Source: https://patents.google.com/patent/CN104474606A/en
Timestamp: 2020-02-17 22:59:35
Document Index: 705409627

Matched Legal Cases: ['Application No. 61', 'Application No. 61', 'art 226', 'art 226', 'art 226', 'art 226', 'art 226', 'art 654', 'art 654', 'art 654', 'art 654', 'art.\n4', 'art.\n5']

CN104474606A - Fluid delivery device - Google Patents
CN104474606A
CN104474606A CN201410635389.7A CN201410635389A CN104474606A CN 104474606 A CN104474606 A CN 104474606A CN 201410635389 A CN201410635389 A CN 201410635389A CN 104474606 A CN104474606 A CN 104474606A
CN201410635389.7A
CN104474606B (en
S.F.莱韦斯克
2009-10-13 Priority to US61/251236 priority
2010-04-16 Priority to US61/325136 priority
2010-10-12 Application filed by 瓦莱里塔斯公司 filed Critical 瓦莱里塔斯公司
2010-10-12 Priority to CN201080046063.0A priority patent/CN102665799B/en
2015-04-01 Publication of CN104474606A publication Critical patent/CN104474606A/en
2017-04-26 Publication of CN104474606B publication Critical patent/CN104474606B/en
The application is divisional application.The application number of original application is 201080046063.0, and the applying date is on October 12nd, 2010, and denomination of invention is " fluid delivery system ".
The application advocates that the name submitted on October 13rd, 2009 is called the U.S. Provisional Patent Application No. 61/251 of " Fluid Delivery Device ", 236 and be called the U.S. Provisional Patent Application No. 61/325 of " Fluid Delivery Device " in the name submitted on April 16th, 2010, the rights and interests of 136, both is integrally incorporated into herein by the mode quoted.
The present invention relates to fluid delivery system by and large, and more particularly relates to for delivering medicament/medicament to portable (ambulatory) device of patient.
Many trials are made by using the dosage (dosing) of the portable pump system medicine that provides such as insulin such and other fluid.Although work well for some system of lasting conveying, use the individual of these systems, particularly in successive doses pattern, need to monitor that this device is to guarantee to carry out seriality and the accuracy of dosage under the changing environmental conditions that such as temperature and air pressure are so nearly.In addition, several selection can be there is for the individual that needs can change drug dose rapidly and exactly, and the available selection of major part is troublesome, unworkable, intrusive mood and/or costliness.
Therefore, will need to provide a kind of simple, directly perceived, cheap mancarried device, it can provide fluid dosing under Patients' rights, and safety under the environmental condition being provided in relative broad range in metering and/or successive doses and concordance.
In one embodiment, provide a kind of fluid delivery system, it comprises housing, and housing has fluid reservoir.Needle set has storage location, ready (armed) position pending and bonding station.Pin to be fluidly communicated with fluid reservoir at bonding station and not fluidly to be communicated with fluid reservoir with during storage location at ready cocked orientation.Biasing member has near-end and far-end, and the near-end of biasing member is connected to housing and the far-end of biasing member is configured in order to carrying capacity to fluid reservoir.Piston component extends through biasing member and is connected to the far-end of biasing member.Piston component is fixed on latched position relative to housing, thus make biasing member not carrying capacity to fluid reservoir; And can move in off-position relative to housing, thus make biasing member carrying capacity to fluid reservoir.Pin is transitioned into ready cocked orientation from storage location makes piston be transitioned into off-position from latched position.
In an embodiment again, fluid delivery system comprises hydraulic basis chamber, and it is connected between biasing member and fluid reservoir.In an embodiment again, fluid delivery system comprises hydraulic pump chamber and flow restrictor, and flow restrictor fluidly connects hydraulic pump chamber and hydraulic basis chamber.In one embodiment, piston comprises the plunger top being connected to hydraulic basis chamber.In one embodiment, at storage location, piston utilizes the pin extending through housing and the cap extended above pin and is connected to described housing releasedly, and cap is connected to pin thus makes to remove described cap and then releases piston.In one embodiment, biasing member comprises at least two overlapping coaxial springs.
In another embodiment, fluid delivery system comprises housing, and housing has fluid reservoir.First biasing member is connected to housing.Second biasing member is in series connected to the first biasing member, and overlapping at least in part with the first biasing member.First biasing member and the second biasing member are configured in order to carrying capacity to fluid reservoir.In an embodiment again, fluid delivery system comprises plunger, and it extends through the first biasing member and the second biasing member.In one embodiment, plunger is connected to the second biasing member at far-end, and is connected to housing releasedly in proximal end.In one embodiment, plunger utilization extends through the pin of housing and plunger and is connected to housing releasedly.In one embodiment, plunger utilizes pin to be connected to housing releasedly, and described pin extends through housing and also comprises the pin covering being connected to pin.
In an embodiment again, fluid delivery system comprises hydraulic basis chamber, and it is connected in the first biasing member and between the second biasing member and hydraulic pump chamber; And flow restrictor, it is connection person's hydraulic basis chamber and hydraulic pump chamber fluidly.In one embodiment, hydraulic pump chamber has the sectional area less than the sectional area of hydraulic basis chamber.In an embodiment again, fluid delivery system comprises sleeve, and the first biasing member and the second biasing member are connected by it.Sleeve has the length equaling overlap length between the first biasing member and the second biasing member substantially.In one embodiment, sleeve has main body, the first flange end and the second flange end, first flange end is extending radially outwardly from sleeve body and is being configured in order to be connected with the end of the first biasing member, and the second flange end is extending radially inwardly from main body and is being configured to be connected with the end of the second biasing member.
In another embodiment, fluid delivery system comprises: attaching surface, and it is configured to engage with skin surface and have the first thermal conductivity; And, hydraulic pump chamber.Hydraulic basis chamber has near described attaching surface and has a part for the outer wall of the second thermal conductivity.Second thermal conductivity is greater than the first thermal conductivity.Flow restrictor fluidly connects hydraulic basis chamber and hydraulic pump chamber.Fluid reservoir is connected to hydraulic pump chamber.Fluid reservoir is configured to comprise the fluid that can be transported to patient.Actuator is connected to hydraulic basis chamber.Actuator is configured in order to pressurize to hydraulic pump chamber to carry described fluid to fluid reservoir with continuing basis speed by hydraulic basis chamber and hydraulic pump chamber transferring energy.In one embodiment, attaching surface comprises thermal insulation member.
In one embodiment, thermal insulation member is removed to expose at least in part the part of the outer wall of the hydraulic basis chamber close with attaching surface at least in part.In one embodiment, fluid reservoir is spaced apart with housing at least in part.In an embodiment again, fluid delivery system comprises housing, and housing has basal surface.The outer wall section of hydraulic basis chamber stretches out from the basal surface of housing.In one embodiment, the part of the outer wall of hydraulic basis chamber has the imaginary tangent line aimed at attaching surface substantially/align.In one embodiment, the part of the described outer wall of hydraulic basis chamber is configured to directly contact skin surface.In one embodiment, the remainder of the outer wall of hydraulic basis chamber has the 3rd thermal conductivity.3rd thermal conductivity is less than described second thermal conductivity.
Accompanying drawing in conjunction with exemplary embodiment is read, and the detailed description of summary of the invention above and hereafter fluid delivery system embodiment will better be understood.But should be appreciated that the present invention is not limited to illustrated precise arrangements/layout and instrumentality.
Fig. 1 is the perspective view of the fluid delivery system according to exemplary embodiment of the present invention.
Fig. 2 is the decomposition diagram of the fluid delivery system shown in Fig. 1.
Fig. 3 is the schematic top, cross-sectional view of the fluid delivery system according to exemplary embodiment of the present invention.
Fig. 4 A is the cross-sectional top view of the fluid delivery system shown in Fig. 1 of intercepting along the line 4A-4A in Fig. 1.
Fig. 4 B is the top fragmentary sectional view of the fluid delivery system shown in Fig. 1 of intercepting along the length of flow restrictor.
Fig. 5 is the elevational sectional view of the fluid delivery system shown in Fig. 1 of intercepting along the line 5-5 in Fig. 1.
Fig. 6 A is the basic hydraulic chamber of fluid delivery system shown in Fig. 1 of intercepting along the line 6A-6A of Fig. 1 and the side cross-sectional, view of biasing member, illustrates and is in initial position.
Fig. 6 B is the side cross-sectional, view that Fig. 6 A being in bonding station is shown.
Fig. 6 C is the side cross-sectional, view that Fig. 6 A being in bonding station is shown after one period of service time.
Fig. 7 comprises compared with the side cross-sectional, view of routine list biasing member, the first biasing member of the fluid delivery system shown in Fig. 1 and the side cross-sectional, view of the second biasing member.
What Fig. 8 was the fluid delivery system shown in Fig. 1 of intercepting along the line 8-8 in Fig. 1 injects button and injects the side cross-sectional, view of hydraulic chamber.
Fig. 9 A on user, be in bonding station Fig. 1 shown in the diagrammatic perspective view of fluid delivery system, and illustrate that user will be injected button and be unlocked.
Fig. 9 B on user, be in bonding station Fig. 1 shown in the diagrammatic perspective view of fluid delivery system, and illustrate that button is injected in user pressing.
Figure 10 A is the local cross-sectional top view of the fluid delivery system shown in Fig. 1 of intercepting along line 4A-4A, wherein injects button and is in original locked position;
Figure 10 B is the partial elevational sectional view of the fluid delivery system shown in Figure 10 A of intercepting along line 10B-10B.
Figure 11 A is the local cross-sectional top view of the fluid delivery system shown in Fig. 1 of intercepting along line 4A-4A, wherein injects button and is in off-position;
Figure 11 B is the partial elevational sectional view of the fluid delivery system shown in Figure 11 A of intercepting along line 11B-11B.
Figure 12 A is the local cross-sectional top view of the fluid delivery system shown in Fig. 1 of intercepting along line 4A-4A, wherein after conveying bolus dose, injects button and is in latched position.
Figure 12 B is the partial elevational sectional view of the fluid delivery system shown in Figure 12 A of intercepting along line 12B-12B.
Figure 13 A is the local cross-sectional top view of the fluid delivery system shown in Fig. 1 of intercepting along line 4A to 4A, wherein injects button and is in latched position and release-push is in latched position and indicates and injects button and be fully deployed.
Figure 13 B is the partial elevational sectional view of the fluid delivery system shown in Figure 13 A of intercepting along line 13B-13B.
Figure 14 is the side cross-sectional, view of the pump chambers of the fluid delivery system shown in Fig. 1 of intercepting along line 14-14, medical piston and fluid reservoir.
Figure 15 is the amplification side cross-sectional, view of the medical piston shown in Figure 14.
Figure 16 A is for being in initially or the perspective view of the fluid delivery system shown in Fig. 1 of storage location.
Figure 16 B is the perspective view of the fluid delivery system shown in Fig. 1, and removes button cap and engage biasing member.
Figure 16 C for be in bonding station Fig. 1 shown in the perspective view of fluid delivery system.
Figure 17 is the elevational sectional view of the fluid delivery system shown in Figure 16 A of intercepting along line 17-17.
Figure 18 is the elevational sectional view of the fluid delivery system shown in Figure 16 C of intercepting along line 18-18.
Figure 19 is the amplification elevational sectional view of a part for the pin with the pin cap shown in Figure 18.
Figure 20 is the exploded partial cutaway view of the locking assembly of the fluid delivery system of Fig. 1.
Figure 21 is the top view partial sectional view of the locking assembly of the fluid delivery system of the Fig. 1 being in initial or ready position to be joined.
Figure 22 for be in locked position of coupler Fig. 1 shown in the top view partial sectional view of locking assembly of fluid delivery system.
Figure 23 A is the partial bottom planar view of the fluid delivery system of Fig. 1, and removes sticking tablet to illustrate the lock button being in initial position.
Figure 23 B is the partial bottom planar view of the fluid delivery system shown in Figure 23 A, and wherein lock button moves at first direction; And
Figure 23 C is the partial bottom planar view of the fluid delivery system shown in Figure 23 A, and wherein lock button moves at first direction and second direction.
In detail referring to accompanying drawing, identical in all of the figs Reference numeral instruction similar components, shows the fluid delivery system being labeled as 110 according to exemplary embodiment of the present invention substantially at Fig. 1 to 23C.Fluid delivery system 110 can comprise one or more feature as herein described, and it is convenient or improve the accurate conveying of fluid and be easy to be used by user or patient.The benefit provided by these features is easy to change the patient's compliance/compliance (patient compliance) improved to some extent and the therapeutic outcome improved to some extent into.
In one embodiment, fluid delivery system 110 is discrete portable insulin delivery pump.Fluid delivery system 110 can be that single uses, disposable and can not re-use.In a preferred embodiment, fluid delivery system 110 is entirely mechanical and hydraulic pressure and does not have electronic unit or aspect.There is provided excellent treatment ability in the non-returnable container that fluid delivery system 110 can use at small-sized single, and high-volume production making (such as, injection-molded) and assembling process can be used to produce, allow to realize low cost commodity.Device of the present invention can be used for range of application widely, include, but is not limited to clinical practice (to drugs etc.) and biomedical research (such as, microinjection enters cell, and core or organelle are transplanted, individual cells or the isolation of hybrid tumor etc.).
In one embodiment, fluid delivery system 110 is the device for distributing, carry or feed fluid or preparation to user or patient.This fluid can be any treatment preparation.In one embodiment, this fluid is low viscosity glue preparation/gel preparation (gel agent).In one embodiment, this fluid is analgesic.In one embodiment, this fluid is insulin.In one embodiment, this fluid is U100 insulin.In another embodiment, this fluid is U200 insulin.In another embodiment, this fluid is U300 insulin.In another embodiment, this fluid is U500 insulin.In another embodiment, this fluid is any insulin between U100 and U500.In other embodiments, fluid can be (but being not limited to) opiate and/or other demulcent/slow releasing agent or analgesic, hormone, spiritual healing compositions or needs continuous dosage or be effectively used for the treatment of any other medicines or the chemicals of patient.The combination (mixing or co-administered) of single fluid and two or more fluid can use fluid delivery system 110 to be transferred." patient " or " user " can be people or non-human animal as used herein, and the purposes of fluid delivery system 110 is not limited in people's medicine, but can be equally applicable to veterinary drug.
Fluid delivery system 110 can in sustained periods of time distributing fluids (that is, basis conveying).In one embodiment, fluid delivery rate in sustained periods of time continuously or close to flowing to user constantly.Fluid delivery system 110 also can distribute the fluid (that is, injecting conveying) of magnitude of recruitment according to demand under the control of patient, based on amount supplement.In one embodiment, as further discussed below, the bolus amount of carrying in the selectable administration of single is predetermined.In a preferred embodiment, fluid delivery system 110 is actuated with hydraulic way, and the one or more reservoir comprised containing the hydraulic fluid of appropriate viscosity or chamber, its for by the power transmission from one or more actuator to fluid and control transfer rate, as discussed further below.
An exemplary embodiment of fluid delivery system 110 is shown in the schematic shown in figure 3, and it illustrates alternative pack and their relation.Fluid delivery system 110 can have the first operable state and the second operable state, first operable state is used for passing through infusion set or pin 312 conveyance fluid with continuous or continuing basis dosage, and the second operable state is used for bolus dose by pin 312 conveyance fluid.In certain embodiments, fluid delivery system can be in the first operable state and the second operable state simultaneously, that is, carry bolus dose supplementing as the basal dose of fluid.In one embodiment, bolus dose is the dosage of fixed increment.In another embodiment, when being started by user, injection functions can be carried and multiplely discrete inject increment.In certain embodiments, basal delivery rate is predetermined and presets.
In one embodiment, fluid delivery system 110 comprises three hydraulic reservoir devices or chamber, and hydraulic basis chamber 314, hydraulic pressure inject chamber 316 and hydraulic pump chamber 318.In certain embodiments, hydraulic pressure injects the chamber of chamber 314 and hydraulic pump chamber 318 share common, and/or the flowing of injecting between chamber 316 and hydraulic pump chamber 318 between hydraulic pressure is unrestricted, as further described in this article.In a preferred embodiment, hydraulic basis chamber 314 and hydraulic pressure inject chamber 316 is by independent and independently basic actuator 320 and inject actuator 322 and come individually and actuate independently.
Now referring to Fig. 3, in one embodiment, hydraulic basis chamber 314 and hydraulic pressure are injected chamber 316 and are acted on hydraulic pump chamber 318, and hydraulic pump chamber 318 acts on fluid reservoir or delivery chamber 324 then, and the latter comprises fluid.In other embodiments, hydraulic basis chamber 314 and hydraulic pressure are injected chamber 316 and are acted on separately in different pump chambers, and each pump chambers is functionally connected to independent fluid reservoir (not shown).
Now referring to Fig. 2, hydraulic basis chamber 314, hydraulic pressure inject chamber 316 and hydraulic pump chamber 318 can be limited by manifold 226.In one embodiment, manifold 226 is integral type single-piece part 226.In one embodiment, manifold 226 is made up of polymer.In one embodiment, manifold 226 is made up of polrvinyl chloride (PVC).In one embodiment, the part of hydraulic pump chamber 318 and fluid reservoir 324 are limited by fluid cartridge 228.In one embodiment, fluid cartridge 228 is made up of polymer.In one embodiment, fluid cartridge 228 is made up of Topas 6017 S-04.Hydraulic basis chamber 314, hydraulic pressure inject chamber 316 and hydraulic pump chamber 318 can be cylindrical.In other embodiments, hydraulic pump chamber 314,316,318 and fluid reservoir 324 have any cross sectional shape, such as square, rectangle or triangle.In one embodiment, the first moveable barrier 230 has separated basic actuator 320 and hydraulic basis chamber 314.In one embodiment, the second moveable barrier 232 has been separated and is injected actuator 322 and inject chamber 316 with hydraulic pressure.In one embodiment, the 3rd moveable barrier 234 has separated hydraulic pump chamber 318 and fluid reservoir 324.The first moveable barrier 232 of moveable barrier 230, second and the 3rd moveable barrier 234 can be piston, as is further described hereinbelow.In other embodiments, the first moveable barrier 232 of moveable barrier 230, second and the 3rd moveable barrier 234 can be any barrier that can transmit movement between such two chambers of such as film or expandable wall.
Hydraulic basis chamber 314 with inject chamber 316 can be parallel on both sides with fluid reservoir 324, isolated at hydraulic pump chamber 318, and aim at (as illustrated) to provide compacter structure with hydraulic pump chamber 318 and fluid reservoir 324 substantially.In one embodiment, hydraulic pump chamber 318 is set to towards the side of fluid delivery system 110.In other embodiments, hydraulic basis chamber 314, hydraulic pressure inject chamber 316 and hydraulic pump chamber 318 is arranged as any structure, and it allows fluid to be communicated with and the profile realized needed for fluid delivery system 110, is such as stacked as triangular construction.
Basis actuator 320 can act on comprise hydraulic fluid hydraulic basis chamber 314 on to pressurize to hydraulic basis chamber 314, and force hydraulic fluid to be entered in hydraulic pump chamber 318 by flow restrictor 336.Generally speaking, but not necessarily, the hydraulic fluid in hydraulic pump chamber 318 can be same or analogous with the hydraulic fluid in hydraulic basis chamber 314 on forming.If compared with not being provided with the situation of flow restrictor 336, actuating of basic actuator 320 can cause hydraulic fluid to flow in hydraulic pump chamber 318 from hydraulic basis reservoir 320 with the speed reduced.Along with the volume of the hydraulic fluid in hydraulic pump chamber 318 increases, the 3rd removable barrier 234 is shifted, compresses or reduce the volume of fluid reservoir 324 and the fluid be contained in wherein is discharged by output aperture or pin 312 with continuing basis speed.In one embodiment, basal rate is substantial constant.
In certain embodiments, inject actuator 322 to act on hydraulic pressure independently and inject on chamber 316.In one embodiment, inject actuator 322 to directly act on hydraulic pump chamber 318.But should be appreciated that, the present invention is not limited to the device comprising basis and inject ability.The device of the present invention with one or more feature as herein described can comprise base power, injects ability, or base power and inject both abilities.
Hydraulic pressure injects the hydraulic fluid that chamber 316 and hydraulic pump chamber 318 all can comprise proper viscosity.Generally speaking, but not necessarily, the composition of the hydraulic fluid in hydraulic pump chamber 318 will be that inject the composition of the hydraulic fluid in chamber 316 with hydraulic basis chamber 314 and hydraulic pressure same or analogous.Inject actuating or be shifted and making the 3rd moveable barrier 234 be shifted independently of actuator 322, compression or the volume and making reducing fluid reservoir 324 are contained in fluid wherein and are discharged by the such output aperture of such as pin 312.Basis actuator 320 and while injecting both actuators 322 operation make to operate separately the compressed fluid reservoir 324 with larger amount than arbitrary actuator.
When it is present, basis actuator 320 and inject both actuators 322 and can be integrated in the system of actuating with hydraulic way, thus make to allow each function to provide independent transfer power to common moveable barrier 234, this makes fluid displacement in common fluid reservoir 324 with from device distributing fluids then.In other embodiments, basis actuator 320 and inject actuator 322 and can be integrated in the system of actuating with hydraulic way thus to make to allow often kind of function to provide independent transfer power to moveable barrier (not shown) separately, this makes fluid be shifted from independent fluid reservoir (not shown) then.The example of the many fluid delivery systems used in conjunction with proposed the present invention is open in U.S. Patent Publication No.2009/0240232, and it is integrally incorporated into herein by the mode quoted.
In one embodiment, fluid delivery system 110 has used the combination of power, high viscosity, very high viscosity or hyperviscosity fluid and flowing restriction with conveyance fluid on continuous or lasting basis.Flow restrictor 336 can be convenient to carry out continuous fluid transmission with basal rate, among other things, particularly between hydraulic basis chamber 314 and hydraulic pump chamber 318, form larger pressure reduction or pressure drop, allow the friction change of relative broad range in system tolerates system, the such as the 3rd movement of removable barrier 234 in fluid cartridge 228; The less change of tolerance flow resistance; And overcome may block in flow path.In one embodiment, the pressure reduction during use between hydraulic basis chamber 314 and hydraulic pump chamber 318 is approximately 10:1.In one embodiment, the pressure reduction during use between hydraulic basis chamber 314 and hydraulic pump chamber 318 is approximately 46:1.In one embodiment, hydraulic basis chamber 314 operates with the pressure between about 20psi and 70psi.In one embodiment, hydraulic basis chamber 314 operates at the pressure of about 46.8psi.In one embodiment, hydraulic pump chamber 318 operates with the pressure of about 0.5psi to about 5psi.In one embodiment, hydraulic pump chamber 318 operates at the pressure of about 1.2psi.
Flow restrictor 336 is suitable for the speed of control flow check through its fluid dimensionally.In one embodiment, flow restrictor 336 has the diameter of about 1-1000 μm.Should be appreciated that, all scopes provided in this article comprise starting point and the terminal (such as, comprising 1 μm and 1000 μm in the scope of about 1 to about 1000 μm) of this scope, and all values between them.Regardless of the shape of flow restrictor 336, the sectional area of opening and the size of length will be confirmed as realizing required flow rate.For example, the diameter of flow restrictor 336 can be about one thousandth to ten (or 2-3 μm) of an inch.Depend on purposes, the size of flow restrictor 336 can be any value, include, but is not limited between 200 nm to 500 nm, or between 500 nm to 1000 nm, or the diameter between 1 to 2 μm or between 5 to 10 μm or between 10-1000 μm.In one embodiment, the external diameter of flow restrictor 336 is about 0.026 inch, and the internal diameter of flow restrictor 336 is one of about 0.00758 inch, 0.00708 inch and 0.00638 inch.In one embodiment, the length of flow restrictor 336 and external diameter keep constant between the devices based on the size of manifold 226, and the internal diameter of flow restrictor 336 can be modified to realize required flow rate.Can select other size and the size of flow restrictor 336, and selected size and size will depend on current application, and depend on especially hydraulic fluid viscosity and by basic actuator 320 applied force.In one embodiment, flow restrictor 336 is made up of topaz.Make to form flow restrictor 336 by topaz and can assist in ensuring that flow restrictor 336 has substantially accurate and constant cross-sectional sizes and shape.Those skilled in the art will understand that, can adopt any suitable flow restrictor 336, and the size and shape of flow restrictor 336 can be different from the required flow rate realizing the fluid mediating/pass under anticipated conditions (comprising temperature and ambient pressure).Flow restrictor 336 without the need to having circular section shape, but can be ellipse, square, rectangle, triangle, polygon or irregularly shaped.By test under concern condition the fluid flow selected by the size and shape empirically determining flow restrictor 336.
Now referring to Fig. 4 B, in one embodiment, flow restrictor 36 extends through the sidepiece 410a of fluid delivery system 110.In one embodiment, flow restrictor 336 extends through hydraulic pressure and injects chamber 316, thus makes hydraulic pressure inject chamber 316 to be fluidly communicated with hydraulic basis chamber 314 by flow restrictor 336 and hydraulic basis chamber 314 and hydraulic pressure are injected chamber 316 and is fluidly communicated with hydraulic pump chamber 318 by unrestricted fluid passage 438.In alternative embodiments, fluid passage 438 is restricted, to delay the transfer rate of bolus dose instead of to make transfer rate close to the rate travel equaling to inject actuator 322.
Continue referring to Fig. 4 B, in one embodiment, flow restrictor 336 comprises guiding connector 440.In one embodiment, guide connector 440 to be sealed by manifold 226, and guide connector 440 to be positioned in fluid passage 438 by flow restrictor 336.In one embodiment, guide connector 440 to comprise opening 440a and inject chamber 316 for fluidly connecting described flow restrictor 336 with hydraulic pressure.Flow restrictor 336 can be fixed to manifold 226 by epoxide.In one embodiment, guide connector 440 and flow restrictor 336 to be made up of trnaslucent materials substantially, thus make can by flow restrictor 336 with guide connector 440 to be inserted in manifold 226 in utilize the resin of ultraviolet-curing to be fixed on manifold 226 by flow restrictor 336 afterwards.
When starting fluid delivery system 110, basic actuator 320 acts on hydraulic fluid, adds the pressure in hydraulic basis chamber 314.Due to the result that this pressure increases, the hydraulic fluid in hydraulic basis chamber 314 starts to flow through flow restrictor 336 and enters into hydraulic pressure and inject in chamber 316.In one embodiment, inject actuator 320 to prevent from hydraulic pressure from injecting chamber 316 expanding, and the hydraulic fluid from hydraulic basis chamber 316 flows through fluid passage 438 and enters in hydraulic pump chamber 318, wherein hydraulic fluid makes the 3rd moveable barrier 234 be shifted, and causes the fluid in fluid reservoir 324 to leave fluid delivery system 110 with continuing basis speed.In one embodiment, basal rate is that preset by manufacturer or predetermined.The embodiment of fluid delivery system 110 can be used to such as, but not limited to 1 minute, 1 hour, 6 hours, 12 hours, 1 day, 3 days, 5 days, 10 days or 1 month equal time scope conveyance fluid continuously.In certain embodiments, fluid is discharged from fluid delivery system 110 to be selected from (but being not limited to) following basal rate: about 0.1 μ l per hour to about 10 μ l, per hour about 10 to about 100 μ l, about 100 μ l per hour to about 1 ml per hour, about 1 ml per hour to about 100 ml, or about 100 ml per hour to about 200 ml.In one embodiment, basal rate is unit about every day 100, and it is 42 μ l per hour or every 24 hours 1000 μ l.Selected speed and transport cycle will depend on current application, and those skilled in the art can determine the suitable dose rates for given application.
Now referring to Fig. 3, the embodiment of fluid delivery system 110 is connected to infusion set or pin 312 by the junction point at the far-end 324a place in fluid reservoir 324.In alternative embodiments, pin 312 can be positioned on the sidewall of fluid reservoir 324.Pin 312 can be substituted by any conveyer device, such as lumen, pin group, conduit-sleeve pipe group or micropin or the microneedle array adhered to by means of one or more lumen.
In one embodiment, during fabrication based on flow restrictor 336 selection, in conjunction with the viscosity of hydraulic fluid and the power of supply on hydraulic basis chamber 314, preset basic flow rate.Alternately, the length of flow restrictor 336 and/or diameter can be adjusted according to demand to change basic flow rate.In other embodiments, the size of flow rate adjustable limiter 336, realizes as the gating slit (not shown) by means of adjustable iris nibs or telescopic limiter Channel Micro valve or pairing.In an alternative em bodiment, electric notor or piezo-electric device (not shown) can be used for opening or closing closed pore, thus affect hydraulic fluid and flow into the speed in pump chambers and the 3rd moveable barrier 234 is shifted.
Hydraulic fluid can be any compressible, flowable material, such as gel or the set of miniature solid pearl.In one embodiment, hydraulic fluid is the material of ultrapure biologically inert.In one embodiment, hydraulic fluid is silicone oil.The upper limit being suitable for viscosity of hydraulic fluid is subject to the size restriction of flow restrictor 336.At its lower limit, hydraulic fluid sufficiently glues, the energy of flow of hydraulic fluid is remain by the combination of size of the pressure versus flow limiter 336 being derived from basic actuator 320 under the environmental condition of relative broad range regulate to a great extent, particularly when there is low atmospheric pressure and/or high environment temperature (its medium viscosity is tended to reduce).
" high viscosity " represents that working hydraulic pressure fluid has at least approximately ISO VG 20 as used herein, or at least about ISO VG 32, or at least about ISO VG 50, or at least about ISO VG 150, or at least about ISO VG 450, or at least about ISO VG 1000, or the viscosity grade of at least about ISO VG 1500 or higher.In one embodiment, hydraulic fluid is very full-bodied fluid." very high viscosity " represents that working hydraulic pressure fluid has the viscosity of from about 80,000 to about 180,000 cP as used herein.In one embodiment, hydraulic fluid is hyperviscosity fluid (such as, from about 180,000 to about 200cP).In one embodiment, hydraulic fluid has 100, the viscosity of 000 centistoke.
In one embodiment, change on the contrary due to viscosity with temperature, importantly keep hydraulic fluid to be in less constant temperature.The time of fluids administration is worn on the body of the user, be continue for fluid delivery system 110.Fluid delivery system 110 can be suitable for being attached on user health via sticking tablet 542 (referring to Fig. 5) dimensionally, as hereafter further describing.Therefore, fluid delivery system 110 will expose to the range of environmental conditions matched with patient lifestyle.If suitably do not controlled the variations in temperature of hydraulic fluid, then higher ambient temperature can cause viscosity to reduce, and causes fluid flow to increase; And lower ambient temperature can cause viscosity to increase, and causes fluid flow to reduce.In one embodiment, hydraulic fluid is made to reach less constant temperature corresponding to user skin temperature.Therefore, in certain embodiments, the structure of fluid delivery system 110 reduces the impact of ambient temperature on hydraulic fluid temperature in device.In one embodiment, because the temperature of user skin is probably higher than the storage temperature of hydraulic fluid, initial fluid transfer rate is that slope rises to continuing basis transfer rate.
Now referring to Fig. 5, the heat by conduction that fluid delivery system 110 can include between wearer's body and the hydraulic fluid in fluid delivery system connects.Heat connects and utilizes the consistent temperature of health regulate or relax the temperature of hydraulic fluid, the temperature of hydraulic fluid otherwise can stand wider change due to variation of ambient temperature.This modulation reduces the viscosity B coefficent of hydraulic fluid, thus reduces because environment temperature changes undesirable change of fluid flow or the conveying caused.
In one embodiment, between hydraulic basis chamber 314 and skin, heat conduction path is provided with.Fluid delivery system can have a kind of the attaching surface 542a possessing the first thermal conductivity, attaching surface 542a and be configured in order to engage with skin surface 544.In one embodiment, the manifold 226 that accommodate hydraulic basis chamber 314 has outer wall 226a.In one embodiment, outer wall 226a has the part 226b that close attaching surface 542a has the second thermal conductivity; Second thermal conductivity is greater than first thermal conductivity of attaching surface 542a.Directly can contact with skin surface 544 one-tenth with the temperature allowing the hydraulic fluid in hydraulic basis chamber to be maintained at the substantial constant corresponding to skin surface 544 temperature near the part 226a of the manifold of attaching surface 542a.In one embodiment, attaching surface 542a and external shell 546 are one.In one embodiment, attaching surface 542a and the base portion 548 being attached to housing 546 (referring to Fig. 2) are one.As used herein, base portion 548 can be considered to the part of housing 546.
In another embodiment, thermal break is located at around the remaining surface directly or such as exposed indirectly to external environment condition by housing 546 of hydraulic basis chamber 314.Thermal break can be any Heat Conduction Material and/or air space as shown in the figure.In a preferred embodiment, the thermal break of thermally conductive pathways and isolating exterior environment is connected (Fig. 5).Connect with the conduction between hydraulic fluid at the skin surface 544 of health to optimize, hydraulic basis chamber 314 can be positioned to become directly to contact with the health of wearer.Fluid delivery system 110 also can be worn on the abdominal part of user, and by the impact covered with medicated clothing to help to reduce further environment temperature change.
As shown in Figure 5, the part 226b that accommodate the manifold 226 of hydraulic basis chamber 314 can arch upward relative to the circumferential surface of base portion 548.In one embodiment, tangent with the attaching surface 542a of sticking tablet 542 substantially from the part 226b of the manifold 226 of base portion 548 extension, thus make the whole basal surface 110b of fluid delivery system 110 be substantially smooth.If exist, then fluid delivery system 110 is bonded to sticking tablet on skin surface 544 or liner 542 is preferably removed in this region, removes district 542a in order to further ensure that the contact (also referring to Fig. 2) preserved outside between wall and skin.Sticking tablet 542 can partly below manifold 226 or above extend, in order to when from preventing manifold sidepiece from extending through releasing district 542a during the motion of fluid delivery system 110 outward extending sticking tablet.In one embodiment, the outer wall of manifold 226 can by thinning (as shown in the figure), or housing or other material can contact in the region of skin surface 544 at close hydraulic basis chamber 314 place to be removed, to reduce the quality of separated to hydraulic fluid and user material to connect to the heat be increased between health with hydraulic fluid.
In order to reduce the impact of ambient temperature on hydraulic fluid temperature further, one or more traditional characteristic can be merged in this device to make hydraulic fluid with external environment condition thermal insulation and to isolate.Hydraulic basis chamber 314 can be the parts being separated with the remainder of manifold (not shown) or isolating.In one embodiment, manifold 226 can be separated by face toward the air gap open in the region of external environment condition with housing 546.In order to further insulating liquid press liquid, then the air gap between hydraulic basis chamber and housing 546 can be divided into independent air pocket and make air decoupling zero in this gap or thermal insulation further.In one embodiment, fluid reservoir 324 is isolated with skin surface 544 heat.In one embodiment, the air gap in housing 546 substantially surround fluid reservoir 324 and is in the temperature colder than skin surface 544 to keep fluid.
In one embodiment, the one or more permission fluid delivery systems 110 in above-mentioned structure operate to the temperature range of 104 ℉ (40 DEG C) at 40 ℉ (5 DEG C).If when there is not heat and connect and hydraulic fluid exposing to this total temperature scope during operation, the flowing variable quantity (every 1 ℉ temperature transition causes the viscosity transition of about 1% magnitude usually) caused due to hydraulic fluid viscosity B coefficent can be introduced through the excessive change of flow of hydraulic fluid of flow restrictor 336, causes unacceptable drug delivery capability.In one embodiment, the thermal control features improved to some extent of fluid delivery system 110 causes every 1 ℉ environment temperature to change the viscosity transition being then less than 1%.For example, these features can cause every 1 ℉ temperature transition that the viscosity transition of about 0.15%, 0.10% or 0.05% then occurs.In one embodiment, be between skin surface 544 and hydraulic fluid at low temperature ranges and only there are about 6 ℉ differences, and have little difference or zero difference between measurements at high temperature limit place.Due in skin surface 544 and the efficient result connected this between hydraulic fluid, then in hydraulic fluid, can be observed the variations in temperature being less than 10 ℉ when surrounding's (environment) variations in temperature higher than 65 ℉.
Referring to Fig. 6 A to Fig. 6 C, in one embodiment, basic actuator 320 applies power to hydraulic basis chamber 314 and comes pressurize hydraulic fluid.Basis actuator 320 can be any device applying power to hydraulic basis chamber 314, such as (but not limited to): wriggling actuator, small bellows crank or be carried on one-tenth pair roller on hydraulic basis chamber 314, compress unit, driven type or piezoelectric type mechanism, expanding volume of gas, heat energy that the ratchet that is carried on plate on hydraulic basis chamber 314 or other structure or stepper motor drive or can directly or indirectly execute stressed other device any or process to the fluid be transferred.In one embodiment, basic chamber 320 is both open loop, thus makes without the need to electronic device, and fluid delivery system 110 can be Purely mechanical.
In one embodiment, basic actuator 320 comprises one or more biasing member, such as the first biasing member 650 and the second biasing member 652.In one embodiment, first biasing member 650 and the second biasing member 652 are spring.In one embodiment, the first biasing member 650 and the second biasing member 652 are spiral compression spring.By the spring applied force being in the less state of compression degree at the end of being greater than stroke when stroke starts by the spring applied force being in compressive state.The power difference caused can have influence on the flow of the hydraulic fluid in fluid delivery system 110, and thus has influence on the flow of the fluid be transferred.
In one embodiment, reduce between initial compressed state and the less state of compression degree by the first biasing member 650 and the second biasing member 652 applied force difference, thus reduce the possible variable quantity of the device capability realizing continual fluid transfer rate.In one embodiment, spring rate (spring rate) (power/deflection) by reducing spring minimizes the power difference between compressive state and the less state of compression degree.Spring rate is reduced by increasing its length.In one embodiment, in order to keep the size of fluid delivery system 110 compact as far as possible and prevent basic actuator 320 to have the power of reduction from start to end, then multiple coaxially stacking biasing member is used.In an alternative em bodiment, the second biasing member 652 is connected to the first biasing member 650 in parallel.But overlapping described first biasing member 650 and described second biasing member 652 further reduce the size of fluid delivery system 110.In one embodiment, the sectional area that the sectional area of hydraulic basis chamber 314 is greater than fluid reservoir 324 is with the larger axial distance of the axial distance the 3rd removable barrier 234 being moved one section of ratio and advanced by the first removable barrier 230 (such as, referring to, Fig. 4 A).Reduce decay at the upper spring force occurred of the total kilometres (stroke) of spring and maintain more constant spring force on hydraulic fluid during operation, thus create the more consistent flow from device of fluid.
Now referring to Fig. 6 A, in one embodiment, the second biasing member 652 is in series connected to the first biasing member 650, and overlaps the first biasing member 650 at least in part.In one embodiment, the first biasing member 650 is coaxial with the second biasing member 652.Relative to being arranged in parallel, the first biasing member 650 and the coaxially arranged of the second biasing member 652 can be preferred.In one embodiment, the near-end 650a of the first biasing member 650 is coupled to housing 546.In one embodiment, near-end 650a abuts the stop part 654 (also referring to Fig. 2) extended from base portion 548.In one embodiment, sleeve 656 makes the near-end 652a of the far-end 650b of the first biasing member and the second biasing member 652 be connected, and the length that sleeve 656 has equals length overlapping between the first biasing member 650 with the second biasing member 652 substantially.In one embodiment, sleeve 656 has main body 656a, the first flange end 656c and the second flange end 656b.First flange end 656c can extend radially outwardly from the main body 656a of sleeve 656, to engage the far-end 650b of the first biasing member 650.Second flange end 656b of sleeve 656 can extend radially inwardly from the main body 656a of sleeve 656, to engage the near-end 652a of the second biasing member 652.The main body 656a of sleeve 656 can be substantially hollow, extends through sleeve 656 and engage the second flange end 656b to allow the second biasing member 652.In one embodiment, the first biasing member 650 and the second biasing member 652 have substantially equal spring rate, thus " floating " between which when both the first biasing member 650 and the second biasing member 652 are all expanded to make sleeve 656.If a biasing member is more strong than another biasing member, so more strong biasing member can be leading, prevents another biasing member from expanding, and eliminates the benefit of many biasing members structure.In one embodiment, the difference of the spring rate between the first biasing member 650 and the second biasing member 652 is not more than about 10%.In one embodiment, the difference of the spring rate between the first biasing member 650 and the second biasing member 652 is not more than about 3%.
Basis actuator 320 can comprise plunger 658, and it extends through the first biasing member 650 and the second biasing member 652.In one embodiment, the far-end 658a of plunger 658 has the flange 658b extended radially outwardly.The flange 658b of plunger 658 can engage the moveable barrier 230 of far-end 652b and first of the second biasing member 652.The near-end 658c of plunger 658 releasably connects stop part 654.Plunger 658 can extend across stop part 654, and utilizes pin 660 and be connected to housing releasedly.In one embodiment, pin 660 extends through housing 546, and pass plunger 658 at least in part and abut stop part 654, thus make pin 660 prevent plunger 658 from extending in hydraulic basis chamber 314 further due to the power of the first biasing member 650 and the second biasing member 652, and can remove from the outside of housing 546.In one embodiment, pin 660 is taper so that more easily remove pin 660.Pin 660 can be connected with button covering 662, thus removing of button covering 662 makes to discharge plunger 658 by user with a step, as is further described hereinbelow.Fig. 6 A to Fig. 6 C shows the basic actuator 320 being in initial position (Fig. 6 A), and this is just removing pin 660 to start or initial described basic actuator 320 (Fig. 6 B) and after one section of all after date basic actuator 320 (Fig. 6 C) in use of conveyance fluid.
Referring to Fig. 7, in one embodiment, the structure of the first biasing member 650 and the second biasing member 652 reduces the reduction being applied to the power on hydraulic basis chamber 314 that the expansion due to the first biasing member 650 and the second biasing member 652 causes.For example, the single spring-compressed spring S of 0.75 inch height is compressed to 1by the power of applying 5.7 pounds.As this single spring S 1when extending to the height of 0.935 inch, the power of applying is decreased to 5.34 pounds.This power of 6.3% reduces will cause the proportional reduction of hydraulic flow rate and then cause the proportional reduction of basal delivery rate from the fluid of fluid delivery system 110.In order to increase the fluid volume that is shifted by fluid delivery system 110 and not increase the decrease of power, basic actuator 320 will need to extend pro rata with required volume increase.In one exemplary embodiment, the dual stacking spring structure S of 0.945 inch height is compressed to 2by the power of applying 5.7 pounds.As dual spring S 2when extending to the height of 1.283 inches, power is reduced to 5.34 pounds.This power of 6.3% reduces to be reduced to ratio with flow rate, but, be different from single spring S 1, shifted volume larger than the situation of single spring 83%, and the length of spring assembly only larger than the situation of single spring 25%.For the loss of 0.36 pound of given spring force, dual spring assembly S 2provide extra 83% increase that spring extends.This provide extra underlay capacity, but loss can not be increased because spring extends.On the contrary, dual spring S 2can be used for conveying equivalent volume (as the embodiment S with single spring 1compare), and cause far much smaller loss (on equivalent development length, power reduces to be reduce with about 45%) due to spring extend through equivalence development length.Should be appreciated that, dual spring as shown in the figure arranges a just embodiment, and also can utilize the spring of more than three or three.
In one embodiment, terminate from conveying to conveying, the power that basic actuator 320 is applied to hydraulic basis chamber 314 has the power reduction being less than 10%.In one embodiment, terminate from conveying to conveying, the power that basic actuator 320 is applied to hydraulic basis chamber 314 has the power reduction being less than 8%.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has the power reduction being less than 6%.In one embodiment, terminate from conveying to conveying, the power that basic actuator 320 is applied to hydraulic basis chamber 314 has the power reduction being less than 5%.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has the power reduction being less than 4%.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has the power reduction being less than 3%.
In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has and is less than predetermined power and reduces, as described above such and have the length being less than about 2 inches.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has and is less than predetermined power and reduces, as described above such and have the length being less than about 1.5 inches.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has and is less than predetermined power and reduces, as described above such and have the length being less than about 1 inch.In one embodiment, terminate from conveying to conveying, basic actuator 320 power be applied on hydraulic basis chamber 314 has and is less than predetermined power and reduces, as described above such and have the length being less than about 0.8 inch.
Referring to Fig. 4 A, in one embodiment, by reducing the power variable quantity making the 3rd removable barrier 234 be shifted required, the conveying concordance of fluid is improved.In a preferred embodiment, one or more by the compressibility of the contact area, contact force and the coefficient of friction that limit or control between moveable barrier 230,232,234 and their chamber wall and hydraulic fluid and the first removable barrier 230, reduce or control for making the 3rd removable barrier 234 be shifted required power.
Referring to Fig. 6 A, the first removable barrier 230 can have thickness t, and thickness t is the minimum thickness in order to form sealing.In one embodiment, the first removable barrier has the thickness t of about 0.05 inch.In one embodiment, the first removable barrier 230 has the protuberance 230a extended in the far-end 658a of plunger 658.In one embodiment, the first moveable barrier 230 comprises the rounded periphery 230b for contacting manifold 226 inner surface.In one embodiment, the peripheral 230b of the first removable barrier 230 is that the remainder of the removable barrier 230 with first becomes one.In one embodiment, the first moveable barrier 230 is made up of brominated butyl (bromo-butyl) rubber.In one embodiment, the first moveable barrier 230 has the measurement/durometer hardness of 40 shore hardness A.
Referring to Fig. 8 to Fig. 9 B, in one embodiment, fluid delivery system 110 can with basal rate continuously or close to distributing fluids continuously, and according to demand or under the control of patient, distribute the fluid of magnitude of recruitment or inject.Fluid delivery system 110 can allow user to carry multiple discrete bolus amount, and user need not watch fluid delivery system 110 or arrange under the clothing of user and carry out the bolus amount of carrying through the clothing (not shown) of user.Each bolus dose can need two discrete motions to carry bolus dose.In one embodiment, by performed multiple button sequence to improve scrupulous plan by user and correct inject dosage.In a preferred embodiment, operated injected conveying by (that is, common, consistent, the conventional) mechanical system circulated, wherein, user performs same action one or many and realizes the one or more bolus dose of each circulation.
Inject increment quantity and each inject increment volume or dosage preset based on the selection of parameters of operating part during fabrication, as is further described hereinbelow.Fluid delivery system 110 can construct in many ways in advance (fast/slow basal rate, large/little bolus volumes, many/to inject increment less) so that multiple treatment needs.
Referring to Fig. 9 A and Fig. 9 B, in one embodiment, eachly to inject by user individually and intentionally start.For example, in one embodiment, eachly inject conveying and need user to carry out multiple (two or more) self contained function, such as button actuation (via injecting release-push 964 and injecting button 966), with guarantee by deliberately and expection transportation means is each injects increment (dosage), and not suddenly, improperly or carelessness unexpectedly carry.Inject button 966 and inject release-push 964 and can be positioned on the not homonymy of fluid delivery system 110.User can make his or her finger along the first Slideslip of fluid delivery system 110 until inject release-push 964 by having depressed, and their finger of continuing to slide in the second side direction of fluid delivery system 110 is until press to have depressed and inject button 966.User can make their finger inject button 964 along the sidepiece slip of fluid delivery system 110 to find and inject release-push 966, and the moving direction of user finger or the orientation of fluid delivery system 110 sidepiece and/or inject button 964 and inject being configured with of release-push 966 to help to indicate to press to have depressed which button to user, and fluid delivery system 110 need not be watched.In one embodiment, inject button 966 and inject release-push 964 and be positioned at two of fluid delivery system 110 not on homonymy.In one embodiment, the not homonymy of fluid delivery system 110 has different length so that facilitate tactile feedback when feeding bolus dose, allow when without when direct sight line operate (such as, at one or more medicated clothing, operating fluid delivery system 110).In one embodiment, inject button 966 and inject release-push 964 and be positioned in the same side of fluid delivery system 110.In addition, " click sound " heard that provided by the arbitrary button 964,966 of pressing feeds back can be convenient to predictable operation further.In one embodiment, inject button 964 and inject release-push 966 and separately there is alternative sounds.
As illustrated in Fig. 9 A and Fig. 9 B, press inject button 966 (Fig. 9 B) described in pressure before press described in pressure and inject release-push 964 (Fig. 9 A).In one embodiment, inject release-push 964 make described in inject actuator 322 and can actuate by injecting button 966, thus make to inject button 966 can not when being activated without when injecting release-push 964 activation (enabled).When user prepares the bolus dose of conveyance fluid, he or she injects release-push 964 by pressure.When by pressure, inject release-push 964 and can start and inject button 966, and cause after pressing pressure and injecting button 966 and inject actuator 322 and move forward one and inject increment.
In certain embodiments, carry discrete dosage unit when fluid delivery system 110 is actuated at every turn, suitable dosage unit will depend on fluid to be conveyed and different.In a particular embodiment, such as, in order to carry insulin, fluid delivery system 110 injects increment (each " click sound ") period conveying 1 to 4 units of insulin (such as, 0.01 to 0.04mL) each.In certain embodiments, fluid delivery system 110 can be carried 36 and inject unit (such as, insulin) in 2 unit increment, that is, in 18 " click sound " processes, carry 36 units.Meanwhile, fluid delivery system 110 can with basal rate conveying additional quantity (such as, 20,30,40 etc. unit) in whole transport cycle.Based on total fluid displacement of fluid delivery system 110 capacity with inject capacity sum.In certain embodiments, fluid delivery system 110 has total fluid displacement of 56,66 or 76 units.In other embodiments, fluid delivery system has total fluid displacement of about 1200 units, 1500 units or 2000 units.
Now referring to Figure 10 A, inject actuator 322 and can comprise position lock or tooth bar 1068, it connects injects button 966 and the second moveable barrier 232.In one embodiment, tooth bar 1068 engages the housing pawl 1170 (referring to Figure 11 A and Fig. 2) fixing relative to manifold 226, and it prevents tooth bar 1068 and the second moveable barrier 232 from outwards moving towards injecting button 966.In one embodiment, injecting button 966 is biased springs away from the second removable barrier 232, and comprising pawl 966a, pawl 966a engages tooth bar 1068 and to move forward one or more predetermined unidirectional ratchet or tooth to make tooth bar 1068, and once be reset after being allowed.
Now referring to Figure 10 B, injecting release-push 964 can engage to control when to have reseted to inject button 966 with injecting button 966.In one embodiment, inject release-push 964 and comprise protuberance 964a, it passes through optionally to slidably pass through and is positioned to inject in the hole 966b (illustrating best in fig. 2) of button 966 to engage injects button 966.In one embodiment, when the protuberance 964a injecting release-push 964 to be in the 966b of hole (as illustrated in Figure 10 B, Figure 12 B and Figure 13 B), the button 966 of injecting in the 966b either end of hole abuts protuberance 964a and prevents injecting button 966 and moves in either direction.In one embodiment, press pressure to inject button 966 and protuberance 964a is shifted out from hole 966b and allows to be reseted by spring-biased to inject button 966 (as shown in Figure 11 B).In one embodiment, inject release-push 966 by spring-biased, thus make by after having depressed and injecting release-push 966, inject release-push 966 described in release and protuberance 964a against is injected on release-push 964 sidepiece what be adjacent to hole 966b; And make press inject button 966 described in pressure time once hole 966b aims at protuberance 964a, then protuberance 964a matches with hole 966b immediately.In one embodiment, inject button 966 utilize torsionspring 1072 and be subject to spring-biased.In one embodiment, inject the same torsionspring 1072 that button 966 carries out bias voltage also carried out spring-biased to injecting release-push 964 to described.
Figure 10 A to Figure 13 B depicts the exemplary sequence of each event of injecting in dosage.Figure 10 A and Figure 10 B depicts before injecting dosage, injects button 966 and the position of injecting release-push 964; Inject release-push 964 and be in activation position, and inject button 966 and be locked to pressing position.Figure 11 A to Figure 11 B depicts activation step; User, by injecting release-push 964 described in pressure to its stop position, makes to inject button 966 and moves to extended position.Inject button 966 to be enabled now an increment dosage.Figure 12 A to Figure 12 B describes the conveying of bolus dose; Inject button 966 under user pressing is described to stop position, cause injecting actuator 322 and to move forward an increment, make the second moveable barrier 232 be shifted and distribute a bolus dose.Inject release-push 964 and turn back to activation position.Figure 13 A to Figure 13 B illustrates the conveying of the last bolus dose of device; User is pressed described in pressure and is injected button 966 to its stop position, makes to inject actuator 322 and to move forward an increment, make the second moveable barrier 232 be shifted and distribute last bolus dose.This starts the locking feature of fluid delivery system 110, makes to inject release-push 964 and slides through hole 1068a (referring to Fig. 8) in tooth bar 1068 to locked position of coupler.In one embodiment, once inject release-push 964 to extend outwardly through hole 1068a, torsionspring 1072 slip away housing 546 ledge 546b and be retained on locked position of coupler (referring to Figure 13 B) so that release-push 964 will be injected injecting to extend between release-push 964 and ledge 546b.Injecting release-push 964 can be locked in place to prevent operation subsequently and to have delivered all bolus dose to user instruction.
In one embodiment, the pressing position that button 966 remains on slightly to arch upward from the outer apparatus surface of housing 546 (that is, from its protuberance, outstanding or extend) is injected.Described in user pressing, inject the result of release-push 964, when injecting button 966 and extending away from housing 546 further, inject actuator 322 and can engage one and inject increment.When user then will inject button 966 pressing get back to its home position (that is, slightly arching upward from housing 546) time, inject actuator 322 and second moveable barrier 232 moved forward fixed amount or increment.The movement of the caused second removable barrier 232 makes hydraulic fluid be shifted, and then makes the 3rd removable barrier 234 move with substantially the same dilatation, from the bolus dose of fluid delivery system 110 distributing fluids.
Second moveable barrier 232 can be when it can maintain sealing when hydraulic pressure injects translation in chamber 316.In one embodiment, when injecting button 966 and start at every turn, the second moveable barrier 232 is displaced the distance equaling a ratchet spacing by tooth bar 1068.
Referring to Figure 14, in one embodiment, fluid reservoir 324 is filled with a certain amount of fluid to be delivered to user at first.In another embodiment, fluid reservoir 324 can be filled before the use by user.In one embodiment, the fluid cartridge 228 of fluid reservoir 324 is made up of rigid material.In one embodiment, fluid cartridge 228 is made up of Topas 6017 S-04.In certain embodiments, fluid cartridge 228 can be made up of polymer, because fluid reduces to fluid cartridge 228 open-assembly time length, (such as, 24 hours at user fill fluid cylinder 228 and after using it), wherein previous fluid cartridge must have lower leaching by glass or other and form with the material of extractibility matter, in order to period fluid storage extended.In addition, because known conveyer device comprises electronic device, this device is unpractical for property uses once a day, and as disclosed in some embodiment of fluid delivery system 110 herein, it is pure machinery.
When medicament, Fluid Volume can be pre-determined by medical professional to provide required dosage at predetermined period.The volume of fluid reservoir 324 can be about 100 μ l, 500 μ l, 1 ml, 3 ml, 5 ml, 10 ml, 30 ml, 50 ml, 100 ml or larger.Fluid cartridge 228 can comprise the barrier film 1474 in the far-end being in fluid cartridge 228.In one embodiment, barrier film 1474 serves as obturator.In other embodiments, barrier film 1474 can be at least part of (not shown) of sidewall.In one embodiment, fluid cartridge 228 includes the distance piece 1476 on the flow of pressurized side of the 3rd removable barrier 234, thus makes the size by changing distance piece 1476 make the large I of fluid cartridge 228 be adapted to the scope of fluid volume.In one embodiment, space 1476 can have strikingly color to help the fluid level indicated in described fluid cartridge 228.Fluid cartridge 228 can comprise sealing member 1478, sealing member 1478 has opening 1478a (referring to Fig. 2), thus makes sealing member 1478 fluid cartridge 228 be sealed on manifold 226 and allow hydraulic fluid to pass distance piece 1476 and/or the 3rd moveable barrier 234 simultaneously.
In one embodiment, barrier film 1474 is made up of the flexible material that such as rubber is such and is assemblied in fluid cartridge 228, with the 3rd removable barrier 234 end vis-a-vis on formed and seal.Barrier film 1474 can be only at the hollow cylinder that the end be installed in fluid cartridge 228 is opened.Barrier film can keep fixed/stationary, and is positioned to aim at pin 312.When pin 312 pierces through barrier film 1474 sidepiece, open the fluid path between fluid delivery system 110 and external environment condition, allow fluid to flow from fluid delivery system 110.In one embodiment, barrier film 1474 is exposed to allow user fill fluid reservoir 324 by the sidepiece of housing 546.Barrier film 1474 can have the hardness being enough to allow pin 312 relative to the remainder movement of fluid delivery system 110, as described in further detail hereinafter.In one embodiment, barrier film 1474 has the hardness of 50 shore hardness A.
Referring to Figure 15, the 3rd moveable barrier 234 can be the plunger slided in fluid cartridge 228.Usually, piston can have coarse size and compressible feature, because non-key on the impact of transfer rate.In one embodiment, but the 3rd moveable barrier 234 of fluid delivery system 110 is configured to any impact minimizing fluid delivery speed.In one embodiment, the 3rd moveable barrier 234 is made up of flexible material and seals to be formed between hydraulic fluid and the fluid to be delivered to user.In one embodiment, the 3rd moveable barrier 234 has the structure that moveable barrier 232 is similar with second.In one embodiment, axial compressibility is minimized.In one embodiment, the axial compressibility of the second removable barrier 232 and the 3rd removable barrier 234 can be greater than the axial compressibility of the first removable barrier 230, and this is owing to the comparatively low voltage difference acted on the second removable barrier 232 and the 3rd removable barrier 234.In so a kind of embodiment, lower axial compressibility allows to be greater than the thickness of the first removable barrier 230 thickness t or length L and allows two contact points.In one embodiment, the 3rd removable barrier 234 is made up of the single material of measurement hardness/durometer hardness between about 35 and about 65 shore hardness A.In one embodiment, for the fluid cartridge 228 be made up of polymer, the measurement hardness/durometer hardness of the 3rd removable barrier 234 is between about 35 and about 65 shore hardness A.In another embodiment, for the fluid cartridge 228 be made up of glass, the measurement hardness/durometer hardness of the 3rd removable barrier 234 is between about 35 and about 45 shore hardness A.In one embodiment, for the fluid cartridge 228 be made up of polymer, the measurement hardness/durometer hardness of the 3rd removable barrier 234 is 55 shore hardness A.In one embodiment, the 3rd moveable barrier 234 comprises butyl rubber.In one embodiment, the 3rd moveable barrier 234 applied 0.0001 inch of Parylene C.In one embodiment, the 3rd removable barrier 234 has the minor diameter of about 0.2425 inch and the major diameter of about 0.2615 inch ± 0.002 inch.
In one embodiment, the 3rd removable barrier 234 comprises the main body 234a with first end 234b and the second end 234c.3rd moveable barrier 234 can comprise the first flange 234d and the second flange 234e.In one embodiment, the first flange 234d and the second flange 234e is integrated with main body 234a, and is close to first end 234b respectively and the second end 234c is extending radially outwardly from main body 234a at uncompressed state.First flange 234d and the second flange 234e can be constructed such that to minimize and the contacting of fluid cartridge 228.Integrated the preventing of the first flange 234d and the second flange 234e and main body 234a is made to occur rolling/rolling and flash-point during using independent O shape ring.In one embodiment, the first flange 234d and the second flange 234e has bending sections periphery at uncompressed state.In one embodiment, this bends the radius r at uncompressed state with substantial constant.In one embodiment, the first flange 234d and the second flange 234e is spaced apart with first end 234b and the second end 234c respectively, to provide suitable supporting for the first flange 234d and the second flange 234e.
In one embodiment, the control of the contact area of the inwall of the 3rd removable barrier 234 convection cell cylinder 228 is solved by the structural design of the first flange 234d and the second flange 234e.In one embodiment, the first flange 234d and the second flange 234e has circular lateral section profile.In this embodiment, the circular contour on the outer surface of the plunger be made up of elastomeric material presents less contact area, and it can utilize minimum power change and deform.Although the size of indivedual piston and cylinder is different due to manufacturing tolerance, reduces contact area by structure disclosed herein and change.Two flanges are provided to provide redundant seal to guarantee the isolation of fluid and hydraulic fluid.
In Additional examples of composition, by suitably selecting contact material to control the coefficient of friction between the 3rd removable barrier 234 and fluid reservoir 324.In this embodiment, one or more suitable painting preparations be applied to the 3rd removable barrier 234 outer surface on and/or fluid reservoir 324 inner surface on minimum co-efficient of friction and the coefficient of friction difference between device and device.In addition, a kind of coating process utilizing Parylene C material can be used.The membrane coat that utilization exceedes the Parylene C material of about 0.0001 inch (2.5 microns) has proved to contribute to the movement of the removable barrier 234 of control the 3rd.Parylene coating preferably conformal/conformal and there is uniform thickness, and essentially no any space or pin hole.Parylene can temperature be applied with molecular level by vacuum deposition process around.The membrane coat of about 0.100 to 76 micron may be had in single operation.In one embodiment, without the need to catalyst or solvent, and can not introduce foreign substance, foreign substance can make coating surface demote.Parylene C is the modified form of Parylene, and it can provide electrical property and physical property better to combine, and comprises low moisture-inhibiting and breathability.
Referring to Figure 16 A to Figure 16 C, in one embodiment, fluid delivery system 110 has multiple exercisable state.At the first operable state or storage location (Figure 16 A), pin 312 engaged or with fluid reservoir 324 separate and do not extend (that is, not being inserted in health) from housing 546.At the second operable state or can bonding station (Figure 16 B), pin 312 can engage with fluid reservoir 324.In the 3rd operable state or joint or enable position (Figure 16 C), pin 312 is fluidly communicated with fluid to be conveyed, and is inserted in health or can be used for being inserted in health.The 4th operable state or disengaging or discardable position (not shown), pin 312 separates with fluid to be conveyed again, is not inserted in health, and by fixing (locking) securely in housing 546.
In one embodiment, button covering 662 cover cap pin 312, prevents from carrying and described pin 312 under inadvertent depression between the time of shipment at fluid delivery system 110.In one embodiment, button covering 662 comprises flange 662a so that gripped by user and remove described button covering 662.In one embodiment, button covering 662 has for protuberance 662b joining with pin 660.Button covering 662 can comprise labelling 662c, and such as word " removes " to indicate user should be what (referring to Fig. 2) to button covering 662.In one embodiment, button covering 662 comprises convex tongue 662d, for providing when by maintaining flange 662a and remove button covering 662 on the opposite side of button covering 662 to the leverage facing to housing 546.In one embodiment, when removing button covering 662, expose the pin button 1680 (Figure 16 B) being connected to pin 312.
In one embodiment, pin 312 is fixed on pin button 1680.In one embodiment, pin 312 is heat fused on pin button 1680, illustrated in Figure 19 at a 1680a place.In other embodiments, pin 312 can move relative to pin button 1680.In one embodiment, remove button covering 662 and make to remove pin 660 from basic actuator 320 simultaneously, to discharge or to start basic actuator 320, thus it is acted on hydraulic fluid.Accordingly, in a preferred embodiment, button covering 662 performs dual-use function, that is: cover cap is lived and protected described pin button 1680 to prevent accidental activation pin 312, and controls basic actuator 320 simultaneously and start.
Referring to Figure 17 and Figure 18, in one embodiment, pin button 1680 disposes pin 312 (Figure 18) when pressing pressure.Pin button 1680 can by spring-biased away from described barrier film 1474.In one embodiment, pin button 1680 by Compress Spring 1784 in addition spring-biased, as launched to describe hereinafter further.Move pin button 1680 from initial position and need the first power.In one embodiment, first power is greater than the remainder that pin button 1680 moved this approach to the second power (such as, being at least greater than the power being derived from spring 1784) needed for bonding station to help user to overcome to be pressed into by pin 312 fear in skin surface 544.In one embodiment, one or more rupturable convex tongue 1682 extends from housing 546, thus make when tongue 1682 convex in first direction d provides the first power breaks, user rapidly and is fully disposed after convex tongue 1862 discharges pin button 1680 or insert pin 312 and help prevent failure or partial insertion or engage attempt.Can deployed position, pin 312 can almost can only move (that is, towards barrier film 1474) in direction of engagement, thus makes pin 312 laterally with seldom or enter barrier film and user without transverse shifting, to assist in ensuring that suitable joint.Once pin 312 is in bonding station, then pin 312 can move to reduce the pain caused relative to the movement of user by pin 312 relative to the remainder of fluid delivery system 110, as mentioned below.In one embodiment, pin 312 is flexible, and the movement retraining pin 312 between joint aging time facilitates the suitable joint of pin 312.
In one embodiment, pin 312 from fluid reservoir 324 at junction point 1474a through can puncture member or barrier film 1474 extend, and to stretch out from housing 546.Pin 312 can move relative to barrier film 1474, or fluid delivery system 110 can move relative to pin 312, thus make when pin 312 extends in skin surface 544 at bonding station, reduce the movement relative to user of the pin 312 that caused by the motion of fluid delivery system 110.Minimize described pin 312 can help to reduce the pain that caused by pin 312 or " clamping sense " relative to the movement of user.
In one embodiment, pin 312 is formed at direction (such as, the direction d in Figure 18) translation perpendicular to barrier film 1474, and in all directions around junction point 1474a pivotable.In one embodiment, pin 312 around junction point 1474a pivotable near barrier film 1474 imaginary hourglass shape path (not shown) border in.In one embodiment, whole pin 312 is configured to due to the flexibility of barrier film 1474 around junction point 1474a pivotable, and is limited by the connection between pin button 1680 and housing 546.In one embodiment, pin 312 is formed at initial position and is positioned at housing 546 completely or is departed from (Figure 17) with fluid reservoir 324 by housing 546 cover cap at least in part; And fluidly to connect with fluid reservoir 324 at bonding station and extend (Figure 18) from housing 546.In one embodiment, pin 312 is configured to after extending from housing 546, piercing through the described component 1474 that can pierce through when pin 312 moves to bonding station from initial position, thus fluid is not come out on skin surface 544 and the adhesion of interference sticking tablet 542.In one embodiment, pin 312 is constructed such that: with pin 312 pierce through described can puncture member 1474 about while, described pin 312 pierces through skin surface 544.
In one embodiment, pin 312 is substantially J-shaped, thus makes its two ends point to equidirectional, but opens in axis and lateral spacing each other.In one embodiment, pin 312 comprises two generallyperpendicular bending, and one end of pin 312 is shorter than the other end.In one embodiment, barrier film 1474 or at least tangent with junction point 1474a surface are parallel with the basal surface 110b of housing substantially, and at bonding station, pin 312 extends from this basal surface 110b.In one embodiment, pin 312 is micropin.In one embodiment, pin 312 is thin pin.In one embodiment, pin 312 is No. 30 pins.In one embodiment, the two ends of pin 312 be oblique angle with help be convenient to pierce through barrier film 1474 and skin surface 544.In one embodiment, pin 312 is configured to rotate around imaginary axis A, fabricate axis A and extend through junction point 1474a perpendicular to barrier film 1474, as shown in Figure 18, thus fluid delivery system can be rotated around axis A, and not exist or the end that at least reduces the pin 312 extended in user body is moved with bow-shaped route.
In one embodiment, once pin 312 is in bonding station, then pin button 1680 is locked in place, and the fluid in fluid reservoir becomes fluid connection via pin 312 and external environment condition (such as, health).Locking component 2088 can be configured to keep when pin is moved to latched position (during Figure 23) from bonding station (Figure 18) first end of pin 312 and the second end to depart from user and fluid reservoir 324 and be contained in housing 546 and be in latched position.In latched position, pin 312 can be avoided to dispose again or engage thus make housing 546 serve as its oneself sharps container.In one embodiment, by using pin release or locking button 1886 and pin 312 is moved to latched position.
Referring to Figure 20, in certain embodiments, spring 1784 between pin button 1680 and base portion 548, and surrounds boss or the sleeve 1680a of the pin button 1680 partly extended on pin 312.In one embodiment, when pin button 1680 be locked in pressing, engage or on position (Figure 18) time, spring 1784 becomes by compression, with pin button 1680 described in bias voltage away from barrier film 1474.Pin button 1680 can be immobilizated on position by locking component, as is further described hereinbelow.When user completes fluid delivery system 110, releasable locking member 2088.In one embodiment, before health removing fluids conveyer device 110, user starts lock button 1886 to make pin 312 from user retraction and to enter in housing 546.In other embodiments, be automatically withdrawn pin when fluid reservoir 324 is essentially sky, or from skin surface 544 automatically removing fluids conveyer device 110 time automatically retraction pin 312.
In one embodiment, locking component 2088 is spring.In one embodiment, locking component 2088 is made up of helical torsional spring.In one embodiment, button 1886 is locked described in locking component 2088 bias voltage, and with the characteristic interaction of pin button 1680 and base portion 548, pin 312 be immobilizated in releasedly pressing or on position (Figure 18) and be non-releasably locked in locked position of coupler (Figure 22).
In one embodiment, locking component 2088 connects maybe can engage with lock button 1886.In one embodiment, lock button 1886 and be there is the surperficial 1886a exposed by housing 546.In one embodiment, the surperficial 1886a of lock button 1886 is exposed by the hole on housing 546 first side in housing 546, and housing 546 has surface that is on the second side of the housing 546 relative with housing first side and that aim at lock button 1886 substantially, thus make user can clamp described lock button 1886 and described housing 546 between thumb and forefinger to inject in release-push 964 at joint and start lock button 1886, prevent the accidental activation when actuator 322 is injected in use from locking button 1886.Lock button 1886 can comprise at least one protuberance 1886b extended from this surface and clamp to help the hands of convenient user.In one embodiment, at least one protuberance 1886b has inclined-plane (referring to Figure 23 A) with convenient clamping further, and helps to indicate to user what direction to drive lock button 1886 toward by sensation.
Referring to Figure 20, in one embodiment, sleeve 1680a surrounds pin 312, and locking component 2088 is towards the spring of sleeve 1680a bias voltage.In one embodiment, sleeve 1680a has at least one and abuts surface, and it is configured to engage with locking component 2088 to prevent from engaging and depart from least one situation in pin 312.In one embodiment, at least one abuts surface and comprises first and abut surperficial 1680b and second and abut surperficial 1680b.
In one embodiment, first abut surperficial 1680b to abut surperficial 1680c along pin 312 in axis and second spaced apart.In one embodiment, first to abut surperficial 1680b be the groove extended radially inwardly.In one embodiment, second the far-end that surperficial 1680c is sleeve 1680 is abutted.In other embodiments, first abuts surperficial 1680b and second, and to abut surperficial 1680c be any surface, and such as protuberance or groove, it engages with locking component 2088 in axis.In one embodiment, base portion 548 comprises the boss that upwards extends or guiding piece 2090 to be used for receiving and guide sleeve 1680a and engaging with locking component 2088.In one embodiment, guiding piece 2090 is loosely assemblied on sleeve 1680a, for allowing pin button 1680 to make pin 312 pivotable relative to some non axial movement of base portion 2090 or pivotable, as described above.Guiding piece 2090 can comprise groove 2090a, and it is configured to receive locking component 2088.In one embodiment, groove 2090a abuts surperficial 1680a at bonding station (Figure 18) and first and aims at, and abuts surperficial 1680b at locked position of coupler (Figure 22) and second and aim at.In one embodiment, locking component 2088 and first abuts surperficial 1680b and engages that pin 312 is immobilizated in bonding station (Figure 18) releasedly, and locking component 2088 and second abuts surperficial 1680c engages that pin 312 is non-releasably immobilizated in latched position (Figure 22).In one embodiment, lock button 1886 to be configured in order to locking component 2088 is positioned latched position when pin 312 departs from user.
Referring to Figure 20, in one embodiment, locking component 2088 is configured in order to provide the feedback that can hear when pin 312 is immobilizated in bonding station, so user be sure of that pin 312 has been fully deployed and has been in bonding station.In one embodiment, guiding piece 2090 comprises protuberance 2090b, and protuberance 2090b is convenient to by locking component 2008 being abutted slip on surperficial 1680a at groove 2090a and first and slipping into its inside to produce " click sound " that can hear.In one embodiment, protuberance 2090b is inclined surface 1886c, and it selectively can engage with locking component 2088.In one embodiment, locking component 2088 abuts against guiding piece 2090 and by bias voltage (referring to Figure 21) above groove 2090a, and presses the described pin button 1680 of pressure and surperficial 1680d is engaged with locking component 2088 and locking component 2088 to be glided through protuberance 2090b and the groove 2090a and first sliding into aligning abuts in surperficial 1680a along guiding piece 2090.In one embodiment, pin button 1680 comprises otch 1680e to be assemblied on barrier film 1474.In one embodiment, the size of otch 1680e loosely meets the profile of barrier film 1474 to support pin 312 relative to housing 546 but to allow pin 312 to move, as described above.
In one embodiment, when user presses the described pin button 1680 of pressure, the groove 2090a and first that the free end of locking component 2088 or the first arm 2088a move to aligning from the initial preload position that abuts both guiding piece 2090 abuts in surperficial 1680a.When pressing the described lock button 1886 of pressure, inclined surface 1886c temporarily or instantaneously can abut from first the first arm 2088a that surperficial 1680a pushes described locking component 2088, due to the result of the power from spring 1784, pin button 1680 is allowed to be retracted into upright or initial position.End along with described lock button 1886, the first arm 2088a of user continuation pressing can abut the surface in housing 546, prevents from further rotating (being similar to the position shown in Figure 21).Then the middle part of the first arm can, at the inclined surface 1886c upper deflecting of lock button 1886, allow the first arm 2088a to bounce back in groove 2090a (Figure 22).Then second of pin button 1680 abuts surperficial 1680c axially can extend across guiding piece 2090 above the first arm 2088a, prevents the translation or press pressure/dispose again (Figure 22) more further of pin button 1680 and pin 312.
Referring to Figure 23 A to Figure 23 C, in one embodiment, lock button 1886 to be configured to meet accident release to prevent locking component 2088 in order to only to discharge locking component 2088 after completing two different motion.In one embodiment, locking button 1886 is configured in order at first direction l 1mobile, and only after moving preset distance along first direction at second direction l 2mobile.In one embodiment, lock button 1886 comprises at least one protuberance 1886d and housing or base portion 548 comprise at least one groove 548a, and each groove 548a is configured to receive one of at least one protuberance 1886d separately.In one embodiment, at least one groove 548 each is not aimed at one of at least one protuberance 1886d at initial position (Figure 23 A), and along first direction l 1aim at (Figure 23 B) with one of at least one protuberance 1886d after lock button 1886 is moved preset distance, and along second direction l 2after lock button 1186 is moved preset distance, then each at least one groove 548a receives one of at least one protuberance 1886d.In one embodiment, first direction l 1with second direction l 2for linear translation.In one embodiment, first direction perpendicular to second direction, as illustrated in Figure 23 A to Figure 23 C.In other embodiments, first direction and second direction can be any direction, such as bending and/or rotation.In one embodiment, button 1886 is locked in a direction opposite the first direction by spring-biased.In one embodiment, lock button 1886 to be immobilizated on first direction by one or more rupturable convex tongue (not shown).In other embodiments, lock button 1886 and comprise more than one button.
Now referring to Fig. 2, in certain embodiments, fluid delivery system 110 can comprise one or more watch window.Watch window can such as on the top side and/or bottom side of fluid delivery system 110.These watch windows allow light transmission so that careful fill fluid reservoir 324, in order to increase observability to determine liquid level and the transmutability of fluid, and allow to observe to strengthen user confidence by the relative position allowing user to observe the 3rd removable barrier 234 during conveying and/or filling.In one embodiment, housing 546 comprises the window 546a aimed at substantially with fluid cartridge 228.In one embodiment, sticking tablet 542 comprises window 542b.Window 542b can be translucent area, or is only the gap in material.In one embodiment, window 542a and 542b aims at substantially.In one embodiment, the remainder of the housing 546 of exposure is opaque, thus only fluid cartridge 228 is seen by housing 546.
In certain embodiments, fluid delivery system 110 comprises binding agent so that fluid delivery system 110 to be attached on the skin surface 544 of user (such as, referring to, Fig. 9 A).Bonding strength preferably should be enough to adhere on the skin surface 544 of user by fluid delivery system 110, continue for the time that the fluid delivery system 110 utilizing medicine to fill carries out treating.Thus, bonding strength can be depending on persistent period for the treatment of and difference (such as, 72 hours, 48 hours, 24 hours, 18 hours, 12 hours etc.).In addition, binding agent should make fluid delivery system 110 can be easy to remove, and can not cause uncomfortable or pain or difficulty improperly when completing use.In certain embodiments, binding agent can be removed in some region, such as in the region of hydraulic basis chamber 314 (referring to, such as, region 542a in Fig. 2), near fluid reservoir 324 (the region 542b referring in such as Fig. 2) and/or pin 312 (referring to such as, region 542c in Fig. 2) so that fluid delivery system 110 contacts with the skin surface 544 of user.
Binding agent can be combined to form sticking tablet 542 with liner.In one embodiment, sticking tablet 542 is the foam pad of non-woven/nonwoven.In one embodiment, sticking tablet 542 comprises the medical foam glue manufactured by 3M.In one embodiment, sticking tablet 542 comprises 3M 9776 material.In one embodiment, the external dimensions that the external dimensions of sticking tablet 542 extends beyond housing 546, to allow the long-pending and/or larger flexibility of the larger adhesive surface of sticking tablet 546, meets user body shape to make profile.In certain embodiments, the region of extension for being derived from housing such as about 0.010 inch, 0.100 inch, 0.250 inch, 0.500 inch or more.Sticking tablet 542 can move in multiple orientation (such as, bend, stretch) to improve wearing comfort and to reduce clamping sense or the sense or reduce the perception of wearer to clamping sense or sense of compacting of compacting.In one embodiment, binding agent is covered by removable film 292 (referring to Fig. 2) at first.In one embodiment, film 292 comprises from the outward extending convex tongue 292a of sticking tablet 542 so that just removed from sticking tablet 542 before being applied to skin surface 544 by fluid delivery system 110.
Referring to Figure 16 A to Figure 16 B, in exemplary use, user is from storage package (not shown) removing fluids conveyer device 110.User then can to fluid cartridge 228 fill fluid.In one embodiment, fluid cartridge 228 is for being pre-charged with.Once be filled with fluid cartridge 228, the removable button covering 662 of user, exposed needle button 1680 and simultaneously start basic actuator 320.Referring to Fig. 9 A, then user can remove film 292 from sticking tablet 542, and is placed on skin surface 544 by fluid delivery system 110.In other embodiments, fluid delivery system 110 was arranged on skin surface 544 before removing button covering 662.Once fluid delivery system 110 is on skin surface 544, and button covering 662 is removed, then user can be pressed the described pin button 1680 of pressure and fluidly connect user and fluid reservoir 324 with joint pin 312 (referring to Figure 18).Once pin 312 engages and in due course, then user can start to inject release-push 964 (Fig. 9 A) and then start injects button 966 (Fig. 9 B) and carries bolus dose.Once complete transport cycle (such as, 24 hours) or user want removing fluids conveyer device 110 in addition, user presses the described lock button 1886 (referring to Figure 23 A-23C) of pressure to be retracted into by pin 312 in housing 546 (Figure 22).Once pin 312 is by housing 546 cover cap, then then user from skin surface 544 removing fluids conveyer device 110, can discard fluid delivery system 110, and repetition above-mentioned steps installs a kind of new fluid delivery system 110.
Those skilled in the art will be appreciated that, when not departing from broad concept of the present invention, can make change shown in above with described exemplary embodiment.Therefore should be appreciated that, the present invention is not limited to the exemplary embodiment illustrating and describe, but expection covers the amendment in the spirit and scope of the present invention as defined by the claims.For example, the concrete feature of exemplary embodiment can be or can not be advocated part of the present invention, and the feature of the disclosed embodiments may be combined with.Word " inwardly " and " outwards " refer to respectively towards the direction with the geometric center away from fluid delivery system.Unless stated particularly in this article, term " ", " one ", " being somebody's turn to do " and " described " are not limited to an element but are alternatively interpreted as representing " at least one ".
Attaching surface, it is configured to engage with skin surface and have the first thermal conductivity;
Hydraulic pump chamber;
Hydraulic basis chamber, its have near described attaching surface and there is the part of the outer wall of the second thermal conductivity, described second thermal conductivity is greater than described first thermal conductivity,
Flow restrictor, it fluidly connects described hydraulic basis chamber and described hydraulic pump chamber,
Fluid reservoir, it is connected to described hydraulic pump chamber, and described fluid reservoir is configured to comprise the fluid that can be transported to patient;
Actuator, it is connected to described hydraulic basis chamber, described actuator is configured to described hydraulic pump chamber pressurization, to carry described fluid to described fluid reservoir with continuing basis speed by described hydraulic basis chamber and described hydraulic pump chamber transferring energy.
2. fluid delivery system according to claim 1, wherein: described attaching surface comprises thermal insulation member.
3. fluid delivery system according to claim 2, wherein: described thermal insulation member is removed at least in part, to expose the part of the outer wall of the described hydraulic basis chamber near described attaching surface at least in part.
4. fluid delivery system according to claim 1, wherein: described fluid reservoir is spaced apart with described housing at least in part.
5. fluid delivery system according to claim 1, it also comprises: housing, and housing has basal surface, and the outside wall portions of wherein said hydraulic basis chamber stretches out from the basal surface of described housing.
6. fluid delivery system according to claim 1, wherein: the part of the outer wall of described hydraulic basis chamber has the imaginary tangent line aimed at described attaching surface substantially.
7. fluid delivery system according to claim 1, wherein: the part of the described outer wall of described hydraulic basis chamber is configured to directly contact described skin surface.
8. fluid delivery system according to claim 1, wherein: the remainder of the outer wall of described hydraulic basis chamber has the 3rd thermal conductivity, described 3rd thermal conductivity is less than described second thermal conductivity.
CN201410635389.7A 2009-10-13 2010-10-12 Fluid delivery device CN104474606B (en)
US61/251236 2009-10-13
US61/325136 2010-04-16
CN201080046063.0A CN102665799B (en) 2009-10-13 2010-10-12 Fluid delivery device
CN201080046063.0A Division CN102665799B (en) 2009-10-13 2010-10-12 Fluid delivery device
CN104474606A true CN104474606A (en) 2015-04-01
CN104474606B CN104474606B (en) 2017-04-26
CN201410634901.6A CN104474604B (en) 2009-10-13 2010-10-12 Fluid delivery system
CN201410635389.7A CN104474606B (en) 2009-10-13 2010-10-12 Fluid delivery device
CN201410634903.5A CN104474605B (en) 2009-10-13 2010-10-12 Fluid delivery system
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