CN1871042B - Internal fluid connector - Google Patents

Abstract

A medical device is provided comprising a reservoir adapted to contain a fluid drug in an interior thereof, and a pump assembly. The pump assembly comprises a pump inlet, a pump outlet and an internal flow path arranged there between, and a fluid connector having an inlet and an outlet. The fluid connector is arranged to be operated from an initial state in which the fluid connector is arranged within the interior of the pump and an actuated state in which fluid communication is established between the interior of the reservoir and the interior of the pump assembly via the fluid connector and with the outlet of the fluid connector being arranged in the flow path of the pump assembly.

Description

Internal fluid connector

Technical field

The present invention relates generally to a kind of pump assembly that is suitable for fluid communication with each other and medical apparatus and instruments of storage tank of comprising.

Background technology

In of the present invention disclosing, mention injection or infusion of therapeutic diabetes the most frequently, yet this only is that typical case of the present invention uses by insulin.

Be used for knowing for patient's portability drug delivery apparatus, and generally comprise and be suitable for comprising liquid drug and have the storage tank of the outlet that is communicated with hollow transfusion needle fluid and be used for passing subject's skin and discharging the discharger of medicine from storage tank with through hollow needle drug delivery.Such apparatus is often referred to as infusion pump (infusion pump).

Basically, infusion pump can be divided into two classes.The first kind comprises the infusion pump that is intended to the pump of the comparison costliness of 3-4, and to be used for a kind of like this initial cost of pump usually be the obstacle of this type therapy to reason for this reason.Although more complicated than conventional syringe and pen, this pump provides the continuous injection of insulin, the advantage that dosage accurately reaches the selectively programmable delivery profile, and user and meals are got in touch and activated medicine group and inject.

In order to overcome the above problems, several trials have been carried out, to provide cost the low and second easy-to-use quasi drugs infusion apparatus.These apparatuses are intended to partly or entirely disposable, and the multiple advantage relevant with infusion pump can be provided and not have incidental cost and inconvenience, and for example, pump can be filled in advance, thereby avoid for the needs of filling or refill the medicine storage tank.The example of such infusion apparatus is from United States Patent (USP) 4,340,048 and 4,552,561 (based on osmotic pumps), United States Patent (USP) 5,858,001 (based on piston pump), United States Patent (USP) 6,280,148 (based on membrane pumps), United States Patent (USP) 5,957,895 (based on current limiter pump (being also referred to as the bleed hole pump)), United States Patent (USP) 5,527,288 (producing pump) based on gas, or United States Patent (USP) 5,814,020 (based on inflatable glue) is learnt, these patents are all for cheap, basically use in the disposable drug infusion apparatus and proposing decades recently, the file of quoting is by with reference to comprising.United States Patent (USP) 6,364,865 disclose a kind of hand-held infusion apparatus, its allow two little bottle-shaped vessels to connect and in one of container build-up pressure, discharge the medicine that in container, comprises thus.

The disposable pump generally comprises the contact skin that is suitable for by bonder is applied on the subject's skin surface is installed, and transfusion needle is arranged to, under the situation of using, it stretches out from the surface is installed, penetrate subject's skin thus, when utensil is in use, cover the place that pin wherein penetrates skin whereby.Transfusion needle can be arranged to for good and all stretch out from the surface is installed, thereby pin inserts by means of applying simultaneously of infusion pump, and this is just as at United States Patent (USP) 2,605,765,4,340,048 and disclosed such in EP1177802, pin can be equipped with the apparatus that is in retracted mode, promptly, the tip far away of pin " is hidden " in the pump apparatus, and this allows user that the pump apparatus is placed on the skin and may not observe pin, and this is just as at United States Patent (USP) 5,858, disclosed such in 001 and 5,814,020.Except that pump, can use to be used for the optional apparatus of transmitting fluid medicine, example is ionotherapy as discussed below.

Although may expect second class described above wholly or in part the durable infusion pump of the comparable tradition of disposable syringe device make significantly more cheaply because too expensive and can not be as the real substitute of traditional infusion pump used in everyday.

Summary of the invention

Consider the problem of above affirmation, the element that the object of the present invention is to provide a kind of skin drug delivery apparatus or system can be installed and be used for it, these elements allow a kind of like this apparatuses or system with convenient and cost effective and efficient manner use.Therefore the structure of system and element should help to provide a kind of permission to operate and the service-strong medical delivery device easily and rapidly.

Of the present invention open in, realize the one or more of above purpose with describing or will realize disclosing and by the embodiment and the aspect of the obvious purpose of being described as being of exemplary embodiments by following.

Thereby, corresponding with first aspect, a kind of medical apparatus and instruments that comprises storage tank and pump assembly is provided, this storage tank is suitable within it that portion holds the fluid medicine.The pump assembly comprises pump inlet, pump discharge and arranges inner flow passage between them.The pump assembly also comprises fluid connector, this fluid connector comprises import and outlet, wherein fluid connector is arranged to from original state and actuating state operation, under this original state, fluid connector is arranged in the inside of pump assembly, under this actuating state, setting up fluid through fluid connector between the pump inlet of the inside of storage tank and pump assembly is communicated with, and the outlet that makes fluid connector is arranged in the flow channel of pump assembly, is communicated with thereby set up fluid between the inside of the inside of storage tank and pump assembly.By this way, the pump assembly is provided with and is used for the pump assembly is connected to built-in actuatable device on the storage tank.

Fluid actuator can be by being arranged in the pump assembly or outer any appropriate device actuating.For example, the pump assembly can comprise that the permission external component engages the actuating opening from initial to actuating state operating fluid adapter thus with fluid connector, and perhaps fluid connector can be discharged or actuating by the electric device that is contained in the pump assembly.

In exemplary embodiments, if pump inlet and pump discharge and the actuating opening that provides are included in the inside of original state lower seal pump and thus flow channel and fluid connector are sealed in sealing member under the initial aseptic condition.Sealing member can be any suitable type, and for example the gas that allows sterilizing gas to pass them after applying sealing member can pass sealing member.Using radiation to come also can use the sealing member that can not pass under the situation to apparatus sterilizing for gas.

Fluid connector can comprise the entrance point of point, but and storage tank can comprise and allow the fluid connector entrance point of point to pass the permeation parts of its insertion.Preferably, can see through film, for example make by elastomeric material or elastomeric compounds but the permeation parts of storage tank comprises the self sealss pin.Accordingly, pump discharge can comprise that the percutaneous apparatus that allows point inserts the self sealss pin that passes and can see through film.

The pump assembly can be in the mechanical pump (for example, membrane pump, piston pump or roller pump) that for example combines with the Electronic Control actuating device, mechanically driven pump (for example, being driven by spring), gas-powered pump or the form of the pump that driven by osmotic engine.In exemplary embodiments, flow channel comprises the variable-volume pump chambers, and flow channel preferably also comprises inlet valve that links with pump inlet and the outlet valve that links with pump discharge.

In exemplary embodiments, medical apparatus and instruments also comprises the percutaneous apparatus (for example, comprising the tip) that is suitable for seeing through subject's skin, and the percutaneous apparatus is arranged to or is suitable for being arranged to being communicated with the pump discharge fluid.

In the context of the present invention, (this term also covers similar terms to the percutaneous apparatus, at the percutaneous that uses of tradition in the art near apparatus and percutaneous near instrument) can be the form of the hollow transfusion needle of point, microneedle arrays or soft blunt intubate itself can provide sharp percutaneous apparatus with the combination that point inserts pin, and inserting pin is retractible after the blunt part of percutaneous apparatus is inserted.Under latter event, reality needn't comprise that by the part of the percutaneous apparatus of retracting device withdrawal of the present invention allowing to make up the percutaneous apparatus passes the tip that skin inserts, and return during the insertion of percutaneous apparatus at a kind of like this tip.Intubate is soft and flexibility with respect to the insertion pin of solid draw point typically preferably.In of the present invention disclosing and in the description in exemplary embodiments, mention the percutaneous apparatus of transfusion needle form the most frequently.The length of percutaneous apparatus can be selected according to practical use, for example, can can have 2-8mm with the hollow steel needle that the cardinal principle right angle inserts with respect to skin surface, the insertion length of 3-5mm preferably, and also can be long slightly with the intubate that insert at the angle of inclination with respect to skin surface, 4-20mm for example.

In other exemplary embodiments, the invention provides a kind of medical assembly that comprises above-mentioned medical apparatus and instruments, this medical assembly also comprises percutaneous apparatus unit, this percutaneous apparatus unit has: the percutaneous apparatus comprises the tip that is suitable for penetrating subject's skin; With the surface is installed, be suitable for being applied on the subject's skin, wherein percutaneous apparatus unit and medical apparatus and instruments are suitable under the situation of using fixed to one anotherly, and wherein the percutaneous apparatus is suitable for being arranged to being communicated with the pump discharge fluid.When percutaneous apparatus unit and medical apparatus and instruments are fixed to one another, can be based upon the percutaneous apparatus and be communicated with, just as fluid connector when percutaneous apparatus unit and medical apparatus and instruments are fixed to one another can be from initially operating to actuating state with fluid between the pump assembly.

Corresponding to another aspect, provide to comprise percutaneous unit and the unitary medical apparatus and instruments of storage tank, wherein the percutaneous unit comprises that being used for passing subject's skin partly transmits fluidic transcutaneous device and be suitable for being applied to installation surface on the subject's skin.The storage tank unit comprises: storage tank, be suitable for holding the fluid medicine, and storage tank comprises and allows transcutaneous device to be arranged to outlet with the internal fluid communication of storage tank; And discharger, be used under the situation of using, passing subject's skin discharge fluid medicine from storage tank with through transcutaneous device.Percutaneous unit and storage tank unit also are included in to use and allow the storage tank unit to be fixed to coupling arrangement on the percutaneous unit under the situation.Percutaneous apparatus unit and storage tank unit can comprise housing, arrange the storage tank of percutaneous apparatus respectively and discharge assembly in this housing.

Term " percutaneous " covers the administration of wherein transporting fluidic form of ownership by a part of skin, for example Intradermal or subcutaneous administration.Transcutaneous device can be for the percutaneous apparatus, spray injection device or make the ion medicament infiltrate the form of the hypodermic electrode of object from the predetermined area on the skin surface by the principle of using the iontophoresis therapy.For the more thorough discussion of iontophoresis therapy, with reference to the United States Patent (USP) of introducing as reference 6,622,037.According to the character of transcutaneous device, discharger can have different structures and character.For example, when using one or more hollow transfusion needles or intubate, discharger can be arranged to pressurize or aspirate fluid medicine from storage tank, and under the situation of iontophoresis therapy, discharger is the device that is used for applying electric current on one group of electrode, i.e. " driving " device.

Corresponding to another aspect, a kind of percutaneous apparatus unit and unitary medical apparatus and instruments of storage tank of comprising is provided, wherein percutaneous apparatus unit comprises: the percutaneous apparatus comprises the tip that is suitable for seeing through subject's skin; With the installation surface, be suitable for being applied on the subject's skin.The storage tank unit comprises: storage tank is suitable for holding the fluid medicine; With discharge assembly, be suitable for the storage tank cooperation with from storage tank with pass subject's skin through the percutaneous apparatus and discharge the fluid medicine.Percutaneous apparatus unit and storage tank unit also are suitable for using under the situation fixed to one anotherly, allow to set up fluid thus between storage tank and percutaneous apparatus and are communicated with.Percutaneous apparatus unit and storage tank unit can be included in to use and allow the storage tank unit to be fixed to discharged coupling arrangement on the percutaneous apparatus unit under the situation.Comprise that two unitary a kind of like this medical apparatus and instruments also can think a kind of medical system.

Term is discharged assembly covering combination the set that can discharge fluidic element or structure from storage tank is provided.Discharging assembly for example can be mechanical pump (for example, membrane pump, piston pump or roller pump), mechanically driven pump (for example, being driven by spring), gas-powered pump that combines with the Electronic Control actuating device or the pump that is driven by osmotic engine.

The surface is installed (for example is suitable for pasting object, user or patient) skin apply, and can be by the outside attachment in surface (for example, but allow medical apparatus and instruments to be connected to coupling arrangement or adhesive bandage or dressing on the skin installing apparatus) being installed or lip-deep bonder is installed is being kept and contact skin by being provided at.Install to skin but the installation surface also can be suitable for putting element through between the skin installing apparatus, for example, append to the receiving unit on it but the skin installing apparatus can comprise medical apparatus and instruments, the opening that the percutaneous apparatus is passed in the receiving unit is inserted in the skin.

By above layout, can realize different notions.For example, by one of at least two different unit are provided, might provide two or more the combination, wherein unitary every kind of combination provides a kind of assembly with different abilities with storage tank in percutaneous apparatus unit, as following further go through.Be provided with under the situation that can discharge coupling arrangement in the unit, one of unit can exchange with new or different unit and allow another unit to re-use, and prolongs thus to re-use unitary operation lifetime.Thereby, the present invention provides a kind of and will provide the element at interface to be included in the first module and the element that drug delivery is provided itself is included in device in Unit second to the user in exemplary embodiments, this allows composition element to make up or exchange simply, reliably to reach user-friendly mode.

For example, the storage tank unit can be provided with certain amount of medicament and delivery pump, this delivery pump comprises that the permission drug delivery surpasses for example 10 days energy source, and percutaneous apparatus unit can be provided with the percutaneous apparatus and lip-deep adhesive surface is being installed, this adhesive surface has 2 days expectation (recommendation) operation lifetime, this allows the storage tank unit to use with 5 percutaneous apparatus unit on 10 days period, and this has significantly reduced the totle drilling cost of using combined apparatus.Storage tank can be filled in advance or is suitable for filling one or many.

On the other hand, percutaneous apparatus unit can be provided with pin for example or soft intubate and allow the pin unit install and the bonder that on the time expand section, uses (for example, be used for the type attached) with the colostomy bag, for example when must infusion during than relatively large medicine, the storage tank unit has the short desired operation life-span.Selectively, the use of pin unit combination ground can be installed with a kind of like this " for a long time " in the different storage tanks unit with dissimilar medicines.

For easy use, when pin unit and storage tank unit are fixed to one another, can be based upon pin and be communicated with, just as discharger can activated and not activated when the unit is disconnected from each other when pin unit and storage tank unit are fixed to one another with fluid between the storage tank.In fact, one or both operations also can manually be carried out by the user.

In exemplary embodiments, to discharge assembly and comprise pump, this pump has the outlet that is suitable for being arranged to the import that is communicated with the outlet fluid of storage tank and is suitable for being arranged to being communicated with percutaneous apparatus fluid, allows transcutaneous device to be arranged to internal fluid communication with storage tank thus.By a kind of layout of sample, pump is as the suction pump from storage tank suction medicine, and this storage tank result must be crushable or use under the situation that can not flatten storage tank and will ventilate.Discharging assembly also can be for being suitable for the form to the device of storage tank pressurization, for example is used for the device of in comprising the storage tank of moveable piston driven plunger.The storage tank unit can comprise more than a storage tank with more than one discharges assembly.For example, single discharge assembly can be used for from discharging medicine more than a storage tank, mix medicine thus simultaneously or replace medicine, perhaps each storage tank can be provided with the discharge assembly, this discharge assembly can be connected on the public percutaneous apparatus or be connected on indivedual percutaneous apparatuses, for example percutaneous apparatus unit can comprise be suitable for being connected to discharge on the assembly more than one percutaneous apparatus.

For the initial aseptic flow channel by pump is provided, flow channel can be arranged between import and the outlet, thus the inside of import and the described pump of exit seal, and flow channel is under the initial aseptic condition thus.By kind of a layout, needn't provide as the unitary storage tank of integral asepsis unit, in fact medicine must provide under aseptic condition.

In example embodiment, the storage tank unit can transform to from the original state that does not have fluid to be communicated with between pump wherein and the storage tank wherein when the pump unit is fixed on the pin unit for the first time between the outlet device of the inlet device of pump and storage tank and set up the irreversible mode of operation that fluid is communicated with.By kind of a layout, avoid harmful substance during the reconnecting of pump and storage tank, to be introduced in the storage tank.

In order to guarantee to be connected with cleaning between the storage tank at pump, under initial condition, the separation of the fluid adapter can be arranged in the inside of pump.A kind of like this fluid connector can comprise the entrance point and the outlet of point, and the outlet of the import of pump and storage tank can be in two membrane-permeable forms of pin.By kind of a layout, the tip of fluid connector, for example connect pin, can pass described two films motion, and thereby move with wherein setting up between the operating condition that fluid is communicated with through fluid connector between the inside at the inside of storage tank and pump in initial condition, the outlet of fluid connector is arranged in the flow channel.Preferably when the storage tank unit was connected on the transcutaneous device unit for the first time, fluid connector moved between two position.Accordingly, during connect a kind of like this first time, to set up two kinds of fluids and be communicated with (between the percutaneous apparatus of percutaneous apparatus and pump and between pump and storage tank), and during connecting afterwards, only set up single new fluid and be communicated with (between unitary percutaneous apparatus of percutaneous apparatus and pump).

In example embodiment, the percutaneous apparatus comprises the first of the far-end with point and is communicated with and has the second portion of second end with the first fluid.Preferably second end of percutaneous apparatus is sharp, and the delivery side of pump device comprises that allowing preferably when two unit are connected to each other to set up between the inside of second end of percutaneous apparatus and pump the pin that fluid is communicated with can see through film.

Accordingly, in yet another aspect, the invention provides a kind of pump, this pump has and is suitable for being arranged to the inlet device that is communicated with fluid supply source fluid, and outlet device, this pump is included in the inner flow passage of arranging between import and the outlet device, import and outlet device seal the inside of described pump and thus flow channel are sealed under the initial aseptic condition, wherein fluid connecting device is arranged in the inside of pump under initial condition, fluid connecting device comprises entrance point and outlet, fluid connecting device is arranged to move in initial condition and between the operating condition that wherein entrance point stretches out from the pump inlet device whereby, whereby between the inside of fluid supply source and pump through fluid connecting device with can set up fluid by means of the outlet that is arranged in the fluid connecting device in the flow channel and be communicated with.

Percutaneous apparatus unit can be equipped with for example from the pin that stretch out on the surface is installed, yet, in order to limit the danger of unexpected pin injury, preferably can most advanced and sophisticatedly therein move with respect to installing between the surperficial extended position that stretches out with wherein most advanced and sophisticated with respect to the initial position that the surface withdrawal is installed in the tip of transcutaneous device.According to the plan method that apparatus is installed on the user, the percutaneous apparatus can move between the two positions when two unit are connected to each other, and will be correct as be installed under the situation on user's the skin in percutaneous apparatus unit before the connection storage tank unit.Yet, be installed on user's the skin at module units before two unit plan under the situation connected to one another, percutaneous apparatus unit preferably includes and is used for the activatable actuating device of user between initial and the extended position tip of mobile transcutaneous device.

In order to prevent the accidental activation of percutaneous apparatus before two unit assemblings, percutaneous apparatus unit can comprise the device that is used for stopping actuating device, when percutaneous apparatus unit and storage tank unit are fixed to one another, discharge this retention device, allow actuating device to activate thus.

In order further to reduce the probability that the percutaneous apparatus injures, the tip of percutaneous apparatus is most advanced and sophisticated therein with respect to the extended position that stretches out on the surface being installed and can being movable between the retracted position of tip with respect to the withdrawal of installation surface wherein.Accordingly, combined apparatus can comprise when retracting device activated, be used for extend and retracted position between the actuatable retracting device of user at tip of mobile percutaneous apparatus.In order to prevent reusing of percutaneous apparatus, transcutaneous device can for good and all be locked in its retracted position.

In order to prevent user error, the actuating device that is used for introducing the percutaneous apparatus can cover retracting device under initial condition, and the actuating of actuating device exposes this retracting device.For example, () form for example, tape is describedly whereby removed the insertion that operation triggers the percutaneous apparatus to the grip device that actuating device can be removed from apparatus, and exposes the retracting device that is used for returning the percutaneous apparatus simultaneously.

As mentioned above, when assembling and taking two unit apart, can activate and not activate the discharge assembly, yet actuating device and retracting device also can be used for activating respectively and not activate the discharge assembly.Just as in initial connection the between pump and the storage tank, the initial activation of discharging assembly can cause starting electronic-controlled installation owing to the beginning of pump action, and do not activate later and will only not activate actual pump action, that control device remains is active the initial activation gate time of control device (for example, from).

More than of the present invention open in, two unit mainly are described as " integral body " unit, however this is an example constructions, and these two " mainly " unit can be subdivided into other unit under the situation of hope thinking.For example, the storage tank unit can be provided with interchangeable control unit, this allow dissimilar control units be connected to the storage tank unit originally on one's body, for example the control unit of the first kind can provide single delivery profile of planting, second control unit can be programmable to revise transportation scheme thus, perhaps controls Unit the 3rd and can comprise permission control unit and external device (ED) communicating devices.Under latter event, control unit can use wireless Long-distance Control and control.Accordingly, storage tank can be interchangeable, allows to use the storage tank of different size or dissimilar medicines.

In another aspect of the present invention, percutaneous apparatus unit provides by above description, and is suitable for disclosed and storage tank unit combination ground uses as above.Accordingly, the present invention also provides a kind of storage tank unit as above disclosed, and this storage tank unit is suitable for disclosed and percutaneous apparatus unit combination ground uses as above.In exemplary embodiments, a kind of like this percutaneous apparatus unit can be provided with hollow needle, this hollow needle comprise have exit opening and be suitable for penetrating subject's skin point far-end and have the near-end of the point of the inlet openings that forms the fluid inlet device, the fluid inlet device is suitable for being arranged to being communicated with fluid supply source fluid.By this layout, pin provides the pin import to be communicated with (for example, being formed by metal) with hydraulic pressure rigidity fluid between the exit opening, like this by monitoring the pressure accumulated detection that has realized early stage obturation of pin upstream.

In yet another aspect, a kind of system is provided, this system comprises the first pin unit and as the above first storage tank unit or the above disclosed storage tank unit that is communicated with at least one other pin unit disclosed, other unit has the ability different with first module.Different abilities can relate to unitary any structural feature, for example the type of the type of the type of pin, the actuatable device of user, conveying/pumping installations or the type of storage tank/medicine.

More particularly, in exemplary embodiments, provide a kind of above disclosed percutaneous apparatus unit and unitary system of a plurality of storage tank of comprising, the discharge assembly that each storage tank unit comprises the storage tank that holds the fluid medicine and is used for the fluid medicine is discharged from storage tank.Percutaneous apparatus unit and storage tank unit comprise and allow the storage tank unit that pairing coupling arrangement to provide storage tank to be communicated with fluid between the percutaneous apparatus is provided on the percutaneous apparatus unit that wherein unitary every kind of combination provides the assembly with different abilities with storage tank in percutaneous apparatus unit.Can realize providing the not commensurability storage tank unit, the storage tank unit that for example have identical medicine, be suitable for presetting storage tank unit that speed discharges, being suitable for the unitary different abilities of storage tank that to select speed to discharge respectively with fixing with difference with distortion of different medicines or given medicine.Storage tank is unitary a kind ofly can be provided with control and to discharge the processor of assembly and operationally be connected to be used on the controller receiving from the separation control tool and flow instruction and the instruction of flowing is transported to the receptor of processor.Receptor can be a wireless receiver.The storage tank unit can also be provided with different input equipment (for example, being used for wireless or wired connection or manually input) or different output device (for example, being used for wireless or wired connection, different display device or different alarm devices).

In another exemplary embodiments, provide a kind of above disclosed a plurality of percutaneous apparatus unit and unitary system of storage tank of comprising, the discharge assembly that the storage tank unit comprises the storage tank that holds the fluid medicine and is used for the fluid medicine is discharged from storage tank.Percutaneous apparatus unit and storage tank unit comprise and allow percutaneous apparatus unit that pairing coupling arrangement to provide storage tank to be communicated with fluid between the percutaneous apparatus is provided on the storage tank unit that wherein unitary every kind of combination provides the assembly with different abilities with storage tank in percutaneous apparatus unit.By provide have such as hollow hypodermic needle, intubate and transfusion needle assembly, and microneedle arrays the percutaneous apparatus unit of different percutaneous apparatuses, by different binding agents is provided, by different insertion or retracting devices is provided, or, can realize different abilities by different coupling arrangements is provided.

The present invention also provides a kind of method, and the method comprising the steps of: the percutaneous apparatus unit that comprises the percutaneous apparatus and the surface is installed is provided; The storage tank unit is provided, this storage tank unit comprises the discharge assembly that is suitable for holding the storage tank of fluid medicine and is used for discharging from storage tank the fluid medicine, and assembling percutaneous apparatus unit and the storage tank unit other step to provide storage tank to be communicated with fluid between the percutaneous apparatus is provided this method.Is communicated with fluid between the storage tank when assembling can be based upon the percutaneous apparatus during two unit, perhaps can sets up this fluid connection when further activating when assembling apparatus, two kinds of selections all limit covering by above.This method can comprise other step: installation is surface mounted on the subject's skin surface; With after installation being surface mounted on the subject's skin surface, activate the percutaneous apparatus to be communicated with setting up fluid between storage tank and the object.

Another kind method provides the drug delivery apparatus with default rate-allocation medicine, the method comprising the steps of: a kind of system is provided, this system comprises percutaneous apparatus unit, this percutaneous apparatus unit comprises percutaneous apparatus and the installation surface that is suitable for being applied on the subject's skin, system also comprises a plurality of storage tanks unit, and each storage tank unit comprises the storage tank that holds the fluid medicine and is used for discharging fluidic discharge assembly with default speed from storage tank; Selection has the storage tank unit of wishing default speed; And the storage tank unit of assembling percutaneous apparatus unit and selection, so that being provided, storage tank is communicated with fluid between the percutaneous apparatus.

As used herein, term " medicine " but be meant that containing can pass any medicine flow medicinal that contains of the conveyer device such as hollow needle in a controlled manner, as liquid, solution, gel or thin float.Representative medicine comprises: medicament, as peptide, albumen, and hormone; Biologically-derived or active agent; Hormone and gene base reagent; Nutrient formulation; And other material of solid (dispersion) or liquid form.In the description of exemplary embodiments, the use of insulin will be mentioned.Accordingly, term " subcutaneous " injection is meant any method that containing is carried for the object percutaneous.And term pin (when not having to stipulate in addition) limits the lancet and means that is suitable for penetrating subject's skin.

Description of drawings

Below, further describe the present invention with reference to the accompanying drawings, in the accompanying drawings:

Fig. 1-11 represents use order for first embodiment of drug delivery apparatus with axonometric chart,

Figure 12 represents unitary another embodiment of storage tank,

Figure 13 represents to be used for pin unit and the storage tank unit of another embodiment of drug delivery apparatus with non-assembled state,

Figure 14 represents the unitary decomposition view of the pin of Figure 13,

Figure 15 represents the axonometric chart of pin unit under first state of Figure 13,

Figure 16 represents the axonometric chart of the needle carrier of Figure 14,

Figure 17 represents the axonometric chart of pin unit under second state of Figure 13,

Figure 18 represents the unitary side view of the pin of Figure 13,

Figure 19 represents the unitary other axonometric chart of the storage tank of Figure 13,

Figure 20 represents the axonometric chart of the unitary inside of storage tank of Figure 13,

Figure 21 represents the unitary decomposition view of another kind of storage tank,

Figure 22 A represents to be connected to the signal summary of the pump on the storage tank,

Figure 22 B represents the decomposition view of pump assembly,

The viewgraph of cross-section of the pump assembly of Figure 22 C presentation graphs 22C,

The partial cross-sectional view of the pump assembly of Figure 22 D and 22E presentation graphs 22C,

Figure 23 A and 23B represent intubate and the percutaneous apparatus that inserts the pin combining form with the signal representative,

Figure 24 represents the axonometric chart of another kind of drug delivery apparatus,

Figure 25 A-25D represents to be suitable for the different dischargers with use of the present invention,

Figure 26 represents to have the unitary medical apparatus and instruments of module storage tank, and

Figure 27 represents to be used for the modular system of medical apparatus and instruments.

In the accompanying drawings, similar structures is mainly distinguished by like reference numerals.

The specific embodiment

When the term that uses below such as " top " and " bottom ", " right side " and " left side ", " level " and " vertical " or similar relative expression, these only refer to accompanying drawing, and do not refer to actual use situation.The accompanying drawing of expression is signal representative, reason for this reason, and the relative size structure of different structure and there only is used for illustration purpose.

At first, with reference to Fig. 1-12,, mainly concentrate on end user's orientation characteristic with describing a kind of embodiment of drug delivery apparatus.Percutaneous apparatus unit 2 comprises the percutaneous apparatus of hollow transfusion needle form, and thereby will be called the pin unit below, yet this pin can anyly wish that the percutaneous apparatus replaces with what be suitable for the fluid drug delivery.

More particularly, Fig. 1 represents that a kind of module skin can install the axonometric chart of medical apparatus and instruments of the form of drug delivery apparatus 1, and this drug delivery apparatus 1 comprises the pin unit 2 and the storage tank unit 5 of cover plate shape.When supply with giving the user, unitary each preferably be enclosed in its oneself pack in the (not shown).

The pin unit comprises: base part 10 has the bottom that is suitable for being applied on user's skin the surface is installed; With housing parts 20, wherein arrange hollow transfusion needle (not shown).Described pin comprises the first pin part, second tip that this first pin partly has the far-end of the point that is suitable for penetrating user's skin and is suitable for being arranged to being communicated with storage tank unit fluid.In illustrated embodiment, can be therein should move with respect to installing between the surperficial extended position that stretches out with wherein most advanced and sophisticated with respect to the initial position that the surface withdrawal is installed at the tip in the tip of pin.And pin can be most advanced and sophisticated therein with respect to the extended position that stretches out on the surface being installed and wherein being moved between the retracted position of tip with respect to the withdrawal of installation surface.The pin unit also comprises: the user who is the first tape parts, 21 forms can grip actuating device, with this actuating device of box lunch when activateding between the initial position and the second position tip of mobile pin; The user who is the second tape parts, 22 forms can grip retracting device, with this retracting device of box lunch when activateding between extended position and retracted position the tip of mobile pin.As can be seen, second tape is initially covered by first tape.Described shell also comprises the actuatable protrusion coupling arrangement 40 of user that is suitable for arranging with a pair of elasticity of corresponding recessed coupling arrangement cooperation on the storage tank unit hook shaped component form, and this allows storage tank unit to be fixed to releasedly on the pin unit under the situation of using.In illustrated embodiment, base part comprises the more inflexible top part 11 that appends on the more softish bonding sheet parts 12, and these bonding sheet parts 12 have provides the bottom adhesive surface that surface itself is installed, and adhesive surface is equipped with peelable screening glass.Base part also comprises and is suitable for the protuberance parts 13 that engage with respective slot on the storage tank unit.

Storage tank unit 5 comprises: fill storage tank in advance, hold fluid drug formulation (for example insulin); With the discharger of Electronic Control pump form, be used under the use situation, going out medicine by faller gill from storage tank.The storage tank unit has the smooth lower surface of cardinal principle on the upper face that is suitable for being installed to base part, and the recessed coupling arrangement 51 that comprises the ledge 50 in the corresponding cavity that is adapted to be received in housing parts 20 and be suitable for engaging with corresponding hook shaped component 31 on the pin unit.Ledge is provided at two interfaces between the unit, and comprises pump discharge and allow the contact making device (not shown) of pump startup when these two unit are assembled.Described lower surface also comprises the window (can't see) that allows the user visually to control the content of storage tank.

First step in installation process is to assemble described two unit (Fig. 2) by the storage tank unit being slided simply engage with the pin unit.When hook shaped component correctly engages the storage tank unit, hear " click is taken " sound (Fig. 3), send the signal that these two unit have suitably been assembled to the user.If wish, also can produce visual or earcon.After this, the user removes peelable 14 and can append to apparatus on user's the skin surface after this to expose adhesive surface (Fig. 4), typically appends to (Fig. 5) on the abdominal part.By activate tape 21 as gripping and draw back by the arrow indication, pin is inserted into whereby, and then infusion starts automatically, thus the infusion (Fig. 6) of beginning medicine.Pin inserts mechanism and can supply with under pre-stressed state, and is discharged by actuating device later on, and perhaps the insertion of pin can be by user " excitation "." buzzing " signal confirm that apparatus is being operated and medicine by infusion.The storage tank unit is provided preferably with under the situation that for example obstruction, failure of pump or content use up and provides advertiser and the sniffer that can listen alarm signal to the user.

For the unitary use of pin, apparatus shelved put in place through recommendation the time period (for example 48 or 72 hours) afterwards-or become under the empty situation or because other reason at storage tank, by as indicating, gripping (Fig. 7) and pulling (Fig. 8) withdrawal tape 22 by arrow, cause the withdrawal of pin, then be stopping automatically of medicine injection, the tape that appends on the bonding sheet after this is used for removing apparatus (Fig. 9) from skin surface, thereby has removed this apparatus from skin.

When removing apparatus, by as indicating, depressing two hook shaped components 31 (Figure 10) simultaneously by arrow, make storage tank unit 5 as breaking away from engage (Figure 11) with pin unit 2 by arrow indication, and two unit are thrown off, pin unit 2 is discardable then.After this, the storage tank unit can use with new pin unit once more, becomes empty up to it.

The storage tank unit can provide fixed basic injection speed, and perhaps it can be used as to have and allows infusion rates to be supplied with by the adjustable unit (Figure 12) of the adjusting device 55 of doctor and/or user/patient's setting.The storage tank unit also can be provided with and allow control device to be programmed or by the device (not shown) of electronic settings.

The apparatus of describing with reference to Fig. 1-11 also can use in selectable mode.For example, the pin unit can be installed on the skin, additional tanks after this.According to the unitary structure of pin, may or prevent from before the additional tanks unit, to introduce described pin.

Figure 13 represents another embodiment of corresponding medical apparatus and instruments 500 substantially with the embodiment of Fig. 1, and this apparatus comprises paster shape pin unit 502 and can append to storage tank unit 505 on it.

Figure 14 represents to comprise the pin unit of upper case part 510, needle carrier 520 and transfusion needle 530 mounted thereto; Actuated components 540; Releasing parts 550; The exploded perspective view of lower case part 560 and sheet material 570.But actuated components comprises user's grip portions 541 and pin actuation part 542, but and releasing parts comprise user's grip portions 551 and pin withdrawal part 552.Under assembled state as shown in Figure 15, the upper and lower housing parts forms shell 503, in this shell 503 pin and needle carrier is installed, and actuating and releasing parts are operably connected on the needle carrier, but user's grip portions is arranged in the outside of this shell.Different with the embodiment of Fig. 1, the pin unit does not comprise the base plate part, but comprise two protuberance parts 561 that extend from shell, the lower surface of protuberance parts and shell is installed on the flexible flake parts, these flexible flake parts are provided with bottom adhesive layer 571 on surface, its underpart, allow the pin unit to append on the subject's skin position.Sheet material also comprise be arranged to lower protrusion 565 aligned opening 572 these lower protrusion 565 around the outlet opening setting that is used for the percutaneous apparatus, just as described thin slice is provided with a large amount of little perforates to improve the respiratory by thin slice.Shell 503 is provided with and allows the storage tank unit to append on the pin unit 505 and from this pin unit to discharge the actuatable coupling arrangement 511 of the unitary user of storage tank, and the storage tank unit comprises the coupling arrangement 506 and the display 587 of corresponding coupling.Display can be indicated for example unitary suitable function, the amount of medicament in storage tank or different error conditions.

As seen, but user's holding assembly 551 of releasing parts is initial by the covering of the part on the actuated components, and this has reduced the user and has missed the probability of using releasing parts rather than actuated components.And actuating and releasing parts (or its part) can be used color coding, correctly use apparatus further to help the user.For example, actuated components can be green with indication " startups ", and releasing parts can be red in to indicate " stopping ".

Figure 16 represents to have the needle carrier 520 of pin 530 and the pin actuation part 542 of actuated components 540 with axonometric chart.The pin actuation part comprises two supporting legs 543 that allow it to slide with respect to shell, and the respective openings 563 that supporting leg is passed in the shell is arranged.Needle carrier is suitable for being connected on the hinge member 562 of lower case part, allows needle carrier thus and pin and the pivot axis that is limited by hinge are pivoted accordingly.In illustrated embodiment, needle carrier is the form of flex foils metal parts, and described carrier comprises by hinge fraction 523 upper arm 521 connected to one another and lower arm 522, allows lower arm to pivot accordingly with respect to upper arm with pivot axis.Lower arm forms the pallet (for example, by welding or bonding) that hollow transfusion needle 530 wherein is installed, and described needle set has: be suitable for seeing through the nose part far away 531 of subject's skin, this distal part is extended perpendicularly with the unitary installation of pin surface substantially; With nearly part 532, be arranged to substantially correspondingly with described pivot axis, and be suitable for engaging the fluid supply source.Thereby when the part of upper arm was installed in the shell, lower arm distal part withdrawal first retracted position in the enclosure of pin therein pivoted with respect to installing between surperficial second extended position that stretches out with distal part wherein.In illustrated embodiment, needle carrier provides and is used for the driving device of mobile lower arm between the two positions.This can be provided by the elastic property with the corresponding sheeting of hinge fraction itself in the present embodiment, and perhaps selectively, secondary spring can be provided between these two arms thus they are pushed open.For the bottom part is locked in the discharged primary importance that is energized, upper arm is provided with: flexible release arm 526 comprises the pallet (catch) 527 that lower arm is supported and be captured in its first biased downward position; And release portion 528, engaging with the skewed surface 544 of pin actuation part 542, described pallet also comprises when lower arm and is suitable for engaging the sloping edge part 529 of lower arm from its extended position when its retracted position moves, as will be described in more detail as follows.

For pin is activated, but the user holds the flexible tape (it preferably includes stick portion it is remained in its illustrated folding initial position) that forms user's grip portions 541, and pin actuation part 542 is pulled out shell, and actuated components 540 breaks away from shell thus fully.More particularly, when inclined surface 544 was moved, it forced pallet (latch) 527 to leave lower arm to discharge it thus, and after this, release portion 528 breaks away from the inclined-plane, allows two supporting legs to pull out from shell.As seeing among Figure 17, when removing actuated components, but user's grip portions 551 of exposure releasing parts.About actuated components, but user's grip portions of releasing parts preferably includes stick portion, it is remained in the illustrated folding initial position.

In illustrated embodiment, releasing parts is for to form and to have the form of the tape of inside and outside end by flexible material, this tape is passed in the opening 512 in the shell, but tape forms user's grip portions 551 and pin withdrawal part 552 thus, the inside end of tape is attached on the shell, and the outer end of tape is attached on the peripheral part of sheet material 570, perhaps selectively, is attached on the peripheral part of shell.That represents in Figure 18 stretches out, and releasing parts is illustrated in its initial position, the withdrawal that forms loop 555 partly be arranged in needle carrier lower arm below, this position allows lower arm to move to its actuated position, and thus pin is moved to its extended position.

When user decision when skin is removed the pin unit, but the user holds user's grip portions 551, and it is lifted away from shell, and its upwards pulling, loop shortens and upwards forces lower arm thus whereby, this position is corresponding with middle release conditions.By this action, lower arm engages the sloping edge part 529 of pallet 527, outwards forces this sloping edge part 529 thus, up to it with Figure 16 in block back below the corresponding lower arm in position represented.When actuated components 540 when the pin unit is removed, needle carrier irreversibly is locked in its retracted position.When the user further draws in releasing parts, the peripheral part of the sheet material of attached releasing parts will lift away from skin, can remove pin unit and the storage tank unit attached with it from skin whereby, this just as reference Fig. 7-9 expression with as described in.

Preferably, actuating and releasing parts can form and be arranged to be communicated with storage tank unit (not shown).For example, one of supporting leg of actuated components can pass shell in its initial position outstanding, engaging the corresponding contact on the storage tank unit thus, this is to the attached pin of indication unit, storage tank unit, and removing of actuated components inserted pointer and thereby can be begun drug infusion.Accordingly, the actuating of releasing parts can be used to stop pump.

In Figure 19, expression is connected to the sidepiece of the pin unit 502 on the storage tank unit.Except that two protuberances parts 561 and the actuatable coupling arrangements 511 of user, the pin unit also comprises and is connected on the storage tank unit and/or engages with it so that the structure with the unitary function interface of storage tank to be provided.More particularly, the pin unit comprises: fluid inlet is provided by the nearly part 532 of the point of the pin that stretches out from the pin unit, and is suitable for engaging the unitary fluid issuing of storage tank; Actuator 515 stretches out from the pin unit, and is suitable for engaging and be actuated at the fluid connector (seeing below) in the storage tank unit; And first and second contact actuator 548,558, be suitable for being bonded on the corresponding contact on the storage unit.The far-end of one of supporting leg 543 of the pin actuator that first contact actuator is stretched out by the opening that is passed in the shell provides, and second contact actuator is provided by the hinge fraction of the shell on the pin withdrawal part 552 that is connected to releasing parts 550.When the pin unit was connected on the storage tank unit for the first time, two contact actuator were will be from shell outstanding and engage corresponding contact on the storage tank unit, and the pointer unit is connected thus.When pin activated, first contact actuator will be return, and throw off the corresponding contact on the storage tank unit thus and begin pump and activate.When pin is withdrawn, second contact actuator will pivot, and break away from the corresponding contact on the storage tank unit and stop pump and activate.

Figure 20 is illustrated in except that the storage tank unit under the top part situation of decapsidate.The storage tank unit comprises: storage tank 760; With the discharge assembly, comprise pump assembly 300 and control thereof and actuating device 580,581.The pump assembly comprises and is used to be connected to percutaneous near outlet on the apparatus (for example, pin 530) 322 and the opening 323 that allows internal fluid connector to activate, sees below.Storage tank 560 is in pre-filling, flexible and form crushable bag, and this bag comprises that the pin that is suitable for being arranged to be communicated with pump assembly fluid can see through film, sees below.Illustrated pump assembly is mechanically actuated membrane pump, yet storage tank and discharger can have any suitable structure, and is for example disclosed as reference Figure 25 A-25D.

Control and actuating device comprise: the pump actuated components, be the form of coil actuator 581, and be arranged to the piston of driven membrane pump; PCB or flexible core print (flex-print) and are used for the microprocessor 583 that control pump especially activates and link to each other; Contact 588,589 is with the contact actuator cooperation on the pin unit; Signal generation apparatus 585 is used for producing and can listens and/or appreciable signal; The display (not shown); And energy source 586.Preferably by the barrier film protection, this barrier film can be formed by the flexible portion of shell in the contact.

In Figure 21, the decomposition view of the storage tank unit 505 of expression Figure 13, this unit comprises: upper case parts 507; Lower case parts 508 have transparent region 509 and the reception groove 504 from the protuberance parts 561 of pin unit extension; Flexible storage tank 760 has the marginal portion 762 of rounding, and membrane element 761 is installed on this marginal portion 762; Pump assembly 300 has the actuator and the circuit board (not shown) that are arranged in storage tank top, and comprises and be used for the electronic component of actuating of control pump.The upper and lower case member is included as the storage tank erecting device that is suitable for engaging and being positioned at the storage tank in the shell of relative upper and lower bump 780 forms.Each bump comprises central cut-out 781, should central authorities' cut-out 781 when the package shell parts be suitable for being bonded on the membrane element on its apparent surface, storage tank is locked in the enclosure to put in place thus.The locking degree will by the elastic property that is applied to pressure on the film, membrane element, and frictional force between protuberance and membrane element determine.On each side of cut-out, bump comprises and can help storage tank is installed in straight line portion 782 in the shell.Straight line portion can engage the initial pre-storage tank of filling and its locking be put in place helping, yet when storage tank became empty and become flat, this clamping may die down.On the contrary, when storage tank becomes empty, be suitable for suitably storage tank being kept putting in place with engaging of film.Straight line portion also can be suitable for clamping and flatten storage tank fully, thereby as auxiliary installation device.The auxiliary installation device (not shown) can engage and the clamping storage tank, and other device (not shown) can for example along welded edge 765, engage and the clamping storage tank in other position.

With reference to Figure 22 A, expression is connected to the signal summary of the pump on the storage tank, and pump comprises following general features: with fluid connector 391, storage tank 390, relief valve 392, import and the outlet 393,394 of storage tank, the pump chambers 395 with associated piston 396, and outlet 397.The flow direction of arrow indication between each element.When piston (in the drawings) motion downwards, negative pressure is based upon pump chambers inside relatively, and this will make inlet valve open, and unlimited primary side that later on will be by relief valve is from the storage tank withdrawn fluid.When piston makes progress (in the drawings) when motion, overvoltage is based upon in the pump chambers relatively, and this will make inlet valve close and make outlet valve and relief valve to open, and fluid will flow to outlet from the primary side of pump chambers by outlet valve and relief valve whereby.Obviously, in common operation, relief valve allows fluid to pass through between fluidic suction and ejection time, and thereby is " passive " during normal running.Yet, under the situation that storage tank is pressurizeed (as contingent) for flexible storage tank, rising pressure in storage tank will be delivered to the primary side of relief valve and through pump chambers to the primary side of relief valve, in this case, will prevent that at the pressure of the primary side of relief valve primary side from opening.

In Figure 22 B, expression utilizes the decomposition view of the pump assembly 300 of the pump principle describe in Figure 22 A, and pump assembly (below be also referred to as pump) is suitable for using with the storage tank unit of Fig. 1-13.Pump is the membrane pump that comprises the plunger actuation pump diaphragm, and this plunger actuation pump diaphragm has flow-control import and outlet valve.Pump has the generic hierarchical structure that comprises first, second and third parts 301,302,303, between these parts, insert first and second membrane layers 311,312, pump chambers 341 is formed in combination by first and second parts and first membrane layer whereby, relief valve 345 is formed in combination by the first and the 3rd parts and first membrane layer, reaches import and outlet valve 342,343 and is formed in combination (seeing Figure 22 C) by the second and the 3rd parts and second membrane layer.All layers are kept with stacked arrangement by outer clamp 310.Pump also comprises import 321 and outlet 322 and connection opening 323, and these three all by the respective diaphragm 331,332,333 of the inner sealing of pump under initial aseptic condition covered.Barrier film can see through or pierce through (for example, being made of paper) by the pin that passes given sealing member introducing or other parts.Outlet comprises that also allowing pump to be connected to out self sealss, pin on the lancet can see through film 334 (for example, rubber-like material).As representing among Figure 22 C, fluid passage (by the black line indication) is formed between import 321 (face as follows) and the inlet valve 342 through the primary side of relief valve 345, be formed between inlet valve, pump chambers 345 and the outlet valve 343, the primary side that reaches through relief valve is formed between outlet valve and the outlet 322, and the fluid passage is formed in the different layers or between it.Pump comprises also and is used for the membranous piston 340 of actuated pump that piston is driven by the external driver device (not shown).

Pump also comprises the fluid connector that is positioned at hollow connection pin 350 forms in the pin chamber 360 slidably, and this pin chamber 360 is arranged in the connection opening back, sees Figure 22 D.The pin chamber passes all layer of formation of pump, and comprises inner sealing film 315, passes this film 315 and arranges pin slidably, and described film is formed by first membrane layer.Pin comprises sharp far-end 351, arranges the near-end of pin piston 352 on it, reaches the proximal open 353 that flows and be communicated with far-end, and pin and piston are arranged slidably with respect to internal diaphragm and chamber.As intelligible, in the pin piston of its initial position keyway 359 bypass by one or more radial arrangement by Figure 22 D.Provide these so that allow steam sterilization and ventilation, otherwise when fluid connector travels forward, catch air in the pin chamber.

The said pump assembly can be provided in the drug delivery apparatus of the type of expression among Fig. 1-2 0.The storage tank unit is attached under the use situation on the pin unit therein, and the near-end 532 of transfusion needle passes the delivery side of pump sealing member and film 334 is introduced, and actuator 515 (seeing Figure 19) passes and connects barrier film 333 and introduce.By this action, connect pin and shift the actuated position of in Figure 22 E, representing onto from its initial position of among Figure 22 D, representing, in this actuated position, far-end passes import barrier film 331 and further passes the pin of arranging near storage tank and can see through the film motion, has set up flow channel via the nearly opening 353 in the pin between storage tank and inlet valve like this.In this position, sealing member is formed between pin piston and the pin chamber.

Obviously, when threw off two unit, the near-end of transfusion needle 532 withdrawed from from pump discharge, for good and all provided pump to be communicated with fluid between the storage tank and connect pin.

In the above-described embodiments, the percutaneous apparatus is the form (for example, represented transfusion needle or pin pick off (not shown)) of integral pin apparatus, yet, the percutaneous apparatus also can for the intubate of inserting the pin combination or the form of pick off, this insertions pin withdraws from after its insertion.For example, first pin part can be (softer) infusion cannula (for example, Teflon

Intubate) and run through the form of the removable insertion pin of layout.Such cannula needle arranges and knows from so-called infusion set that such infusion set typically is used for providing the transfusion place with (durable) infusion pump combinedly.

Thereby Figure 23 A and 23B schematically represent intubate and insert the pin combination how to be arranged in given medical apparatus and instruments 600 (part expression), in the shell 601 in for example infuse apparatus or the infusion set.More particularly, this medical apparatus and instruments comprises percutaneous assembly 650, and this percutaneous assembly 650 comprises that (it for example can be soft Teflon to the softer intubate 651 of being carried by lower member 653

The intubate type) and the combination that is arranged in slidably in the intubate and inserts pin 661 (for example, making) by the point that upper member 663 is carried by the medical grade rustless steel, two parts are mounted to and allow intubate, insert pin correspondingly moves axially.Intubate comprise allow it with or be arranged to the nearly import (not shown) that is communicated with the fluid source fluid.Medical apparatus and instruments also comprises having the opening 621 that is used for intubate and the base plate 620 of releasing parts 622.Lower member comprises elastomeric seal 652, passes this elastomeric seal 652 and arranges the insertion pin.Intubate and to insert how pin to install in apparatus according to two parts can be straight or crooked, for example with pivot axis corresponding arc or with the corresponding straight line of rectilinear motion, as showing.Upper member comprises parts is locked in coupling components 667 in the initial position together, make of the far away opening extension of the far-end of insertion pin from intubate, as representing among Figure 23 A, and substrate comprises and is used for lower member is locked in coupling components 657 in the extended position, and the opening that the far-end of intubate is passed in the base plate extends (seeing Figure 23 B).Between the shell and upper member of apparatus, first spring 668 is arranged to the upper offset upper member.Accordingly, apparatus also comprises second spring 658 to the upper offset lower member.Medical apparatus and instruments also comprises and corresponding gripping pulling-on piece 676 of illustrated embodiment in Fig. 1 and pulling parts 677.

Under the situation of using, assembly or manually or by discharging inserts helps for example is passed in the spring-loaded part (not shown) of the opening effect in the shell, moves downward, and makes whereby to have the intubate of stretching out the insertion pin and pass the subject's skin insertion.In this position, lower member engages coupling components 657, thus intubate is locked in its extended position, just as coupling components 667 is discharged by releasing parts 622, allows upper member to return its initial position by means of first spring thus.

When the user plans when delivery instrument is removed on the surface, the user holds the grip portions of pulling-on piece and is spurring it substantially with on the first direction that skin surface parallels, by this action, flexible tape 677 discharges coupling components 657 from lower member, whereby lower member and thus intubate withdraw by means of second spring.When intubate when skin is return, the user uses new expansion pulling-on piece to draw back whole delivery instrument from skin surface, for example by this pulling-on piece of pulling on away from the direction of skin surface.

In Figure 24, expression with reference to Fig. 1-12 describe be applicable to after the embodiment (that is, the pin unit being installed at first) of apparatus of installation process.

More particularly, Figure 24 represents the axonometric chart of the medical apparatus and instruments of drug delivery apparatus 100 forms, and this drug delivery apparatus 100 comprises pin shell 110, has the base component 130 on the installation surface, bottom 133 that is suitable for being applied on the subject's skin, reaches separate pump unit 150.In illustrated embodiment, base component comprise be attached on the flexible adhesive patch parts 132 than rigidity top part 131, these adhesive patch parts 132 have provides the bottom adhesive surface that surface itself is installed.The pin shell can integrally form with base component, perhaps is attached to it as separative element, and two elements combination ground form the platform unit.In illustrated embodiment, the pin unit comprises shell 111, in this shell 111, arranges hollow needle 112 pivotally.

Shell comprises first and second openings (or window) that covered by first and second lid arrangements.In illustrated embodiment, first lid arrangement is the form that pin can see through diaphragm of rubber 121, and the second lid barrier film is introduced in the form of the pierced through scraps of paper in the inside of shell for allowing element.The scraps of paper are permeable for sterilizing gas, and the scraps of paper, diaphragm of rubber and shell are provided for encapsulating the aseptic isolation of pin part in combination.

Pin comprises: the first pin part 113, have first tip that is suitable for penetrating subject's skin, and first pin part is extended perpendicularly with the installation surface substantially; With the second pin part 114, be communicated with through middle needle part 115 fluids with first pin part, and have second tip, second pin part is arranged with the installation surface substantially with paralleling.Pin is connected on the shell by installing component 117, allow pin and the axis that partly limits by second pin to pivot accordingly, whereby pin therein first pin part pass diaphragm of rubber and move with respect to the initial aseptic position that the surface withdrawal is installed and the tip of first pin part wherein with respect to installing between the surperficial second position of stretching out.Shell also comprises the bias component 118 to initial position biasing pin.Usually, " downstream " of pin partly (here: be known as distal part first), and " upstream " of pin partly (: second portion) be known as nearly part here.

Storage tank (or pump) unit 150 comprises the shell of wherein arranging storage tank and discharger.Storage tank is suitable for holding fluid medicine (for example, fill in advance or be suitable for being filled by the user), and comprises that the outstanding pin that is suitable for being arranged to be communicated with the second pin segment fluid flow can be through the outlet device of film 155 forms.The discharger (not shown) is suitable for using under the situation from storage tank and passing subject's skin and discharge medicine through hollow needle.The pump unit also comprises the inclined plane part 156 that adjacent storage tank outlet is arranged.Storage tank and discharger can have any suitable structure, and be for example disclosed as reference Figure 25 A-25D.

Mounting platform comprises receiving unit, and receiving unit and pump unit comprise that permission pump unit is fixed to the pairing coupling arrangement 160 on the platform unit.This pairing coupling arrangement is releasable, allows durable or repeatedly uses the pump unit to be attached on the disposable platform unit repeatedly.

In using situation, the platform unit (for example is installed on user's skin, by being arranged in lip-deep bonder is installed), and the pump unit by make its substantially and install the surface slide with paralleling engages with the platform unit and attached with lock onto on the platform unit.Operating period afterwards, to give prominence to film and inclined plane part is moved into pin and engages, destroying paper thus stops and covers 122, in this operating period, setting up fluid between second pin part and storage tank is communicated with, just as pin pivots from its initial position to its second position, the first prong end penetrates diaphragm of rubber and user's skin thus.

The pump unit connected with percutaneous pin is introduced after, but primer pump.This automatically takes place in the time of can working as two unit of connection, and perhaps by the actuatable starting drive of isolating user, for example the start button (not shown) takes place.

In can selecting the embodiment (not shown), second pin part can be regularly, and (that is, be attached on the installing component 117 non-rotatingly), middle needle part 115 is forced when downward by elastic bending by inclined plane part 156 at it.In a kind of like this layout, can save bias component 118.

In the above-described embodiments, a kind of conveyer device that comprises with the combined flexible storage tank of the example of discharger has been described.Yet storage tank and discharger can be to be suitable for being arranged in skin the interior any kind of drug delivery apparatus can be installed.And, because pin of the present invention also can be the form of pin pick off, so the inside of medical apparatus and instruments can comprise the sensor device that is suitable for the cooperation of pin pick off.

In Figure 25 A-25E, schematically illustrate the example that is suitable for the discharger that uses with the present invention, yet these only are examples, just as the direct application that needn't be suitable in the delivery instrument of above expression is arranged in the expression of each element.More particularly, Figure 25 A represents pump installation, and this pump installation comprises: medicine accommodation tube 1010 forms storage tank, and has and allow the packaged unit far away 1011 that is connected with pin and be slidably disposed its interior piston 1015; Flexible toothed piston rod 1020 (for example, as at United States Patent (USP) 6,302, in 869 disclosed like that); Motor 1030, discharging medicine from tube, motor is by control device 1040 controls through gear 1031 piston rod for it, and the energy that is used for control device and motor is provided by battery 1050.When after insert is thrown off with delivery instrument (by the device of expression not) or during, can activate described pump by the actuatable device (not shown) insertion of isolating user pin.

Figure 25 B represents pump installation, and this pump installation comprises: medicine accommodation tube 1110 has far away and near packaged unit 1111,1112 and is slidably disposed its interior piston 1115; Gas generation apparatus 1120 is communicated with through conduit 1121 fluids with the inside of tube, is used for driven plunger discharging medicine from described tube, and gas generation apparatus is by control device 1140 controls, and is used for the energy that control device and gas produces and is provided by battery 1150.That works as above instructions activates for pump.In detail openly can for example the finding in the United States Patent (USP) 5,858,001 of this gas generation apparatus that is used for the drug delivery apparatus.

Figure 25 C represents pump installation, and this pump installation comprises: medicine accommodation tube 1210 has far away and near packaged unit 1211,1212 and is slidably disposed its interior piston 1215; Osmotic engine 1220 is communicated with through conduit 1221 fluids with the inside of tube, is used for driven plunger to discharge medicine from tube.Osmotic engine comprises the first rigidity storage tank 1225 that comprises saline solution and wraps aqueous second and can flatten 1226, two storage tanks of storage tank by semipermeable membrane 1227 separation.When supplying with the user, fluid connector 1228 between second storage tank and barrier film can cut off barrier film (for example, weak welding) sealing by the user, and this barrier film is when cutting off, to allow process of osmosis to begin, because water passes barrier film and enters the suction of first storage tank from second storage tank.That works activates for pump such as above indication.In detail openly can for example finding in the United States Patent (USP) 5,169,390 of osmotic drive principle.

Figure 25 D represents pump installation, and this pump installation comprises that the medicine that is arranged in the secondary storage tank 1311 of inflexible fluid filled holds flexible storage tank 1310, and this secondary storage tank 1311 is communicated with primary storage tank 1320 fluids by the conduit 1330 that comprises flow limiter 1331.Primary storage tank is the form with tube of movable piston 1321, and accommodates viscous drive fluid.Spring 1340 is arranged to act on piston with from first to the second storage tank drive fluid, discharges medicine from flexible storage tank thus when flexible storage tank is connected on the transfusion needle (not shown).Flow can be determined by the viscosity of the pressure that is produced by spring in drive fluid, drive fluid and the flow resistance (that is tap hole principle) in flow limiter.When after insert is thrown off with delivery instrument (device by not expression or) when inserting a needle into by the actuatable device (not shown) of isolating user, pump can activated by back-moving spring or by discharging prestressed spring.The example that is used for this principle of drug infusion is learnt from DE 25 52 446.In can selecting structure, can be directly pressurize to discharge medicine through flow limiter to the medicine storage tank, for example as at United States Patent (USP) 6,074, in 369 disclosed like that.

Figure 26 shows the corresponding medical apparatus and instruments 900 of embodiment with Fig. 1-11, yet, the storage tank unit has the modular structure that comprises " durable " control unit 910 that is suitable for being installed on the storage tank unit 920, and this storage tank unit 920 comprises storage tank and passes through contact 921 controllable discharge assemblies by control unit.Percutaneous apparatus unit 930 can be with in Fig. 1-11 identical.Percutaneous apparatus unit and storage tank unit comprise and allow the storage tank unit that pairing coupling arrangement (931) to provide storage tank to be communicated with fluid between the percutaneous apparatus is provided on the percutaneous apparatus unit, and controller unit and storage tank unit comprise and allow controller unit to be fixed on the storage tank unit to control the pairing coupling arrangement (917,921) of discharge assembly.Control unit can comprise the one or more of following feature: agitator, RF emitter, RF receptor, display, medicine group's button 918 (as expressed) or other user input apparatus, reserve battery, memorizer.And control unit can be suitable for providing firm discharge, and perhaps it can be that programmable (for example, through Long-distance Control) is to offer constant speed rate or given distribution.Different control units also can use together with different storage tank unit (for example, comprising different medicines or not commensurability medicine) or with different pin unit (for example, comprising pin or soft intubate).As described above, controller can be used as durable apparatus by the user, yet (simpler) controller pattern can append on the storage tank unit in advance, and can be as the device that various disposable apparatuses are provided.

Figure 27 represents to comprise the modular system of a plurality of dissimilar control units except that basic pin chip unit 930 and basic storage tank unit 920.Remote controllers 940 can use with some of control unit combinedly.Control unit can be in only the form by the remote-controllable system unit 911 of remote controllers control.Its distortion 912 can be added medicine group button 918, and permission user medication is rolled into a ball and needn't be used remote controllers.Control unit may be provided in various programming Control unit 913, and each is provided at firm discharge indicated on the unit.A kind of like this unit is intended for use not have the purposes of remote controllers, and can comprise represented display 919.Control unit 914 able to programme also can be provided, and this for example allows the practitioner is the control unit programming at single patient.Any of the open control unit that model 915 representatives and storage tank unit and pin unit are combined.

In the above description of preferred embodiment, the functional different structure and the device that provide a description for different elements are so be described to notion of the present invention to the obvious degree of those skilled in the art's reader.The detailed construction and the detailed description that are used for different elements are considered to, the purpose of the common design process that the route of being narrated in this manual by those skilled in the art edge carries out.

Claims (13)

1. medical apparatus and instruments comprises:

(a) shell (507,508);

(b) storage tank (760) is arranged in the described shell, and this storage tank is suitable within it that portion holds the fluid medicine, and

(b) pump assembly (300) is arranged in the described shell, and this pump assembly comprises:

(i) pump inlet (321), pump discharge (322) and be arranged in inner flow passage (341,342,343) between described pump inlet and the pump discharge, and

(ii) fluid connector (350), this fluid connector is arranged in the inside of described pump assembly under original state, and described fluid connector comprises import (351) and outlet (353),

(iii) wherein, described pump inlet and pump discharge are included in the inside of original state lower seal pump assembly and thus flow channel and fluid connector are sealed in sealing member (331,332) under the initial aseptic condition,

Wherein, fluid connector is arranged to from original state and actuating state operation, under this original state, fluid connector is arranged in the inside of pump assembly, under this actuating state, between the pump inlet of the inside of storage tank and pump assembly, set up fluid and be communicated with, and the outlet of fluid connector is arranged in the described flow channel of pump assembly, be communicated with thereby between the inside of the inside of storage tank and pump assembly, set up fluid via fluid connector.

2. medical apparatus and instruments according to claim 1 comprises allowing external component to engage with fluid connector with the actuating opening from original state to actuating state operating fluid adapter thus.

3. medical apparatus and instruments according to claim 2, wherein, pump inlet, pump discharge and activate opening and be included in the inside of original state lower seal pump assembly and thus flow channel and fluid connector be sealed in sealing member under the initial aseptic condition.

4. according to each described medical apparatus and instruments among the claim 1-3, wherein, fluid connector comprises the entrance point of point, inserts the permeation parts (761) that passes but storage tank comprises the fluid connector entrance point that allows point.

5. medical apparatus and instruments according to claim 4 wherein, can see through film but the permeation parts of storage tank comprises the self sealss pin.

6. according to each described medical apparatus and instruments in the above claim, wherein, flow channel comprises the variable-volume pump chambers.

7. medical apparatus and instruments according to claim 6, wherein, flow channel also comprises inlet valve that links with pump inlet and the outlet valve that links with pump discharge.

8. according to each described medical apparatus and instruments in the above claim, wherein, pump discharge comprises that the percutaneous apparatus that allows a point inserts the self sealss pin that passes and can see through film.

9. according to each described medical apparatus and instruments in the above claim, also comprise being used for the actuator of actuated pump assembly.

10. according to each described medical apparatus and instruments in the above claim, also comprise having the percutaneous apparatus (530) that is suitable for through the tip of subject's skin, this percutaneous apparatus is arranged to or is suitable for being arranged to being communicated with the pump discharge fluid.

11. one kind comprises the medical assembly according to each described medical apparatus and instruments among the claim 1-9, also comprises percutaneous apparatus unit (502), this percutaneous apparatus unit comprises:

-percutaneous apparatus (530) comprises the tip that is suitable for seeing through subject's skin,

-surface (571) is installed, be suitable for being applied on the subject's skin,

-wherein, described percutaneous apparatus unit and medical apparatus and instruments are suitable under the situation of using fixed to one another, and

-wherein, described percutaneous apparatus is suitable for being arranged to being communicated with the pump discharge fluid.

12. medical assembly according to claim 11 wherein, when percutaneous apparatus unit and medical apparatus and instruments are fixed to one another, are set up fluid and is communicated with between percutaneous apparatus and pump assembly.

13. according to claim 10 or 11 described medical assemblies, wherein, when percutaneous apparatus unit and medical apparatus and instruments were fixed to one another, fluid connector was operated from the original state to the actuating state.

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