CN1863566B

CN1863566B - Patch-like infusion device

Info

Publication number: CN1863566B
Application number: CN2004800292697A
Authority: CN
Inventors: C·钦德里奇; R·松德雷格; G·豪厄尔; W·哈丁; A·拉斯托维奇; L·韦德里纳
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2003-08-12
Filing date: 2004-08-12
Publication date: 2010-09-01
Anticipated expiration: 2024-08-12
Also published as: CN1863564A; CN100509069C; CN1863566A

Abstract

A system and method for a patch-like, self-contained substance infusion device (700) which provides hidden patient needles (760) that includes a rigid bladder (712) used with a non-distensible bladder film (740), such as a metallized film. The device (700) can be attached to skin via an adhesive surface and a push button (780) activation assembly can be used to remove an interlock (730), allowing a disk, or Belleville spring (735) assembly to apply constant pressure to a fluid reservoir assembly (710). The push button (780) assembly allows the release of one or more spring-loaded patient needles (760) into the skin, and establishes a fluid path between the patient needles (760) and the pressurized fluid reservoir thereby delivering an infusion into the skin. The push button (780) activation assembly further allows the release of safety mechanisms (794) which are driven by spring (793) and released by trap-door (790).

Description

Patch-like infusion device

Technical field

The present invention relates generally to material delivery apparatus, and relate to flaky, the self-contained material infusion set that can be used for carrying various materials or medicine to the patient with improvement valve, spring and release mechanism.It is No.60/494 according to 35 U.S.C. § 119 (e) at the serial number of application on August 12nd, 2003 that the application requires to have precedence over people such as Chris Cindrich, people such as 286 U.S. Provisional Patent Application that is entitled as " Patch-Like Infusion Device " and ChrisCindrich are No.60/558 at the serial number of application on April 2nd, 2004, the priority of 611 the U.S. Provisional Patent Application that is entitled as " Patch-Like Infusion Device With Improved Valve; Spring AndSafety Mechanisms " merges the full content with reference to each described patent here.This application comprise with people such as Charles D.Shermer be No.10/623 at the serial number of application on July 22nd, 2003, the theme that 702 the non-temporary patent application of the U.S. that is entitled as " Patch-LikeInfusion Device " is relevant merges the full content with reference to described patent here.

Background technology

A lot of people are in such as the people who suffers under the diabetic disease states such as those and use the fluid transport therapy (such as injection of insulin every day) of certain form to keep the strict control of its glucose level.Current, in injection of insulin treatment example, exist two kinds every day insulin treatment main pattern.First kind of pattern comprises syringe and novopen.These devices use simple and cost lower, but they all need to be needled into when being generally every day three to four times per injection.Second kind of pattern infusion pump therapy, described therapy need be bought the pump that can use about 3 years costliness.The original cost of described pump has high obstacle for such therapy.Yet,, used the most of patients of pump would rather utilize pump to keep the life of their remainder from the viewpoint of user.Although this is that it has advantages such as continuous infusing insulin, accurate dose and sequencing time of delivery table because infusion pump is more complicated than syringe and novopen.This causes tighter glucose control and the health sensation that improves.

When the patient of oral medicine agent finally transferred insulin and they to and increases for the interest that strengthens treatment, user was paid close attention to insulin pump usually.Yet except expensive (being approximately 8 to 10 times of daily cost of syringe therapy) and limited operating life of insulin pump, insulin pump has also embodied more ancient technology and has used trouble.In addition, from the viewpoint of life style, the pipe (being referred to as " infusion set ") that makes pump be connected with transport portion on being placed in the user abdominal part is very inconvenient, and described pump is heavier, and therefore carrying of described pump becomes burden.

Therefore consider the considerable growth of pump therapy and the increase of day injection volume, growing for the expectation of better therapy.In this injection example and similar injection example, that satisfies this growth expectation fully be a kind of insulin input of form or inject, the best features that described form has made up injection treatment every day (low-cost and be easy to use) and the best features (injection and accurate dose continuously) of insulin pump and avoided the shortcoming of every kind of therapy.

Propose several suggestions, that is, provide with low cost and easy to use need not lying in bed or " wearable " drug infusion device.It partly or entirely is disposable that in these devices some is decided to be.In theory, such device can provide many advantages of infusion pump and not have fringe cost and not convenient property.Yet, unfortunately, many in these devices all have and comprise (because the specification of employed entry needle and/or length cause) if the compatibility between the employed material and interaction and the inappropriate startup of the user shortcomings such as (for example, because " humidity " that the too early startup of device causes injections) that may break down in the formation of user discomfort, material to be carried and infusion set.Making and control is needled into and has also met with difficulty aspect the degree of depth, especially when using short and/or thin specification entry needle.Acupuncture may hurt with the contacted people of equipment therefor also be problem.

Therefore, exist, and provide for insulin and non-insulin and be applied in the simplicity of manufacture view and use progressive for the current infusion set alternative demand of (such as being used for insulin institute infusion pump).

Summary of the invention

An object of the present invention is to provide a kind of patch-like infusion device, described device can be worn on skin expediently, and the injection of desired substance is provided simultaneously, and by using one or more microneedle that minimum uncomfortable property is provided.

Another object of the present invention provides a kind of patch-like infusion device, and described device provides the hidden pin different with traditional entry needle before using with between the operating period.

Another object of the present invention provides a kind of patch-like infusion device, and described device can be fixed in the patient by adhesion surface, carries out the conveying of pressurization, the implantation of patient's pin and the container contents of contents container afterwards by setting up procedure.

Another object of the present invention provides a kind of patch-like infusion device, and described device uses bladder and Belleville spring or other saucerspring assemblies to pressurize as contents container.

Another object of the present invention provides a kind of patch-like infusion device, and described device pressurizes to the content of contents container by removing the Beller spring holding tray.

Another object of the present invention provides a kind of patch-like infusion device, and described device can be activated by put on suitable power vertical or level promotion surface in setting up procedure.

Another object of the present invention provides a kind of patch-like infusion device, and described device can carry out macroscopic examination to the device context thing before using, between the operating period and after using.

Another object of the present invention provides a kind of patch-like infusion device, and described device can remove patient's pin medicated cap and/or adhesive lid in one or more operations.

Another object of the present invention provides a kind of patch-like infusion device, and described device helps to carry out from injecting and reducing or eliminate the difference aspect injection technique between the user.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises the protection mechanism of improvement, and described protection mechanism is used for protecting patient's pin intentionally or unintentionally down when skin surface removes.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises the valve system of improvement, and described valve system is used for before device uses and aseptic baffle plate and wiper seal were provided between the operating period.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises Beller spring and the spring catch mechanism that is used for the improvement that is used in combination with infusion set.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises that the molding technique of improvement is to utilize structural material better.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises the microneedle formation technology and the material of improvement.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises the actuating mechanism of improvement, and described actuating mechanism comprises pivot arm and magnetic apparatus.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises various spring mechanism of improvement.

Another object of the present invention provides a kind of patch-like infusion device, and described device comprises charge mechanism, stock indicator and the aseptic packaging of improvement.

By be provided for lamellar, can wear, the system and method for self-contained material infusion set realized these and other purposes basically, described material infusion set provides one or more hidden substantially patient's pins, described patient's pin can be positioned to contents container assembly fluid and be communicated with, and described contents container assembly comprises and can not expand the rigidity cryptomere part that membrana sacciformis is used in combination such as metal film etc.The start assembly that promotes type is provided, and described start assembly can be used for removing and keeps pin and make the Beller spring assembly apply evenly basic and constant compression force to the content of container assemblies.The start assembly of described afterwards promotion type discharges one or more spring load patient pins and makes described patient's pin form fluid passage in patient's skin and between patient's pin and pressurization institute container contents, thereby the content immersion is transported in the skin of user.When infusion set is finished and remove, can connect a plurality of release mechanisms to cover disposable pin.

Description of drawings

From the detailed description of having done below in conjunction with accompanying drawing, will understand various purposes, advantage and the novel feature of the preferred embodiment of the present invention, wherein:

Fig. 1 is the cross-sectional view that used first embodiment of the lamellar syringe of sidepiece button Face or transfusion system before starting;

Fig. 2 is another cross-sectional view that uses first embodiment of the lamellar syringe of sidepiece button Face or transfusion system after starting;

Fig. 3 is the cross-sectional view of the container subassembly of the lamellar syringe of Fig. 1 or transfusion system;

Fig. 4 is the cross-sectional view of the Beller spring subassembly of the lamellar syringe of Fig. 1 or transfusion system;

Fig. 5 is the cross-sectional view of first embodiment of the promotion valve subassembly of the lamellar syringe of the Fig. 1 in the closed position or transfusion system;

Fig. 6 is the cross-sectional view of first embodiment of the promotion valve subassembly of the lamellar syringe of the Fig. 1 in being shown in an open position or transfusion system;

Fig. 7 is the cross-sectional view of second embodiment that draws the valve subassembly of the lamellar syringe of Fig. 1 or transfusion system;

Fig. 8 is the cross-sectional view of first embodiment that pushes away/draw the valve subassembly of the lamellar syringe of Fig. 1 or transfusion system;

Fig. 9 is the cross-sectional view that used second embodiment of the lamellar syringe on ceiling button surface or transfusion system before starting;

Figure 10 is the cross-sectional view of second embodiment of the lamellar syringe of Fig. 9 after starting or transfusion system;

Figure 11 sees top view in the past from the first perspective angle of the container subassembly of second embodiment of the lamellar syringe of Fig. 9 or transfusion system;

Figure 12 and 13 is to use the exploded view of another kind of pattern of second embodiment of the lamellar syringe on ceiling button surface or transfusion system;

Figure 14 saw top view in the past from the lamellar syringe of Figure 12 or the first perspective angle of transfusion system before starting;

Figure 15 is the lamellar syringe of Figure 12 before starting or the cross-sectional view of transfusion system;

Figure 16 is the lamellar syringe of Figure 12 before starting or the side view of transfusion system;

Figure 17 is the lamellar syringe of Figure 12 before starting or another cross-sectional view of transfusion system;

Figure 18 sees top view in the past from the lamellar syringe of Figure 12 or the first perspective angle of transfusion system after starting;

Figure 19 is the lamellar syringe of Figure 12 after starting or the cross-sectional view of transfusion system;

Figure 20 is the lamellar syringe of Figure 12 after starting or the side view of transfusion system;

Figure 21 is the lamellar syringe of Figure 12 after starting or another cross-sectional view of transfusion system;

Figure 22 (a) is a plurality of figure of the container subassembly of the lamellar syringe of Figure 12 or transfusion system to 22 (e);

Figure 23 is the cross-sectional view of the valve subassembly of the lamellar syringe of the Figure 12 in the closed position or transfusion system;

Figure 24 is the cross-sectional view of the valve subassembly of the lamellar syringe of the Figure 12 in being shown in an open position or transfusion system;

Figure 25 is the exploded view of the 3rd embodiment of lamellar syringe or transfusion system;

Figure 26 is the lamellar syringe of Figure 25 before starting or the cross-sectional view of transfusion system;

Figure 27 is the lamellar syringe of Figure 25 after starting or the cross-sectional view of transfusion system;

Figure 28 is that top view is in the past seen at the first perspective angle from the 4th embodiment of lamellar syringe or transfusion system before starting;

Figure 29 sees another top view in the past from the lamellar syringe of Figure 28 or the second perspective angle of transfusion system after starting and before the withdrawal;

Figure 30 sees another top view in the past from the lamellar syringe of Figure 28 or the 3rd perspective angle of transfusion system after starting and before the withdrawal;

Figure 31 sees another top view in the past from the lamellar syringe of Figure 28 or the 4th perspective angle of transfusion system after withdrawal;

Figure 32 is the cross-sectional view of the valve subassembly of the lamellar syringe of the Figure 28 in the closed position or transfusion system;

Figure 33 is the cross-sectional view of the valve subassembly of the lamellar syringe of the Figure 28 in being shown in an open position or transfusion system;

Figure 34 sees top view in the past from the first perspective angle of the another kind of pattern of the 4th embodiment of lamellar syringe or transfusion system;

Figure 35 sees another top view in the past from the second perspective angle of the lamellar syringe of Figure 34 or transfusion system;

Figure 36 sees top view in the past from the first perspective angle of the another kind of pattern of the 4th embodiment of lamellar syringe or transfusion system;

Figure 37 is the cross-sectional view of the 5th embodiment of lamellar syringe or transfusion system;

Figure 38 to 41 has the lamellar syringe of Figure 37 of extended cover device or the cross-sectional view of transfusion system;

Figure 42 and 43 is top views of the container subassembly of the lamellar syringe of Figure 37 or transfusion system;

Figure 44 to 48 is lamellar syringe or the container of transfusion system and the cross-sectional views of valve subassembly of the Figure 37 in the closed position;

Figure 49 is the lamellar syringe of Figure 37 or 2 cross-sectional views of injecting patient's pin manifold subassemblies of transfusion system;

Figure 50 to 54 sees view in the past from the first perspective angle of the installation step of the lamellar syringe of Figure 40 or transfusion system;

Figure 55 to 60 is cross-sectional views of Beller spring and follower;

Figure 61 is the cross-sectional view of first variant of the improvement valve example in the closed position;

Figure 62 is the cross-sectional view of second variant of the improvement valve example in the closed position;

Figure 63 is the cross-sectional view of the 3rd variant of the improvement valve example in the closed position;

Figure 64 is the amplification cross-sectional view of the 4th variant of the improvement valve example in the closed position;

Figure 65 is the amplification cross-sectional view of the 5th variant of improvement valve example, and its split shed comprises tapered surface;

Figure 66 is the cross-sectional view of the improvement valve example of the Figure 65 in the closed position;

Figure 67 is the cross-sectional view of the improvement valve example of the Figure 65 in being shown in an open position;

Figure 68 is the cross-sectional view of the improvement valve example of Figure 65, and its split shed comprises convergent and flat surfaces;

Figure 69 to 71 is views of improvement valve rod stopper rod example;

Figure 72 to 74 is views of improvement overmolded valve rod stopper rod example;

Figure 75 is the view of improvement rotary valve embodiment;

Figure 76 is the detailed cross sectional view of the improvement rotary valve embodiment of Figure 75;

Figure 77 is another kind of pattern improvement rotary valve embodiment and the cross-sectional view of filling cover;

Figure 78 is the perspective view of another kind of improvement rotary valve embodiment;

Figure 79 (a) is the cross-sectional view of first, second and phase III of fluid path of the improvement rotary valve embodiment of Figure 77 to 79 (c);

Figure 80 is the cross-sectional view of the improvement valve subassembly in the closed position;

Figure 81 is the cross-sectional view of the improvement valve subassembly in being shown in an open position of Figure 80;

Figure 82 is the improvement Beller spring that is in a fixed position and the cross-sectional view of pin example;

Figure 83 is in the improvement Beller spring of the Figure 82 in the release position and the cross-sectional view of pin example;

Figure 84 (a) is the perspective view of first, second and the 3rd improvement Beller spring and pin example structure to 84 (c);

Figure 85 is the force vector figure of improvement Beller spring and pin example structure;

Figure 86 is the improvement Beller spring that is in a fixed position in the example infusion set and the cross-sectional view of pin example, is used to illustrate button and causes that pin loosens;

Figure 87 is in the improvement Beller spring of the Figure 86 in the release position and the cross-sectional view of pin example;

Figure 88 is the cross-sectional view of improvement Beller spring and opening battle pin example;

Figure 89 is the improvement Beller spring of Figure 88 and second cross-sectional view of opening battle pin example;

Figure 90 is the perspective view of the related overmolded Beller spring of the embodiment of the invention;

Figure 91 and 92 be respectively be in loosen with bending position in the cross-sectional view of overmolded Beller spring of Figure 90;

Figure 93 is to use Beller spring and pin friction function so that device is remained on the cross-sectional view of the device example under the starting state;

Figure 94 is the top view of the improved container example of device;

Figure 95 is the top view of the improvement arm/fluid path example of device;

Figure 96 is the cross-sectional view of improvement arm/fluid path example of the device of Figure 95;

Figure 97 is Figure 94 and 95 the improved container and the installation diagram of arm/fluid path example that is in the non-rigging position;

Figure 98 is Figure 94 and 95 the improved container and the installation diagram of arm/fluid path example that is in the rigging position;

Figure 99 is the cross-sectional view that is used for first sealing device of the container of Figure 98 and arm/fluid path examples of components;

Figure 100 is the cross-sectional view that is used for second sealing device of the container of Figure 98 and arm/fluid path examples of components;

Figure 101 to 105 is cross-sectional views of the topology example of patient's pin manifold;

Figure 106 is the cross-sectional view of improvement patient's needle hub and manifold;

Figure 107 is the view of porous patient microneedle;

Figure 108 is the view with patient's microneedle of a plurality of side openings;

Figure 109 and Figure 110 are the cross-sectional views with device of arm assemblies;

Figure 111 to 115 is the cross-sectional views with device of magnetic start assembly;

Figure 116 (a) is the sketch map of dog link function safety example to 116 (c);

Figure 117 is the perspective view that is in the withdrawal wedge shape shield under the retracted mode;

Figure 118 is the perspective view that is in the withdrawal wedge shape shield of the Figure 117 under the extension state;

Figure 119 is the perspective view of balladeur train gigback of the shield of Figure 117;

Figure 120 is the perspective view that is in the withdrawal slit shield in the initial position;

Figure 121 is the perspective view that is in the withdrawal slit shield of the Figure 120 in the position;

Figure 122 is the perspective view that is in the withdrawal slit shield of the Figure 120 in the retracted position;

Figure 123 is the perspective view that is in the bucket shape shield in the retracted mode;

Figure 124 is the perspective view that is in the bucket shape shield of the Figure 123 in the extension state;

Figure 125 is the perspectivity interior view that is in the bucket shape shield of the Figure 123 in the retracted mode in the device that does not start;

Figure 126 is the perspectivity interior view that is in the bucket shape shield of the Figure 123 in the retracted mode in the device that starts;

Figure 127 is the perspectivity interior view that is in the bucket shape shield of the Figure 123 in the extension state in the device that starts;

Figure 128 is the perspective view that is in the ratchet lock shield in the retracted mode;

Figure 129 is the perspective view that is in the ratchet lock shield of the Figure 128 in the extension state;

Figure 130 is the perspective view of ratchet lock mechanism of the shield of Figure 128;

Figure 131 is the perspective view of pulling out shield that is in the retracted mode;

Figure 132 is the perspective view of pulling out shield that is in the Figure 131 in the extension state;

Figure 133 is in the retracted mode another to pull out the perspective view of shield;

Figure 134 is the perspective view of pulling out shield that is in the Figure 133 in the extension state;

Figure 135 is the perspective view that is in the torsion spring shield in the initial position;

Figure 136 is the perspective view that is in the torsion spring shield of the Figure 135 in the position;

Figure 137 is the perspective view that is in the torsion spring shield of the Figure 135 in the retracted position;

Figure 138 is the perspective view with hinged shield of Monolithic spring;

Figure 139 is the perspective view with hinged shield of viscous drive hinge;

Figure 140 is the perspective view with spring shield of annular Monolithic spring;

Figure 141 is the perspective view with spring shield of hoop type Monolithic spring;

Figure 142 shows the view of inordinate rotation shield;

Figure 143 shows the cross-sectional view of the cam effect safety that are in the SBR;

Figure 144 is the cross-sectional view that is in the cam effect safety of the Figure 143 in the erected state;

Figure 145 is the cross-sectional view that is in the cam effect safety of the Figure 143 in the fired state;

Figure 146 is the cross-sectional view of the cam effect safety of the Figure 143 in being in a safe condition;

Figure 147 is the cross-sectional view of another cam actuation gear;

Figure 148 and 149 is the perspective views that stir shield;

Figure 150 is the perspective view that is in the improvement manifold spring in the enable position not;

Figure 151 is another perspective view that is in the manifold spring of the Figure 150 in the enable position not;

Figure 152 is the perspective view that is in the manifold spring of the Figure 150 in the enable position;

Figure 153 is the perspective view that is in another improvement manifold spring in the enable position not;

Figure 154 is the perspective view that is in the manifold spring of the Figure 153 in the enable position;

Figure 155 is the perspective view that is in another improvement manifold spring in the enable position not;

Figure 156 is the perspective view that is in the manifold spring of the Figure 155 in the enable position;

The cross-sectional view of the filler opening that is provided by button is provided Figure 157;

After showing and fill, Figure 158 is in the cross-sectional view of the valve module in the appropriate location;

Figure 159 shows the cross-sectional view of closing of button window after the filling of the valve module of Figure 158;

Figure 160 shows the cross-sectional view of closing window of the valve module of Figure 158;

Figure 161 shows the view of valve, button valve opening and button alignment before rotating;

Figure 162 shows the view of valve, button valve opening and button alignment after rotating;

Figure 163 shows the cross-sectional view of valve, button valve opening and button alignment after rotating;

Figure 164 shows the top view of the container of the witness marking before the injection;

Figure 165 shows the side view of the container of the Figure 164 that injects witness marking before;

Figure 166 shows the top view of the container of the shortage labelling after the injection;

Figure 167 shows the side view of the container of the Figure 166 that injects shortage labelling afterwards;

Figure 168 is the isometric view of nested type packaging system when empty the time;

Figure 169 is the isometric view of the nested type packaging system of Figure 168 when being filled;

Figure 170 is the isometric view of nested type packaging system with Figure 168 of four devices that are used to fill;

Figure 171 is the isometric view of nested type packaging system with Figure 169 of four devices that are in the high end position that is used for filling;

Figure 172 is the cross-sectional view of the nested type packaging system of Figure 168;

Figure 173 is the top view of the nested type packaging system of Figure 168 when being filled;

Figure 174 is the cross-sectional view of the nested type packaging system of Figure 168 in two bags; And

Figure 175 is the cross-sectional view of the nested type packaging system of Figure 168 when being boxed and pack.

In all figure, similar accompanying drawing should be understood that to represent similar part, parts or structure.

The specific embodiment

Below described embodiments of the invention can be used as be used for the infusion set that connects by binding agent with the material (such as medicine or medicine) of preliminary assay dosage flow to user easily, sheet-type device.Described device is self-contained and is connected to the skin surface of user by being located at binding agent on the basal surface.After suitably being located by user and starting, the pressure that loosens Beller spring or other disc springs in the device on the vessel surface can be used for via the content of pin manifold by one or more patient's microneedle emptying flexible containers.Material in the container is transported in the skin of user by the microneedle of squeezing in the skin afterwards.It should be understood that wherein use dissimilar energy storage devices (described energy storage device can be machinery, electric power and/or chemistry) other embodiment of replacement Beller spring or disc spring also are feasible.

To understand as those skilled in the art, have the lamellar injection disclosed in the multiple execution literary composition or the mode of transfusion system.Although embodiment and following description in will describing with reference to the accompanying drawings should not think that described embodiment has comprised all various replacement designs and embodiment that the present invention comprised.In each disclosed embodiment, described device all is known as transfusion device; Yet, described device also can be under than the speed of injecting faster of the common execution of infusion set injection mass.For example, described content can be transferred in the time that is as short as the several seconds or a couple of days of growing to.

In first embodiment of the device shown in Fig. 4, show push-button design 100 at Fig. 1, the wherein startup and the excitation of actuating unit in a multi-functional/step procedure.Fig. 1 is that cross-sectional view, Fig. 2 of being in first embodiment of the lamellar syringe of the use sidepiece button in the starting state not or transfusion system are that cross-sectional view, the Fig. 3 that is in this embodiment under the starting state is the cross-sectional view of the container subassembly of embodiment shown in Fig. 1, and Fig. 4 is the cross-sectional view of the Beller spring subassembly of embodiment shown in Fig. 1.

Fig. 1 comprises button 105, upper case 110, lower case 115, container value assembly 120, Beller spring 130, spring holding tray 135, manifold component 140, at least one patient's pin 141 and container 150 to the device of Fig. 4.Described device also can comprise the pin shield 111 that is used to protect pin 141 and removal before using.Described button comprises at least one inclined element 106, and described inclined element 106 has and is used for when button 105 is mobile between the starting period inclined surface 107 that engages with the external diameter 136 of dish 135.When as shown in Figure 2 inside promotion button 105, inclined surface 107 makes at least one side direction top offsets of dish 135, and this internal diameter 137 that causes described dish is to bottom offset.In this case, the internal diameter 137 of dish 135 is pulled up from the center of Beller spring 130, to flexible member 151 application of forces of container 150, content is pressed against on the stiffener 152 of container 150 after the pull-off spring 130.As shown in Figure 4, container 150 comprises flexible member 151 and the stiffener 152 that is adjacent to Beller spring 130.Beller spring 130 is held away from flexible member 151 by outstanding internal diameter 137 interference engagement with dish 135.

Button 105 also comprise be used for and the valve element 121 contacted surperficial 108 of valve module 120 so that between container 150 and patient's pin 141, form flow path.As shown in Figure 3, when valve element 121 was inwardly promoted, push-pull type valve module 120 formed flow path between container outlet 153 and excircle fluid path 154.When inwardly being promoted, the valve element end 122 of increase allows to come from the diameter that reduce of the fluid of container 150 around valve element 121 from bag 123 displacements, and enters into fluid path 154 towards manifold component 140, and pin wherein 141.Fluid path 154 is arranged on and can be used for promoting in the fluid path arm 155 of pin manifold 140.

When button 105 was inwardly promoted, support component 109 moved outside the shoulder 142 of manifold component 140, thereby makes manifold component 140 be driven towards the patient skin surface (not shown) downwards.Described manifold component can be driven by multiple device (such as disc spring), and perhaps the flexural property by external diameter fluid passage arm 155 is driven.Fluid passage arm 155 can be configured so that compressing manifold component 140 when supported element 109 discharges.

In embodiment shown in Figure 4, when button 105 is pushed, realize described function at Fig. 1 with orderly and/or mode simultaneously.At first, button 105 mobile opened the valve module 120 that at least one allows container 150 to be communicated with fluid between patient's pin 141.Second, the mobile spring holding tray 135 of having removed of button 105 is loosened Beller spring 130, the three, moving of button 105 removed support component 109 from patient's pin manifold 140, allows manifold 140 as being advanced such as the pushing of devices such as fluid passage arm 155 or manifold spring (not shown).

Particularly, button 105 comprises a series of sloping portions 107, and described sloping portion 107 engages with spring holding tray 135 when button 105 slippages, thereby and loosens the Beller spring 130 content pressurization for container 150.Button 105 also engages with promoting valve 120, mobile between the container 150 that starts current pressurization and the manifold component 140.Button 105 also removes one or more support components 109 or remove from patient's pin manifold component 140, makes manifold 140 by driving such as driving devices such as fluid passage arm 155 or one or more driving spring (not shown), and immobilized patients pin 141.

The valve module 120 of recommending of embodiment shown in Fig. 1 was constituted for before being pushed in the open position by button 105 and limits container chamber (promptly, when be arranged on

element

151 and 152 or container 150 between the time) and patient's pin manifold 140 between flow, and recommending valve module 120 can be made of the valve module 120,222,226 and 228 of any amount, as described in greater detail.

First embodiment that promotes valve module 222 has been shown in Fig. 5 and Fig. 6.Fig. 5 is the cross-sectional view of the valve module 122 in the closed position, and Fig. 6 is the cross-sectional view of the valve module of the Fig. 5 in being shown in an open position.Valve module 222 comprises the plastic button 223 that is slidably engaged in the rubber retainer 224 that is communicated with container 150 fluids.Valve module 222 has original state and starting state, and comprise major diameter far-end and have 226 groups on a near-end ratchet with 225 groups in the outstanding burr of distal radial or rib reduce the diameter near-end.In original state, valve 222 distal rib 225 are used for preventing that microorganism from entering fluid path 227, and the near-end ratchet form sealing so that with drug safety be collected in the container 150.When preventing fluid from the internal drain of container for a long time and prevent medicine from external container when contaminated in the identical time, 226 groups of boths of 225 groups in rib and ratchet carry out crucial task.

In use, button 223 will be finally be pushed into starting state under and the ratchet group will be advanced from engaging with rubber retainer 124 by button 105 mobile, and this permission medicine flows out from container 150, crosses ratchet 226 and enters valve fluid path 154.Simultaneously, distal rib is also pushed for 225 groups naturally, and the positions of rib 225 itself move to such position, make their directly the fluid in guiding container 150, by valve fluid path 227 and from fluid path 154 down to patient's pin manifold (not shown).

In the position shown in Fig. 5, plastic button 223 comprise be arranged on securely in the rubber retainer 124 have a ratchet 226 reduce the diameter near-end, and prevent any fluid overflow container 150.Because button 105 makes plastic button 223 be bonded in the rubber retainer 224 and displacement in rubber retainer 224, therefore form opening in the proximal end, described opening allows to be communicated with the fluid of container 150, shown in the arrow among Fig. 6.Valve module 222 also can be comprised in the container subassembly 150, so that can provide successive fluid path 154 between container contents and patient's microneedle 141 by container subassembly 150.

Figure 7 illustrates second embodiment of valve module 242.Fig. 7 is the cross-sectional view of second embodiment in being shown in an open position.Valve module 242 comprises plastic button 247, and is configured so that as drawing valve.As shown in Figure 7, when being pushed forward, plastic button 247 is communicated with the fluid of container 150 with container 150 openings pairing ground joint and prevention.When container 150 openings are pulled up, the gap that is produced allows to be communicated with and to flow in the fluid path 154 towards patient's pin manifold (not shown) along the fluid of the taper seat of button 247.

Valve module 242 has original state and starting state, and comprises major diameter far-end, the tapered segment 244 with 243 groups on ratchet far away and reduce diameter near-end 245.In original state, valve 242 ratchets 243 far away are used for stoping microorganism to enter fluid path 246, and tapered segment 244 and near-end 245 form sealing so that with drug safety be collected in the container 150.Ratchet 243, tapered segment 244 and reduce in the diameter near-end 245 each and prevent for a long time that all fluid is from the internal drain of container 150 and prevent that equally for a long time medicine is outside contaminated from container 150.

In use, button 247 will be finally by the button (not shown) of replacing pattern mobile be pushed into starting state under and tapered segment 244 with reduce diameter near-end 245 and will advance from joint with container 150 openings, this allows medicine to flow out from container 150, crosses to reduce diameter near-end 245 and enter valve fluid path 246.Simultaneously, ratchet far away moves to such position for 243 groups, make they directly from container 150, guide fluid, by valve fluid path 246 and from fluid path 154 down to patient's pin (not shown).

Figure 8 illustrates the 3rd embodiment of valve module 262.Fig. 8 is the cross-sectional view of the 4th valve module embodiment in being shown in an open position, and valve module 262 comprises plastic components 263, is configured so that as promoting valve or drawing valve.As shown in Figure 8, when being pulled outwardly when moving, plastic components 263 blocking container openings and prevention are communicated with the fluid of container 150.When plastic components is pushed forward, plastic components and register and allow container 150 to be communicated with fluid between patient's pin manifold 140 (not shown).

Valve module 262 has original state and starting state, and comprises the far-end with 264 groups on ratchet far away and increase diameter near-end 265.In original state, valve 262 ratchets 264 far away are used for stoping microorganism to enter fluid path 267, and the end 266 that increases diameter near-end 265 and stopper insertion element 270 form sealing so that with drug safety be collected in the container 150.Ratchet 264 and increase in the diameter near-end 265 each and prevent for a long time that all fluid is from the internal drain of container 150 and prevent that equally for a long time medicine is outside contaminated from container 150.

In use, element 263 will be finally be pushed into starting state under and increase diameter near-end 265 will advance from the joint with the end 266 of stopper insertion element 270 by button 105 mobile, this allows medicine to flow out from container 150, crosses to increase diameter near-end 265 and enter valve fluid path 267.Simultaneously, ratchet far away moves to such position for 264 groups, make they directly from container 150, guide fluid, by valve fluid path 267 and by opening 268 and 269 from fluid path 154 down to patient's pin (not shown).

In second embodiment of the device as shown in Fig. 9 to 11, show push-button design 280, the wherein also startup of actuating unit in a multi-functional/step procedure, but the pin manifold centers on the hinge through that is arranged on the some place relative with the pin manifold with container assemblies.Fig. 9 is that cross-sectional view, Figure 10 of being in second embodiment of the lamellar syringe on the use ceiling button surface in the starting state not or transfusion system are in the cross-sectional view of second embodiment under the starting state and the top view of the container subassembly that Figure 11 is embodiment shown in Fig. 9 and Figure 10.As first embodiment, can use a step starting drive.

Fig. 9 comprises upper case 281, lower case 282, Beller spring 283, spring holding tray 284, manifold component 285, at least one patient's pin 286 and has flexible member 289 and the container 287 of stiffener 288 to the device of Figure 11.At Fig. 9 in embodiment shown in Figure 11, Beller spring 283 is kept by dish 284 and loosens subsequently, but and the spring 130 of basic and Fig. 1, coil 135 similar with container 150 in inverted position compression container 287, so that the stiffener 288 of container 287 is configured so that to comprise manifold component 285 at first end, and comprise linkage 291 at second end.

In the embodiment of Figure 11, hinged container 287 is loosened by loosening device such as button (not shown) etc. at Fig. 9, thereby loosens after the Beller spring 283 flexible member 289 application of forces of container 287, content is pressed against on the stiffener 288 of container 287.As shown in Figure 10, when being loosened, spring 290 drives manifold component 285 and container 287 towards patient's skin surface (not shown) downwards away from dish 284, loosens Beller spring 283 and is the container contents pressurization.Any amount of valve module all can be used for forming the fluid path between container 287 and the manifold 285.

In the embodiment shown in Figure 11, under situation about loosening, Beller spring 283, manifold component 285, patient's pin 286 and container 287 turn to startup and with in the position, realize described three kinds of functions with orderly and/or mode simultaneously at Fig. 9.The first and second, described startup allows spring 290 rotary containers 287 and manifold 285, and this has removed spring holding tray 284, loosens Beller spring 283 and begins flowing from container 287.The 3rd, described startup also allows manifold 285 to advance by 290 pushings of manifold spring the time and lays pin 286.

The another kind of pattern of second embodiment has been shown in Figure 12 to 24.In the pattern of second embodiment shown in Figure 12 to 24, show push-button design 300, the wherein startup of actuating unit in a multi-functional/step procedure.Figure 12 and 13 is to use the ceiling button surface to press portion's shell 305 downwards with the permission user and device is turned to the exploded view of second embodiment of startup and lamellar syringe in using the position or transfusion system.Figure 14 to 17 is views of second embodiment of the lamellar syringe of Figure 12 before starting or transfusion system.Figure 18 to 21 is views of second embodiment of the lamellar syringe of Figure 12 after starting or transfusion system.Figure 22 (a) is a plurality of figure of the container subassembly of the lamellar syringe of Figure 12 or transfusion system to 22 (e).Figure 23 and 24 be respectively be in close with open position in lamellar syringe or the container subassembly of transfusion system and the view of valve subassembly of Figure 12.

As shown in Figure 12 and 13, the second embodiment of the present invention comprise have upper case 305, the infusion set 300 of Beller spring holding tray 310, at least one Beller spring 315, container film 320, container subassembly 325, at least one patient's microneedle 340 and lower case 350.Container subassembly 325 also comprises spool 326 and valve seat 328, and hinge mechanism 327 (such as pin).Hinge mechanism 327 is received by at least one the pin opening 329 that is arranged on the lower case, allows upper case 305, Beller spring holding tray 310, Beller spring 315, container film 320, container subassembly 325 and patient's microneedle 340 to turn to start and with in the position.User can be suppressed upper case 305 so that Beller spring 315 is loosened from coiling 310, and Beller spring 315 is compressed on content on the container subassembly 325 to flexible member 320 application of forces afterwards.The operation of user also drives patient's microneedle 340 downwards towards patient's skin surface (not shown) and away from dish 310.Simultaneously, the valve subassembly (that is, spool 326 and valve seat 328) of promotion of describing in more detail with reference to Figure 23 and 24 below user can start or pulling type, thus between container and patient's microneedle 340, form fluid path.

Figure 14 to 17 is views of the device 300 of Figure 12 before starting.Figure 14 shows the isometric view of the rotatable parts (that is, upper case 305, Beller spring holding tray 310, Beller spring 315, container film 320, container subassembly 325 and patient's microneedle 340) before turning to startup around lower case 350 and using in the position.Figure 15 shows and is starting and be positioned at the localized cross-sectional view with rotatable parts before in the position.Figure 16 shows and is starting and be positioned at the isolating side view with rotatable parts before in the position and lower case 350.

Figure 18 to 21 is views of the device 300 of Figure 12 after starting.Figure 18 shows to turn to around lower case 350 and starts and at the isometric view with the rotatable parts (that is, upper case 305, Beller spring holding tray 310, Beller spring 315, container film 320, container subassembly 325 and patient's microneedle 340) after in the position.Figure 19 shows and is starting and be positioned at the localized cross-sectional view with rotatable parts after in the position.Figure 20 shows and is starting and be positioned over the side view that engage of rotatable parts after in the position with lower case 350.

Figure 22 (a) is a plurality of figure of container subassembly of the device 300 of Figure 12 to 22 (e).Figure 22 (a) is the top view of container subassembly of the device 300 of Figure 12.Figure 22 (b) is that first side view, Figure 22 (c) are that second side view and Figure 22 (d) are the 3rd side views of container subassembly of the device 300 of Figure 12.Figure 22 (e) is the bottom view of container subassembly of the device 300 of Figure 12.

Figure 23 and 24 be respectively be in close with open position in the container subassembly 325 of device 300 of Figure 12 and the view of valve subassembly (that is, spool 326 and valve seat 328).Particularly, spool 326 comprises the ratchet 332 of a plurality of projectioies, in the time of in being in the closed position shown in Figure 23, and the fluid path 333 between protruding ratchet 332 blocking-up container path 330 and the patient's pin path 331.When spool 326 inwardly was pushed in the valve seat 328, protruding ratchet moved to such an extent that leave fluid path, allows the content of container to advance to pin path 331 from container path 330 via path 333.

The same with the first embodiment of the invention 100 among Fig. 1, the third embodiment of the present invention 300 also can be configured so that to provide flaky, wearable, bulk substance infusion set, and described device can be used for carrying multiple medicine to the patient.Device 300 is before using and hidden patient pin 340 was provided between the operating period, and described device 300 can be fixed in the patient by the adhesive surface (not shown) that is located on the lower case 350.Aforesaid, can realize container contents (promptly by removing or remove spring holding tray 310, be included in the content between container film 320 and the container subassembly 325) pressurization, so that be the content pressurization, and described device can be activated so that lay patient's pin 340 by the top surperficial reasonable power of promotion that puts on upper case 305 again.In this case, device 300 is convenient to from the difference of injecting and reducing or eliminating on the user injection technique.

In the 3rd embodiment of the device shown in Figure 25 to 27, show push-button design 400, wherein the also startup and the excitation of actuating unit in a multi-functional/step procedure.Figure 25 is the exploded view of the 3rd embodiment of lamellar syringe or transfusion system.Figure 26 and 27 is cross-sectional views of the 4th embodiment of the lamellar syringe of Figure 25 before starting and afterwards or transfusion system.

In the third embodiment of the present invention shown in Figure 25 to 27, infusion set 400 comprises that button 405, container subassembly 410, Beller spring keep handle 430, at least one Beller spring 435, container film 440, container film surface 442, T shape pin 445, at least one patient's microneedle 460 and lower case 470.T shape pin 445 also comprises valve module 450, and lower case 470 can comprise adhesive surface 475.

As shown in Figure 25 to 27, embodiments of the invention 400 can be configured so that to provide flaky, wearable, bulk substance infusion set, and described device can be used for carrying multiple medicine to the patient.Device 400 is before using and hidden patient pin 460 was provided between the operating period, and described device 400 can be fixed in the patient by adhesive surface 475.Keep handle 430 can realize the pressurization of container contents (that is, being contained in the content between container film 440 and the container film surface 442) by removing or remove spring, thereby loosen Beller spring 435 so that be the container contents pressurization.Described afterwards device can be by inwardly being slidably engaged button 405 towards device and being restarted.When button 405 advanced, the scalariform opening 406 in the button 405 loosened the right angle element 446 of T shape pin 445, thereby loosened T shape pin 445, and the disc spring 408 in the annular opening 410 in being set at T shape pin 445 allows 460 declines of patient's pin when driving forwards.In this case, patient's microneedle 460 is in place.When T shape pin 445 descended, the opening 451 of valve 450 alignd with fluid channel 452, and described fluid channel 452 is communicated with fluid container, thereby forms fluid path between container contents and patient's pin 460.

Figure 26 and 27 is before starting and the cross-sectional view of device 400 afterwards.In Figure 26 (Beller spring is not shown for simplicity keeps handle 430, lower case 470 and adhesive surface 475), T shape pin 445 is supported by scalariform opening 406, compression spring 408.Keep handle 430 to be removed at spring, in device 400 positions that can be placed on the skin surface (not shown) with after loosening Beller spring 435.When button 405 was pushed, scalariform opening 406 loosened the right angle element 446 of T shape pin 445, thereby loosened T shape pin 445, and allowed patient's pin 460 to descend, as shown in Figure 27.In Figure 27, the in place and opening 451 valve 450 of patient's microneedle 460 aligns with fluid channel 452, and described fluid channel 452 is communicated with fluid container, thereby forms fluid path between container contents and patient's pin 460.

In the 4th embodiment of the device shown in Figure 28 to 31, show push-button design 500, wherein the also startup and the excitation of actuating unit in a multi-functional/step procedure.Figure 28 to 31 is top views of the 4th embodiment of lamellar syringe or transfusion system.Figure 32 and 33 be respectively be in close with open position in the lamellar syringe of Figure 28 or the partial cross section view of the valve subassembly of transfusion system.

As shown in Figure 28 to 31, described device comprises button 505, spring 510, manifold arms 520, excitation rings 530, ejects opener 540, container 550, valve module 560 and valve engagement pawl 570.Spring 510 has first and

second tabs

521 and 522 respectively at the opposite side place, and be fixed in the device 500 so that when second tab raises, apply downward force by first tab, and when raising, first tab applies downward force by second tab, described power be applied in below each tab ring 530 parts (promptly, 511,513,514) or on the manifold part (that is, 520).The Beller spring (not shown) also is arranged under the container 550.Also provide the lid (not shown) to cover upper member, still omitted described lid here for convenience of description.The device of Figure 28 is constituted between the retracted position as shown in loading position (as shown in Figure 28), startup or ignition location (as shown in Figure 29 and 30) and Figure 31 and operates.

Particularly, as shown in Figure 28, aforesaid substantially be applied to sheet-type device 500 on the skin surface (not shown) after, the power on the button 505 of putting on will make button 505 pivot, or about putting 506 bendings.When button 505 pivoted, the linear element 508 of button 505 was at first ratchet, 509 places contact excitation rings 530, such swivel becket 530 as shown by arrow A.When ring 530 rotated, spring 510 dropped in the groove 512 and drives manifold downwards and manifold arms 520 from connecting rod 511.In addition, when ring 530 rotates, eject opener 540 and be engaged with on the ring 530 by sloping portion 582 (seeing Figure 35 and 36), ring 530 is used for making that ejecting opener 540 is separated with Beller spring, is the pressurization of container 550 contents thereby loosen Beller spring.After button 505 was loosened for the first time, the linear element 508 of button 505 loosened first excitation rings, 530 first ratchets 509 owing to the elastic force of pivoting point 506 is withdrawn, and is positioned at the second excitation rings ratchet, 516 back, as shown in Figure 30.In this case, for the second time promoting button 505 makes excitation rings 530 further rotate, the relative tab 521 of spring 510 is relax in 517, and the lower springs tab 522 of front is upwards reached inclined upper connecting rod 513, allow manifold arms 520 to raise and withdrawal patient pin 541, as shown in Figure 31.

Except that the above, button 505 also engages with valve module 560 by ratchet 570.The described valve of describing in more detail with reference to Figure 32 and 33 is pushed in the open position after a while, and the fluid that allows to be provided by continuous path 561 between valve 560 and the manifold arms 520 is communicated with.As shown in Figure 32 and 33, when valve module 560 comprises in the closed position at contact surface 562 be arranged on the soft plastic element 572 of extending between the increase near-end 571 in the rubber seal 564.Valve module 560 can be formed in the manifold arms 520 (that is in molded connection the between manifold arms 520 and the container 550) so that successive fluid communication path is provided in single container assemblies.

Particularly, as shown in Figure 32, promote valve module 560 and comprise the soft element 572 that is slidably engaged in the rubber seal 564 that is communicated with container 550 fluids.Valve module 560 has original state and starting state, and comprises the major diameter far-end with 573 groups in the outstanding burr of distal radial or rib and extend to the diameter main body that reduces that increases near-end 571.In original state, valve 560 distal rib 673 are used for preventing that microorganism from entering fluid path 574, and increase that near-end 571 forms sealing so that with drug safety be collected in the container 550.From external container when contaminated, the 571 groups of boths in 573 groups in rib and end carry out crucial task when preventing fluid from the internal drain of container for a long time and at the same medicine that prevents in long-time.

In use, element 572 will finally be pushed under the starting state by the mobile of button 505, and contact between ratchet 570 and contact surface 562.As shown in Figure 33, moving of element 572 makes that increasing near-end 571 advances from engaging with rubber seal 564, and this allows medicine to flow out from container 550, crosses to increase near-end 571 and enter valve fluid path 574.Simultaneously, distal rib is also pushed for 573 groups naturally, and the positions of rib 573 itself move to such position, make fluid in their guiding containers 550, by valve fluid path 574 and from fluid path 561 down to patient's pin manifold (not shown).

In second pattern of the 4th embodiment shown in Figure 34,35 and 36, can use and replace embossed metal sheets spring 510 and the valve module 560 shown in spring and valve pattern replacement Figure 28 to 31.In Figure 34 and 35, show have basic for annular cross section and be coiled in container 550 and spring 581 above the manifold arms 520.In addition, replace the valve module 560 of the promotion type shown in Figure 28, any amount of valve module 584 (such as below will be in greater detail) can be provided.In addition, the combination of excitation rings and spring can be used among above-described other embodiment.In this case, can be the benefit that excitation rings is provided for a plurality of promotion button functions.

Figure 35 and 36 also is used to illustrate ejection opener 540, when ring 530 rotates, eject opener 540 and engage with sloping portion 582, this is used for ejection opener 540 and Beller spring (not shown) are separated, loosen Beller spring, thus pressurizing vessel 550 contents.In Figure 36, show the ejection opener 583 of second pattern, described ejection opener 583 engages with sloping portion 582 substantially as mentioned above like that.

In the 5th embodiment of the device shown in Figure 37 to 41, show push-button design 700, wherein the also startup and the excitation of actuating unit in a multi-functional/step procedure.Figure 37 to 41 is cross-sectional views of the 7th embodiment of lamellar syringe or transfusion system.Figure 42 to 44 is cross-sectional views of the container subassembly of the lamellar syringe of Figure 37 or transfusion system.Figure 45 to 47 be respectively close with open position in the cross-sectional view of valve subassembly of the lamellar syringe of Figure 37 or transfusion system, and Figure 48 is the cross-sectional views of two emission patient pin manifold subassemblies of the lamellar syringe of Figure 37 or transfusion system.Figure 49 to 53 is views of the example installation step of the lamellar syringe of Figure 37 or transfusion system.

In the fifth embodiment of the present invention, infusion set 700 comprises that upper case 705, container 710, Beller spring keep handle 730, at least one Beller spring 735, container film 740, patient's pin manifold 745, at least one patient's microneedle 760 and lower case 770.In Figure 42 to 44, illustrate in greater detail container 710, and container 710 also comprises having the excircle arm 711 that extends to the fluid communication path 713 of manifold 745 from valve module 750.Container 710 also comprise be provided with the rigid element 712 relative with film 740, be trapped in material between them and arrange it to such an extent that be communicated with valve module 750 fluids.The different materials tenon bonding portion of describing in detail with reference to Figure 101 below manifold 745 can comprise 746.Device also comprises the valve module 750 that is adjacent to button 780.In Figure 45 to 46, illustrate in greater detail valve module 750.At last, as below will describing in detail and illustrate, provide the security component of improvement so that after use, start and the protection microneedle.

As shown in Figure 37 to 41, embodiments of the invention 700 can be configured so that to provide flaky, wearable, bulk substance infusion set, and described device can be used for carrying multiple medicine to the patient.Device 700 is before using and hidden patient pin 760 was provided between the operating period, and described device 700 can be fixed in the patient by the adhesive surface (not shown) that is arranged on the lower case 770.After can realizing suitably arranging, simple operations by button 780 installs 700 startup.Particularly, being slidably engaged of button 780 is used to loosen Beller spring 735, thereby is the content pressurization of container 710.Button 780 engages and also is used to open valve module 750, forms successive fluid communication path between container 710 contents and patient's microneedle 760.At last, button 780 engages and is used for support component (not shown) and patient's pin manifold 745 are separated, thereby position patient pin 760 and finishing device start.When stating function in realization, button 780 engages and also is used to loosen the security component that will describe in more detail after a while, thereby reduces the danger of being stung by patient's pin 760.The obvious advantage of the foregoing description is included in the single push-botton operation each the ability that realizes these functions.In addition, another obvious advantage comprises, comprises the use of the continuous fluid communication path of container subassembly.

Return and come, substantially as mentioned above like that suitably after the arrangement apparatus 700, by towards the inside sliding button 780 of device and starting drive 700 with reference to Figure 37.This is slidably engaged towards keeping handle 730 to drive sloping portion 782.When sloping portion 782 when keeping handle 730 to engage, keep handle 730 from the fixing position displacement of Beller spring 735, make spring 735 pressurize for container 710.Particularly, this step is loosened Beller spring 735, allows on its flexible film that is compressed on container 710 740, is the pressurization of the container contents between film 740 and the rigid element 712.This setting up procedure also is used for making the support section displacement below manifold 745, loosen patient's pin manifold 745 that the compression by excircle arm 711 (or spring of aforesaid any amount) is urged downwardly and lay patient's pin 760.At last, setting up procedure also is used to open valve module 750, forms fluid communication path between container 710 and patient's pin 760.

Particularly, as shown in Figure 45,46 and 47 cross-sectional view, valve module 750 comprises the plastic button 751 that is slidably engaged in the rubber retainer 752 that is communicated with container 710 fluids.Valve module 750 has original state and starting state, and comprise major diameter far-end and have 754 groups on a near-end ratchet with 753 groups in the outstanding burr of distal radial or rib reduce the diameter near-end.In use, button 751 will be finally be pushed into starting state under and ratchet will advance from engaging with rubber retainer 752 for 754 groups by button 780 mobile, and this permission medicine flows out from container 710, crosses ratchet 754 and enters fluid path 713.Aforesaid, the obvious advantage of above-mentioned each embodiment is included in the ability that realizes each step in the single push-botton operation.In addition, another obvious advantage comprises, comprises the use of the continuous fluid communication path of container subassembly.

A series of assembling Figure 49 to 53 show an example assembling that is used for said apparatus.In Figure 49, lower case 770, fixedly Beller spring 730 buttons 780 are produced to such an extent that be used for receiving vessel and upper case.In Figure 50, container 710, manifold 745 (comprise and appoint needle selector 719) are produced to such an extent that drop in the lower case 770, as shown in Figure 51.In Figure 52, prepare upper case 705 subsequently so that drop on the lower case 770, as shown in Figure 53.

In above-mentioned each embodiment, the container of infusion set (promptly, Fig. 4 150) but can by be used for one or more not extensible flexible films (promptly, Fig. 4 151) (such as metal film) rigid element of being connected (promptly, Fig. 4 152) constitute, and between first and second films (wherein any one in first film and second film also is disposed on the rigid element) or between first film and rigid element, can comprise any amount of material.Rigid element or container base can by container than hard portion constitute and as flexible film can suppress thereon than hard portion.Rigid element can comprise to be located at and is used for the middle body and the flange of the dome framework of heat seal flexible film around the rigid element periphery, or is placed on rigid element and forms the membrane cover of contents container or chamber between them.Because at least one wall of chamber comprises that at least one wall of flexible film and chamber comprises rigid surface, therefore one or more Beller springs (that is, 130 of Fig. 4) can be positioned to and be adjacent to flexible film and be used for applying substantially invariable pressure and being container chamber and content pressurization to flexible film.

Be set to the flexible film that is used for to container as the Beller spring of the had spring follower that below will describe in more detail and apply substantially all even constant compression force, the content of the container between compacting flexible film and the rigid element, and oppress out content from container by one or more flow paths via required valve module (that is, 120 of Fig. 1).As the above mentioned, container also can be made of two or more flexible, not extensible films, and wherein content can be comprised between the described film and at least one film is attached to rigid element so that be provided for suppressing and be the rigid basement of container contents pressurization.In another embodiment of container subassembly, automatically regulate flow velocity to one or more low flow velocitys that progressively reduce from initial high speed.The series number of application was No.10/396 on March 26th, 2003, further described other details of regulating flow velocity in 719 people's such as Jim Fentress the U.S. Patent application that is entitled as " Multi-Stage Fluid Delivery Device And Method ", merged full content here with reference to described patent application.

The flexible film of container subassembly (that is, the element 151 of Fig. 4) can be made by not extensible material or laminated material, such as washing film or other similar materials.For example, can be used in the container of first embodiment a feasibility flexible layers press mold (promptly, the element 151 of Fig. 4) can constitute so that, be the 4th layer that constitutes by polyester or nylon afterwards by first polyethylene layer known to ordinary skill in the art, second chemosphere for the 3rd metal level of selecting based on shielding character provides attachment mechanism.By using washing film or the metal film that is connected with rigid element, improved the shielding character of container, thereby increased or improve the pot-life that is contained in content wherein.For example, comprise in container contents under the situation of insulin, the main contact material in the container of the foregoing description comprises linear low density polyethylene (LLDPE) (LLDPE), low density polyethylene (LDPE) (LDPE), recycled olefins copolymer (COC) and Teflon.As described in greater detail, the main contact material in all the other flow paths of container contents comprises polyethylene (PE), pharmaceutical grades acrylic acid and rustless steel.Extend the described material that contacts with the content of container and preferably pass through ISO 10-993 and other bio-compatible property testings that is suitable for.

Described container preferably can also store the container contents of predetermined pot-life and can not cause adverse effect to content and preferably can use under multiple environmental condition in the controllable environment that is suitable for.In addition, the protection that is provided by the parts of container does not allow gas, liquid and solid material to be transferred in the content (or from wherein transmission come out) under the speed greater than the permission that satisfies the required pot-life.In above shown embodiment, container material can be stored and operate in the temperature range that approximately Fahrenheit 34 to 120 is spent, and can have the pot-life in two to three years.

Except that satisfying stability requirement, described container also can be by successfully guaranteeing operation by any amount of leak testing (such as holding the 30psi sample under the prerequisite of oozing 20 minutes can not leaking).Except that filling, the storage that brings by the structure of described container and carry advantage also to comprise below will to describe in more detail minimize headspace and adaptive capacity.

The best evacuation of described container before filling, as described in greater detail.By before filling with described container evacuation, and only in hard base plate or rigid element, have slight sinking, can make that headspace and the excess waste in the container minimizes.In addition, the shape of container can be constituted the type that is suitable for employed excitation mechanism (dish or the Beller spring that for example, have arbitrary diameter quantity and height dimension).In addition, during filling, use the flexible container of evacuation to make any air or bubble in the container of being filled minimize.The use of flexible container also is very favorable when device is subjected to can causing increasing internal container pressure external pressure or variations in temperature.In such a case, flexible container expands and contacts with content, thereby prevents owing to expand and contractility causes may leak.

Another feature of container comprises that permission carries out the ability of particle inspection automatically when filling, and perhaps carries out particle inspection in use by user.One or more container barriers (such as rigid element) can be by molded the forming of transparent, limpid plastic material, thereby can check the material that is contained in the container.Transparent, limpid plastic material is preferably the recycled olefins copolymer, and described recycled olefins copolymer is characterised in that, high transparent and definition, low extractibility and with the biocompatibility that is contained in the material in the container.In described application, container comprises the very small feature (that is, during checking can rotate) that may hinder inspection.

Container (promptly in the above-described embodiments, Fig. 4 150) with patient's microneedle (promptly, among Fig. 1 141) fluid path between is that similar or identical materials constitutes by those of recited above and containers, and satisfies various biocompatible and store test.For example, as shown in following chart 1, comprise at the device context thing under the situation of insulin, the main contact material in the container of embodiment comprises linear low density polyethylene (LLDPE), recycled olefins copolymer and Teflon, and can comprise transparent limpid plastics.Main contact material in all the other flow paths between the microneedle of container and patient's pin manifold comprises ethylene, medicinal acrylic acid, and/or rustless steel.

Chart 1

Path components	Material
Path components	Material	Container	Polyethylene, recycled olefins copolymer and/or Teflon
Container film	The washing film, such as polyethylene, aluminum, polyester and/or have the nylon of chemical tie layer, such as the product A 83 of producing by Beacon Converters of Saddle Brook N.J.	Container	Polyethylene, recycled olefins copolymer and/or Teflon
Container film		Patient's pin manifold	Ethylene and/or medicinal acrylic acid
Patient's pin	Rustless steel	Patient's pin manifold	Ethylene and/or medicinal acrylic acid

Particularly, patient's pin (that is, 141 among Fig. 1) can be made by rustless steel, and patient's pin manifold (that is 140 among Fig. 1) can be made by ethylene and/or medicinal acrylic acid.When contacting with the content extension of container, described material is preferably by ISO10-993 bio-compatible property testing.

As shown in each embodiment, be used for to container apply substantially evenly, constant force is so that oppress out in the device of content and comprise plate-like or Beller spring (that is, 130 among Fig. 1) from container, and is referred to as constant force spring hereinafter sometimes.Constant force spring is used for storage power, thereby when making it to loosen by exciting bank is the container pressurization in use.The holding tray (or handle (that is 135 among Fig. 1)) that is arranged in a plurality of alligator clamps center remains on Beller spring under the case of bending.In this case, between the storage life, prevent Beller spring the film (that is 151 among Fig. 4) of container go up or any all the other device features on exerting pressure.Holding tray has competent rigidity with antagonistic spring tension force and distortion, and can not lose efficacy under normal tensile load.

When Beller spring is pulled away from holding tray, alligator clamp descends, in this case, and the application of force on the membrane cover of container.The edge of Beller spring is limited in around the excircle of container.For the conveying of the container contents of carrying out Intradermal, Beller spring can be configured so that to be preferably in and produce about 1 to 50psi pressure in the container, is more preferably and produces about 2 to 25psi pressure, and best is to produce about 15 to 20psi pressure.In order to carry out subcutaneous injection or transfusion, the pressure in about 2 to 5psi scopes can be enough.The diameter of the size of Beller spring can be preferably 1.26 inches between 1.15 to 1.50 inches, and comprises the spring follower that is used for whole 600 μ l conveyings.

Figure 55 to 60 shows the example of various types Beller spring follower 800 (a) to 800 (c), and each spring follower all can be used in combination with the Beller spring 802 in the foregoing description.In every kind of pattern, displacement component 800 is set to and is adjacent to Beller spring 802, so that when Beller spring 802 in crooked and release position (promptly, loosen by holding element) between when mobile, spring 802 applies substantially invariable power on displacement component or follower 800, rather than directly go up the application of force at the flexible film (that is 151 among Fig. 4) of container.Follower 800 applies more equally distributed power to container film 804 again.

For example, organize as shown in 55 and 56,57 and 58 and 59 and 60 with the figure that loosens Beller spring 802 positions as showing bending respectively, example follower 800 (a), 800 (b) and 800 (c) conform to the shape of rigid container wall 806 (a), 806 (b) and 806 (c).Therefore, when as shown in Figure 56,58 and 60 loosen Beller spring 802 time, Beller spring 802 is pressed in follower 800 (a), 800 (b) and 800 (c) on rigid container wall 806 (a), 806 (b) and 806 (c) respectively tightly, makes dead leg loss minimize.In order further to reduce described loss, also can provide Beller spring as the following overmolded of describing in more detail with reference to Figure 90 to 92.

Each embodiment described above also comprises at least one patient's pin, or microneedle (that is, Fig. 1 141), but also can comprise some (such as three) microneedle.Each microneedle preferably is at least 31 specifications or littler, such as being 34 specifications, and being fixed on and can being positioned in the patient's pin manifold (that is 140 among Fig. 1) that is communicated with fluid container.When in device, comprising not only a microneedle, microneedle also can have the combination of different length or specification or different length and specification, and can comprise one or more holes along principal length, described Kongzui be positioned near the needle tip well or pin inclined-plane (if the bevelled words of needle set) near.

In the above-described embodiments, when when infusing under the required longer time of injection than the direct injection device of bigger sleeve pipe of common needs or pin, a plurality of 34 gage needle that are used for the transport box content are actual.In disclosed embodiment, can use any microneedle of its target as corium or subcutaneous space, yet, above-described embodiment comprise length be 1 and 4mm between (promptly, subcutaneous injection microneedle 2mm), and the layout of these patient's pins can be linearity or non-linear array, and according to specifically using the required any amount of pin that comprises.

Patient's pin is disposed in patient's pin manifold.In patient's pin manifold of above-mentioned each embodiment (that is, Fig. 1 140), each patient's needle set has at least one fluid communication path, or feed well.Manifold can only have a path that is used for one or more patient's pins, and a plurality of fluid paths or the groove of carrying content respectively to each pin perhaps can be provided.These paths or groove also can comprise the zigzag path that is used to content to be carried, thereby influence fluid pressure and transporting velocity, and as flow limiter.Depend on concrete application, groove in patient's pin manifold or path can change in width, the degree of depth and configuration aspects, and wherein well width between about 0.015 and 0.04 inch, is preferably 0.02 inch usually, and is configured so that to make that the dead angle in the manifold minimizes.

Above-described device is applicable to patient's (especially human patients) and distributes various materials, comprises medicine and medicament.When with in the text the time, medicament comprises the material of the biologically active that can be transferred by health film and surface (particularly skin).The example that below lists in detail comprises antibiotic, antiviral agent, analgesic, anesthetis, anorexigenic, antiarthritic, antidepressants, hydryllin, anti-inflammatory agent, antineoplastic agent, vaccine (comprising dna vaccination) etc.Can comprise human growth hormone, insulin, protein, peptide and fragment thereof for other materials of patient through corium or subcutaneous delivery.Protein and peptide can exist naturally, synthetic or reorganization generation.In addition, described device can be used in the cell therapy, as during dendritic cell.Can be from by the medicine that uses the present invention, selecting in the group of formations such as vaccine can be according to other material of the inventive method conveying, use comprises Alpha-1 antitrypsin, anti-angiogenic agent, anti-sense agent, butorphanol, calcitonin and analog, Ceredase, the COX-II inhibitor, the dermatosis medicament, dihydroergotamine, dopamine is made medication and antagonistic, enkephalin and other morphine-like peptides, epidermal growth factor, erythropoietin and analog, follicle stimulating hormone, G-CSF, glucagon, GM-CSF, granisetron, growth hormone and analog (comprising growth hormone releasing hormone), growth hormone antagonist, hirudin and such as the hirudin analog of Hirulog, the IgE inhibitor, insulin, insulinotropin and analog, the insulin type growth factor, interferon, interleukin, Leutenizing hormone, Leutenizinghormone releasing hormone and analog, the low-molecular-weight heparin, M-CSF, metoclopramide, midazolam, monoclonal antibody, the pain agent of anaesthetic Yunnan, nicotine, nonsteroid anti-inflammatory drugs, oligosaccharide, ondansetron, parathyroid hormone and analog, pth antagonist, prostaglandin antagonists, prostaglandin, the reconstitution cell soluble recepter, scopolamine, serum gaonist and antagonist, Sildenafil, terbutaline, thrombolytic, tissue plasminogen activator, TNF--, and TNF--antagonist, has or do not have the diagnosis of the disease that the medicines such as vaccine of carrier/adjuvant carry out, alleviate or treat, comprise and addiction, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease, meningococcus, measles, viral parotitis, rubella, chickenpox, yellow fever, respiratory syncytial virus, Ticks is propagated Japanese encephalitis, streptococcus pneumoniae, streptococcus, typhoid fever, influenza, hepatitis (comprises A, B, C and E type hepatitis), otitis media, rabies, poliomyelitis, HIV, parainfluenza virus, rotavirus, Epstein Barr Virus, CMV, chlamydia, atypical haemophilus, Moraxella catarrhalis, the human papillomavirus, the tuberculosis that comprises BCG, gonorrhea, asthma, atheroschlerosis malaria, the E-escherichia coli, Alzheimers, H. pylorus, Salmonella, diabetes, cancer, herpes simplex, preventive drug that human papilloma etc. are relevant and therapeutic antigen are (including, but not limited to protein subunit matter, peptide and polysaccharide, the polysaccharide conjugates, toxoid, gene-based vaccines, active attenuation agent, reassortant, deactivation, full cell, virus and bacteria carrier), and comprise such as the medicament that is used to catch a cold, the Anti-addiction medicament, the medicament of agaist allergic symptoms, antiemetic, the medicament of anti-obesity, antiosteoporeteic, anti-infectives, analgesics, anesthetis, anorexigenic, antiarthritic, anti-cough with asthma agent, spasmolytic, antidepressant, antidiabetic medicine, antihistamine, anti-inflammatory agent, antimigraine, the motion sickness agent thing, antinauseant, antineoplastic agent, antiparkinsonism drug, pruritus, psychosis, antipyretic, anticholinergic, the benzodiazepine antagonistic, vasodilator (comprises common vasodilator, coronary vasodilator, peripheral vasodilator and cerebral vasodilator), the bone stimulant, the central nervous system beta stimulant, hormones, hypnotic, immunosuppressant, muscle relaxant, intend the vagus nerve medicine, parasympathomimetic agent, prostaglandins, protein, peptide, polypeptide and other macromolecules, psychostimulant, tranquilizer, other materials of all main therapeutic agents such as sexual hypofunction medicine and tranquillizer, and such as the U.S. Patent No. 6 that is entitled as " Method of Intradermally Injecting Substances ", 569, main diagnosis such as the tuberculin described in 143 and other hypersensitivity medicaments merges the full content with reference to described patent here.

But the vaccine dosage form that system and a method according to the invention is carried can be from choosing by bringing out the group that immunoreactive antigen or antigenic component constitute human pathogenic bacteria, described antigen or antigenic component come from HIV-1 (such as tat, nef, gp120 or gp160), nerpes vinrus hominis (HSV), such as gD or derivatives thereof or direct early protein (such as the ICP27 that comes from HSV1 or HSV2), cytomegalovirus (CMV (the esp mankind)) (such as the gB or derivatives thereof), rotavirus (comprising active attenuated virus), Epstein Barr Virus (such as the gp350 or derivatives thereof), varicella zoster virus (VZV, such as gpl, II and IE63), perhaps come from hepatitis virus, such as hepatitis b virus (for example hepatitis B surface antigen or derivatives thereof), hepatitis a virus (HAV), hepatitis C virus and hepatitis E virus, perhaps come from other viral pathogens, such as paramyxovirus: respiratory syncytial virus (RSV, such as F and G protein or derivatives thereof), parainfluenza virus, Measles virus, mumps virus, human papillomavirus (HPV6 for example, 11,16,18 HPV such as grade), flaviviruses (for example, yellow fever virus, dengue virus, Far East Russian encephalitis virus, Japanese encephalitis virus) or influenza virus (that grows in ovum or the mdck cell activates virus all the life or not, the division influenza virus, perhaps full influenza virus particles or refining or its recombinant cell protein matter, HA for example, NP, NA or M protein, or its combination), perhaps come from bacterial pathogen, comprise N. gonorrhea and N.meningitidis (for example capsule polysaccharide and conjugates thereof such as eisseria spp, the siderophillin conjugated protein, the lactotransferrin conjugated protein, PilC, adhesin); S. aurococcus (for example M protein or its fragment, C5A protease, lipoteichoic acids), S.agalactiae, S. sudden change; H.ducreyi; Moraxella spp comprises M catarrhalis, is also referred to as Branhamella catarrhalis (for example high molecular and low-molecular-weight adhesin and invasion); Bo Erdeshi bacillus spp comprises B. pertussis (for example pertactin, pertussis toxin, PT or derivatives thereof, filamenteous hemagglutinin, adenyl cyclase, pili), B. parapertussis and B.bronchiseptica; Mycobacterium spp, comprise M. tuberculosis (for example ESAT6, antigen 85A ,-B or-C), M.bovis, M. leprosy bacillus, M.avium, M. paratuberculosis M.smegmatis; Logionella belongs to spp, comprises L.pneumophila; Escherichia spp, comprise enterotoxic E. escherichia coli (for example, moving the living factor, heat-labile toxin or derivatives thereof, heat-stable toxin or derivatives thereof), enterohemorragic E. escherichia coli, enteropathogenic E. escherichia coli (for example shiga toxin shape toxin or derivatives thereof); Vibrio spp comprises V. cholera (for example cholera toxin or derivatives thereof); Shigella spp comprises S.sonnei, S.dysenteriae, S.flexnerii; Yersinia spp comprises Y.enterocolitica (for example, Yop protein), the Y. plague, Y. pseudotuberculosis; Campylobacter spp comprises C.jejuni (for example toxin, adhesin and invasion) and C. escherichia coli; Salmonella spp comprises S.typhi, S.paratyphi, S.choleraesuis, S. intestinal inflammation; Listerella spp comprises L.monocytogenes; Breathe out bit and belong to spp, comprise H. pylorus (for example urease, catalase, vacuolate toxin); Pseudomonas spp comprises P.aeruginosa; Staphylococcus spp comprises S.aureus, S.Epidermidis; Enterococcus spp comprises E.faecalis, E.faecium; Fusobacterium spp comprises C.tetani (for example tetanus toxin and derivant thereof), C. bacillus botulinus (for example Botulinum toxin and derivant thereof), C.difficile (for example clostridial toxin A or B and derivant thereof); Bacillus spp comprises B.anthracis (for example, Botulinum toxin and derivant thereof); Corynebacterium spp comprises C.diphtheriae (for example diphtheria toxin, diphtherotoxin and derivant thereof); Borrelia bacterium spp, comprise that B.Burgdorferi (for example, OspA, OspC, DbpA, DbpB), B.garinii (for example, OspA, OspC, DbpA, DbpB), B.afzelii (for example, OspA, OspC, DbpA, DbpB), B.andersonii (for example, OspA, OspC, DbpA, DbpB), B.Hermsii; Ehrlichia spp comprises E.equi and human Granulocytic Ehrichiosis; Dermacentroxenus spp comprises R.rickettsii; Chlamydia spp comprises C.Trachomatis (for example, MOMP, heparin conjugated protein), C. pneumonia (for example MOMP, heparin conjugated protein), C.psittaci; Leptospira spp comprises L.interrogans; Treponema spp comprises T. pallidum (for example, thin outer membrane protein), T.denticola, T.hyodysenteriae; Perhaps come from parasites, comprise P.Falciparum such as deformable body spp; The bow type belongs to spp, comprises T.gondii (for example SAG2, SAG3, Tg34); Endamoeba spp comprises E.histolytica; Babesia spp comprises B.microti; Trypanosoma spp comprises T.cruzi; Giardia comprises the G. Lamblia; Leshmania spp comprises L.major; Pneumocystis spp comprises P.Carinii; Hair drips and belongs to spp, comprises T.vaginalis; Schisostoma spp comprises S.mansoni; Or come from yeast, such as Candida spp, comprise the C. mammilary body; Cryptococcus spp comprises C.neoformans, as is entitled as described in the PCT patent publication No. No.WO 02/083214 of " VaccineDelivery System ", merges the full content with reference to described patent here.

Comprise that also other are used for M. preferred specially good effect antigen lungy, for example Tb Ra12, TbH9, Tb Ra35, Tb38-1, Erd 14, DPV, MTI, MSL, mTTC2 and hTCC1.Be used for M. protein lungy and comprise that also wherein at least two (being preferably three) polypeptide M. tuberculosis are merged into more the fusing protein and the variant thereof of larger protein.Preferred fusion comprises Ra12-TbH9-Ra35, Erd14-DPV-MTI, DPV-MTI-MSL, Erd14-DPV-MTI-MSL-mTCC2, Erd14-DPV-MTI-MSL, DPV-MTI-MSL-mTCC2, Tb H9-DPV-MTI.Be used for chlamydial most preferred antigen and comprise for example high molecular weight protein (HWMP), ORF3 and putative membrane protein matter (Pmps).The preferred bacterium vaccine comprises the antigen that comes from streptococcus spp, comprise S.pneumoniae (for example capsule polysaccharide and conjugates thereof, PsaA, PspA, streptolysin, choline-conjugated protein) and proteantigen pneumolysin (biochemistry Biophys Acta, 1989,67,1007; People such as Rubins, the microorganism pathogenesis, 25,337-342), with and mutant detoxifcation derivant.Other preferred vaccines comprise the antigen that comes from haemophilus spp, comprise H.influenzae type B (" Hib ", for example PRP and conjugates thereof), atypical H.influenzae, for example OMP26, high molecular adhesin, P5, P6,3-protein d and lipoprotein D, and fimbrin and fimbrin derived peptide or book copying variant or its fusion protein.The derivant surface antigen of hepatitis B is as known in the art, and comprising PreS1, PreS2 S antigen.One preferred aspect in, vaccine dosage form of the present invention comprises HIV-1 antigen, gp120, in the time of especially in being illustrated in Chinese hamster ovary celI.In another embodiment, vaccine dosage form of the present invention comprises the gD2t that above limits.

Divided by on beyond the mass transport that lists, described apparatus and method also can be used for extracting material there from the patient, or the level of certain material in the monitored patient.The example of the material of can be monitored or extracting comprises blood, interstitial fluid or blood plasma.Can analyze the material that is extracted afterwards so that carry out the analysis of aspects such as analytical element, glucose, medicine.

Above-described embodiments of the invention preferably include and promote surface (that is, button) design, and wherein said device can be arranged and be fixed in skin surface, and are energized and/or start by suppressing button lightly or promoting the surface.Particularly, in a first step, user takes out described device and removes the adhesive cover (not shown) and/or the pin medicated cap from aseptic packaging.Before taking out described device and using from aseptic packaging, above-mentioned feature allows user testing fixture and content wherein, comprise inspection part disappearance and damage, expiration date, blur or color change medicine etc.After using, user once more testing fixture to guarantee to have carried all dosage.In this, as described in detail later, described device also can comprise effective dosage indicator, the perhaps dosage indicator that for example constitutes by readable specification area, described readable specification zone for the surface area of crust of the device at least 20% and be accurate to labelling dosage+/-10%.

Next procedure is a skin surface of device being arranged and is applied to user.Photo is the same, and user can be compressed on described device on the skin securely.Described device comprises having the basal surface that device is fixed in the adhesive layer of user skin.This basal surface can be smooth, curved shape or any suitable shape, and comprises adhesive layer on it, the transportation before preferably with its covering.Before using, user release adhesive cover layer (such as the film that covers binding agent), thus expose the binding agent that is used to be arranged on the skin.

After taking out, user can be placed on device on the skin and suppress to guarantee suitable bonding.Aforesaid, after suitably locating, start described device by the promotion surface (that is 305 among Fig. 1) of sliding button (that is 105 among Fig. 1) or compacting top casing.This setting up procedure loosens Beller spring, and it is compressed on the flexible film of container, is the container pressurization.This setting up procedure also is used to loosen patient's pin manifold and makes that patient's pin is in place.At last, setting up procedure also is used to open aforesaid one or more valve module or flow path, forms fluid communication path between container and patient's pin.The obvious advantage of above-described each embodiment is included in the ability that single promotes to realize in the operation each step.In addition, another obvious advantage comprises the use of the continuous fluid communication path that is arranged in container assemblies fully.

After being activated, during user stays described device in position usually, perhaps wear described device a period of time, so that complete conveyer device content, removed and abandoned described device under the hypodermic prerequisite can not injuring afterwards such as ten minutes to 22 hours.Yet, deliberately or under the unexpected situation about removing, as described in greater detail, can use one or more safety measures to cover because startup causes the pin that exposes.If yet do not promote that button and button slide and patient's pin extends described safety measure and also can be configured so that and need not use, avoid pre-device safe in utilization.

For fear of be not intended to or unexpected acupuncture, device have a mind to reuse, and, the locking pin release mechanism can be provided and after skin surface removes device, automatically start the locking pin release mechanism at once in order to protect the pin that exposes.In first pattern of the security feature embodiment that is described in greater detail below, can provide the flexible safety element, adhesive coverage is provided described flexible safety componentry with the contacted flat surfaces part of patient skin.In case after being loosened, skin surface makes this element remain on the appropriate position.After removing described device from skin surface, described element extends to the position of protection patient microneedle.The safety element of Yan Shening is locked in the position and prevents unexpected injury or expose patient's pin afterwards.The another kind of pattern of security feature embodiment comprises flexible patient's pin medicated cap (that is, Fig. 1 111), and it is used to protect patient's pin and sterility protection is provided.Described patient's pin medicated cap is used for protection patient pin during device is made, and protects user before using, and sterility protection is provided any before removing the time.Can the pin medicated cap be connected with patient's pin manifold by interference fit.

Except that the performance characteristic of the above, another feature of above-described embodiment is the ability that forms two or more different self-contained subassemblies that can assemble flexibly (that is, container subassembly and main body subassembly).Each subassembly all is self-contained and is stable, and has the ability that container subassembly and remaining part are separated, and the unnecessary processing for remaining part is avoided in the filling of said detachable vessel and inspection simultaneously.In addition, if any remaining part all should be dropped, will abandon container contents lavishly.In addition, the container subassembly does not comprise unnecessary parts, therefore can bring low granule load to padding.In addition, all they can not be unfolded because of carelessness all energy storage components in the main body subassembly so during the filling of container.Particularly, do not comprise spring in the container subassembly, this prevents the chance of the spring relaxation that appearance is not expected during filling.As previously discussed, the minimum extraneous component in the container subassembly has reduced granule load, and only comprises necessary parts, such as container and lid.There is not buoyant element, and only needs to insert build-up member usually.In addition, described container can be placed on the top of device, and this can fill and clearly observe medicine container by transparent component, thereby allows user or maker to observe container contents.

Any amount of parts that provided in the above-mentioned one exemplary embodiment all can have miscellaneous function and feature to realize expected result better.Particularly, one exemplary embodiment can be used as the improvement material that below will describe in more detail, valve and Beller spring structure, safety and packing method and material, thereby realizes expected result.For example, return with reference to Fig. 1, button 105 engages with promoting valve 120, starts flowing between present container 150 that pressurizes and the manifold component 140.The push-pull type valve module 120 of embodiment shown in Fig. 1 is constituted for and limited flowing between container 150 and the patient's pin manifold 140 before being pushed in the open position by button 105, and can be made of any amount of improvement valve module that below will describe in more detail.

As shown in Figure 61 to 63, improvement valve module 1200 can be made of the push-pull type valve rod 1206 that is placed on by in the opening 1201 in path 1202 and the shell 1203 that container (not shown) fluid is communicated with.Figure 61 and 63 shows and draws valve 1200 and 1400 in the closed position, and Figure 64 shows the promotion valve 1500 in the closed position.

Conventional valve assemblies generally includes the plastic components that is slidably engaged in the rubber retainer that is communicated with fluid container, and wherein said plastic components comprises that the near-end that is positioned over regularly in the rubber retainer spills container to stop any fluid.Owing to be bonded in the rubber retainer plastic components and displacement in the rubber retainer by button, therefore form opening in the proximal end of plastic components, this permission is communicated with fluid container.Yet described assembly needs independently rubber stopper or retainer, and the near-end of plastic components is placed on wherein.

In Figure 61 to 63, show valve embodiment 1200,1300 and 1400, wherein valve body 1206,1306 and 1406 is made of elastomer.The described valve and the rib of valve 1207,1307 and 1407 parts are made of elastomer, and this can save independently rubber stopper or sealing (that is, 224 of Fig. 6).In addition, Figure 62 and 63 valve have the linear measurement that is enough to avoid rib 1307 and 1407 to contact and damage with fluid path leakage hole 1204 and 1304.

Particularly, in each in Figure 61 to 63, all provide the opening 1202,1302 and 1402 that is communicated with container (not shown) fluid.Second opening 1204,1304 and 1404 that is communicated with patient's pin manifold (not shown) fluid also is provided.When valve body 1206,1306 and 1406 when the closed position moves to open position, valve body 1206,1306 and 1406 potted component or rib 1207,1307 and 1407 move respectively so that respectively between opening 1202 and 1204, between the opening 1302 and 1304, provide fluid communication path between the opening 1402 and 1404.Yet, do not allow described potted component with allow edge of opening with abrasive manner act on valve body 1206,1306 and 1406 or potted component 1207,1307 and 1407 on mode contact openings (especially opening 1204,1304 and 1404).In each valve embodiment 1200,1300 and 1400 by opening or closing in the valve position potted component 1207,1307 and 1407 and opening 1204,1304 and 1404 between provide competent gap to avoid this point.For example, the rib 1307 of Figure 62, fully arranged proper valve close, open or be in close and open mode between the time avoid contacting with opening 1304.Provide other improvement and description by the following valve body of describing in more detail to these potted components.

Valve module shown in Figure 64 to 68 is also finished low-pressure fluid-tight, high pressure fluid-tight simultaneously and is prevented the complex task that microorganism enters.Valve embodiment 1500 needs two parts, and these two parts form fluid valve system together.First parts are that valve rod stopper rod 1502, the second parts are that valve rod stopper rod 1502 is accommodated in cylindrical body open 1504 wherein.Whole fluid valve system is comprised in the fluid container, therefore can be used for the medicine of liquid form is contained in the infusion set 100 of Fig. 1.

Valve 1500 has original state and starting state, and the near-end group and the far-end group that comprise radially outstanding burr or

rib

1506 and 1508 respectively as shown in Figure 64 to 68.In original state, the near-end rib of valve 1506 form sealing with safety of medicine be collected in the container (not shown), and distal rib 1508 is used for preventing that microorganism from entering into fluid path 1510.When preventing fluid from the internal drain of container for a long time and prevent medicine from external container when contaminated in the identical time, 1508 groups of boths of 1506 groups in rib and rib carry out crucial task.

In use, valve rod stopper rod 1502 will be finally by button (not shown) mobile be pushed under the starting state and the changing function of

rib

1506 and 1508 to carry out new responsibility.When being pushed into, the near-end rib will advance to for 1506 groups in the amplification cavity 1512 that is communicated with fluid container, and this allows medicine to flow out from container, crosses near-end rib 1506 and enters valve fluid path 1510.Simultaneously, distal rib is also pushed for 1508 groups naturally, and the positions of rib 1508 itself move to such position, make fluid in their guiding containers, by valve fluid path 1510 from lateral port 1514 flow out and from last fluid path (not shown) down to patient's pin (not shown).

Because 1508 groups of distal rib are drawn fluid from lateral port 1514, therefore 1508 groups of works that must play high pressure sealing now of distal rib are correctly discharged from suitable lateral port 1514 in order to guarantee fluid, rather than cross distal rib 1508 itself and spill, this can cause fluid to run off.In order to ensure successfully realizing this point, valve module also can comprise slightly tapered cylinder valve body openings 1504, and wherein valve rod stopper rod 1502 advances as shown in Figure 65 to 68.In the time of in being in original state shown in Figure 65 to 67 or closed condition, the distal rib 1508 that this cone body opening 1504 allows to form fluid-tight " obtains to set " safely.That is to say that in the time of in the closed position, the rib 1508 of valve rod stopper rod 1502 loosens usually always in the inside diameter ranges of cylinder valve body openings 1504.Therefore as time goes by, when finally moving in the open position, rib 1508 will be lost certain ability that applies required radial pressure on main body.

When distal rib 1508 when hindering the barrier that microorganism enters, shown in the arrow A among Figure 67, this reduces radial pressure is permissible, and valve will still play a role fully.Yet moving forward and their main effect when changing into the mobile high pressure sealing that overcomes arrow B rather than hindering the barrier that microorganism enters when distal rib 1508 as shown in Figure 68 requires distal radial rib 1508 preferably as fluid-tight.Therefore if distal rib 1508 " obtains setting " when close, if so they in non-tapered opening progressive words they can not carry out this task effectively when opening.Therefore, in the embodiment shown in Figure 65 to 68, assembly 1500 also has conical body openings 1504, thereby when distal rib 1508 from original state when starting state moves forward, because conical body openings 1504 has the internal diameter that reduces, therefore whether they will be by " pressurization once more ", so distal rib 1508 can work effectively, and " obtain to set " irrelevant with 1500 down periods of valve.

Advantage with conical body openings 1504 is that it has only realized multi-sealed and the fluid flow target by single molding part.Be used in such as the typical valve in this system and comprise the elastic packing that is used in combination with the valve rod stopper rod or plug, thus acquisition and the identical seal feature of embodiment shown in Figure 64 and 65.That is to say, in the embodiment shown in Figure 64 and 65,, therefore save sealing or fill in because used valve rod stopper rod 1502 partly constitutes (as hereinafter describing in detail with reference to Figure 69 and 72) by rigid element or element with softish overmolded.Because Figure 69 and 72 embodiment have realized therefore demonstrating the task of all requirements tangible cost savings owing to reduced total number of spare parts, and simple manufacturing and linkage editor are provided by part still less.

A kind of method that is configured for saving a kind of like this valve rod stopper rod 1502 of resilient plug is to use one/two injection-molded program shown in Figure 69 to 74.In Figure 69,70 and 71, rigid polyethylene element 1520 is constituted as the core element of valve 1502 and forms rigid structure, and comprises the main body 1522 that increases far-end 1521, be used for supporting subsequently a plurality of far-end burrs, is used to flow path that reducing diameter main body 1523 and being used for supporting subsequently the near-end 1524 that the minimally of a plurality of near-end burrs increases of gap is provided.Perspective view, Figure 70 that Figure 69 shows core element 1520 show the side view of core element 1520 and the cross-sectional view that Figure 71 shows core element 1520.In an exemplary embodiment, increasing far-end 1521 has the diameter that is approximately 0.288 inch and is approximately 0.030 inch thickness.Main body 1522 has the diameter that is approximately 0.099 inch and be approximately 0.25 inch length between end 1521 and main body 1523.Reducing diameter main body has the diameter that is approximately 0.040 inch and be approximately 0.023 inch length between end 1524 and main body 1522.The near-end 1524 that increases has the thickness of the diameter that is approximately 0.10 inch and 0.01 inch and has 45 ° of tapered ends that extend vertically from it.

In the second injection-molded program shown in Figure 72,73 and 74, elastomer overmolded part 1530 is arranged on the core element 1520 of Figure 69 to 71.Figure 72 shows the side view of the perspective view of the core element 1520 of overmolded, core element 1520 that Figure 73 shows overmolded and the cross-sectional view of the core element 1520 that Figure 74 shows overmolded.Formed valve element or valve rod stopper rod comprise distal seal burr 1531 and proximal seal burr 1532, and this provides such surface, and the identical sealing that is provided with independent plug can be provided in the valve opening on described surface.In this case, described valve has been save the needs of independent rubber stopper in the valve or retainer.In an exemplary embodiment, the far-end burr 1531 of overmolded has the diameter that is approximately 0.177 inch and is approximately 0.016 inch thickness.The near-end burr 1532 of overmolded has the thickness of the diameter that is approximately 0.114 inch and 0.02 inch and has 45 ° of tapered ends that extend vertically from it.

Improvement valve rod stopper rod and opening only are the improvement mechanisms that the embodiment of the invention provided.In another improvement valve embodiment, infusion set can use rotary valve 1535 to provide fluid to be communicated with as infusion set.Figure 75 is that side view, Figure 76 of rotary valve is in the cross-sectional view that uses the rotary valve in preceding and the use.Valve 1535 can have simple installing valve aligned portions between path 1536 and 1537, thereby allows from the container (not shown) to pin 1538 fluid to be communicated with when as shown by arrow A such rotation of valve.Another rotary valve embodiment 1540 has been shown in Figure 77,78 and 79, has had distinct filling, injection and closed position or state.As shown in Figure 77 to 79, rotary valve can comprise from arm 1548 extensions and be assemblied in first in second pipe 1544 in rotating mode manages 1542, and by lever arm 1548 transfusion needle 1546 is invested first pipe 1542.Each pipe all comprises a plurality of openings that are used to align so that filling position, closed position and injection position are provided, as described in greater detail.

In filling position, as shown in Figure 79 (a), the filling opening 1541 in second pipe 1544 aligns with first filling opening 1543 of managing in 1542, thereby is communicated with fluid container by the vessel port 1554 in second pipe 1544.This only allows filling opening 1541 to be communicated with fluid between the container.In the injection position shown in Figure 79 (b), the filling opening 1543 in first pipe 1542 is blocked, and the injection openings 1552 in first pipe 1542 is alignd with the vessel port 1554 in second pipe 1544.In the closed position shown in Figure 79 (c), all openings in first pipe and second pipe are all blocked.

When device is carried and valve when being in the closed position shown in the cross-sectional view 1550 among Figure 79, fluid enters by the hole 1552 in second pipe, 1544 sidepieces but the sidewall of first pipe 1542 makes it to stop.In this position, by lever arm 1548 transfusion needle 1546 is invested first pipe 1542, yet, seal between the fluid path between the pin and the first pipe inside and the fluid path of second pipe 1544, and lever arm 1548 is disposed under the certain angle so that pin 1546 is remained on user skin top.

When device was activated, lever arm 1548 rotations were so that pin 1546 enters in the skin.This rotation makes the pipe 1542 of winning align to allow fluid flow with the sidepiece hole 1552 in second pipe 1544 in the second sidepiece hole 1554 of pipe inner rotation in first pipe 1542.Described fluid flow into first pipe by the sidepiece hole 1554 in first pipe 1542 from the second sidepiece hole 1552 of pipe 1544 central authorities with flow in the fluid path in the lever arm 1548, flowing downward and flow out from pin 1546 along lever arm 1548 enters into user skin.Sidepiece hole 1554 in first pipe 1542 is positioned to and makes it only just open fluid path when pin 1546 has entered into the skin desired depth.

Because rigid lever arm 1548 is as fluid path, so rotary valve embodiment does not need the flexible fluid path between valve and pin.In addition, the time limit that valve is opened is directly relevant with the position of pin in skin, thereby has got rid of the probability of being opened by valve before suitably being arranged in the skin at pin.

Open the operation of valve and insert pin in identical operations and part by combination, the assembling of the fluid path of the embodiment shown in Figure 75 to 79 and valve is simple and is reduced to still less part.In addition,

pipe

1542 and 1544 need not to complete circle, but also can only be circular arc.Fluid path can be along the groove (not shown) under the lateral of first pipe 1542, and described groove aligns with the hole 1552 on second pipe 1544.Fluid path also can be along the inboard downward groove (not shown) of second pipe 1544, and described groove aligns with the hole 1554 on first pipe 1542.Fluid path also can be made of the groove (not shown) in second pipe, 1544 inwalls and the outer wall of first pipe 1542.In another kind of variant, lever arm 1548 can be attached to outside (or second) pipe 1544 of rotation, and wherein inner (or first) pipe 1542 is fixed, so that fluid flow into second pipe 1544 from first pipe 1542.In every kind of variant, in hole that valve-type aligns with the valve of opening fluid path for the motion of inserting by the combination pin and/or the groove one.

In another rotary valve embodiment shown in Figure 80 and 81, infusion set also can use the improvement rotary valve mechanism between container channel and patient's pin fluid path.Figure 80 and 81 show respectively close with open position in valve module.In Figure 80, because the position of rotation of arm 1559 causes not alignment of fluid path opening 1557 and 1558.When arm 1559 rotated in the direction of arrow A, such as being placed when patient's pin when in place, the element 1555 in the element 1556 entered into the position shown in Figure 81, become alignment and allow fluid flow of fluid path opening 1557 and 1558.

With reference to Fig. 1,, therefore also be referred to as constant force spring being used for applying even substantially, constant power so that oppress out from container in the device 100 of content and comprise plate-like or Beller spring 130 to container.Aforesaid, constant force spring 130 is used for storage power, thereby when making it to loosen by exciting bank is the container pressurization in use.In Fig. 1, be arranged in holding tray, the handle of a plurality of Beller springs folder center or sell 135 Beller spring remained under the case of bending.In this case, exert pressure on the film 151 of Beller spring at container 150 or on any all the other device features preventing between the storage life.

When being pulled away from from Beller spring 130 when keeping pin 135, alligator clamp is loosened and the application of force on the membrane cover 151 of container 150.The edge of Beller spring 130 is limited in around the excircle of container 150 usually, and in order to carry out the intradermal delivery of container contents, Beller spring can be configured so that to be preferably in and produce the pressure of about 1psi to 50psi in the container, be more preferably and produce about 2 to 25psi pressure, best is to produce about 15 to 20psi pressure.In order to carry out subcutaneous injection or transfusion, the pressure in about 2 to 5psi scopes can be enough.

For these values, during treating, preferably keep constant or approaching constant infusion pressure.Beller spring mechanism 130 provides described a kind of device near constant force, and described power can change near constant compression force.Aforesaid, a kind of method that loads for Beller spring is to make alligator clamp deflection and pin being inserted in the increase internal diameter of formed opening.In order to turn back to non-deflected position, described alligator clamp must at first advance and reduce the distance of internal diameter, and this is impossible when pin is in the appropriate location, thereby spring is remained in the loading position.Triggering Beller spring is the straightforward procedure that removes pin, but because Beller spring is clipped in and has caused tangible frrction load on the pin, even therefore when using lever arm, it also is bigger spurring the required power of described pin.If between alligator clamp and pin, on lever arm, apply " moment ", remove and just become more or less freely.

In the improvement embodiment shown in Figure 82, show the Beller spring 1560 that comprises a plurality of alligator clamps 1562, pin 1564, lever arm 1566 and fulcrum 1568.When power is applied in the far-end of lever arm 1566, on Beller spring folder 1562, brought out counteracting force at fulcrum 1568 places.The power that further applies will make pin 1564 rotate up to its bullet from Beller spring 1560, remove pin 1564 as shown in Figure 83.

The sampling of several (but the non-whole pin 1564) geometry that can use this ultimate principle has been shown, and described sampling comprises circular pegs (a), wide lever pin (b) and narrow lever pin (c) so that provide rotation to promote in Figure 84 (a), 84 (b) and 84 (c).Circle geometry as shown in structure (a) allows to loosen power F ₁... F _nBe applied in part (a) excircle any position on every side, top or bottom are as shown in Figure 85, with release pins 84 (a).Wide bar geometry shown in the structure (b) allows to loosen narrower outer the placing to loosen as the common pin that is had of button (b) that power is applied in part.Narrow bar geometry shown in the structure (c) allows to loosen power and is applied in from the sidepiece rather than the end of bar (c).About the structure (a) of Figure 84, shown in the trying hard among Figure 85, apply at the extreme place of circular pegs (a) and to loosen power, cause longer effective lever arm, thereby reduce required power.

But the easiness of assembling in total height that two factors of the position that power of influence is applied in are devices and the manufacturing.Cross section in Figure 86 and 87 there is shown the application of force and loosens a kind of method of Beller spring.In the time of in the position in being in the infusion set that its button is activated, the button 1570 common as directed right parts that are pushed to, and slope 1572 by lever arm 1566 on pin 1564 application of force so that remove pin 1564 from Beller spring 1560.As shown in the perspective view in Figure 88 and 89, the another kind of pattern that can further reduce this improvement embodiment of required pullout forces provides split ring 1574 on the outside of pin 1564.Split ring 1574 must have low-friction coefficient so that can remove pin 1564 from the internal diameter of split ring 1574, and when as shown in Figure 89 remove pin 1564 time be enough to damage the breach gap so that Beller spring 1560 is activated.

In above each embodiment, fulcrum 1568 all is critical with respect to the centrage of pin 1564 and the position and the height of height for function.In order to make maximizing efficiency, make pin 1564 clear away Beller springs 1560 thereby should so arrange and weigh fulcrum 1568 so that it can cause enough pin displacements, but need the minimum power of loosening.Arrange fulcrum 1568 to such an extent that will provide bigger pin displacement from the centrage of pin 1564 is farther, but increased be used on the lever arm to remove pin 1564 required loosen power.Equally, arrange fulcrum 1568 to such an extent that will provide littler pin displacement from the centrage of pin 1564 is nearer, but reduced be used on the lever arm to remove pin 1564 required loosen power.

In order to guarantee reliable operation in some applications, especially have in the application of very easily curved alligator clamp at those, described mechanism must be designed to be the not only alligator clamp that makes fulcrum cross over Beller spring.Therefore, from this point, the structure among Figure 84 (a) and (b) be more suitable in these application than structure (c).From conceptive, structure (c) will perhaps only can be configured it and work by widening fulcrum 1568 simply by a plurality of narrow, intensive alligator clamp operations.If not only alligator clamp of Beller spring 1560 is not crossed in certain situation, so contacted single alligator clamp just may slide with the deflection irrespectively of other alligator clamps and at the situation lower edge pin 1564 that does not cause pin to slide with respect to other alligator clamps and cause spring relaxation malfunctioning.

Figure 90 to 92 shows the improvement embodiment of Beller spring 1580, and this Beller spring 1580 can be used in combination and replace Beller spring 1560 with above-mentioned improvement pin uncoupling gear.The size of improvement Beller spring 1580 is generally the diameter with about 1.15 inches to 1.50 inches (being preferably 1.26 inches), and can comprise that spring follower 1592 is to allow as above with reference to the described basic all conveyings of container contents of Figure 55 to 60.In the described below improvement Beller spring 1580, Beller spring comprises conventional springs main body 1581, and the elastomer 1582 of overmolded, space between described elastomer 1582 main body covered 1581 and the filling alligator clamp, so that when Beller spring 1580 advances between bending and release position, spring applies substantially all even constant power on entire container film surface.The elastomer of overmolded is filled under the situation of not damaging the Beller spring performance in " dead angle " between the alligator clamp.

Beller spring improvement embodiment 1580 shown in Figure 90 to 92 can be used as main fluid chamber pressing mechanism.Above-mentioned infusion set comprises such Beller spring usually, and described Beller spring is suitable for applying required pressure on described fluid-filled chamber when can be on fluid-filled chamber crooked, afterwards, discharges fluid in the described fluid-filled chamber by displacement.As shown in Figure 91 and 92, filling inherent in the design of chamber is to fill the rigidity side in chamber 1598 so that provide structure for filling chamber 1598, and the flexible film side of filling chamber 1598, the deformable of described flexible film side is so that receive the arm that is biased into the Beller spring in the filling chamber so that discharge the fluid of filling in the chamber.Although Beller spring and fill the chamber applicable to for filling chamber pressurization and conveyance fluid, because the rigid nature of described filling chamber and Beller spring, Beller spring is eventually can not be fully consistent with the shape of the rigidity side in filling chamber 1598.When spring was being filled in the chamber " reducing as far as possible ", conforming shortage caused some fluids can not release from fill the chamber fully.Described fluid loss is worthless.

Improvement Beller spring 1580 of the present invention comprises and being used for by manage to make this fluid loss arrive assembly to a certain degree with elastomeric material overmolded Beller spring 1580, especially between the alligator clamp of Beller spring 1580,, elastomer fills the chamber so that allowing Beller spring 1580 to adapt to more completely.This makes Beller spring 1580 discharge more fluid when no longer having the gap between the alligator clamp, and reduces fluid loss.An example of the described use of overmolded Beller spring 1580 has been shown in Figure 91 and 92.Spring 1580 elastomer-filled regional 1582 at " dead angle " of filling under the prerequisite of not damaging performance between the alligator clamp.

Elastomer can be molded on the whole Beller spring 1580, can allow Beller spring 1580 both for filling the chamber pressurization thereby form to have, and is consistent with the profile of filling the chamber fully again so that discharge the spring of filling all the fluidic compliant surfaces in the chamber.As shown in container cross section Figure 91 and 92, Beller spring 1590 also comprises overmolded elastomer follower 1592, and is similar to the follower of Figure 55 to 60, but is used as the overmolded surface of Beller spring 1590.Follower 1592 is provided and more has been adapted to shape in the container, especially filled the rigidity side in chamber 1598, so that when Beller spring 1590 advances, avoid the dead angle of filling by follower 1592.

Be adjacent to Beller spring 1590, flexible film sealing 1594 is set to the fluid bag 1596 that covers with rigid chamber wall 1598 positioned opposite.As shown in Figure 91, when being loosened, Beller spring 1590 comes out content compressing from fill the chamber.In the embodiment shown in Figure 91, spring 1590 is by discharging the fluid in the bag fully with elasticity follower 1592 " extruding " bag of overmolded.The advantage that above-described described elastomer covers Beller spring 1590 and elasticity follower 1592 is that it has strengthened Beller spring and can not damage its performance as the prelum of filling the chamber to guarantee to find time to fill the fluid in the chamber fully as the performance of " pushing ".

Another advantage relevant with the use of Beller spring assembly is to use in the mode of producing the ability of the friction that Beller spring produced.For example, as shown in device cross section Figure 93, keep the friction between pin 1635 and the Beller spring 1630 to can be used for device 1600 is remained on non-relaxation state.As shown in Figure 93, show exemplary device 1600 and have push-button design, wherein single multi-functional/step procedure in the startup and the excitation of implement device 1600.Figure 93 is to use the example lamellar syringe that sidepiece button 1605 is activated or the cross-sectional view of transfusion system.

The device of Figure 93 comprises that button 1605, upper case 1610, lower case 1515, container draw valve module 1620, Beller spring 1630, spring to keep pin 1635, manifold component 1625 and container 1650.Described device also comprises flexible spring follower 1655.Described device also can comprise the adhesive surface 1616 with covering 1617, and described covering 1617 is fixed together with pin medicated cap 1618 so that a step removes.In the device shown in Figure 93, when button 1605 is pushed, realize two functions with orderly and/or mode simultaneously, rather than three functions of Fig. 1 device.At first, button 1605 mobile opens that fluid between the patient's microneedle 1640 that is used for container 1650 and manifold 1625 is communicated with draws valve 1620.Aforesaid, described valve 1620 can be made of any amount of valve that draws.The second, the mobile of button 1605 removed the spring holding tray or sold 1635, loosens Beller spring 1630.Yet the friction between pin 1635 and the spring 1630 also is used for rotating container 1650 is remained on punctured position.When button loosened Beller spring 1630, one or more manifold driving springs 1660 made container 1650 be rotated down about linkage 1652, and pin 1640 is pushed in the patient skin.

Button 1605 has tapered surface 1606, and tapered surface 1606 also comprises along the center extension of tapered surface 1606 and sells 1635 slits that can therefrom pass, 1608 (not shown).When compacting button 1605, force the tapered surface 1606 of slit to advance to such an extent that cross pin 1635, this forces pin 1635 on tapered surface 1606 and away from spring 1630.The moving of button 1605 also is used to open draws valve 1620.After being enough to open the short distance of drawing valve 1620, pin 1635 is mentioned fully with pull-off spring 1630 and container 1650.

Particularly, between the storage life by Beller spring 1630 being remained under the tension force with the inconsistent pin 1635 of the contained spring of spring 1630 folder, and stop them to move closelyer (that is, reducing the internal diameter of medium pore in the Beller spring).They must move closelyer so that loosen when alligator clamp passes the center.Must pass central authorities when keeping the tension force of spring 1630 when its bending, this allows a pin 1635 to be disposed in (that is the internal diameter of the medium pore in the Beller spring 1630) between the alligator clamp.Yet described device must also automatically insert transfusion microneedle 1640, and described microneedle 1640 is attached to container by one or more drive springs 1660.Before device 1600 was used, these driving springs 1660 were compressed so that stores, because microneedle 1640 is inserted into, so entire container 1650 is mobile with microneedle 1640 when operative installations 1600.

In the embodiment shown in Figure 93, pin 1635 and friction between the Beller spring 1630 are used as and remain on driving spring 1660 under the compressive state and will install 1600 modes that remain under the starting state not.User removes pin 1635 and starting drive 1600 by moving of button 1605 from Beller spring 1630.The Beller spring 1630 that not only allows to loosen that removes of pin 1635 is container 1650 pressurizations, but also loosen container 1650 and pin 1640 so that be rotated down under the power of driving spring 1660, and described moving is enough to pin 1640 is inserted in the patient skin (not shown).Pin 1635 keeps tension force at Beller spring 1630 and driving spring 1660 on both, thereby only needs once-through operation with two diverse operations of setting in operation.

In other devices, user need be carried out two or more different steps to realize the pressurization of container and loosening of patient's pin.Other devices have the button that once promotes to carry out two steps by user, but need more complicated button assembly to realize the correct time limit of operation.In the embodiment shown in Figure 93, the described time limit engages with device.This can realize as the mode that keeps the compression on the driving spring as Beller spring 1630 alligator clamps on container driving spring uncoupling gear, the utilization pin 1635 by utilizing Beller spring and pin system.When Beller spring 1630 removes pin 1635, having eliminated friction, thereby can allow driving spring 1660 that pin 1640 is pushed among the patient.

Aforesaid, Beller spring can be on container crooked so that by discharging the fluid in the amount discharge container.Aforesaid, container itself can comprise rigidity side and flexible film side, and the deformable of described flexible film side is to receive the arm of spring.Yet, as described in greater detail, can provide container to improve for material and structure technology aspect.

In typical infusion set, container is normally made by the material with extensive chemical and/or drug resistance characteristic.This material can not bond together with other materials usually fully.Improved container embodiment of the present invention shown in Figure 94 to 100 has introduced at least a other materials, described material can bond together fully with other materials (such as pin), and comprises the device that is used for can not bonding material being locked in this new material.This will have strong drug resistance characteristic can not be bonding material (such as container 1700) but be separated with adhesives (such as needle hub/spring arm 1720 of Figure 95).These two independent sectors are engaged with each other by sealing interlocking (seal with O ring lock 1730 shown in Figure 99 and Figure 100 or elastic packing lock 1740) and do as a whole playing a role afterwards.Figure 94 is the view that view, Figure 95 of container provided the container arm of fluid path.Figure 96 is the perspective view of the container arm of Figure 95.Figure 97 is the container of Figure 94 and 95 and the installation diagram of arm, and Figure 98 shows the parts of assembling.

Improved container embodiment of the present invention comprises the fluid path that container 1700 is provided and holds needle hub/spring arm 1720, each all by two independently molding part constitute.Figure 94,97 and 98 container 1700 can be made by the material with extensive chemical and/or drug resistance characteristic.Needle hub/spring arm 1720 and formed Figure 95,96,97 and 98 fluid path 1724 can be made by any amount of plastic material, and can comprise the monofilm sealing along the fluid path between valve tap 1722 and the pin opening 1726.Can container 1700 and needle hub/spring arm 1720 be assembled together by the valve system 1730 that is fit to shown in Figure 99 and 100 or 1740 afterwards.Figure 99 and 100 shows first and

second valves

1730 and 1740 that are used in combination with the assembly of Figure 94 to 98.

In typical infusion set, the structure of container and needle hub/spring arm comprises container and the fluid path that is made of a part.Yet aforesaid, container 1700 need be made by the material with extensive chemical and/or drug resistance characteristic.Unfortunately, this material can not bond together fully with other materials (that is pin).The advantage of separating two parts as shown in Figure 94 to 97 is, can more simply pin 1728 be assemblied in the spring arm interface.They can be inserted into molded or bonding, rather than mechanically be fixed in can not adhesives in.

The dense block example of the assembly that is used for finishing Figure 98 has been shown in Figure 99 and 100.In Figure 99, valve rod stopper rod 1732 is disposed in the cylinder open 1734 in spring arm/fluid path shell 1720.Spring arm/fluid path shell 1720 comprise with container 1700 in opening 1702 match reduce diameter element 1736, and by 1738 sealings of O shape circle.Bar 1732 comprises a plurality of ribs 1733 and increases near-end 1739 that it plays to above with reference to described those the similar substantially effects of Fig. 5 and Fig. 6.In Figure 100, O shape circle 1738 is replaced by the elasticity outside seal 1748 that reduces diameter element 1746 external surface peripherals.All the other valve functions are basic as described with reference to Figure 99.

But also comprise can not be bonding and use that adhesives engages for additional improvement needle hub below of the present invention.This embodiment uses two injection-molded programs, and described molded program has the ability that makes the thermoplastic of two or more different essence form fluid-tight.Owing to consider that described material is different, so they no doubt can not bond together.In normal two injection-molded programs, the adhesion characteristic by plastics to be used forms sealing usually.In the situation of described below improvement interface embodiment, between plastics, there is not adhesion characteristic, thereby utilizes a plurality of unique design to form interference fit, therefore form fluid-tight.

In Figure 101, show the cross-sectional view of complete bonding portion 1750, and bonding portion 1750 comprises fluid path 1752, film phonograph seal 1754 and first injection molding 1760.Afterwards second injection molding 1758 is arranged on around first injection molding 1760 and fixed needle 1756.As shown in Figure 101, first injection molding 1760 is molded to such an extent that have an outstanding dovetail shape shape, thus when second injection molding provide in cooling around each dovetail shape and when shrinking and second injection molding 1758 between mechanical caging.

Particularly, after suitably cooling and many injection-molded of standard program, make second injection molding 1758 with having the material (such as Merlon) of expecting processing feature.In this case, make first injection molding 1760 with transparent plastic material.Transparent plastic material is preferably recycled olefins copolymer (CCP), and described recycled olefins copolymer is characterised in that, has high transparent and clarity, and is contained in low extractibility and biocompatibility between the material in the container.This material can not be adhered to such as another kind of materials such as Merlon naturally.

Geometry as CCP first injection molding shown in Figure 102 to 105 of the cross-sectional view of complete molded

assembly

1751,1753,1755 and 1757 can comprise any amount of dovetail shape and latch-up structure.In each case, after the suitable cooling of first injection molding, use such as the material of Merlon and make second injection molding, and be injected into the dovetail shape on every side so that they can surround each dovetail shape.When second injection molding shrinks, when arriving to a certain degree as all plastic shrink, it will exert pressure and have the effect of " clamping " dovetail shape on the inclined surface of dovetail shape.This is clamped and formed fluid-tight closely between two kinds of different materials, if not just can not form fluid-tight like this between described different materials.

Above-described improvement embodiment of the present invention can also go up the successive fluid path of formation in two kinds of different material types (that is, 1760 and 1758) in a part.Thereby this has reduced number of components and has reduced cost, otherwise must use snap fit and (may also need) potted component (such as O shape circle) to form successive fluid path.This not only can cause owing to the increase of number of components increasing cost, and has increased the manufacturing complexity.In addition, described structure can obtain the desired character of two or more different materials and reduce the advantage of infringement, and the words that only form described structure with one or another kind of material may cause described infringement else if.

For example, by using such as molded first injection molding of the material of CCP (that is, 1760), present embodiment can utilize the beneficial drug carrying capacity of described material.Unfortunately, in fact described material does not demonstrate any other general, positive manufacturing or processing feature.For example, CCP is difficult to bond together with pin.Therefore, the available material such as Merlon of second injection molding (that is, 1758) is made, and pin is easy to be adhered to Merlon, and can not cause adverse effect to the medicine that is contained in the part of being made by CCP.

It should be understood that and to be implemented in this principle that forms fluid-tight between two different slightly materials by variety of way.Cardinal principle is the canalization or the contraction of administering a kind of material on the surface of second material in such a way, and described mode promptly causes the sealing of pressure sensitive closely between described material.In the embodiment of improved characteristics of the present invention, realized this point by the variant that uses dovetail shape notion.As shown in Figure 103 to 105, in improving locking, the contraction on vertical and vertical surface also can be used for forming sufficient fluid-tight.

Described notion can further be improved to the improvement that comprises, assembling molded for high volume and auto-programming.The notional in early days in every way improvement of dovetail shape arrangement representing comprises the simplification of molded program and uses contraction in the molded thermoplastic operation to form wiper seal between different materials.Further developed the ability that bonds together with patient's pin among the improvement interface embodiment that is described in greater detail below.

Each embodiment of above-described infusion set comprises at least one or a plurality of patient's pin or microneedle.Each microneedle preferably is at least 31 specifications or littler, such as being 34 specifications, and being fixed in patient's pin manifold and can be used for demarcating required corium of concrete application or subcutaneous space.

Patient's pin is disposed in patient's pin manifold, and each patient's needle set has at least one fluid communication path.Manifold can only have a path that is used for one or more patient's pins, and a plurality of fluid paths of carrying content respectively to each pin perhaps can be provided.In the embodiment of the improvement shown in Figure 106, be formed with mini needle hub 1770 so that locking pin 1772 is snap-fitted to it in corresponding pin manifold 1771 afterwards.

In small infusion set, medicament reservoir has the attribute that is suitable for medicine stored and remain under the liquid form usually.Yet, cause identical container to have the feature that is not suitable for forming the required peripheral fabrication schedule of firm delivery device because medicine stores attribute.Although preferably making fluid container and drug conveying the most at last give to have between patient's the pin directly is communicated with, the thermoplastic that is used for storage of pharmaceutical is not easy to bond together with other materials.Therefore, aforesaid, pin may be bonded at hardly on the identical container material and form the fluid path of expectation and can not occur that the bonding pin that causes may drop owing to lack by force.

Improvement interface embodiment of the present invention shown in Figure 106 has solved this problem by the needle hub part 1770 as the independent sector spacing container.Like this, isolating interface 1770 can be configured so that suitably to play a role (that is, as fixed pin manifold), can be used as medicament reservoir (that is, as the biocompatibility container) (not shown).Unfortunately, when a complicated part is constituted as two more during simple parts, because the increase of instrument, processing, storage aspects such as (that is, get the raw materials ready and preserve unit or SKUs), in fact this increased totle drilling cost.Yet because its simple attribute of making, the improvement embodiment shown in Figure 106 can economize on resources for a long time.

Can be in the simple moulding instrument in standard under the high cavitation molding interface 1770.Can under high speed, carry out the molded and available molded described interface 1770 of material that bonds together with pin (such as pin 1772) of being suitable for automatically.Because the described interface 1770 of positioning requirements does not relate to a large amount of processing yet, and can mechanically invest manifold 1771 by the snap fit that tapered surface 1773 is provided, and saves high material of cost and program.In addition, before reality was inserted into interface 1770 in the manifold 1771, present embodiment can carry out simple fluid path continuity test.

Aforesaid, the microneedle of device can have different length or specification, and can comprise one or more holes along principal length, needle point or pin inclined-plane.When such microneedle was used to carry medicine, they can be owing to multiple former thereby obstruction.In another improvement pin embodiment of the present invention, provide a kind of microneedle, although described microneedle can be carried out the conveying of medicine under situation about may stop up.

Pin side-looking in Figure 107 there is shown first variant that improves embodiment, wherein by using porous material along at least a portion of pin main body, being communicated with at the fluid that expected degree is provided between the inside of pin and the outside and having constituted pin 1811.If therefore the needle point of pin 1811 is blocked, still can take place to flow by porous material.Second variant that improves embodiment has been shown in Figure 108, and wherein except that main tap 1819, pin 1813 is along at least a portion of pin main body (be preferably in the needle point of pin 1813 around) a plurality of micropores 1817 of use.If needle point is blocked, this allows to flow by micropore 1817.By in structure, using porous material or can obtaining each variant by increasing the hole subsequently.

The improvement of the improvement of pin, the improvement of Beller spring and material usage also can be applicable to having and start in the improved device as described in greater detail.In another the device improvement shown in Figure 109 and 110, the improvement of actuating unit starts and excitation in a multi-functional/step procedure, and use pivot arm 2770 accurately control the time limit with simultaneously near container and patient skin surface.Figure 109 is the cross-sectional view that is in first embodiment of described lamellar syringe under the starting state not or transfusion system, and Figure 110 is the cross-sectional view of the embodiment shown in being under the starting state.

The device of Figure 109 comprises upper and lower shell (not shown), container diaphragm assembly 2740, patient's pin manifold component 2750 and container 2760.The pivot arm 2770 of extending between manifold 2750 and needle 2780 also is provided.Show actuating mechanism 2790, described actuating mechanism 2790 can be made of any amount of device (such as the button of Fig. 1).

In the embodiment shown in Figure 109 and 110, when device starts, two functions have been realized with order and/or mode simultaneously.The first, actuating mechanism 2790 loosens manifold 2750, and described manifold 2750 is driven by one or more manifold springs 2795 subsequently, makes pivot arm 2770 rotate about pivot 2775.The second, the pivot arm 2770 of rotation is arranged in patient's pin manifold 2750 on the patient skin 2751, and needle 2780 is driven in the container barrier film 2740.In this case, the pivot arm of rotation is as the fluid communication path between container 2760 and the patient's pin manifold 2750.Therefore present embodiment penetrates into microneedle in the patient skin 2751 by single operation (such as the simple push of device button (not shown)) and opens valve medicine is all injected, and the transmission of fluid between container and patient is provided.

Improvement embodiment shown in Figure 109 and 110 comprises pivot arm 2779 or pipe, and described pivot arm 2779 comprises a plurality of entry needles 2753 at one end under the right angle, and comprises a needle 2780 that points to relative direction at other end place.The pipe of pivot arm 2770 has pivoting point 2775 between two ends, this makes transfusion needle 2753 have to thrust and certain moving range that patient skin 2751 is required also makes needle 2780 thrust the container diaphragm assembly 2740 that is incorporated in the container 2760 simultaneously.Carry out pivot action by one or more springs 2795, and be maintained in the equipment position by actuating mechanism 2790.

As shown in Figure 110, when actuating mechanism 2790 was activated, spring 2795 began to make that the pipe of pivot arm 2770 rotates about pivoting point 2775.When the pipe of pivot arm 2770 rotated, the end with pipe of transfusion device pin manifold 2750 moved down, and pin 2753 is pushed in the patient skin 2751.The other end of the pipe of pivot arm 2770 moves up, and promotes needle 2780 to such an extent that pass barrier film 2740.When needle 2780 thrust the distally of barrier film 2740, medicine was released and passes needle 2780 from container 2760, downward along the pipe of pivot arm 2770, and discharged from the transfusion needle 2753 of manifold 2750 and enter in patient's body.Because before actuating mechanism 2790 is pushed or use above-described any pressurization technology to be container 2760 pressurizations with it simultaneously, so medicine will flow.

Compare with conventional apparatus, this improvement of the present invention starts embodiment and is simpler device and comprises the part that reduces quantity, therefore is easy to assembling.For example, in conventional apparatus, transfusion needle moves with needle with being perpendicular to one another and is connected by pipe usually.The mobile part that this improvement embodiment constitutes with a continuous rigid rotating part 2770 has replaced three mobile parts in the fluid path commonly used among other embodiment (that is, right angle lower slider two parts and a flexible part).Replaced the flexible pipe that may be difficult to assemble with the hard parts that is easier to assemble.

Start among the embodiment in another improvement shown in Figure 111 to 115, described device can use the captivation of magnet or the repulsive force application of force and by the fluid path drive fluid on fluid.These embodiment apply with also can be used for magnetic force pin are pushed into power required in the skin.The potential energy of the magnet of internal system can be not in time passing and dissipate, and magnet can be kept apart fully reducing the power on the polymer that their captivations and being applied to each other are used to hold them, thereby reduce creep.Can be according to the intensity adjustments magnet separating distance and the intensity that make that described mechanism optimization is required.

As shown in the cross section installation drawing of Figure 111, device 1800 has fluid container 1815, fluid path 1820 and the actuating mechanism 1825 of upper case 1805, lower case 1810, film covering.When being activated (promptly, make mechanism 1825 move by button or similar installation, break away from magnet 1805) time, each magnetic upper and

lower shell

1805 and 1810 captivation are oppressed out the content in the container 1815 together by fluid path 1820, and enter in patient's body via pin 1822.In the cross section installation drawing of Figure 112, the container of the magnet top that the repulsive force of first and second magnets is used for engaging from being arranged in is oppressed out content.

As shown in Figure 112, the fluid cavity 1830 of transparent covering is disposed in the top of the piston 1835 that engages with top magnet 1840 (in this example, the N utmost point is at last S utmost point infra).When being activated, the top magnet is repelled (in this example, the S utmost point is at last N utmost point infra) by lower magnet 1845, forces piston 1835 to enter into the content of chamber 1830.Content goes out and is forced in the manifold 1855 by opening 1850 (aforesaid, described opening can assemble valve) is oppressed.Manifold can be made of so that move when being driven by manifold spring 1860 material with lower resistance (such as polypropylene or polyethylene).

In another startup improvement embodiment shown in the device cross-sectional view of Figure 113, device comprises upper case 1865, lower case 1870, fluid container 1875 (transparent flow body cavity), fluid path 1880 and upper and lower magnet 1882 and 1884.Available steel plate (not shown) replaces

magnet

1882 or 1884, and this also can obtain required captivation.When being activated (, by button or similar installation), upper and

lower magnet

1882 and 1884 captivation or the captivation of magnet and steel plate are oppressed out the content in the container 1815 together by fluid path 1880, and enter in patient's body via pin 1881.The central injection patient pin mechanism that comprises the above any amount mechanism is used in lays patient's pin 1881 and causes minimizing of dead angle between the starting period.

Shown in side-looking Figure 114 and 115 another starts among the improvement embodiment with using afterwards before use, described device comprises the magnetic upper case 1890 with a plurality of pins 1894 and has the magnetic lower case 1892 of a plurality of opening (not shown), and concentric and each opening of described opening and pin 1894 all has is enough to the diameter that makes that each pin 1894 passes.Equally also available steel plate (not shown) replaces

magnet

1890 or 1892, and this also can obtain required captivation.When using mechanism 1896 to be activated (, by button or similar installation displacement), the captivation compressing pin 1894 of upper and

lower magnet

1890 and 1892 captivation or magnet and steel plate is by the opening of lower case 1892, and enter patient's skin surface 1895, as shown in Figure 115.

Above-mentioned each device all is used for by the sheet-type device transportation of substances.Be arranged in user on one's body and after being activated, user is perhaps worn described device a period of time in staying described device in position usually, removes and abandon described device under the hypodermic prerequisite can not injuring afterwards.Yet, deliberately or under the unexpected situation about removing, as described in greater detail, can use one or more safety measures to cover because startup causes the pin that exposes.

Usually, passive safety systems is most preferred.If this allows device to remove or user " is forgotten " and carried out self-protection under the situation that has security step in accident.Because the typical usage of this device provides the human growth hormone, this supplies with at night usually, can think that therefore user (such as the child who wears described device) in fact can wear them the whole night, although conveying in this case only needs less than 10 minutes.If device drops in the meantime, if there is not passive system, pin may sting user or care-giver again.Solution is to limit startup during use or comprise passive safety systems.

Usually there are three options about security system.First option is that pin is withdrawn in the device.Second option is the protection pin can not coming off, and the 3rd option is to destroy described pin in the mode of avoiding acupuncture.Although every kind of pattern all can be set up, do not exist basically to be used for not destroying pin and causing user to suffer to destroy under the situation of danger of acupuncture the feasible method or the device of pin.Other system is such as active system, probed into a kind ofly to add artificial protection and/or the destruction that button promotes or similar operations carries out by auxilliary, or manually removed safety measure.Provide the detailed description of passive embodiment of the present invention below, provided the detailed description of the active embodiment of the present invention afterwards.

In order to prevent unintentionally or the repeated use of having a mind to of unexpected acupuncture, device and cover the pin that exposes, the locking pin release mechanism can be provided, and at described locking pin release mechanism automatically starting when skin surface removes device.Can multiple pattern provide improvement release mechanism embodiment, comprise that safety device (passive), the pin of " mousetrap " type mentioned and the safety device (active or passive) of cover type and the safety device (active or passive) of rotation pin type of manifold.

Another kind of improvement release mechanism embodiment described below comprises the horizontal barrier of the spring-loaded pivot mechanism (passive) that has and do not have " ratchet " type locking part, the interlock at artificial flicking top or the following horizontal barrier mechanism (active) of gummed, pull out and lock protection mechanism (passive), spring-loaded lifting is converted to horizontal shield (passive), auxiliary pin withdrawal " slide plate " (passive or active) that slit is arranged of spring, be used to mention the torsion spring (passive) of pin, has and do not have the hinged smooth shield (passive) of binding agent, and after use the safety device (active or passive) and the bistable state sheet spring (active or passive) of needle bent.

First improvement security implementation example or the mousetrap safety device has been shown in Figure 37 to 41.Among this safety device embodiment under being in standby or bias state, the sleeve that combines with spring (that is safety spring) is contracted to allow pin to expose and to use.When skin removes device, spring deflects into its not bias state, and to surround and the mode of protection pin is extracted sleeve and be arranged in around the pin.

In first example of the mousetrap type safety device shown in Figure 37, show pushbutton unit 700, the wherein startup and the excitation of actuating unit in an aforesaid multi-functional/step procedure.Figure 37 is to use the sidepiece button to be activated and comprises the example lamellar syringe of the present invention's first improvement security implementation example or the cross-sectional view of transfusion system.

The device of Figure 37 comprises button 780, upper case 705, lower case 770, mousetrap door 790, latch 791 and door pivoting point 792.Safety spring 793 and spring spool 794 also are provided, and in Figure 38, have clearly show that them.When button 780 was pushed, mobile at least one valve 750 of having opened of button 780 had been removed the spring holding tray or has been sold 730, and had removed the support component (not shown) from patient's pin manifold 745 theres, allowed manifold 745 to advance.Latch 791 has also been loosened in moving of button 780, yet, when device is adhered on the user skin, do not allow moving of mousetrap door 790.

An aspect of this embodiment of the invention is, in this state, safety spring 793 is in the steady state of the application of force under bias state not (that is, in the state shown in Figure 38 to 41).This is constant exert pressure by device attached thereon surface (that is patient's skin) and the binding agent that is used for adhering apparatus bear.Therefore, known safe spring 793 is to operate and to keep their embedding state in the expectation time limit with the mode that is embedded in intravital pin 760 counterproductives of patient.Yet because described power is safety spring 793 power when the application of force of guaranteeing pin 760 final protection when skin surface removes device, so this power is that body function is required.Therefore in order to offset this power, another aspect of the embodiment of the invention is to comprise mousetrap door 790.

Mousetrap door 790 is used for capturing safety spring 793 in a kind of mode that reduces the power of safety spring 793 actual transmissions to the skin surface.Mousetrap door 790 uses lever principle (such as what found in the general mousetrap) to produce the mechanical advantage of mousetrap door 790 on safety spring 793.Therefore, when being folded in mousetrap door 790 on the safety spring 793, safety spring 793 is exerted pressure at the predetermined point place of range gate pivoting point 792 on mousetrap door 790, and this has reduced the power of safety spring 793 of the ratio multiple of distance between the door pivoting point 792 of pressure dotted or gate 790 of safety spring 793.In use, skin surface will only be felt sub-fraction rather than its whole power of actual forces of safety spring 793.

Yet, when when skin surface removes device, as shown in Figure 38 to 41, when safety spring advances to its complete deployed condition safety spring of following time 793 with mousetrap door 790 strippers.Because the mechanical dominance at the hinged mousetrap door 790 in door pivoting point 792 places causes the initial pressure of safety spring 793 on mousetrap door 790 lighter.Yet, when mousetrap door 790 is pushed and pivot away from device, reduced mechanical dominance pro rata.Therefore, thus safety spring 793 will speed up in its length terminal or realize whole intensity of safety spring 793 near end of advancing.These safety spring 793 intensity are to be used to guarantee any locking mechanism, can spring 793 power safe in utilization be engaged and lock with the resistance that overcomes brake unit necessary such as the first brake unit (not shown) on the safety spring sleeve 794 and any second brake unit (not shown).At last, when safety spring 793 is launched fully, spring spool 794 will protect pin 760 and brake unit will not allow to shrink, and therefore prevent that pin 760 is acquired or reuses.

The second improvement release mechanism embodiment has been shown in Figure 116, and perhaps pin is mentioned the also safety device of cover type, and described safety device comprises the part that is commonly referred to as dog link 1950 or " crank and the crosshead that slit is arranged ".In the document that is entitled as 251 pages of Ingenious Mechanisms forDesigners (Industrial Press), disclosed other details of described method, merged here with reference to its related content.In the present embodiment, pin manifold 1956 is connected with spring loading crank 1952.Crank 1952 has the pin 1954 that communicates with manifold 1956, and therefore when crank 1952 rotations, manifold 1956 is driven to imbed described pin (not shown) downwards.Crank 1952 is stopping the rotation to allow fluid to be transferred with the some place of the complete insert depth of expression pin.When user skin removed device, crank 1952 " is loosened " and can continue to be rotated allowing manifold 1956 further to move down, and according to the principle of dog link, this is retracted to home with pin manifold 1956 from skin.

As shown in Figure 116, use the scotch yoke mechanism that engages with patient's pin manifold 1956 to realize described lifting, and be illustrated as using position (b) and position (c), use back in front position (a), the use.Torsion spring 1952 has pin or cam arm 1954, and described cam arm 1954 has the cam that drives by the manifold element 1956 that slit is arranged.When spring 1952 applied revolving force, arm 1954 was driven into manifold 1956 in the skin surface (not shown), and described skin surface also blocks being advanced further of arm 1954.When being removed, arm 1954 does not advance, and in this case, promotes and withdrawal manifold 1956.

The mousetrap of release mechanism and dog link type embodiment are passive systems, and described system does not need user execution additional step to make needle set that safety be arranged.Described passive system must use some device to trigger expansion of release mechanism, and the most effective passive system is to feel to approach skin surface and when those of expansion release mechanism when skin surface removes." sensation " of skin is meant the element of sensation and the direct relation between the unfolded element.The power of above-described embodiment by release mechanism that user is felt on skin is reduced to imperceptible low value and has improved the design of traditional passive safety.

As shown in Figure 117 to 122, be included in its an alternative embodiment of the invention of having launched afterwards pin to be pulled out and use oblique mechanism from skin.Aforesaid, miniature apparatus infusionis comprises at least one driving spring, and described driving spring is used for making pin or string pin to be embedded to user skin.Intentionally arrange driving spring by this way, that is, it can be driven into pin in the skin.In the embodiment shown in Figure 117 and 118, when transfusion is finished, can will provide such as mechanisms such as inclined-planes 1004 and arrange to such an extent that allow user to make inclined-plane 1004 and manifold 1000 or syringe needle or pin array engage, and by promoting inclined-plane 1004 towards manifold 1000, described pin (not shown) can be inclined upwardly, or is drawn out from the skin of user.Yet,, carry out this lifting operation of pin so with regard to the power that overcomes driving spring if allow the driving spring (not shown) to rest in the position of the application of force on the manifold 1000 of pin.

As shown in Figure 117 and 118, show passive withdrawal wedge-shaped design, described design has patient's pin manifold 1000, described patient's pin manifold 1000 has the basic pin 1002 for circle that extends from its opposite side, so that engaged with the inclined-plane on inclined-plane 1004 when manifold 1000 drives by spring 1008 when the inclined-plane.Inclined-plane 1004 can be prematurely by not promoting manifold 1000 by binding skin sensing pull-out elements 1006 fixed slits 1012.Aforesaid, whole assembly is set in the infusion set.After using,, therefore remove described device and bonding pull-out elements 1006 is pulled out from install downwards from skin because device is bonded on the skin surface (not shown).At this moment, the slit 1012 of wedge shape 1004 is separated with pull-out elements 1006 and wedge shape 1004 is driven on the pin 1002 of manifold 1000, as shown in Figure 118.This has promoted manifold 1000 and the pin (not shown) is withdrawn into device and the pin opening is covered internally by wedge shape 1004.

In the present embodiment, wedge shape 1004 or shield be a molded part and be disposed in the start button (not shown) and manifold 1000 between.Spring 1008 also is arranged between wedge shape 1004 and the button.The stroke difference that spring 1008 is got between the required stroke that only is enough to compensate for button and withdrawal by prestrain is just passable.During skin sensing pull-out elements 1006 keeps wedge shape 1004 in position.Skin sensing pull-out elements 1006 is remained in the sidepiece recess 1014 of pull-out elements 1006 by button parts (not shown) slidably.

When button was pressed, it moved the gap that is used to loosen the sidepiece recess 1014 of skin sensing pull-out elements 1006 parts and simultaneously spring 1008 is pressed into its full displacement place up to existence.Because the existence of skin makes skin sensing pull-out elements 1006 rest in the position.Manifold 1000 is loosened and pin is placed in the skin.After skin removes, the binding agent on skin sensing pull-out elements 1006 high surface areas is pulled outwardly, and this has discharged the wedge shape 1004 that is under the spring stress state.Wedge shape 1004 moves forward, and promotes manifold 1000, and withdrawal pin and covering enter the hole.

In the present embodiment, existence can controlled dynamic balance problem.The spring 1008 that is used to drive wedge shape 1004 can lose power upon deployment.Be arranged on the manifold 1000 and and when being compressed, increase power by driving wedge shape 1004 lifting manifolds 1000 at the manifold driving spring (not shown) that is pressed downward system on the manifold 1000.This may be overwhelmed by the wedge shape spring 1008 of very strong bias voltage, yet this has influenced the required power of compacting button unfriendly.

Therefore, another pattern of the foregoing description has been shown in Figure 119.The notion of present embodiment comprises manifold 1000 and the balladeur train of being launched forward together 1005.Manifold driving spring (not shown) directly drives balladeur train 1005, and manifold 1000 is connected with balladeur train 1005.In this case, by manifold being pushed away brake portion 1007 after the safety release, wedge shape 1004 is used for manifold 1000 and balladeur train 1005 are separated.Therefore when their maintenances are pressed at present independently on the balladeur train 1005, need not to overcome the driving spring of manifold.

The initial stroke that another pattern of improvement design is to use wedge shape 1004 promotes the driving spring of manifold 1000 to such an extent that do not form straight line so that their are crooked and no longer can apply normal load on manifold 1000 during withdrawing.These two kinds of patterns also have the manifold of making 1000 and can not be fired again and reusable advantage.

In Figure 117,118 and 119 embodiment, shield is passive and covers described pin fully with material.Described shield is with having that high-intensity molding part constitutes and can or not influence the binding agent that the pin location exists to the skin surface application of force during injecting.Pin is maintained at inside and spring 1008 all is minimum the loading all the time after using.Present embodiment does not need therefore unfolded spring 1008 compacting driving springs of dynamic balance and skin adherence surface needs to remove security protection.Therefore, low adhering skin or high friction are significant.In addition, comprise three parts, caused the longer stroke operation of assembling complexity and needs (that is, increasing plant bulk).In addition, the same with great majority compression spring mechanism, described spring also may experience creep.

The sloped element 1004 that is comprised in this embodiment of the invention comprises inclined plane shape, described inclined plane shape shallow be enough to overcome on the inclined-plane friction (promptly, friction when promoting manifold 1000 between pin 1002 and the inclined-plane 1004) and the power of driving spring (, promote the power of manifold 1000 downwards) both, if not so shallow, " stroke " of button or translation will be longer unfriendly.Aforesaid, another aspect of present embodiment is that the use of translation on inclined-plane is to influence the manifold spring, such as " knock the bar of driving spring " above manifold 1000.Present embodiment uses such structure (not shown), described structure be not only from skin, pull out pin required and also be with driving spring from its with state that pin manifold 1000 engages under remove required, thereby eliminate the power that driving spring applies, and make that the corresponding lifting of pin is easier.

Another aspect of present embodiment comprises a kind of like this structure, and when described pin has successfully been pulled out from skin and turned back in the device, described structure will provide horizontal barrier on pin.These pins are enough little usually, so that they need special feature suitably to be embedded in the skin of user to guarantee them.These pin parts extend to the bottom of device naturally, unless and withdrawal otherwise all will be difficult to cover by simple laterally barrier fully, described horizontal barrier may make that pin is crooked and fracture.Therefore in the situation on inclined-plane itself, this embodiment of the present invention can be used for lift pins so that laterally barrier is unfolded under the prerequisite of the pin that do not fracture, and this is because the pin that fractures can be harmful to environment.

Another embodiment similar to the dog link type comprises that the V-arrangement slit mechanism that uses as Figure 120,121 and 122 as shown in launches to be used for afterwards with pin their from mechanism that skin is pulled out.In the passive withdrawal slit designs of this embodiment of the invention, the operation of user starting apparatus by pushing manifold is to start described device.After carrying, user removes device and binding agent is pulled out little locking from the path of main slide plate from skin.The hole that described afterwards manifold is withdrawn in the device and pin therefrom passes is covered by slide plate.

As shown in Figure 120, show passive withdrawal slit designs, described passive withdrawal slit designs has from the slide plate 1015 of the pin 1016 of its opposite side extension, so that engage, and in slit 1020, drive slide plate 1015 by a pair of spring 1025 with V-shaped groove 1020 in being formed on element 1022.Aforesaid, whole assembly is set in the infusion set.Aforesaid, user passes through press device (manifold described in the foregoing description or button (not shown)) thereby suppresses the spring 1025 shown in Figure 120 and the operation of starting apparatus.By loosening after device (such as the user button) starts described device, spring 1025 is loosened and by slit 1020 guiding the time, driving element 1022 is towards skin surface compressing slide plate 1015.Slide plate 1015 advances to maximum pin insertion point and the skin surface (not shown) stops it further to advance downwards, and spring 1025 makes it to stop to advance backward, and the inclination ledge of slit 1020 stops it further forward.When device no longer contacted with skin, slide plate 1015 was by the free upwards slit that promotes and further advance to forward slit 1020 downwards.Being traveling on the manifold (not shown) that is arranged on below the slide plate 1015 of slide plate 1015 applies upward force and makes pin be withdrawn in the device and coverage hole, the complete closed pin afterwards.

Present embodiment provides the covering fully of pin with material, and it molded can be had very high intensity.Very little power is applied on the skin and mechanism can not influence the binding agent that is present in the pin place during injecting.After using, pin is remained on inside safely, so present embodiment clearly provides the visual feedback of " in the use " or " using the back " state, and need not additional parts.Yet, need skin adherence to remove safety device, thrust with high friction and can have difficulties thereby hang down.In addition, the same with the foregoing description, need longer stroke operation (that is, increasing plant bulk).In addition, the same with great majority compression spring mechanism, described spring also may experience creep, therefore can relate to high-tensile strength and keep and sheetage on device lifetime.

Another improvement security implementation example of the present invention is a passive complete closed shield described below.Figure 123 is the perspective bottom diagram of device, shows the view of the embodiment of the bucket shape security protection part of infusion set before starting, and Figure 124 is the perspective bottom diagram of device, shows the view of bucket shape security protection part after starting.

Rotation shield 1030 can be provided with power and be kept loading before button 1042 is pressed in " top " position of rotation by prestrain torsion spring 1032.Shield 1030 is loosened and can be rotated freely afterwards, but owing to contact user skin on the adhesive coverage surface 1045 of device, therefore stops it to rotate to complete expanded position.When described device no longer contacted user skin, such as when device is removed or come off, shield 1030 no longer stopped by skin surface and the Rotate 180 degree, locked afterwards in position in, cover patient's pin 1040 fully and avoid needle stick injury.

As shown in Figure 123, pin 1040 is hidden in the opening 1035 on the adhesive coverage surface, bottom 1045 of device usually.User uses adhesive surface 1045 that device is fixed on and suppresses start button 1042 on the skin afterwards to start infusion set.When device was removed, shield 1030 by flicking down and be locked in the appropriate location of pin 1040 tops to avoid user to see or to touch pin.

Shield 1030 be mold pressing and formed sheetmetal part by torsion spring 1032 prestrains.As what can in showing Figure 125 that opens lower case of device, find out, show the shield 1030 that is withdrawn in the device, the leading edge of shield 1030 comprises the lock arm 1034 on the cross bar member 1036 that is laid on device, thereby keeps it to fix.When showing shield 1030 and prepare the button 1042 as shown in Figure 126 of the perspective view of opening lower case of device of rotation and be activated, the lock arm 1034 that the tab 1044 on the button 1042 promotes cross bar member 1036 rotates under the loading of spring when skin surface is removed to allow shield 1030.Figure 127 shows the perspective view of opening lower case of device when making shield 1030 rotations.Tab 1044 extends from button 1042, thereby is helping to prevent that skin is clipped between button and the cross bar member 1036 between the starting period.

Loosen among the embodiment at another, the sub-arm (not shown) is arranged on the position of 90 degree with respect to lock arm 1034.The sensing of this arm is along the shifting axle of button and kept shield 1030 fixing before using.When button 1042 was pressed, the cam parts (not shown) on the button 1042 promoted sub-arm so that it can be by slit decline and only discharges shield 1030 by applying less power to the side.The tolerance susceptiveness that this also helps to eliminate button 1042 positions allows shield 1030 to be arranged in the bottom of device simultaneously.This also can be torsion spring 1032 and more space is provided and needs littler device height.

When the infusion set administration, the shield 1030 of Figure 123 to 127 is positioned on the skin surface.When device when intentionally or unexpectedly being removed, because the effect of torsion spring 1032 causes bucket-shaped shield 1030 to turn down and be locked on the tab 1046 in the hole 1048 by opening 1035, wherein spring catch is removed between the starting period.

In the present embodiment, realized locking by arm 1034 and/or the hasp structure that is arranged in shield 1030 front ends.Thereby the outside pusher arm 1034 of power that is used to engage the shield locking is crossed the small size part of cross section and will be tried hard to keep and hold lowlyer.The large scale that the power that is used to eliminate shield 1030 is crossed perpendicular to the cross section that moves of locking is applied in.This makes that the power be used to engage locking is less and has bigger power simultaneously to eliminate locking.

Torsion spring 1032 can be loaded on the pin (not shown) on the shield 1030, and spring arm can be locked in below the tab (not shown) on the spring back, thus reloading spring and form stable subassembly.Before the button subassembly, by with pivot device, be pressed in two groups of hasps in the lower case to form this pivot such as the mobile jib (not shown) of shield 1030, this shield assembly will be assembled to downwards in the lower case of infusion set from the top.An arm of spring can be loosened being compressed on the end enclosure, and an arm of spring can be locked in below the tab on the spring back, thus " excitation " security protection thing.

Security implementation example shown in Figure 123 to 127 is another example that covers the passive safety systems of pin 1040 with material fully.Described material is constituted as metallic stamping pieces, and it can allow littler wall thickness.In this case, described embodiment only requires to have anti-high-intensity two slave parts that damage.In addition, the minimum force that puts on the skin of shield is located farther from the pin contact point than other embodiment.Yet shield 1030 needs the certain space in the device, and this can make that device is longer, and shield 1030 is compressed on the skin during carrying.Shield opening 1035 has also removed near the big adhesive surface the pin 1040.In addition, the same with great majority compression spring mechanism, described spring also may experience creep, and this ability that may select and constitute required pivot tube with spring is relevant.

Because bucket or shield 1030 advance to extended position from retracted position, so the foregoing description also can be equipped with the improvement locking mechanism.In this case, shield is that molding part and replacement have flexible lock, and thereby the pivot of shield can " be equipped with ratchet " around prevent reversing.Figure 128 is the perspective view of the improvement security protection thing embodiment of infusion set before starting, and Figure 129 is the perspective view of the improvement security protection part of infusion set before starting.

As shown in Figure 128, button 1050 but not shell keep shield 1055.When button 1050 was pressed, shield 1055 was loosened and aforesaid substantially being placed on the skin.When skin surface removes device, the spring (not shown) is at pivoting point place reversing shield 1055 and ratchet mechanism 1060, when rotating, it engages, so that during ratchet mechanism 1060 keeps shield 1055 in position with pallet 1061 on the apparatus main body.Figure 130 at length shows ratchet mechanism 1060.On shield 1055 arms 1057, have hook tooth 1059, and corresponding wedge or pallet 1061 are disposed on the device.Present any local rotation is all locked.

Ratchet can have enough big hook tooth 1059 overcoming elimination load, yet that they do not have is big to giving prominence to and enter in the user body from the bottom of device.In addition,, require ratchet 1060 that shield 1055 is hidden in the device, thereby increase height of devices in order to realize these targets.Competent elastic force is provided so that on ratchet 1060 increment ground drive shield 1055, yet the dynamic balance between the total travel of must be noted that and the creep result.In addition, because spring is not arranged to such an extent that be held naturally and the time must be loaded in the device in assembling, this need be staggered in button between manifold and the shield, and therefore final assembling is more complicated.

Ratchet lock provides another kind of passive security implementation example, and described embodiment covers pin fully with material and can be formed by the high strength component moulding.Present embodiment only needs two auxiliary components and will lock so that firm safety under full expand or the unfolded situation of part.Other embodiment of force rate that put on the skin surface are located farther from the pin site.Yet present embodiment needs the certain space in the device, and this can make that device is longer.The same with the foregoing description, shield 1055 is compressed on the skin during carrying, and the shield opening has removed near the big adhesive surface of pin.In addition, also may experience creep with the same described spring of great majority compressions spring mechanism and the process medi-spring in being assemblied in device must load.The ratchet lock that so approaches pivoting point also needs very high intensity.

Another kind of improvement security implementation example of the present invention is that passive complete closed described below is pulled out the design implementation example.The bottom perspective view of the device of the embodiment of the security protection thing part of infusion set before Figure 131 and Figure 133 show and start, and Figure 132 and Figure 134 show the startup bottom perspective view of the device of security protection thing part afterwards.

In the use of the embodiment of Figure 133, infusion set 1060 is prepared and used to user substantially as mentioned above like that at Figure 131.When skin removes device, invest during adhesive sheet 1062 on the shield 1065 will pull out shield 1065 and be locked in position before binding agent 1062 leaves skin surface.Secure Shell or shield 1065 are provided, and described shield 1065 comprises and the contacted flat surfaces part of patient skin.Flat surfaces comprises binding agent disposed thereon 1062, therefore when the patient when skin removes device, binding agent 1062 will be used for launching (promptly from the inside of device, withdrawal or extraction) shield 1065, thereby cover patient's pin 1067, otherwise will expose at described patient's pin 1067 when the patient removes device on one's body.The security protection thing 1065 of Yan Shening is locked in the position and avoids unexpected injury or be exposed to patient's pin afterwards.

Shield 1065 is metal parts of mold pressing, and described metal parts is assembled in the device 1060 and is maintained in the appropriate location to prevent that shield 1065 was activated before using by button 1064 when removing binding agent liner and pin medicated cap (not shown).Binding agent 1062 is arranged in two parts substantially, on most of basal surface that is positioned at device 1060, on the basal surface that is positioned at shield 1065.When device 1060 when being removed, these two move independently and since button 1064 has been pushed now shield move.In the embodiment shown in Figure 134 and 135, in shield 1065, have a plurality of directional slits and tab 1063.Shield 1065 is drawn out up to it and is captured between the top and tab 1063 of slit, thereby is locked in the position by the angled tab on the shield 1065.

The assembly of present embodiment can be snap-fitted to the device from the bottom.When needs engaged with initial lock, button also was snap-fitted in the appropriate location.Pull out embodiment and be another the passive security implementation example that provides as independent sector and good locking is provided, described being locked under the manpower load can not damaged by pressure.Yet present embodiment needs the certain space in the device, and owing to needing bigger adhesive area at the pin place and comprising at least one non-adhesive coverage hole at the place, bottom, therefore may be difficult to expose.This also causes the big stroke of needs, and limited covering is provided on dorsal part.In addition, when removing, can avoid under the unfolded situation contacting with pointing.

Another improvement security implementation example of the present invention is passive torsion spring withdrawal design described below.Figure 135 is the perspective view of embodiment that is in the security protection thing part of the infusion set in the initial position, Figure 136 is the perspective view that is in the security protection thing part in the position, and Figure 137 is the perspective view that is in the security protection thing part in the final retracted position.

Present embodiment comprises the inner torsion spring 1070 of the prestrain on the pin 1074 that is positioned on the manifold 1076.Can use two springs if necessary.When button 1075 was pushed, manifold 1076 was loosened and spring leaves fault block 1071 and promote the drive pin 1072 on the manifold 1076 so that promote manifold 1076 downwards to riding position under suitable speed.When device runs out and when skin is removed, a kind of in two kinds of situations may be taken place.The first, be designed to be that the manifold 1076 with additional over travel continues forward and spring 1070 comes off from drive pin 1072, turn over turnback, and catch the contraction pin 1074 on the manifold 1076, thereby promote manifold 1076 withdrawal pin (not shown).In the replacement pattern of present embodiment, allow manifold 1076 to move to the side slightly, thereby go up retracting spring 1070 from drive pin 1072 (drive pin 1072 slightly be shorter than shrink pin 1074), thereby be turned on the contraction pin 1074 on the manifold 1076, shrink pins thereby promote manifold 1076.

But the mobile terminal of spring 1070 should have competent gap to carry out 180 ° of danger of rotating avoiding damaging from drive pin 1072 when spring arm when contraction pin 1074 passes.Yet, in case after being contracted, spring 1070 is just with manifold 1076 with pin is preserved and discarded described device.Present embodiment does not need auxiliary component.

The same with above-mentioned other embodiment, there is a kind of so passive release mechanism, wherein manifold is trigger and does not need auxiliary component.During injecting, do not have additional force to be applied on the skin, and pin is remained on inside safely after using.With pull out the design different, present embodiment does not influence the binding agent that is present in the pin place.Yet, require to have the gap to avoid since the transfer arm of spring 1070 cause and may damage for user.In addition, the same with great majority compression spring mechanism, described spring also may experience creep, and can relate to spring size and force mode.

Other improvement security implementation examples of the present invention comprise the passive hinged shield design implementation example of the following stated.Figure 138 is in the perspective view that spring drives the security protection thing part of the infusion set in the articulated position, Figure 139 is the perspective view that is in the security protection thing part of viscous drive articulated position, Figure 140 is the perspective view with security protection thing of the annular whole catch spring that remains in the retracted position, and Figure 141 is the perspective view that is in the catch spring in the enable position.

In Figure 138 and 139, show hinged shield 1080 and 1085 respectively.In the time of on being positioned at device, hinged shield 1080 and 1085 is smooth.Shield 1080 and 1085 is locked into smooth being pushed respectively up to button 1082 and 1086, in each case, shield 1080 and 1085 is all loosened, but the binding agent that device is remained on the health is fixed on shield 1080 and 1085 on the skin in the flat position.When skin removes device, owing to promoted by spring element 1081 and/or adhesive surface 1083 respectively, shield 1080 and 1085 " is upspring ", and is locked in the appropriate location by tab 1087.

In each embodiment, shield 1080 and 1085 all can be the metal parts that is hinged on 1: 1089 place fully and rotates from device guaranteeing.Hinged metal shield 1080 is driven into by spring element 1081 extends and latched position.Particularly, shield 1080 can be configured and have a plurality of bend arms 1081, described bend arm 1081 will be as spring action on the surface of device.Arm 1081 is loaded on the bottom enclosure of device and button 1082 is locked in the front (usually at distance hinge 1089 some place farthest) of spring in the retracted position.When button 1082 was pushed, shield 1080 rotated freely but skin keeps smooth with shield around hinge 1089.When skin removes infusion set, alligator clamp 1081 self, or combined with the binding agent 1083 that offers spring 1085 outwards spurs shield 1080 and 1085 and during a plurality of tabs 1087 by the device front are locked in position.

Because above-described each spring embodiment can be long and/or thin part, therefore all be configured so that to have the ability of opposing failure load usually.In addition, spring 1080 and 1085 is suitable for the protective number that provides suitable, even also is like this in the situation with long-duration load and long stroke.After engaging, spring 1080 and 1085 all is enough to remain on according to need on the hinge 1089 after engaging.

As shown in Figure 140, the replacement pattern of the foregoing description comprises the shield 1090 that has as the natural hinge of spring.Button 1091 remains on shield 1090 in the position shown in Figure 140.After being loosened, shield 1090 is biased into the shape shown in Figure 141.Therefore after the startup of device and removing, the operating spring 1090 by natural hinge is started as the shape shown in Figure 141, covers the pin (not shown).The substrate of device also can comprise at least one recess, described its trailing edge of recess lockable when shield 1090 is advanced.

Above-described hinged shield embodiment provides another kind of complete passive, general safety shield, and described shield can simply assemble and pass through the hasp startup of button.This feature guarantees that well device keeps low-grade.Yet present embodiment comprises bender element, and requires to block the balance between purpose and the part hardness.Also operate by opening and lead to described pin, and spring is easy to damage in some cases.In addition, present embodiment during carrying to the skin imposed load at pin place and depend on the hinge globality to a great extent.

Be used for another kind of passive design at micro-infusion device protection pin and be when user when skin removes device or from user outside rotation pin or make pin " excessively rotate " to home.In the improvement shown in Figure 142 rotation shield embodiment, principal character is to use rotation imbedding pin 1101, and removes pin 1101 in the same or analogous rotation of use " path " from skin surface 1104 removes.In the embodiment shown in Figure 142, single pin fixed arm 1100 is around first 1102 rotation.When pin 1101 contact skin surfaces 1104, pin 1101 is placed and stops around advancing of axle 1102.Use up and when skin surface 1104 removes device, restart pin fixed arm 1100 to be sent back in the device (not shown) at device around the rotation of axle 1102.Pin fixed arm 1100 also can be around second 1106 rotation to cover pin 1101 once more after using.

Aforesaid, a preferred feature of infusion set is successive fluid path, because it has the potential of the manufacturing of the quantity that reduces sterile barrier and simplification device, so this is preferred.Therefore, comprise via pin fixed arm 1100 embodiment that pin 1101 rotates in the user skin 1104 has been promoted these advantages.This embodiment also provides pin 1101 has been rotated in the user skin 1104 to imbed them, afterwards when making pin " excessively rotation " to home when skin surface 1104 removes pin 1101.Excessively rotation utilizes the single path that pin advances and can be used as passive or active security system.In addition, the potential of the safety of providing is provided under the prerequisite of globality that does not have infringement fluid path of 1101 from the medicament reservoir to the pin or manufacturability in described mechanism.

Another embodiment of the passive safety systems of micro-infusion device provides and started not loading of spring when removing.Aforesaid, such infusion set uses the pin array to carry out subcutaneous injection.They are shot in in patient's body under thrusting the required speed of skin layer by means of spring.After injection has taken place, be preferably in and after the patient removes device there, cover the pin that is in exposure in some way to prevent needle stick injury during the processing subsequently.If driving spring can not load or change in some way, can easily pin be turned back in the crust of the device, they just no longer threaten like this.In the present embodiment, provide the arm that is made of the bendable curved beam, described arm can load and be constituted for the ejaculation pin by cam.Figure 143 to 146 shows the embodiment that uses an auxiliary component to realize this task.

As shown in Figure 143 to 146, show the cross-sectional view of the device that comprises cam arm mechanism.Described mechanism comprises that having at least one extends and the arm 1110 of the follower 1112 that is connected slidably with cam shedding 1114 from arm.Described arm also comprises patient's pin manifold 1116 at far-end, and described patient's pin manifold 1116 is releasably remained in the appropriate location by trigger mechanism 1118.Cam shedding 1114 is arranged on slidably in the element 1124.In use will see four basic status of present embodiment, will illustrate and describe in detail this four basic status below.

In first state, or in the ready position shown in Figure 143, the static and assembly of arm 1110 has been prepared to be started by user.This is the assembling and the loading structure of product normally.In second state, or in the spring cocked position shown in Figure 144, user start button (not shown) and element 1124 moved on to the right side.When by the power that puts on pin 1120 element 1124 being moved to the right side, arm 1110 keeps static and is driven in the deflected position about the mobile of static follower 1112 by cam shedding 1114.Because pin 1120 and trigger 1118 all are connected in button, therefore each moving all is arranged in arm 1110 under this case of bending by cam shedding 1114 and follower 1112.User is equipped spring by this way in use, and this has the advantage of the prestrain assembly that is better than having eliminated stress relevant with loading spring and creep.In this state, trigger 1118 and breech lock 1122 are engaged and prepared to be launched at once by user before using.

In the 3rd state, or in the transmitting site shown in Figure 145, being moved further of button moves forward trigger 1118 enough far with unloaded spring (that is, release arm 1110), and pin 1116 is driven in the skin surface 1117.Breech lock 1122 is triggered by the opening that is located in the element 1124, allows arm 1110 and element 1124 all to be laid on the skin surface 1117.The moment coupling of the residue spring in follower 1112, cam shedding 1114 and the arm 1110 applies light pressure to skin surface 1117.

In one of four states, or in the home shown in Figure 146, device from skin surface 1117 remove and since follower 1112 with make that element 1124 has rotated being connected of cam shedding 1114.This makes arm 1110 loosen once more to be its initial condition that wherein pin 1116 is withdrawn in the shell.Above-mentioned whole system all can be set in the infusion set.The auxiliary usage of the cam/follower effect that is used in combination with device has been shown in Figure 147, Figure 147 shows such example, wherein screwing element is used to spring to load, and described spring is used for that patient's pin is pushed into patient's neutralization and takes out from the patient, and is the container contents pressurization.

Particularly, Figure 147 shows embodiment distortion or screwing element 1125 with spring 1126 loadings that are used in the device.Spring 1126 is fixing by pin or button 1127, and when loosening, forces element 1129 forward, and the pin 1131 that wherein is arranged in the groove of element 1129 is forced to downwards afterwards upwards, and is corresponding with the groove in the element 1129.Force pin 1131 and the container and the needle assembly 1133 that pivot to lower compression downwards.Being moved further of element 1129 forces pin 1131 upwards, makes progress at the auxiliary assembly 1133 that forces down that comes from assembly 1133 contacted springs 1126.

Aforesaid, passive safety systems is most preferred, yet active security system also is practical and can be used in some application.Aforesaid, usually there are three kinds of options about security system, comprise pin is withdrawn in the device, covers pin and enter with cancellation and damage pin in the mode of avoiding needle stick injury.A plurality of passive release mechanisms have been described above in detail.To describe a plurality of active release mechanism embodiment of the present invention below in detail.

Improvement of the present invention has been shown in Figure 148 and 149 has ejected shield release mechanism embodiment.Remove when removing device, user ejects shield 1130 downwards and shield 1130 is locked in the appropriate location to avoid contact pin 1135, and the function of device is basic with above-described identical.

As shown in Figure 148 and 149, shield 1130 is the flat board of plastics or metal basically, during the press portion of described shield 1130 by the brake portion 1137 of operative installations edge is held in position.When device was on the skin surface during use, shield 1130 was smooth substantially.After removing, user is caught the extension tab of the brake portion 1137 on the shield 1130 and is ejected shield 1130 with " compression failure also covers " pin 1135 about hinge 1139.Also can provide the lock (not shown) so that shield 1130 is fixed together with irremovable mode and device when being closed after using.When shield 1130 was locked in the position, pin 1135 and pin opening both were covered fully and are locked.

The assembly of present embodiment can comprise the snap fit on the pivot, and presses fit in the initial position.Also can carry out this operation in early days, so that it is in the suitable position and is positioned on the bottom of device when the remainder of assembling device in manufacturing.Also can on the top of shield 1130, binding agent be set.Provide a kind of so active release mechanism by single part, and have low-grade simple assemblies and solid protection is provided.Yet described mechanism is active, and this needs extra user step.In addition, the binding agent on the shield 1130 can cause device floating, and the compression failure pin may have problems.In addition, must arrange carefully that pivot 1139 is to obtain full rotation and to avoid incomplete locking.

Aforesaid, the improvement embodiment of release mechanism can various types be provided, comprise that mousetrap type safety device, pin are mentioned and the safety device of the safety device of cover type and rotation pin type of manifold.All describe in detail above passive and source mechanism is arranged, yet several mechanisms can be provided as active or passive.A plurality of active/passive release mechanism of the present invention will be described below in more detail.

About above-described passive release mechanism, mention and several embodiment such as safety device embodiment of cover type also can be used as the active system that user uses such as pin, but they manufacture with low cost and use in very solid.For example, pin mention and the safety device of cover type in, by driving spring pin being imbedded required power may be higher.Therefore, overcoming these power by user in common active release mechanism may be higher and also may have a probability of the incomplete covering of pin.Yet mention and the favourable part that covers embodiment is that each all has the inclined-plane as passive release mechanism embodiment above-mentioned several.Therefore, be used as under the situation of active release mechanism, mention and cover that embodiment also can comprise the inclined-plane so that obtain to be better than the advantage of driving spring aspect the pin mentioning, and comprise the probability that removes driving spring fully, this has significantly reduced the required power of user masking device.Final advantage in the active and passive release mechanism is, therefore the expansion of the horizontal barrier that these notions can help to become whole with ramp structure manufactures with low cost, very solid in being easy to use and using.

In can be used as the another kind improvement security implementation example of active or passive mechanisms, can provide pin crooked release mechanism.In this embodiment (not shown), described mechanism can comprise the foraminous plate of tool, and pin passes from described hole in use and course of conveying.After using, in active or passive mode, the removable so that edge of plate mesopore of plate on the pin of unusual small dimension, apply shear-type load and to edgewise bend they, cover them simultaneously.

Yet, must carefully avoid damaging pin and change the required dynamics of needle bent, this is because they should be bent very near the mounting points that has very little moment arm.This embodiment can be used as active or passive mechanisms, and comprises low-grade simple black box.

In can be used as the another kind improvement security implementation example of active or passive mechanisms, bistable state sheet spring mechanism can be provided, have the single spring of the pin that can drive and withdraw.Provide and use thin plastics or sheet metal, can form will be along the bias system of either direction work.By bistable spring, user only need overcome stable resistance, afterwards " interlock " will provide in another kind of steady statue and lay at a high speed.Opposite when device uses up, user only need apply identical little power and install the pin of will withdrawing.

In the another kind of pattern of present embodiment, thin plastic components (not shown) can be provided and support at one end to be gone up and slight mutually extruding.When moment is applied in the compression end, plastics will be bited into more stable structure.When moment was removed, plastic components rebounded.Described bistable spring can be used as active or passive mechanisms, and can constitute the simple black box with low grade and provide high-speed.

Great majority among the previous designs embodiment all may be made in active pattern, and this can simplify their parts and be that the expansion power of application user can be eliminated the needs with trigger sensing skin.Also have kind of a conception of species, wherein the direct force that acts on button or other likes by user is carried out withdrawal, mobile manifold under the situation without middle springs or miscellaneous part afterwards.

Except that the improvement security implementation example of the above, other improvement embodiment of the present invention comprises improvement manifold spring, improvement filling mechanism, improvement package mechanism and improvement dosage terminal time limit indicating mechanism.

Aforesaid, during one or more patient's pin manifold spring relaxation in being arranged on infusion set, patient's pin manifold is pushed ahead usually.With reference to Figure 37,38 and 39 exemplary device has been described.Yet Figure 37,38 and 39 manifold spring also can comprise the improvement spring of Figure 150 to 156, will describe in detail below.

In Figure 150 to 156, show several improvement manifold spring embodiment.In Figure 150,151 and 152, show the perspective view of improvement manifold spring first embodiment.Figure 150 and 151 shows the spring in loading or the bending position, and Figure 152 shows the spring in release or the release position.Spring 1140 comprises first and second

adjacent elements

1148 and 1145, and they are connected so that produce acute angle substantially when loosening as among Figure 152.In the time of in being in loading position, first element 1148 is fixed on the arc 1144 that second element 1145 provides.Bigger perpendicular elements 1142 is arranged on first element 1148 so that engage with button in the device, thereby loosens first element 1148 and exert pressure by the element 1146 of basic bending from arc 1144.

In operation, loading spring 1140 is disposed in manifold 1151 tops in the device.Spring 1140 is disposed in pin manifold 1151 tops, such as the manifold among Figure 34 520.In Figure 34, spring 581 is provided to manifold 520 application of forces, and spring 1140 can be disposed in manifold 1140 tops and to the manifold application of force.In Figure 150 and 151, the joint by first and

second elements

1148 and 1145 remains on spring 1140 under the stress state.When the button (not shown) was activated, perpendicular elements 1142 engaged by contacting with button member 1159, made second element 1148 move away from the fixed first element arc 1144, was loosened up to second element 1148.After being loosened, the basic annular contact area 1146 of second element 1148 drives manifold 1151.Annular contact area 1146 guarantees that spring contacts the central spot that is provided at manifold 1151 in the whole stretching, extension of spring 1140 with manifold.Suitable manifold stroke has also been guaranteed in described contact.Other embodiment of improvement manifold spring have been shown in Figure 153 to 156 and have carried out like that as mentioned above substantially.

In Figure 153, the fixedly arc 1144 of Figure 150 is replaced by the bigger element 1147 that extends from button joint element 1149.When button engages with element 1149, element 1147 loose springs and suppress manifold 1151 forward, aforesaid.In Figure 155, the fixedly arc 1144 of Figure 150 is replaced by the bonding part between element 1141 and 1143 equally, and carries out like that as mentioned above substantially when discharging.Each comprises that all little brake unit is to avoid unexpected disengagement.

In Figure 157 to 163, show improvement " pass through button " filling mechanism and method, described mechanism and method can be used in combination with above-described any infusion set and improvement.

Step 1 shown in Figure 157 shows to-fill procedure.The partial cross sectional illustration of device 1150 has gone out to be adjacent to container and has driven 1154 button 1153.In button 1153, comprise hole 2153, this in addition the assembling after also allow to open 1154 filling devices 1150 by container.In the step 2 shown in 158, after filling by button hole 2153, valve module 1156 is assembled in the vessel port 1154.Therefore, can to use button 1153 starter gate valves 1156, need limiting holes 2153 in some way by hole 2153 assembling valve modules 1156.In step 3, provide element 1158 with X button hole 2153 inlet ports or observation window, to allow the startup of the valve 1156 shown in Figure 159.After closing, as shown in Figure 160, prepare to press the button 1153, thus starter gate valve assembly 1156.

In an alternate embodiment of the invention, valve 1156 can be inserted into by opening 2153, rotates to complete step 3 afterwards.As shown in the top view of the button in Figure 161 and 162 1153, valve 1156 is configured so that to have elliptical shape, and it is inserted in the hole 2153 of similar shape of button 1153 slidably.Elliptical shape can be designed to by the rotation as shown in the cross-sectional view of Figure 163 asymmetrical so that in case after being in the position in the vessel port, the rotation of valve 1156 allows the valve flange perpendicular to opening.This allows button 1153 (even having opening 2153), so that promote valve 1156 when button 1153 moves forward.This option has been eliminated and has been provided with element 1158 to such an extent that be close to button observation window 2153 to allow the needs of starter gate valve in Figure 157 to 160.

Another improvement embodiment relates to device filling and content indication.As shown in Figure 164 to 167, whether above-mentioned infusion set can be equipped with the dosage terminal indicator and be supplied to to allow user to observe medicine, whether has been fed into still less degree, and whether described degree is supplied to.

In some infusion sets, can have transparent vessel, user can be understood thoroughly container fully.Usually, when causing transparent material not to be used in combination with liquid owing to chemical reaction, perhaps water/when gas transmission speed was higher, solution can comprise the use of the combination of transparent and non-transparent material.Non-transparent material can be any amount of material, such as having the aluminum that is used for flexible demand or being used for the laminated material of the coating material of rigid demand.Embodiments of the invention described below comprise the container 1160 that is made of flexible, non-transparent material that is used for barrier film 1162 and rigidity transparent material 1164.Also provide and be used for the visual detector 1166 between administration begins and finishes, distinguished.This visual detector can be the labelling that manifests or disappear when appearing at the transfusion end.

As shown in Figure 164 and 165, the protruding burr 1168 that is made of the soft material on the indicator 1166 contacts with flexible diaphragm 1162, and because the existence of the content of container causes having certain distance with rigidity transparent material 1164.Yet protruding burr 1168 produces visible deformation or the profile 1169 that can see by transparent material 1164 in flexible diaphragm 1162.An example of described profile 1169 has been shown in Figure 164.As shown in Figure 166 and 167 after container 1160 is cleared because the shortage of content causes contacting with rigidity transparent material 1164 in the container 1160, make protruding burr 1168 be crushed.Eliminated the distortion 1169 of flexible diaphragm 1162 afterwards, as shown in Figure 166.Therefore present embodiment can be used for providing the direct observation of fluid distribution, yet other embodiment can comprise that also multiple modes such as timer and pressure control/pick off provide the indication of dosage terminal.

For above-described embodiments of the invention are provided, flexible material is provided as barrier film 1162.In when beginning injection, " deformable signal " 1168 is applied on the flexible diaphragm 1162, and therefore, the power that puts on the protruding burr 1168 is the power that puts on film 1162 and the container contents, thus this cause to a great extent burr 1168 than small deformation.When transfusion or injection end or approaching the end, barrier film or film 1162 contact with the hard transparent part 1164 of container 1160, and protruding burr 1168 is compressed on the container and labelling 1160 disappears.

Improve among the visual indication embodiment at of the present invention another, the micro-infusion device can comprise another part, that is, be used for visually indicating and when finish drug conveying.Aforesaid, several designs of infusion set comprise the pin manifold combined to similar parts, and described infusion set is continued to use in the common direction of the patient skin that inserts and moved.The pin manifold is removed so that withdraw from patient's skin afterwards.This part can be used for providing described visual detector with the upper body and the lower case of the shell of device.

In infusion process, lower case is attached to patient skin, and upper body is apart from skin case member farthest.This upper case is normally visual for patient's (perhaps using the people of infusion set).The parts of aforesaid so-called pin manifold are disposed in the infusion set.One or more microneedle or very little sleeve pipe for good and all are fixed in this pin manifold.This pin manifold also is attached to fluid container in every way, so that form successive, leakproof, fluid path.Provide described path with allow fluid from fluid container by one or more fluid control devices, by pin manifold and microneedle far-end and enter in patient's body.

Begin or during near beginning in the infusion program of drug conveying, sleeve pipe thrusts and enters patient skin with fluid, liquid, gas or steam medicine that transport box was provided.Medicine selectively is imported in the target area of patient below the epidermis.So that can carry out drug conveying, the manifold spring is along basic vertical and promoted by the pin manifold towards the direction of patient skin surface (and along direction parallel with telescopic major axis) usually in order to thrust skin.Aforesaid, the pin manifold moves also can be designed to rotating mechanism, yet, also can comprise the outstanding indicator component of this improvement visual detector embodiment.During in the infusion program end of drug conveying or near end, by moving the pin manifold along common direction and/or moving the pin manifold and in patient's body, extracted sleeve pipe out by edge and its before mobile opposite direction away from skin.

Total distance that the pin manifold is advanced in example embodiment can be near 3 to 6 millimeters (3mm be to 6mm).Yet the decision design feature is to make high or " highly " that this infusion set of advancing takes place minimize.For other functional demands, the pin manifold is in the highest parts in the infusion set normally.In this understanding, " height " direction is perpendicular to the direction of skin surface in the zone that infusion set is arranged.For those reasons and in order to adapt to required moving, before storing, using and at the pin manifold, move so that before sleeve pipe is inserted in the skin, the top surface of pin manifold will be close to the inner surface of upper body or contact with inner surface.When beginning during infusion program, the pin manifold moves away from the inner surface of upper body during sleeve pipe inserts, and forms gap or interval between upper body and pin manifold.When finishing fluid administration, pin manifold and sleeve pipe are contracted, thereby turn back to its original position.Embodiments of the invention comprise the part that is arranged on pin manifold top place, and patient or user can be observed by the part in the upper body.

In first embodiment, the pin manifold can have cylinder-prism or be similar to prismatical part, and described part can be outstanding from the top surface and/or the top surface top of pin manifold.Should give prominence to part can be Unitarily molded with the pin manifold bodies, and perhaps it can be the independent sector that invests the pin manifold bodies.Should outstanding part be contrast color highly reflective and/or bright so that optimum visual.

Corresponding with the outstanding part of above-described pin manifold, can provide opening in common position and with suitable size by top shell, or it is provided as transparent window or the moulded lens shape device that is assemblied in top shell or assembles by top shell.Outstanding part on the pin manifold will fit slidingly in the top shell opening or by the assembling of top shell opening, or fit slidingly in the spill pocket areas on the transparency window interior zone.In order to hold the indicator of pivot or text type, can in top shell, provide the bigger rectangle or the form of elliptical shape.

Aforesaid, the outstanding part on the pin manifold be contrast color highly reflective and/or bright so that optimum visual.In other embodiments, monochromatic indicator can comprise text, and such as word " Ready ", " OK " or " Start ", they are visual in the example of opening or form.

In addition, by increasing at least one slave part, another embodiment with two-position indicator also is feasible.This two-position or pivot indicator can comprise the above-mentioned text of quoting as proof (labelling) before the transfusion, and when the pin manifold is advanced downwards and be in the backstroke, spring whole or that invest the pivot indicator can eject indicator to form visual auxiliary text, such as word " End ", " Done " or " Remove ".Mobile part with labelling also can slide rather than pivot with respect to the pin manifold.

In use, the above-described embodiment of the invention allows surround lighting to pass transparent lens or form in the top shell, and described surround lighting is from arranging to such an extent that be close to outstanding indicator surface reflection the spill bag of the spill bag of form or form.Eyes by user after the light that is reflected is transmitted by form afterwards receive.In essence, when the pin manifold was in top or the retracted position, the indicator form of infusion set was as bright object that transparent lens centered on and occur.Owing to have diametrically opposite color with the environmental surfaces of top shell, so indicator is visual.

When the pin manifold is downward, or when being in " sleeve pipe insertion " position, outstanding indicator part has certain distance apart from form.The light that passes form under being in this operator scheme reflection and from infusion set irrespectively at the infusion set scattering-in, so form is shown as dead color.Whether in this case, in fact this embodiment of the present invention indicates pin manifold and telescopic position, rather than indicate fluid and partially or completely escape and enter from infusion set in patient's body.Yet user also can use other usings method to explain the visual variation in the indicator form.

Use for convenience and the protectiveness purpose, above-described embodiment has normally packed.Therefore, in another improvement embodiment of the present invention, a kind of packaging system is provided, described system allow all as previously discussed those in advance the filler device asepticize, can carry, anti-pollution, and the filling content is such as the medicine of forms such as liquid, gas, powder.Device itself is not anti-pollution, but surface of package is antipollution.

Packaging system shown in Figure 168 to 175 comprises the array type packing, or group cover 1170, described group of cover 1170 will a plurality of filler device 1175 in advance remains in the qualification position (promptly, vertically), and provide and can be flexible outer packaging, for example

soft bag

1185 and 1190, or inflexible outer packaging, for example case 1180.

After producing any infusion set that comprises above-described improvement embodiment, described device can be assembled in the opening 1171 of sky group cover 1170 of Figure 168, and up to being full of as shown in Figure 169, perhaps the part as shown in Figure 170 is full of.Each opening all also comprises a plurality of ribs 1196, as described in greater detail.Provide afterwards such as bag 1185 and bag 1190 (as shown in the Figure 174 that shows the integral packaging example) or box 1180 and bag 1190 (as shown in the Figure 175 that shows the integral packaging example) and waited outer packaging, thereby guaranteed to resist the integrity of germ contamination.Bag 1185 can have inner vacuum, and bag 1190 can have or not have inner vacuum.Rigid case 1180 can have Tyvek, paper, film or rigidity cover, and bag 1190 can have or not have inner vacuum.Usually, outer packaging can comprise another packing, increases this packing to prevent dust and box or bag contact (that is dust cover).Can make this integral packaging (that is, group cover 1170 and outer packaging) sterilize by gamma-radiation, oxirane, E ray or other proper sterilization methods.

When device 1175 need be filled the time, enter with preventing microorganism the filled chamber as gnotobasis from outside sterilization integral packaging.Outer bag 1190 (that is, dust cover) is removed and the box of outer packaging or bag (that is, 1180 or 1185) are opened with taking-up group cover 1170 afterwards, and the group cover with device 1175 is placed on the filling machine (not shown), and filling device 1175 afterwards.

For the ease of to-fill procedure, filling machine can use

rib

1195 and 1196 and each opening 1171 bottom that is located at group cover 1170 as shown in the top view of the group of Figure 173 cover in big opening 1198, lifting device 1175 as shown in Figure 171.

Rib

1195 and 1196 and opening 1198 if to be provided for needing power on the top of laminar air flow around the modifying device 1175 and device be that device 1175 provides support.Rib 1195 also can be used for holding device 1175 and rib 1196 can be used for determining the center of device.For concrete to-fill procedure, device 1175 need be maintained in the tram so that the filling head of filling machine (not shown) with install 1175 and align, shown in the arrow among Figure 171.The device that moves up as shown in Figure 171 allows filling machine to have auxiliary device so that aligning apparatus 1175 carefully.

Usually, packing is used in combination with syringe, and wherein syringe is disposed in the group cover that is made of plastic plate and bell glass, and the outer packaging that is made of rigid case is provided.Embodiments of the invention do not comprise plate and bell glass, and only are the layout of rib 1195 and 1196.Lower front surface has been guaranteed in

rib

1195 and 1196 use, and allows laminar air flow to be present in the described chamber flowing around device 1175, and except that above-described hoisting power is provided the quality of improvement filling also.

Other advantages relevant with above-described embodiment are to have flexible bag 1185 rather than rigid case 1180 as outer packaging, allow the vacuum in the bag 1185 that the visual detector of packing globality is provided like this.In this pattern, the vacuum that loses is represented non-integral.In addition, flexible bag 1185 is cheaper than box 1180 is provided.In a preferred embodiment, provide the structure that has group cover 1170 and do not have the outer bag 1185 of vacuum, and second bag 1190 of increase that does not also have vacuum, contact with first bag to avoid dust.

Although only describe several embodiments of the present invention above in detail, those skilled in the art can easily be understood that, can make many corrections in an exemplary embodiment under the prerequisite that does not significantly deviate from novelty technology of the present invention and advantage.Therefore, all described corrections all should be included in protection scope of the present invention.

Claims

1. one kind is used for by the patient skin injection medicine being input to the intravital device of patient, and described device comprises:

Have the pin hole on basal surface, the described basal surface and the shell of top surface;

Be suitable for thrusting tissue and being suitable for passing the entry needle that described pin hole moves;

Be arranged on the container of described enclosure, described container is communicated with the entry needle fluid;

Be used to the compression system of described container pressurization;

It is characterized in that, described device also comprises protective element, described protective element comprises the part of the described basal surface of described shell, and be suitable for moving along the bow-shaped route rotation that is basically perpendicular to basal surface, described protective element has and is arranged on around the pin hole and substantially by the contact skin part of adhesive coverage, and pivot, described protective element has the basic coplanar primary importance of basal surface with described shell of protective element wherein, and wherein protective element covers the second position of pin at least in part around pivot rotation and protective element;

When described device is placed on the patient skin, the contact skin part of protective element temporarily adheres on the skin, and when when skin removes device, protective element and skin bonding is enough to make protective element to center on pivot to rotate to the second position from primary importance.

2. as claimed in claim 1 being used for is input to the intravital device of patient by the patient skin injection with medicine, it is characterized in that, described device also comprises mousetrap door, latch and door pivoting point, described protective element comprises spring spool and safety spring, wherein, when described device was placed on the patient skin, mousetrap door was captured described safety spring in the mode that reduces the power of safety spring actual transmissions on the patient skin surface; When removing described device from skin surface, safety spring pushes away described device with mousetrap door, and safety spring is launched fully, and spring spool is protected described pin.