CN104307071A

CN104307071A - Self-injection device

Info

Publication number: CN104307071A
Application number: CN201410533055.9A
Authority: CN
Inventors: R·桑德埃格; J·亚历山大; C·克里斯滕森; R·乔治; J·英格莱拜; P·蔡斯; C·宾厄姆
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2009-12-16
Filing date: 2009-12-16
Publication date: 2015-01-28
Anticipated expiration: 2029-12-16
Also published as: CN104307071B

Abstract

The invention discloses a self-injection device (100), wherein the device is used for conveying medicament into the body of a patient by injecting into the skin of the patient or injecting and penetrating through the skin of the patient. The device comprises a body (104,116), an injection needle (152), and a pressurization system, wherein the body is provided with a container (160) for accommodating medicament; the container is arranged in the body; the injection needle is used for penetrating into the skin of the patient; the needle (152) is provided with a cavity and is communicated with the container (160); the pressurization system is used for pressurizing the container (160). The device further comprises indicator equipment (124), wherein the indicator equipment can be seen from the outer side of the device (100), and the indicator equipment is used for indicating that medicament conveyance is basically completed.

Description

From injection device

This divisional application is the divisional application based on Chinese invention patent application 200980163436.X (international application no PCT/US2009/006570), denomination of invention " from injection device ", the patent application of 16 days of the applying date in December, 2009.

Technical field

The present invention relates to a kind of material delivery apparatus on the whole, and it has the patient convenience of improvement, ease for use and efficiency.The present invention also relates to a kind of paster shape on the whole, from holding type material infusion or from injection device, described device can be used in carrying many kinds of substance or medicine to patient.More specifically, the present invention relates to a kind of there is dosage end indicator patch-like infusion or from injection device.

Background technology

A large amount of people (such as standing the people of such as diabetes and so on situation) uses the infusion of therapeutic of certain form of infusion of insulin such as every day and so on, to maintain the tight control to its blood sugar level.At present, in infusion of insulin treatment example, there is the Main Patterns of two kinds of insulinizes every day.First mode comprises syringe and novopen.These devices use simple and cost is lower, but they need pinprick when per injection, are generally every day three times to four times.Second pattern comprises infusion pump therapy, and this needs to buy the expensive pump continuing about 3 years.The high cost (being approximately 8 times to 10 times of the daily rate of syringe treatment) of pump and finite lifetime are that the height of this treatment hinders.Insulin pump also represents older technology and uses loaded down with trivial details.In addition, from the angle of life style, the pipe fitting (being called " infusion cover group ") be connected to by pump in the delivery site being positioned at patient's abdominal part is very inconvenient, and pump is heavier thus make to carry pump and become burden.But, from the angle of patient, used the overwhelming majority in the patient of pump preferably to retain pump in its remaining years.Although this is because infusion pump than syringe and pen more complicated but there is provided the advantage that the continuous infusion of insulin, exact dose and movement schedule able to programme arrange.This causes the health perception of closer glycemic control and improvement.

Consider that the number of times of the growth that viewed pump is treated and injection every day increases, the interest for better healing increases.In this infusion example with in similar infusion example, meet completely needed for this increase interest be following insulin conveying or infusion format: its best features by injection for curing every day (low cost and ease for use) combines with the best features (continuous infusion and exact dose) of insulin pump, and it also avoid respective shortcoming.

Some trials are carried out to provide low cost and free-standing easy to use or " Wearable " drug infusion pumps.Some in these devices mean partially or completely droppable.In theory, such device can provide the lot of advantages of infusion pump and not have thing followed cost and inconvenience.But, unfortunately, following shortcoming is much suffered: comprise the discomfort (divider and/or length due to used entry needle) of patient, the compatibility between institute's transportation of substances and the material used in the structure of infusion device and interaction and the possible fault when correctly not activating (such as, because the premature activation of device causes " wet type " to inject) by patient in these devices.Also run in the mill and difficulty in the penetration depth controlling pin, especially when using the entry needle of short and/or meticulous divider.Also be problem to the probability of the needlestick injury of the personnel contacted with used device always.

Therefore, there is the demand of the substitute to current infusion device (such as the infusion pump of insulin), it provides the simplicity of manufacture further and improves for the use of insulin and non-insulin application.

Summary of the invention

One aspect of the present invention is to provide a kind of patch-like infusion or from injection device, described device can be dressed against skin expediently, simultaneously by using one or more micropin provide the infusion of expectation material and provide minimum discomfort.Another aspect of the present invention is to provide this infusion with dosage end indicator or from injection device.

Above-mentioned and/or other aspects of the present invention realize by providing following apparatus: described device is used for by being expelled in patient skin or being injected through patient skin and conducting drugs in patient body, described device comprises: body, described body has reservoir, and described reservoir is arranged in described body for accommodation medicine; Entry needle, described entry needle is for thrusting the skin of patient, and described needle set has inner chamber and is communicated with described reservoir; And compression system, described compression system is for the described reservoir that pressurizes.Described device also comprise can outside device the visible pointer device being used to indicate drug conveying and substantially completing.

Above-mentioned and/or other aspects of the present invention realize by providing following apparatus: described device is used for by being expelled in patient skin or being injected through patient skin and conducting drugs in patient body, and described device comprises: body; Reservoir, described reservoir is arranged in described body for accommodation medicine; Entry needle, described entry needle is for thrusting the skin of patient and implementing from the medicine of reservoir; And compression system, described compression system is for the described reservoir that pressurizes.Described device also comprise can outside device the visible dosage end indicator being used to indicate drug conveying and substantially completing.

Of the present invention in addition and/or other aspects and advantage will part explaination in the following description, and will from explanation part apparent, or to be understood by practice of the present invention.

Accompanying drawing explanation

From detailed description with reference to the accompanying drawings, above-mentioned and/or other aspects of embodiments of the invention and advantage will be easier to understand, wherein:

The axonometric chart of the patch-like infusion under the pre-activated state before Fig. 1 illustrates and is in activation or the embodiment from injection device;

The infusion device that Fig. 2 illustrates Fig. 1 is in the partial exploded view under pre-activated state;

The infusion device that Fig. 3 illustrates Fig. 1 is in the partial exploded view under pre-activated state, and wherein activator appliance button is outwarded winding to show more details;

The infusion device that Fig. 4 illustrates Fig. 1 is in the exploded view more completely under pre-activated state;

The infusion device that Fig. 5 illustrates Fig. 1 is in the sectional view under pre-activated state;

The infusion device that Fig. 6 illustrates Fig. 1 is in the sectional view under pre-activated state, and wherein activator appliance button is outwarded winding;

Fig. 7 illustrates the partial exploded view of infusion device between the installation period of release mechanism of Fig. 1;

Fig. 8 illustrates the infusion device partial exploded view after the activation of Fig. 1;

Fig. 9 illustrates the infusion device exploded view more completely after the activation of Fig. 1;

Figure 10 illustrates the infusion device sectional view after the activation of Fig. 1;

Figure 11 illustrates the partial exploded view of infusion device after the expansion of release mechanism of Fig. 1;

Figure 12 illustrates the sectional view of infusion device after the expansion of release mechanism of Fig. 1;

Figure 13 illustrates the basal surface of release mechanism;

Figure 14 further illustrates the structure of release mechanism;

Figure 15 A-Figure 15 D illustrates dosage end indicator and the operation in the infusion device of Fig. 1 thereof;

Figure 16 A and 16B illustrates another dosage end indicator and operation thereof of the infusion device being arranged in Fig. 1;

Figure 17 A and 17B illustrates another dosage end indicator;

Figure 18 illustrates the dosage end indicator of Figure 17 A be arranged in the infusion device of Fig. 1;

Figure 19 A and 19B illustrates another dosage end indicator and operation thereof;

Figure 20 A and 20B illustrates the operation of the dosage end indicator of Figure 19 A of the infusion device being arranged in Fig. 1;

Figure 21 A and 21B illustrates another dosage end indicator and operation thereof;

Figure 22 A and 22B illustrates the operation of the dosage end indicator of Figure 21 A of the infusion device being arranged in Fig. 1;

Figure 23 A-23C illustrates the embodiment of the labelling being used to indicate drug conveying process;

Figure 24 A and 24B illustrates another dosage end indicator and operation thereof;

Figure 25 A and 25B illustrates the operation of the dosage end indicator of Figure 24 A of the infusion device being arranged in Fig. 1;

Figure 26 A and 26B illustrates another dosage end indicator and operation thereof;

Figure 27 A and 27B illustrates the operation of the dosage end indicator of Figure 26 A of the infusion device being arranged in Fig. 1;

Figure 28 illustrates the embodiment of the infusion device with injection port.

Detailed description of the invention

Present by detailed reference embodiments of the invention, example of the present invention is illustrated in the drawings, and wherein, identical Reference numeral represents identical element all the time.Described embodiment makes the present invention instantiating by referring to accompanying drawing.

Embodiments of the invention described below can be used as easily, patch-like infusion or from injection device 100 with within a period of time or the disposable material carrying predicted dose fully to patient, such as liquid medicine or medicament.This device is preferably supplied to end user with pre-filled state (namely medicine or medicament have been arranged in the reservoir of device).Although patch-like infusion as herein described or can be adopted by patient and/or caretaker from injection device 100 (such as, shown in Fig. 1), conveniently, the user of this device is hereinafter referred to as " patient ".In addition, conveniently, such as the term at " vertically " and " level " and " top " and " bottom " and so on is for representing the relative direction about the infusion device 100 arranged on a horizontal surface.But should be understood that, infusion device 100 is not limited to this direction, and infusion device 100 may be used for any direction.In addition, the alternative use of term " infusion device " and " from injection device " not means restricted to describe enforcement device of the present invention.Do not have and fall within the scope of the invention from the infusion device of injectability, do not perform yet falling within the scope of the invention from injection device of continuous infusion.Conveniently, but not conduct restriction, use term " infusion device " in the following description.

The patch-like infusion device 100 of Fig. 1 is from holding type and is attached to the skin surface (as will be described in more detail below) of patient by the bonding part on the basal surface that is arranged on infusion device 100.Locate once correct and activated by patient, the pressure energy released in the flexible reservoir of loose spring action in device is enough in the content being emptied reservoir via pin manifold by one or more patient's pin (such as, micropin).The material being positioned at reservoir is carried through patient skin by the micropin being driven to skin subsequently.Should be understood that, other embodiments are possible, and wherein spring is replaced by dissimilar energy storage device, and these energy storage devices can be mechanical, electronics and/or chemistry in essence.

As will be determined by the skilled person understood, there is the number of ways constructing and use patch-like infusion device 100 disclosed herein.Although the embodiment described with reference to the accompanying drawings and explanation below, embodiment disclosed herein not means limit and is invented the various optional design and implementation example comprised by the disclosure.In each disclosed embodiment, this device is called as infusion device, but this device also can with the speed injection mass of faster than the usual speed realized by typical infusion device a lot (large preparation).Such as, content can be transferred within the period be as short as several seconds or grow to several days.

In the embodiment of the device shown in Fig. 1 to Figure 12, show the push-button design of patch-like infusion device 100, wherein, the activation of device and excitation with single multi-functional/step process realizes.Fig. 1 illustrates the assembled embodiment of the infusion device 100 be under pre-activated state.Fig. 2-Fig. 6 illustrates partial exploded view and the sectional view of the infusion device 100 be under pre-activated state, Fig. 7 illustrates the partial exploded view of infusion device 100 between the installation period of release mechanism, Fig. 8-Figure 10 illustrates infusion device 100 exploded view after the activation and sectional view, and Figure 11 and Figure 12 illustrates the exploded view of infusion device 100 after release mechanism launches and sectional view.Infusion device 100 is configured at pre-activated state (such as, shown in Fig. 1, Fig. 2 and Fig. 5), activate or excited state (such as, shown in Fig. 8-Figure 10) and retract or operation between safe condition (such as, shown in Figure 11 and Figure 12).

As shown in fig. 1, the embodiment of patch-like infusion device 100 comprises bottom enclosure 104, release mechanism 108, flexible needle lid 112, top casing 116, reservoir sub-component 120, dosage end indicator (EDI) 124 and activator appliance button 128, and activator appliance button 128 comprises patient interface surface 132.In addition, as shown in Fig. 2-Fig. 6, infusion device 100 also comprises rotor or activates ring 136, pressing spring 140, arch metal plunger 144 and driving spring 148.

Flexible needle lid 112 is by protection at least one pin 152 (being hereafter described in more detail) and provide aseptic barrier portion and provide the safety of patient and device.Pin lid 112 protects pin 152 during device manufacture, protects patient before the use, and any time before the removal provides aseptic barrier portion.According to an embodiment, pin lid 112 attaches to pin manifold via press-fit, and at least one pin 152 is arranged in this pin manifold.In addition, according to an embodiment, the pin opening 156 (being hereafter described in more detail) of release mechanism 108 is shaped to closely corresponding with the periphery of pin lid 112.

Such as, as as shown in Fig. 2, Fig. 3, Fig. 5, Fig. 6, Fig. 8, Figure 10 and Figure 12, reservoir sub-component 120 comprises reservoir 160, reservoir arched sealing member 164, valve 168, at least one pin 152 and to be arranged between valve 168 and pin 152 and to produce at least one passage 172 (such as, see Fig. 8) of flow path between which.Reservoir 160 comprises vault 176.In addition, reservoir sub-component 120 comprises removable pin lid 112 optionally to cover this at least one pin 152.According to an embodiment, reservoir sub-component 120 also comprises reservoir arm sealing member 180, thus covers passage 172.Preferably, pin 152 comprises pin manifold and Duo Gen micropin 152.

Such as, as shown in Figure 5, the reservoir arched sealing member (flexible membrane) 164 of reservoir sub-component 120 is arranged between plunger 144 and vault 176.Reservoir contents (such as, medical material) for infusion device 100 is arranged in the space between reservoir arched sealing member 164 and vault 176.The combination in reservoir arched sealing member 164, vault 176 and the space between them limits reservoir 160.Vault 176 is preferably transparent in observing reservoir contents.Reservoir arched sealing member 164 can be made up of on-expansible material or laminated material (such as metal coating or other similar substances).Such as, a kind of possible flexible layer press mold that can use in reservoir arched sealing member 164 comprises the first polyethylene layer, the second chemosphere as known in those of skill in the art to be provided for the attachment means of the 3rd metal level chosen based on barrier feature and to comprise polyester fiber and/or nylon the 4th layer.Using metal coating or metalized film by combining with rigid element (such as, vault 176), improving the barrier performance of reservoir 160, thus increase or improve the shelf-life of the content held within it.Such as, when reservoir contents comprises insulin, the dominant touch material in reservoir 160 comprises linear low density polyethylene (LLDPE), Low Density Polyethylene (LDPE), cyclic olefine copolymer (COC) and Teflon.As described in more detail below, dominant touch material in the residue flow path of reservoir contents also may comprise COC and LLDPE and thermoplastic elastomer (TPE) (TPE), medical grade acrylic acid, rustless steel and pin binding agent (such as, the binding agent of UV solidification).Keep extending this material contacted with the content of reservoir 160 to test preferably by ISO10-993 and other biocompatibility be suitable for.

Reservoir sub-component 120 also preferably can store and deleteriously can not affect content in enforceable controlled environment within the regulation shelf-life of reservoir contents, and can apply in a variety of environmental conditions.In addition, the barrier portion provided by the parts of reservoir sub-component 120 does not allow gas, liquid and/or solid material to be transported in content than the speed meeting the desired speed that the shelf-life allows large or to transport out content.In above shown embodiment, reservoir material can store and operate in the temperature range of about 34 degrees Fahrenheit to 120 degrees Fahrenheits, and can have the shelf-life of more than 2 years or 2 years.

Except meeting stability requirement, reservoir sub-component 120 can also guarantee operation to successfully pass the leak-testing (such as the sample of 30psi being kept 20 minutes No leakage) of any amount.As described in more detail below, stem from other fillings of the configuration of reservoir, store and carry benefit to comprise the head space of adaptability and reduction.

In one embodiment, reservoir 160 is emptying before filling.In vault 176, only there is slight recess by emptying reservoir 160 before filling, can the too much refuse in reservoir 160 and head space be dropped to minimum.In addition, the shape of reservoir can be configured to the type (such as, pressing spring 140 and plunger 144) being suitable for used excitation mechanism.In addition, during filling, use the flexible reservoir 160 be drained to reduce to be positioned at any air or the bubble of the reservoir 160 of filling.Flexible reservoir 160 is used also to be useful especially when infusion device 100 stands the change (this can cause the reservoir internal pressure increased) of external pressure or temperature.In this case, flexible reservoir 160 enlargement and contraction together with reservoir contents, thus prevent may the revealing of causing due to enlargement and contraction power.

The another feature of reservoir 160 comprise allow filling the moment automatically carry out the ability of particle inspection or carved the ability of carrying out particle inspection by patient in use.One or more reservoir barrier portion (such as vault 176) can be formed by transparent molding plastic material clearly, and this material made it possible to being contained in reservoir checks.Transparent plastic material is clearly preferably cyclic olefine copolymer, it is characterized in that the high grade of transparency and definition, low extract (low extractables) and the biocompatibility with the material be contained in reservoir 160.From the name of the Zeon chemical company of Kentucky State Louisville, a kind of suitable material can be called that the material of " BDCCP resin " obtains, and be registered as DMF No.16368 by U.S. food and FAD.In this applications, reservoir 160 comprises and minimum may hinder the feature of inspection (that is, allow and during checking rotate).

Passage arm 172 is set to the form of at least one the flexible bow-shaped arm extending to pin manifold or micropin 152 from valve 168.Bow-shaped arm has the groove 174 (such as, see Fig. 2) formed wherein.In order to arrange the fluid path between valve 168 and pin manifold or micropin 152, reservoir arm sealing member 180 covering groove 174.Fluid path between reservoir 160 and micropin 152 (to be arranged in passage arm 172-such as, and shown in Fig. 8) form by with the above material similar or identical for the material of reservoir 160.Such as, passage arm 172 can be made up of the material identical with vault 160, and reservoir arm sealing member 180 can be made up of the material identical with reservoir arched sealing member 164.According to an embodiment, two passage arms 172 are all as the fluid path between valve 168 and pin manifold or micropin 152.According to another embodiment, in passage arm 172 only one be used as fluid path, and remaining passage arm 172 provides structure support.In such an embodiment, groove 174 is only extending to pin manifold or micropin 152 by the passage arm 174 being used as fluid path from valve 168 completely.

Passage arm 172 is sufficiently flexible to bear activating force.The position of the passage arm 172 in comparison diagram 2 and Fig. 8, (be hereafter described in more detail) when micropin 152 is driven in patient skin, passage arm 172 (is covered by reservoir arm sealing member 180 in Fig. 2, for the sake of clarity, reservoir arm sealing member 180 is removed in fig. 8) elastic deformation.Between this deformation phases, passage arm 172 must maintain the integrity of the fluid path between valve 168 and pin manifold or micropin 152.In addition, the material for passage arm 172 meets various biocompatibility and On-board test.Such as, as shown in table 1 below, when infusion device content comprises insulin, the dominant touch material in reservoir 160 comprises linear low density polyethylene, cyclic olefine copolymer and Teflon, and also can comprise transparent plastics clearly.Dominant touch material in residue flow path (passage 62) between reservoir 160 and the micropin 152 of pin manifold comprises COC and/or medical grade acrylic acid, LLDPE, TPE and rustless steel and pin binding agent.

Table 1

More specifically, micropin 152 can be made up of rustless steel, and pin manifold can be made up of polyethylene and/or medical grade acrylic acid.This material is tested preferably by ISO10-993 biocompatibility when extending contact with the content of reservoir.

The valve 168 be arranged between reservoir 160 and passage 172 is optionally allowed and the fluid limited between reservoir 160 and passage 172 flows.Valve 168 moves between preactivate position (such as, shown in Fig. 2, Fig. 3 and Fig. 6) Yu active position (such as, shown in Fig. 8-Figure 10).When being in active position, valve allows that the fluid between reservoir 160 and passage 172 flows and allows that the fluid to pin manifold and micropin 152 flows thus.

In use, valve 168 will finally be pushed in active position by the motion of activator appliance button 128, and this is illustrated best by the motion of valve 168 between Fig. 5 and Figure 10.As shown in Figure 10, the motion of valve 168 makes the enlarged distal tip portion of valve 168 advance, thus allows that medicine is downward through fluid path to arrive pin manifold in reservoir 160 flow channel 172.

Above-described embodiment comprises at least one pin 152 or micropin 152, but may comprise some (such as two) illustrated micropins 152.Every root micropin 152 is preferably at least 31 dividers (gauge) or less such as 34 dividers, and is anchored in patient's pin manifold that can be arranged as and be communicated with reservoir 160 fluid.Micropin 152 comprises the combination more than also having different length or divider or different length and divider a when piece at infusion device 100, and one or more port can be comprised along body length, near the needle point that described port is preferably arranged on micropin 152 or near pinpoint inclined plane (if arbitrary micropin 152 has).

According to an embodiment, the divider of micropin 152 controls the transfer rate of the reservoir contents of infusion device 100.When than usually inject with middle injector longer period period that (needing larger needle guard or pin) be associated carries out infusion time, use multiple 34 dividers 152 to be practical to carry reservoir contents.In the disclosed embodiment, target can be used to be any micropin 152 of Intradermal or subcutaneous space, but illustrated embodiment comprise length Intradermal micropin 152 of (such as, 4mm) between 1mm and 7mm.The layout of micropin 152 can be linear or non-linear array, and can comprise the micropin 152 as any amount needed for application-specific.

As above-mentioned, micropin 152 is positioned in pin manifold.In pin manifold, every root micropin 152 is provided with at least one fluid communication path or passage 172.Manifold can only have single path for one or more micropin 152, or can arrange by reservoir contents dividually fixed line to multiple fluid path of every root micropin 152 or passage.These paths or passage can also comprise the crooked route of advancing for content, thus affect fluid pressure and transfer rate, and as flow limiter.Be positioned at the path of pin manifold or passage and can depend on application and to width, the degree of depth and configuration set point, wherein channel width is typically between 0.015 inch and 0.04 inch, be preferably 0.02 inch, and be configured to reduce the dead angle in manifold.

According to an embodiment, reservoir sub-component 120 has pair of holes 184 and 188 and locates about bottom enclosure 104 to help reservoir sub-component 120.First post 192 of bottom enclosure 104 and the second post 196 (being hereafter described in more detail) are inserted through corresponding hole 184 and 188.

In the exploded view that reservoir sub-component 120 is removed, Fig. 4, Fig. 7 and Fig. 9 illustrate bottom enclosure 104 and comprise basic cylindrical shell 200, and pressing spring 140 and plunger 144 are arranged in this cylindrical shell 200.According to an embodiment, cylindrical shell 200 comprises multiple recess channel 204, to guide the multiple lower limb 208 of correspondence and the foot 212 of plunger 144 when plunger is mobile in housing 200.Lower limb 208 and foot 212 form plunger projection 214 jointly.Such as, as shown in Fig. 4, Fig. 7 and Fig. 9, recess channel 204 only extends along the part in cylindrical shell 200 path downward from the top of cylindrical shell 200.Below recess channel 204, be provided with opening 216, the foot 212 of plunger 144 can extend to the outside of cylindrical shell 200 by opening 216.Opening 216 is L shape substantially, the horizontal component with the base portion place being positioned at cylindrical shell 200 and the vertical portion of substantially aiming at recess channel 204.

When infusion device 100 is in pre-activated state, pressing spring 140 is compressed (such as, as shown in Fig. 4-Fig. 6) by plunger 144, and the foot 212 of plunger 144 is substantially disposed in the horizontal component of opening 216.The power of pressing spring 140 makes the biased top (such as, the ledge of cylindrical shell 200) against the horizontal component of opening 216 of foot 212 of plunger 144.As described in more detail below, pressing spring 140 forms compression system with the pressurizing reservoir 160 when infusion device 100 is activated together with plunger 144.

As described in more detail below, rotor 136 rotates between preactivate position (such as, illustrating in Fig. 2-Fig. 4) Yu active position (such as, illustrating in Fig. 8-Figure 10) around the base portion of cylindrical shell 200.When rotor 136 rotates to active position from preactivate position, with the surface 220 of rotor 136 (such as, shown in Fig. 4) in the foot 212 of at least one foot engagement pistons 144 that engages at least one and plunger 144 is rotated, the vertical portion of foot 212 and opening 216 and recess channel 204 are aimed at.At this some place, pressing spring 140 makes that plunger 144 moves up and foot 212 is guided by rising passway 204.

Pressing spring 140 is included in apply basic uniform power to reservoir 160 in infusion device 100, to be expelled from reservoir 160 by content.Pressing spring 140 is for stored energy, and it is releasing pine moment pressurizing reservoir 160 in use.Pressing spring 140 is kept under compression by the joint between the foot 212 of plunger 144 and cylindrical shell 200.On the film (described below) that this joint prevents pressing spring 140 stress to be applied to reservoir 160 at memory period or any remaining device feature (except bottom enclosure 104 and plunger 144).The enough rigidity of plunger 144 to resist spring tension and distortion, and lost efficacy under not being taken in common load.

As above-mentioned, when rotor 136 rotates to active position from preactivate position, rotor 136 engages with at least one in the foot 212 of plunger 144, and makes plunger 144 rotate to make the vertical portion of foot 212 and opening 216 and recess channel 204 to aim at.The pressing spring 140 of compression makes plunger 144 move up subsequently, and power is applied on the film of reservoir 160 for this reason.Pressing spring 140 can be configured to preferably produce from about 1psi to the pressure of about 50psi in reservoir 116, and is more preferably from about 2psi to the intradermal delivery of the pressure of about 25psi for reservoir contents.In order to percutaneous injection or infusion, the scope of about 2psi to about 5psi can be enough.

According to an embodiment, activator appliance button 128 comprises patient interface surface 132, and patient urges this surface 132 to activate infusion device 100.Activator appliance button 128 also comprises hinge arms 224 and activation arms 228 (such as, all shown in Figure 3).The hinge arms 224 of activator appliance button 128 comprises the cylindrical shape part with opening.Activation arms 228 comprises protruding 230 (such as, see Fig. 3).According to an embodiment, protruding 230 comprise load-bearing surface 232 and are set to the locking surface 234 adjacent with the cantilevered end of load-bearing surface 232.According to an embodiment, protruding 230 form acute angle with the major part of activation arms 228.

The first post 192 be arranged in bottom enclosure 104 upwards extends from bottom enclosure 104.According to an embodiment, (such as, as shown in figs. 4 and 7), the base portion of the first post 192 comprises a pair planar side 236 and a pair circular side 240.In addition, such as, as shown in figs. 4 and 7, the second post 196 and the first and second driving spring base portions 244 and 248 upwards extend from bottom enclosure 104.As will be described in more detail below, the corresponding end of the first and second driving spring base portion 244 and 248 anchoring driving springs 148.First driving spring base portion 244 is set to adjacent with the second post 196 and has space between which.

According to an embodiment, Fig. 3 and Fig. 6 illustrates the position of activator appliance button 128 relative to bottom enclosure 104, for assembling activator appliance button 128.In this position, the opening of the cylindrical shape part of hinge arms 224 makes activator appliance button 128 can horizontal slip (through planar side 236) and engaging with the first post 192.Hinge arms 224 (and thus activator appliance button 128) can rotate around the first post 192 subsequently.When activation arms 228 moves in the space between the second post 196 and the first driving spring base portion 244, protruding 230 and activation arms 228 at least one elastic deformation, until the cantilevered end of the load-bearing surface 232 of protruding 230 is through the maintenance surface 252 of the second post 196.The cantilevered end of the load-bearing surface 232 of projection 230 moves through the maintenance surface 252 (such as, see Fig. 4) of the second post 196 and the locking surface 234 of protruding 230 and keeps the joint on surface 252 to provide expresses audition click sound and the tactile feedback that activator appliance button 128 is in preactivate position.

Back with reference to Fig. 2-Fig. 4 and Fig. 7-Fig. 9, rotor 136 comprises activation protuberance 256 and driving spring keeper 260 in addition.When patient urges activator appliance button 128, the activation arms 228 of activator appliance button 128 engages with activation protuberance 256, thus rotor 136 is rotated to active position from preactivate position.

When rotor 136 is in preactivate position, driving spring 148 remains in preactivate position by driving spring keeper 260.As aforementioned, the opposite end of the first and second driving spring base portion 244 and 248 anchoring driving springs 148.In about midpoint of driving spring 148, be provided with the basic U-shaped protuberance as shown in such as Fig. 2 and Fig. 3, engage for the driving spring keeper 260 of rotor 136.Therefore, when rotor 136 is in preactivate position and driving spring 148 engages with driving spring keeper 260, driving spring 148 is maintained at extended state.And when (namely driving spring keeper 260 releases loose driving spring 148, when rotor to rotate from preactivate position to such as such as Fig. 8-Figure 10 during illustrated active position), driving spring 148 drives micropin 152 to be extended to the outside of infusion device 100 by the opening 300 (and by the opening in release mechanism 108, being hereafter described in more detail) in bottom enclosure 104.

Thus, as will be described in more detail below, with single multi-functional/step process realizes the activation of infusion device 100 and excitation and comprises and urge by patient the rotation that activator appliance button 128 and rotor 136 cause due to the joint between the activation arms 228 and the activation protuberance 256 of rotor 136 of activator appliance button 128.As mentioned above, the rotation of rotor 136 makes plunger 144 rotate and releases loose plunger 144 is positioned at reservoir 160 fluid with pressurization.In addition, driving spring 148 is released pine by the rotation of rotor 136 from driving spring keeper 260, thus drives micropin 152 to extend to the outside of infusion device 100.Single multi-functional/step process is also included in when activator button 128 is urged and makes valve 168 from preactivate position to the motion of active position because activator button 128 engages with movement of valve 168, thus starts fluid via the flowing of passage 172 between reservoir and micropin 152.

As above-mentioned, patch-like infusion device 100 also comprises release mechanism 108.In order to prevent from being not intended to or unexpected needlestick injury, the intentional recycling of anti-locking apparatus and the pin in order to shield exposure, be provided with locking pin release mechanism 108.Automatically release mechanism 108 is activated immediately when being removed from patient skin surface by infusion device 100.According to a hereafter embodiment in greater detail, flexible adhesion pad 264 is attached to the bottom part of bottom enclosure 104 and the bottom part of release mechanism 108.Adhesive pad 264 contacts with patient skin and keeps infusion device 100 in place on a skin surface during use.Such as, as shown in fig. 11 and fig, when being removed from skin surface by infusion device 100, release mechanism 108 extends to the position of shielding micropin 152.When folly extended, release mechanism 108 locks in place and prevent unexpected injury or the exposure of patient's pin 152.

Usually, passive type security system is expected most.This makes device can certainly protect when situation about surprisingly removing or patient forgets are provided with security step.A kind of typical use due to this infusion device 100 is to provide the human growth hormone of supply at usual night, therefore, it is possible to desirably the patient (such as child) dressing this device can dress them in fact all night long, even if expection conveying can complete within the time being less than 10 minutes.When not having passive type system, if infusion device 100 drops, then micropin 152 can thrust in patient or caretaker's body again.Solution is restraint or comprise passive type security system during use.

About security system, typically there are three options.First option is retracted in device by pin 152.Second option is that shielding needle 152 is close to eliminate, and the 3rd option destroys pin 152 and prevents pricking wound.The other system of such as proactive system and so on utilizes manually shielding and/or destroys, or uses other button to press or loose security feature is manually released in similar action.Detailed description to passive type secured embodiment of the present invention is provided below.

The drawer type design embodiments that a secured embodiment of the present invention is passive type, encapsulate completely, such as release mechanism 108.Fig. 5, Figure 10 and Figure 12 be a diagram that respectively release mechanism 108 before activation, activate after and the three-dimensional cutaway view of release mechanism 108 infusion device 100 after the expansion.

When being removed from skin by infusion device 100, flexible adhesion pad 264 (being attached to the basal surface of bottom enclosure 104 and the basal surface of release mechanism 108) is by pull-out release mechanism 108 and by release mechanism 108 locks in place before adhesive pad 264 releases loose skin surface.In other words, adhesive pad is removed from skin surface required power and be greater than the power launched needed for release mechanism 108.According to an embodiment, such as, as shown in Figure 13, release mechanism 108 comprises the flat surface portions 268 contacted with patient skin.Flat surfaces 268 is in following position: wherein a part (shown in broken lines in Figure 13) for adhesive pad 264 is attached to release mechanism 108, make when infusion device 100 is removed from skin by patient, adhesive pad 264 will work to be launched from infusion device 100 by release mechanism 108, thus shielding micropin 152, otherwise this micropin 152 will expose when being removed from patient by infusion device 100.When release mechanism 108 extends completely, release mechanism 108 locks in place and prevent unexpected injury or the exposure of micropin 152.

According to an embodiment, adhesive pad 264 is set to basic two parts, and one is positioned in the major part of the basal surface of bottom enclosure 104, and one is positioned on the basal surface of release mechanism 108.When infusion device 100 is removed, the independently mobile and release mechanism 108 of two pasters can rotate relative to bottom enclosure 104.According to another embodiment, two parts form as one the flexible adhesion pad 264 of formula, and one of them part is arranged in the major part of the basal surface of bottom enclosure 104, and a part is arranged on the basal surface of release mechanism 108.

According to an embodiment, release mechanism 108 is metallic stamping pieces.According to another embodiment, release mechanism 108 is made up of the material substantially identical with bottom enclosure 104.As shown in Figure 14, release mechanism 108 guide post 288 that comprises front shielding part 272, be arranged on a pair insertion projection 276 of the office, rear portion of release mechanism 108, be separately positioned on a pair pivot protrusion 280 at the upper rearward end place of the marginal portion 284 of release mechanism 108, upwards extend from the bottom interior surface of the substantially flat of release mechanism 108 and also from the locking column 292 that the bottom interior surface of release mechanism 108 upwards extends.Front shielding part 272 extends when launching release mechanism 108, patient and micropin 152 to be shielded on marginal portion 284.Guide post 288 comprise the recess that is positioned at wherein with when rotor 136 is in preactivate position and the safety of rotor 136 keep protuberance 296 (such as, shown in Fig. 7 and Fig. 9) engage, launched before the activation of infusion device 100 to prevent release mechanism 108.

In addition, as above-mentioned, release mechanism 108 comprises pin opening 156.Before expansion release mechanism 108, pin opening 156 is overlapping to be provided for the space that micropin 152 moves at least partly with the opening 300 in bottom enclosure 104.Locking column 292 is set to adjacent with the forward edge of pin opening 156 respectively.Bottom enclosure 104 comprises guide post opening 304 (such as, shown in Fig. 7 and Fig. 9), be set to adjacent with the opposite side edge of bottom enclosure 104 insert bump openings 308 (such as a pair, in Fig. 4, one of them is shown) and a pair pivotable seat 312 (such as, shown in Fig. 7 and Fig. 9) of being arranged on the relative both sides of bottom enclosure 104.

Referring again to Figure 14, insert protruding 276 and respectively comprise coupling part 316 and extension 320.According to an embodiment, coupling part 316 from the bottom interior surface of release mechanism 108 towards the rear of infusion device 100 to become non-perpendicular angle to extend about the bottom interior surface of release mechanism 108.Extension 320 respectively substantially vertically extends from extension 320 towards the respective outer of release mechanism 108.In order to be assembled in bottom enclosure 104 by release mechanism 108, release mechanism 108 be remained the angle about about 45 ° of bottom enclosure 104 one-tenth, and insertion protruding 276 is inserted through insertion bump openings 308.Subsequently release mechanism 108 is rotated to a position, make guide post 288 be inserted through guide post opening 304, and the bottom interior surface of release mechanism 108 is basically parallel to the basal surface of bottom enclosure 104 and contacts with this basal surface.

Referring again to Fig. 7 and Fig. 9, although these views illustrate the resolution characteristic being in rotor 136, Fig. 7 in active position and Fig. 9 be convenient to illustrate this stage be assembled into by release mechanism 108 in bottom enclosure 104.But, should be understood that, should before activation release mechanism 108 be assembled in bottom enclosure.As shown in Figure 4, after release mechanism 108 rotates up, release mechanism 108 moves backward relative to bottom enclosure 104, pivot protrusion 280 is made to cross the corresponding leading edge of pivotable seat 312 and be arranged on the top of pivotable seat 312, locking column 292 is set to adjacent with the lateral edges of the opening 300 of bottom enclosure 104, and the safety of rotor 136 keeps protuberance 296 to engage with guide post 288.

Be back to Figure 14, each in locking column 292 comprises the wedge-like portion 328 of the cylindrical extension 324 extended substantially vertically from the flat bottom inner surface of release mechanism 108 and the end being arranged on cylindrical extension 324.When the height of wedge-like portion 328 increases relative to the bottom interior surface of release mechanism 108, the width of wedge-like portion 328 increases.

When release mechanism 108 launches and is rotated down relative to bottom enclosure 104, wedge-like portion 328 against the respective side edge of the opening 180 of bottom enclosure 104, thus causes locking column 192 elastic deformation toward each other.When release mechanism 108 launches completely, protruding 280 become and rest against in pivotable seat 312.In addition, the top edge of wedge-like portion 328 is through the feather edge of opening 300, and locking column 292 skips back to its substantially non-deformation state, thus provides audition click sound and tactile feedback to express release mechanism 108 and be fully expanded and micropin 152 is capped thus.Be back to Figure 11 and Figure 12, once release mechanism 108 launches completely and locking column 292 has skipped back to its substantially non-deformation state, the top edge of wedge-like portion 328 is just adjacent to opening 300 engage with the basal surface of bottom enclosure 104, thus prevent release mechanism 108 from rotating up relative to bottom enclosure 104, and prevent micropin 152 from exposing.In addition, as above-mentioned, front shielding part 272 makes patient and micropin 152 shield.

Therefore, release mechanism 108 is the passive type secured embodiment being set to single-piece, and the good locking that can not damage under being provided in manpower load.Use this passive type release mechanism, during injecting, do not have other power to be applied on skin, and after usage micropin 152 is remained in infusion device 100 safely.

Infusion device 100 use after, patient can again testing fixture to guarantee that whole dosage is transferred.Thus, according to an embodiment shown in Figure 15 A-Figure 15 D, infusion device 100 comprises dosage end indicator (EDI) 124.EDI124 comprises the first and second arms 336 and 340 of main body or post 332 and the top basic horizontal extension relative to main body 332.

EDI124 also comprises the spring arm 344 that is bent upwards of top from 332 of main body.According to an embodiment, spring arm 344 promotes the bottom side against reservoir sub-component 120, thus make EDI124 towards bottom enclosure 104 elastic biasing, with guarantee such as infusion device 100 transport and dispose period EDI124 can not freely move out infusion device 100.According to an embodiment, spring arm 344 promotes the bottom side against vault 176.

Be back to Fig. 4, main body 332 to be arranged in EDI passage 348 and to move substantially vertically in the channel.According to an embodiment, EDI channel setting is adjacent with of guiding in the lower limb 208 of plunger 144 and the recess channel 204 of foot 212.First arm 336 extends across the top of this recess channel 204.

Be back to Figure 15 A, vertical extrusion or beacon 352 upwards extend from the end of the second arm 340.When being exported by reservoir contents, beacon 352 extends through the EDI opening 356 (such as, see Figure 15 C) in top casing 116, arrives at dosage terminate to express.According to an embodiment, EDI124 is formed as one-piece construction.

As shown in Figure 15 B, when plunger 144 is upwards advanced in cylindrical shell 200 due to pressing spring 140 after the activation, one in the foot 212 of plunger 144 contacts with first arm 336 of EDI124.During reservoir contents conveying, foot 212 by EDI124 upwards lifting, thus overcomes the biased of spring arm 344, and causes beacon 352 to extend through EDI opening 356 gradually.Back with reference to Figure 10, when after activating, medicine is just discharged from reservoir 160, beacon 352 partly extends from infusion device 100.Once the conveying of reservoir contents completes and plunger has realized its complete stroke, vertical extrusion 352 just extends, shown in Figure 15 D completely.Thus, EDI124 adopts the linear movement of plunger 144 to produce the linear movement of EDI124, and the linear movement of this EDI124 can be visible in the outside of infusion device 100, thus expresses the conveying of reservoir contents.

Figure 16 A and 16B illustrates another dosage end indicator (EDI) 360 in infusion device 100 and operates.As shown in fig. 16, the base portion 364 of the beacon 368 of EDI360 has different colors from the remainder of beacon 368.As illustrated in figure 16b, base portion 364 shows that outside infusion device 100 conveying of medicine completes substantially as seen.In other respects, EDI360 and EDI124 is similar substantially.

Figure 17 A and 17B illustrates another dosage end indicator (EDI) 372.As shown in figs. 17 a and 17b, EDI372 comprises main body 376, from the first arm 380 of main body 376 extension and also from the first spring arm 384 and the second spring arm 388 that main body 376 extends.In addition, beacon 392 extends from the end of the first arm 380.According to an embodiment, beacon 392 comprises base portion 396 and top 400.According to an embodiment, base portion 396 from the remainder of beacon 392, there is different colors at least partially.In this embodiment, the different colours part of base portion 396 shows that outside infusion device 100 conveying of medicine completes substantially as seen.

As shown in figure 17 a, EDI372 also comprises a pair stabilizing arm 412 and 416 extended from main body 376.Stabilizing arm 412 and 416 stablizes EDI372 in EDI372 moving process.Figure 18 illustrates the EDI372 be arranged in infusion device.As shown in Figure 18, cylindrical shell 200 comprises the passage 420 of the main body 376 holding EDI372 movably.Stabilizing arm 412 contacts the outside of cylindrical shell 200 to stablize EDI372 in EDI372 moving process with 416.

After the activation, when plunger 144 is advanced in cylindrical shell 200, the foot 212 of plunger 144 contacts and the main body 376 of lifting EDI372, is therefore the motion of main body 376 and the motion of beacon 392 thus by the conversion of motion of plunger 144.

First spring arm 384 and the second spring arm 388 all have the spring arm post 404,408 being arranged at its end separately.According to an embodiment, spring arm post 404 contacts the bottom side of reservoir sub-component 120 with 408, thus EDI372 is inwardly flexibly biased, to guarantee that (such as in transport and disposal infusion device 100 process) EDI372 does not extend to outside infusion device 100 before dosage terminates relative to top casing 116 together with spring arm 384 and 388.According to an embodiment, spring arm post 404 and 408 promotes the bottom side against vault 176.

When plunger 144 arrives at the terminal of its stroke of advancing, pressing spring 140 acts on making every effort to overcome on plunger 144 and takes the biased of the first spring arm 384 and the second spring arm 388, thus cause signal post 392 to extend to outside infusion device 100 and shows that the conveying of medicine completes substantially thus.

Figure 19 A and 19B respectively illustrates another dosage end indicator (EDI) 424 and operation thereof.As shown in figure 19, EDI424 comprises the post 428 with helical form face 432.EDI424 also comprises the arm 436 that extends from the end of post 428 and vertically extrusion or beacon 440, and described vertical extrusion or beacon 440 extend through EDI opening 444 (see Figure 20 A) top casing 116 with can outside infusion device 100 from the end of arm 436.According to an embodiment, EDI opening 444 is arcuate slot.Post 428 also has the base portion 448 for EDI424 being rotationally attached to bottom enclosure 104.

Figure 19 B illustrates the helical form face 432 of the lateral edges of contact plunger 144.Figure 20 A illustrates the infusion device 100 be in pre-activated state.According to an embodiment, in the whole motor process of plunger, the helical form face 432 of EDI424 carries the edge against plunger 144.Therefore, when plunger 144 after the activation in cylindrical shell 200 on advance time, the contact between the edge of plunger 144 and helical form face 432 causes that EDI424 rotates.According to an embodiment, the interaction in plunger 144 motor process between helical form face 432 and the edge of plunger 144 causes that post 428 rotates the rotating cycle complete less than.In other words, the pitch in helical form face 432 causes that post 428 rotates the rotating cycle complete less than in plunger 144 motor process.

When EDI424 rotates, beacon 440 correspondingly rotates in EDI opening 444.And when beacon 440 arrives at the end of EDI opening 444, as illustrated in figure 2 ob, EDI424 indicates the conveying of medicine substantially to complete.

Be similar to Figure 19 A and 19B, Figure 21 A and 21B illustrates another dosage end indicator (EDI) 452 and operation thereof.As shown in figure 21 a, EDI452 comprises the post 456 with helical form face 460.In addition, post 428 has the base portion 462 for EDI452 being rotationally attached to bottom enclosure 104.EDI452 also comprises signal indicator 464 on top of this, and signal indicator 464 can by the EDI opening 468 (see Figure 22 A) in top casing 116 outside infusion device 100.

Figure 21 B illustrates the helical form face 460 of the lateral edges of contact plunger 144.Figure 22 A illustrates the infusion device 100 be in pre-activated state.According to an embodiment, in the whole motor process of plunger, the helical form face 432 of EDI424 carries the edge against plunger 144.Therefore, when plunger 144 after the activation in cylindrical shell 200 on advance time, the contact between the edge of plunger 144 and helical form face 460 causes EDI424 to rotate.Compared with the EDI424 of Figure 19 A, helical form face 460 has meticulousr pitch.Therefore, EDI452 is more rotatably in plunger 144 and EDI424 stroke procedure.According to an embodiment, the interaction in plunger 144 motor process between helical form face 460 and the edge of plunger 144 causes that post 456 rotates at least one complete rotating cycle.In other words, the pitch in helical form face 460 causes and rotates at least one complete rotating cycle at plunger 144 motor process center pillar 456.According to an embodiment, EDI452 rotates over a complete rotating cycle in the stroke procedure of plunger 144.

According to an embodiment, signal indicator 464 is such as arrow.Correspondingly, there is at least one labelling 472 in the exterior section of the top casing 116 adjacent with EDI opening 468.When EDI452 rotates in EDI opening 468 due to the stroke of plunger 144, signal indicator 464 outside infusion device 100, can indicate the process of drug conveying thus relative to the rotation of labelling 472.

According to an embodiment, the pitch in helical form face 460 is restricted to and causes that post 456 rotates just complete less than two rotating cycle in the stroke procedure of plunger 144.Therefore, as shown in Figure 22 B, after just complete less than 2 rotating cycle of advancing, EDI452 indicates the conveying of medicine substantially to complete.

As shown in Figure 23 A-23C, the various labellings adjacent with the EDI opening in top casing 116 can be adopted to indicate the process of drug conveying.Such as, Figure 23 A illustrates labelling 476, and shown labelling 476 comprises the scale with scale.The labelling 476 that this and arc EDI opening matches together can adopt with EDI424.But as a rule it is to be appreciated that various labelling also together can adopt with the EDI opening of various shape and various EDI embodiment.

Figure 23 B illustrates labelling 480, and described labelling 480 comprises the symbol of the expanded state representing reservoir 160.Such as, a symbol instruction reservoir 160 is full of substantially, intermediate symbols instruction reservoir 160 is full of half and therefore the conveying of medicine completes half substantially substantially, and the 3rd symbol instruction reservoir 160 is empty substantially and therefore the conveying of medicine completes substantially.

Figure 23 C illustrates labelling 484, depends on the direction of rotation of corresponding EDI, and described labelling 484 comprises point numerical symbol of the mark of the expanded state representing reservoir 160 or the drug conveying completed.Such as, if turn clockwise EDI and the labelling 484 with arrow signal indicator together adopt, then the motion of this EDI will the expanded state of instruction reservoir 160.On the contrary, if having arrow signal indicator be rotated counterclockwise EDI and labelling 484 together adopts, then the motion of this EDI will indicate the mark of drug conveying completed.

Figure 24 A and 24B illustrates another dosage end indicator (EDI) 488 and operation thereof.According to an embodiment, EDI488 is Pressure Sensitive Tape 488.When plunger 144 arrives at the terminal of its stroke of advancing, the pressure (power due to pressing spring 140) of plunger 144 is given to Pressure Sensitive Tape 488.Pressure against Pressure Sensitive Tape 488 causes that color changes, and therefore indicates drug conveying substantially to complete.Because the top of reservoir (window be such as placed in one) is transparent, so color change is visible.

According to an embodiment, EDI488 is arranged in reservoir 160, such as, in the interior surface of transparent vault 176.At the destination county of the stroke of advancing of plunger 144, the pressure against the plunger 144 of reservoir arched sealing member 164 is transferred to Pressure Sensitive Tape 488 by reservoir arched sealing member 164, thus causes that its color changes.

Figure 24 A and 25A illustrates the infusion device 100 be in pre-activated state.According to an embodiment as shown in Figure 24 A and 25A, with can from can outside infusion device 100 in the body that EDI488 is arranged at infusion device 100.In addition, when EDI488 is configured such that proper plunger 144 arrives at the terminal of its stroke of advancing, the foot 212 of plunger 144 contacts Pressure Sensitive Tape 488 due to the power of pressing spring 140, and causes that the color of Pressure Sensitive Tape 488 changes against the pressure of the foot 212 of Pressure Sensitive Tape 488.Figure 24 B with 25B illustrates and contacts Pressure Sensitive Tape 488 at foot 212 and cause color change thus the infusion device 100 that completes of instruction drug conveying.

Figure 26 A and 26B illustrates another dosage end indicator (EDI) 492 and operation thereof.According to an embodiment, EDI492 is the dyestuff bag with the chamber 496 and 500 that at least two are separated.When plunger 144 arrives at the terminal of its stroke of advancing, the pressure (power due to pressing spring 140) of plunger 144 is given to dyestuff bag 492, thus the separator 504 between two chambers 496 and 500 is broken.Once separator 504 is broken, the contents mixed of two chambers 496 and 500 and mixture changes color, therefore indicates drug conveying substantially to complete.

According to an embodiment, chamber 496 has yellow dye and chamber 500 has blue dyestuff.Once separator 504 breaks, blue dyestuff and yellow dye mix and form green dye, thus instruction drug conveying completes substantially.

According to an embodiment, EDI492 is arranged in reservoir 160, such as, on the inner surface of transparent vault 176.At the destination county of the stroke of advancing of plunger 144, the pressure against the plunger 144 of reservoir arched sealing member 164 is transferred to dyestuff bag 492 by reservoir arched sealing member 164, thus causes that its color changes.

Figure 26 A and 27A illustrates the infusion device 100 be in pre-activated state.According to an embodiment as shown in Figure 26 A and 27A, with can from can outside infusion device 100 in the body that EDI492 is arranged at infusion device 100.In addition, when EDI492 is configured such that proper plunger 144 arrives at the terminal of its stroke of advancing, the foot 212 of plunger 144 contacts dyestuff bag 492 due to the power of pressing spring 140, and separator 504 is broken against the pressure of the foot 212 of dyestuff bag 492 and causes the color change of dyestuff bag.Figure 26 B with 27B illustrates and contacts dyestuff bag 492 at foot 212 and cause color change thus the infusion device 100 that completes of instruction drug conveying.

Figure 28 illustrates the embodiment of the infusion device 700 with injection port 704.It is close that injection port provides reservoir 708 that is emptying or that be partially filled, and the combination of material or material can be injected in reservoir by patient before activation.Alternatively, pharmaceutical production person or pharmacists can adopt injection port 704 to fill infusion device 700 to use the combination of material or material before being sold.Nearly all in other, infusion device 700 is similar to previously described infusion device 100.

The operation of infusion device 100 will be described now.The above embodiment of the present invention preferably includes button (activator appliance button 128) design, and wherein, infusion device 100 can be located and is attached to skin surface, and is energized by urging activator appliance button 128 and/or activates.More specifically, at first step, patient from aseptic packaging (not shown) moving-out device, remove the lid (not shown) of adhesive pad 264.Patient also removes pin lid 112.When by infusion device 100 from packaging shift out time and before the use (such as, see Fig. 1, Fig. 2, Fig. 4 and Fig. 5), the infusion device 100 being in pre-activated state enables patient's testing fixture and content wherein, comprise check lose or damage parts, the Expiration Date, atomization or color offset medicament, etc.

Next step is that infusion device 100 is located and is applied on the skin surface of patient.The same with patche, infusion device 100 urges on skin by patient securely.The side of adhesive pad 264 is attached to the basal surface of bottom enclosure 104 and the basal surface of release mechanism 108, and infusion device 100 is fixed to the skin of patient by the opposition side of adhesive pad 264.These (bottom enclosure 104 and release mechanism 108) basal surfaces can for smooth, curve or formalize in any suitable manner, and adhesive pad 264 is fixed on these basal surfaces.According to an embodiment, before transportation, the lid (such as film) of adhesive pad 264 is applied on the patient side of adhesive pad 264, during transportation to protect bonding part.As above-mentioned, before the use, patient peels off adhesive cover, thus adhesive pad 264 is exposed to for arranging against skin.

After removing adhesive cover, infusion device 100 can be arranged against skin by patient, and urges to guarantee suitable attachment.As above-mentioned, once suitably locate, just activate this device by urging activator appliance button 128.This activation step releases loose plunger 144 and pressing spring 140, thus makes plunger 144 can urge flexible membrane (reservoir arched sealing member 164) against reservoir 160, thus pressurizing reservoir.This activation step also for driving spring 148 is released pine from the driving spring keeper 260 of rotor 136, thus drives micropin 152 to be rested in patient body by micropin 152 to extend (the pin opening 156 by the opening 300 in bottom enclosure 104 and release mechanism 108) to the outside of infusion device 100.In addition, activate step and valve 168 is opened, thus be based upon the fluid communication path via passage 172 (such as, see Fig. 8-Figure 10) between reservoir 160 and micropin 152.Significant benefit stems from and operates with single button the ability of each realized in these actions.In addition, another significant benefit comprises use and is included in continuous fluid communication path in reservoir sub-component 120 completely.

Once be activated, infusion device 100 is typically retained the conveying completely for reservoir contents of in place or object wearing device by patient within a period of time (such as ten minutes to 72 hours).Substantially completing of drug conveying is indicated by EDI (such as, EDI124).Patient removes subsequently can not to has destruction skin below or tissue with drop device.When deliberately or unexpected remove time, one or more security feature launches the micropin 152 shield exposure.More specifically, when infusion device 100 is removed from skin by patient, adhesive pad 264 makes release mechanism 108 launch from infusion device 100, thus shielding micropin 152, otherwise when being removed from patient by infusion device 100, micropin 152 can expose.When release mechanism 108 extends completely, release mechanism 108 locks in place and prevent unexpected injury or the exposure of micropin 152.But, not yet to be urged and micropin 152 not yet extends if security feature can be configured to activator appliance button 128, do not launch, thus before preventing from using, release mechanism launches.After usage, patient can again testing fixture to guarantee that whole dosage is transferred.Such as, patient can observe the inside of reservoir by transparent vault 176 and/or check EDI124.

Described embodiment is suitable for patient and especially human patients implements many kinds of substance, comprises medicine and medicinal agent.As used herein, medicinal agent comprise can be carried through body film and surface and especially for skin there is bioactive material.The example more itemized below comprises antibiotic, antiviral agent, analgesics, anesthetis, fenisorex, anti-arthritic, antidepressants, antihistaminic, antibiotic medicine, antineoplastic agent, vaccine (comprising DNA vaccination) etc.Human growth hormone, insulin, albumen, polypeptide and fragment thereof can be comprised to other materials of patient's Intradermal or subcutaneous delivery.Proteins and peptides can be abiogenous, synthesis or restructuring produces.In addition, this device can use in cell therapy, as during the Intradermal infusion of dendritic cell.Can other materials of carrying of method according to the present invention can from by prevention, diagnosis, alleviate, the medicine for the treatment of or using in cure diseases, choose in the group that vaccine etc. are formed, wherein, medicine comprises: α-1 antitrypsin, anti-angiogenic drugs, antisense, butorphanol, calcitonin and analog, Ceredase, COX-II inhibitor, Dermatological Agents, dihydroergotamine, dopamine-receptor stimulant and antagonist, enkephalin and other opioid peptide, epidermal growth factor, erythropoietin and analog, follicule-stimulating hormone (FSH), G-CSF, glucagon, GM-CSF, granisetron, growth hormone and analog (comprising growth hormone releasing hormone), growth hormone receptor antagonist, hirudin and hirudin analog (such as HIRULOG), IgE inhibitor, insulin, pancreotropic hormone and analog, insulin-like growth factor, interferon, interleukin, swash lutein, human luteinizing hormone's releasing hormone and analog, low molecular weight heparin, M-CSF, metoclopramide, Midazolam, monoclonal antibody, narcosis analgesic, nicotine, non-steroidal anti-inflammatory drug, oligosaccharide, ondansetron, parathyroid hormone and analog, parathyroid hormone receptor antagonist, prostaglandin antagonists, prostaglandin, recombinant soluble receptor, scopolamine, hydroxytryptamine agonist and antagonist, sulfonylpyrimidine benzene, terbutaline, thrombolytics, histoplasmosis activator, TNF, with TNF-antagonist, vaccine, has or does not have carrier/adjuvant, comprises and (includes but not limited to protein subunit to following relevant preventative and therapeutic antigen, polypeptide and polysaccharide, polysaccharide conjugate, toxoid, based on the vaccine of gene, attenuated live vaccine, reassortant vaccine, deactivation vaccine, full cell, virus and bacteria carrier): addicted, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease, meningitis, measles, parotitis, rubella, chickenpox, yellow fever, respiratory syncytial virus, tick-borne Japanese encephalitis, streptococcus pneumoniae, streptococcus, typhoid fever, influenza, hepatitis (comprises A type, Type B, C type and E type hepatitis), otitis media, rabies, polioencephalitis, HIV, parainfluenza virus, rotavirus, Epstein-Barr virus, CMV, chlamydia, typeable haemophilus, moraxelle catarrhalis, human papilloma virus, pulmonary tuberculosis (comprising BCG), gonorrhea, asthma, arteriosclerosis, malaria, escherichia coli, senile dementia, helicobacter pylori, Salmonella, diabetes, cancer, herpes simplex virus, human papilloma and other similar substances, comprise other materials of all primary treatments, such as common cold drug, drug-breaking medicine, antiallergic agent, Bendectin, antiadipositas drug, anti-osteoporotic, anti-infective, analgesic, anesthetics, fenisorex, anti-arthritic, anti-asthmatic, anticonvulsant, antidepressants, antidiabetic drug, antihistaminic, antibiotic medicine, antimigraine, anti-motion sickness medicine, Bendectin, antineoplastic agent, anti-Parkinson syndrome medicine, antipruritic, psychosis, antipyretic, anticholinergic agent, benzodiazepine receptors antagonist, vasodilation (comprises general blood vessel, coronary artery, external perihaemal canal and cerebrovascular), osteo stimulative agent, central nervous system stimulant, hormone, sleeping pill, immunosuppressant, muscle relaxant, parasympatholytic, parasympathomimetic agent, prostaglandin, albumen, peptide, polypeptide and other macromole, analeptic, tranquilizer, sexual hypofunction and tranquilizer, and Main Diagnosis is such as being called the U.S. Patent No. 6,569 of " method of intradermally injecting substances " in name, the tuberculin described in 143 and other irritated medicaments, the full content of this patent is clearly incorporated to herein by the mode of reference.

Can the vaccine formulation of system and a method according to the invention conveying can choose from by eliminating the group that forms antigen or the antigenic component of the immune response of human body cause of disease, this antigen or antigenic component stem from HIV-1 (such as tetanus antitoxin, nef, gp120 or gp160), nerpes vinrus hominis (HSV) (such as gD or derivatives thereof, or early protein such as stems from the ICP27 of HSV1 or HSV2 immediately), cytomegalovirus (CMV (espespecially people) (such as gB or derivatives thereof), rotavirus (comprising active attenuated virus), Epstein-Barr virus (such as gp350 or derivatives thereof), varicella zoster virus (VZV, such as gpI, II and IE63) or stem from hepatitis virus (such as hepatitis virus B (such as HbsAg or derivatives thereof), hepatitis A virus (HAV), hepatitis C virus and E Hepatitis virus), or stem from other viral pathogens such as hepatitis virus paramyxovirus: respiratory syncytial virus (RSV, such as F and G-protein or derivatives thereof), parainfluenza virus, Measles virus, mumps virus, human papilloma virus (HPV, such as HPV6, HPV11, HPV16, HPV18), banzi virus (such as, yellow fever virus, dengue virus, tick-brone encephalitis virus, Japanese encephalitis virus) or influenza virus (complete active or inactivation of viruses, cracking influenza virus (growing in ovum or mdck cell), or full influenza virus particles or its purification or recombiant protein (such as HA, NP, NA, M albumen or its combination)), or stem from bacterial pathogen, such as neisseria, comprise Diplococcus gonorrhoeae and Neisseria meningitidis (such as capsular polysaccharide and conjugate thereof, transferrin binding protein, newborn iron-binding protein, PiLC, adhesins), micrococcus scarlatinae (such as M albumen or its fragment, C5A protease, lipoteichoic acid), streptococcus agalactiae, Streptococcus mutans, Haemophilus ducreyi, Moraxella, comprises this Salmonella of mucositis Morakot, also referred to as branhamella catarrhalis (such as, high molecular and low-molecular-weight adhesins and invasion), Bordetella, comprises bacillus pertussis (such as pertactin, pertussis toxin, PT or derivatives thereof, filamentous hemagglutinin, adenyl cyclase, pili), Bordetella parapertussis and bordetella bronchiseptica, Mycobacterium, comprises mycobacterium tuberculosis (such as ESAT6, antigen 85A, 85B or 85C), Mycobacterium bovis, Mycobacterium leprae, shame dirt paratuberculosis mycobacteria, mycobacterium paratuberculosis, smegma bacillus, Legionnella, comprises legionella pneumophilia, Escherichia, comprise escherichia coli (such as colonization factor, heat strangle toxin or derivatives thereof, heat-stable toxin or derivatives thereof), enterohemorrhagic Escherichia coli, enteropathogenic E.Coli (such as congratulating endotoxin toxin or derivatives thereof), vibrio, comprises vibrio cholera (such as cholera toxin or derivatives thereof), shigella, comprises Shigella sonnei, dysentery bacterium, Shigella flexneri, yersinia's genus, comprises Yersinia enterocolitica (such as firelight or sunlight albumen), bacillus pestis, artificial tuberculosis yersinia genus, campylobacter, comprises campylobacter jejuni (such as toxin, adhesins and invasion) and campylobacter coli, salmonella belongs to, and comprises Salmonella typhi, paratyphosus A bacillus, Salmonella choleraesuis, Salmonella enteritidis, listeria, comprises Listeria monoeytogenes, Helicobacter, comprises helicobacter pylori (such as urase, catalase, VacA), Rhodopseudomonas, comprises bacillus pyocyaneus, staphylococcus, comprises staphylococcus aureus, staphylococcus epidermidis, Enterococcus, comprises enterococcus faecalis, enterococcus faecalis, fusobacterium, comprise clostridium tetani (such as tetanus toxin and derivant thereof), bacillus botulinus (such as Botulinum toxin and derivant thereof), clostridium difficile (such as, clostridial toxins A or B and derivant thereof), Bacillus, comprises Bacillus anthracis (such as botulinum toxin and derivant thereof), corynebacterium, comprises diphtheria corynebacterium (such as diphtheria toxin, diphtherotoxin and derivant thereof), Borrelia, comprise Bai Shi Borrelia (such as OspA, OspC, DbpA, DbpB), Borrelia garinii (such as OspA, OspC, DbpA, DbpB), A Fuxini burgdorferi (such as OspA, OspC, DbpA, DbpB), Anderson burgdorferi (such as OspA, OspC, DbpA, DbpB), borrelia hermsii, Ehrlichia, comprises the medicament of Ehrlichia equi and human granulocytic ehrlichiosis, rickettsiae, comprises rickettsia rickettsii, chlamydiaceae, comprises chlamydia trachomatis (such as MOMP, hepatic binding protein (HBP)), Chlamydia pneumoniae (such as MOMP, hepatic binding protein (HBP)), chlamydia psittaci, Leptospira, comprises leptospria interrogans, the close body that revolves belongs to, and comprises Treponoma palladium (such as, rare outer membrane protein), treponema denticola, treponema hyodysenteriae, or stem from parasite, such as Plasmodium, comprise plasmodium falciparum, toxoplasma, comprises toxoplasma gondii (such as SAG2, SAG3, Tg34), Entamoeba, comprises Entamoeba histolytica, Babesia, comprises babesia microti, trypanosoma, comprises schizotrypanum cruzi, Giardia, comprises Giardia lamblia, leishmania, comprises leishmania major, pneumocystis, comprises pneumocystis pneumoniae, Trichomonas, comprises trichomonal vaginitis, schistosomicide, comprises Schistosoma mansoni, or stem from yeast, such as Candida, comprise Candida albicans, Cryptococcus, comprises cryptococcus, as what describe in the PCT public announcement of a patent application No.WO02/083214 being called " vaccine delivery system " in name, the full content of this application is incorporated to herein by the mode of reference.

These also comprise for other preferred specific antigens phthisical, such as Tb Ral2, Tb H9, Tb Ra35, Tb38-1, Erd14, DPV, MT1, MSL, mTTC2 and hTCC1.Fusion rotein and mutation thereof is also comprised, wherein phthisical at least two, preferred three peptide fusion are larger albumen for phthisical albumen.Preferred fusion comprises Ra12-TbH9-Ra35, Erd14-DPV-MT1, DPV-MT1-MSL, Erdl4-DPV-MT1-MSL-mTCC2, Erd14-DPV-MT1-MSL, DPV-MT1-MSL-mTCC2, TbH9-DPV-MT1.Most preferredly comprise such as high-molecular-weight protein (HWMP), ORF3 and putative membrane protein (Pmps) for chlamydial antigen.Preferred bacterial vaccine comprises the antigen stemming from Streptococcus, comprise streptococcus pneumoniae (such as capsular polysaccharide antigen and conjugate thereof, PsaA, PspA, streptolysin, choline binding protein) and proteantigen pneumolysin (Biochem Biophys Acta, 1989,67,1007; Rubins et al., Microbial Pathogeneisi, 25,337-342 (biochemistry and biophysics document, 1989,67,1007; Lu Bin etc., microorganism pathogeny, 25,337-342 page)) and sudden change detoxified derivaties thereof.Other preferred bacterial vaccines comprise the antigen stemming from haemophilus, comprise Type B hemophilus influenza (" Hib ", such as PRP and conjugate thereof), typeable Haemophilus influenzae (such as OMP26, high molecular bacterial cell surface adhesins, P5, P6, D albumen and L lipoprotein) and fimbrin and fimbrin derivant peptide or its multiple copy mutation or fusion rotein.The derivant of HbsAg is well-known in the art, and comprises PreS1, PreS2S antigen etc.In preferred at one, vaccine formulation of the present invention comprises HIV-1 antigen, gp120, particularly when expressing in Chinese hamster ovary celI.In a further embodiment, vaccine formulation of the present invention comprises as gD2t defined above.

Except carrying the above material enumerated, infusion device 100 also can be used in extracting material from patient, or monitoring material level in patients.The example of material that is monitored or that extract can comprise blood, interstitial fluid or slurry.The material extracted subsequently can be analyzed for analysis thing, glucose, medicine etc.

Although describe some example embodiments of the present invention in detail above, it will be appreciated by those of ordinary skill in the art that a lot of modification is possible and substantially can not depart from new instruction of the present invention and advantage in the exemplary embodiment.Therefore, all these modification mean and are included in claims and equivalent scope thereof.

Claims

1. a medicament delivery device, comprising:

Body, described body has and is arranged on reservoir in described body for accommodation medicine;

Entry needle, described entry needle is for thrusting the skin of patient, and described pin is communicated with described reservoir fluid;

Presser unit and plunger, described plunger can be mobile for the described reservoir of contact in described body under the effect of the power of described presser unit; And

Pointer device, described pointer device substantially completes for instruction drug conveying as seen outside described device, the motion-activated described pointer device of wherein said plunger, and the conversion of motion of described plunger is the motion of visible described pointer device outside described device by wherein said pointer device;

Wherein, described pointer device comprises:

Main body; And

Beacon, described beacon is connected to described main body;

Wherein, when described plunger arrives at the terminal of its stroke of advancing, described plunger first time contacts described pointer device, and described contact is because the power of described presser unit causes;

Wherein, the pressure against the described plunger of dosage end indicator causes that described beacon extends to outside described device.

2. device according to claim 1, wherein, the base portion of described beacon comprises the color different from the remainder of described beacon, shows that drug conveying completes substantially thus when the color of the base portion of described beacon is visible outside described device.

3. device according to claim 1, wherein said pointer device also comprises:

First arm and the second arm, described first arm and the second arm extend from the first end of described main body; And

Spring arm, described spring arm extends from the first end of described main body;

Wherein said beacon extends from the end of described second arm.

4. device according to claim 1, wherein said pointer device also comprises:

At least one stabilizing arm, at least one stabilizing arm described extends from described body and stablizes described pointer device for described pointer device moving process; And

First arm, described first arm extends from described main body;

Wherein said beacon extends from the end of described first arm.

5. device according to claim 3, wherein:

It is protruding that described plunger comprises the plunger extended from its edge; And

Described in described plunger projection contacts, the first arm is with the motion by the conversion of motion of described plunger being described beacon.

6. device according to claim 3, wherein:

Described reservoir comprises the reservoir arched sealing member of vault and flexible on-expansible;

Vault described in described spring arm contact with by described dosage end indicator towards preactivate location bias; And

When described plunger arrives at the terminal of its stroke of advancing, making every effort to overcome of described pressing spring takes the biased of described spring arm, thus causes that described beacon extends to outside described device.

7. device according to claim 1, wherein:

Described body comprises cylindrical shell, and described plunger moves in described cylindrical shell; And

Described cylindrical shell comprises the passage of the main body holding described dosage end indicator movably.

8. device according to claim 4, wherein:

Described dosage end indicator also comprises at least one spring arm, and described spring arm has the spring arm post extended from its end;

In described beacon motor process, described spring arm post contact described vault with by described dosage end indicator towards preactivate location bias; And

9. device according to claim 4, wherein:

Described body comprises cylindrical shell, and described plunger moves in described cylindrical shell;

Described cylindrical shell comprises the passage of the main body holding described dosage end indicator movably; And

Described dosage end indicator is stablized in described dosage end indicator moving process in the outside that at least one stabilizing arm described contacts described cylindrical shell.