CN102886084B - Drug delivery device - Google Patents

Drug delivery device Download PDF

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Publication number
CN102886084B
CN102886084B CN201210182317.2A CN201210182317A CN102886084B CN 102886084 B CN102886084 B CN 102886084B CN 201210182317 A CN201210182317 A CN 201210182317A CN 102886084 B CN102886084 B CN 102886084B
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CN
China
Prior art keywords
substrate
intubate
reservoir
injection portion
fluid delivery
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Active
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CN201210182317.2A
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Chinese (zh)
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CN102886084A (en
Inventor
希涅·T·梅耶勒德
拉斯·W·莫恩森
斯特芬·吉尔恩
埃洛·霍尔登
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Unomedical AS
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Unomedical AS
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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
    • A61M5/14Infusion 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
    • A61M5/14Infusion 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
    • A61M5/158Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
    • A61M2005/1581Right-angle needle-type devices
    • 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

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

Abstract

The application relates to a device for an intermittent or continuous administration of a therapeutical substance, such as insulin, comprising an injection part and a fluid delivery part (3, 4). The fluid delivery part normally comprises a reservoir (4), a delivery device e.g. in form of a pump, and a housing (3), and the injection part normally comprises a base plate (10), a cannula part (1, 1b) comprising a body providing a through-going opening leading liquid to a cannula (9), wherein the cannula (9) extends past the proximal side of the base plate and means (21) for fixation of the base plate to the skin of the user, and a flexible part is arranged in an area between the subcutaneously positioned section of the cannula (9) and the fluid delivery part (3, 4).

Description

Administration device
The application is the Chinese patent application No.200680048755.2(applying date: on December 22nd, 2006; Denomination of invention: administration device) divisional application.
Technical field
The present invention relates to equipment that is off and on a kind of or administering therapeutic material such as insulin constantly, described equipment comprises injection portion and fluid delivery part.Described fluid delivery part generally includes reservoir, the transporter of such as pump and housing, and injection portion generally includes substrate, and cannula part comprises the intubate that extends beyond substrate proximal lateral and for substrate being fixed to the device on user's skin.
Background technology
EP-A1-1.527.792 and EP-A1-1.495.775 all describes a kind of armarium, and it comprises percutaneous and enters unit and reservoir.Described percutaneous enters unit and comprises and transmit the percutaneous access device of fluid for the parts of skin through curee, and is applicable to the mounting surface that is applied in subject's skin.Storage unit comprises the reservoir being applicable to comprise fluid drug and the outlet arranged with allowing percutaneous access device and reservoir internal fluid communication.Described equipment comprises discharger, such as pump simultaneously, and fluid drug is discharged from reservoir and passed the skin of curee by percutaneous access device by this device in use.Percutaneous enters unit and storage unit comprises the coupling device that can discharge cooperation further, and it allows described storage element to be secured to percutaneous in use to enter on unit.The object of this invention is to provide a kind of can with a kind of drug delivery device easily, on the be arranged on skin that uses of cost-saving mode or system.
According to this section of document, the insertion pin (113,212 or 412) in the embodiment of description is arranged on pin enclosure interior pivotly, and it can move stretching out between advanced position.When entry needle is inserted into, it penetrates one deck barrier film to penetrate the skin of curee.After pin is inserted into, described system does not have flexible effect.
US 2004/0204673A1 describes the conveying equipment for fluid substances of a kind of lighter weight and low cost, and this equipment can adjust and plan the conveying of fluid; Described equipment comprises the housing around storage chamber.Allotter is communicated with to distribute limited amount fluid from reservoir with storage chamber fluid.Described allotter is controlled by the electronic microcontroller of conveying equipment for fluid substances.Described conveying equipment for fluid substances comprises communication member further, and it is for receiving the information from remote control device, and described remote control device is not mechanically connected with conveying equipment for fluid substances of the present invention.Also comprise the spout assembly be communicated with allotter fluid, described liquid drug leaves conveying equipment for fluid substances and percutaneous enters the health of mammalian patient from this outlet.
Housing 702 and 802 all can be made up of flexible material, maybe can be provided with and allow when patient moves the flexible hinge region that conveying equipment for fluid substances 10 is bending, thus prevent from being separated and be conducive to patient comfort, but how do not indicate this hinge area in the document should construct.
Summary of the invention
The object of this invention is to provide a kind of equipment for conveyance fluid, described equipment comprises pump, reservoir and injection portion, and in use, this equipment ensure that wearer bears less discomfort.Equipment according to the present invention be configured with transport portion touched or moving influence time reduce the device of transfer operation from from relatively heavier transport portion to injection portion.
According to claim 1, the present invention includes the equipment for conveyance fluid, this equipment comprises injection portion and fluid delivery part, and wherein said fluid delivery part comprises reservoir, the transporter of such as pump form and housing, and wherein said injection portion comprises: substrate; Cannula part, comprise the main body running through opening having and liquid is guided to intubate, wherein intubate extends beyond the proximal lateral of substrate; With the device be fixed to by described substrate on the skin of user, wherein, in the region that intubate is placed between subcutaneous part and fluid delivery part, flexible portion is provided with.
One of them part flexible means that it has elasticity, can be out of shape when not rupturing, it is nonrigid material, but be not exclusively the rigid material moving to another position from a position, it has elasticity to a certain degree, thus when external influence factor is born as thrust or pulling force effect in one end of flexible portion, these external influences can not directly be passed in intubate when intubate is inserted into, but these effects are absorbed at least in part.Flexibility both can be determined by material behavior, and can be again determined by the physical arrangement of material, such as described material can have fold etc.Because transport portion is easy to be subject to extraneous factor impact, the thrust occurred when walking up and down as user or pulling force effect, it is therefore desirable that these effects are not passed in the intubate through user's skin.Described flexible portion absorbs these effects at least in part and ensures that intubate can not be affected, and namely can not be pulled out or move everywhere thus cause discomfort or the pain of user.
According to an embodiment, described flexible portion is integrated in described substrate, according to this embodiment, and described substrate portion ground or be made up of flexible material fully.
According to the second embodiment, described flexible portion is integrated in the main body of described cannula part, wherein said main body have liquid guided to intubate run through opening, according to this embodiment, the main part ground of described cannula part or be made up of flexible material fully.
According to the 3rd embodiment, described flexible portion is integrated in described fluid delivery part.
According to the 4th embodiment, described flexible portion is be arranged on the separate unit between described fluid delivery part and described injection portion.According to this embodiment, described separate unit is partly or wholly made up of flexible material.
Described cannula part and/or substrate and/or separate unit are partly made up of flexible material, mean that a fraction of the Zone Full of described part/plate/unit is such as made from a variety of materials or is made up of the structure with such as hole, wherein this structure increases the elasticity of described material in one or more dimension.If described part/plate/unit is made up of flexible material completely, the selection of material and the size of material, thickness and/or the peripheral shape of such as described part/plate/unit will determine its flexibility.
For above-mentioned each unit, suitable flexible material can be elastomer.
When described flexible portion is independent component, it forms interface between described injection portion and transport portion, thus flexible transition is provided, this flexible transition provides the absorption of the transferable impact produced for the weight and volume by described fluid delivery system.
According to an embodiment, described fluid delivery part and described injection portion can be separated and be re-engaged.
According to an embodiment, described substrate has clamp device, and it is for connecting and disconnecting the described conveyer device stretched out by the distal side of described substrate.
According to an embodiment, the housing of described fluid delivery part also has the housing for described injection portion.
When described fluid delivery part provides housing, the housing due to described fluid delivery part has complete detachable protective lid, therefore can visually check complete fluid path for user.Equally also can form flexible substrate, thus not need housing and over cap, housing and over cap will make substrate so not soft.
According to an embodiment, flexible portion is formed by having the region reducing scantling." reduction scantling " both can be the reduction of thickness and material " highly ", also can be the reduction of lateral part and material " width ".
According to the second embodiment, flexible portion is formed by with the softer and region that the material having more flexible/elastic is made.
According to the 3rd embodiment, the region that flexible portion is made up of a kind of like this material is formed, and wherein said material has extension and compressed capability because of its shape, such as, by pleating folding or undulatory material.
According to an embodiment, described intubate and described transport portion are not interconnected by non-flexible region.
According to an embodiment, when described transport portion and described injection portion couple together, form the fluid-tight fluid from described reservoir being guided to described intubate and connect.
According to an embodiment, due to when described fluid delivery part is separated with described injection portion, the opening leading to reservoir is stopped, in therefore during described two parts are separated, can prevent microorganism from entering the described reservoir of described fluid delivery part.
According to an embodiment, described reservoir has two positions, primary importance and the second position, when in said first position, the first barrier that the outlet of reservoir can not be passed by microorganism, the second barrier that opening can not be passed by microorganism is run through, when at the second position, by forming the fluid opened opening through described first and second barriers connect in running through of described reservoir and described cannula part in cannula part.According to this embodiment, one or two in described barrier comprises the material that can be penetrated by needlelike object, and wherein when described needlelike object is retracted, described opening is closed.Described needlelike object can be blunt nosed or tip.Barrier described in one or two can comprise hard surface, and this surface is moved to form opening in the outlet being arranged at outlet tube and the described region run through between fluid passage.
According to an embodiment, comprise mounting mat for the device be fixed on the skin of user by described substrate, this mounting mat sticks to the proximal lateral of described substrate and/or the proximal lateral of described cannula part.
According to an embodiment, described substrate has the grid with periphery bonding portion, and the connecting rod that one or more and described outer peripheral portion interconnects.Described substrate has the outer peripheral portion of circle or ellipse, and described connecting rod has the one end being connected to described outer region and the second end being connected to central area.Described substrate has three or more connecting rods.
According to an embodiment, described substrate does not have intubate retaining part before the use, and such as, described substrate has opening, and intubate retaining part can insert via this opening.
According to an embodiment, one end of described intubate has a main body, and this main body comprises solid wall and protection sealing member, to protect the fluid intake of described intubate.
According to an embodiment, the injection portion comprising substrate has the Part I of described cannula part, and this Part I is used as the register control of Part II, and wherein Part II comprises intubate and will be inserted with entry needle.
Described intubate is inserted with an insertion equipment, this insertion equipment has the device corresponding with the surface of described substrate, and when the described device of described insertion equipment and the respective surfaces of described substrate in conjunction with time, described insertion equipment is located by this way, that is, the intubate such as comprising main body can relative to described substrate predictably and correctly insert.The such as Part I of described cannula part is equipped with the device for described Part II being locked in ideal position.
According to an embodiment, described substrate is non-releasably connected to described mounting mat.
" reservoir ", for keeping the part of equipment for liquid, described liquid is the medicine of any kind will carried to patient with specified quantitative in specified time interval.Described " transport portion " is keep fluid storage and ensure that liquid is sent to a part for the equipment of injection portion by pumping and the amount that such as controls adding liquid.Described " injection portion " defines a kind of port be fixed on user's skin, and it is provided with such as such as, for liquid being sent to the device of user, intubate, and described injection portion does not comprise any heavier or bulky part.Described injection portion can comprise one or more independent sector, and wherein one or more parts are non-releasably connected on base portion, and described one or more part can on skin substrate being fixed to patient before or after be secured on base portion.
When flexible region is arranged between relatively heavier conveying equipment and injection device; transmission action from conveying equipment to injection portion is prevented from or is lowered at least significantly, and the injection site that protection is arranged on subcutaneous intubate can not be subject to the impact due to any interactional major part promoted or contact described transport portion and cause.Usual transport portion is physically separated with injection portion the transmission preventing action by relatively long pipe, but when transport portion and injection portion are set together, user will feel less discomfort according to during equipment of the present invention wearing.
By using adapter, the direct effect between transport portion and injection portion can be avoided, and two parts are fixed on the skin of patient as a unit simultaneously.
Described intubate can be stretched out from the side of the proximal lateral of injection portion main body or main body.If intubate is identical with the embodiment shown in Fig. 4 with Fig. 7 and stretch out from the side of main body, then intubate can be bent usually, and preferably uses at least in part by the soft intubate made with the material of flexibility.If described intubate is stretched out from as shown in figure 12 the same from the proximal lateral of main body, then described intubate can be made up of harder material such as metal, or it can be made up with the material of flexibility of soft.
According to the present invention, described connector pin can be one end of independent pin, and the other end of this independent pin is used as intubate.When connector pin and intubate are formed as a pin, described pin is made up of metal or hard polymer usually, but it also can be made at the polymer that intubate end is unhardened and soft by being such as hardened at connector end.Described independent pin can be made up of two kinds of different materials simultaneously, and harder material is used for connector end, and relatively soft material is used for intubate end.Connector pin and intubate can be separated at least two pins simultaneously.Described injection portion can be provided with known soft intubate, wherein this soft intubate can be inserted under the help being attached to the insertion pin on individual interposers, and described connector pin can be made up of harder material and be secured on injection portion or transport portion.
Described flexible region is made up of the region of the scantling with reduction, as opening or otch can be arranged on material, or reduce the thickness of material, or by the more soft region having more flexible material and make, or its region can be made up of a kind of like this material is formed, wherein said material has extension and compressed capability because of its shape or structure, such as, by pleating or folding material.
Under notconnect state, namely when reservoir is separated with injection portion, because the opening leading to reservoir when described two parts are separated is stopped, therefore can prevent microorganism from entering described reservoir.When such as connector pin is attached on conveying equipment, the opening on the barrier film of adapter is closed when removing connector pin.
In another embodiment, the reservoir of transport portion has two positions, primary importance and the second position, when in said first position, the first barrier that the outlet of reservoir can not be passed by microorganism, run through the second barrier that opening can not be passed by microorganism in cannula part, when at the second position, connect by forming the fluid opened described reservoir and described cannula part through described first and second barriers.Noun " passes " and comprises all methods making to flow through or walk around barrier, in most of embodiment that the present invention describes, penetrate described barrier by pin and pass barrier, but also have a kind of example (Figure 18 A and B), wherein by lid being shifted onto side and therefore forming flow channel and pass described barrier.
If described barrier comprises the material that can be penetrated by needlelike object, wherein when described needlelike object is retracted, described opening is closed, and wherein said needlelike object is blunt nosed or tip, this means needlelike object or advances past described barrier or cut through described barrier.
In another embodiment, at least one barrier comprises harder surface, and namely this surface can not be penetrated by least more blunt pin, and described more blunt pin moves thus region between the outlet and the entrance running through fluid passage of outlet tube forms opening.
Described equipment is fastened on the skin of patient by mounting mat is applied to the proximal lateral of base proximal end side or infusion part usually, and the described mounting mat method be attached on base portion or infusion part comprises glue, Velcro (Velcro), is molded.
In one embodiment, described base portion can be formed as grid.Described outer peripheral portion can be formed with opening or be formed as forming coherent (coherent) part of base circumference.Described base portion has grille-like and means that it is formed by the one or more connecting rods connected each other, and if exist, can also be formed with outer peripheral portion.The base portion of this form can have desirable flexibility easily, and it can be any ideal form that may need, thus injection portion and transport portion can be fitted on mounted equipment.
In one embodiment, described injection portion is independently partly formed by least two, wherein Part I is non-releasably connected on base portion, and the Part II comprising intubate on skin base portion being installed to patient before or after be set up over the first portion.The advantage of the segmentation of injection portion is that it makes the application of equipment have more motility.Described Part II can comprise relatively little main body, and wherein intubate is distally stretched out side, and its distal side protected by barrier film.Described Part II can such as be sold with being arranged on together with the base portion in inserter.
If injection portion is made up of more than one independent sector, then Part I can have the device be locked in by Part II on ideal position.Equally, described Part II can have the device for Part II being locked onto the ideal position on Part I, or the first and second parts can have corresponding locking device separately.
Accompanying drawing explanation
Below in conjunction with accompanying drawing, embodiments of the invention are described:
Fig. 1 shows the first embodiment of the present invention looked over above the B-B straight line shown in Fig. 3, and wherein said transport portion is arranged on the side of injection portion.
Fig. 2 shows the zoomed-in view that circle in the embodiment of Fig. 1 marks part.
Fig. 3 shows the embodiment of looking from instruction straight line B-B side.
Fig. 4 shows the first embodiment that transport portion is separated with injection portion.
Fig. 5 shows the embodiment in Fig. 4 with the zoomed-in view of the part of circles mark.
Fig. 6 A shows the second embodiment of the present invention of looking from described injection portion side.
Fig. 6 B shows the embodiment identical with Fig. 6 A intercepted by line B-B.
Fig. 7 shows in the embodiment of Fig. 6 B with the zoomed-in view of the part of circles mark.
Fig. 8 A shows injection portion and the base portion of the second embodiment be separated with described transport portion.
Fig. 8 B shows the zoomed-in view by the part of circles mark in the embodiment of Fig. 8 A.
Fig. 9 shows transport portion and the injection portion of the second embodiment.
Figure 10 A shows the embodiment identical with Fig. 8 A from different angles.
Figure 10 B shows in the embodiment of Figure 10 A with the zoomed-in view of the part of circles mark.
Figure 11 shows the 3rd embodiment of the conveyer device of the present invention being in connection status, and in this embodiment, described transport portion is arranged on the top of injection portion.
Figure 12 shows the 3rd embodiment of the described device being in released state.
Figure 13 shows two parts of described 3rd embodiment respectively from upper and lower both sides.
Figure 14 shows the 4th embodiment of conveyer device of the present invention." A " shows the transport portion of looking from the side, and wherein injection portion is ready to be connected with described transport portion, and " B " shows the transport portion of looking from rear, and " C " shows the injection portion of going seen from above.
Figure 15 shows the 4th embodiment that (the line V-V) from the side that be in released state looks.
Figure 16 shows the 4th embodiment that (the line V-V) from the side that be in connection status looks.
Figure 17 shows the 5th embodiment of conveyer device of the present invention, between described transport portion and injection portion, wherein have fluid-tight locking.
Figure 18 A and 18B shows the part of the amplification of the 5th embodiment being in two states, and described device closes fluid flowing in primary importance, opens fluid flowing in the second position.
Figure 19 shows another embodiment guaranteeing that the fluid-tight of fluid from transport portion to injection portion transmits.
Figure 20 shows the 6th embodiment with base portion, and described base portion has central connector and peripheral injection part.
Figure 21 shows the conveyer device being in the 6th embodiment of engagement state and base portion of looking from top and side.
Figure 22 shows the sectional view of the 6th embodiment of the Figure 21 being in engagement state.
Figure 23 shows the enlarged drawing of the connector part of Figure 22.
Figure 24 shows the enlarged drawing of the syringe part of Figure 22.
Figure 25 shows the view of the transport portion of the 6th embodiment of looking from below.
Figure 26 shows the 7th embodiment with base portion, and described base portion has adapter and the injection portion of center combination.
Transport portion and the base portion of the 7th embodiment of engagement state that what Figure 27 showed from the side and went seen from above be in.
Figure 28 shows the sectional view being in the 7th embodiment of engagement state of Figure 27, and the zoomed-in view of the adapter/syringe part combined.
Figure 29 shows the view of the transport portion of the 7th embodiment of looking from below.
Figure 30 shows the 8th embodiment with base portion, and described base portion is furnished with adapter and the syringe part of center combination, and the part of wherein said combination is divided into unit.
Figure 31 shows the transport portion being in the 8th embodiment of engagement state and base portion of looking from top and side.
Figure 32 shows the sectional view of the 8th embodiment of the Figure 31 being in engagement state and the zoomed-in view of the adapter/injection portion of combination.
Figure 33 shows the 9th embodiment with elliptical base, and described base portion is furnished with central connector and peripheral injection device part.
Figure 34 shows the transport portion being in the 9th embodiment of released state and base portion of looking from below, and the reservoir of looking from the side and base portion.
Figure 35 shows the transport portion being in the 9th embodiment of engagement state and base portion of looking with top from the side.
Figure 36 shows the sectional view of the 9th embodiment of the engagement state being in Figure 35, and the enlarged drawing of described injection portion.
Figure 37 shows the tenth embodiment of the device for conveyance fluid, and it comprises injection portion and fluid delivery part, and in Figure 37, these two parts illustrate with the state be separated.
Figure 38 shows the injection portion of the tenth embodiment of going seen from above.
Figure 39 a and 39b shows the transport portion of the tenth embodiment of looking from below, and in Figure 39 a, described injection portion does not have mounting mat, and described transport portion is engaged, in Figure 39 b, merely illustrate described transport portion.
Figure 40 shows the embodiment of described injection portion, and it has the clamp device for the described transport portion arranged at center and periphery.
Figure 41 a-b shows the different embodiments of the housing of transport portion, and it is also used as the housing of injection portion.
Detailed description of the invention
Fig. 1-3 shows the first embodiment according to equipment of the present invention, wherein transport portion and injection portion secured to one another.Embodiment in Fig. 1 is the view looked over above the B-B straight line Fig. 3, and Fig. 2 shows the sub-fraction of Fig. 1 under amplification form.Described equipment comprises injection portion, and described injection portion comprises sightless substrate 10, cannula part 1 and unshowned installation unit in Fig. 1, and this installation unit is generally mounting mat.Described cannula part 1 comprises main body, and described main body has and guides liquid to run through opening to intubate 9, and wherein said intubate 9 is placed in subcutaneous after injection.Described equipment comprises adapter 2 further and has the transport portion of smooth lid 3, and described transport portion comprises unshowned pump and reservoir 4.Flexible pipe 5 forms fluid and is connected between injection portion with translator unit; and connector pin 6 can pierce through the protection sealing member 7 and barrier film 8 to ensure the fluid path from transport portion to injection portion; the entrance of wherein said protection sealing member 7 covering connector 2, described barrier film 8 covers reservoir entrance.Described equipment is in connection status in fig. 1-3, and wherein said injection portion and transport portion link together and be ready to use.
Fig. 2 shows the zoomed-in view of the adapter 2 in Fig. 1.In this embodiment, described adapter 2 comprises the molding part of non-flexible material, described molding part have one end be connected to the other end is provided with flexible pipe 5 connector pin 6 run through opening.Under the state that adapter 2 is not connected to described reservoir 4, described connector pin 6 extends into a sealing chamber, and described sealing chamber comprises the wall formed by cylindrical shape extension and the resilient protection sealing member 7 of adapter 2 respectively.In connection status; described protection sealing member 7 is pushed towards the inwall of the adapter 2 around connector pin 6; and when adapter 2 is connected on reservoir 7; described connector pin 6 first pierce through the protection sealing member 7 also penetrates barrier film 8, subsequently to form the path from adapter 2 to the inside of reservoir 4.In this embodiment, described adapter 2 is non-releasably fastened on substrate 10, and wherein said substrate 10 is an integral part of injection portion.
Shown in Fig. 3 be use described equipment time from the side to Fig. 1 in embodiment.Substrate 10 along patient placed and be fastened on it patient by such as adhesive pad.Intubate 9 is stretched out from the proximal lateral of the substrate 10 below injection portion, and described injection portion is covered by housing 3, and described housing 3 is provided by transport portion 3,4.Described transport portion 3,4 is secured to the distal side of the substrate 10 on injection portion side, and it is covered by housing 3 equally.
Usually the proximal lateral of substrate 10 is fixed to it patient by glued portion or viscous layer, but also can uses substrate 10 can being clung patient and do not allow the installation of equipment moving of any kind.Described glued portion or viscous layer are fixed on the substrate 10 by glue, Velcro, be molded etc.
In a preferred embodiment, described transport portion is secured to the distal side of substrate 10 by one or more Magnet be embedded in substrate 10.Described dismountable transport portion has corresponding magnet, and this Magnet can make transport portion in use keep original position.By means of the Magnet on substrate 10 and/or transport portion 3,4, can detection system condition, if whether transport portion is by correctly fastening, whether the flow flowing through described equipment can accept, how long transport portion is secured on substrate has, through the volume size etc. of described equipment.
Fig. 4 shows the first embodiment being in released state, wherein can see the substrate 10 of fastening injection portion 1, for transport portion being fastened to the object 11 of substrate 10, and the flexible part 12 of substrate 10.In order to be fastened to by transport portion on base portion 10, described transport portion 3,4 is pushed down from top towards base portion 10.Flexible part 12 is made up of two thinner connectors, and described comparatively thin connection will be formed straight line and it is made by the mode removing material from substrate portion 10.Even if the transport portion being fastened on the end opposite of base portion 10 is touched or promotes or only move due to the motion of user, the structure of described base portion 10 still allows subcutaneous injection intubate 9 to remain in resting position together with flexible pipe 5.
Fig. 5 shows the enlarged partial view of the first embodiment in Fig. 4.Fig. 5 illustrates in greater detail intubate 9 and how to remain in original position by the main body of cannula part 1; Described injection portion is connected on described adapter 2 by flexible pipe 5.Be secured on base portion 10 and illustrate in a transparent manner in the drawings with the adapter 2 of transport portion in the same side of base portion 10, thus described connector pin 6 can be seen.Described adapter 2 is preferably made up of PP, ABS or similar material.
In the first embodiment described in figs. 1-5, the flexible region between transport portion 3 and injection portion 1 is made up of flexible pipe 5.Described flexible pipe can be manufactured into an extrude tubes, and it can by PUR(polyurethane), PP(polypropylene), PE(polyethylene), silicones or any other have enough flexibilities or such as have flexible form material with the pipe of fold make by providing.
By inserter help or manually intubate 9 is inserted into subcutaneous together with the remainder of injection portion.
The housing 3 of transport portion 3,4 is made up of relatively hard material, as PP or ABS(poly-(acrylonitrile, butadiene, styrene)), housing can be enable like this to resist foreign impacts.
Fig. 6 A show from look over towards injection portion side, according to the second embodiment of the equipment for conveyance fluid of the present invention.Fig. 6 B shows the view that identical embodiment intercepts from straight line B-B.Fig. 7 shows the zoomed-in view in the region being connected injection portion and transport portion 3,4 in embodiment by adapter 2.In Fig. 6 A, 6B and 7, described transport portion and injection portion are all connected to base portion 10, and this state i.e. state of in use described equipment.
In a second embodiment, described injection portion 1 is connected on transport portion 3,4 by flexible pipe 5, and described flexible pipe 5 is formed as corrugated tube in this embodiment and is preferably made up of silicones, PUR, PP/PE etc.The flexible part 12 of described base portion 10 is formed as the V-type connection of relative thin, and this connection is made by removing material from the plane of base portion 10.This embodiment is provided with slide rail 11, and it is used as object transport portion 3,4 being fastened to base portion 10.In this embodiment, described connector pin 6 is secured on transport portion 3,4.When transport portion and adapter 2 are bonded together, described connector pin 6 penetrates barrier film 7, thus forms the flow passage from reservoir 4 to intubate 9.
Fig. 8 A and 8B shows the embodiment be under state that transport portion 3,4 and base portion 10 be separated, can see two slide rails 11 like this.
Fig. 8 B shows the zoomed-in view of the adapter 2 in Fig. 8 A.In this embodiment, described adapter 2 comprise be made up of non-flexible material there is the molding part running through opening, wherein this one end running through opening is connected with flexible pipe 5, and the other end is provided with barrier film 7.The flexibility of described flexible pipe 5 obtains by using soft flexible material, but in this embodiment, the flexibility of described pipe 5 by adopt a kind of stable-namely have certain rigidity-and the material with fold form flexible pipe 5 and obtain.Reservoir 4 is provided with connector pin 6 and cylindrical shape extension, and described extension can be protected connector pin 6 and can be provided with protection sealing member (not shown in Fig. 8 B).Under the state that adapter 2 is not connected to reservoir 4, connector pin 6 extends in a sealing chamber, and described sealing chamber comprises the wall and an optional unshowned resilient protection sealing member that are formed by the cylindrical shape extension of reservoir 4.In connection status; described protection sealing member (if any) is pushed towards the inwall of the reservoir 4 around connector pin 6; and when adapter 2 is connected on reservoir 4; described connector pin 6 first pierce through the protection sealing member; penetrate described barrier film subsequently, to form one from reservoir 4 to the path of adapter 2 inside.In this embodiment, adapter 2 is non-releasably fastened on substrate 10, and wherein said substrate 10 is integral parts of described transport portion 3,4.
Fig. 9,10A and 10B also illustrate equipment according to a second embodiment of the present invention.Fig. 9 shows transport portion 3, base portion 1 and injection portion, and how relative to each other to locate before they are joined, and indicate when on the object 11 that conveying equipment 3,4 is secured to base portion 10 to form the arrow with the direction of motion during connection of injection portion 1.Figure 10 A shows the embodiment identical with Fig. 8 A from different perspectives, and Figure 10 B shows the zoomed-in view of the adapter 2 that the embodiment in Figure 10 A marks with circle.In this embodiment, intubate 9 is crossing out from injection device and the vertical skin inserting user.If intubate 9 is made up of soft flexible material, then needs to use and insert pin to penetrate the skin of user.This can manually have the insertion pin that the proximal openings through intubate 9 stretches out come by providing a kind of.Described insertion pin sharply stretches out from the proximal openings of intubate 9, and it such as penetrates the far-end that the barrier film covered in intubate 9 enters into intubate, or enters into described intubate by side.When inserting pin and entering intubate 9 by side, need to provide the in-position that there is certain and close, thus can prevent microorganism from entering into described equipment when inserting pin and being removed after insertion is completed.The described equipment of this embodiment can utilize inserter to be inserted into, such as, utilize from inserter disclosed in the PCT application No.DK2005/050010 of December in 2005 application on the 9th.If intubate is stretched out from the proximal lateral of injection portion, then inserter disclosed in the PCT application DK02/00640 that can utilize such as JIUYUE in 2002 application on the 27th.
In embodiment shown in Figure 11, transport portion 3,4 is positioned at the top of injection portion.In this embodiment, transport portion is fastened in a part for the base portion 10 surrounding cannula part 1 releasedly.Flexible part 12 around the described substrate 10 of injection portion setting is formed as circular folding material, and this material is the material identical with the core of injection portion of thinner form, or has the different materials of softer or more flexible characteristic.In fig. 11, described transport portion 3,4 and injection portion are bonded together, and as during the described equipment of use, and define the connection allowing fluid to flow to intubate 9 from reservoir.The view that left view and right view two of respectively illustrating that linearly D-D and E-E intercept with vertical angle are different.In this embodiment, the object 11 for being fastened in injection portion by transport portion 3,4 is formed the circular contour erect from base portion 10, and has outwardly portion, and object 11 matches with the corresponding protuberance 13 on transport portion.When being fastened on cannula part 1 by transport portion 3,4, two one or two hands 14 are promoted together, and this makes corresponding protuberance outwards move and allow injection portion to enter into the central opening of transport portion 3,4.When user unclamps handle portion 14, described corresponding part is got back to middle position and cannula part 1 is locked in the central opening place of transport portion 3,4.
Transport portion 3,4 is combined with adapter 2; Adapter 2 has the connector pin 6 run through, and this adapter is by the impact of spring 15.When user promotes transport portion 3,4 towards injection portion, spring 15 is compressed, and described in run through connector pin 6 and be forced to through barrier film 8, described barrier film 8 for the protection of the content in reservoir not by infected by microbes.Connecting needle 6 be forced to penetrate barrier film 8 while or before this or after this, the barrier film 7 that connector pin 6 also will be forced to through the entrance for the protection of intubate 9, thus form fluid be connected between unshowned reservoir with intubate 9.By the material selecting material, barrier film 8 easily to contact with adapter 2 with other for spring 15, should ensure to there is flexibly connecting between adapter 2 and transport portion 3,4.Preferably when adapter 2 is led by the wall of the central extension of transport portion 3,4 from a position to the motion of another location, described adapter 2 is secured on spring 15, and described barrier film 8 is made up of a kind of material of abundant softness, to ensure when equipment is in connection status, adapter 2 is connected on transport portion 3,4 flexibly.In this embodiment, adapter 2 must not be secured on transport portion 3,4 or in injection portion 1, adapter 2 can be used as stand-alone interface separate unit or with transport portion 3,4 or injection portion integral.
Shown in Figure 12 is embodiment in Figure 11, under this embodiment is in the state that injection portion is separated with transport portion 3,4, and makes spring 5 be in lax and extension state.In this state, described in run through the barrier film 8 that connector pin 6 had not both penetrated transport portion 3,4, do not penetrate the barrier film 7 of cannula part 1 yet.
Figure 13 shows the three dimensional form of the embodiment in Figure 11 and 12.The injection portion 1 that this view illustrates transport portion 3,4 from the side and joins on transport portion, wherein when engaged, these two parts correspond to each other.
The embodiment illustrated in Figure 11-13 can be inserted into by inserter type disclosed in the PCT application DK02/00640 of JIUYUE in 2002 application on the 27th.After injection portion is inserted into, base portion 10 is fixed on skin by user.Injection portion be in suitable after, transport portion can be fastened in injection portion 1 by user subsequently, and wherein said transport portion comprises at least one reservoir and transporter such as pump.If adapter 2 is the form of stand-alone interface, then adapter should be placed before conveyer device 3,4 is fastened to injection portion, and described adapter provides suitable cooperation by between the injection portion selected and the transport portion 3,4 of selection subsequently.
When introduce describe in Fig. 1-13 with in claim during required flexible region, owing to can drawing to side when not affecting intubate 9 and do not upset and insert position, pushing away, carrying and mobile transport portion 3,4, therefore can by define by the size of use part in deckle circle really all dimensions on mobilely describedly can discharge transport portion 3,4, the position usually upsetting insertion portion can cause patient's discomfort.
All parts of embodiment are fixed on the skin of patient, and this realizes by applying a mounting mat usually, wherein this mounting mat is attached to the proximal lateral of base portion 10, if or embodiment base portion 10 is not provided, then mounting mat is attached to the proximal lateral of infusion part.The means be attached to by mounting mat on base portion 10 or infusion part 1 can comprise and utilize gluing, Velcro, molded etc.
Figure 14 shows one embodiment of the present of invention, can ensure that fluid can be sent to the intubate 9 of cannula part 1 from the reservoir of transport portion 3,4 and send patient to thus to fluid-tight in this embodiment.
In fig. 14, " A " shows the described equipment of the three dimensional form of passing by from the side, wherein this equipment comprises transport portion 3,4 simultaneously and comprises the injection portion of cannula part 1, " B " shows the transport portion 3,4 of the three dimensional form looked over from below, and " C " shows the injection portion 1 of the three dimensional form of passing by seen from above.
Figure 15 shows the embodiment identical with Figure 14, and it is the side view intercepted from straight line V-V.In fig .15, described transport portion 3,4 is separated with injection portion, and connector pin 6 is protected by downward barrier film 8b, and described barrier film 8b enters into reservoir for preventing antibacterial from the end of connector pin 6.Barrier film 8a penetrates for the other end preventing the entrance of reservoir and be connected device pin 6.In fig .15, the reservoir 4 illustrated is positioned at the top of connector pin 6, and shows the reservoir cover 4a above reservoir 4.When such as needing to change the ampoule forming reservoir 4, described reservoir cover 4a can be removed.In this embodiment, reservoir 4 has flexible wall, and it is surrounded by ring 16, and described ring 16 can reduce the volume of reservoir, and therefore fluid can be pumped to patient from reservoir 4.In this embodiment, cannula part 1 also has inlet membrane 7 and for transport portion 3,4 being fastened to the object 11 in injection portion, described object 11 is formed the circular contour erect from substrate 10, and it combines with the outer surface of the housing of injection portion 1.The outwardly portion of described object 11 installs with the corresponding protuberance 13 on transport portion 3,4.When transport portion 3,4 is secured in injection portion, promote two handles parts 14 together to force corresponding protuberance 13 outside, and allow injection portion to enter central opening in transport portion 3,4.When user's release handle part 14, corresponding part 13 is got back to the position at more center and injection portion is locked onto the central opening place of transport portion 3,4.In this embodiment, cannula part 1 can be made up of nonrigid material, and to provide a flexible portion, its flexibility increased ensure that the motion of transport portion 3,4 can not be transferred into intubate 9.
Figure 16 shows and Figure 14,15 identical embodiments, but in figure 16, transport portion 3,4 is bonded together as in use with injection portion.In this position, connector pin 6 penetrates three all barrier film 8a, 8b and 7, and reservoir 4 with form fluid between injection portion and be connected.
Figure 17 shows the decomposition view of embodiment, and the second fluid that wherein said equipment comprises between the reservoir of transport portion 3,4 and injection portion is tightly connected.This embodiment comprise comprise pump and reservoir transport portion, the first spring 15, top seal pad 17, lower seal pad 18, second spring 19 and injection portion, this injection portion comprise comprise intubate 9 cannula part 1, insert pin 20, outer wall 26 and mounting mat 21.In addition the outer surface of described transport portion, lid or housing 2 have groove 24, and the outer surface of the described outer wall 26 of injection portion has corresponding joint tongue 25.
How the independent part that figure 18 illustrates in the embodiment shown in Figure 17 works together.Show the inside of injection portion and transport portion 3,4 in this drawing.Figure 18 illustrates the possible position of reservoir 4 in transport portion 3 and the outlet 22 stretched out from reservoir 4.At the port of export, the least significant end namely in Figure 18, outlet 22 is provided with the opening and sealing gasket that laterally point to, and described sealing gasket is for ensureing the fluid tight contact between the wall of the core of cannula part 1 and the outlet of outlet 22.The inside of cannula part 1 comprises the fluid passage 23 run through, and described fluid passage 23 has the inlet opens of the vertical wall of the core being horizontally through injection portion.For providing the flexible portion of cannula part 1, described outer wall 26 can be made up of elastic or nonrigid material.Desired extent of elasticity will depend on the physical features of conveying equipment, i.e. size and weight.
In primary importance, the transport portion comprising reservoir 4 and pump can be retracted from injection portion, and the first spring 15 is stretched, and wall, i.e. cannula part 1 that the outlet of outlet 22 is injected the core of part stopped.Lower seal pad 18 is in and can stops on a higher position of fluid passage 23 entrance, and the second spring 19 is stretched.
In the second position, transport portion 3,4 is promoted by towards injection portion, and the first spring 15 and the second spring 19 are all compressed.Be used as when primary importance to stop that the lower limb that the lower seal pad 18 of barrier of antibacterial is now transferred part 3,4 promotes downwards, and therefore open the entrance of fluid passage 23.When the joint tongue 25 of injection portion touches the upside of the groove 24 of transport portion 3,4, transport portion move downward stopping, and in this position, the opening of outlet 22 is corresponding with the entrance of fluid passage 23.
Figure 19 shows the embodiment that the fluid-tight between reservoir with injection portion is connected.In this embodiment, described flexible portion can be provided by elasticity " bubble " 26 and 27.This equipment comprises transport portion 3,4, such as in figs. 1-10 shown in, but reservoir is only shown in Figure 19.This equipment is configured with the reservoir exporting and covered by the deformable film 26 of bubble shape; This film can prevent microorganism from entering reservoir when transport portion does not engage with injection portion 1.The film of bubble shape means that described film does not have smooth surfaces externally and internally, and has convex surfaces externally and internally, and the needle point of described film not only covering connector pin 6, and cut the larger part of going back covering connector pin 6.The entrance of described injection portion 1 is also covered by the film of deformable bubble shape.In this embodiment, connector pin 6 is secured in injection portion 1, but described connector pin 6 also can be secured on transport portion 3,4, if connector pin 6 is secured on transport portion, then need to provide the unit equipment with two pins: connector pin 6 and intubate 9.If described equipment is provided with the connector pin 6 be separated with intubate 9, then can use soft intubate.
Figure 19 A shows the 3-D view of described equipment, and wherein this equipment is in transport portion 3,4 and injection portion 1 is separated thus makes the state that fluid can not flow between the two sections.Figure 19 B shows the state identical with Figure 19 A, but this figure is the view by seeing from vertical angles cutting equipment, in Figure 19 C, together with transport portion 3,4 is pulled to injection portion 1, and the fluid of reservoir 4 flows in patient body by injection portion 1 and intubate 9 now.When described two films are pulled to together, thin film deforms and pointy connector pin 6 penetrates two films and forms fluid connection, each bubble-shaped film can be formed as having different hardness, thus when being out of shape minimum film pushing and being out of shape maximum film, the film making distortion minimum by utilizing different hardness forms base portion, thus can to expecting that the position penetrating described film controls.
Film 26 and 27 can be made up of silicones or polyurethane (PUR), or can be schematically shown by other but the flexible polymer system that can not be penetrated by microorganism becomes.
Connector pin 6 is made up of relatively hard material, and as metal or hard polymer, wherein " relatively hard material " means that described material at least should have some strength, namely enough hard, to penetrate film 26,27.
In the embodiment of Figure 19 A, B and C, one end of connector pin 6 is independent pin, and its other end is then used as intubate 9.When connector pin 6 and intubate are formed a pin, it will be made up of metal or hard polymer usually, but it can also be hardened by such as connector end and intubate end is unhardened and be soft.Described independent pin can be made up of two kinds of different materials simultaneously, adopts harder material at connector end, and adopts relatively soft material at intubate end.
Connector pin 6 and intubate 9 can also be separated simultaneously, and will become there are two pins according to device fabrication of the present invention.Injection portion 1 can be provided with the intubate of known softness, this intubate by be attached at insertion pin on the inserter of separation auxiliary under be inserted into, and connector pin 6 is made up of relatively hard materials, and is secured on injection portion 1 or transport portion 3,4.
In this embodiment, independent pin is bending, and namely connector pin 6 points to the direction parallel with patient skin, and intubate 9 points to the direction vertical with patient skin.Connector pin 6 according to the present invention can point to any parallel or be away from the direction of patient, and intubate 9 can point to any direction that can be inserted into patient skin.
The place that all medicines that equipment according to the present invention may be used for benefiting by lasting absorption drug products to patient are relevant with all conditions; The patient that preferably the invention is intended to as suffering from diabetes provides a kind of and can provide the safety of the insulin of lasting adjust dosages to patient and be easy to the equipment of operation.
In one embodiment, reservoir is divided into the chamber of multiple separation, wherein each chamber can provide different medicines, or active ingredient is such as provided in a chamber, and solvent is provided in other chamber, different chambers can comprise the medicine of variable concentrations or have the medicine of different activities composition.
Figure 20-25 shows one embodiment of the present of invention, and wherein adapter 2 is placed in the middle position of substrate 10, and cannula part 1b is secured to the outer peripheral portion of substrate 10.Cannula part 1b arranges and makes user to observe injection site on the outer periphery.In addition, the cannula part of the present embodiment is arranged by this way, namely intubate 9 is inserted into the angle A departing from 90 ° relative to the distal surface of substrate 10, usual angle A is between 110 ° to 170 °, wherein the distal surface of substrate 10 forms one side of described angle, and the another side of intubate 9 angulation inserted.
In this embodiment, by providing flexible portion 12 to be combined on the substrate 10 by flexible portion, wherein said flexible portion is constructed by substrate 10 and forms four spokes as wheel.Can by changing the width of described part 12, the thickness of baseplate material 10 or described part 12(spoke) quantity change the elasticity of flexible portion 12.
Cannula part is two parts unit, and it comprises non-releasably fastening Part I 1a on the substrate 10 and comprises the Part II 1b running through the main body of opening providing and guide flow direction intubate 9, and wherein intubate 9 extends in the proximal lateral of substrate 10 after such insertion.The fluid that cannula part 1a, 1b are partly formed between patient with reservoir is connected.
By at least two kinds of diverse ways, the present embodiment can be placed on the skin of patient.According to a kind of method, first the substrate 10 comprising Part I 1a is placed on patient skin, the Part II 1b of the maintenance intubate of cannula part 1 is inserted into subsequently, such as by the inserter of particularly suitable, this method makes user more careful when placement is equipped with the substrate 10 of adhesive pad usually.According to second method, comprise Part I 1a and keep the substrate 10 of Part II 1b of intubate by being applicable to keep being inserted into together with the inserter of whole equipment, this method is compared with the method described before, and it reduces by installation steps.
In this embodiment, Part I 1a is provided with inside ledge 1c, and Part II 1b be provided with outwardly, can the fastening hook 1d of pivotable.When Part II 1b is arranged in Part I 1a, first hook 1d outwardly is outwards promoted by inside ledge 1c, and by after ledge 1c, gives prominence to hook 1d and get back to original position and be locked in Part II 1b by Part I 1a.
Substrate 10 is provided with three for transport portion 3,4 being fastened to the object 11 of the vertical placement on substrate 10; The quantity of described object 11 is optional, and object 11 can be molded together with substrate 10 or after forming substrate 10 such as by gluing or weld and be fastened on substrate 10.Object 11 is provided with chute 11a, and wherein chute 11a defines the direction that transport portion 3,4 moves when being fastened on substrate 10 by transport portion 3,4.Chute 11a corresponds to the ledge 11b on transport portion 3,4.In this embodiment, chute 11a is not parallel with the surface of substrate 10, but a difference angle B: 0 ° of <B<45 °, wherein a side of angle B is the distal surface of substrate 10, and another side is the remote edge of chute 11a.Described angle B makes it possible to transport portion 3,4 to be screwed on substrate 10 together with the center of the round-shaped and adapter 2 of transport portion 3,4.
Adapter 2 is made up of the molded body be non-releasably fastened on substrate 10, and it is provided with inner compartment, and the entrance of this inner compartment is protected by barrier film 7.When transport portion 3,4 is secured on substrate 10, barrier film 7 is connected pin 6 and penetrates.Allow fluid to enter into flexible pipe 5 by the bottom of inner compartment and opening 5a and be sent to it patient by intubate 9.Flexible pipe 5 is connected on the Part I 1a of injection portion, and when the Part II 1b of intubate 9 is placed in Part I 1a, defines the fluid passage from flexible pipe 5 to intubate 9.
The fluid being sent to patient of 0.5-3ml preserved usually by the reservoir 4 of the embodiment illustrated.
Figure 26-29 shows one embodiment of the present of invention, and wherein connector pin 6 is inserted directly in injection portion, does not namely have separative coupling part.Cannula part 1 is placed in the center position of substrate 10, and therefore user can observe injection site.
In this embodiment, flexible portion 12 is made up of substrate 10, and is formed as the spoke of four in wheel.
Cannula part 1 is a unit, and it comprises the molded body with inner compartment.When the transport portion comprising reservoir 4 is placed on tram, can be entered in described inner compartment through protection sealing member 7 by connector pin 6.Fluid from inner compartment is exported by intubate 9.
Substrate 10 is similar to the embodiment in Figure 20-25, and wherein this embodiment is provided with three for the fastening object 11 transport portion 3,4 being fastened to the vertical placement on substrate 10; The quantity of described object 11 is optional.
In the embodiment of Figure 26-29, while substrate 10 is placed on patient skin, the intubate 9 of injection portion is inserted into, and described intubate 9 is inserted into 90 ° of angles.For inserting described equipment, the inserter of type as shown in EP 1429826 can be used.
The embodiments of the invention that Figure 30-32 illustrates are similar to the embodiment shown in Figure 26-29, just this embodiment not separative adapter of tool.Cannula part 1a, 1b are placed on the center of substrate 10, and therefore it can make user observe injection site.
In this embodiment, flexible portion 12 is same is made up of substrate 10 and forms four spokes as wheel.
The cannula part of two parts unit comprises the Part I 1a be non-releasably fastened on the substrate 10 and Part II 1b comprising intubate 9.According to the present invention, first substrate 10 is placed on the skin of patient, and the intubate retaining part 1b of cannula part is inserted into assigned address subsequently.The embodiment that similar Figure 20-25 illustrates, the Part I 1a of this embodiment is provided with inside ledge 1c, Part II 1b is provided with also fastening pivotly hook 1d outwardly, and Part II 1b can be locked on ideal position by the corresponding part of described hook 1d.
Figure 33-36 shows one embodiment of the present of invention, and wherein cannula part 1 is secured to the outer peripheral portion of substrate 10, can perform the injection of inclination from the position of this outer peripheral portion, and user can be made to observe injection site.In this embodiment, cannula part is two parts type, and it comprises by the Part I 1a be non-releasably fastened on substrate 10 and the Part II 1b comprising intubate 9.Described Part I 1a is provided with inside ledge 1c, Part II 1b be provided with outwardly and can the fastening hook 1d of pivotable.
The flexible portion 12 of this embodiment constructs according to substrate 10 equally, but flexible portion described herein 12 is formed as the form of similar grid.According to this embodiment, by changing the quantity of the width of described flexible portion 12, the thickness of baseplate material 10 or described flexible portion and connecting rod 12, the flexibility of flexible part 12 can be changed.
Substrate 10 is provided with two for transport portion 3,4 being fastened to the object 11 of the vertical placement on substrate 10; The quantity of described object 11 is optional, and object 11 can be molded together with substrate 10, or formation substrate 10 after by such as gluing or welding and be fastened on substrate 10.Object 11 is provided with chute 11a, and wherein chute 11a defines the direction of described transport portion 3,4 movement when being fastened on substrate 10 by transport portion 3,4.In this embodiment, each object 11 is provided with chute 11a, and this chute 11a defines the direction of motion of the transport portion 3,4 when being fastened on substrate 10 by transport portion 3,4.In this embodiment, each object 11 all has two chute 11a, an angle B and each chute 11a tilts: 0 ° of <B<90 °.Described chute 11a corresponds to the ledge 11b of transport portion 3,4.Because transport portion 3 moves along the passage that clearly limits being secured in the process on substrate 10, the interaction therefore between the chute 11a of the substrate 10 and ledge 11b of transport portion 3 ensure that connector pin 6 can through the protection sealing member 7 of injection portion 1b by correct insertion.
Usually, when cannula part 1 is made up of two parts unit 1a, 1b, the method be fixed to by described equipment on the skin of patient can comprise the following steps:
If-substrate 10 is provided with tacky surfaces, such as, be non-releasably combined with adhesive pad, then the adhesive side of substrate 10 can such as come out by removing release liner,
-substrate 10 comprising a part of injection portion 1a is placed on the skin of patient,
-usually by using insertion equipment to be inserted by the Part II of injection portion 1b in the position defined by Part I 1a, wherein this insertion equipment can be that multipurpose inserts equipment or single-use inserts equipment,
-transport portion 3 is placed in the top of substrate 10.
Figure 37-39 illustrates one embodiment of the present of invention, and wherein cannula part 1 is positioned at the center of the substrate 10 of injection portion.Described substrate 10 is constructed to three flexible portions 12 in this embodiment, this flexible portion 12 can be such as molded together with cannula part 1 or be non-releasably attached on mounting mat 21, and wherein said pad also can provide stability to a certain degree for insertion portion.Described flexible portion 12 is relatively flats, and namely it is highly less than its width, and it can provide the material of the structure with imaginable flexibility to make for injection portion by a kind of.
The elasticity of described flexible portion 12 can be changed by the width of the quantity and described flexible portion 12 that change described flexible portion 12 and thickness.
Cannula part 1 comprises main body, this main body have guide liquid to unshowned intubate 9 run through opening, wherein the proximal lateral of intubate 9 in injection portion after being inserted into is stretched out, and namely cannula part 1 partly forms fluid and is connected between patient with reservoir 4.Intubate 1 is also provided with annular vertically wall 11, and in this embodiment, this annular vertically wall 11 forms the clamp device of conveying equipment 3.
The transport portion of this embodiment engages by two parts being pressed together with injection portion.
Figure 40 shows another embodiment, and wherein injection portion does not arrange mounting mat, and transport portion simultaneously by being rotated down described transport portion and by the vertical object 11 that it is engaged to periphery is secured in injection portion in central cannula part.Transport portion is fixed to the position near user's skin by this periphery object 11.
In this embodiment, flexible portion 12 is constructed by substrate 10, and forms three spokes as wheel.
Described cannula part 1 is a unit, and it comprises the molded body with inner compartment.Can by such as entering described inner compartment when the transport portion comprising housing 3 and reservoir 4 is positioned at tram by connector pin pierce through the protection sealing member.
Substrate 10 is similar to the embodiment of Figure 20-25, and it has three for transport portion 3,4 being fastened to the object 11 of the vertical placement on substrate 10; In addition, the outer wall of cannula part 1 is provided with chute 11a, and this chute 11a is defined in the direction of motion of described transport portion 3,4 when being fastened on substrate 10 by transport portion 3,4.Described chute 11a is corresponding with the ledge of transport portion 3,4.When transport portion reaches substrate 10, vertical outer peripheral portion 11 outwards pivotable, and return vertical position along with vertical outer peripheral portion 11 pivotable, described transport portion arrives its terminal position and has engaging sound simultaneously.Described equipment remains on the position of user's skin by the kayser provided by the collaborate between transport portion and outer peripheral portion 11 simultaneously.
Figure 41 a-b shows the different embodiments of the housing 3 of transport portion.
Also disclose the equipment for conveyance fluid according to following any one:
1, for the equipment of conveyance fluid, comprise injection portion and fluid delivery part (3,4), wherein said fluid delivery part comprises reservoir (4), the transporter of such as pump form and housing (3), and described injection portion comprises:
-substrate (10),
-cannula part (1,1b), comprises the main body running through opening having and fluid is guided to intubate (9), and wherein intubate (9) extends beyond the proximal lateral of substrate (10), and
-described substrate is fixed to device (21) on the skin of user,
It is characterized in that, in the region being placed between subcutaneous part and fluid delivery part (3,4) of intubate (9), be provided with flexible portion.
2, the equipment according to item 1, is characterized in that, described flexible portion is integrated in described substrate (10).
3, the equipment according to item 2, is characterized in that, described substrate (10) is partly or wholly made up of flexible material.
4, the equipment according to item 1, is characterized in that, described flexible portion is integrated in have described in described cannula part (1) and fluid is guided to the running through in the main body of opening of intubate (9).
5, the equipment according to item 4, is characterized in that, the main part of described cannula part (1) ground or be made up of flexible material fully.
6, the equipment according to item 1, is characterized in that, described flexible portion is integrated in described fluid delivery part (3,4).
7, the equipment according to item 1, is characterized in that, described flexible portion is for being arranged on the separate unit between described fluid delivery part (3,4) and described injection portion.
8, the equipment according to item 7, is characterized in that, described separate unit is partly or wholly made up of flexible material.
9, the equipment according to item 1, is characterized in that, described fluid delivery part (3,4) and described injection portion can be separated and be re-engaged.
10, the equipment according to item 1, is characterized in that, described substrate (10) has clamp device (11), and it is for connecting and disconnecting the described conveyer device (3,4) extended from the distal side of described substrate (10).
11, the equipment according to item 1, is characterized in that, the housing (3) of described fluid delivery part (3,4) additionally provides the housing of described injection portion.
12, the equipment according to item 1, is characterized in that, flexible portion (5,12) is formed by having the region reducing scantling.
13, the equipment according to item 1, is characterized in that, flexible portion (5,12) is by with softer and have more the region that flexible material makes and form.
14, the equipment according to item 1, is characterized in that, the region that flexible portion (5,12) is made up of the material by its shape with extension and compressed capability is formed, and described material is such as by pleating folding or undulatory material.
15, the equipment according to aforementioned any one, is characterized in that, described intubate (9) and described transport portion (3,4) are not interconnected by non-flexible region.
16, the equipment according to item 1-15, is characterized in that, when described transport portion (3,4) and described injection portion is bonded together time, formed by fluid from described reservoir guide to described intubate (9) fluid-tight connect.
17, the equipment according to item 16, it is characterized in that, due to when described fluid delivery part (3,4) is separated with described injection portion, the opening leading to reservoir (4) is stopped, therefore, in during described two parts are separated, prevent microorganism from entering the reservoir (4) of described fluid delivery part.
18, equipment according to item 17, it is characterized in that, described reservoir (4) has two positions, i.e. primary importance and the second position, when in said first position, the first barrier (8 that the outlet of reservoir (4) can not be passed by microorganism, 8a, 26) stop, cannula part (1, the second barrier (7 that the entrance running through opening 1b) can not be passed by microorganism, 18, 27) stop, when at the second position, by passing described first and second barriers at described reservoir (4) and described cannula part (1, running through 1b) between opening, to form the fluid opened to connect.
19, the equipment according to item 18, is characterized in that, one or two in described barrier (8,8a, 26,7,8b, 27) comprises the material that can be penetrated by needlelike object, and wherein when described needlelike object is retracted, described opening is closed.
20, the equipment according to item 19, is characterized in that, described needlelike object is blunt.
21, the equipment according to item 19, is characterized in that, described needlelike object is tip.
22, the equipment according to item 18, it is characterized in that, one or two in described barrier (18) comprises hard surface, and this surface is moved, to form opening in the region between the outlet being arranged at outlet (22) and the entrance running through fluid passage (23).
23, the equipment according to item 1-22, it is characterized in that, device for being fixed on the skin of user by described substrate (10) comprises mounting mat, and this mounting mat sticks to the proximal lateral of described substrate (10) and/or the proximal lateral of described cannula part (1,1b).
24, the equipment according to item 2 or 12, is characterized in that, the form that described substrate (10) is grid, has the connecting rod (12) that coherent outer peripheral portion and one or more and described outer peripheral portion interconnect.
25, the equipment according to item 24, is characterized in that, described substrate (10) has the outer peripheral portion of circle or ellipse, and described connecting rod (12) has the one end being connected to described outer region and the second end being connected to central area.
26, the equipment according to item 24-25, is characterized in that, described substrate (10) has three or more connecting rods (12).
27, the equipment according to item 1-26, is characterized in that, described substrate (10) is not provided with intubate (9) before the use.
28, the equipment according to item 27, is characterized in that, a part for described substrate (10) has opening, and intubate (9) can be inserted via this opening.
29, the equipment according to item 28, is characterized in that, one end of described intubate (9) has a main body, and this main body comprises solid wall and the protection sealing member (7,7a) for the protection of described intubate (9) entrance.
30, the equipment according to item 27-28, it is characterized in that, described substrate (10) is equipped with the Part I (1a) of cannula part, and this Part I is used as the register control of Part II (1b), and wherein Part II (1b) comprises intubate (9) and will be inserted with entry needle.
31, the equipment according to item 30, is characterized in that, the Part I (1a) of described cannula part is equipped with the device for described Part II (1b) being locked in desired location.
32, the equipment according to item 28-31, it is characterized in that, described intubate (9) is inserted with an insertion equipment, this insertion equipment has the device corresponding with the surface of described substrate (10), and when the described device of described insertion equipment and the respective surfaces of described substrate in conjunction with time, described insertion equipment is located by this way, that is, comprise and provide the intubate of the main body of fluid passage (9) can be predicted ground and correctly insert relative to described substrate (10) to intubate.
33, the equipment according to item 1, is characterized in that, described substrate (10) is non-releasably connected with a mounting mat.

Claims (13)

1. for the conveying equipment of conveyance fluid, comprise injection portion and fluid delivery part, wherein said fluid delivery part comprises reservoir, pump and housing, and described injection portion comprises:
-substrate,
-substrate is fixed to device on the skin of user,
-cannula part, comprises main body and intubate, described main body have fluid guided to intubate run through opening, described intubate extends beyond the proximal lateral of substrate during use,
Wherein, described substrate is provided with the clamp device for connecting and disconnect described fluid delivery part, described clamp device extends from the distal side of substrate, described substrate is included in the surface of described distal side, described surface corresponds to the insertion equipment for cannula part, and described cannula part is configured to be inserted into and be attached on substrate after substrate has been located on the skin of the patient, and
Wherein said conveying equipment comprises adapter and connector pin further, wherein said adapter is attached on substrate, wherein when described substrate is connected with described fluid delivery part, described connector pin penetrates the barrier film of the entrance covering described adapter and covers the barrier film of entrance of reservoir of described fluid delivery part, and wherein when described substrate and described fluid delivery section break, the barrier film that described connector pin had not both penetrated the entrance of the described adapter of described covering does not penetrate the barrier film of the entrance of the reservoir of the described fluid delivery part of described covering yet.
2. conveying equipment according to claim 1, is characterized in that, described fluid delivery part and described injection portion can be separated and be re-engaged.
3. conveying equipment according to claim 1, is characterized in that, when described fluid delivery part and described injection portion are bonded together, the fluid-tight formed fluid guides to described intubate from described reservoir connects.
4. conveying equipment according to claim 1, it is characterized in that, due to when described fluid delivery part is separated with described injection portion, the opening leading to reservoir is stopped, therefore, in during described fluid delivery part is separated with described injection portion, prevent microorganism from entering the reservoir of described fluid delivery part.
5. conveying equipment according to claim 1, it is characterized in that, described reservoir has primary importance and the second position, when in said first position, the first barrier that the outlet of reservoir can not be passed by microorganism, the second barrier that the entrance running through opening in cannula part can not be passed by microorganism, when at the second position, by forming the fluid opened opening through described first and second barriers connect in running through of described reservoir and described cannula part.
6. conveying equipment according to claim 5, is characterized in that, one or two in the first barrier and the second barrier comprises the material that can be penetrated by needlelike object, and wherein when described needlelike object is retracted, described opening is closed.
7. conveying equipment according to claim 1, is characterized in that, comprises mounting mat for the device be fixed on the skin of user by described substrate, and this mounting mat sticks to the proximal lateral of described substrate and/or the proximal lateral of described cannula part.
8. conveying equipment according to claim 1, is characterized in that, described substrate is not provided with intubate before the use.
9. conveying equipment according to claim 1, is characterized in that, described main body comprises the protection sealing member of solid wall and the entrance for the protection of described intubate.
10. conveying equipment according to claim 1, is characterized in that, described substrate is equipped with the Part I of cannula part, and this Part I is used as the register control of Part II, and wherein Part II comprises intubate and will be inserted with entry needle.
11. conveying equipments according to claim 10, is characterized in that, the Part I of described cannula part is equipped with the device for described Part II being locked in desired location.
12. conveying equipments according to claim 1, it is characterized in that, described insertion equipment has the device corresponding with the surface of described substrate, and when the described device of described insertion equipment and the respective surfaces of described substrate in conjunction with time, described insertion equipment is located by this way, and namely described cannula part can be predicted ground relative to described substrate and correctly insert.
13. conveying equipments according to claim 1, is characterized in that, described substrate is non-releasably connected with a mounting mat.
CN201210182317.2A 2005-12-23 2006-12-22 Drug delivery device Active CN102886084B (en)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US75368405P 2005-12-23 2005-12-23
US60/753,684 2005-12-23
DKPA200600103 2006-01-24
DKPA200600103 2006-01-24
US76223106P 2006-01-25 2006-01-25
US60/762,231 2006-01-25
US81676706P 2006-06-27 2006-06-27
US60/816,767 2006-06-27

Related Parent Applications (1)

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CN2006800487552A Division CN101365504B (en) 2005-12-23 2006-12-22 Device for administration

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CN102886084B true CN102886084B (en) 2015-01-14

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Publication number Priority date Publication date Assignee Title
DK3590566T3 (en) * 2013-12-19 2021-08-09 Medtronic Minimed Inc BODY CARRIED INJECTOR
CN111166438A (en) * 2016-03-29 2020-05-19 美敦力公司 A apparatus is kept somewhere to skin table for guiding puncture
WO2023131567A1 (en) * 2022-01-10 2023-07-13 Shl Medical Ag Adhesive pad

Citations (2)

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Publication number Priority date Publication date Assignee Title
CN1556716A (en) * 2001-02-22 2004-12-22 ���Ͽع����޹�˾ Modular infusion device and method
CN1558782A (en) * 2001-09-27 2004-12-29 ��ŵҽ�����޹�˾ Injector device for placing a subcutaneous infusion set

Patent Citations (2)

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Publication number Priority date Publication date Assignee Title
CN1556716A (en) * 2001-02-22 2004-12-22 ���Ͽع����޹�˾ Modular infusion device and method
CN1558782A (en) * 2001-09-27 2004-12-29 ��ŵҽ�����޹�˾ Injector device for placing a subcutaneous infusion set

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CN102886084A (en) 2013-01-23

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