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CN105833395A - Self-injection device - Google Patents

Self-injection device Download PDF

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Publication number
CN105833395A
CN105833395A CN201610178516.4A CN201610178516A CN105833395A CN 105833395 A CN105833395 A CN 105833395A CN 201610178516 A CN201610178516 A CN 201610178516A CN 105833395 A CN105833395 A CN 105833395A
Authority
CN
China
Prior art keywords
needle cover
patient
infusion device
reservoir
pin
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Granted
Application number
CN201610178516.4A
Other languages
Chinese (zh)
Other versions
CN105833395B (en
Inventor
R·桑德埃格
L·韦德林
C·宾厄姆
B·彼得森
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Becton Dickinson and Co
Original Assignee
Becton Dickinson and Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Becton Dickinson and Co filed Critical Becton Dickinson and Co
Priority to CN201610178516.4A priority Critical patent/CN105833395B/en
Priority claimed from CN200980163434.0A external-priority patent/CN102753212B/en
Publication of CN105833395A publication Critical patent/CN105833395A/en
Application granted granted Critical
Publication of CN105833395B publication Critical patent/CN105833395B/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202Devices for protection of the needle before use, e.g. caps
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/142Pressure infusion, e.g. using pumps
    • A61M5/14244Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body
    • A61M5/14248Pressure infusion, e.g. using pumps adapted to be carried by the patient, e.g. portable on the body of the skin patch type
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178Syringes
    • A61M5/31Details
    • A61M5/32Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321Means for protection against accidental injuries by used needles
    • A61M5/3213Caps placed axially onto the needle, e.g. equipped with finger protection guards
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/14Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
    • A61M5/1414Hanging-up devices
    • A61M5/1415Stands, brackets or the like for supporting infusion accessories
    • A61M2005/1416Stands, brackets or the like for supporting infusion accessories placed on the body of the patient

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Dermatology (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

The invention discloses a drug delivery device (100), which comprises main bodies (104, 116) and an injection needle (152), and further comprises a needle cover (114), a binding part (264), a releasing lining (500) and connecting devices (112, 520, 512, 508, 524), wherein the main bodies are provided with storage devices (164, 176) which are used for accommodating drugs; the injection needle penetrates into skin of a patient, and by virtue of the needle (152), drug paths between the storage devices (164, 176) and the patient are provided; the needle cover (114) is used for selectively covering the injection needle (152); the binding part (264) is used for selectively sticking the device to the patient; the releasing lining (500) selectively covers the patient side of the binding part (264); and by virtue of the connecting devices, the needle cover (114) and the releasing lining (50) are connected, so that either the needle cover (114) or the releasing lining (500) is removed from the device (100), and the other one of the needle cover (114) and the releasing lining (500) is removed.

Description

From injection device
This divisional application is based on Chinese invention patent application number 200980163434.0 (international application no PCT/ US2009/006573), denomination of invention " from injection device ", the divisional application of the applying date in December, 2009 patent application of 16 days.
Technical field
Present disclosure relates generally to a kind of material delivery apparatus, it has the patient convenience of improvement, ease for use and effect Rate.The present invention further relates to a kind of paster shape on the whole, from holding type material infusion or from injection device, described device can be used in Many kinds of substance or medicine is carried to patient.More particularly it relates to there is needle cover and bonding is released pine lining integral type and removed Patch-like infusion or from injection device.
Background technology
A large amount of people (such as standing the people of such as diabetes etc situation) use certain of such as infusion of insulin every day etc The infusion of therapeutic of the form of kind, to maintain the tight control to its blood sugar level.At present, in infusion of insulin treatment example, deposit Main Patterns two kinds of insulin treatments every day.First mode includes syringe and novopen.These devices use simple And cost is relatively low, but they need pin to prick when per injection, generally three times a day to four times.Second pattern includes infusion pump Treatment, this needs to buy the expensive pump continuing about three years.High cost (about the 8 of the daily rate of syringe treatment of pump Times to 10 times) and finite lifetime be that the high of this treatment is hindered.Insulin pump also represents older technology and uses loaded down with trivial details.This Outward, from the perspective of life style, pump is connected to pipe fitting (referred to as " the infusion set being positioned in the delivery site of patient's abdominal part Group ") it is the most inconvenient, and pump is heavier so that carry pump to become burden.But, from the perspective of patient, use The overwhelming majority in the patient of pump preferably retains pump in its remaining years.Although this is because infusion pump more more complicated than syringe and pen but There is provided the advantage that the continuous infusion of insulin, exact dose and movement schedule able to programme arrange.This causes closer blood The health perception that sugar controls and improves.
In view of viewed pump treat increase and every day injection number of times increase, for better healing interest just Increasing.In this infusion example with in similar infusion example, fully meeting this increase interest, to be desirable for following insulin defeated Send or infusion format: it is by the best features of the best features (low cost and ease for use) of injection for curing every day Yu insulin pump (continuous infusion and exact dose) combines, and it also avoid respective shortcoming.
Have been carried out some trials to provide low cost and free-standing easy to use or " Wearable " infusion of drug Device.Some in these devices mean the most droppable.In theory, such device can provide infusion The lot of advantages of pump and there is no thing followed cost and inconvenience.But, unfortunately, much suffering in these devices is following scarce Point: include the discomfort (due to the divider of entry needle used and/or length) of patient, carried material with at infusion device In structure use material between compatibility and interaction and correctly do not activated (such as, due to device by patient Premature activation and cause " wet type " to inject) in the case of possible fault.Run in the mill and controlled pin Penetration depth in difficulty, especially when using the entry needle of short and/or fine divider.Connect to the device used The probability of the needlestick injury of the personnel touched also the most individual problem.
Accordingly, there exist the demand of substitute to the current infusion device infusion pump of insulin (such as), it enters one Step provides the simplicity manufactured and the use for insulin and non-insulin application to improve.
Summary of the invention
It is an aspect of the invention to provide a kind of patch-like infusion or from injection device, described device can advantageously support Dress by skin, simultaneously by using one or more micropins provide the infusion of expectation material and provide the discomfort of minimum.This The another aspect of invention is to provide this infusion or from injection device, wherein remove this infusion or from the needle cover of injection device and Bonding is released pine lining and can be integrated in single operation.
Above-mentioned and/or other aspects of the present invention are by providing medicament delivery device realization, described medicament delivery device bag Including: body, described body has and is arranged in described body for accommodating the reservoir of medicine;And entry needle, described injection Pin is for thrusting the skin of patient, and described pin provides the path for medicine between described reservoir and patient.Described Device also includes: needle cover, and described needle cover is for optionally covering described entry needle;Bonding part, described bonding part is for by institute State device and be optionally attached to patient;Release pine lining, described in release pine lining for selectivity cover described bonding part patient Side;And attachment means, described attachment means is used for making described needle cover be connected with described pine lining of releasing so that described needle cover and institute State release pine lining in one from described device remove by described needle cover and described release pine lining another from described dress Put and remove.
Above-mentioned and/or other aspects of the present invention are also by providing medicament delivery device realization, described medicament delivery device Including: for thrusting the entry needle of patient skin;For described device selectivity being attached to the bonding part of patient;For selecting Property cover described bonding part patient-side release pine lining, described in release pine lining there is the opening being located therein;And be used for selecting Selecting property covers the needle cover of described entry needle.Described needle cover includes: pin covering part, and described pin covering part has releases pine than described The flange that the opening of lining is big;Mid portion, described mid portion orientate as adjacent with described flange and than described in release pine lining In opening little;And holding part, described holding part is orientated as adjacent with described mid portion and has and release than described The big part of opening of pine lining, is maintained on described mid portion for by described pine lining of releasing.
Other and/or other aspects of the present invention and advantage will part be explained in the following description, and will be from explanation Middle part apparent, or be appreciated that by the practice of the present invention.
Accompanying drawing explanation
From detailed description with reference to the accompanying drawings, above-mentioned and/or other aspects of embodiments of the invention and advantage will more Easy to understand, wherein:
Fig. 1 illustrates the patch-like infusion under the pre-activated state being in before activation or from the embodiment of injection device Axonometric chart;
Fig. 2 illustrates the infusion device of Fig. 1 and is in the partial exploded view under pre-activated state;
Fig. 3 illustrates the infusion device of Fig. 1 and is in the partial exploded view under pre-activated state, and wherein activator appliance button is outwarded winding To show more details;
Fig. 4 illustrates the exploded view more completely that the infusion device of Fig. 1 is under pre-activated state;
Fig. 5 illustrates the infusion device of Fig. 1 and is in the sectional view under pre-activated state;
Fig. 6 illustrates the infusion device of Fig. 1 and is in the sectional view under pre-activated state, and wherein activator appliance button is outwarded winding;
Fig. 7 illustrates the infusion device of Fig. 1 partial exploded view during the installation of release mechanism;
Fig. 8 illustrates the infusion device of Fig. 1 partial exploded view after the activation;
Fig. 9 illustrates the infusion device of Fig. 1 exploded view more completely after the activation;
Figure 10 illustrates the infusion device of Fig. 1 sectional view after the activation;
Figure 11 illustrates the infusion device of Fig. 1 partial exploded view after the expansion of release mechanism;
Figure 12 illustrates the infusion device of Fig. 1 sectional view after the expansion of release mechanism;
Figure 13 illustrates the basal surface of release mechanism;
Figure 14 further illustrates the structure of release mechanism;
Figure 15 A-Figure 15 D illustrates dosage end indicator and the operation in the infusion device of Fig. 1 thereof;
Figure 16 illustrates the embodiment of the infusion device with injection port;
Figure 17 illustrates the adhesive pad in the infusion device being positioned at Fig. 1 and bonds the embodiment releasing pine lining;
Figure 18 illustrates the pin covering part of the needle cover in the infusion device being positioned at Fig. 1;
Figure 19 illustrates the embodiment of the needle cover of the pin covering part including Figure 18;
Figure 20 A to Figure 20 C illustrates the reality of the needle cover of the pin covering part including Figure 18 in the infusion device being positioned at Fig. 1 Execute example;
Figure 21 A and Figure 21 B illustrates the reality of the needle cover of the pin covering part including Figure 18 in the infusion device being positioned at Fig. 1 Execute example;
Figure 22 A-Figure 22 D illustrates the embodiment of the needle cover in the infusion device being positioned at Fig. 1;
Figure 23 A and Figure 23 B illustrates the embodiment of the needle cover in the infusion device being positioned at Fig. 1;
Figure 24 illustrates the embodiment of the needle cover in the infusion device being positioned at Fig. 1;
Figure 25 A and Figure 25 B illustrates the embodiment of the needle cover in the infusion device being positioned at Fig. 1.
Detailed description of the invention
Reference will now be made in detail to now embodiments of the invention, the example illustration of the present invention in the accompanying drawings, wherein, identical accompanying drawing Labelling represents identical element all the time.Described embodiment makes the present invention instantiating by referring to accompanying drawing.
The embodiment of present invention described below can act as easily, patch-like infusion or from injection device 100 with The material of predicted dose, such as liquid medicine or medicament in a period of time or is disposably carried fully to patient.This device is excellent Selection of land is supplied to end user with pre-filled state (i.e. medicine or medicament has been positioned in the reservoir of device).Although herein Described patch-like infusion or can be used by patient and/or caretaker from injection device 100 (such as, shown in Fig. 1), but For convenience, the user of this device is hereinafter referred to as " patient ".It addition, for convenience, such as " vertically " and " level " and " top Portion " and the term of " bottom " etc for representing the relative direction about the infusion device 100 arranged on a horizontal surface.But It is, it should be appreciated that infusion device 100 is not limited to this direction, and infusion device 100 may be used for any direction.Separately Outward, the replacement of term " infusion device " and " from injection device " uses and is not intended as limiting with description enforcement assembly of the invention Property.Not there is the infusion device from injectability fall within the scope of the present invention, do not perform continuous infusion from injection device also Fall within the scope of the present invention.For convenience, but without limitation, term " infusion device " is used in the following description.
The patch-like infusion device 100 of Fig. 1 is from holding type and by gluing of being arranged on the basal surface of infusion device 100 Conjunction portion is attached to the skin surface (as will be described in more detail below) of patient.Once it is properly positioned and is activated by patient, releasing Pine spring acts on the pressure in the flexible reservoir in device and can be used in via pin manifold by one or more patient's pins (such as, micropin) empties the content of reservoir.The material being positioned at reservoir is defeated by the micropin being driven to skin subsequently Send through patient skin.It should be appreciated that other embodiments are possible, wherein spring is replaced by different types of energy storage dress Putting, these energy storage devices can be substantially machinery, electronics and/or chemistry.
As will be determined by the skilled person understood, there is structure and use patch-like infusion device disclosed herein The number of ways of 100.Although the embodiment described in reference to the accompanying drawings and description below, but embodiment disclosed herein is also Non-mean various optional design and the embodiment that limit is included by the disclosed invention.In each open embodiment, this device quilt It is referred to as infusion device, but this device also is able to more a lot (big preparation) soon than the speed generally realized by typical case's infusion device Speed injection mass.Such as, content being as short as several seconds or can be carried in the period of long extremely several days.
In the embodiment of the device shown in Fig. 1 to Figure 12, it is shown that the push-button design of patch-like infusion device 100, Wherein, activation and the excitation of device realizes with single multi-functional/step process.Fig. 1 illustrates be under pre-activated state defeated The assembled embodiment of dispensing device 100.Fig. 2-Fig. 6 illustrates the partial exploded view of the infusion device 100 being under pre-activated state And sectional view, Fig. 7 illustrates the infusion device 100 partial exploded view during the installation of release mechanism, and Fig. 8-Figure 10 illustrates Infusion device 100 exploded view after the activation and sectional view, and Figure 11 and Figure 12 illustrates infusion device 100 at release mechanism Exploded view after expansion and sectional view.Infusion device 100 is configured in pre-activated state (such as, institute in Fig. 1, Fig. 2 and Fig. 5 Show), activate or excited state (such as, shown in Fig. 8-Figure 10) and retract or safe condition (such as, institute in Figure 11 and Figure 12 Show) between operate.
As shown in fig. 1, the embodiment of patch-like infusion device 100 includes bottom enclosure 104, release mechanism 108, needle cover The flexible needle covering part 112 of 114, top casing 116, reservoir sub-component 120, dosage end indicator (EDI) 124 and Activator appliance button 128, activator appliance button 128 includes patient interface surface 132.It addition, as shown in Fig. 2-Fig. 6, infusion device 100 also include rotor or activate ring 136, pressing spring 140, arch metal plunger 144 and driving spring 148.
Flexible needle covering part 112 is by least pin of protection 152 (describing in more detail below) and provides aseptic Barrier portion and the safety of patient and device is provided.Pin covering part 112 protects pin 152 during device manufactures, before the use Protection patient, and the aseptic barrier portion of any time offer before the removal.According to an embodiment, pin covering part 112 Attaching to pin manifold via press-fit, at least pin 152 is arranged in this pin manifold.It addition, according to an embodiment, safety The pin opening 156 (being described in more below) of mechanism 108 is shaped to the most corresponding with the periphery of pin covering part 112.
Such as, as shown in Fig. 2, Fig. 3, Fig. 5, Fig. 6, Fig. 8, Figure 10 and Figure 12, reservoir sub-component 120 includes reservoir 160, reservoir arched sealing member 164,168, at least pin 152 of valve and be arranged between valve 168 and pin 152 and at them Between produce at least one passage 172 (for example, with reference to Fig. 8) of flow path.Reservoir 160 includes vault 176.It addition, storage Storage sub-component 120 includes that the pin covering part 112 that can be removed is optionally to cover this at least pin 152.According to one Embodiment, reservoir sub-component 120 also includes reservoir arm sealing member 180, thus covers passage 172.Preferably, pin 152 wraps Include pin manifold and Duo Gen micropin 152.
Such as, as shown in Figure 5, the reservoir arched sealing member (flexible membrane) 164 of reservoir sub-component 120 is arranged on post Between plug 144 and vault 176.Reservoir contents (such as, medical material) for infusion device 100 is arranged on and encircles between reservoir In space between shape sealing member 164 and vault 176.Reservoir arched sealing member 164, vault 176 and the space between them Combination limit reservoir 160.Vault 176 is preferably the most transparent can observe reservoir contents.Reservoir arch is close Sealing 164 can be made up of on-expansible material or laminated material (such as metal coating or other similar substances).For instance, it is possible to A kind of possible flexible layer press mold used in reservoir arched sealing member 164 includes the first polyethylene layer, as in this area Second chemosphere known to the skilled person with provide for the attachment means of the 3rd metal level chosen based on barrier feature, And include the 4th layer of polyester fiber and/or nylon.By being utilized in conjunction with metal with rigid element (such as, vault 176) Plated film or metalized film, improve the barrier properties of reservoir 160, thus increase or improve the guarantor of the content being accommodated within The matter phase.Such as, when reservoir contents includes insulin, the dominant touch material in reservoir 160 includes linea low density Polyethylene (LLDPE), Low Density Polyethylene (LDPE), cyclic olefine copolymer (COC) and Teflon.As being described in more below , the dominant touch material in the residue flow path of reservoir contents may also include COC and LLDPE and thermoplastic Property elastomer (TPE), medical grade acrylic acid, rustless steel and pin binding agent (such as, the binding agent of UV solidification).With reservoir 160 Content keep extend contact this material preferably by ISO 10-993 and other be suitable for biocompatibility test.
Reservoir sub-component 120 preferably in enforceable controlled environment in the regulation shelf-life of reservoir contents In can store without deleteriously affecting content, and can apply in a variety of environmental conditions.It addition, by reservoir The barrier portion that the parts of assembly 120 provide is impermissible for ratio, gas, liquid and/or solid material are met institute of desired shelf-life The speed that the speed allowed is big is transported in content or is carried out content.In embodiments shown above, store equipment Material can store and operate within the temperature range of about 34 degrees Fahrenheits to 120 degrees Fahrenheits, and can have 2 years or 2 years The above shelf-life.
In addition to meeting stability requirement, reservoir sub-component 120 can also be to successfully pass any number of leakage Test (such as the sample of 30psi being kept 20 minutes No leakage) and guarantee operation.As described in more detail below, stem from Other of the configuration of reservoir are filled, are stored and carry benefit and include the head space of adaptability and reduction.
In one embodiment, reservoir 160 empties before filling.By emptying reservoir 160 before filling also And only there is in vault 176 slight recess, it is possible to the too much refuse in reservoir 160 and head space are preferably minimized. It addition, the shape of reservoir can be configured to be suitable to type (such as, pressing spring 140 and the plunger of used excitation mechanism 144).It addition, use the flexible reservoir 160 being drained to reduce during filling be positioned at the reservoir 160 filled Arbitrarily air or bubble.(this can to use flexible reservoir 160 to stand the change of external pressure or temperature at infusion device 100 Cause increase reservoir internal pressure) time be also particularly advantageous.In this case, flexible reservoir 160 and reservoir Content is expanded together and shrinks, thus prevents cause due to expansion and contractility may reveal.
The further feature of reservoir 160 includes that being allowed in the filling moment automatically carries out the ability of particle inspection or existed by patient The moment is used to carry out the ability of particle inspection.One or more reservoir barrier portions (such as vault 176) can by transparent clearly Plastic material be molded, this material made it possible to being contained in reservoir checks.Transparent plastics material clearly Material is preferably cyclic olefine copolymer, it is characterised in that the high grade of transparency and definition, low extract (low extractables), And with the biocompatibility of the material being contained in reservoir 160.A kind of suitably material can be from Kentucky State Louis The material of entitled " the BD CCP resin " of the Zeon chemical company of Wei Er obtains, and is stepped on by U.S. food and FAD It is designated as DMF No.16368.In this applications, reservoir 160 includes that the feature checked that may hinder of minimum (that is, is allowed in Rotate during inspection).
Passage arm 172 is set to extend to the shape of at least one flexible bow-shaped arm of pin manifold or micropin 152 from valve 168 Formula.Bow-shaped arm has the groove 174 (for example, with reference to Fig. 2) formed wherein.In order to arrange between valve 168 and pin manifold or micro- Fluid path between pin 152, reservoir arm sealing member 180 covering groove 174.Between reservoir 160 and micropin 152 Fluid path (be arranged in passage arm 172-such as, and shown in Fig. 8) by or phase similar to the above material for reservoir 160 Same material is constituted.Such as, passage arm 172 can be made up of the material identical with vault 160, and reservoir arm sealing member 180 Can be made up of the material identical with reservoir arched sealing member 164.According to an embodiment, two passage arms 172 both function as Fluid path between valve 168 and pin manifold or micropin 152.According to another embodiment, in passage arm 172, only one is used as fluid Path, and remaining passage arm 172 provides structure support.In such an embodiment, groove 174 only will be used as fluid road The passage arm 172 in footpath extends fully into pin manifold or micropin 152 from valve 168.
Passage arm 172 must be sufficiently flexible to bear activating force.The position of the passage arm 172 in comparison diagram 2 and Fig. 8, when When micropin 152 is driven in patient skin (being described in more below), passage arm 172 is (by reservoir arm sealing member in Fig. 2 180 cover, and for the sake of clarity, reservoir arm sealing member 180 is removed in fig. 8) elastic deformation.During this deformation, logical Road arm 172 must be maintained between the integrity of the fluid path between valve 168 and pin manifold or micropin 152.It addition, for passage The material of arm 172 meets various biocompatibility and storage test.Such as, as shown in following table 1, when in infusion device Tolerant when including insulin, the dominant touch material in reservoir 160 include linear low density polyethylene, cyclic olefine copolymer and Teflon, and also be able to include transparent plastics clearly.Residual stream between the micropin 152 of reservoir 160 and pin manifold Dominant touch material in dynamic path (passage 62) include COC and/or medical grade acrylic acid, LLDPE, TPE and rustless steel and Pin binding agent.
Table 1
More specifically, micropin 152 can be made up of rustless steel, and pin manifold can be by polyethylene and/or medical grade propylene Acid is constituted.This material is preferably surveyed by ISO 10-993 biocompatibility when extending contact with the content of reservoir Examination.
The valve 168 being arranged between reservoir 160 and passage 172 is optionally allowed and limits reservoir 160 and passage Fluid flowing between 172.Valve 168 is preactivate position (such as, shown in Fig. 2, Fig. 3 and Fig. 6) with activation position (such as, Shown in Fig. 8-Figure 10) between move.When being in activation position, the fluid stream between reservoir 160 and passage 172 allowed by valve Move and thus allow and flow to the fluid of pin manifold and micropin 152.
In use, valve 168 will be finally pushed in activation position by the motion of activator appliance button 128, and this is by valve 168 Motion between Fig. 5 and Figure 10 most preferably illustrates.As shown in Figure 10, the motion of valve 168 makes the enlarged distal tip portion row of valve 168 Enter, thus allow that medicine and is downward through fluid path to arrive pin manifold in reservoir 160 flow channel 172.
Above-described embodiment includes at least pin 152 or micropin 152, but may comprise some (such as two) diagram Micropin 152.Every micropin 152 is preferably at least 31 dividers (gauge) or the least such as 34 dividers, and be anchored at can It is arranged as in the patient's pin manifold being in fluid communication with reservoir 160.Micropin 152 is when infusion device 100 includes more than one It also is able to the combination with different length or divider or different length and divider, and one can be comprised along body length Individual or multiple ports, described port is preferably provided near the needle point of micropin 152 or pinpoint inclined plane (if arbitrary micropin 152 There is one) near.
According to an embodiment, the divider of micropin 152 controls the transfer rate of the reservoir contents of infusion device 100. When more defeated than carrying out on generally longer with the period that middle injector injection (needing bigger needle guard or pin) the is associated period During note, using multiple 34 dividers 152 is practical to carry reservoir contents.In the disclosed embodiment, it is possible to use target Be any micropin 152 of Intradermal or subcutaneous space, but diagram embodiment include length between 1mm and 7mm (such as, Intradermal micropin 152 4mm).The layout of micropin 152 can be linearly or nonlinearly array, and can include as by specific should With required any number of micropin 152.
As above-mentioned, micropin 152 is positioned in pin manifold.In pin manifold, every micropin 152 is provided with at least one fluid even Path or passage 172.Manifold can only have single path for one or more micropins 152, or can arrange and will store Storage content is routed to multiple fluid paths or the passage of every micropin 152 dividually.These paths or passage are all right Including the crooked route advanced for content, thus affect fluid pressure and transfer rate, and as flow limiter.Position Path in pin manifold or passage can depend on application and to width, the degree of depth and configuration set point, wherein channel width Typically range between 0.015 inch and 0.04 inch, it is therefore preferable to 0.02 inch, and be configured to reduce dead in manifold Angle.
According to an embodiment, reservoir sub-component 120 has pair of holes 184 and 188 to help reservoir sub-component 120 Position about bottom enclosure 104.First post 192 of bottom enclosure 104 and the second post 196 (being described in more below) are inserted through Corresponding hole 184 and 188.
In the exploded view that reservoir sub-component 120 is removed, Fig. 4, Fig. 7 and Fig. 9 illustrate bottom enclosure 104 and include base This cylindrical shell 200, pressing spring 140 and plunger 144 are arranged in this cylindrical shell 200.According to an embodiment, circle Barrel-type casing 200 includes multiple recess channel 204, multiple with the correspondence guiding plunger 144 when plunger moves in housing 200 Lower limb 208 and foot 212.Lower limb 208 and foot 212 collectively form plunger projection 214.Such as, as shown in Fig. 4, Fig. 7 and Fig. 9, depression is logical Road 204 extends from the part in the path of the top down of cylindrical shell 200 only along cylindrical shell 200.Logical in depression Road 204 opening 216 is arranged below, the foot 212 of plunger 144 can be extended to outside cylindrical shell 200 by opening 216 Side.Opening 216 is substantially L-shaped, have the horizontal component at the base portion being positioned at cylindrical shell 200 and with recess channel 204 base The vertical portion of this alignment.
When infusion device 100 is in pre-activated state, pressing spring 140 is compressed (such as, such as Fig. 4-Fig. 6 by plunger 144 Shown in), and the foot 212 of plunger 144 is substantially disposed in the horizontal component of opening 216.The power of pressing spring 140 makes plunger The foot 212 of 144 is biased against the top (such as, the ledge of cylindrical shell 200) of the horizontal component of opening 216.As below In greater detail, pressing spring 140 forms compression system to pressurize when infusion device 100 is activated together with plunger 144 Reservoir 160.
As described in more detail below, rotor 136 (such as, is schemed around the base portion of cylindrical shell 200 in preactivate position 2-Fig. 4 illustrates) rotate between position (such as, illustrating in Fig. 8-Figure 10) with activating.When rotor 136 rotates from preactivate position During to activation position, at least one the foot engagement pistons 144 engaged with the surface 220 (such as, shown in Fig. 4) of rotor 136 Foot 212 at least one and make plunger 144 rotate so that the vertical portion of foot 212 and opening 216 and recess channel 204 alignments.At this point, pressing spring 140 makes that plunger 144 moves up and foot 212 is guided by rising passway 204.
Pressing spring 140 is included in infusion device 100 to apply substantially homogeneous power to reservoir 160, with by content Thing expels from reservoir 160.Pressing spring 140 is used for storing energy, and it is releasing pine moment pressurizing reservoir in use 160.Pressing spring 140 is kept under compression by the joint between foot 212 and the cylindrical shell 200 of plunger 144.This connects Closing prevents pressing spring 140 from putting stress upon the film (described below) of reservoir 160 or any remaining dress at memory period Put on parts (in addition to bottom enclosure 104 and plunger 144).Plunger 144 is sufficiently rigid with opposing spring tension and deformation, and And should not lose efficacy under common load.
As above-mentioned, when rotor 136 rotates to activation position from preactivate position, rotor 136 and the foot 212 of plunger 144 In at least one engage, and make plunger 144 rotate so that the vertical portion of foot 212 and opening 216 and recess channel 204 Alignment.The pressing spring 140 of compression makes plunger 144 move up subsequently, and exerts a force to the film of reservoir 160 for this On.Pressing spring 140 can be configured to preferably produce from about 1psi to the pressure of about 50psi in reservoir 116, and And more preferably from about 2psi to the pressure of about 25psi for the intradermal delivery of reservoir contents.For percutaneous Injection or infusion, about 2psi to the scope of about 5psi can be enough.
According to an embodiment, activator appliance button 128 includes patient interface surface 132, and patient urges this surface 132 to swash Infusion device 100 alive.Activator appliance button 128 also includes hinge arms 224 and activation arms 228 (such as, all figure 3 illustrates).Swash The hinge arms 224 of device button 128 alive includes the cylindrical portion with opening.Activation arms 228 include protruding 230 (for example, with reference to Fig. 3).According to an embodiment, protruding 230 include load-bearing surface 232 and are set to the cantilevered end phase with load-bearing surface 232 Adjacent locking surface 234.According to an embodiment, protruding 230 and the major part formation acute angle of activation arms 228.
The first post 192 being arranged in bottom enclosure 104 upwardly extends from bottom enclosure 104.According to an embodiment (example As, as shown in figs. 4 and 7), the base portion of the first post 192 includes a pair planar side 236 and a pair circular side 240.It addition, example As, as shown in figs. 4 and 7, the second post 196 and the first and second driving spring base portions 244 and 248 are from bottom enclosure 104 Upwardly extend.As will be described in more detail below, the first and second driving spring base portions 244 and 248 anchor driving spring 148 Corresponding end.First driving spring base portion 244 is set to adjacent with the second post 196 and has space between which.
According to an embodiment, Fig. 3 and Fig. 6 illustrates the activator appliance button 128 position relative to bottom enclosure 104, with For assembling activator appliance button 128.In this position, the opening of the cylindrical portion of hinge arms 224 makes the activator appliance button 128 can Level is slided (through planar side 236) and engages with the first post 192.Hinge arms 224 (and thus activator appliance button 128) It is then able to rotate around the first post 192.When activation arms 228 moves between the second post 196 and the first driving spring base portion 244 Space in time, protruding 230 and activation arms 228 at least one elastic deformation, until the load-bearing surface 232 of protruding 230 Cantilevered end is till the holding surface 252 of the second post 196.The cantilevered end of the load-bearing surface 232 of protruding 230 is moved Locking surface 234 and holding surface 252 through the holding surface 252 (for example, with reference to Fig. 4) of the second post 196 and projection 230 Joint provide and express activator appliance button 128 and be in the audition click sound of preactivate position and sense of touch feedback.
Referring back to Fig. 2-Fig. 4 and Fig. 7-Fig. 9, rotor 136 comprises additionally in activation protuberance 256 and driving spring keeps Device 260.When patient urges activator appliance button 128, the activation arms 228 of activator appliance button 128 connects with activating protuberance 256 Close, so that rotor 136 rotates from preactivate position to activating position.
When rotor 136 is in preactivate position, driving spring 148 is maintained at preactivate by driving spring keeper 260 In position.It has been observed that the opposite end of the first and second driving spring base portion 244 and 248 anchoring driving springs 148.Driving At the approximately mid-point of spring 148, be provided with the substantially U-shaped protuberance as shown in such as Fig. 2 and Fig. 3, for rotor 136 Driving spring keeper 260 engages.Therefore, it is in preactivate position when rotor 136 and driving spring 148 is protected with driving spring When holder 260 engages, driving spring 148 is maintained at extended state.And when pine driving spring released by driving spring keeper 260 148 (that is, when rotor rotates the activation position of diagram to the most such as Fig. 8-Figure 10 from preactivate position), driving spring 148 Drive micropin 152 with (and by the opening in release mechanism 108, the most detailed by opening in bottom enclosure 104 300 Thin describe) extend to the outside of infusion device 100.
Thus, as will be described in more detail below, swashing of infusion device 100 is realized with single multi-functional/step process Live and excitation includes being urged activator appliance button 128 and rotor 136 due to the activation arms 228 at activator appliance button 128 by patient And the joint activated between protuberance 256 of rotor 136 and the rotation that causes.As it has been described above, the rotation of rotor 136 makes plunger 144 rotate and release pine plunger 144 with the fluid being positioned at reservoir 160 that pressurizes.It addition, the rotation of rotor 136 is by driving spring 148 release pine from driving spring keeper 260, thus drive micropin 152 to extend to the outside of infusion device 100.Single many Function/step process is additionally included in when activator button 128 is urged and makes valve 168 owing to activator button 128 engages and move valve 168 From preactivate position to the motion activating position, thus start fluid via the passage 172 stream between reservoir and micropin 152 Dynamic.
As above-mentioned, patch-like infusion device 100 also includes release mechanism 108.In order to prevent unintentionally or unexpected needlestick injury, The intentional of anti-locking apparatus recycles and in order to shield the pin of exposure, is provided with locking pin release mechanism 108.When by infusion device 100 automatically and immediately activate release mechanism 108 when patient skin surface removes.According to the enforcement being described in more below Example, flexible adhesion pad 264 is attached to the bottom of bottom enclosure 104 and divides the bottom with release mechanism 108 to divide.Adhesive pad 264 and trouble Person's skin contacts and keeps infusion device 100 the most in place during use.Such as, as in Figure 11 and Figure 12 Shown in, when being removed from skin surface by infusion device 100, release mechanism 108 extends to shield the position of micropin 152.When complete When entirely extending, release mechanism 108 locks unexpected injury that is in place and that prevent patient's pin 152 or exposure.
Generally, passive type security system is most desired.This makes device forget to be provided with in unexpected situation about removing or patient Can be from protection in the case of security step.Supply owing to a kind of typical use of this infusion device 100 is to provide usual night The human growth hormone answered, therefore, it is possible to the patient (such as child) desirably dressing this device can dress the most all night long They, even if expection conveying can complete within the time less than 10 minutes.In the case of there is no passive type system, if infusion Device 100 drops, then in micropin 152 can thrust patient or caretaker's body again.Solution is restraint during use Or including passive type security system.
About security system, there may typically be three options.First option is to be retracted in device by pin 152.Second choosing Item is that shielding pin 152 is close to eliminate, and the 3rd option is to destroy pin 152 and prevent pricking wound.Such as proactive system etc Other system utilize manually shielding and/or destroy, or use other button to press or pine is manually released in similar action Security feature.Provide below the detailed description of the passive type secured embodiment to the present invention.
The drawer type design embodiments that one secured embodiment of the present invention is passive type, encapsulate completely, such as safe machine Structure 108.Fig. 5, Figure 10 and Figure 12 be a diagram that respectively release mechanism 108 before activation, activate after and release mechanism The three-dimensional cutaway view of 108 infusion devices 100 after the expansion.
When being removed from skin by infusion device 100, flexible adhesion pad 264 (is attached to the basal surface of bottom enclosure 104 Basal surface with release mechanism 108) by pull-out release mechanism 108 and adhesive pad 264 release pine skin surface before by safety Mechanism 108 locks in place.In other words, adhesive pad is removed from skin surface required power more than launching release mechanism 108 institute The power needed.According to an embodiment, such as, as shown in Figure 13, what release mechanism 108 included contacting with patient skin is smooth Surface portion 268.Flat surfaces 268 is in following position: wherein a part (shown in broken lines in Figure 13) for adhesive pad 264 is attached Being connected to release mechanism 108 so that when infusion device 100 is removed from skin by patient, adhesive pad 264 will work to pacify Full mechanism 108 launches from infusion device 100, thus shields micropin 152, otherwise should when being removed from patient by infusion device 100 Micropin 152 will expose.When release mechanism 108 is fully extended, release mechanism 108 locks meaning that is in place and that prevent micropin 152 Outer injury or exposure.
According to an embodiment, adhesive pad 264 is set to basic two parts, an end table being positioned at bottom enclosure 104 In the major part in face, and on a basal surface being positioned at release mechanism 108.When infusion device 100 is removed, two pasters are only Vertical mobile and release mechanism 108 can rotate relative to bottom enclosure 104.According to another embodiment, two parts are formed as The flexible adhesion pad 264 of integral type, in the major part of the basal surface that one of them part is arranged on bottom enclosure 104, and one Part is arranged on the basal surface of release mechanism 108.
According to an embodiment, release mechanism 108 is metallic stamping pieces.According to another embodiment, release mechanism 108 by with The essentially identical material of bottom enclosure 104 is made.As shown in Figure 14, release mechanism 108 includes front shielding part 272, is arranged on A pair insertion projection 276 of the office, rear portion of release mechanism 108, it is separately positioned on marginal portion 284 upper of release mechanism 108 A pair pivot protrusion 280 at rearward end, from the upwardly extending guide post of bottom interior surface of the substantially flat of release mechanism 108 288 and also from the upwardly extending locking column of bottom interior surface 292 of release mechanism 108.Front shielding part 272 is in marginal portion Extend on 284 to make patient shield with micropin 152 when launching release mechanism 108.Guide post 288 includes the recess being located therein To keep protuberance 296 (such as, shown in Fig. 7 and Fig. 9) when rotor 136 is in preactivate position with the safety of rotor 136 Engage, to prevent release mechanism 108 from launching before the activation of infusion device 100.
It addition, as above-mentioned, release mechanism 108 includes pin opening 156.Before launching release mechanism 108, pin opening 156 Least partially overlapped with the opening 300 in bottom enclosure 104 to provide the space for micropin 152 motion.Locking column 292 is respectively It is set to adjacent with the forward edge of pin opening 156.Bottom enclosure 104 includes that guide post opening 304 is (such as, in Fig. 7 and Fig. 9 Shown in), be set to opposite side edge adjacent pair with bottom enclosure 104 and insert bump openings 308 (such as, shown in Fig. 4 One of them) and a pair pivot seat 312 (such as, Fig. 7 and Tu being arranged in the opposite sides of bottom enclosure 104 Shown in 9).
Referring again to Figure 14, insert protruding 276 and respectively include coupling part 316 and extension 320.According to an enforcement Example, coupling part 316 from the bottom interior surface of release mechanism 108 towards the rear of infusion device 100 with about release mechanism 108 Bottom interior surface become non-perpendicular angle to extend.Extension 320 each from extension 320 towards the phase of release mechanism 108 Should essentially perpendicularly extend in outside.In order to release mechanism 108 is assembled in bottom enclosure 104, release mechanism 108 is remained Become the angle of about 45 ° about bottom enclosure 104, and insertion protruding 276 is inserted through insertion bump openings 308.Subsequently Release mechanism 108 is rotated to a position so that guide post 288 is inserted through guide post opening 304, and release mechanism 108 Bottom interior surface be basically parallel to the basal surface of bottom enclosure 104 and contact with this basal surface.
Referring again to Fig. 7 and Fig. 9, although these views illustrate is in the rotor 136 activated in position, but Fig. 7 and The resolution characteristic of Fig. 9 is easy to this stage that release mechanism 108 is assembled in bottom enclosure 104 by diagram.It is to be understood, however, that It is, it should before activation release mechanism 108 is assembled in bottom enclosure.As shown in Figure 4, at release mechanism 108 upwards After rotation, release mechanism 108 is moved rearwards by relative to bottom enclosure 104 so that pivot protrusion 280 crosses pivot seat 312 Corresponding leading edge and be arranged on pivot seat 312 top, locking column 292 is set to the opening 300 with bottom enclosure 104 Lateral edges adjacent, and rotor 136 safety keep protuberance 296 engage with guide post 288.
Being back to Figure 14, each in locking column 292 includes from the flat bottom inner surface of release mechanism 108 the most vertical The cylindrical extension 324 directly extended and the wedge-like portion 328 of the end being arranged on cylindrical extension 324.Work as wedge shape When the height of part 328 increases relative to the bottom interior surface of release mechanism 108, the width of wedge-like portion 328 increases.
When release mechanism 108 launches and is rotated down relative to bottom enclosure 104, wedge-like portion 328 is against outside bottom The respective side edge of the opening 180 of shell 104, thus cause locking column 192 elastic deformation toward each other.When release mechanism 108 is complete When entirely launching, protruding 280 become resting against in pivot seat 312.It addition, the top edge of wedge-like portion 328 is through opening 300 Feather edge, and locking column 292 skips back to its basic undeformed state, thus provide audition click sound and sense of touch feedback to express Release mechanism 108 is fully expanded and thus micropin 152 is capped.Being back to Figure 11 and Figure 12, once release mechanism 108 is complete Complete launch and locking column 292 has skipped back to its basic undeformed state, the top edge of wedge-like portion 328 just with opening 300 phase Adjacent ground engages with the basal surface of bottom enclosure 104, thus prevents release mechanism 108 from rotating up relative to bottom enclosure 104, And prevent micropin 152 from exposing.It addition, as above-mentioned, front shielding part 272 makes patient shield with micropin 152.
Therefore, release mechanism 108 is arranged to the passive type secured embodiment of single-piece, and provides under manpower load not The good locking that can damage.Use this passive type release mechanism, do not have other power to be applied on skin during injecting, And after usage micropin 152 is retained securely in infusion device 100.
After infusion device 100 uses, patient can check again for device to guarantee that whole dosage is carried.With regard to this Speech, as shown in Figure 15 A-Figure 15 D, infusion device 100 includes dosage end indicator (EDI) 124.EDI 124 includes main body 332 and the first and second arms 336 and 340 of extending relative to the top basic horizontal of main body 332.
EDI 124 also includes the spring arm 344 that the top of 332 from main body is bent upwards.According to an embodiment, spring Arm 344 is pushed against the bottom side of reservoir sub-component 120, so that EDI 124 is towards bottom enclosure 104 elastic biasing, with really Guarantor such as will not move freely through out infusion device 100 in the transport of infusion device 100 and disposal period EDI 124.
Being back to Fig. 4, main body 332 is arranged in EDI passage 348 and the most generally vertically moves.EDI passage Adjacent with in the recess channel 204 of the lower limb 208 guiding plunger 144 and foot 212.First arm 336 extends across this depression The top of passage 204.
Being back to Figure 15 A, vertical extrusion 352 upwardly extends from the end of the second arm 340.When by reservoir content During thing output, vertical extrusion extends through the EDI opening 356 (for example, with reference to Figure 15 C) in top casing 116, to have expressed Terminate through arriving at dosage.According to an embodiment, EDI 124 is formed as one-piece construction.
As shown in Figure 15 B, when plunger 144 after the activation due to pressing spring 140 in cylindrical shell 200 to During upper traveling, in the foot 212 of plunger 144 contacts with first arm of EDI 124.The phase is carried at reservoir contents Between, foot 212 is by EDI 124 upwards lifting, thus overcomes the biasing of spring arm 344, and causes vertical extrusion 352 gradually to prolong Extend through EDI opening 356.Referring back to Figure 10, vertical extrusion 352 partly extends from infusion device 100.Once reservoir The conveying of content completes and plunger has been carried out its complete stroke, and vertical extrusion 352 is the most fully extended, as Figure 15 D Shown in.Thus, EDI 124 uses the linear movement of plunger 144 to produce the linear movement of EDI 124, the line of this EDI 124 Property motion can be visible in the outside of infusion device 100, thus express the conveying of reservoir contents.
Figure 16 illustrates the embodiment of the infusion device 400 with injection port 404.Injection port provides emptying or portion Point reservoir 408 close filled so that the combination of material or material can be injected into reservoir by patient before activation In.Alternatively, pharmaceutical production person or pharmacists can use injection port 404 to use the group of material or material before being sold Close and fill infusion device 400.At other aspects nearly all, infusion device 400 is similar to previously described infusion device 100.
The operation of infusion device 100 be will now be described.The above embodiment of the present invention preferably includes button, and (activator appliance is pressed Button 128) design, wherein, infusion device 100 can position and be attached to skin surface, and by urging activator appliance button 128 And energized and/or activation.More specifically, at first step, patient's moving-out device and moving from aseptic packaging (not shown) Pine lining (in greater detail below discuss) is released except adhesive pad 264.Patient also removes needle cover 114 (discussing the most in more detail below). When infusion device 100 is removed from the package and before the use (for example, with reference to Fig. 1, Fig. 2, Fig. 4 and Fig. 5), it is in pre-sharp The infusion device 100 of the state of living enables the patient to check device and content therein, including check lose or damage parts, The medicament of Expiration Date, atomization or color offset, etc..
Next step is that infusion device 100 is positioned and is applied on the skin surface of patient.As patche, patient Compel securely to be pressed on skin by infusion device 100.The side of adhesive pad 264 is attached to basal surface and the peace of bottom enclosure 104 The basal surface of full mechanism 108, and infusion device 100 is fixed to the skin of patient by the opposition side of adhesive pad 264.In optional enforcement In example, adhesive pad 264 can be by the basal surface of the basal surface and release mechanism 108 that are applied directly to bottom shell 104 Bonding part substitutes.This bonding part will be covered by releasing pine lining before infusion device 100 uses.These (bottom enclosure 104 Hes Release mechanism 108) basal surface can be smooth, curve or shape in any suitable manner, and adhesive pad 264 are fixed on these basal surfaces.As discussed in more detail below, according to an embodiment, before transportation, pine lining is released (such as film) is applied on the patient-side of adhesive pad 264, during transportation to protect bonding part.As above-mentioned, before the use, Patient is peeled off and is released pine lining, arranges so that adhesive pad 264 (or bonding part) exposes for against skin.
After removing and releasing pine lining, infusion device 100 can be arranged by patient against skin, and urges to guarantee to fit When attachment.As above-mentioned, the most suitably position, just activate this device by urging activator appliance button 128.This activation step is released Pine plunger 144 and pressing spring 140, so that plunger 144 can be urged against flexible membrane (the reservoir arch of reservoir 160 Sealing member 164), thus pressurizing reservoir.This activation step is additionally operable to protect driving spring 148 from the driving spring of rotor 136 Holder 260 releases pine, thus drives micropin 152 to extend (by the opening 300 in bottom enclosure 104 and the pin of release mechanism 108 Opening 156) to the outside of infusion device 100 and micropin 152 is rested in the patient.It addition, activate step to make 168 dozens, valve Open, thus set up between reservoir 160 and micropin 152 via the fluid communication road of passage 172 (for example, with reference to Fig. 8-Figure 10) Footpath.Significantly benefit stems from the ability of each realizing in these actions with single button operation.It addition, another is significant Benefit includes using the continuous fluid communication path being entirely included in reservoir sub-component 120.
Once be activated, patient typically within a period of time (such as ten minutes to 72 hours) by infusion device 100 retain the conveying completely for reservoir contents of in place or object wearing device.Patient remove subsequently with drop device and not Can have the following skin of destruction or tissue.When deliberately or surprisingly removing, one or more security features launch with shielding sudden and violent The micropin 152 of dew.More specifically, when infusion device 100 is removed from skin by patient, adhesive pad 264 makes release mechanism 108 Launch from infusion device 100, thus shield micropin 152, the otherwise micropin 152 when infusion device 100 is removed from patient Can expose.When release mechanism 108 is fully extended, release mechanism 108 lock unexpected injury that is in place and that prevent micropin 152 or Expose.But, not yet urged and micropin 152 not yet extends, no if security feature can be configured to activator appliance button 128 Launch, thus before preventing from using, release mechanism launches.After usage, patient can check again for device to guarantee whole dose Amount is carried.Such as, patient can observe the inside of reservoir by transparent vault 176 and/or check EDI 124.
Described embodiment is suitable for implementing many kinds of substance, including medicine and medicine to patient and especially human patients With agent.As used herein, medicinal agent includes being carried through body film and surface and especially has biological activity for skin Material.The example enumerated in further detail below includes antibiotic, antiviral agent, analgesics, anesthetis, fenisorex, arthritis Medicine, antidepressants, antihistaminic, antibiotic medicine, antineoplastic agent, vaccine (including DNA vaccination) etc..Can be to patient's Intradermal or subcutaneous Other materials of conveying include human growth hormone, insulin, albumen, polypeptide and fragment thereof.Albumen and polypeptide can be nature That occur, synthesis or restructuring produces.It addition, this device can use in cell therapy, such as the Intradermal at dendritic cell During infusion.Can the method according to the invention conveying other materials can be from by preventing, diagnose, alleviate, treat or controlling More choosing in the group that in disease, the medicine of use, vaccine etc. are constituted, wherein, medicine includes: α-1 antitrypsin, anti-angiogenic life Patent medicine, antisense, butorphanol, calcitonin and the like, Ceredase, COX-II inhibitor, Dermatological Agents, dihydroergotamine, many Bar amine receptor agonist and antagonist, enkephalin and other opioid peptide, epidermal growth factor, erythropoietin and similar Thing, follicule-stimulating hormone (FSH), G-CSF, glucagon, GM-CSF, granisetron, growth hormone and the like (include growth hormone Releasing hormone), growth hormone receptor antagonist, hirudin and hirudin analog (such as HIRULOG), IgE inhibitor, islets of langerhans Element, pancreotropic hormone and the like, insulin-like growth factor, interferon, interleukin, sharp lutein, human luteinizing hormone Releasing hormone and the like, low molecular weight heparin, M-CSF, metoclopramide, Midazolam, monoclonal antibody, narcosis analgesic, Nicotine, non-steroidal anti-inflammatory drug, oligosaccharide, ondansetron, parathyroid hormone and the like, parathyroid hormone receptor are short of money Anti-agent, prostaglandin antagonists, prostaglandin, recombinant soluble receptor, scopolamine, hydroxytryptamine agonist and antagonist, sulphur Acyl pyrimidine benzene, terbutaline, thrombolytics, histoplasmosis activator, TNF and TNF-antagonist;Vaccine, with or without load Body/adjuvant, (includes but not limited to protein subunit, polypeptide and polysaccharide, many including to following relevant preventative and therapeutic antigen Sugar conjugate, toxoid, vaccine based on gene, attenuated live vaccine, reassortant vaccine, deactivation vaccine, full cell, virus and Bacteria carrier): addicted, arthritis, cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease, meningitis, measles, the parotid gland Inflammation, rubella, chickenpox, yellow fever, respiratory syncytial virus, tick-borne Japanese encephalitis, streptococcus pneumoniae, streptococcus, typhoid fever, stream Sense, hepatitis (including A type, Type B, c-type and E type hepatitis), otitis media, rabies, polioencephalitis, HIV, parainfluenza virus, colyliform Virus, Epstein-Barr virus, CMV, chlamydia, typeable haemophilus, moraxelle catarrhalis, human papilloma virus, pulmonary tuberculosis (include BCG), gonorrhea, asthma, arteriosclerosis, malaria, escherichia coli, senile dementia, helicobacter pylori, Salmonella, sugar Urine disease, cancer, herpes simplex virus, human papilloma and other similar substances, including other things of all primary treatments Matter, such as common cold drug, drug-breaking medicine, antiallergic agent, Bendectin, antiadipositas drug, anti-osteoporotic, anti-infective, analgesia Medicine, anesthetics, fenisorex, anti-arthritic, anti-asthmatic, anticonvulsant, antidepressants, antidiabetic drug, antihistaminic, antiinflammatory Medicine, antimigraine, anti-motion sickness medicine, Bendectin, antineoplastic agent, anti-Parkinson syndrome medicine, antipruritic, psychosis, solution The medicine of a warm nature, anticholinergic agent, benzodiazepine receptors antagonist, vasodilation (include general blood vessel, coronary artery, external perihaemal canal and Cerebrovascular), osteo stimulative agent, central nervous system stimulant, hormone, sleeping pill, immunosuppressant, muscle relaxant, parasympathetic Nerve block medicine, parasympathomimetic agent, prostaglandin, albumen, peptide, polypeptide and other macromole, analeptic, tranquilizer, property Hypofunction and tranquilizer and Main Diagnosis are such as such as the United States Patent (USP) in entitled " method of intradermally injecting substances " No.6, the tuberculin described in 569,143 and other allergy medicaments, the full content of this patent is clear and definite by the way of reference It is expressly incorporated herein.
Can system and a method according to the invention conveying vaccine formulation can be from by eliminating human body cause of disease Choosing in the group that the antigen of immune response or antigenic component are constituted, this antigen or antigenic component stem from HIV-1 (such as broken wound Wind antitoxin, nef, gp120 or gp160), nerpes vinrus hominis (HSV) (such as gD or derivatives thereof, or early protein immediately For example originating from the ICP27 of HSV1 or HSV2), cytomegalovirus (CMV (espespecially people) (such as gB or derivatives thereof), colyliform Virus (include activity attenuated virus), Epstein-Barr virus (such as gp350 or derivatives thereof), varicella zoster virus (VZV, such as GpI, II and IE63) or stem from hepatitis virus (such as hepatitis virus B (such as HbsAg or derivatives thereof), Hepatitis A virus (HAV), hepatitis C virus and E Hepatitis virus);Or stem from other viral pathogens such as hepatitis virus Paramyxovirus: respiratory syncytial virus (RSV, such as F and G-protein or derivatives thereof), parainfluenza virus, Measles virus, the parotid gland Scorching virus, human papilloma virus (HPV, such as HPV6, HPV11, HPV16, HPV18), banzi virus (such as, yellow fever virus, Dengue virus, tick-brone encephalitis virus, Japanese encephalitis virus) or influenza virus (full activity or inactivation of viruses, cracking influenza virus (in ovum or mdck cell grow) or full influenza virus particles or its purification or recombiant protein (such as HA, NP, NA or M albumen or a combination thereof));Or stemming from bacterial pathogen, such as neisseria, including Diplococcus gonorrhoeae and meningitis Neisser Bacterium (join by such as capsular polysaccharide and conjugate thereof, transferrin binding protein, breast iron-binding protein, PiLC, bacterial cell surface Base);Micrococcus scarlatinae (such as M albumen or its fragment, C5A protease, lipoteichoic acid), streptococcus agalactiae, Streptococcus mutans; Haemophilus ducreyi;Moraxella, including this Salmonella of mucositis Morakot, also referred to as branhamella catarrhalis (such as, high molecular and the adhesins of low-molecular-weight and invasion);Bordetella, including bacillus pertussis (such as pertactin, pertussis toxin, PT or derivatives thereof, filamentous hemagglutinin, adenyl cyclase, pili), secondary hundred Day coughs Bordetella and bordetella bronchiseptica;Mycobacterium, including mycobacterium tuberculosis (such as ESAT6, Antigen 85A, 85B or 85C), Mycobacterium bovis, Mycobacterium leprae, shame dirt paratuberculosis mycobacteria, mycobacterium paratuberculosis, Smegma bacillus;Legionnella, including legionella pneumophilia;Escherichia, including escherichia coli (such as colonization factor, Heat strangles toxin or derivatives thereof, heat-stable toxin or derivatives thereof), enterohemorrhagic Escherichia coli, enteropathogenic E.Coli (example As congratulated endotoxin toxin or derivatives thereof);Vibrio, including vibrio cholera (such as cholera toxin or derivatives thereof);Will Hayes Bacillus, including Shigella sonnei, dysentery bacterium, Shigella flexneri;Yersinia's genus, including Yersinia enterocolitica (the most firelight or sunlight albumen), bacillus pestis, artificial tuberculosis yersinia genus;Campylobacter is (such as toxin, thin including campylobacter jejuni Bacterium cell surface ligand and invasion) and campylobacter coli;Salmonella belongs to, including Salmonella typhi, paratyphoid A sand Door bacterium, Salmonella choleraesuis, Salmonella enteritidis;Listeria, including Listeria monoeytogenes;Helicobacter, Including helicobacter pylori (such as urase, catalase, VacA);Rhodopseudomonas, including bacillus pyocyaneus;Fructus Vitis viniferae ball Pseudomonas, including staphylococcus aureus, staphylococcus epidermidis;Enterococcus, including enterococcus faecalis, enterococcus faecalis;Fusobacterium, bag Include clostridium tetani (such as tetanus toxin and derivant thereof), bacillus botulinus (such as Botulinum toxin and derivant thereof), Clostridium difficile (such as, clostridial toxins A or B and derivant thereof);Bacillus, including Bacillus anthracis (such as botulinum toxin and derivant thereof);Corynebacterium, including diphtheria corynebacterium (such as diphtheria toxin, diphtherotoxin and derivant thereof);Bao Rou Family name's Spirochaetes, including Bai Shi Borrelia (such as OspA, OspC, DbpA, DbpB), Borrelia garinii (such as OspA, OspC, DbpA, DbpB), A Fuxini burgdorferi (such as OspA, OspC, DbpA, DbpB), Anderson burgdorferi (such as OspA, OspC, DbpA, DbpB), borrelia hermsii;Ehrlichia, including Ehrlichia equi and human granular leukocyte Property the sick medicament of Paul Ehrlich body;Rickettsiae, including rickettsia rickettsii;Chlamydiaceae, including chlamydia trachomatis (such as MOMP, hepatic binding protein (HBP)), Chlamydia pneumoniae (such as MOMP, hepatic binding protein (HBP)), chlamydia psittaci;Leptospira Belong to, including leptospria interrogans;Close rotation body belongs to, including Treponoma palladium (such as, rare outer membrane protein), the tooth close spiral shell of dirt Rotation body, treponema hyodysenteriae;Or stem from parasite, such as Plasmodium, including plasmodium falciparum;Toxoplasma, Including toxoplasma gondii (such as SAG2, SAG3, Tg34);Entamoeba, including Entamoeba histolytica;Babesia, including Babesia microti;Trypanosoma, including schizotrypanum cruzi;Giardia, including Giardia lamblia;Leishmania, including large Big leishmania;Pneumocystis, including pneumocystis pneumoniae;Trichomonas, including trichomonal vaginitis;Schistosomicide, including Man Schistosomicide;Or stem from yeast, such as Candida, including Candida albicans;Cryptococcus, including cryptococcus;As PCT Patent Application at entitled " vaccine delivery system " is announced described in No.WO 02/083214, this application whole interior Hold and be expressly incorporated herein by the way of reference.
These also include for other preferred specific antigens phthisical, such as Tb Ral2, Tb H9, Tb Ra35, Tb38-1, Erd 14, DPV, MT1, MSL, mTTC2 and hTCC1.Fusion protein and change thereof is also included for phthisical albumen Kind, the most phthisical at least two, preferred three peptide fusion are bigger albumen.Preferably merge and include Ra12- TbH9-Ra35、Erd14-DPV-MT1、DPV-MT1-MSL、Erdl4-DPV-MT1-MSL-mTCC2、Erd14-DPV-MT1- MSL, DPV-MT1-MSL-mTCC2, TbH9-DPV-MT1.Most preferably include such as high molecular egg for chlamydial antigen (HWMP), ORF3 and supposition memebrane protein (Pmps) in vain.Preferably bacterial vaccine includes the antigen stemming from Streptococcus, including Streptococcus pneumoniae (such as capsular polysaccharide antigen and conjugate thereof, PsaA, PspA, streptolysin, choline binding protein) and Proteantigen pneumolysin (Biochem Biophys Acta, 1989,67,1007;Rubins et al., Microbial Pathogeneisi, 25,337-342 (biochemistry and biophysics document, 1989,67,1007;Lu Bin etc., Microorganism pathogeny, page 25,337-342)) and sudden change detoxified derivaties thereof.Other preferred bacterial vaccines include being derived from In the antigen of haemophilus, including Type B hemophilus influenza (" Hib ", such as PRP and conjugate thereof), typeable influenza addicted to Blood bacillus (such as OMP26, high molecular bacterial cell surface adhesins, P5, P6, D albumen and L lipoprotein), And fimbrin and fimbrin derivant peptide or its multiple copy mutation or fusion protein.Spreading out of HbsAg Biology is well known in the art, and includes PreS1, PreS2S antigen etc..A preferred aspect, the present invention's Vaccine formulation includes HIV-1 antigen, gp120, particularly when expressing in Chinese hamster ovary celI.In a further embodiment, the present invention Vaccine formulation include gD2t as defined above.
In addition to the material that conveying is listed above, infusion device 100 also is able to for extracting material, or prison from patient Control material level in patients.The example of the material that can be monitored or extract includes blood, interstitial fluid or slurry.Taken out The material taken subsequently can be analyzed for analyte, glucose, medicine etc..
As above-mentioned, according to an embodiment, infusion device 100 includes that needle cover 114 and the pine of releasing for adhesive pad 264 serve as a contrast In.Needle cover 114 was removed before the use of infusion device 100 with releasing pine lining.It addition, needle cover 114 and release pine lining from Infusion device 100 removes and abandons afterwards.One solution is by needle cover and to release pine lining combination so that removing also of needle cover Remove and release pine lining.Another solution is by needle cover and to release pine lining combination so that releases removing of lining of pine and also removes needle cover. Alternatively, needle cover also is able to abandon with releasing pine lining simultaneously.
Figure 17 illustrates the adhesive pad 264 of infusion device 100 and bonds the embodiment releasing pine lining 500, and Figure 18 diagram The pin covering part 112 of needle cover 114.It addition, Figure 19 illustrates needle cover 114A (including pin covering part 112) and releases pine lining The embodiment of 500.As shown in Figure 17, adhesive pad 164 includes needle cover opening 504, and releases pine lining 500 and include liner opening 508.Figure 18 illustrates the eyelet 512 and shoulder or flange 520 that pin covering part 112 includes having perforated openings 516.As front Stating, according to an embodiment, pin covering part 112 is attached to pin manifold via press-fit.Although Figure 17 and Figure 18 is not identical Ratio, but liner opening 508 is less than flange 520 more than eyelet 512, and thus eyelet 512 is inserted into through lining Opening 508 so that flange 520 contacts with releasing pine lining 500.It addition, needle cover opening 504 is more than the horizontal stroke of pin covering part 112 Cross section so that whole pin covering part 112 is inserted into through needle cover opening 504.
As shown in Figure 19, needle cover 114A includes pin covering part 112 and keeps part or pull bossing 524.Draw Dynamic bossing 524 includes that be inserted in perforated openings 516 pulls protruding arm 528.Figure 19 illustrates at eyelet 512 After being inserted through liner opening 508, once pull protruding arm 528 to insert perforated openings 516, pull bossing 524 just will Release pine lining 500 to be maintained in needle cover 114A.According to an embodiment, eyelet 512 and pull at least in bossing 524 Individual sufficiently flexible so that after pulling protruding arm 528 to insert in perforated openings 516, pull the bossing 524 can be from such as In Figure 19, the position of diagram rotates about 90 °, to reduce the external dimensions of infusion device 100 or profile for packaging.It addition, Although pulling bossing 524 to rotate forward or backward, but pull bossing 524 towards activator appliance button 128 (with In Figure 20 B, the embodiment of diagram is similar) rotation more effectively reduce the exterior contour of infusion device 100.
In order to install the embodiment of diagram in Figure 19, pin covering part 112 is inserted through pin opening 156 and via being press-fitted Conjunction is attached to pin manifold so that eyelet 512 extends to the outside of infusion device 100.Subsequently, adhesive pad 264 is attached to outside bottom Shell 104 and release mechanism 108 so that the needle cover opening 504 of adhesive pad 264 is the most corresponding with pin opening 156.It addition, release pine lining In 500 be attached to adhesive pad 264 so that eyelet 512 is inserted through liner opening 508 and releases pine lining 500 and flange 520 phase Contact.It should be appreciated that adhesive pad 264 can apply with releasing pine lining 500 in single operation.Next step, pull projection Arm 528 is inserted through perforated openings 516, thus fixes and release pine lining 500, and will release pine lining 500 and the combination of needle cover 114A.
Releasing pine lining 500 and needle cover 114A to remove, patient grasps and pulls bossing 524.Owing to releasing pine Lining 500 is maintained at and pulls between bossing 524 and flange 520, therefore by this individual part of patient not only by pin Lid 114 removes from pin manifold, and will release pine lining 500 and remove from adhesive pad 264.Exist further, since release pine lining 500 Removing to be maintained at afterwards from infusion device 100 and pull between bossing 524 and flange 520, therefore patient can be easily That abandons combination releases pine lining 500 and needle cover 114A.
Similar to the embodiment of Figure 19, Figure 20 A-Figure 20 C illustrates the embodiment of needle cover 114B.In this embodiment, as Shown in Figure 20 A, pull bossing 532 to have and pull protruding arm 536, pull protruding arm 536 at adhesive pad 264 and to release pine lining In 500 install after insert eyelet 512 perforated openings 516 in.But, compare with the embodiment of Figure 19, pull bossing 532 is substantially flat.As illustrated in figure 2 ob, this flat configuration provides profile less compared with the embodiment of Figure 19, from And need the less big envelope for packaging.It addition, during assembly, the configuration pulling bossing 532 as illustrated in figure 2 ob Can reduce the lateral stress for needle cover 114B, it is close that this can advantageously ensure that between pin covering part 112 and pin manifold Envelope.
It addition, according to an embodiment, scale is right to contribute to pulling on bossing 532 to pull protruding arm 536 to include Accurate at the primary importance substantially aligned with pin covering part 112 and the second substantially parallel with the basal surface of bottom enclosure 104 In putting.Figure 20 C illustrates and releases pine lining 500 and needle cover 114B in the combination removed from infusion device 100 and prepare to abandon.
Figure 21 A and Figure 21 B illustrates needle cover 114C and releases another embodiment of pine lining 560.Release pine lining 560 to include drawing Dynamic protruding 564.It addition, needle cover 114C includes pin covering part 112 and clip part 568.Clip part 568 includes a pair cantilever Formula card wing clamping part 572.Each in card wing clamping part 572 can elastic deformation and have inclined plane so that when clip part Time in 568 insertion perforated openings 516, inclined plane engages with eyelet 512 and contacting between them makes card wing clamping part 572 gradually Deformation.After the tail edge of inclined plane moves through perforated openings 516, it is corresponding that card wing clamping part 572 is back to it substantially Not deformed position, thus clip part 568 is locked in eyelet 512, and pine lining 560 will be released be maintained at clip part Between 568 and flange 520.
Releasing pine lining 560 and needle cover 114C in order to remove combination, patient grasps and pulls that to release pulling of pine lining 560 convex Play 564.Being maintained between clip part 568 and flange 520 owing to releasing pine lining 560, this individual part will release pine lining 560 Remove from infusion device 100 with needle cover 114C.Figure 21 B illustrates after removing from infusion device 100 and prepares to abandon Combination release pine lining 560 and needle cover 114C.
Compare with Figure 18, Figure 19, Figure 20 A-Figure 20 C, Figure 21 A and Figure 21 B, at Figure 22 A-Figure 22 D, Figure 23 A, Figure 23 B, figure 24, in Figure 25 A and Figure 25 B the needle cover of diagram each in, pin covering part and pull bossing to be formed integrally as list One structure.Such as, Figure 22 A-Figure 22 D illustrates needle cover 114D including pin covering part 112D He pulling bossing 580, institute State pin covering part 112D and pull bossing 580 to be connected by hinges, and be thus formed integrally as single knot Structure.Hinges can be set to the thin flexiplast part being attached to by the plastic part that two are more rigid together, thus More rigid part is enable relative to each other to rotate so that hinges is rotation axis.In other words, the thin support plate of hinges (web) provide for the rotation between the component being connected by hinges.Such as, as shown in Figure 22 B and Figure 22 C, movable Hinge makes to pull the bossing 580 can be in the primary importance (Figure 22 B) being substantially directed at pin covering part 112D and distance One position is of about between the second position (Figure 22 C) of 90 ° and moves.In the second position, needle cover 114D provide less profile and Allow the less big envelope for packaging.Further, since the less profile being in the second position and configuration, needle cover 114D less may be used Can receive unexpected shock during assembly, and thus reduce the lateral stress for needle cover 114D, this can be conducive at pin Sealing between covering part 112D and pin manifold.
As shown in FIG. 22 A, a pair cantilevered pulls protruding alar part 584 to pull bossing 580 to include.Pull the protruding wing Each in portion 584 can elastic deformation and have inclined plane so that insert liner opening pulling on bossing 580 Time in 508, inclined plane with release pine lining 500 and engage and contacting between which makes to pull protruding alar part 584 gradually to become Shape.After the tail edge of inclined plane moves through liner opening 508, protruding alar part 584 is pulled substantially to be back to it corresponding Not deformed position, thus will release pine lining lock onto in needle cover 114D, and will release pine lining 500 be maintained at pull projection the wing (for example, with reference to Figure 22 A and Figure 22 D) between portion 584 and flange 520D.
Releasing pine lining 500 and needle cover 114D in order to remove combination, patient makes to pull bossing 580 to revolve from the second position Forward primary importance to so that pull bossing 580 to be substantially directed at pin covering part 112D.Subsequently, patient grasps and pulls Pull bossing 580.It is maintained at pulls between protruding alar part 584 and flange 520D owing to releasing pine lining 500, this single dynamic Make to release pine lining 500 and needle cover 114D removes from infusion device 100.Figure 22 A illustrates and is removing from infusion device 100 The combination of period release pine lining 500 and needle cover 114D.Subsequently, combination release pine lining 500 and needle cover 114D prepare be abandoned.
Figure 23 A and Figure 23 B illustrates can be with the another embodiment of needle cover 114E releasing pine lining 500 combination.Needle cover 114E includes pin covering part 112E and pulls bossing 588, pulls bossing 588 to include a pair pulling protruding hook 592. Release pine lining 500 and this can elastic deformation fully at least one pulled in protruding hook 592 so that pull protruding hook 592 are inserted into through liner opening 508.After this insertion, release pine lining 500 flange 520E with pull protruding hook It is maintained in needle cover 114E between 592.
As shown in Figure 23 A, in addition to flange 520E, pin covering part 112E also includes the post 596 extended from it, post 596 have post hook 600.Corresponding with post 596, pull bossing 588 to include slit 604.According to an embodiment, needle cover 114E is formed integrally as single structure, and pulls bossing 588 to be connected to pin covering part 112E by hinges.
When pulling bossing 588 from first be substantially directed at the main shaft or longitudinal axis of pin covering part 112E When putting the second position (Figure 23 B) that (Figure 23 A) rotates to distance primary importance about 90 °, post hook 600 and the edge of slit 600 Engage and maintain or lock in the second position for pulling on bossing 588.When being arranged on infusion device 100, The bossing 588 that pulls of needle cover 114E being configured to be in the second position provides little profile, and thus allows for wrapping The little big envelope of dress infusion device 100.It addition, during assembly, needle cover 114E being configured to be in the second position can reduce For the lateral stress of needle cover 114E, this can advantageously ensure that the sealing between pin covering part 112E and pin manifold.
In order to by combination release pine lining 500 and needle cover 114E remove from infusion device 100, first patient applies enough Power so that edge and the post hook 600 of slit 604 depart from and make to pull bossing 588 to rotate to first from the second position Put so that pull bossing 588 to be substantially directed at pin covering part 112E.Subsequently, patient grasps and pulls lobe Divide 588.Being maintained at pull between protruding hook 592 and flange 520E owing to releasing pine lining 500, this individual part will release loose lining 500 and needle cover 114E remove from infusion device 100.Subsequently, combination release pine lining 500 and needle cover 114E prepare be abandoned.
Figure 24 illustrates can be with the another embodiment of needle cover 114F releasing pine lining 500 combination.Needle cover 114F includes pin Covering part 112F and pull bossing 608, pulls bossing 608 to include a pair pulling protruding hook 612.Release pine lining 500 and this can elastic deformation fully at least one pulled in protruding hook 612 so that pull protruding hook 612 to insert Enter through liner opening 508.After this insertion, release pine lining 500 and at flange 520 and pull holding between protruding hook 612 In needle cover 114F.
According to an embodiment, needle cover 114F is formed integrally as single structure.As shown in Figure 24, bossing is pulled Main shaft or the longitudinal axis of 608 form about 90 ° of angles relative to main shaft or the longitudinal axis of pin covering part 112F.
When being arranged on infusion device 100, have and pull needle cover 114F of bossing 608 to provide little profile, and Thus allow the little big envelope for packing infusion device 100.It addition, during assembly, it is right that the configuration of needle cover 114F can reduce In the lateral stress of needle cover 114F, this can advantageously ensure that the sealing between pin covering part 112F and pin manifold.
In order to by combination release pine lining 500 and needle cover 114F remove from infusion device 100, patient grasp and pull Dynamic bossing 608.It is maintained at pulls between protruding hook 612 and flange 520F owing to releasing pine lining 500, the most this single dynamic Make to release pine lining 500 and needle cover 114F removes from infusion device 100.Subsequently, combination release pine lining 500 and needle cover 114F Preparation is abandoned.
Figure 25 A and Figure 25 B illustrates can be with another embodiment of needle cover 114G releasing pine lining 500 combination.Such as Figure 25 A Shown in Figure 25 B, needle cover 114G includes pin covering part 112G and pulls bossing 616, pulls bossing 616 to include Pull protruding hook 620 for a pair.Release pine lining 500 and at least one pulled in protruding hook 620 can elastic fully be become by this Shape so that pull protruding hook 612 to be inserted into through liner opening 508.After this insertion, release pine lining 500 and cover at pin The flange 520G of cover 112G and pulling is maintained in needle cover 114G between protruding hook 620.
According to an embodiment, needle cover 114G is formed integrally as single structure, and pulls bossing 588 by living Moving and be hingedly attached to pin covering part 112G, hinges is attached in bistable hinge.Can be at such as shampoo or cosmetic The bistable hinge found on product bottle cap keeps stable in two positions.Such as, two settling positions of needle cover 114G are: with Primary importance (Figure 25 A) that the main shaft of pin covering part 112G or longitudinal axis are directed at substantially and away from primary importance about 90 ° The second position (Figure 25 B).In the bistable hinge of needle cover 114G, thin material support plate effect spring-like, to pull on Bossing 616 is towards the first and second location bias.Such as, during rotating towards the second position from primary importance, bistable State hinge pulls on bossing 616 towards primary importance biasing until reaching to overturn point (tipping point), at this At Dian, bistable hinge pulls on bossing 616 towards second position biasing.
When being arranged on infusion device 100, needle cover 114G being configured to be in the second position pull bossing 616 provide little profile, and thus allow the little big envelope for packing infusion device 100.It addition, during assembly, it is in The configuration of needle cover 114G in two positions can reduce the lateral stress for needle cover 114G, and this can advantageously ensure that and cover at pin Sealing between part 112G and pin manifold.
In order to by combination release pine lining 500 and needle cover 114G remove from infusion device 100, first patient pulls on convex Play part 616 and rotate to primary importance from the second position so that pull bossing 616 the most right with pin covering part 112G Accurate.Subsequently, patient grasps and pulls bossing 616.It is maintained at pulls protruding hook 620 with convex owing to releasing pine lining 600 Between edge 520G, the most this individual part will release pine lining 500 and needle cover 114G removes from infusion device 100.Subsequently, group Close release pine lining 500 and needle cover 114G prepare be abandoned.
According to an embodiment, needle cover 114 (such as, needle cover 114D, 114E, 114F or 114G) is injection molding and is molded as such as The single parts of thermoplastic elastomer (TPE) (TPE).According to another embodiment, needle cover 114 (such as, needle cover 114D, 114E, 114F or 114G) form with double injection technique injection molding.Such as, the bossing 580 that pulls of needle cover 114D can be by polypropylene mould System forms, and pin covering part 112D of needle cover 114D can be molded by TPE, thus have flexibility or elastic deformability with Adapt to the press-fit with pin manifold.
It addition, according to an embodiment, when needle cover 114 is arranged on infusion device 100 (such as with pin manifold press-fit) Time, needle cover 114 and rotor 136 interlock the rotation preventing rotor 136 in needle cover 114 before removing.
As above-mentioned, needle cover 114 removed before infusion device 100 uses with releasing pine lining (such as, 500).Therefore, these Removing action can by use described embodiment be integrated in individual part, thus increase the convenience of patient, ease for use and Efficiency.It addition, by removing the company being optionally maintained in needle cover 114 afterwards and releasing between pine lining from infusion device 100 Connecing, described embodiment can be abandoned by simplifying it and increase patient convenience, usability and efficiency further.
Although some example embodiments of the present invention being described in detail above, but those skilled in the art holding Readily understood, a lot of modification are possible new teaching and advantage without substantially deviateing the present invention in the exemplary embodiment. Therefore, all these modification mean and are included in the range of claims and equivalent thereof.

Claims (1)

1. a medicament delivery device, including:
Body, described body has the reservoir being disposed therein for accommodating medicine;
Entry needle, described entry needle is for thrusting the skin of patient, and described pin provides between described reservoir and patient Path for medicine;
Needle cover, described needle cover is for optionally covering described entry needle;
Bonding part, described bonding part is for being optionally attached to patient by described device;
Release pine lining, described in release pine lining for optionally covering the patient-side of described bonding part;And
Attachment means, described attachment means is used for making described needle cover to be connected with described pine lining of releasing so that described needle cover and described Release pine lining in one from described device remove by described needle cover and described release pine lining another from described device Removing, described attachment means removes from described device to fasten institute afterwards in described needle cover and the described one released in pine lining State needle cover and described release pine lining.
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WO2006031500A2 (en) * 2004-09-10 2006-03-23 Becton, Dickinson And Company Reconstituting infusion device

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US20010025168A1 (en) * 1997-06-16 2001-09-27 Elan Corporation Plc Pre-filled drug-delivery device and method of manufacture and assembly of same
CN1671430A (en) * 2002-07-22 2005-09-21 贝克顿·迪金森公司 Patch-like infusion device
WO2006031500A2 (en) * 2004-09-10 2006-03-23 Becton, Dickinson And Company Reconstituting infusion device

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CN111867654A (en) * 2018-03-15 2020-10-30 益首药物治疗股份公司 Injection or infusion device comprising a modified release liner

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