label="L\; p"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">L</figure-callout>}}{p}_{}{}_1+\frac{A}{\mathrm{\&rho;L}}{p}_2\\ {\mathrm{<figure-callout\; id="2"\; label="p"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">p</figure-callout>}}_2=-\frac{{\mathrm{\&rho;a}}^2}{V_2}{v}_r\\ s^2{v}_r=-\frac{\mathrm{RA}}{L}s\&CenterDot;v_r+\frac{A}{\mathrm{\&rho;L}}(-\frac{{\mathrm{\&rho;a}}^2}{{\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2}.)v_r-\frac{A}{\mathrm{\&rho;L}}{p}_1\\ ({\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">s</figure-callout>}}^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{<figure-callout\; id="2"\; label="Aa"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">Aa</figure-callout>}}^2}{{\mathrm{LV}}_2})v_r=-\frac{A}{\mathrm{\&rho;L}}{p}_1\\ v_r=\frac{-A/\mathrm{\&rho;L}}{s^2+\mathrm{RA}/\mathrm{L\; s}+{\mathrm{<figure-callout\; id="2"\; label="Aa"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">Aa</figure-callout>}}^2/L{V}_2}{\mathrm{<figure-callout\; id="1"\; label="p"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">p</figure-callout>}}_1\end{array}\right|$

Perhaps

$\frac{p_1}{{\mathrm{<figure-callout\; id="0"\; label="p"\; filenames="A200780007335E01241.png,A200780007335E01251.png"\; state="\{\{state\}\}">p</figure-callout>}}_0}=-\frac{V_0}{V_1}\frac{{\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">s</figure-callout>}}^2+2\mathrm{\&zeta;}{\mathrm{\&omega;}}_{n}s+\stackrel{.}{\mathrm{\&alpha;}}{\mathrm{\&omega;}}_n^2}{{\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">s</figure-callout>}}^2+2\mathrm{\&zeta;}{\mathrm{\&omega;}}_{n}s+{\mathrm{\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="n"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">n</figure-callout>}}^2}|$

Wherein:

${\mathrm{\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="n"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">n</figure-callout>}}^2=\frac{a^{2}A}{L}(\frac{1}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}+\frac{1}{V_2});$

And $\mathrm{\&alpha;}=\frac{V_1}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1+{\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2}.$

Similarly, be p based on " cross system " transfer function to the measurement of arbitrary end of port 128 ₂/ p ₀, provide by following formula:

$\left.\begin{array}{c}s\&CenterDot;p_1+\frac{V_0}{V_1}s\&CenterDot;p_0-\frac{\mathrm{\&rho;}{a}^2}{V_1}s\&CenterDot;v_r=0\\ s\&CenterDot;p_2+\frac{\mathrm{\&rho;}{a}^2}{V_2}s\&CenterDot;v_r=0\\ s^2\&CenterDot;v_r=-\frac{\mathrm{RA}}{L}s\&CenterDot;v_r-\frac{A}{\mathrm{\&rho;L}}{p}_1+\frac{A}{\mathrm{\&rho;L}}{p}_2\\ p_1=\frac{\mathrm{\&rho;}{a}^2}{V_1}{v}_r-\frac{V_0}{V_1}{p}_0\\ s^2\&CenterDot;v_r=-\frac{\mathrm{RA}}{L}s\&CenterDot;v_r-\frac{A}{\mathrm{\&rho;L}}\&CenterDot;\&CenterDot;\frac{{\mathrm{\&rho;a}}^2}{V_1}{v}_r-\frac{A}{\mathrm{\&rho;L}}(-\frac{V_0}{V_1}{p}_0)+\frac{A}{\mathrm{\&rho;L}}{p}_2\\ v_r=\frac{\frac{{\mathrm{AV}}_0}{\mathrm{\&rho;L}{V}_1}}{s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_1}}{p}_0+\frac{\frac{A}{\mathrm{\&rho;L}}}{s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_1}}{p}_2\\ s\&CenterDot;p_2+\frac{{\mathrm{\&rho;a}}^2}{V_2}s\&CenterDot;[\frac{\frac{{\mathrm{AV}}_0}{\mathrm{\&rho;L}{V}_1}}{s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_1}}{p}_0+\frac{\frac{A}{\mathrm{\&rho;L}}}{s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_1}}{p}_2]=0\\ [s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_1}+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_2}]p_2=-\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_2}\&CenterDot;\frac{V_0}{V_1}{p}_0\\ \frac{p_2}{p_0}=-\frac{V_0}{V_1}\frac{\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_2}}{s^2+\frac{\mathrm{RA}}{L}s+\frac{{\mathrm{Aa}}^2}{{\mathrm{LV}}_2}\&CenterDot;\frac{V_1+V_2}{V_1}}\\ \frac{p_2}{p_0}=-\frac{V_0}{V_1}\frac{{\mathrm{\&alpha;\&omega;}}_n^2}{s^2+2\mathrm{\&zeta;}{\mathrm{\&omega;}}_{n}s+{\mathrm{\&omega;}}_n^2}\end{array}\right|$

Use the volume estimation of cross system phase place

Similarly, use same principle, be easy to the transfer function of deriving, utilize the pressure in the pressure representative fixed volume chamber 129 in the variable volume chamber 121 that fixed volume chamber 129 connects with it via port one 28.Especially, described transfer function is:

$\frac{p_2}{{\mathrm{<figure-callout\; id="1"\; label="p"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">p</figure-callout>}}_1}=\frac{1}{\frac{V_2{L}_p}{a^2{\mathrm{<figure-callout\; id="2"\; label="A\; p\; s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">A</figure-callout>}}_p}{s}^{}{}^2+\frac{{\mathrm{RV}}_2}{a^2}s+1}=\frac{\frac{a^2{A}_p}{V_2{L}_p}}{s^2+\frac{{\mathrm{RV}}_2}{a^2}\frac{a^2{A}_p}{V_2{L}_p}s+\frac{a^2{A}_p}{V_2{L}_p}}$

$=\frac{{\mathrm{\&omega;}}_n^2}{{\mathrm{<figure-callout\; id="2"\; label="s"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">s</figure-callout>}}^2+\frac{{\mathrm{RA}}_p}{L_p}s+{\mathrm{\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="n"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">n</figure-callout>}}^2}$

In aforesaid arbitrary situation, the system resonance frequency can be expressed as variable volume V ₂Function:

${\mathrm{\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="n"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">n</figure-callout>}}^2=\frac{a^{2}A}{L}(\frac{1}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}+\frac{1}{V_2}),\mathrm{or}\frac{1}{{\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2}=\frac{{\mathrm{\&omega;}}_n^{2}L}{a^{2}A}-\frac{1}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}|.$

Because other all parameters all is known, therefore can for example calculate variable volume V based on resonant frequency ₂, but derive V ₂Other method may be favourable, and further describe in this application.A parameter that is not constant in this equation is speed of sound a, and it can be calculated or otherwise derived or measure based on relevant temperature.

Such as described, can adopt various strategies inquiring described system, thus derivation volume V ₂According to some embodiment of the present invention, excite described system by driver part 1214 with single-frequency, monitor one or more transducer ( mike 1208 and 1209, response Fig. 9) simultaneously.Catch described response as complex signal, the amplitude and the phase place that keep-up pressure and change.Advantageously, the single query frequency is near the resonance of system in mid-stroke, and this is to follow the maximum phase of volume to change because realized thus in being used for emptying the gamut of chamber.

Response that can correction signal mike 1208, the common-mode effect that causes with the characteristic of eliminating owing to the dependence frequency that excites microphone 1202 (being shown in Fig. 6) or driver part 1214 (being shown in Fig. 9).As the plural number of microphone signal than (complex ratio) and the correction signal that obtains can be expressed as m _i, wherein, sample continuous time of index i representation signal.

Be similar to second order machinery Helmholtz resonator (Helmholtz resonator), with the formal representation of transfer function, described signal can be represented as:

$\left.\begin{array}{c}{m}_i\&ap;-\frac{V_0}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}\frac{\frac{\mathrm{A\&gamma;RT}}{L{V}_2}}{s_{\mathrm{<figure-callout\; id="2"\; label="i"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">i</figure-callout>}}^2+\frac{\mathrm{\&lambda;A}}{L}{s}_i+\frac{\mathrm{A\&gamma;<figure-callout\; id="2"\; label="RT\; L\; V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">RT</figure-callout>}}{L{V}_{}}\&CenterDot;\frac{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1+V_2}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}}=\frac{-\frac{V_0}{{\mathrm{<figure-callout\; id="1"\; label="V"\; filenames="A200780007335E01141.png,A200780007335E01151.png"\; state="\{\{state\}\}">V</figure-callout>}}_1}\&CenterDot;\frac{\mathrm{A\&gamma;R}}{{\mathrm{L\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="c"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">c</figure-callout>}}^2}\&CenterDot;\frac{T_1}{{\mathrm{<figure-callout\; id="2"\; label="V"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">V</figure-callout>}}_2}\&CenterDot;\frac{\mathrm{\&alpha;}}{{\mathrm{\&epsiv;}}_{v,i}}}{\frac{s_i^2}{{\mathrm{\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="c"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">c</figure-callout>}}^2}+\frac{\mathrm{A\&lambda;}}{{\mathrm{L\&omega;}}_c}\&CenterDot;{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}\&CenterDot;\frac{s_i}{{\mathrm{\&omega;}}_c}+\frac{\mathrm{A\&gamma;R}}{{\mathrm{L\&omega;}}_{\mathrm{<figure-callout\; id="2"\; label="c"\; filenames="A200780007335E02041.png"\; state="\{\{state\}\}">c</figure-callout>}}^2}\&CenterDot;\frac{T_i}{V_1}\&CenterDot;\frac{({\mathrm{\&epsiv;}}_{v,i}+{\mathrm{\&Psi;}}_{\mathrm{1,2}})}{{\mathrm{\&epsiv;}}_{v,i}}}\\ =\frac{-{\mathrm{\&kappa;}}_{0.i}\frac{\mathrm{\&alpha;}}{{\mathrm{\&epsiv;}}_{v,i}}}{{\stackrel{\&OverBar;}{s}}_i^2+{\mathrm{\&psi;}}_1\&CenterDot;{\stackrel{\&OverBar;}{s}}_i\&CenterDot;{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}+{\mathrm{\&psi;}}_{0,i}\frac{{\mathrm{\&Psi;}}_{\mathrm{1,2}}+{\mathrm{\&epsiv;}}_{v,i}}{{\mathrm{\&epsiv;}}_{v,i}}}=\frac{-{\mathrm{\&kappa;}}_{0,i}\mathrm{\&alpha;}}{{\stackrel{\&OverBar;}{s}}_i^2{\mathrm{\&epsiv;}}_{v,i}+{\mathrm{\&psi;}}_1\stackrel{\&OverBar;}{s_i}{\mathrm{\&epsiv;}}_{v,i}+{\mathrm{\&psi;}}_{0,i}({\mathrm{\&Psi;}}_{\mathrm{1,2}}+{\mathrm{\&epsiv;}}_{v,i})}\\ =\frac{-{\mathrm{\&kappa;}}_{0,i}\mathrm{\&alpha;}}{[{\mathrm{\&psi;}}_{0,i}({\mathrm{\&Psi;}}_{\mathrm{1,2}}+{\mathrm{\&epsiv;}}_{v,i})-{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2{\mathrm{\&epsiv;}}_{v,i}]+i\&CenterDot;{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}{\mathrm{\&epsiv;}}_{v,i}}\&CenterDot;\frac{[{\mathrm{\&psi;}}_{0,i}({\mathrm{\&Psi;}}_{\mathrm{1,2}}+{\mathrm{\&epsiv;}}_{v,i})-{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2{\mathrm{\&epsiv;}}_{v,i}]-i\&CenterDot;{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}{\mathrm{\&epsiv;}}_{v,i}}{[{\mathrm{\&psi;}}_{0,i}({\mathrm{\&psi;}}_{\mathrm{1,2}}+{\mathrm{\&epsiv;}}_{v,i})-{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2{\mathrm{\&epsiv;}}_{v,i}]-i\&CenterDot;{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}{\mathrm{\&epsiv;}}_{v,i}}\\ =\frac{-{\mathrm{\&kappa;}}_{0,i}\mathrm{\&alpha;}[{\mathrm{\&psi;}}_{0,i}{\mathrm{\&Psi;}}_{\mathrm{1,2}}+({\mathrm{\&psi;}}_{0,i}-{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2){\mathrm{\&epsiv;}}_{v,i}]+i\&CenterDot;{\mathrm{\&kappa;}}_{0,i}\mathrm{\&alpha;}{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}{\mathrm{\&epsiv;}}_{v,i}}{{[{\mathrm{\&psi;}}_{0,i}{\mathrm{\&Psi;}}_{\mathrm{1,2}}+({\mathrm{\&psi;}}_{0,i}+{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2){\mathrm{\&epsiv;}}_{v,i}]}^2+{\mathrm{\&psi;}}_1^2{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}^2{\mathrm{\&epsiv;}}_{v,i}^2}\end{array}\right|$

Here, the normalization variable is introduced into, thereby maintains the useful dynamics range aspect calculating that related parameter is positioned at order unit.Final expression formula is expressed divided by common denominator by real part and imaginary part.Obtain the ratio of real part μ and imaginary part v, (that is, the phase place cotangent),

$\frac{{\mathrm{\&mu;}}_i}{v_i}\&ap;-\frac{({\mathrm{\&psi;}}_{0.i}-{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i^2){\mathrm{\&epsiv;}}_{v,i}+{\mathrm{\&psi;}}_{0,i}{\mathrm{\&Psi;}}_{\mathrm{1,2}}}{{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}{\mathrm{\&epsiv;}}_{v,i}}$

Error may be defined as:

$E=\frac{1}{M}\mathrm{\&Sigma;}{[{\mathrm{\&mu;}}_i{D}_i+v_i{N}_i]}^2$

Wherein N and D represent the molecule and the denominator of described model respectively.

If minimize described error, then realized best fit about each model parameter.Can adopt any method model of fit parameter.In one embodiment of the invention, adopt the gradient descending method to seek minima:

$\left.\begin{array}{c}\frac{\&PartialD;E}{{\&PartialD;\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}}=\frac{2}{M}\mathrm{\&Sigma;}{\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{v,i}{D}_i{e}_i\\ \frac{\&PartialD;E}{{\&PartialD;\mathrm{\&epsiv;}}_b}=\frac{2}{M}\mathrm{\&Sigma;}({\mathrm{\&mu;}}_i\frac{{\&PartialD;D}_i}{{\&PartialD;\mathrm{\&epsiv;}}_b}+v_i\frac{{\&PartialD;N}_i}{{\&PartialD;\mathrm{\&epsiv;}}_b})e_i=2\mathrm{\&Sigma;}({\mathrm{\&mu;}}_i\frac{{\&PartialD;D}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}+v_i\frac{{\&PartialD;N}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}})e_i\frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&epsiv;}}_b}\\ \frac{{\&PartialD;D}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}={\mathrm{\&psi;}}_1{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_i{\mathrm{\&epsiv;}}_{\mathrm{\&lambda;}}\\ \frac{{\&PartialD;N}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}={\mathrm{\&psi;}}_{0,i}{\stackrel{\&OverBar;}{\mathrm{\&omega;}}}_1^2\\ \frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&epsiv;}}_b}=1\\ \frac{\&PartialD;E}{{\&PartialD;\mathrm{\&delta;}}_d}=\frac{2}{M}\mathrm{\&Sigma;}({\mathrm{\&mu;}}_i\frac{{\&PartialD;D}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}+v_i\frac{\&PartialD;N_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}})e_i\frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&delta;}}_d}\\ \frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&delta;}}_d}=\exp ({-t}_i{\mathrm{\&epsiv;}}_{\mathrm{\&tau;}}/\mathrm{\&tau;})\\ \frac{\&PartialD;E}{{\&PartialD;\mathrm{\&epsiv;}}_{\mathrm{\&tau;}}}=\frac{2}{M}\mathrm{\&Sigma;}({\mathrm{\&mu;}}_i\frac{{\&PartialD;D}_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}+v_i\frac{\&PartialD;N_i}{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}})e_i\frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&epsiv;}}_{\mathrm{\&tau;}}}\\ \frac{{\&PartialD;\mathrm{\&epsiv;}}_{v,i}}{{\&PartialD;\mathrm{\&epsiv;}}_{\mathrm{\&tau;}}}={\mathrm{\&delta;}}_d\frac{t_i}{\mathrm{\&tau;}}\exp ({-t}_i{\mathrm{\&epsiv;}}_{\mathrm{\&tau;}}/\mathrm{\&tau;})\end{array}\right|$

For each application-specific of the present invention, obtained the interval of each continued time domain sample, and be used for match Model in Time Domain parameter and the interval number of sampling is advantageously optimized.When but fluid flows with constant relatively speed slowly,, have been found that to sample to the cycle of 3 τ from τ/3 be effective as in basal insulin is carried.In another egregious cases, when carrying the fluid of injecting relatively greatly, on the time scale of exponential decay time constant, fluid may only be present in short-term in the allocation space 122.In this case, on the shorter period of characteristic decay time, sample.

According to a preferred embodiment of the invention, based on the cross system phase measurement of carrying out with single stimulating frequency, according to the fluid volume of the match of the model of volume-time being determined distribute by allocation space 122.And, during the initial part of pump stroke,, combine and carry out preliminary surveying and operate with measuring agreement, as now described with calibration system with reference to the flow chart shown in Figure 117.Advantageously save computer resource and reduce power consumption by the metering process of label 1170 overall marks, prolong the service time between charging or replacing power supply 1211 (being shown in Fig. 9) thus, provide the desired accuracy of measurement of mode conveyance fluid that has above-mentioned resolution with every stroke by frequency calibration simultaneously.

Before each pump stroke or at it, begin at 1171 o'clock, or in both cases, processor 1210 starts the self calibration phase place 1172 of AVS system.Do not measure until the electronics transition that causes owing to actuated pump significantly decay.In step 1173, with a series of frequency, mike and speaker gain are set, and driver part 1214 activated wherein common the employing substantially near five frequencies in abutting connection with acoustical area 1290 (perhaps being known as " acoustic chamber " here) resonance.Usually adopt the frequency in the 6-8kHz scope, but be to use any frequency all to belong to the scope of the invention.At each when frequency activates beginning in succession, in the period of 5ms roughly, data acquisition is delayed, until acoustics transition decay substantially.

For 64 infrasonics circulation persistent period roughly, following image data: to the sampling of the temperature reading that provided by temperature sensor 132 (Figure 70 B illustrates), and signal mike 1209 is sampled respectively with respect to the real part and the imaginary part represented with ρ and ι of the ratio of the output signal of benchmark mike 1208 in step 1174.In order to describe the purpose of AVS system, the plural number ratio of signal, perhaps microphone signal can be called as " signal " here with respect to other functional combination of described benchmark.

Based on the measurement of roughly carrying out on period of 200ms in each frequency under each frequency, derive a cell mean and variance for each of signal real part under each frequency and imaginary part and for temperature reading.Analysis to these numerical value in step 1175 makes whether can determine error is arranged in prescribed limit.Unusual transfer function is the exemplary system fault advantageously, described fault includes but not limited to the fault in mike or other pick off, speaker, transducer, electronic device, mechanical component, the fluid intake, bad acoustic seal, excessive environmental noise, and excess impact and vibration.Additionally, in step 1176, determine the functional dependence relation of the phase angle of signal as frequency function.The phase angle of signal, promptly the arc tangent of its imaginary part and real part ratio can be used as phase measurement, yet can use any phase measurement within the scope of the present invention.Can be by the fitting of a polynomial of phase place and frequency or the described functional dependence relation of otherwise deriving.In step 1177,, perhaps otherwise, under the cubing frequency, determine the slope of phase place, and carry out cubing frequency based on described fitting of a polynomial.Additionally, and importantly, phase place is shown in the fluid that contains in the dispensed chambers 122 the unusual slope of frequency and has bubble.

For the following section of each pump stroke, activated drive parts 1214 under single-frequency substantially are thus at the gas that excites on acoustics under this frequency in the acoustics neighboring region 1290.Generally be collected and equalization in the regulation sampling interval in 64 circulation roughly based on the signal data of signal mike 1209 with respect to the output signal plural number ratio of benchmark mike 1208.Write down real part and the imaginary part and the temperature data of described signal for each sampling interval.Based on the data that are sampled and gather, Model in Time Domain is carried out match.In various embodiments of the invention, as mentioned above, adopt the gradient descending method, thereby during each pump stroke, make the model of fit parameter, be i.e. the baseline volume V of the long-pending chamber 121 of variable capacity _B, peak displacement V _DAnd the error minimize among the die-away time τ, the fluid volume of carrying by dispensed chambers 122 is provided thus.

With reference now to Figure 10,, distributes spring 130 can have and can have a plurality of helical grooves 131 with the complementary spiral of diaphragm or fan shape.The embodiment of spring can apply roughly active force uniformly on diaphragm as shown.This roughly uniform active force helps diaphragm to work as and keeps the roughly shape of spill when it expands.Groove 131 allows air freely by spring, and therefore most of air are not trapped between spring and the diaphragm.

With reference now to Figure 11 A and 11B,, inject for representative basis transport pulse (Figure 11 A) and for the typical case that conveying (Figure 11 B) illustrates the volumetrical kinetic measurement of dispensed chambers 122 (shown in Figure 5) and the example of the cumulative volume of discharging from dispensed chambers 122 calculated.As from Figure 11 A as seen, actuated pump sending component 16 causes that dispensed chambers 122 expanded from about 0 to about 1.5 μ l in about 2 second time, measured as acoustic volume pick off 550.Notice that elasticity dispensed chambers 122 is shunk and discharge its fluids by high impedance output from chamber 122 in about 30 seconds period, wherein the exponential damping kinetics relation is by about 6 seconds half-life (t _1/2) characterize.From utilize the measurement of being undertaken by pick off 550, calculate, and notice that also it rises to about 1.5 μ l exponentially from the cumulative volume of dispensed chambers 122 outputs.Can find that high impedance output introducing between actuated pump assembly and the most of displacement of conveying fluid postpones.Can consider the t of the impedance level selective system of the elastic acting force that applies by dispensed chambers 122 and output _1/2Characteristic.In various embodiments, time constant can change with economize on electricity and eliminate drifting problem.Time constant can for example be t _1/2=2 seconds or t _1/c=2 seconds.

Figure 11 B illustrates and utilizes the kinetics of injecting FLUID TRANSPORTATION of FLUID TRANSPORTATION device 10 to distribute.About No. 29 pumps actuatings (that is, pulse) in succession fast all move on to fluid the elasticity dispensed chambers 122 from fluid source, cause that therefore corresponding change takes place the parameter of being measured by acoustic volume measuring transducer 550.The volume that can notice dispensed chambers 122 expand into about 1.5 μ l in first pump pulse, this numerical value is similar to observed numerical value in Figure 11 A.Realize that allocation component 120 discharges under the other pulsation pumping under the pulse spacing in desired period fully being shorter than, dispensed chambers 122 volumes further expand; This expansion reaches maximum about 6 μ l.Pump surging stops and finding that the volume of chamber 122 reduces with the exponential damping kinetics relation after about 85 seconds, thereby discharges its contained fluid fully with about 30 seconds time after stopping pumping.The t that is used for this final discharging _1/2Be used for that the basis shown in Figure 11 A carries basic identical.Notice that the accumulation output volume that calculated raises with the substantial linear dynamic behavior and reach maintenance level when stopping pumping in pump period.

In described system,, therefore, can in several seconds, determine fault by cubing but not by pressure measxurement detection failure state.Figure 11 C-11F shows the pick off 550 of Fig. 5-7 and surveys various types of malfunctions.With reference to all explanation of figure 5-7 description about Figure 11 C-11F.

Figure 11 C is illustrated in the kinetics of exporting with respect to the time about the pick off 550 of pumping pulse in the normal operating state and distributes.In contrast, Figure 11 D illustrates the expected results that obstruction takes place in allocation component 120 downstreams; Pick off 550 detects (or undiminished) volume of the fluidic increase in dispensed chambers 122 apace.

At low volume state shown in Figure 11 E-11F.In Figure 11 E, reach roughly maximum sensor signal, be too fast decay subsequently; This state can be illustrated the internal leakage in pump 16, flowline 310 or the allocation component 120.The kinetics of Figure 11 F distributes and has the low peak volume signals and can represent failure of pump, vacant reservoir 20 or be positioned at the obstruction of dispensed chambers 122 upstreams.The delayed expansion that dispensed chambers 122 activates in response to pump also can be illustrated the problem in the flowline 310.Pick off 550 also may be able to be surveyed the bubble in the fluid.Can activate siren in response to the detection of malfunction.

Figure 12 illustrates the circulation flow chart of describing acoustic volume sensing and compensation (corresponding to the control loop 360 of Fig. 2 A-3).Pick off can be measured the Fluid Volume that distributes from device 10 based on the amplitude of the circulation change in the variable volume chamber 121 that is brought out by pumping circulation.For example, pick off 550 can repeat to obtain the acoustics frequency spectrum (step 2611) of resonance variable volume chamber 121 and reference space chamber 127 and keep parameter for each pumping pulse, and the volume that this parameter is updated in conjunction with the gas in the variable volume chamber 121 reduces.Correspondingly, the parametric representation that is updated has entered the net flow scale of construction in the dispensed chambers 122.When having fully delay between pulse, the fluid that enters in the dispensed chambers 122 is substantially equal to the volume that has been distributed by device 10.Alternately, pick off 550 can increase by the gas volume of repeated measure in variable volume chamber 121, with the amount of determining to be distributed by device (postponing if exist fully between pulse).The acoustics frequency spectrum is compared with the model frequency spectrum in the enquiry form, and this model frequency spectrum can be corresponding to having bubble, do not have bubble or having any one or all (steps 2621) of dispensed chambers 122 of the bubble of varying dimensions.Enquiry form can contain obtain by experiment, use a model definite or according to the working experience established data.Enquiry form can have representative and contain bubble and/or the representative data about the normal condition of a plurality of degrees of expansion of dispensed chambers 122 that change.If the summation match of frequency spectrum and renewal proper flow model (step 2631), then obtain another acoustics frequency spectrum and in step 2611 place repetitive cycling.If not match of the summation proper flow model of frequency spectrum and/or renewal is then determined to exist low or is stopped up flow (step 2641).Be lower than prediction or set numerical value by utilization, perhaps be lower than the summation of the renewal of the two, the volume of the constant super scope of variable volume chamber 121 can be illustrated low or stop up to flow.If detect low or stop up flow regime, siren will be triggered (step 2671) then.Siren can comprise audible signal, vibration or these two.If do not find low or stop up flow regime, then described device determine described frequency spectrum whether match corresponding to the model (step 2661) of the state that in dispensed chambers 122, has bubble.If determine to exist bubble, then start the reaction that can comprise alarm and/or compensation behavior, described compensation behavior can comprise that interim increase pump rate (step 2651) and described step 2611 place that circulates in begin once more.If determine not exist bubble, the siren malfunction (step 2671) that is triggered and is not determined then with signal.Embodiments of the invention also can utilize as examining U.S. Patent Application Serial No.60/789 jointly, the bubble detection of the use AVS technology that discloses in 243, and described patent application is bonded to here by reference.

The pump 16 of Fig. 2 A-3 is actuated allocation component 120 with fluid from reservoir 20.When the allocation component used according to Fig. 6-7, needn't use the high accuracy pump, because the feedback that offers pump 16 by allocation component 120 allows to regulate pump 16 based on the accurate measurement that is transferred volume.Each pumping pulse can have enough low volume to allow carrying out fine compensation based on feedback.Therefore can adopt a lot of different pump 16 schemes.Be described below the various possible embodiment of pump 16.

Figure 13 and 14 roughly is illustrated in the alternate embodiments according to some members in the FLUID TRANSPORTATION device of the embodiment of the invention.Figure 13 illustrates the flowline 310 that has pump 16, and described flowline has the pumping element 2100 between upstream one-way valve 21 and downstream one-way valve 22.Pumping element 2100 can use actuator so that a part of flowline is out of shape, thereby produces pressure in flowline 310.Upstream one-way valve 21 suppresses from the refluence of pumping element 2100 towards the fluid source (not shown), and downstream one-way valve 22 suppresses from volume sensing chamber 120 to pumping element 2100 refluence.As a result, fluid is driven along the direction of spout assembly 17, and this spout assembly comprises high impedance channel in one embodiment.

In the alternate embodiments shown in Figure 14, the function by combined valve pump 2200 execution pumping elements promptly, produces pressure in flowline 310 and upstream one-way valve 21.Therefore, the pump 16 in Figure 14 embodiment is formed by two members, that is, and and combined valve pump 2200 and downstream one-way valve 22, but not be used for three members of Figure 13 embodiment.Can use other embodiment of pump 16.The combination of valve and pump function can realize that some of them are described with reference to figure 15A-16 and 22-56 below by various mechanisms in valve pump 2200.

Among a lot of embodiment that are described below, all directly or indirectly (for example be used for the lift valve of inlet valve 21, the lift valve that is used for outlet valve 22 and pumping actuated components 54, as in Figure 50-56) be communicated with flowline 310, thus each of these elements all can form various fluid pressures or react for various fluid pressures.As pointed in the above, upstream and downstream valve (also can be called import and outlet valve here) is a check valve.In the check valve of other type, described valve can be volcano valve (volcano), flapper valve, check-valves or duckbill valve, or exports the valve of other type of bias current towards device.Be to authorize on January 12nd, 1993 the U. S. application No.5 of Dean L.Kamen, disclosed the example of volcano valve in 178,182, this United States Patent (USP) is combined in here by reference.

In the embodiment shown in Figure 15 A-15D, pump comprises inlet valve 21 and outlet valve 22, and wherein each valve includes fluid inlet, fluid issuing and movable part (for each valve, movable part is a part of barrier film 2356).Pump also comprises pumping element 2100.Pumping element is positioned at inlet valve 21 downstreams and outlet valve 22 upstreams.In the following description, outlet valve is from the closed position, that is, fluid does not flow through outlet valve.Yet, when enough pressure is provided when fluid,, make fluid pressure open described outlet valve, and fluid can flow through outlet valve 22 then by on the lift valve 9221 of barrier film and outlet valve, exerting pressure to open valve.Single mechanical action not only block pumps import but also and then actuate by pump discharge under the mobile meaning, Figure 15 A can be considered to combined valve pump (as the object among Figure 14 2200) to the embodiment of 15D.

This pumping installations has the advantage that movable part and moistening line components is separated into the opposite side of flexible barrier barrier film 2356.As a result, wetted portions (flowline 310) can be arranged in disposable member but movable part can be arranged in the reuse member.

In the preferred embodiment of pumping mechanism, fluid source is non-pressurized reservoir.When the movable part of inlet valve is shown in an open position and has negative pressure in the pumping chamber, exist and aspirate fluidic pressure differential towards inlet valve from reservoir.Can utilize the membranous elasticity in the pumping chamber to form this negative pressure.In an alternate embodiments, the spring that can be built in the barrier film can be used for assisting the membranous of pumping chamber to rebound.Non-pressurised reservoir can subside, thereby when from reservoir suction fluid, subsides accordingly in the reservoir and reduce its volume.As a result, prevent from reservoir, to form negative pressure or air.

In the preferred embodiment of pumping mechanism, after inlet valve cut out, pressure was applied to the pumping chamber to actuate fluid from the pumping chamber towards outlet valve.Open outlet valve and allow fluid to flow through the fluid issuing of outlet valve by the pressure that the pumping campaign forms.

Movable part can be any parts that can play a role as mentioned above.In certain embodiments, movable part is flexible partition or elasticity pumping film.In other embodiments, movable part is spherical rigid structure or can prevents effusive another object of the opening of fluid from fluid path.

In practice, can before using, pour into pumping mechanism.Therefore, pumping mechanism circulates by a plurality of strokes, and from the flowline air-out, the most of or all air in flowline are discharged from.Because fluid volume that have in pumping chamber outside but that be between the valve is little, therefore a lot of pumping mechanisms that here disclose have the ability of " perfusion certainly ".When pump was actuated air in the pump chambers, it basically formed enough pressure to send outlet valve.Backward stroke subsequently therefore can form enough negative pressure so that pump from the reservoir pumping liquid.If " extremely " volume of pump is too big, then the air in the pumping chamber cannot form enough pressure to overflow from outlet valve.As a result, pump may shut-down operation.

Figure 15 A-15D, 16 and 22-56 a plurality of embodiment of pumping mechanism are shown.With reference now to Figure 15 A-15D,, an embodiment of pumping mechanism is shown, with a plurality of steps in the example pumping process: 1. fluid is through inlet valve 21 (shown in Figure 15 B); 2. inlet valve cuts out (shown in Figure 15 C); With 3. when fluid pressure is opened outlet valve 22 pumping actuated components 54 actuate fluid towards the downstream and make it flow through fluid issuing (shown in Figure 15 D).

The pumping mechanism of Figure 15 A-15D comprises movable part, and described movable part is a part of flexible partition 2356 in this embodiment.Inlet valve and outlet valve comprise the lift valve 9221,9222 as the valve blockage device.Each of lift valve 9221,9222 and pump actuated components 54 includes spring 8002,8004,8006.Pump plate 8000 is attached to pump actuated components 54 and import lift valve 9221 and as its terminal point of spring 8004,8002 separately.

Term " lift valve " is used for expression and exerts pressure to influence the parts of diaphragm position towards movable part (that is barrier film).Though can use other design, be described below some particular example (in conjunction with Figure 50-56) that the spring that utilizes structure with mechanical advantage and principle loads the lift valve valve.Yet the mechanism except lift valve can be used in the execution identical function.In Figure 15 B-15D, inlet valve 21 comprises a part and the lift valve 9221 of fluid inlet and fluid issuing, barrier film 2356.Outlet valve 22 comprises fluid inlet, fluid issuing, a membranous part and lift valve 9222.

In the embodiment shown in Figure 15 A-15D, limit fluid path 310 by the structure (object 9310 among Figure 15 A) that can be inflexible or have certain flexibility (preferably flexibility is lower than barrier film 2356).Shown in Figure 15 A, shell structure 9310 defines valve chamber 9321,9322 and pumping chamber 2350; Three chambers of all this all are arranged in fluid path 310.

With reference now to Figure 15 B-15D,, inlet valve 21, outlet valve 22 and pump element 2100 all have fluid inlet and fluid issuing.Pumping actuated components 54 has fluid mobile herein pumping chamber 2350 after leaving inlet valve.Pumping actuated components 54 is exerted pressure on barrier film 2356, forms normal pressure in flowline.

Shown in Figure 15 B-15D (and similar for the valve seat 4070 that is used for outlet valve shown in Figure 50-56), when barrier film was not activated by the lift valve 9221 of inlet valve, the valve seat 9121 in the inlet valve 21 preferably separated with barrier film 2356.

Flowline 310 is limited partly by barrier film 2356.In this embodiment, barrier film 2356 separates the some parts of pumping mechanism with fluid.Therefore, wetted and pumping actuator 54 of flowline 310 and valve lift valve 9221,9222 are not wetted.Yet the alternate embodiments of pump does not need to comprise the barrier film 2356 that contacts with flowline 310.On the contrary, different movable parts can be used to valve and/or pump.Therefore in a further embodiment, the only some parts of flowline 310 separates with pumping mechanism, Wetting pump sending component partly.

Import lift valve 9221 comprises end 8018, and the surf zone of import lift valve of the membrane portions of contact flow pipeline 310 is represented in this end.Pumping actuated components 54 comprises the end 8012 of the membrane portions of contact flow pipeline 310.Similarly, outlet lift valve 22 comprises the end 8022 of the membrane portions of contact flow pipeline 310.Exerting pressure on its respective regions of barrier film 2356 in the end 8018,8022 of valve lift valve, stops or open the appropriate section of flow path 310.Also exerting pressure on membranous respective regions in the end 8012 of pressure actuated parts, thereby causes flowing by flowline 310.

Pumping actuated components 54 is centered on by plunger biasing spring 8004.Plunger biasing spring 8004 has the supporting construction that is positioned at pump plate 8000 and is positioned at the terminal point at 8014 places and also keeps the pumping actuated components.

Import lift valve 21 is centered on by import lift valve spring 8002, but in alternate embodiments, the import lift valve self is elastic and therefore the function of spring is provided.Import lift valve spring 8002 have be positioned at pump plate 8000 place and near the terminal point of the end 8018 of import lift valve 9221.

Outlet lift valve 9222 is centered on by passive outlet lift valve spring 8006.Outlet lift valve spring 8006 has terminal point and the close lip protruding 8020 that exports the end of lift valve 9222 that is positioned at outlet lifting valve plate 8024.

In each situation, spring 8002,8004,8006 stopped and does not disturb the surf zone 8018,8012,8022 of contact barrier film 2356 before respective end portions.

In a preferred embodiment, fluid pumping device also comprises at least one shape memory actuator 278 (for example, conductive shapes memorial alloy lead) along with the temperature change shape.Can utilize heater, perhaps more easily by applying the temperature that electric current changes shape memory actuator.Figure 15 B-15D illustrates the embodiment with a shape memory actuator 278, yet, (be described below) shape memory actuator 278 that can exist in other embodiments more than one.In one embodiment, shape memory actuator is the shape memory wire that utilizes the nickel/titanium alloys structure, for example NITINOL ^TMPerhaps Yet, in other embodiments, also can use any device that can produce active force, for example solenoid.In certain embodiments, shape memory actuator 278 has about 0.003 inch diameter and about 1.5 inches length.Yet, in other embodiments, shape memory actuator 278 can make by any alloy that can utilize heat to shrink (thereby and expand can be by applying auxiliary the carrying out of mechanism that active force is stretched to alloy initial length on alloy, it is spring, but this mechanism is not necessarily), thus as among the embodiment that describes, activate pumping mechanism here.In certain embodiments, the diameter of shape memory actuator 278 can be required any length to required any diameter and length from 0.001 inch.Usually, diameter is big more, and obtainable contraction power is high more.Yet being used for the desired electric current of heating wires will increase along with diameter usually.Therefore, the diameter of marmem 278, length and component can influence and be used to activate the required electric current of pumping mechanism.Irrelevant with the length of shape memory actuator 278, the actuation force constant.The increase of actuation force can produce by the diameter that increases shape memory actuator 278.

Shape memory actuator 278 is connected to pump plate 8000 by adapter 8008.Adapter 8008 is described below in further detail.Shape memory actuator 278 is connected to fluid pumping device by terminal point adapter 8010.According to device that wherein uses pumping mechanism or system, the terminal point link position will change.Terminal point adapter 8010 is described below in further detail.

Figure 15 B-15D illustrates flowline that has been poured 310 as discussed above and pumping mechanism.With reference now to Figure 15 B,, inlet valve 21 is opened, and pumping actuated components 54 is not pressed on the barrier film 2356.During outlet valve 22 is in the closed position.Shape memory actuator 278 is in the expanding position.In this configuration, fluid is drawn into inlet valve 21 fluid inlets from the reservoir (not shown).(though illustrate as the protuberance in the barrier film in the inlet valve zone, the suction fluid can cause the barrier film depression in this step, and perhaps barrier film does not deform).When the import lift valve was shown in an open position, fluid can flow to fluid issuing and enter pumping chamber 2350 from fluid inlet.At this moment, outlet lift valve end 8022 is pressed on the barrier film 2356 and sealing outlet valve 22 tightly.

Below with reference to Figure 15 C, electric current has been applied to shape memory actuator 278, and shape memory actuator shrinks towards required final lengths from beginning length.The contraction of shape memory actuator 278 is towards flowline 310 pulling pump plates 8000.Import lift valve 9221 and pumping actuated components 54 all are connected to pumping plate 8000.The motion of plate 8000 is towards barrier film 2356 pulling import lift valve 9221 and pumping actuated components 54.Shown in Figure 15 C, import lift valve end 8018 is pressed on the barrier film 2356 securely, with diaphragm seal to valve seat 9121 and close inlet valve 21.(motion of import lift valve can be actuated in the imported valve chamber, and promptly the small amount of fluid in the object 9321 among Figure 15 A flows through the fluid inlet or the fluid issuing of inlet valve 21.)

Side by side, pumping actuated components 54 is towards pumping chamber 2350 its paths of beginning.During this process, when import lift valve spring 8002 is compressed (at this moment, import lift valve end 8018 is pressed securely onto flowline 310), pump plate 8000 and pumping actuated components 54 continue to advance towards flowline 310.Import lift valve spring 8002 allows pump plate 8000 along with pump actuated components 54 continues to move towards flowline 310, even when import lift valve 9221 no longer can be advanced.

With reference now to Figure 15 D,, zone on pumping chamber 2350 and fluid that pumping actuated components 54 is pressed onto barrier film 2356 are pumped, thereby increase the fluidic pressure in the pumping chamber 2350.Outlet lift valve end 8022 keeps being pressed in securely on (assisting down of outlet lift valve spring 8006) barrier film 2356, thereby the fluid inlet and the fluid issuing of sealing outlet valve 22 are until opening from pumping chamber 2350 effusive fluidic pressure actuated outlet valves 22.When reaching enough pressure, fluid leaves by the fluid issuing of outlet valve 22, has therefore overcome 22 pairs of barrier film 2356 applied pressures of outlet valve.When stopping when flowing, passive spring 8006 is actuated outlet valve 22 and is closed.

During driving stroke, pump actuated components spring 8004 is loaded.Finally, pump actuated components spring 8004 will spur pump actuated components 54 away from barrier film 2356.As a result, during lax stroke, spring 8004 turns back to pump actuated components 54 and pumping plate 8000 slack position of Figure 15 C; Load import lift valve spring 8002 and can also provide energy for backward stroke.When pumping plate 8000 during near its slack position, the end cap that its engages import lift valve 9221 to be mentioning the import lift valve and it is pulled away from base, thereby opens inlet valve 21.Pump actuated components spring 8004 is also unloaded during backward stroke.

When reach import lift valve spring 8002 wherein be in the threshold values of pump plate 8000 pars apart from the time, will utilize pump actuated components spring 8004 de-ballast pump plates 8000.Elastic diaphragm 2356 in pumping chamber 2350 will turn back to its starting position.This forms negative pressure, and when inlet valve is opened, fluid will flow to fluid issuing by the fluid inlet of inlet valve and flow towards pumping chamber 2350.Therefore, pumping mechanism will be in the state shown in Figure 15 B now.

When during actuated pump, repeat whole pump sequences of describing about Figure 15 B-15D by shape memory actuator 278 is applied electric current at every turn.

So-called here barrier film comprises barrier film 2356, thus its can by can produce necessary characteristic as here as described in any elastomeric material of playing a role make.Additionally, diaphragm material can comprise biocompatible material, thereby can not hinder the operation of pump or reduce fluidic therapeutic value.Multiple biocompatible elastic material may be suitable, comprises nitrile and silicones.Yet different treatment fluid components may require to select different elastomeric materials.

Can above-mentioned pumping mechanism be described also just like the various embodiment that describe here according to length of stroke.A kind of mode of determining length of stroke is the total variation of utilization in the shape memory actuator length of a cycle period of shape memory actuator pucker ﹠ bloat.This difference will be determined total distance that pump rod is advanced and therefore determine to flow out inlet plenum 2354 and flow to pumping chamber 2350, outlet chamber 2352 and the last fluid total volume that flows out outlet chamber 2352.The another way of determining length of stroke is the travel distance of pump plate 8000.For pratial stroke, pump plate 8000 will not reach its maximum travel distance.In one embodiment, very little stroke or little stroke are started continuously, in the mode of continuous or rule from the fluid of reservoir pumping microlitre volume to outlet.For example, little stroke can be shifted less than the volume of 20%, 10% or 1% pumping chamber 2350.

Figure 16 illustrates the modification of the pumping mechanism embodiment shown in Figure 15 B.In Figure 16, use two kinds of different shape memory actuators-one long and short one.Figure 16 illustrates the embodiment of pumping mechanism shown in Figure 15 B, and wherein shape memory wire 278 centers on pulley 286 tensionings and splits into long strand and short strand.Common junction as negative terminal can be positioned at the long and short splitted position of strand.The circuit that utilizes the arbitrary of two alternative paths or two and realize allows to regulate pump action power and/or length of stroke.In alternate embodiments, material piece, for example the Kevlar material extend to active force plate 8000 around pulley from common junction, and two isolating shape memory wires extends to its corresponding support member from common junction.Have two leads of different length by use, these embodiment provide pumping pattern and the exhaust mode as being described below.

About using the shape memory actuator variable to change stroke, for the shape memory actuator of given length, stroke depends on the number of variable: 1. total time of energising/heating; 2. total voltage; Diameter with 3. shape memory actuators.At some variable embodiment shown in Figure 17-19.Yet, in certain embodiments, can when keeping length, conduction time and voltage, change stroke.These embodiment comprise a plurality of shape memory actuators (seeing Figure 19) and a plurality of switch (seeing Figure 17) on a shape memory wire.As discussed above, also can be by revising any one or a plurality of variable obtains required length of stroke.

Additionally, the timing to shape memory actuated heating or energising can change with the control stroke.Shape memory actuator is heated at every turn and can be regarded as a pulse.For example the factor of pulse frequency, pulse duration and length of stroke can influence the fluidic amount of carrying at certain hour.

Figure 17-19 additionally describes to have the embodiment of the pump of fluid pumping pattern and exhaust mode.When activateding, exhaust mode applies parts by active force and has applied the enhanced compression stroke that applies and/or increase displacement of active force.Can be based on the relevant situation of probability that in pump, has air or understanding and activate exhaust mode.For example, can work as pipeline when being attached to reservoir, when detecting bubble, perhaps when detecting insufficient flow, activate exhaust mode by pick off or sensor device by pick off or sensor device.Alternately, described two kinds of patterns can be used for given pumping pulse is selected between the fluid of less and larger volume that is shifted.

With reference now to Figure 17,, briefly shows and utilize shape memory actuator 278 activate and pump that have a plurality of operator schemes.When pumping chamber 2350 was filled fluid, pump was operated with fluid pumping pattern.During fluid pumping pattern, electric current flows between negative electricity lead-in wire 2960 and positive electrical lead 2961, causes alloy shape memory actuator 278 resistance heated and causes phase change and power stroke thus.In one embodiment, between the pumping mechanism flush phase or when there is bubble 2950 in suspection in pumping chamber 2350, the path flow that exhaust mode activated and electric current extends along length between negative electricity lead-in wire 2960 and positive electrical lead 2965; The result has the compression stroke of higher active force and displacement that active force applies parts 2320 should be enough to air 2950 is displaced to pump discharge 2370 from pumping chamber 2350.In alternate embodiments, the positive and negative lead-in wire can be put upside down.

With reference now to Figure 18,, briefly shows the alternative pump of shape memory actuator 278 with a plurality of equal length.Other actuator can for example be used to increase the actuation pressure on the pumping chamber 2350, with obstruction or the bubble in other zone of eliminating flowline, pumping chamber or pumping mechanism.Other actuator can also provide standby to any pumping device.Single shape memory actuator may be able to produce enough active forces to eliminate bubble from the pumping chamber.Additionally, in the embodiment shown in Figure 18, according to the length of second shape memory actuator, other return spring may be necessary.

When reservoir at first was attached to the flowline with pump, pumping mechanism (object 16 among Figure 13-14) was usually by fills with air.Because a variety of causes, air can also enter pumping mechanism during normal running.Because the air ratio fluid is easy to compression more, so, then apply compression stroke and may be not enough to produce enough pressure, with the opening pressure of customer service pumping mechanism check valve with the fluidic length that is enough to be shifted if in flowline, there are a large amount of air.Correspondingly, pumping mechanism may shut-down operation.Yet,, may expect that actuate air passes through pipeline between flush phase or when in pump, harmlessly having little air.Therefore, the embodiment shown in Figure 18 can be used in and produces extra active force in this case.

Figure 19 briefly shows the alternative pump 16 with a plurality of shape memory actuators.The first, short shape memory actuator 2975 has first electrical lead 2976 and second electrical lead 2977.Short actuator 2975 can produce the fluidic compression stroke in the pumping chamber 2350 that is enough to be shifted; At the short shape memory alloy actuator 2975 of normal fluid pumping pattern operating period use.When the signal exhaust mode or require bigger when being pumped fluid volume, can be by using the second long shape memory alloy actuator 2970 along placing actuator length between first electrical lead 2973 and second electrical lead 2972 to send electric current.Be included in the short circuit of the power path between first electrical lead 2972 and second electrical lead 2971 by formation, long shape memory alloy actuator 2970 can also be used as the reserve actuator that is used for the operation of fluid pumping pattern.Short shape memory actuator 2975 can also be used to change stroke capacity to provide better control under the fluid volume speed that reduces.The multi-modal actuator of Figure 17-19 be not limited to shown in pumping element use, but can use with any one of the various embodiment of pumping mechanism described herein, described embodiment comprises those of those and the valve pump that adopts as be described below of the fluid pumping device that uses as be described below.Therefore, by forming required length of stroke to the length shapes memory actuator energising/heating that required length of stroke is provided.

With reference now to Figure 20 A and 20B,, each all illustrates an embodiment who is used for attachment shape memory actuator.These different embodiment can be used in any mechanism or device that have wherein adopted shape memory actuator 278 described here.With reference to figure 20A and Figure 20 B, shape memory actuator 278 is fed in the grommet 280.Grommet 280 is attached to parts 284 then.Though two embodiment of this attachment pattern only are shown, and various other patterns are used among other embodiment.Can use other pattern that grommet is attached to a part or any fixed position.

With reference now to Figure 21 A and 21B,, two exemplary embodiments that attachment is used for the shape memory actuator 278 of pumping mechanism 16 are shown.In each of these embodiment, shape memory actuator 278 is designed to rotate around pulley 286.With reference to figure 21A, shape memory actuator 278 is attached to the part of preferably being made by the KEVLAR material 288 by grommet 280.An end of shape memory actuator 278 is illustrated as being attached to parts 284 by dog screw device 289.With reference now to Figure 21 B,, an end of shape memory actuator is illustrated as being attached to parts 284 by grommet 280.

The various embodiment of pumping mechanism shown here.Pumping mechanism can comprise inlet valve, pumping actuated components and outlet valve.As discussed above, dissimilar check valves can be used for alternate embodiments.Though the skeleton diagram shown in Figure 15 A-15D has illustrated an embodiment, following accompanying drawing illustrates alternate embodiments.

With reference now to Figure 22 and Figure 23,, the side view and the cross section of a part of pumping mechanism is shown.In this embodiment, the pumping actuated components is a pumping elongate finger member part 32.When active force was applied on the finger 32, finger 32 was depressed movable part and is reduced the internal volume of flowline.

The part of the pumping mechanism among Figure 22 and 23 only illustrates the pumping chamber.When combined, applying metamorphosis power, actuate fluid and flow towards the spout assembly (not shown) to movable part 23 with check valve ( object 21 and 22 among Figure 13).Shown in Figure 22 and 23, finger 32 be point concentrating active force, but in other embodiments, finger 32 can be flat or any other suitable shape.Spring 31 is used for pressing finger 32 with respect to elastomeric element 23 offset of giving up the throne towards contracting, thus under the situation that does not apply active force finger 32 turn back to contract move back, decompressed position.As shown in figure 23, motor can be used to active force is applied on the finger 23.Yet, in other embodiments, use shape memory actuator.Various types of motors are suitable, comprise motor and piezo-electric motor.

With reference to Figure 22 and 23, to off normal in response to applying active force by preventing movable part 23 by finger 32, backstop 33 restriction finger 32 potential advancing are supported movable part 23, and are guaranteed to reduce the volume of flowline or pumping chamber.As shown in figure 22, backstop 33 can advantageously have and elastomeric element 23 complementary shapes.In various embodiments, pump 16 can comprise lever or crank, and this lever or crank are driven by motor on an end, and at place, the other end elasticity of compression parts 23.

With reference now to Figure 24,, another embodiment of pumping actuated components is shown about a part of pump.Motor or shape memory actuator (not shown) apply turning effort power to one group of projection 42 that connects.These projectioies 42 are as the pumping actuated components and apply active force to movable part 23 in turn.Correspondingly, the active force intermittent pulse is applied to movable part 23.Backstop 33, as shown in the figure, can in housing 44, advance and by spring 46 towards elastomeric element 23 bias voltage upwards.

With reference now to Figure 25,, is illustrated in the embodiment of the force application assembly of (being plunger) 54 that have the pumping actuated components in the plunger barrel 52 here.Motor causes that plunger 54 alternately returns and insert in the plunger barrel.When plunger 54 was return, negative pressure was drawn into fluid passage 51 and the inner chamber 56 from the reservoir (not shown).When plunger 54 was inserted into, the pressure of the increase that combines with the check valve (not shown) was towards allocation component (not shown) drive fluid.Inner chamber 56 is connected to passage 51 and plunger barrel inner chamber 56 via interface channel 58 volume reduces along with the reeve action of plunger 54, actuates fluid thus by flowline 310.

Figure 26 and 27 illustrates another embodiment, and wherein the pumping actuated components is a plunger 54.Force application assembly and comprise shape memory actuated 278 linear actuator drives plunger 54.In Figure 26, shape memory wire 278 is in low temperature, the swelling state and is attached to first support member 241 and plunger attachment end cap 244.244 of end caps are attached to biasing spring 243 in turn, and described biasing spring is attached to second support member 242 in turn.When lead 278 was in swelling state, biasing spring 243 was in relaxed state.Figure 27 illustrates shape memory actuator 278 and is in the contraction state owing to guiding line 278 applies electric current and heats simultaneously.When shrinking, active force is applied on the end cap 244, thereby causes the insertion campaign and the corresponding pump action of plunger 54.In contraction state, biasing spring 243 is in the high potential energy state.When stopping to apply electric field, Nitinol lead 278 cools off once more and expands, and plunger 54 is turned back to its state of moving back that contracts to allow biasing spring 243.Shown in Figure 21 A-21B, shape memory actuator 278 can be around one or the winding of more pulleys.

Figure 28-30 illustrates various embodiment, wherein realizes pumpings by the pumping actuated components 54 that uses shape memory actuator 278 to compress the movable part that forms the pumping chambers.The pumping chamber is defined by check valve 21,22.Figure 28 illustrates and comprises that wherein the pumping actuated components is the embodiment of the pumping mechanism of the plunger 54 in the plunger barrel 52.This mechanism also comprises lever 273, fulcrum 274, and shape memory actuator 278.Shape memory actuator 278 is maintained in the housing 298 and is attached to conductive support 279 an end and is attached to the plus end 275 of lever 273 in the other end.273 on lever is attached to fulcrum 274 in turn and is attached to plunger 54 at the second end place in its center.Apply electric current and flow through terminal 275, shape memory actuator 278 and conductive support 279, cause that thus shape memory actuator 278 shrinks, cause lever 273 effectively shrinking back around fulcrum 274 pivots and plunger 54 to cause electric current.Outage allows cooling shape memory actuator 278, allows it to expand.Return spring 276 is via lever 273 effects, plunger 54 is turned back to the on position in the plunger barrel 52.Return spring 276 is maintained in the housing 277.O shape ring 281 prevents that fluid from revealing from plunger 54-plunger barrel 52 assemblies.The insertion of plunger 54 and shrinking back causes that fluid flows through flowline along the direction of being determined by the orientation of two check-valves (first check valve 21 and second check valve 22).Can use any suitable backflow prevention device, it comprises check valve, check-valves, duckbilled valve, flapper valve and volcano valve.

Figure 29 illustrate have plunger 54, plunger barrel 52 and another embodiment of pumping mechanism of comprising the force application assembly of shape memory actuator 278.Yet unlike the embodiment shown in Figure 28, this embodiment does not comprise lever.Shape memory actuator 278 is maintained in the housing 298 and an end and is attached to conductive support 279 and is attached to plunger end cap 244 in the other end by contact 275.Plunger end cap 244 is attached to plunger 54.In case apply competent electric current by contact 275, then shape memory actuator 278 shrinks.This contraction causes the pulling on plunger end cap 244, to realize in the plunger 54 insertion plunger barrels 52.Outage allows cooling shape memory actuator 278, allows it to expand thus.When lead expanded, return spring 276 played a role plunger 54 is turned back to the retracted position in the plunger barrel 52.Return spring 276 is maintained in the housing 277.O shape ring 281 prevents that fluid from revealing from plunger 54-plunger barrel 52 assemblies.The insertion of plunger 54 and shrink back and cause that fluid flows through flowline along the direction of determining by directed first check valve 21 and second check valve 22.

With reference now to Figure 30,, the embodiment of the pumping device that uses plunger 54 and plunger barrel 52 is shown.In this embodiment, form is that the shape memory actuator 278 of lead that is arranged in the axle of plunger 54 is used for applying active force on plunger.Shape memory actuator 278 extends to support base 299 from plunger end cap 272 by the axle the plunger 54 and by passage 58.O shape ring 281 and 282 sealed plungers 54, plunger barrel 52 and passage 58.Apply electric current to first lead-in wire, 258 and second lead-in wire 257 and cause shape memory actuator 278 heating, this causes shape memory actuator 278 to shrink.The contraction of shape memory actuator 278 makes downward active force be applied on the plunger end cap 272, and this downward active force is enough to overcome the upwards biasing force of return spring 276, and actuation plunger 54 enters in the inner chamber 290 of plunger barrel 52 thus.The expansion of shape memory actuator 278 allows return spring 276 that plunger 54 is turned back to retracted position.The insertion of plunger 54 and shrink back and cause that fluid flows through flowline along the direction of determining by directed first check valve 21 and second check valve 22.

Figure 31 illustrates the alternate embodiments of pumping mechanism.The pumping actuated components is the assembly 101 in conjunction with the function of reservoir and pumping mechanism.Under the order of controller 501, motor 25 actuation plunger 102 are actuated fluid by first check valve 106 thus to form pressure in reservoir 104.Fluid enters the elasticity dispensed chambers 122 of the volume sensing component 120 with pick off 550 then, and flow to spout assembly 17.Can comprise optional second check valve 107.Guarantee that via the feedback control of controller 501 between pick off 550 and motor 25 required fluid flow is to the patient.First check valve 106 is used for preventing that the elastic acting force owing to the dispensed chambers 122 of volume sensing component 120 from making reverse fluid flow when chamber is filled and expand.Second check valve 107 be used for preventing fluid from spout assembly 17 or patient's 12 reverse flow to dispensed chambers 122.In this embodiment, pick off 550 can be surveyed the volume in the dispensed chambers 122 immediately.

Figure 32-34 briefly shows the cross sectional view of combined valve pump 2200.Figure 32 illustrates to have before activating and is positioned at the collection chamber 2345 of rest position and the valve pump 2200 of pumping chamber 2350; Figure 33 is illustrated in the valve pump 2200 that is in during the compression stroke in the actuating state; And Figure 34 is illustrated in the pump that is in when compression stroke finishes in the actuating state.Pump inlet 2310 and the upstream fluid source fluid of for example reservoir are communicated with and are connected to the first end of passage 2360.Passage 2360 is connected to collection chamber 2345 at the second end place, and this collection chamber is communicated with fenestra 2390 fluids that place elasticity pumping film 2340.Collection chamber 2345 is being defined by elasticity pumping barrier film 2330 by elasticity pumping film 2340 and on second side on first side.In various materials, pumping barrier film 2330 can be made by latex or silica gel.Pumping chamber 2350 is led in the downstream of fenestra 2390.During the charge pump and activating between the circulation, fluid is advanced by pump inlet 2310, passage 2360, collection chamber 2345 and fenestra 2390 from the fluid source of for example reservoir, arrives pumping chamber 2350 then.Check valve 22 prevents that fluid from leaving pumping chamber 2350 via pump discharge 2370, unless until and competent fluid pressure be applied on the check valve 22 so that till check valve 22 opens.In Figure 32, pumping actuated components 2320 is illustrated as being in the rest position, and elasticity pumping barrier film 2330 is illustrated as being in the lax structure with minimal surface zone, has maximized the volume of collection chamber 2345 thus.Though in this embodiment, the pumping actuated components is illustrated as sphere, and in other embodiments, thereby the pumping actuated components can be any actuated components that can activate and elasticity pumping barrier film 2330 is applied sufficient active force actuating pumping mechanism.

As seen from Figure 33, when during compression stroke, activating pumping actuated components 2320,2320 beginnings of pumping actuated components are advanced and dilatational elasticity pumping barrier film 2330 towards the fenestra 2390 of elasticity pumping film 2340, thereby cause that the fluid that is collected in the collection chamber 2345 flows backwards.Apply in the stroke at active force later on, as shown in figure 34, pumping actuated components 2320 will be delivered to fenestra 2390 with elasticity pumping barrier film 2330 with sealing means.For auxiliary seal, pumping actuated components 2320 can have the shape with the shape complementarity of fenestra 2390.For example, pumping actuated components 2320 can be spheric or taper and fenestra 2390 can be the cylindricality through hole.Apply this stage of stroke at active force, will be suppressed from the refluence of pumping chamber 2350.Pumping actuated components 2320 continues to advance and will make 2340 distortion of elasticity pumping film and increase pressure in the pumping chamber 2350, continues sealing fenestra 2390 simultaneously and flows backwards from pumping chamber 2350 preventing.When the pressure in the pumping chamber 2350 applies sufficient fluid pressure to check valve 22, fluid will flow through pump discharge 2370 from pumping chamber 2350.During backward stroke, pumping actuated components 2320, elasticity pumping barrier film 2330 and elasticity pumping film 2340 turn back to the slack position shown in Figure 32.During backward stroke, the internal pressure of pumping chamber 2350 and collection chamber 2345 will descend, and this will flow through pump inlet 2310 and passage 2360 from fluid source by inducing fluid and impel once more valve pump 2200 is filled.

With reference now to Figure 35,, the summary cross sectional view of an embodiment of elasticity pumping film 2340 is shown.Diaphragm body 2515 can be by the elastomeric materials of for example silica gel.Can comprise that also diaphragm spring 2510 is with to flexible or be that elastic body 2515 is given elasticity.Diaphragm spring 2510 can embed in the elasticity pumping film 2340 or near elasticity pumping film 2340 and arrange.The example of an embodiment of diaphragm spring 2510 shown in Figure 36.Can use diaphragm body 2515 that comprises submissive material and the combination of the diaphragm spring 2510 that comprises elastomeric material; Consequently pumping film 2340 will present high-seal and have high flexibility when contact is pumped the elasticity pumping barrier film 2330 of actuated components (not shown, as to see Figure 32-34) distortion.Valve seat 2517 can be around fenestra 2390 location.Valve seat 2517 can be with the receptor of the crushed element that acts on elasticity pumping barrier film 2330.Active force applies parts 2320 can make 2330 distortion of pumping barrier film, thereby causes barrier film 2330 distortion and contact valve seat 2517 with sealing means.If apply enough active forces, thereby then valve seat can strain prevent that to guarantee thoroughly sealing fluid from flowing backwards.Usually can differently select the depth of section of valve seat 2517 and the ratio of cross-sectional width that itself and flowing environment are complementary.

With reference now to Figure 36,, the example of the diaphragm spring 2510 of the pumping film 2340 that is used for Figure 35 is shown.Outside anchor ring 2520 is connected by at least three elastic arms 2530 with inner anchor ring 2540.The center of inner anchor ring 2540 has spring eye 2550, and described spring eye can be aimed at the fenestra 2390 of pumping film 2340 as shown in figure 35.

With reference now to Figure 37,, show a skeleton diagram, this skeleton diagram with comprise that the force application assembly of pumping actuated components 2320, actuator and lever 273 has shown the cross sectional view that is shown in the valve pump 2200 among Figure 32-34 in front combinedly.When by the excitation of the actuator of for example shape memory actuator 278, lever 273 pivots to start compression stroke around fulcrum 274.Hammer body 2630 is outstanding from lever 273.During compression stroke, the pumping actuated components 2320 of hammer body 2630 contact spherings, cause that the pumping actuated components advances in the space of supporting construction 2660, and pumping actuated components 2320 is pressed to elasticity pumping barrier film 2330, remains to the fenestra 2390 that is arranged in elasticity pumping film 2340 with sealing means until pumping actuated components 2320.When lever 273 continued to advance, pumping actuated components 2320 caused 2340 distortion of pumping film.When enough fluid pressures were applied on the check valve 22, check valve 22 was opened.This allows fluid to flow through pump discharge 2370 from pumping chamber 2350.When shape memory actuator 278 coolings, the elasticity of the elasticity of pumping film 2340 and pumping barrier film 2330 will cause that lever 273 turns back to the starting position of being determined by lever stop part 2650 and lever brake component 2640.Alternately, the return spring (not shown) can be used for lever 273 is turned back to the starting position.Though be illustrated as spheroid, active force applies projection or other appropriate format that parts 2320 can alternately be piston, lever 273.

Figure 38 briefly shows the cross sectional view of the embodiment of the valve pump that uses elasticity cylindricality flexing 2670.In one embodiment, elasticity cylindricality flexing is made by rubber, but in other embodiments, it can be made by any elastomeric material.Cylindricality flexing 2670 has central corridor 2675, and against a plurality of resilient radial fins 2672 of housing 2673 sealing arrangements.The fluid that enters pump inlet 2310 is through passage 2360 and be collected in the zone of check valve 22 upstreams: the central corridor 2675 of collection chamber 2345, cylindricality flexing 2670, and pumping chamber 2350.The mode that the pumping chamber is communicated with collection chamber 2345 fluids by central corridor 2675 connection.During the pumping mechanism compression stroke, pumping actuated components 2320 applies active force to elasticity pumping barrier film 2330, makes its distortion, is remained to the valve seat 2680 of cylindricality flexing 2670 hermetically until elasticity pumping barrier film 2330; Stop from collection chamber 2345 to pump inlet 2310 refluence thus.The continuing to advance of pumping actuated components 2320 causes 2670 distortion of cylindricality flexing; Till pressure in the pumping chamber 2350 increases when being enough to open check valve 22.Fluid can flow through pump discharge 2370 then.

Pumping actuated components 2320 is illustrated as sphere in Figure 38.Yet in other embodiments, pumping actuated components 2320 can be the Any shape that can play a role as mentioned above.

With reference now to Figure 39,, the alternate embodiments of the cylindricality flexing 2670 (being shown among Figure 38) that adopts elastic part 2680 and rigidity cylinder support 2690 is shown.Be similar to the cylindricality flexing 2680 of Figure 38, the elastic part of cylindricality flexing 2670 comprises the valve seat 2680 of sealing central corridor 2675 when applying active force by pumping actuated components 2320.Therefore, elastic part 2680 distortion of cylindricality flexing 2670 are to transmit pressure to pumping chamber 2350.

Figure 40-44 is schematically shown in the cross sectional view of the alternate embodiments of valve pump in the various actuating state.The valve pump 2200 of Figure 40-44 has flexible sheet spring 6100 and elastic packing barrier film 6120, and they bring into play the function of elasticity pumping film 2340 functions that are similar to valve pump 2200 shown in Figure 32-34 together.Figure 40 illustrates the valve pump 2200 that is in the state of resting.In the state of resting, fluid can flow to the top 2346 of collection chamber 2345 from import 2360, by the hole in the diaphragm spring 6,100 6110 and enter in the bottom 2347 of collection chamber 2345.Fluid can continue by one or more opening 6130 in the seal dissepiment 6120 then and enter pumping chamber 2350.Under the low-pressure state, stop fluid further to flow by check valve 22.Spring diaphragm 6100 and seal dissepiment 6120 all can be by elasticity, biocompatible material structures.Spring diaphragm 6100 can have the elasticity higher than seal dissepiment 6120.For example, spring diaphragm 6100 can be a flexible biologically inert plastics disk and seal dissepiment 6120 can be silicones or Fluorosilicone elastomers.

Figure 41 and 42 illustrates and is in two valve pumps 2200 in middle, the local actuating state.Pumping actuated components 2320 makes pumping barrier film 2330 distortion and actuates it by collection chamber 2345 and press spring diaphragm 6100, and spring diaphragm then is out of shape in turn and is forced to press seal dissepiment 6120.This point in compression stroke, by the hole 6110 of spring diaphragm 6100, perhaps by the opening 6130 in the seal dissepiment 6120, perhaps the refluence by the two all is suppressed.Seal dissepiment opening 6130 allows to form sealing with respect to the skew of spring eye 6100 between spring diaphragm 6100 and seal dissepiment 6120.In certain embodiments, sealing can utilize the backup seal between filled chamber elasticity pumping barrier film 2330 and spring diaphragm 6100 to be replenished (for example, the embodiment of Figure 43-44 lacks this backup seal).Circumferential ridge (not shown) around spring fenestra 6110 can be as valve seat to strengthen described sealing.

With reference now to Figure 42,, the continuing to advance of pumping actuated components 2320 causes that pumping barrier film 2330, spring diaphragm 6100 and seal dissepiment 6120 further are out of shape.As a result, the fluid in the pumping chamber 2350 is compressed and actuates check valve 22 until fluid pressure and open; Further compression causes that fluid flows out by exporting 2370.

In Figure 43, briefly show the alternate embodiments of the valve pump 2200 of Figure 40-42.In this embodiment, pumping actuated components 2320 passes through elasticity pumping barrier film 2330.Pumping barrier film 2330 is attached to the periphery of pumping actuated components 2320 hermetically in the midpoint along pumping actuated components 2320 length.When activateding, only sealed barrier film 6120 sealings in diaphragm spring hole 6110 are in case backflow; Elasticity pumping barrier film 2330 will not contact hole 6110.The alternate embodiments of device shown in Figure 40 shown in Figure 44.

With reference now to Figure 45,, the cross sectional view of the alternate embodiments of combined valve pump 2200 is shown.Shape memory actuator 278 activates compression stroke, lifts (lever) to cause elasticity pump blade 2710 around fulcrum 274, and this causes 2330 distortion of elasticity pumping barrier film.Elasticity pump blade 2710 and elasticity pumping barrier film 2330 to have shallow regional 2730 and the step pumping chamber 2720 in dark zone 2740 in fluid exert pressure.Early interim in compression stroke, pump blade 2710 causes that elasticity pumping barrier film 2330 blocks the passage 2360 that pump inlet 2310 is connected to step pumping chamber 2720.When compression stroke continued, active force was applied to the fluid in the step pumping chamber 2720, and the fluid pressure in step pumping chamber 2720 is enough high to open check valve 22.Fluid leaves pump discharge 2370 then.Pump blade 2710 can all or part of elastomeric materials by for example rubber.In certain embodiments, elastomeric material comprises non-resilient side's bolt (spline).Alternately, in certain embodiments, apply elasticity by Hookean region 2750, therefore, Hookean region 2750 is only elastic parts of the pump blade 2710 among these embodiment.In these embodiments, the bottom of Hookean region 2750 contact step pumping chambers 2720.The elasticity of pump blade 2710 allows compression stroke continuation after shallow regional 2730 the base portion 2780 of pumping vanes 2710 contacts.The return spring (not shown) turns back to the starting position with pump blade 2710 during backward stroke.

With reference now to Figure 46,, the cross sectional view of the alternate embodiments of pumping mechanism is shown.This embodiment comprises elasticity pump blade 2710.Elasticity pump blade 2710 comprises to pump blade 2710 provides elastic Hookean region 2830.Hookean region 2830 is attached to pump blade 2810 with pumping actuated components 2820.When using with valve pump (not shown), it is (not shown that the elasticity pump blade 2710 of Figure 42 will stop up intake channel, in Figure 45, be shown 2360) and apply further pressure in flexible region 2830 places bending to allow active force to apply the fluid of parts 2820 in step pumping chamber (not shown, as in Figure 45, to be shown 2720) then.Active force apply parts 2820 can be all by the elastomeric materials of for example rubber.Yet in alternate embodiments, the zone that only contacts pumping chamber (not shown) bottom is made by elastomeric material.Elasticity pump blade 2710 will turn back to its relaxed shape during backward stroke.

With reference now to Figure 47,, the cross sectional view of another embodiment of pumping mechanism is shown.Described pumping mechanism is illustrated as wherein lever and is in and activates the interstage, and wherein inlet valve 2941 is closed.Pumping mechanism comprises flowline 2930, is membranous movable part 2330, inlet valve 2941 lift valves 2940, pumping actuated components 2942, pumping chamber 2350 and outlet valve 22 in this embodiment.Inlet valve 2941 and pumping actuated components 2942 each by by return spring 276 around and the shape memory actuator 278 that is connected to lever 273 activate.Lever 273 activates inlet valve 2941 and pumping actuated components 2942.Lever 273 comprises the elongated spring members 2910 that is attached to the lever 273 that is articulated in fulcrum 274 and ends at valve actuation hammer body 2946.Spring members 2910 can be crooked.Spring members 2910 is away from lever 273 and towards the position of inlet valve 2941 ground bias voltage valve actuation hammer bodies 2946.Lever 273 has the pump that is not attached to spring members 2910 and activates hammer body 2948, and contiguous pumping actuated components 2942 location.

Electric current causes that shape memory actuator 278 shrinks and lever 273 pivots around fulcrum 274.Described pivot places valve actuation hammer body 2946 and actuates the position that inlet valve 2941 cuts out.When shape memory actuator 278 continued to shrink, lever 273 continued to pivot and pump activates hammer body 2948 pump actuated components 2942 is pressed to pumping chamber 2350, even when further compressing elongated spring members 2910.When realizing enough pressure, fluid pressure is opened outlet valve 22, and fluid flows out by this valve.

During lax stroke, return spring 276 unloads and lever 273 is turned back to the starting position, discharges pumping actuated components 2942.Inlet valve 2941 is opened.The elasticity of pumping chamber 2350 causes that pumping chamber 2350 fills once more.

With reference now to Figure 48 and 49,, they briefly show, and pumping mechanism wherein adopts crank throw 7200 and the cross section of embodiment that valve pump 2200 is combined with the bias current valve.Crank throw 7200 will be remembered the active force that actuator 278 produces by linearity configuration and be transformed into horizontal pump action power.Figure 48 illustrates described mechanism and is in and rests or once more in the fill pattern, and Figure 49 illustrates described mechanism and is in the actuating state.Actuator 278 contractions causing crank throw 7200 rotates and is pressed against active force around axle 7210 and applies on the parts 2320.This drives elastic diaphragm 7220 and is sealed in elasticity pumping film 2340 and actuates fluid from pumping chamber 2350 towards dispensed chambers 122.Return spring 276 is cooperated with return spring support member 7221 to discharge pump action power, causes 2350 expansions of pumping chamber and aspirates fluids from reservoir 20.Still with reference to Figure 48 and 49, bias current valve 4000 is shown also, it has valve spring 4010, lift valve or plunger 4020.

In some embodiment of above-mentioned pumping mechanism, be correlated with in one or more aspect of following valve operation explanation.With reference now to Figure 50,, the example of pent bias current valve 4000 is shown.Valve spring 4010 applies active force hermetically valve barrier film 4060 is pressed to around the valve seat 4070 of the terminal hole of valve export 4040 on lift valve 4020.Valve seat 4070 can comprise that circumferential raised portion is to improve sealing.As explaining with reference to figure 54-55 below, the back pressure that the effect by the elasticity allocation component forms should be not enough to cause the refluence by bias current valve 4000.Shown in Figure 51, when pump activated, should produce enough pressure so that barrier film 4060 and lift valve 4020 break away from from valve seat 4070, allow fluid to flow thus, by inlet plenum 4050 and flow to valve export 4040 from valve inlet 4030.Figure 52-53 illustrates the alternative valve with valve seat 4070 of not being with circumferential raised portion.

With reference now to Figure 54 and 55,, illustrate how exemplary bias current valve is distinguished the signal of flowing and flowing backwards forward.The valve in the closed position represented in Figure 54 summary.The back pressure of outlet in 4040 applies active force and so lift valve 4020 can not be shifted out than the zonule the contiguous valve seat 4070 of elastomeric valves barrier film 4060.With reference now to Figure 55,, this figure has briefly showed the valve between pumping actuated components period of energization.The fluidic pressure that is pumped applies active force on the zone greater than the zone that is adjacent to valve seat of barrier film 4060.As a result, inlet pressure has bigger mechanical advantage so that lift valve 4020 breaks away from valve seat, and takes place immediately in response to feasible the flowing forward of the action of pumping actuated components.Therefore, be used for being shifted the required critical pressures of lift valve 4020 in import than lower in outlet.Correspondingly, thus the active force that is associated with fluid inlet and fluid issuing apply the spring bias effect power in zone and size can be selected mobile substantially along forwards to.

With reference now to Figure 56,, the cross sectional view of scalable bias current valve 4130 is shown, described valve is to be similar to the operate of the bias current valve among Figure 50, but allow to regulate and open the necessary pressure of valve, i.e. " opening pressure " (in certain embodiments, can from 0.2 to 20 pound per square inch or " psi ").Regulate opening pressure by rotating spring tensioning screw 4090, described rotation changes the volume of recess 4080 with compression or decompress(ion) valve spring 4010, changes spring 4010 bias effect power thus.Valve spring 4010 towards valve barrier film 4060 biased pistons 4100 so that it is actuated valve seat.The active force that plunger 4100 performances are similar to the fixation power lift valve of bias current valve (being shown 4020 and 4000 in Figure 50-53 respectively) applies function.Compression valve spring 4010 will increase its biasing force, increase opening pressure thus.On the contrary, separate pressing spring 4010 and will reduce its biasing force and relevant opening pressure.Valve spring 4010 coaxially locatees and applies its bias effect power on plunger 4100 around the axle of plunger 4100.In certain embodiments, the axle of plunger 4100 can be shorter than length valve spring 4010 and recess 4080, freely is shifted in response to the fluid pressure that increases in fluid inlet 4030 to allow it.Plunger 4100 can have brings into play the necessary virtually any size of function as required.As in the embodiment of Figure 50-53, wetted portions can be arranged in single use portion 2610 and active force apply member (for example, plunger and spring) but can be arranged in reuse part 2620.Operating principle also is similar; In fluid inlet 4030 with respect to outlet

Bigger mechanical advantage be beneficial to more forward and flow but not flow backwards.Alternately, plunger 4100 can be raised valve (being illustrated as 4020 in Figure 50-55) and substitutes.In certain embodiments, may expect to eliminate the valve seat of rising; In these embodiments, plunger can be spheric or can concentrate another shape of active force.

Bias current valve 4000 alleviates or prevents to enter from dispensed chambers 122 refluence of pumping chamber 2350 basically.As in Figure 50-56, valve spring 4010 bias voltage lift valves or plunger 4040 are to press to valve seat 4070 with barrier film 7220, and its mode makes to providing mechanical advantage by flowing forward of line 310.By performance pumping barrier film 2330 and the membranous function of valve, barrier film 7220 allows flowline 310, pumping chamber 2350 and pumping film 2340 (for example to be arranged in a member, single use portion 2610) and the remainder of pumping mechanism is arranged in second, removable member (for example, but reuse part 2620).But, can realize economy and convenience by in reuse part 2620, settling more durable and member costliness.

The pumping mechanism of describing in above various embodiment can be used in various devices with pumping fluid.As an exemplary embodiment, the pumping mechanism of describing in Figure 59 A-59E, Figure 60 A-60D and Figure 60 A-60C will be described to be integrated in the fluid pumping device.

With reference to Figure 57 and 58, the alternative way that is used for the fluid signal is shown.They are two skeleton diagrams, and wherein reservoir 20 and pump 16 are coupled to allocation component 120.In the embodiment shown in Figure 57, reservoir and pump in series are connected to allocation component 120.In the embodiment shown in Figure 58, divide pipeline 150 to connect and turn back to reservoir 20 from the output of pump 16.Because most of fluid output of pump 16 is returned to reservoir 20 via minute pipeline 150, so pump 16 can comprise the various pumping mechanisms 16 that can not bring into play Figure 57 illustrated embodiment required function.Therefore, adopt therein among some embodiment of big volume pumping mechanism, it is functional to divide pipeline 150 to give little volume to big volume pumping mechanism.Check valve 21 and 22 is directed and included with the backflow that prevents from not wish to take place with equidirectional.

With reference now to Figure 59,, the fluid skeleton diagram of an embodiment of fluid pumping device is shown.In this embodiment, fluid is arranged in the reservoir 20 that is connected to flowline 310.Flowline 310 is communicated with pumping mechanism 16, is separated by barrier film 2356.Fluid is pumped into delivery device or sleeve pipe 5010 so that flow to the patient by current limiter 340.Should be appreciated that delivery device or sleeve pipe 5010 are not parts of device itself, but be attached to the patient so that conveyance fluid.Descriptive system embodiment and they comprise delivery device or sleeve pipe 5010 in further detail below.

With reference now to Figure 59 B,, the alternate embodiments of skeleton diagram shown in Figure 59 A is shown.In Figure 59 A illustrated embodiment, fluid is pumped through current limiter 340 then by sleeve pipe 5010.Yet in Figure 59 B, fluid is not pumped through current limiter; But fluid is pumped through the sleeve pipe 5010 with same impedance.

In Figure 59 A and 59B, in one embodiment, utilize the pump stroke rough calculation to be pumped into patient's fluid volume.Length of stroke will provide the rough estimate to the volume that is pumped into the patient.

With reference now to Figure 59 C,, the fluid skeleton diagram of an embodiment of fluid pumping device is shown.In this embodiment, fluid is arranged in the reservoir 20 that is connected to flowline 310 by partition 6270.Flowline 310 is communicated with pumping mechanism 16, separates by barrier film 2356.Fluid is pumped into variable volume delivery chamber 122 and arrives sleeve pipe 5010 so that flow to the patient by current limiter 340 then.

Use comprises aforesaid acoustic volume sensing (AVS) assembly, variable volume delivery chamber 122 and distributes allocation component 120 definite fluid volumes of being carried of spring 130.Be similar to pumping mechanism, barrier film 2356 forms variable volume dispensed chambers 122.Barrier film by with pumping mechanism 16 (describing in detail in the above) in barrier film 2356 identical materials (perhaps, in certain embodiments, different materials) make.The AVS assembly is described in the above in further detail.

With reference now to Figure 59 D,, the alternate embodiments of Figure 59 C illustrated embodiment is shown, in this embodiment, between variable volume delivery chamber 122 and sleeve pipe 5010, there is not current limiter.With reference now to Figure 59 E,, the alternate embodiments of Figure 59 C illustrated embodiment is shown, this embodiment has alternative pumping mechanism 16.

With reference now to Figure 59 A-59E,, reservoir 20 can be any fluid source, includes but not limited to syringe, can subside reservoir medicated bag, vial, glass medicine bottle (glass vile) or can hold fluidic any other container that will be transferred safely.Partition 6270 is the junction points between flowline 310 and reservoir 20.The various embodiment of partition 6270 and reservoir 20 are described below in further detail.

FLUID TRANSPORTATION device embodiment shown in Figure 59 A-59E can be used in the fluid of carrying any kind.Additionally, this embodiment can be as one, two or three mating part and being used independently.With reference now to Figure 60 A-60D,, the identical embodiment that describes about Figure 59 A-59D is illustrated as being separated into a plurality of mating parts.Part X comprises moveable part and part Y comprises flowline 310 and barrier film 2356.In some embodiment of this design, part Y is a single use portion and part X is non-single use portion.The not direct contacting with fluid of part X, only part Y is the part with wetting zones.In above embodiment, reservoir 20 can have virtually any size, and or is integrated in the disposable unit or disposable unit independently.In arbitrary embodiment, reservoir 20 can be filled once more.Reservoir 20 is integrated among the embodiment among the single use portion Y therein, and reservoir 20 can be manufactured into and be filled with fluid, perhaps uses syringes to fill reservoirs 20 by patient or user by partition 6270.Reservoir 20 is among the embodiment of independently component therein, reservoir 20 can be manufactured into and be filled with fluid, perhaps, patient or user pass through to use syringe (not shown) filling reservoirs 20 or manually use syringe filling reservoir 20 by partition 6270 as the partition 6270 of a part of reservoir loading device (not shown, as to describe in further detail below).Be described below relevant further details of filling the process of reservoir 20.

Though described various embodiment about Figure 59 A-59E and Figure 60 A-60D, pumping mechanism can be any pumping mechanism of here describing as embodiment or have similar functions and the alternate embodiments of feature.For example, with reference now to Figure 61 A, be shown to have the representative module that comprises pumping mechanism 16 with similar embodiment shown in Figure 59 A.This is in order to illustrating, and that describe or that play a role similarly here any pumping mechanism 16 can be used in the described fluid pumping device.Similarly, Figure 61 B and Figure 61 C are the representatives of system that comprises the embodiment of Figure 59 B and Figure 59 C respectively.

In the operable device of patient, can realize the summary of above-mentioned fluid pumping device.There are a plurality of embodiment.Described device can be independent devices or be integrated in another device.Described device can have virtually any size or shape.Described device can be portable or non-portable.Term " portable " means the patient and can tie up in the pocket zone of health or otherwise carry described device.Term " non-portable " means described device and is arranged in health institution or family, and in addition, the patient can not bring to their mobile almost any position with described device.The remainder of this explanation will be paid close attention to the portable device as exemplary embodiment.

About portable device, described device can be worn by the patient or be carried by the patient.The patient wears among the embodiment of described device therein, for this illustrative purposes, it is called " patch pump ".When the patient carries described device,, it is called " portable pump " for this illustrative purposes.

Following explanation can be applicable to the various embodiment about patch pump embodiment or portable pump embodiment.In various embodiments, this device comprises housing, pumping mechanism, flowline, movable part, reservoir, power supply and microprocessor.In various embodiments, allocation component for example comprises in certain embodiments that the volume sensing device of AVS assembly is included in the described device.And embodiment can also comprise current limiter, do not describe but give among this figure below because flowline to be illustrated as be homogeneous, with simplified schematic.For this illustrative purposes, when comprising allocation component, exemplary embodiment will comprise the AVS assembly.Though the AVS assembly is a preferred embodiment, in other embodiments, can use the volume sensing device of other type.Yet, in certain embodiments, do not use the volume sensing device, but reservoir self will be determined the fluidic volume carried, perhaps be suitable for pump stroke and come to determine roughly the volume carried.Should be appreciated that the summary device that illustrates is intended to illustrate some changes in the described device here.Each all also can comprise sensor housing, vibrating motor, antenna, radio device or other member of describing about Figure 70-70D by the embodiment of these skeleton diagrams representative.Therefore, these to describe not be to be intended to limit described member but in order to illustrate how various members can be interrelated in device.

With reference now to Figure 62 A,, the skeleton diagram of individual devices 10 is shown.Housing 10 can have Any shape or size and be adapted to desired use.For example, when described device is used as paster, described device will be enough compact so that itself can be worn.When described device is used as portable pump, thereby described device will enough compactly correspondingly be used.In certain embodiments, housing is made of plastics, and in certain embodiments, plastics are the plastics of any injection-molded fluid compatible, for example Merlon.In other embodiments, housing is made by the combination of aluminum or titanium and plastics or any other material, and described in certain embodiments material is light-weight and durable.Other material can include but not limited to rubber, steel, titanium and alloy thereof.Shown in Figure 62 A, device 10 can have required virtually any size or required form.

Figure 62 A-69B is the skeleton diagram that representative embodiment is shown.Accurately design depends on several factors, includes but not limited to device size, Power Limitation and desired use.Therefore, Figure 62 A-69B is intended to the various features of outlines device and possible combination, yet those of ordinary skills can be easy to design and implement practical devices.As an example, be described below and illustrate device embodiment.Yet these embodiment are intended to restriction, and are intended to example.

With reference now to Figure 62 B,, about the paster device, in certain embodiments, housing 10 comprises the regional form 342 of insertion.This form allows to have a position on one's body the patient, is inserted into also in sight in this position delivery device or sleeve pipe (not shown).Shroud 5030 zones of device 10 are shown here.Form 342 includes but not limited to plastics by being that transparent any material is made.Be in the particular location though form 342 is shown on the device with concrete shape, form 342 can be integrated in required any position in any housing embodiment.

With reference now to Figure 63 A,, device 10 is shown.Reservoir 20 is illustrated as being connected to flowline 310, and flowline is connected to pumping mechanism 16 then.Allocation component 120 is illustrated as being connected to flowline 310.Pumping mechanism 16 separates with flowline 310 by barrier film 2356 with allocation component 120.Shroud 5030 is positioned at the downstream of cubing device.Shape memory actuator 278 is illustrated as being connected to pumping mechanism 16.In microprocessor on the printed circuit board (PCB) 13 and power supply or accumulator 15 are included in.Also can between allocation component 120 and shroud 5030, realize aforesaid flow resistance.

With reference now to Figure 63 B,, the similar device 10 shown in Figure 63 A is shown, just in this embodiment, do not comprise allocation component.In this embodiment, the fluid volume of being carried will depend on pump stroke (number and length), reservoir 20 (volume and time), both or in front about monitoring the described any other method of institute's conveyance fluid volume.

With reference now to Figure 63 C,, the similar device 10 shown in Figure 63 B is shown, just device 10 comprises dispensed chambers 122 and sensor housing 5022.

With reference now to Figure 64 A,, an embodiment of patch pump device 10 is shown.This embodiment is based on the embodiment of the device 10 shown in Figure 63 A.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 optionally, but illustrates as exemplary embodiment), power supply 15 and microprocessor and printed circuit board (PCB) 13.They are non-moistening elements, that is, and and their not direct contacting with fluid.Base portion Y contains flowline 310 and barrier film 2356.When reservoir 20 was built in the described device, reservoir also was comprised on the base portion Y.Yet reservoir 20 is among the embodiment of independently component therein, and reservoir 20 is connected to flowline (see Figure 66 A-66D and with reference to their explanation) when assembling fully, and is not built in the described device.

The patch pump device also comprises shroud 5030.This is the zone at cover pipeline 5031 places.The part of flowline 310, cover pipeline 5031 allow sleeve pipes (perhaps other delivery device) to receive fluids and to patient's (not shown) conveyance fluid.

With reference now to Figure 65 A,, in certain embodiments, sleeve pipe 5010 is directly inserted in patient's body by housing 5030.Sleeve pipe 5010 is connected to the partition (not shown) that cover pipeline 5031 is connected to sleeve pipe 5010.

With reference now to Figure 65 B,, in other embodiments, use insertion external member (comprise sleeve pipe and pipeline, not shown in Figure 65 B, in Figure 64 B, be shown object 5033 and 5010); Therefore, the pipeline 5033 that inserts external member will be connected to the sleeve pipe (not shown) being connected on the end on cover pipeline 5030 and the opposed end at pipeline.

Refer again to Figure 64 A, in use, inside is contained fluidic reservoir 20 (as mentioned above, be molded among the base portion Y or independently and be attached to base portion Y) and is connected to flowline 310.Microprocessor on the printed circuit board (PCB) 13 sends signal, with actuating pumping mechanism 16 and by being applied to the current start stroke of shape memory actuator 278.Fluid flow to allocation component 120 or AVS assembly from reservoir 20 flowline 310.Here, determine fluid in the AVS chamber accurate volume and actuate fluid and flow out the AVS chamber, flow to cover pipeline 5031 and shroud 5030.

With reference now to Figure 64 B,, device is illustrated as being connected to the insertion external member shown in Figure 64 A, that is, and and pipeline 5033 and sleeve pipe 5010.In Figure 64 C, the base portion Y of device is illustrated as using binding agent paster or pad 3100 and is attached to patient 12 health.Be noted that in this embodiment element 3100 can be pad or paster.Yet as describing in detail more below, object 3100 is called as paster, and object 3220 is called as pad.Use object 3100 just to simple and clear purpose; Yet, in certain embodiments, use pad, therefore object 3220 will be suitable in those situations.

Thereby inserting the sleeve pipe 5010 that utilizes sleeve pipe partition 5060 to be coupled to cover pipeline 5031 by shroud 5030 is inserted in patient's 12 bodies.Yet about shown in Fig. 2 B and described, base portion Y can be attached to the patient by the insertion external member that comprises pipeline 5033 and sleeve pipe 5010 fluid as in the above.In Figure 64 B and 64C, base portion Y can or be attached to the patient before inserting sleeve pipe 5010 afterwards.Refer again to Fig. 2 C, in case sleeve pipe 5010 in inserting patient's 12 bodies after then will be directly receive fluid and need not infuse and set pipeline (shown in Figure 64 B) from device.Base portion Y is before inserting sleeve pipe 5010 or utilize binding agent paster 3100 to be attached to patient 12 afterwards.With reference now to Figure 64 D,, in sleeve pipe 5010 has been inserted into patient's 12 bodies after, the top X of device 10 and then be attached to the base portion Y of device 10.

Such as below description, the binding agent paster can have a lot of embodiment, and in some cases, described paster is placed on the top of device.Therefore, the paster that illustrates in these embodiments only is an embodiment.As mentioned above, pad if you are using, will be placed in the position identical with paster among Figure 64 A-64D.

With reference now to Figure 66 A-66D,, in this embodiment, reservoir 20 is illustrated as separated components.Shown in Figure 66 A, base portion Y comprises the reservoir cavity 2645 with partition pin 6272.Shown in Figure 66 B, reservoir 20 at first is placed in the top reservoir cavity 2640.At this moment, reservoir 20 is not attached to device.Now, with reference to figure 66C, in the time of on top X is placed in base portion Y, reservoir 20 is sandwiched in the base portion reservoir cavity 2645.Shown in Figure 66 D, by the top being attached to active force that base portion Y forms partition pin 6272 is pushed in the partition 6270 with reservoir 20, this partition 6270 is connected to reservoir 20 flowline 310 of base portion Y.

With reference now to Figure 67 A-F,, the alternate embodiments of Figure 64 A, 64C and 66A-66D illustrated embodiment is shown.In these alternate embodiments, except shroud 5030, base portion Y comprises sensor housing 5022.With reference now to Figure 69 A-69B,, sensor housing 5022 and shroud 5030 include the outlet that arrives base portion Y downside, are shown 5022 and 5030 in Figure 69 A respectively.Embodiment shown in Figure 69 B depiction 69A, wherein sharp object is outstanding by housing.Sensor housing holds pick off.In certain embodiments, pick off is an analyte sensor.The analyte of institute's sensing comprises blood-glucose, but in other embodiments, and this analyte sensor can be the analyte sensor of required any kind.

With reference now to Figure 67 B,, base portion Y is illustrated as being positioned on patient 12 the health.Pick off 5020 is illustrated as being inserted in patient's 12 bodies by base portion Y sensor housing 5022.With reference now to Figure 67 C,, in certain embodiments, sleeve pipe 5010 and pick off 5020 side by side are inserted into and enter in patient's 12 bodies by their corresponding housings (5030 and 5022).Below with reference to Figure 67 D, base portion Y be illustrated as utilizing sleeve pipe 5010 and by base portion Y be attached to patient 12 pick off 5020 both be attached to the patient.

With reference now to Figure 67 E,, base portion Y is illustrated as being attached to patient 12 and passing through the sleeve pipe 5010 that shroud 5030 inserts.In this embodiment, sensor housing 5022 is illustrated as not having pick off.Yet pick off 5020 is shown in the another location and inserts in patient's 12 bodies.Therefore, do not require that pick off 5020 is inserted into by base portion Y, still, below described with monitor blood-glucose and can implement in this way by the relevant embodiment of sleeve pipe pumping insulin.Additionally, can implement in this way with in response to or relate to other relevant embodiment of fluids administration of analyte level.

With reference now to Figure 67 F,, the device 10 that has pick off 5020 and sleeve pipe 5010 by base portion Y is illustrated as having top X thereon.Once more, in the embodiment shown in Figure 66 A-66D, in case top X is placed on the base portion Y, then reservoir 20 is connected to flowline 310 by fluid.

With reference now to Figure 68,, the embodiment of the portable pump embodiment of device 10 is shown.In this device 10, comprise that the insertion external member of sleeve pipe 5010 and pipeline 5033 must be connected to the flowline in the device 10 patient 12.Therefore, sleeve pipe 5010 is not directly connected to patient 12 by portable pump device 10 in this embodiment.Additionally, though this embodiment can bring into play the function of describing about analyte sensor and fluid pump as below, pick off 5020 will be similar to the embodiment of pick off 5020 shown in Fig. 5 F and be positioned at the outside of portable pump device 10.

With reference now to Figure 70-70D,, patch pump that is described and portable pump embodiment all additionally contain the various members (but in Application Example) of allocation component, and for the embodiment that comprises the AVS assembly, the various members of allocation component comprise at least one mike, temperature sensor, at least one speaker, variable volume dispensed chambers, variable volume chamber, port and reference chamber.In certain embodiments, this device contains one or more in the following device: vibrator motor (and, in those embodiment, motor driver), antenna, radio device, skin temperature transducer, inject button, and one or more other button in certain embodiments.In certain embodiments, described antenna is the quarter-wave tracking antenna.Antenna can be half-wavelength or quarter-wave tracking, dipole, one pole or loop antenna in other embodiments.Described radio device is the 2.4GHz radio device in certain embodiments, but in other embodiments, described radio device is the 400MHz radio device.In a further embodiment, described radio device can be the radio device of any frequency.Therefore, in certain embodiments, described device comprises that intensity is enough to and the radio device of communicating by letter at the receptor in several feet distances of described device.In certain embodiments, described device comprises second radio device.In certain embodiments, described second radio device can be special long distance wireless electric installation, for example 433 or the 900MHz radio device, perhaps, in certain embodiments, have any frequency in ISM frequency band or other frequency band, not shown in Figure 70-70D, described device contains screen and/or user interface in certain embodiments.

Explanation to these members and various embodiment thereof can be applicable to two kinds of type of device below, and and then can be applicable to the various embodiment that describe about each type of device.With reference now to Figure 67 F,, just to illustrative purpose, sleeve pipe 5010 and pick off 5020 all have been inserted in the device 10.And with reference to figure 70-70D, various members (some of them and nonessential being included among all embodiment) are illustrated as the electrical connection that those members represented in summary.Therefore Figure 70-70D represents the various elements that can be included in the described device.According to dimensional requirement, Power Limitation, purposes and preference and other variable, these elements can mixed and coupling.Figure 70 illustrates the relation of Figure 70 A-70D.

Described device contains at least one microprocessor 271.This microprocessor can be to handle the microprocessor that makes described device move any speed of necessary various electrical connections at least.In certain embodiments, described device contains the microprocessor more than, and shown in Figure 70 A-70B, described device is shown to have two microprocessors 271.

Microprocessor 271 (a plurality of microprocessors perhaps in certain embodiments) is connected to main printed circuit board (hereinafter, " PCB " refers to term " printed circuit board (PCB) ") 13.The power supply that is accumulator 15 in certain embodiments is connected to main PCB 13.In one embodiment, accumulator 15 is the lithium polymer storage batteries that can be recharged.In other embodiments, described accumulator can be the removable accumulator or the chargeable accumulator of any kind.

In certain embodiments, described device comprises the radio device 370 that is connected to main PCB 13.Radio device 370 uses antenna 3580 to communicate by letter with remote controllers 3470.Therefore communication between device 10 and remote controllers 3470 be wireless.

In certain embodiments, described device contains vibrating motor 3210.Vibrating motor 3210 is connected to the motor driver 3211 on main PCB 13 motor drivers 3211.

Some embodiment comprise and inject button 3213.Injecting press-button structure 3213 that button 3213 made by rubber or any other suitable material by user Xiang Ke applies active force and plays a role.This active force activates the press-button actuated of injecting of injecting press button 3214 that is attached on the main PCB 13.Switch 3214 activates single injecting, and it will illustrate the fluid of concrete predetermined will be fed to the patient.The user push inject button 3213 after, in certain embodiments, device 10 will produce alarm (for example, activate vibrating motor 3210 and/or send signal to remote controllers) to illustrate button 3213 to be pressed to the user.The user for example needs then, confirms to inject and should be transferred by press push button 3213.In a further embodiment, remote controllers 3470 inquiry users inject and be transferred with affirmation.

Similarly inquiry/response sequence can be used for various embodiment with test and report patient response.For example, described device can be configured to by producing alarm (for example, audition and/or haptic alerts) and waiting for patient's response (for example, actuation button 3213) and the test patient response.Can be at different time (for example, per five minutes) or when for example detecting the anomaly analysis thing level that monitors via analyte sensor or carrying out this test during via the state of the unusual body temp of temperature sensor monitors.If the patient does not provide suitable response in the given time, but then the reuse part can send alarm to remote controllers or keeper.For because device fault or other are former thereby may become and lose for consciousness or the incapabitated patient, this test and report may be valuable especially.

NITINOL circuit on the main PCB 13 (reference figuration memory actuator, in certain embodiments, be the NITINOL strand) 278 provides electric current to the NITINOL adapter.Shown in Figure 67 F and Figure 70 A, this device can comprise two NITINOL adapters 278 (with two NITINOL strands).Yet as mentioned above, in certain embodiments, this device comprises a NITINOL adapter (with a NITINOL strand).

In certain embodiments, this device comprises the temperature sensor 3216 shown in Figure 70 B.Temperature sensor 3216 is positioned on the downside of base portion Y and sensing patient's skin temperature.Skin temperature transducer 3216 is connected to the signal conditioner by 3217 representatives.Shown in Figure 70 B, Signal Regulation 3217 is represented as a square frame, yet this device comprises a plurality of signal conditioners as required, and each all filters unlike signal.Below, AVS temperature sensor 132, AVS mike 133 and analyte sensor 5020 all are connected to the signal conditioner of representing in as a square frame of 3217.

AVS speaker 134 is connected to the loudspeaker drive 135 on the main PCB 13.AVS speaker 134 is the audition additional loudspeaker in one embodiment.Yet, in other embodiments, speaker 134 (contain voice coil loudspeaker voice coil speaker, have the magnet of solenoid) be piezoelectric speaker (be shown in Figure 50, represent an embodiment of described device).

Still with reference to figure 70-70D, in certain embodiments, antenna 3580 has special-purpose PCB3581, and this special use PCB is connected to main PCB 13 then.And in certain embodiments, each all has the special-purpose PCB 1332,1333 that is connected to main PCB 13 AVS mike 133.Can use traditional method, for example flexible circuit or lead are connected to main PCB 13 with various PCB.

With reference to figure 67F, for the purpose of illustration, device 10 is shown as exemplary embodiment.Yet the layout of various piece can change, and a lot of embodiment are shown below.Yet other alternate embodiments is not illustrated, but can be determined based on size, power and purposes.

According to alternate embodiments, single use portion 2610 can comprise reservoir 20 and comprise accumulator alternatively.Reservoir 20 can form one or otherwise be connected to single use portion with single use portion.Accumulator can be to be used for main or unique power supply of described device or can be back-up source, but and the electronic device that can be used on reuse part and/or single use portion electric power is provided.Reservoir 20 and accumulator generally all require periodic replacement, so these two members are included in the convenience that this increase of changing simultaneously can be provided to the user in the single use portion 2610.Additionally, by in each accumulator of changing when changing reservoir, the user can more difficultly make exhaustion of the accumulators.

Single use portion 2610 can be additionally or is alternately comprised processor, this processor can be used for, for example, in the situation that breaks down (for example, but the fault of the master controller in the reuse part) continue the operation of some device, in the situation that breaks down, producing alarm, but perhaps partly provide status information to reuse.About status information, processor can keep following the tracks of the operation history of single use portion and various characteristics and reserved state information in case between the installation period of single use portion 2610 by user, FLUID TRANSPORTATION device 10 and/or user interface 14 visits.For example, processor can storage and shelf life, maximum exposure or operative temperature, manufacturer, the relevant states such as safety distribution restriction that are used for the treatment of.If it is unacceptable that described device is determined any one of these positioning indicators, then described device can be refused to illustrate single use portion to use to pump and allocation component power supply and to the user.But processor can be by the storage battery power supply in reuse part or the single use portion.

More generally, this device can be configured to via bar code reader, perhaps (comprise from any single use portion via the RFID technology, for example, single use portion 2610 and any as used herein disposable member, for example fluid reservoirs, accumulator or sharp-pointed cartridge case or each sharp-pointed member), for example, from placing the processor of single use portion, obtain status information.If described device detects single use portion existing problems (for example, but it is expired to be used for reuse invalid model numbering or fluid partly), then described device can be taked remedial action, as, for example prevent or stop device operation and produce suitable alarm.

Other member can be included among some embodiment.For example, can adopt standby fault-finding and announcement mechanism.Described device can adopt audible alarm.The microphone 1202 of pick off 550 can be used for audible alarm, and perhaps other speaker can comprise microphone and be used for audible alarm.Device vibrating mechanism 3210 also can be used as siren.If detect the system failure that requirement is paid close attention at once, then two sirens all can activated.Additionally, can be used as the backup of main accumulator and adopt chargeable storage or ultracapacitor.If arbitrary accumulator all can not be worked, then controller can activate one or more siren, thereby sends at least one announcement of accumulator failure.

Siren can also be used for illustrating device correctly to work to the user.For example, the user may be about carrying injecting of specific period to described device programming.The user may expect to know that the conveying of being programmed correctly carries out.Processor can use vibrating motor or audio sound to illustrate successful programming to carry.Therefore, in some embodiment of described device, can adopt some mechanisms to provide feedback sure or that negate to patient or user.

Mike also can be used to survey the shortage of any abnormal vibrations or normal vibration, and triggers alarm state.In various embodiments, the mike of acoustic volume sensing system can be used to carry out this supervision, can comprise that perhaps independent mike is to be used for this supervision.Also can check the execution cycle, operate to determine described device by the pump vibration that utilizes mike inspection expection.If mike detects incorrect vibration,, then can activate siren if perhaps correct vibration is not detected.

With reference now to Figure 71,, briefly shows the various members of device 10.In an embodiment of device 10, top X cooperates with base portion Y and reservoir 20 is sandwiched between top X and the base portion Y.Clamping action power allows reservoir partition 6272 to match with base portion Y.In certain embodiments, delivery device 5010 and analyte sensor 5020 all insert and enter in patient's (not shown) body by base portion Y.

In a lot of embodiment, base portion Y and reservoir 20 are that single use portion and top X are non-single use portion.Delivery device 5010 and analyte sensor also all are disposable.

As previously discussed, the patch pump device can be disposable in whole or in part.Figure 72 illustrates the embodiment of the FLUID TRANSPORTATION device 10 with disposable and non-once part.In this embodiment, single use portion Y contains the member that directly contacts with fluid, comprise the reservoir 20 that to subside, pump (not shown), variable volume dispensed chambers 122 (allocation component 120 be positioned at a part on the X of top) and current limiter (not shown), and reservoir is connected to the fluid path (not shown) and the check valve (not shown) of the pumping mechanism of variable volume dispensed chambers 122.Additionally, single use portion Y comprises reservoir cavity 2645.

But reuse part X comprises the element of allocation component 120, except being positioned at the variable volume dispensed chambers 122 on the single use portion Y.In certain embodiments, allocation component 120 is AVS assemblies.Describe the AVS assembly in the above in detail.With reference now to Figure 73,, integrated acoustic volume measuring transducer is illustrated on PCB.

With reference now to Figure 74,, device shown in Figure 49 10 is shown.Base portion single use portion Y comprises reservoir cavity 2645.Top non-once part X comprises accumulator 15 and allocation component 120.Mike 133 and diaphragm spring 130 are shown.In certain embodiments, allocation component 120 comprises the mike more than.Though run through this explanation, each mike all is known as 133, and this does not illustrate mike always identical.In certain embodiments, mike is identical, and in other embodiments, mike is different.

In Figure 74, top non-once part X also comprises main PCB 13, vibrating motor 3210 and pumping actuated components 54.Top, non-once part X comprise AVS assembly or allocation component 120.In Figure 74, mike 133 is shown.Top, non-once part X also comprise the accumulator 15 of the electronic device power supply that can be used on non-once part and/or single use portion.In certain embodiments, this accumulator 15 is rechargeable.Can recharge by the method that is described below.Single use portion Y comprises the moistening member with flowline (not shown) and pump.In Figure 74, only pumping plunger 54 can be seen.This embodiment of device 10 can also comprise above-mentioned a lot of elements, includes but not limited to flow resistance, flexible partition, shroud and sensor housing.Can use any pumping mechanism.

With reference now to Figure 75,, can see device 10 shown in another view of multicomponent more therein.In Figure 75, device 10 is shown to have and comprises coiling microtubule current limiter 340 and be connected the base portion single use portion Y of import 21 with the flowline 310 of outlet 22 valves.Pumping actuated components 54 also is shown.Top X comprises main PCB 13, vibrating motor 3210, two mikes 133, speaker 134, reference chamber 127 and fixed volume chambers 129.Accumulator 15 also is shown.Because select very little diameter for current limiter 340, may cause flowline 310 obstructions (for example) owing to polymerization of protein in the treatment fluid, therefore may expect to use the longer pipeline of length with larger diameter.Yet for the pipeline that has length at the housing intermediate package of patch size, the necessary crooked pipeline of possibility is to form crooked route, and is that for example coil or snakelike.

With reference now to Figure 76,, the decomposition view of the device 10 shown in Figure 72,74 and 75 is shown.Top, non-once part X are illustrated as separating with base portion single use portion Y.In practice, the reservoir (not shown) will be placed between top X and the base portion Y part.In case top X and base portion Y are assembled to form device 10, then reservoir will be connected to flowline 310.

With reference now to Figure 77,, the decomposition view of another embodiment of the device 10 that comprises disposable base portion Y and non-once top X part is shown.Also comprise reservoir 20, keep the binding agent 3100 and bridge joint 5040 equipment of delivery device 5010 and pick off 5020.This device 10 comprises the trace and the domed shape of sphering more.Accumulator 15 and main PCB 13 are illustrated as being positioned on the X of top.Base portion Y comprises reservoir cavity 2645.At binding agent 3100 shown in the two-piece type embodiment.Bridge joint 5040 is used for inserting delivery device 5010 and pick off 5020 by base portion Y.Reservoir 20 is shown to have irregularly shaped, yet in other embodiments, reservoir 20 can have Any shape and can be varying sized according to required fluid displacement.In this embodiment of device 10, non-moistening member is arranged in top non-once part X and the moistening member is arranged in base portion single use portion Y.

When assembled, device 10 can utilize binding agent middle section (not shown) to be attached to together.Alternately, device 10 can use any one embodiment of a lot of embodiment that are used for locking that describe mechanically to be locked into together here.Though be described below some embodiment here, a lot of other embodiment are conspicuous, and when device shape changes, in a lot of situations, lockset also will change.

With reference now to Figure 78,, the decomposition view of another embodiment of device 10 is shown.Top non-once part X is basic domed shape, yet protrusion X1 is illustrated as holding the mechanism among the X of top.Therefore, device shape can change and can comprise polyp portion (polyps) and protrusion, scrobicula and other textured feature, to be suitable for the various designs of described device.

Reservoir 20, delivery device 5010 and pick off 5020 are shown.Delivery device 5010 and pick off 5020 can insert and enter in patient's (not shown) body by base portion Y.Below being shown in, base portion Y has binding agent 3100 or pad 3220.In practice, binding agent 3100 or pad 3220 can at first be attached to skin and base portion Y.Then, delivery device 5010 and pick off 5020 insert (not shown, be illustrated as 5020 and 5010 in Figure 79) in patient's body by base portion Y.Then by at first reservoir 20 being placed top X to be sandwiched in then between top X and the base portion Y, perhaps, reservoir 20 placed reservoir cavity 2645 and be sandwiched in top X then and base portion Y between, reservoir 20 is placed reservoir cavity 2645.Arbitrary mode all can be used.Final result is that reservoir 20 is connected to the flowline (not shown) that is arranged in base portion Y by partition on the reservoir 20 (illustrating) and partition pin (not shown, as to see 6272) with being reversed.Then, by using binding agent, perhaps in this embodiment by mechanically using lockset 654 that top X and base portion Y are clipped together and top X being fixed to base portion Y.

Base portion Y comprises those wetted members.Base portion Y is disposable.Top X comprises non-moistening member.Top X right and wrong are disposable.With reference now to Figure 79,, base portion Y comprises variable volume dispensed chambers 122, inlet valve 21 and outlet valve 22 and pumping chamber 2350.As shown in the drawing, those elements are illustrated as covering the barrier film as the zone of chamber or valve.Therefore, base portion Y comprises barrier film, and this barrier film keeps wetting zones securely, therefore, has kept such as the non-wetting zones in the (not shown) of top.Shown in Figure 79, pick off 5020 and delivery device 5010 have been inserted in their corresponding housings and by base portion Y and have arrived patient's (not shown).Base portion Y is shown to have reservoir cavity 2645, but need to connect the reservoir (not shown), thereby has been connected from the reservoir to the chamber and to the flowline of delivery device.

With reference now to Figure 80,, the top X of described device is shown.Top X comprises those non-moistening members, comprises, as shown in the figure, temperature sensor 3216, diaphragm spring 130, inlet valve lift valve 21 and outlet valve lift valve 22 and pumping actuated components 54.Top Y comprises that also recess 2640 is to hold the reservoir (not shown).

With reference now to Figure 81 A-81C,, illustrates and be used to be shown in the sequence of clamping the process of reservoir 20 between top X and the base portion Y.Shown in Figure 81 A, the reservoir 20 of top X and X outside, top is shown.Reservoir comprises partition 6270.Top X comprises reservoir recess 2640.Below, shown in Figure 81 B, prepare the top so that carry out clamping with base portion Y.With reference now to Figure 81 C,, reservoir 20 is placed among the base portion Y, wherein under the partition side direction.Partition will be connected and reservoir is connected to the flowline (not shown) with the telescopic partition pin (not shown) that has among the base portion Y.In alternate embodiments, reservoir can comprise and have telescopic pin but not partition, and fluid path can comprise the reservoir interface that has partition, but not has telescopic pin.

Below with reference to Figure 82, top X is shown, wherein pumping mechanism 16 embodiment is decomposed.Pumping mechanism 16 is mounted in the pumping mechanism housing 18 among the X of top.A part of the lockset 654 that base portion Y also is shown and top X and base portion Y are clipped together.

With reference now to Figure 83,, base portion Y is shown, wherein with fluid path assembly 166 as the barrier film 2356 that decomposes from base portion Y.This illustrates that in some embodiment of device fluid path assembly 166 is to insert among the base portion Y and the individual components that utilizes barrier film 2356 to clamp.Also illustrate in the figure, binding agent in certain embodiments or pad 3100/3220 comprise the hole that is used for delivery device and pick off (not shown).With reference now to Figure 84,, the bottom view of base portion Y is shown.The bottom of fluid path assembly 166.

With reference now to Figure 85 A and 85B,, another embodiment of device is shown.In this embodiment, also the disposable top X of right and wrong comprises and injects button 654.Reservoir 20 illustrates with decomposition view, yet in one embodiment, reservoir 20 is built among the base portion Y.In another embodiment, reservoir 20 is removable and uses the described process of another embodiment be similar in the above about device to be placed in the reservoir cavity 2645.

Base portion Y is disposable and comprises the wetted portions of device 10.Pick off 5020, sleeve pipe 5010, variable volume dispensed chambers 122, inlet valve zone 21, outlet valve zone 22 and pumping chamber 2350.Volume dispensed chambers, inlet valve zone 21, outlet valve zone 22 and pumping chamber 2354 are all covered by diaphragm material, and described diaphragm material can have single barrier film or different membranous form.

Utilize the locking mechanism 654 on top X and the base portion Y that device 10 is clipped together.With reference now to Figure 85 C-85D,, device 10 is the retaining mechanisms 654 that are illustrated as being shown in an open position among (Figure 85 C) and clamping or closed position (Figure 85 D).Can also see as what describe in detail more in the above and inject button 3213.

The lid (not shown) can be provided in any one of described device embodiment, substitutes reservoir and top when base portion is connected to the patient to be removed when reservoir.Described lid will not contain electric member, therefore, can use in moisture state.Yet in some cases, reservoir can be removed and not use any lid.

Sleeve pipe and inserter

Figure 86 A briefly shows the transfusion and the representative embodiment of sensor cluster 5040, and described assembly comprises can be the delivery device of sleeve pipe or pin 5010 and comprise sensor probe 5025 and the analyte sensor of pick off base portion 5023.Bridge joint 5070 is securely in conjunction with transfusion sleeve pipe 5010 and analyte sensor base portion 5023.Delivery device 5010 is defined by partition 5060 on upside, and described partition allows fluid to flow and supply to the patient by delivery device 5010 from fluid source.Pick off base portion 5023 be analyte sensor be not inserted into the intravital part of patient.In one embodiment, base portion 5023 contains the electric contact that is useful on the blood-glucose electro chemical analysis.Probe 5025 is outstanding from the base portion 5023 of analyte sensor 5020.

With reference now to Figure 86 B,, in this embodiment, delivery device 5010 is to use introducing pin 5240 to be introduced into the intravital sleeve pipe of patient.In the time of in being inserted into patient's body, introducing pin 5240 and be arranged in sleeve pipe 5010.After inserting sleeve pipe 5010 in patient's bodies, introduce that pin 5240 is removed and partition 5060 is sealed with respect to fluid source, here among some embodiment of the device of Miao Shuing, described fluid source is a flowline.In certain embodiments, sensor probe 5025 is associated with introducing pin 5072, and this helps skin penetrating, to insert sensor probe 5025.In the time of in sensor probe 5025 is inserted into patient's body, pick off is introduced pin 5072 in certain embodiments at least in part around sensor probe 5025.

In other embodiments, delivery device 5010 is pins and does not need to introduce pin 5240.In these embodiments, delivery device 5010 is inserted in patient's body and partition 5060 sealant flow body sources.

In Figure 86 A and 86B, when delivery device 5010 and sensor probe 5025 were all suitably arranged, active force was applied to bridge joint 5070.This actuates delivery device 5010 and sensor probe 5025 enters in patient's body.In case be positioned at patient's body, then by hole actuation of release 5052, thereby delivery device 5010 separated with partition 5060, and pick off base portion 5023 is separated with bridge joint 5070.With reference to figure 86B, wherein used introducing pin 5240 and 5072, they remain after inserting usually and are attached to bridge joint 5070.

Described bridge joint can be made by any material requested that comprises plastics.Sleeve pipe can be any sleeve pipe in this area.Partition 5060 can be made and had any design that can produce required function by rubber or plastics.Delivery device is among the embodiment of pin therein, and any pin all can be used.Use therein among the embodiment that introduces pin, any pin, pin device or introducing device all can be used.

Transfusion and sensor cluster require to apply active force, thereby are inserted in patient's body.And transfusion and sensor cluster require to discharge delivery device and pick off from transfusion and sensor cluster.Therefore, active force and release member all can manually be activated, and, carry out the personnel of these functions that is, perhaps, insert device and can be used to correctly activate described assembly.With reference now to Figure 87 A-87E,, illustrating can be by the example with the inserter 5011 of manual mode of operation.Delivery device 5010 and pick off 5023 are bridged 5070 and keep.Inserter 5011 comprises and is used for both lids 5012 of delivery device 5010 and pick off 5023.Shown in Figure 87 B-87E, use inserter 5011, delivery device 5010 and pick off 5023 all are inserted in this device 10.Though Figure 87 A illustrates the sharp object that is exposed, in certain embodiments, lid 5012 encapsulated sharp object fully before insertion process.

Inserter 5011 can be manually actuated, but also can be bonded in another inserter device, thereby can the application machine advantage.With reference now to Figure 88 A-88B,, an embodiment of inserter device 5013 is used to be similar to the equipment of inserter 5012 shown in Figure 87 A-87E.The mechanism of inserter device 5013 is shown among Figure 88 C-88D.Actuation lever 5014 retracting springs (shown in Figure 88 C-88D) or provide allow inserter 5012 to be inserted into another mechanical advantage in the device (not shown).Inserter 5012 therefore will discharge delivery device 5010 and pick off 5023 and then inserter 5012 can be removed from inserter device 5013 and inserter device 5013 is filled once more, perhaps inserter device 5013 and inserter 5012 can go out of use.

Various insertion devices have here been described.Yet, in other embodiments, used different insertion devices, perhaps delivery device and pick off are manually introduced.

Can comprise and be used for transfusion and sensor cluster 5040 are fixed to the feature of automatic inserter.For example, in Figure 86 A-86B, be illustrated as the pin that 5052 release member can receive automatic inserter spare.With reference to figure 89A and 89B, the representative embodiment of automatic inserter 5100 is shown.Shown in the front view of Figure 89 A, inserter 5100 is included in the pin 5130 of advancing in the pin slit 5140 that inserts in the cartridge case recess 5120.In practice, transfusion and sensor cluster (not shown, be shown 5040 in Figure 86 A and 86B) are pressed in the cartridge case recess 5120, cause pin 5130 be inserted into infuse and sensor cluster in the hole in (in Figure 86 A and 86B, being illustrated as 5052).Shown in the rearview of Figure 89 B, cocking lever 5145 is used to prepare inserter 5100 so that discharge.Inserter 5100 is held skin then or aims at shroud on the base portion (not shown) and sensor housing and be released by depression of trigger 5110.When discharging, pin 5130 is advanced in their slit 5140, actuates delivery device and pick off (all not shown) thus and enters in patient's body.5160 restriction transfusions of inserter footing and sensor cluster are advanced downwards.Inserter also can automatically be introduced pin (not shown, as to see Figure 86 B) from transfusion and sensor cluster withdrawal.

Before distributing to the terminal use, transfusion and sensor cluster can be by prestrains in inserter 5100.Shown in Figure 90, in other embodiments, the sharp object that cartridge case 5080 can be used for protecting user and protection to keep in Figure 56 A and 56B are illustrated as 5040 assembly.With reference to Figure 90 and Figure 86 A-86B and Figure 89 A, in cartridge case embodiment 5080, transfusion and sensor cluster 5040 embed in the cartridge case 5080.Cartridge case 5080 is installed in the cartridge case recess 5120.Pin 5130 is can be by hole 5052 outstanding and enter in the groove 5090 in the cartridge case 5080.After activating inserter 5100, when the patient advanced, pin was advanced in groove 5090 to insert sharp object at cartridge case 5080.Cartridge case 5080 can be by constructed of rigid materials.

With reference now to Figure 91 A-91C,, a plurality of views of the embodiment of the inserter mechanism that is used for inserter are shown, for example in Figure 89 A and 89B, be illustrated as 5100 one.Figure 91 A illustrates the perspective view of an embodiment of inserter mechanism, and Figure 91 B illustrates front view, and Figure 91 C illustrates side view.Inserter 5100 has cocking lever 5145, and it is connected to hammer body stage clip slide block 5330 via stage clip connecting rod 5350, and is used for stage clip slide block 5330 is moved to load situation.Power spring 5390 is connected to trigger 5110 with hammer body stage clip slide block 5330, and, when being compressed, providing and insert delivery device or transfusion and the necessary downward active force of sensor cluster (not shown).Triggering hammer body 5340 is placed between the below and a pair of stage clip connecting rod 5350 of hammer body stage clip slide block 5330; Trigger hammer body 5340 and transmit the kinetic energy that when depression of trigger 5110, discharges from power spring 5390.The triggering hammer body 5340 that is energized impacts the cartridge case bolt 5380 that is positioned at the below.Cartridge case bolt 5380 is coupled to the cartridge case housing 5370 that holds cartridge case, for example, shown in Figure 90 one of them.Cartridge case bolt 5380 is placed in also that contracting gives up the throne puts so that cartridge case housing 5350 is turned back on the top of return spring 5360.

Figure 92 A-92F briefly shows and is used for perk (cock) and discharges the time series that has with reference to the inserter 5100 of the described type of figure 91A-91C.Figure 92 A illustrates inserter 5100 and is in the rest position.Reduce stage clip lever (not shown, as to see Figure 91 A, 5145) and cause that hammer body stage clip slide block 5330 reduces and joint triggers hammer body 5340.Figure 92 B illustrates hammer body stage clip slide block 5330 and is in the position of reduction, and it engages and triggers hammer body 5340 in this position.The rising cocking lever causes that hammer body stage clip slide block 5330 and hammer body 5340 are raised, so compression power spring 5390; The position is shown among Figure 92 C as a result.After guaranteeing correctly to locate inserter 5100 with respect to base portion (not shown) and/or patient skin, trigger is depressed, and sends downwards thus and triggers hammer body 5340; Figure 92 D illustrates and is in triggering hammer body 5340 in transit.Shown in Figure 92 E, trigger hammer body 5340 and impact cartridge case bolts 5380, cause that it advances downwards, be inserted in the one or more pins that keep in the cartridge case housing (not shown), and compression retracteding position spring 5360.Figure 92 F illustrates return spring 5360 and is in the process of upwards actuating cartridge case bolt 5380; This causes the cartridge case housing and the cartridge case (not shown) and the employed any introducing pin that is associated that wherein comprise retreat.

With reference now to Figure 93 A-93C,, illustrates and be used for embodiment of seasonal effect in time series among the base portion Y is inserted and be fixed to delivery device (that is, sleeve pipe or pin 5010).Figure 93 A illustrates the base portion Y with the lock feature 5210 that is positioned at shroud 5030 tops.When inserting delivery device or sleeve pipe 5010, base portion Y locatees against patient 5220 skin usually.Figure 93 B illustrates and actuates sleeve pipe 5010 by the shroud 5030 among the base portion Y.In the figure, use and introduce pin 5240, it runs through the partition (not shown) and coaxially locatees in sleeve pipe 5010; The sharp point of introducing pin 5240 occurs so that pierce through patient 5220 from the top (not shown) of sleeve pipe 5010.During inserting sleeve pipe 5010, elasticity lock feature 5210 is pushed to a side.Figure 93 C illustrates the shroud 5030 of sleeve pipe 5010 by base portion Y and is fully inserted into, and wherein cannula tip is fully inserted in patient's 5220 bodies.Introduce that pin 5240 has been removed and partition 5060 with respect to fluid source or the self sealss of flowline (not shown).Elasticity lock feature 5210 abutment sleeve 5010 prevent that thus sleeve pipe 5010 from moving with respect to base portion Y.Though Figure 93 A-93C illustrates sleeve pipe 5010, can use and with lock feature of describing 5210 and method transfusion shown in Figure 86 B and sensor cluster inserted shown in Figure 93 A-93C.

With reference now to Figure 92 G-92H,, in order to inserter, for example be illustrated as 5100 at that the insertion cartridge case bolt retaining mechanism that uses together shown in Figure 91 A-92F.Cartridge case bolt retaining mechanism can be used as interlocking, discharges when the accident of mechanism during by perk preventing.Retaining mechanism comprises brake component 5420, and this brake component 5420 prevents that cartridge case bolt 5380 from moving downward in the time of in being bonded on brake component recess 5410.Shown in Figure 92 G, when stage clip lever 5145 is in the closed position, stage clip lever 5145 contact brake component levers 5440, thereby rotation brake spare 5420 and prevent that brake component 5420 is inserted in the brake component recess 5410.Place the brake component spring 5430 between brake component 5420 and the brake component spring support 5450 to be in compression position.Cartridge case bolt 5380 and triggering hammer body 5340 move freely.Shown in Figure 92 H, when stage clip lever 5145 rotates in upper/lower positions, brake component lever 5440 is released, allow brake component spring 5430 to actuate brake component 5420 thus and be inserted into (brake component 5420 is illustrated as being arranged in recess, but is illustrated as 5410 at recess described in Figure 92 G) in the recess here; Prevent moving downward of cartridge case bolt 5380 thus.The returning and then brake component 5420 turned back to unlocked position of stage clip lever 5145.Cartridge case bolt 5380 freely moves downward in trigger process then.

With reference now to Figure 94 A-94C,, illustrate sleeve pipe 5010 is coupled to base portion Y and forms an embodiment of the process that fluids are communicated with flowline 310, its middle sleeve is the traditional sleeve (shown in Figure 86 B) of requirement introducing pin.Figure 94 A illustrates and has two partitions the cross sectional view of the sleeve pipe 5010 of (introducing pin partition 5062 and flowline partition 5270).Introduce the path 5280 of the hollow needle (not shown, as in Figure 94 B, to be illustrated as 5290) of pin partition 5062 sealing guide thimbles 5010.Sleeve pipe introduce pin 5240 be illustrated as being positioned at introduce pin partition 5062 tops and just in time insert introduce pin 5240 before.

With reference now to Figure 94 B,, introduces pin 5240 and be illustrated as inserting by introducing pin partition 5062.The user is coupled to sleeve pipe 5010 among the base portion Y, and described base portion has towards last rigid hollow pin 5290.During inserting sleeve pipe 5010 among the base portion Y, introduce pin 5240 and pierce through flowline partition 5270, be communicated with between flowline 310 and path 5280, to form fluid.If base portion Y is retained as the (not shown) against the patient during inserting sleeve pipe 5010 among the base portion Y, then between flowline 310 and path 5280, forms the fluid connection being pierced the approximately identical time of time with patient skin.With reference now to Figure 94 C,, the sleeve pipe 5010 that is fully inserted among the base portion Y is shown, introduce wherein that pin is removed and form fluids and be communicated with flowline 310.

In alternate embodiments, by the insertion of auxiliary delivery device of the vibrating motor of cooperating and/or pick off with the FLUID TRANSPORTATION device.With the insertion of delivery device and/or pick off side by side, vibrating motor can activated.

Binding agent

With reference now to Figure 95,, the top perspective of an embodiment that is used for for example object of FLUID TRANSPORTATION device 10 is fixed to the binding agent paster 3100 of patient's (not shown) skin is shown.Though binding agent paster 3100 is illustrated as present shape, can use other shape.Can use any binding agent paster 3100 that can keep the FLUID TRANSPORTATION device securely.

FLUID TRANSPORTATION device 10 be securely held in by binding agent parts 3111 be attached to patient skin binding agent paster 3100 middle section 3130 below.

These binding agent parts 3111 scatter with radial pattern and by regional 3121 spaces between two parties from middle section 3130.The radial arrangement of binding agent parts 3111 allows with fast way device 10 to be attached to the patient.In certain embodiments, middle section 3130 covers whole devices 10, yet, in other embodiments, the part of middle section 3130 covering devices 10.Middle section 3130 can also comprise interlocking attachment feature (not shown), and it can be supported by the complementary interlock feature (not shown) of device 10.In alternate embodiments, device 10 is attached on the top of middle section 3130 (for example, by binding agent or interlock feature) securely.

Binding agent paster 3100 normally flat and constitute by polymer flake or fabric.Binding agent paster 3100 can be supplied adherent binding agent on a side, and is subjected to for example protection of the release liner of peelable plastic sheet, and it will be looser to being attached to described release liner comparing binding agent with paster 3100.Described liner can be single serialgram, perhaps can be divided into a plurality of zones that can be removed respectively.

In illustrative examples, the liner that is used for middle section 3130 can be removed and not remove the liner that is used for binding agent parts 3111.In order to use binding agent paster 3100, the binding agent that newly exposes that the user removes the liner of middle section 3130 and device 10 pressed to middle section is to be attached to middle section 3130 with device 10.The user is placed into described device on the skin then once more, removes liner from binding agent parts 3111, and the binding agent parts are attached to skin, and utilizes other parts to repeat attaching process.The user can adhere to all binding agent parts 3111 or some parts only, and saves other binding agent parts 3111 to use in another day.Only in a couple of days, keep attachment securely because be generally used for being attached to the binding agent of skin, therefore use one group of binding agent parts 3111 (for example, every 3 to 5 days) will prolong device 10 at same date not and keep being attached to securely time, cost and the sense of discomfort that often relates to when time of skin and minimizing are used described device once more.Different small pieces can have for example different colours or digital labelling, adhere to the appropriate time of various binding agent parts 3111 with indication.Binding agent parts 3111 can comprise perforation, make it fragile more with respect to middle section 3130, thereby used binding agent parts can be removed after using.With reference to figure 79-83 the additional embodiments that is used to prolong the persistent period that makes that device 10 maintenances are adhered to has been discussed in the above.

Figure 96 briefly shows the cross sectional view of FLUID TRANSPORTATION device 10, the sleeve pipe 5010 that wherein is inserted into be securely held in binding agent paster 3100 below.Pad 3220 can be included between device 10 and the patient skin 3250 and allow air flow to skin.Can flow by in pad 3220, comprising the air that path 3230 is increased to skin.Also can by use separately a plurality of pads or by utilizing high porosity material structure pad 3220 to form paths 3230.Therefore, pad 3220 can have Any shape and size, and in certain embodiments, pad 3220 constitutes by a plurality of isolating.Pad 3220 can be attached to the downside of device 10 during manufacture, perhaps can be attached to device 10 by the user.Alternately, pad 3220 can be placed on the skin by user's loosely before using binding agent paster 3100.Pad 3220 can comprise submissive material, for example the porous polymer foam.

Figure 97 illustrates embodiments of the invention, and it uses the first binding agent paster 3100 and other binding agent paster 3300 so that the device (not shown) is fixed to the patient.At first, the device (not shown) is positioned and uses the binding agent paster 3100 of lamellar-binding agent parts 3111 to be fixed to the patient skin (not shown) so that use and utilize.Middle section 3130 can be positioned at (as shown) on the described top device or be fixed on it below.After long or short a period of time, locate the second binding agent paster 3300, so that its middle section is positioned on the top of the first binding agent paster 3100, and be fixed to patient skin in the zone between two parties of the binding agent parts 3320 of the second binding agent paster between the binding agent parts 3111 of the first binding agent paster.Weak section can be provided so that remove the loose or unwanted binding agent parts 3111 relevant with the early stage paster of placing 3100.

With reference now to Figure 98 and 99,, the embodiment that binding agent paster 3100 wherein has been divided at least two less binding agent pasters is shown.In these embodiments, binding agent paster 3100 is divided into two binding agent pasters 3410 and 3420, and each all has around the binding agent parts 3111 of central void 3430 radial arrangement.These two binding agent pasters 3410 and the about 180 ° semicircle of 3420 each equal generate, but can use other configuration, for example: each all launches three pasters of 120 ° or each all launches four pasters of 90 °.In certain embodiments, binding agent can comprise the paster more than four.The formula of 360 °/n is abideed by in the configuration of describing about these embodiment, and wherein n is the paster number.But, in other embodiments, according to the shape of device, the inapplicable shown here and formula described.In a further embodiment, described paster also can cover the scope more than 360 °, and so crossover.

Shown in the perspective view of Figure 99, owing to there is central void (not shown, shown in Figure 98), middle section 3130 has the form that is used for adhering to along the periphery of device 10 localized thin band.Two pasters 3410 and 3420 are attached to the skin (not shown) securely with device 10 together.In the embodiment that describes at reference Figure 95, when path 3230 was provided, air can flow between binding agent parts 3111 and below device 10 especially.

Figure 100 illustrates and comprises and use a plurality of binding agent pasters to make device 10 keep being attached to the perspective view of embodiment of the time of patient's (not shown) before removing with prolongation.When device 10 was held in place (perhaps by all the other binding agent pasters 3410 and/or pass through the user), one in a plurality of part binding agent pads 3420 was removed.The binding agent paster 3420 that is removed is substituted by new alternative binding agent paster (not shown) then.Substituting the binding agent paster can be identical with the pad that removed 3420 or can have binding agent parts 3111, these binding agent parts 3111 in alternative configuration to allow to adhere to the new skin between the zone that bonded dose of paster 3420 before covers.Can change remaining binding agent paster 3410 in a similar fashion then.What for example the labelling of color code can be used to indicate the binding agent paster uses the time.Paster also can have color change mechanism and expire with the probable life of indicating them.Decorative pattern such as image and design can be included on the paster.

Figure 101 briefly shows the embodiment that wherein a plurality of binding agent parts 3111 are attached to patient 12 and are connected to annular central zone 3130 via tether 3730.Tether 3730 can be fiber or rope and can be elastic to alleviate the motion that device 10 carries out in response to patient's 12 motions.Use tether 3730 also to increase available selection for the skin site of binding agent parts 3111.

The binding agent that is used for the described embodiment of Figure 95-101 can be any effective and safe binding agent that can be used on the patient skin.Yet in one embodiment, used binding agent is a 3M production code member 9915, the medical nonwoven adhesive tape of light and shade weaving lace (value spunlace).

Clamp and locking

Figure 102 A-102C briefly shows a kind of being used for the top of FLUID TRANSPORTATION device and base portion is clamped or be locked to together mechanism.At first, the front view of anchor clamps 6410 is shown with reference to figure 102A.Figure 102 B illustrates the base portion Y with the keyhole 6440 that is used for two anchor clamps; Corresponding keyhole also can be included in the (not shown) of top.With reference now to Figure 102 C,, top X and base portion Y can aim at and anchor clamps 6410 can pass through keyhole (not shown, be illustrated as 6440 in Figure 102 B) insertion.Cause that with 90 ° of rolling clamps 6410 mast 6430 moves in the latched position.Depress cam lever 6400, engaged the cam 6415 that is hinged to fixture pin 6420, with pushing top X.As a result, top X and base portion Y utilize clamping action power to be maintained between cam 6415 and the mast 6430.Rising cam lever 6400 has discharged clamping action power, and anchor clamps 6410 can half-twist and withdrawal to allow separately top X and base portion Y.In certain embodiments, lever can be with the over cap that acts on top X.

The alternate embodiments that clips together in a plurality of parts that are used for shown in Figure 103 A-103D described device.Perspective view and Figure 103 B that Figure 103 A illustrates cam guide 6500 illustrate top view.Cam guide 6500 has keyhole 6440 and inclined surface 6510.Figure 103 C illustrates the cam-follower 6520 with central pin 6540, and wherein termination 6560 is in first end place attachment and bar 6550 is attached to opposed end.Shown in the cross sectional view of Figure 103 D, cam-follower (not shown, shown in Figure 103 C) can be inserted in the keyhole (not shown, as to be shown among Figure 103 C) in top X, base portion Y and the cam guide 6500.The motion that is attached to the lever 6530 of central pin 6540 causes that cam-follower is (not shown, be shown among Figure 103 C) rotation, this causes that bar 6550 advances and thus turning effort power is converted to the active force that clamps base portion Y and top X between cam-follower termination 6560 and bar 6550 securely along inclined surface (not shown, be shown 6510 in Figure 103 C).

Reservoir

In the exemplary embodiment that is used to keep the fluidic reservoir that subsides shown in Figure 104-106C.The reservoir that can subside has at least one part or the wall of depression when fluid withdraws from, and keeps ambient pressure in the portion within it thus.In most of embodiment, salable port (for example, partition) is included in the reservoir.This port allows to utilize syringe that fluid filled is fallen this reservoir and be connected to flowline with being used for do not have revealing.Alternately, adapter can be used for reservoir is connected to flowline.Alternately, with reference to shown in Figure 71, pin can be associated with reservoir and partition can be associated with the terminal of flowline as in the above.Reservoir can be by plastic material the structure known and fluid compatible that comprises in reservoir, even for the very short persistent period.In certain embodiments, reservoir can subside fully, that is, reservoir does not comprise any inflexible body surface.

With reference now to Figure 104,, the cross sectional view of reservoir 20 is shown.Between rigidity reservoir body 6200 and flexible reservoir barrier film 6330, be formed for keeping the fluidic cavity 2645 of certain volume.The periphery of flexible partition 6330 surrounding cavity 2645 is attached hermetically, to hold fluid in cavity 2645.Flexible partition 6330 is given crushability to reservoir 20; It is to internal strain when from cavity 2645 pumping fluids.

Partition 6270 seatings are the cervical region 6240 that extends from body 6200.Partition 6270 is as the interface between cavity 2645 and the flowline.In some devices, flowline ends at the pin (not shown).In these embodiments, described pin can be inserted through partition 6270, to lead to pin chamber 6280 parts of cavity 2645.By partition 6270 being positioned between end cap 6250 and the flange (not shown), partition 6270 positions can be kept, and wherein this flange is formed on the inwall 6281 of pin chamber 6280 and the place, joint portion of end cap boring 6282.In end cap boring 6282, can utilize frictional fit to keep end cap 6250.When inserting end cap 6250, its position is subjected to the restriction of the wall 6261 of end cap boring 6282.The part of the most close partition 6270 of end cap 6250 can have central hole, inserts and enters in the partition 6270 by end cap 6250 to allow pin.Alternately, end cap 6250 can be by needle-penetration.

Figure 105 illustrates the perspective view of reservoir 20 inside that can subside.Edge 6230 allows attachment flexible reservoir barrier film, and described barrier film can be by welding, clamp, adhere to or other proper method attachment, to form fluid-tight.Can comprise that safeguard structure 6290 flows out to cavity 2645 or from cavity 2645 to allow fluid flow, still prevent that pin from entering in the cavity, prevent that thus it from may pierce through the reservoir barrier film.

Figure 106 A-106C illustrates the alternate embodiments of reservoir, and wherein end cap 6250 is attached to partition 6270 wall 6320 of reservoir hermetically.Wall 6320 can be for example by the flexible flake structure, for example PVC, silicones, polyethylene are perhaps by the ACLAR film configuration.In certain embodiments, wall 6320 can be by the thermoformable polyethylene sheets structure that utilizes the ACLAR thin film to form.Flexible flake and fluid compatible.Described wall may be attached to stiff case, perhaps for example can pass through the part of the formed flexible plastic pouch in end of folding and welding plastic thin slice.Figure 106 A illustrates the end cap 6250 that is sealed to wall 6320 via circular fin 6350.Partition 6270 can insert from the pivoted frame 6340 that end cap 6250 is given prominence to.But pivoted frame 6340 can at room temperature be inflexible material structure, for example low density polyethylene (LDPE) by can at high temperature being out of shape.With reference now to Figure 106 B,, hot press 6310 or another equipment that is used to melt or process are used to fusing or crooked pivoted frame 6340 on partition 6270.With reference now to Figure 106 C,, partition 6270 is illustrated as being fixed to end cap 6250.

Some fluid is for the store status sensitivity.For example, insulin is stable to a certain extent in common its vial of storage in transportation, but may be unsettled when contacting some plastics for a long time.In certain embodiments, reservoir 20 is by this constructed in plastic material.In this case, can be just in time before using, utilize fluid filled reservoir 20, thereby fluid exists in than short-term with plastics and contacts.

Reservoir is filled the station

With reference now to Figure 107,, the reservoir filling station 7000 that is used to utilize fluid filled reservoir 20 is shown.Fluid can utilize syringe 7040 to extract out and fill station 7000 by use from its original container and be introduced into the reservoir 20.Fill station 7000 and can comprise the filling station base portion 7010 of substantially rigid that is hinged to the filling station lid 7020 of substantially rigid via hinge 7030.Correspondingly, stand and 7000 can be opened and closed to accept and to keep reservoir 20.The pin 7050 that is attached to syringe 7040 can be inserted into by covering the filler opening 7060 in 7020 and passing reservoir partition 6270 then.Cover 7020 be inflexible because fill the station, thus it advancing of syringe 7040 is construed as limiting and so control pin 7050 and penetrate the degree of depth in the reservoir 20, to prevent to pierce through the downside of reservoir 20.When supported from the teeth outwards the time, supporting leg 7070 will be stood and 7000 be remained in the obliquity.7000 are tilted because stand, thus when fluid by when syringe 7040 injection enters the reservoir 20, air will be tending towards rising towards partition 6270.After syringe 7040 entered the injection of the fluid of aequum in the reservoir 20, syringe 7040 can be used to remove any surplus air in the reservoir 20.Because it is inflexible filling station base portion 7010 and lid 7020, so flexible reservoir 20 can not be extended to above fixed volume usually and prevent from reservoir 20 is excessively filled.Base portion 7010 and lid 7020 can utilize fastener to be locked into together, and perhaps heavy lid can be used for further stoping the reservoir excessive expansion and excessively fill.

With reference now to Figure 108 A and 108B,, the alternate embodiments that reservoir is filled station 7000 is shown.In this embodiment, the reservoir (not shown) be placed in cover 7020 and base portion 7010 between the space in.Hinge 7030 attachment covers 7020 and base portion 7010.Shown in Figure 108 B, the reservoir (not shown) is positioned at inside, and syringe (not shown) pin (not shown) is inserted in the filler opening 7060.Filler opening 7060 is directly connected to the partition (not shown) of reservoir.Form 7021 is represented flowline with the fluid volume that is injected into reservoir.

Fluid delivery system generally includes FLUID TRANSPORTATION device and external user interface, but in certain embodiments, completely or the internal user interface of part be included in the device.Described device can be any device or its modification of here describing.

Figure 109 A illustrates the data acquisition of the exemplary embodiment that is used for fluid delivery system and the flow chart of control scheme.Patient or health worker utilize external user interface 14, and this external user interface 14 is generally the base station or is independent of FLUID TRANSPORTATION device 10 and the handheld unit that holds.In certain embodiments, user interface 14 is integrated with computer, portable radiotelephone phone, personal digital assistant or other consumer's device.User's interface unit can be via radio frequency emissions (for example, via LF, RF or standard wireless protocol, for example " bluetooth ") carry out continuously or data communication intermittently with FLUID TRANSPORTATION device 10, but also can connect and connect via data cable, optics connection or other proper data.External user interface 14 is communicated by letter with processor 1504 with input control parameter, for example body weight, fluid dosage range or other data, and accepting state and function renewal, for example exist because stop up mobile, leakage, empty reservoir, bad battery condition, need repairing, expired, that carried or that residual fluid total amount or unverified disposable member cause any error condition.Interface 14 can transmit rub-out signal to patient monitoring people or Medical Technologist by phone, Email, pager, instant message or other suitable communication media.Reservoir actuator 1519 comprises actuator 1518 and reservoir 1520.Allocation component 120 is transmitted and the mobile relevant data of passing through flowline to processor 1504.Processor 1504 uses the action of flow-data control actuators 1518, with the mobile increase that will be derived from reservoir pump assembly 1519 or be reduced to roughly required dosage and regularly.Alternatively, the feedback controller 1506 of processor 1504 can receive the data relevant with the operation of reservoir pump assembly 1519 with acquisition mode, for example open or short trouble, perhaps actuator temperature.

Figure 109 B illustrates the alternate embodiments of the flow chart among Figure 102 A.In this embodiment, the shortage of allocation component/pick off has been eliminated the feedback based on fluid volume.

With reference now to Figure 110 A,, is illustrated in the flow chart of an embodiment of the overall operation of the FLUID TRANSPORTATION device in the fluid delivery system.The user uses switch or from external user interface start-up system (step 2800).System is initialised by load default numerical value, operational system test (step 2810) and acquisition variable element, for example required basis and bolus dose.Can use user interface by the user, that is, use the entering apparatus or the parameter of the touch screen on the user interface for example, select variable element (step 2820) by preserving from memory load.Calculate actuator regularly (step 2830) based on the performance of FLUID TRANSPORTATION device that estimate or calibration.Allocation component is activated (step 2840) when the FLUID TRANSPORTATION device activates beginning.Allocation component data collection 2835 is by activating and carrying and continue.During operation, allocation component provides data, and these data allow to determine to have flow through the fluidic cumulative volume and the flow rate of dispensed chambers in one or more period.The FLUID TRANSPORTATION device activated to cause the moving pipeline of fluid flows and to enter dispensed chambers (step 2840).Medicine flow to the patient with given pace from dispensed chambers, and this speed determined by the outlet impedance, and in certain embodiments, the active force that is applied by diaphragm spring and determined (step 2860) by the active force that pump applies.If have that the user stops to interrupt, low flow regime, flow or utilize the detection of other reservoir volume sensor and determined the situation of reservoir for sky based on the accumulation of estimating, perhaps arbitrary part of system has any other alert action, perhaps have user-defined any other alert action, then system will stop and notifying the user (step 2870).If there is no user's stop signal, reservoir are empty determining or another alarm indicator, then check to determine whether needing control actuator regularly (step 2880) owing to the deviation between actual and the required flow rate or owing to the user changes required flow rate.If do not need to regulate, then this process is returned step 2840.Regulate if desired, then this process is returned step 2830.With reference now to Figure 110 B,, the flow chart of another embodiment of the FLUID TRANSPORTATION device overall operation in the fluid delivery system is shown.In this embodiment, make the periodic decision of adjusting actuating based on variation or another feedback of user's input.In this embodiment, do not comprise allocation component with the pick off that is used for definite volume; Therefore regulate based on alternative feedback mechanism.

Radio communication

With reference now to Figure 111,, is illustrated in the fluid delivery system and uses the layout of coil with the embodiment that is used for induction charging and radio communication.As previously mentioned, user's interface unit 14 can be to implement with the form of the hand-held user's interface unit 14 of FLUID TRANSPORTATION device 10 radio communications.Can in FLUID TRANSPORTATION device 10, adopt secondary coil (being solenoid) 3560, as the wireless transceiver antenna that combines with wireless controller 3580.Secondary coil 3560 also can be used as secondary transformer, is used at least in part device accumulator 3150 being charged in combination with battery charging circuit 3540.In this embodiment, user's interface unit 14 contains and is useful on the primary coil 3490 that energy is coupled to secondary coil 3560 with induction mode.When user's interface unit 14 during near FLUID TRANSPORTATION device 10, primary coil 3490 excitation secondary coil 3560.3540 power supplies of 3560 pairs of battery charging circuits of the secondary coil that is energized are with 3150 chargings of the accumulator in the fluid delivery device 10.In certain embodiments, primary coil 3490 also as antenna to launch in combination with wireless controller 3470 and from FLUID TRANSPORTATION device 10 reception information.

With reference now to Figure 112,, some embodiment comprise remote radio communication (for example, 20-200 foot or farther) hardware in FLUID TRANSPORTATION device 10.Therefore, can telemonitoring FLUID TRANSPORTATION device 10.

Still with reference to Figure 112, the intermediary transceiver 6600 of being carried by the patient can provide the advantage of telecommunication usually, does not increase size, weight and the power consumption of FLUID TRANSPORTATION device 10 simultaneously.Shown in the data flow diagram of Figure 112, can wear FLUID TRANSPORTATION device 10 and use short distance hardware and related software that the data emission is received data to intermediary transceiver 6600 or from it.For example, device 10 can be equipped on the distance of 3-10 foot roughly and launch data.Intermediary transceiver 6600 can receive these data and use remote hardware and software to these data of user's interface unit 14 transfers then.Intermediary transceiver 6600 also can be accepted control signal and to these signals of device 10 transfers from user's interface unit 14.Alternatively, user's interface unit 14 also can with FLUID TRANSPORTATION device 10 direct communications that are arranged in scope.When this direct communication can be configured to occur over just intermediary transceiver 6600 and is not detected or alternately whenever be in each other in the scope at user's interface unit 14 and FLUID TRANSPORTATION device.

Can launch the data of a lot of types in this way, include but not limited to:

Activate regularly relevant data with pump and can be launched into intermediary transceiver 6600 and be arrived user's interface unit 14 by transmitted in sequence from other data of allocation component with cubing;

Alarm signal can be transmitted into FLUID TRANSPORTATION device 10 and can be launched from FLUID TRANSPORTATION device 10;

Can launch in order to confirm the signal of data reception to FLUID TRANSPORTATION device 10 to intermediary transceiver 6600 and from middle transceiver 6600 from user interface 14;

Can use intermediary transceiver 6600 to be used to change the control signal of the operating parameter of device 10 to FLUID TRANSPORTATION device 10 emission from user's interface unit 14.

With reference now to Figure 113,, the plane graph of the specific embodiment of intermediary transceiver 6600 is shown.Short range transceiver 6610 is communicated by letter with near FLUID TRANSPORTATION device.The short range transceiver of device and intermediary transceiver 6600 can use one or more agreement of a lot of agreements and the known tranmitting frequency (for example radio frequency emissions) that is used for junction service to communicate.The data that intermediary transceiver 6600 receives be transported to can be in memorizer 6620 (for example, flash chip) microprocessor 6630 of storage data, and retrieve data as required.Microprocessor 6630 also is connected to the remote transceiver 6640 that carries out data communication with user interface.For example, intermediary transceiver 6600 and user's interface unit can be operated according to bluetooth standard, and described bluetooth standard is to use the radio frequency of about 2.45MHz and can reaching the spread spectrum protocol of operating on about 30 feet distance.The Zigbee standard is the alternative standard of operating in the ISM frequency band of about 2.4GHz, 915MHz and 868MHz.Yet, can use any radio communication.

Alternatively, the data that received of microprocessor 6630 analysis are to survey the failure condition relevant with described device or to keep in repair needs.Some examples of malfunction include but not limited to:

Surpass to set restriction the time interimly lack received data;

Lack data reception acknowledgement signal from device or user's interface unit;

The overflow of device memory 6620 or nearly overflow situation;

Low-power;

Receive too high, low or incorrect periodic cubing excessively from FLUID TRANSPORTATION device 10.

Based on this accident analysis, microprocessor 6630 can trigger siren 6650 (for example, bell or buzzer).Microprocessor 6630 can also be to remote device communications and warning system state.Remote device can be for example, to use the user's interface unit of long-range transceiver 6640, FLUID TRANSPORTATION device 10 or the user's interface unit and the FLUID TRANSPORTATION device of use close range transceiver.When receiving the siren signal, user's interface unit can be relayed to Medical Technologist or patient monitoring people (for example, by pager or phone or other communication means) with the siren signal via longer distance then.

Power supply 6670 can be rechargeable, and can store enough energy with continued operation a period of time, for example, and at least 10 hours.Yet the operating time will change based on purposes and device.Thereby the FLUID TRANSPORTATION size of devices can reduce it can easily carry in pocket, wallet, briefcase, knapsack etc.An embodiment of device comprises the device that is used to bear conventional impact or overflow.Can comprise additional features in certain embodiments, include but not limited to ornamental feature or for example can play video game, transmission and reception instant message, watch digital video, in the ability of the large-scale consumer electronic devices of listening to the music etc. any one.Can comprise that the third party controls with in one day a period of time or the cancellation of all time durations or limit the use of this function.Alternately, this device can be as far as possible little and simple, and only be used on longer distance, repeating closely signal.For example, memorizer and analysis ability can be removed.

With reference now to Figure 114,, the data flow diagram that is used for system embodiment is shown.Intermediary transceiver 6600 is illustrated as general patient interface, and this general patient interface carries out short-range communication and will be relayed to one or more user interface relevant with those devices via long distance from the information of those devices with a plurality of devices.The example of device comprise can wear, transplantation or inner medical device, comprise fluid delivery system, glucose sensor, have the knee joint of integrated strain transducer, device is carried in instrument electron probe, defibrillator, pacemaker and other treatment that can wear of pill form.Because various types of devices and can utilize different short-range communication standard and frequency from the device of different manufacturers is supported a plurality of protocol with hardware (for example, a plurality of antennas and circuit) and software so intermediary transceiver 6600 can comprise.

Battery charger

With reference now to Figure 115 and 116.An embodiment 7100 who is used for the equipment of battery recharge is shown.In Figure 15, the top of FLUID TRANSPORTATION device 2620, non-once partly are illustrated as disconnecting from the base portion of FLUID TRANSPORTATION device, single use portion.Battery charger 7100 is used for the accumulator (not shown) charging to top 2620.In Figure 116, top 2620 is illustrated as being positioned on the battery charger 7100.Lockset 6530 is shown and is closed, and top 2620 is connected to battery charger 7100.Therefore, the lockset 6530 that is used for top 2620 is connected to the base portion (not shown) also is used for top 2620 is connected to battery charger 7100.Butt joint can form direct electric power and connect, and perhaps can utilize induction coupling transfer electrical power.And in some embodiment of system, the patient adopts a plurality of non-once parts 2620 of rotation; That is, when using the second non-once part (not shown), a non-once part 2620 is charged.

Here the various embodiment of Miao Shuing comprise element dissimilar and configuration, as, for example pump structure, pump actuator, volume sensor, current limiter, reservoir (and reservoir interface), sharp-pointed inserter, housing, locking mechanism, user interface, built-in (on-board) peripheral hardware (for example controller, processor, power supply, network interface, pick off) and other peripheral hardware (for example, handheld remote controller, base station, transponder, filling station).Should be noted that alternate embodiments can be in conjunction with the various combinations of these elements.Therefore, for example, the pump configuration that embodiment of reference describes (for example, the pump that illustrates and describe with reference to figure 15-15D) can with the pump actuator of various configurations (for example, have the single operation pattern single shape memory actuator, have a plurality of shape memory actuators of single shape memory actuator, same size or the different size of multiple modes of operation) in anyly use together, and can be used to have the device of any current limiter of the various combinations (perhaps not having other element) of other element and/or various current limiters.

And then, though described various embodiment with reference to non-pressurised reservoir here, should be noted that in certain embodiments or can use pressurized reservoir down at some state (for example, between perfusion and/or exhaust cycle).Especially, for example follow the retraction of the pump actuated components 54 that illustrates and describe with reference to figure 15A-15D, pressurized reservoir can be so that the filling pump chamber.

Additionally, though but with reference to the pump motor that places housing reuse part various embodiment have been described here, should be noted that pump and/or pump motor can be alternately for example be arranged in single use portion with the various members ground of contacting with fluid.As about in other motor of describing some, place the motor of single use portion can comprise one or more shape memory actuator here.

Should be noted that to have comprised division header for simplicity, and they are not to be intended to limit the scope of the invention.

In various embodiments, comprising of here disclosing is used to control and measure fluid flow and is used for setting up those method of operating of communicating by letter between associated components can be used as the computer program realization, and described product is in order to use with suitable controller or other computer system (being commonly called " computer system " here).This realization can comprise sequence of computer instructions, this sequence of computer instructions is fixed on the tangible medium, computer-readable medium (for example magnetic disc, CD-ROM, ROM, EPROM, EEPROM or hard disk) for example perhaps can be transferred on the computer system via the modem or other interface device that for example are connected to the communication adapter of network by medium.Described medium can be tangible medium (for example optics or analog communication line) or the medium that utilizes wireless technology (for example microwave, infrared or other lift-off technology) realization.Sequence of computer instructions can be implemented in the desired function of describing in front about described system here.Those skilled in the art should understand that this computer instruction can be with multiple programming language programming, to be used for a variety of computer architectures or operating system.

And then, this instruction can be stored in any storage component part, in for example quasiconductor, magnetic, light or other storage component part, and can use any communication technology (for example optics, infrared, acoustics, radio, microwave or other lift-off technology) to be launched.Expect that this computer program can be used as and (for example has incidental printing or electronic literature, shrink-wrapped software) removable media and distributing, utilize computer system prestrain (for example on the ROM of system, EPROM, EEPROM or hard disk) or via network (for example the Internet or WWW) by server or broadcasting bulletin system distribution.Certainly, some embodiments of the present invention can be implemented with the form of software (for example computer program) and hardware combinations.Additional embodiments of the present invention is all as hardware or implement with the form of software (for example computer program) substantially.

Should be noted that size, size and the quantity listed are exemplary here, and the present invention never is subject to this.In exemplary embodiment of the present invention, the length of the FLUID TRANSPORTATION device of patch size can be for roughly 6.35cm (～2.5 inches), width are roughly 3.8cm (～1.5 inches) and highly are roughly 1.9cm (～0.75 inch), but, equally, these sizes only are exemplary, and can change on a large scale for different embodiment sizes.

Though described principle of the present invention here, those skilled in the art should understand that this explanation only provides by way of example, but not as limitation of the scope of the invention.Except exemplary embodiment shown here and that describe, also can conceive other enforcement in the scope of the invention.The modification of making by those of ordinary skills and substitute and be considered to belong to scope of the present invention.

Claims (74)

1. one kind is distributed the fluidic method of treatment from pipeline, comprising:

The inlet line that can be connected to the upstream flow body source is provided, and described inlet line is in downstream and pumping chamber in fluid communication, and described pumping chamber has pump discharge; And

The brake function force applying assembly, thus flow backwards by described import when the described pumping chamber of pressurization limit fluid when actuating the stream through described pump discharge.

2. according to the process of claim 1 wherein, activate described force application assembly and comprise the stroke of the described force application assembly of use during driving stroke, flow backwards and the described pumping chamber that pressurizes with restriction in single mechanical action.

3. according to the method for claim 2, wherein, the travel limits of the given degree of described active force actuating assembly flows backwards, and the stroke of the higher degree described pumping chamber that pressurizes.

4. according to the process of claim 1 wherein, activate described force application assembly and comprise by stopping up described inlet line and limit refluence towards described fluid source.

5. according to the method for claim 1, also comprise:

By use place passive valve between dispensed chambers and the described pumping chamber prevent fluid from described dispensed chambers reverse flow to described pumping chamber.

6. according to the process of claim 1 wherein, activate described force application assembly and comprise the use shape memory actuator.

7. according to the method for claim 6, wherein, use described shape memory actuator to be included in induced phase change in the shape memory wire, to center on pulley to described force application assembly transfer function power.

8. according to the method for claim 1, also comprise:

Measure and mobile relevant parameter by described pipeline; And

Regulate the operation of described pump based on measured parameter.

9. method according to Claim 8 wherein, is measured the stereomutation that comprises the elastomeric chamber of determining to place described pumping chamber downstream with mobile relevant parameter by described pipeline.

10. according to the method for claim 9, wherein, measure described parameter and comprise the measurement of use acoustic volume.

11. according to the method for claim 10, wherein, the crooked flow resistance that is positioned at described elastomeric chamber downstream provide be enough to cause described elastomeric chamber in response to pumping expansible flow resistance.

12. method according to Claim 8 also comprises: cause fluid by crooked flow resistance conduit from described pump discharge flow further downstream.

13. according to the method for claim 12, wherein, described conduit has at least two elbows.

14. according to the method for claim 12, wherein, described conduit coils.

15. according to the method for claim 12, wherein, described conduit has serpentine shaped.

16. according to the method for claim 12, wherein, described conduit has at least one based on described fluidic viscosity and density, and length and the internal diameter that provides predetermined impedance to select is provided.

17. according to the method for claim 16, wherein, described catheter diameter is enough big, thereby prevents because fluid flow produces obstruction by described conduit.

18. method according to claim 1, wherein, described inlet line, described pumping chamber, described pump discharge and described force application assembly be encapsulated in patch size housing in, and activate described force application assembly and comprise that the processor that uses in the housing activates described force application assembly to cause.

19. according to the method for claim 12, wherein, described housing has full-size, and described conduit has greater than described maximum sized length.

20., activate described force application assembly and comprise and use shape memory actuator to respond to according to the process of claim 1 wherein.

21., wherein, use shape memory actuator to comprise that use is by one in a plurality of power paths with different length of described shape memory actuator according to the method for claim 20.

22. method according to claim 21, wherein, described force application assembly has and is used in normal mode of actuating the normal running that flows through described pump discharge and the fill-up mode that is used to pour into described pumping chamber, and wherein, use described shape memory actuator to be included in the long power path that uses the short power path of described shape memory actuator during the normal mode of described force application assembly and during the fill-up mode of described force application assembly, use described shape memory actuator.

23., wherein, activate described force application assembly and comprise and use a plurality of shape memory actuators to respond to according to the method for claim 20.

24., wherein, use a plurality of shape memory actuators to comprise and use them so that standby operation to be provided according to the method for claim 23.

25. according to the method for claim 23, wherein, the shape memory actuator that uses a plurality of shape memory actuators to comprise to use different numbers is to provide different actuation force or lengths of stroke.

26., wherein, use a plurality of shape memory actuators to comprise the shape memory actuator of at least two kinds of different lengths of use according to the method for claim 23.

27. method according to claim 23, wherein, described force application assembly has and is used in normal mode of actuating the normal running that flows through described pump discharge and the fill-up mode that is used to pour into described pumping chamber, and wherein, use short shape memory actuator and during the fill-up mode of described force application assembly, use long shape memory actuator during using a plurality of shape memory actuators to be included in the normal mode of described force application assembly.

28., wherein, use a plurality of shape memory actuators to comprise the shape memory actuator of at least two kinds of different sizes of use according to the method for claim 23.

29. a system that is used for pumping fluid by pipeline, described system comprises:

The pumping chamber, it has, and the import that is communicated with the fluid source fluid to provide can be provided, and pump discharge; And

Force application assembly, it is suitable for providing compression stroke to described pumping chamber,

Wherein, when from described pumping chamber when described pump discharge is actuated fluid, described compression stroke produces restriction for fluid from the refluence of described pumping chamber by described import.

30. system according to claim 29, wherein, described force application assembly is coupled to imported valve actuator and pump actuator, thereby when described pump actuator makes fluid when described pumping chamber is urged into described pump discharge, described compression stroke is actuated at the imported valve that is connected between described import and the described fluid source, to close described valve.

31. according to the system of claim 30, wherein, described force application assembly comprises plate, described plate is connected to described valve actuator, described pump actuator and motor, is used to coordinate the operation of described valve actuator and described pump actuator.

32. according to the system of claim 31, wherein, described motor comprises shape memory actuator.

33. according to the system of claim 32, wherein, described motor comprises at least one pulley, it adapts to the reuse part but described pulley is used for folding described shape memory actuator.

34. according to the system of claim 29, wherein, described force application assembly comprises motor.

35. according to the system of claim 34, wherein, described motor comprises shape memory actuator.

36. according to the system of claim 35, wherein, described shape memory actuator is electrically connected, thereby a plurality of power paths with different length by described shape memory actuator are provided.

37. system according to claim 36, wherein, described force application assembly has normal mode that is used for the described pumping chamber of operation under normal pumping state and the fill-up mode that is used to pour into described pumping chamber, and wherein uses long power path during short power path that uses described shape memory actuator during the normal mode of described force application assembly and the fill-up mode at described force application assembly.

38. according to the system of claim 34, wherein, described motor comprises a plurality of shape memory actuators.

39. according to the system of claim 38, wherein, described a plurality of shape memory actuators provide the standby operation of described force application assembly.

40. according to the system of claim 38, wherein, the shape memory actuator of different numbers is used to the actuation force or the length of stroke that provide different.

41. according to the system of claim 38, wherein, described a plurality of shape memory actuators comprise the shape memory actuator with at least two kinds of different lengths.

42. system according to claim 41, wherein, described force application assembly has normal mode that is used for the described pumping chamber of operation under normal pumping state and the fill-up mode that is used to pour into described pumping chamber, and wherein uses long shape memory actuator using short shape memory actuator during the normal mode of described force application assembly during the fill-up mode at described force application assembly.

43. system according to claim 41, wherein, described force application assembly is operated with the basic schema and the pattern of injecting at least, when being in described basic schema, described pumping chamber is with basic speed output fluid, and it is described when injecting pattern when being in, described pumping chamber is to inject speed output fluid, the described speed of injecting is wherein used long shape memory actuator using short shape memory actuator during the basic schema of described force application assembly during the pattern of injecting at described force application assembly greater than described basic speed.

44. according to the system of claim 38, wherein, described a plurality of shape memory actuators comprise the shape memory actuator with at least two kinds of different sizes.

45., comprise also and the placed in-line downstream of described pump discharge allocation component that described allocation component comprises the elasticity dispensed chambers according to the system of claim 29.

46., also comprise the pick off that is used to measure with mobile relevant parameter by described pipeline according to the system of claim 45.

47. according to the system of claim 29, wherein, described pumping chamber, described import, described outlet and described active force actuating assembly are the members that size is suitable for the FLUID TRANSPORTATION device worn as paster.

48., also comprise the high impedance conduit of the bending that is positioned at described allocation component downstream according to the system of claim 45.

49. according to the system of claim 48, wherein, described conduit has at least two elbows.

50. according to the system of claim 48, wherein, described conduit coils.

51. according to the system of claim 48, wherein, described conduit has serpentine shaped.

52. according to the system of claim 48, wherein, described conduit has at least one based on fluidic viscosity and density, and length and the internal diameter that provides predetermined impedance to select is provided.

53. according to the system of claim 48, wherein, the internal diameter of described conduit is enough big, thereby prevents because treatment liquid causes obstruction by described pipe flow.

54., also comprise the passive valve that is used to force towards the one-way flow of described output according to the system of claim 29.

55. according to the system of claim 54, wherein, described passive valve is positioned at the downstream of described pumping chamber.

56. according to the system of claim 55, wherein, described passive valve is positioned at the upstream of described allocation component.

57. system according to claim 29, wherein, at least one part of described pipeline and disposable member form one, but and described force application assembly and detachable reuse member formation one, but and the described reuse member of the adjacency of the diaphragm material on the described disposable member.

58. according to the system of claim 57, wherein, described diaphragm material covers the zone of the described pumping chamber of qualification, imported valve and passive valve in the described pipeline, thereby forces the one-way flow towards described output.

59. according to the system of claim 58, wherein, described force application assembly makes metamorphosis power put on and covers each the regional diaphragm material that defines described valve, to realize closing of described valve.

60. according to the system of claim 58, wherein, described force application assembly makes metamorphosis power put on the diaphragm material that covers the zone that defines described pumping chamber, to realize actuating fluid from described pumping chamber.

61. according to the system of claim 29, wherein, the described pumping chamber of compression with actuate flow by described outlet before, described force application assembly is realized the sealing of described import.

62. according to the system of claim 61, wherein, described active force applies parts and comprises inlet seal parts and the pump pressure parts that contract.

63. system according to claim 62, wherein, described active force applies parts and comprises driver part, contract parts and activate described inlet seal parts of the described pump pressure that activates described driver part via Packing spring, thereby even when described pump pressure contract parts when on described pumping chamber, applying pump action power described active force apply parts and also constantly load described Packing spring.

64. system according to claim 62, also comprise and activate the contract driver part of parts of described inlet seal parts and described pump pressure, described inlet seal parts comprise the Packing spring between the one support member of described driver part and described seal member, described inlet seal parts slidably are arranged in the opening of described driver part

The described pump pressure parts that contract comprise return spring between distally compression member support member and described driver part,

Wherein during driving stroke, even when driving described pump pressure towards described pumping chamber and contract parts, when described driver part when the axle of described seal member slides, described driver part compresses described Packing spring to transmit activation force via the all-in-one-piece support member to described seal member.

65. according to the system of claim 64, wherein, even contract parts when applying pump action power on described pumping chamber when described pump pressure, described Packing spring also is compressed.

66. according to the system of claim 65, wherein, described compression member also comprises by limiting the distally stop of backward stroke with contacting of described support member.

67. system according to claim 65, wherein, described seal member comprises the nearside extension, and described nearside extension extends beyond the opening of described driver part, thereby during backward stroke, described driver part engages and makes described extension displacement to allow to flow through described import.

68. according to the system of claim 29, wherein, described force application assembly is activated by shape memory actuator.

69. according to the system of claim 54, wherein, described passive valve comprises lift valve, described lift valve utilizes the lift valve biasing spring and is biased on the barrier film of institute's seating.

70. according to the system of claim 69, wherein, a kind of mechanical dominance helps the lifting of described lift valve.

71. a valve that is used for one-way flow, described valve comprises:

First with import and outlet, described outlet has the valve seat along circumferential setting;

Have active force and apply the second portion of parts; And

The barrier film that separates described first and described second portion,

Wherein, described active force applies parts and applies biasing force, thereby barrier film is remained against described valve seat to limit towards flowing of described outlet or flowing from described outlet with sealing means, unless the fluid pressure in described import or described outlet is enough to overcome described biasing force, make described barrier film break away from described valve seat thus and form and pass through flowing of described valve

Wherein, when described barrier film is held described valve seat with sealing means, compare with described outlet fluid downstream, the fluid of described import upstream contacts described membranous bigger zone, give bigger mechanical dominance for described upstream fluid thus and make described valve response open, and promote from described import and to the one-way flow of described outlet in the lower pressure of described import department and the elevated pressures in the described outlet.

72., wherein, be the reuse part but described first is single use portion and described second portion according to the valve of claim 71.

73. according to the valve of claim 71, wherein, described active force applies parts and also comprises spring and lift valve.

74., also comprise the mechanism that is used for the regulating spring active force according to the valve of claim 73.

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