EP1455869A2 - Dispositif pour administrer une substance, pourvu d'un element de sortie et d'un capuchon de bouchon - Google Patents

Dispositif pour administrer une substance, pourvu d'un element de sortie et d'un capuchon de bouchon

Info

Publication number
EP1455869A2
EP1455869A2 EP02781046A EP02781046A EP1455869A2 EP 1455869 A2 EP1455869 A2 EP 1455869A2 EP 02781046 A EP02781046 A EP 02781046A EP 02781046 A EP02781046 A EP 02781046A EP 1455869 A2 EP1455869 A2 EP 1455869A2
Authority
EP
European Patent Office
Prior art keywords
stopper
administration device
face
diameter
container
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.)
Withdrawn
Application number
EP02781046A
Other languages
German (de)
English (en)
Inventor
Ulrich Haueter
Hanspeter Heiniger
Erich Imhof
Urs Kipfer
Daniel Peter
Bruno Reihl
Hanspeter Stoller
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.)
F Hoffmann La Roche AG
Roche Diagnostics GmbH
Original Assignee
Disetronic Licensing AG
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 Disetronic Licensing AG filed Critical Disetronic Licensing AG
Publication of EP1455869A2 publication Critical patent/EP1455869A2/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31513—Piston constructions to improve sealing or sliding
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES 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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod

Definitions

  • the invention relates to a device for the administration or distribution of an injectable product with an output member and an active substance container and a stopper cap for a stopper of the active substance container according to the preamble of the independent claims.
  • An administration device as it relates to the invention is e.g. B. delivery devices for injection or infusion of a liquid active ingredient solution, preferably a medicinal liquid, such as. B. a solution with insulin or growth hormones.
  • the dispensing device is preferably portable devices, in particular in the form of so-called injection pens or infusion pumps.
  • Such an administration device has an active substance container, in which a liquid active substance solution is accommodated, which is poured out through an outlet of the container by means of an output member which engages a stopper or piston within the active substance container.
  • the terms plug and piston are used in the same sense.
  • Injection pens such as. B. are known from WO 93/16740, but also pump devices such as those found in. B. from EP-B-0 143 895 for infusion or infusion and injection of drug solutions are known, have a housing in which an injectable product is received in a container, ie in a drug or drug container. A piston is slidably received in the container. When the piston is moved in the feed direction towards an outlet of the container, a dose of the product is due to displacement by the piston from the container through the Outlet poured out.
  • the container generally an ampoule, is fixed in the housing in such a way that an output member of a dispensing mechanism of the injection pen or of the pump device presses the piston in the feed direction in order to dispense the product.
  • the delivery mechanism essentially comprises at least two elements, the already mentioned output member and a drive device for the output member.
  • the output member projects toward the piston into the container when the container is received in the housing.
  • the drive device is in engagement with the output member in such a way that the output member can be pushed in the feed direction by actuation of the drive device.
  • the drive device is both by turning, such. B.
  • the output member of which has a sawtooth-like structure, such as a toothed rack, and the drive device is equipped with corresponding counter elements.
  • the drive device is generally only actuated by turning, the rotation causing the output member to be advanced.
  • the liquid drug solution is expelled through a cannula placed on the injection pen.
  • a rear end of the cannula is connected to the active substance solution by projecting through a piercing membrane of the container inside the injection pen.
  • a front end of the cannula protrudes from the injection pen and can pierce the skin.
  • Pump devices have a cannula for skin penetration at one end of an infusion tube opposite the pump.
  • a further cannula is attached to the pump-side end of the infusion tube and is used to penetrate the piercing membrane of the container.
  • the cannula is first pushed through the skin and then, by operating the drive device with the delivery mechanism, be it manually or by motor, the active substance solution from the active substance container through the Infusion tube, or poured through the cannula into the body.
  • the distribution takes place in such a way that when the dispensing mechanism is actuated, the plunger is advanced a certain distance in the direction of the outlet of the container, as a result of which the active substance solution is displaced into the infusion tube or the cannula.
  • the patient can be informed of the occlusion or leak by means of an acoustic or vibratory alarm signal and further advancement of the output member can be stopped so that no further pressure build-up between the piston and cannula or, in the event of a leak, not further active ingredient to lose. Both phenomena mean that no active ingredient is supplied to the patient, which can be particularly dangerous with insulin therapy. In the case of an occlusion, there is also the risk that too much active substance will be administered if the occlusion is suddenly released, with serious consequences for the patient.
  • an active substance container consists of a cylindrical ampoule in which a slide-displaceable stopper is arranged, the outer surface of which has three sealing lips.
  • An output member of a drive device is arranged opposite the plug, the end face of which is formed by a flat flange.
  • the three sealing lips serve to minimize the sliding friction and at the same time seal the ampoule to the outside, so that when the plug is pushed forward by means of the driven member onto an outlet of the ampoule, no active ingredient escapes from the ampoule against the direction of advance.
  • the first sealing lip closest to the active ingredient is primarily responsible for sealing.
  • the second sealing lip mainly takes on a securing function, while the third sealing lip does not fulfill any essential task.
  • a surface of the stopper, which faces an end face of the driven member, and the end face are formed by flat surfaces which lie flat on top of one another to advance the stopper by means of the driven member.
  • essentially the entire plug surface is covered by the end face of the output member, so that the largest possible contact area is created.
  • a diameter of a flange of the output member which forms the end face is just large enough that the flange forms the inner circumferential surface of the ampoule, i.e. the inner wall of the ampoule, just not touching it and therefore there is no additional friction.
  • the object of the invention is to minimize the plug friction forces as far as possible, to provide reliable administration of a product and safe handling of an administration device.
  • the invention solves the problem by an administration device according to claim 1 and by a stopper cap according to claim 15.
  • Advantageous refinements of the invention emerge from the subclaims. Accordingly, in the case of a device for administering or dispensing a liquid active substance solution from an active substance container with a displaceably mounted stopper and with an output element for displacing the stopper, according to the invention there is a contact surface between a surface of the stopper and an end face of the output element or an attachment part of the output element during the displacement of the stopper is smaller than the surface of the stopper.
  • the end face is formed by the surface facing the stopper.
  • the surface can be formed by the driven member itself or by an attachment to the driven member.
  • the end face is also possible for the end face to be composed of surfaces of the driven member and the attachment.
  • the end face for forming the contact surface rests on the surface of the stopper when the plug is displaced such that a substantial part of this surface is not covered or touched by the end face.
  • the contact area is therefore smaller than the surface of the plug, preferably it is at least 9: 7 smaller. It is particularly advantageous if the contact area is smaller than the surface by more than half.
  • the advantages achieved by the invention are essentially to be seen in the fact that the contact surface between the output member and the plug causes the plug to deform slightly. That in that the contact area is smaller than the surface of the stopper or the free area of the stopper surface bends when the driven member is advanced in the direction of the driven member, so that the diameter of the stopper becomes slightly smaller, at least in some areas of the outer surface of the stopper and thereby reducing the friction on the container wall.
  • the end face of the driven member or the top part of the driven member is uneven.
  • the end face of the driven member can have a bulge or elevation in the direction of the plug in a central region.
  • the surfaces are preferably convex or conical.
  • the end face of the output member or the Attachment part uneven, such as convex or conical, and the surface of the stopper is planar.
  • the surface of the stopper can then be planar or also uneven.
  • the diameter of the face can almost correspond to the inner diameter of the active substance container.
  • the end face can be formed by a disk-shaped flange and a disk projecting therefrom. According to the invention, this results in a small contact area with respect to the surface of the stopper and the flange on the inner wall of the container can ensure that the driven member is guided.
  • the diameter of the disc is smaller than the diameter of the disc-shaped flange. The diameter of the disc-shaped flange according to the inner diameter of the active substance container and the diameter of the disc according to the desired size of a contact surface.
  • an active substance container with a cylindrical shape is selected, which is closed off by a cylindrical stopper.
  • the plug is at least largely made of an elastic material, such as an elastomer, i.e. when subjected to a force, it can deform and return to its original shape without the application of force.
  • the stopper is preferably elastic on its outer lateral surface, so that the stopper can bend or deform in the region of the lateral surface when being pushed forward.
  • the cylindrical stopper can have one or preferably a plurality of sealing lips on its outer circumferential surface, which lie on its outer circumference against the inner circumferential surface of the active substance container.
  • the surface of the stopper, which faces the driven member, is preferably planar, but may have an unevenness as described above.
  • the unevenness of the end face of the driven member or an attachment part of the driven member is preferably arranged centrally in the middle or extends in a ring shape in the circumferential direction around an outer region of the surface. This ensures a symmetrical application of force to the stopper during feed and prevents the stopper from tilting when the force is applied.
  • a stopper cap for a stopper of an active substance container which can be displaced by an output member for the administration of an active substance from the active substance container, which is preferably sleeve-shaped and, according to the invention, surrounds the stopper on its outer lateral surface in such a way that a circumferential direction closed part of the outer surface remains free.
  • the cap is therefore partially pushed between the stopper and the inner surface of the active substance container. A sufficient part of the stopper remains free, which abuts the inner circumferential surface of the container all around, so that no active substance can escape from the container in the direction of the driven member.
  • the stopper cap is preferably attached to the stopper only before an active substance container or an ampoule is inserted into an administration device. During the storage of the active substance container outside the administration device, the entire outer surface of the stopper therefore lies against the inner surface of the active substance container and ensures a secure seal. Before the active substance container is inserted into the administration device, the stopper cap is attached, thus reducing the contact area of the stopper on the container wall, so that the frictional forces of the stopper on the container wall can be reduced.
  • the material of the stopper cap has less friction on the inner wall of the container than the stopper itself, or there is little play between the inner wall of the container and the outer wall of the cap, whereby the stopper can be compressed so that it fits into the cap.
  • the cap has an edge in the direction of the stopper, which has a spiral shape.
  • the cap consists essentially of a sleeve part that is closed on one side on which the output member engages. On the other side, which faces the plug, the sleeve part is open and has an edge which points in the direction of the plug.
  • the peripheral surface of the sleeve part runs parallel to the inner surface of the active substance container, the outer diameter of the sleeve being slightly smaller than the inner diameter of the container.
  • the edge of the sleeve part is preferably cut in a spiral shape.
  • FIG. 2 shows a perspective section through an active substance container with a stopper according to the prior art
  • Figure 3a shows a perspective section through a second embodiment of a
  • FIG. 3b shows a perspective view of a conical component
  • Figure 4 shows a cross section of a third embodiment of an output member according to the invention and Figure 5 shows a perspective section through an active ingredient container with a
  • Stopper and a stopper cap according to the present invention are identical to Stopper and a stopper cap according to the present invention.
  • FIG. 1 shows an output member 10 with a flat flange 11 attached on the end face and a rear part of an active substance container 1 according to the prior art, as described above.
  • the active substance container 1 consists of a cylindrical ampoule 1 in which a slidable plug 2 is received, the outer surface of which has three sealing lips 3a, 3b and 3c.
  • a surface 5 of the plug, which faces the driven member 10, is designed as a planar surface.
  • An end face 4 of the flange 11 lies opposite the surface 5 of the stopper and is also planar. The diameter of the end face 4 is slightly smaller than the diameter of the surface 5.
  • the end face 4 comes to lie on the surface 5 and forms a contact area which is almost the same Fills the entire surface 5 of the stopper. It is therefore not possible for the plug to bulge or bend when it is being advanced, and thus to reduce the frictional forces of the plug 2 on the inner wall of the active substance container 1.
  • Figure 2 shows a first embodiment according to the invention in which the size of the contact area is significantly reduced compared to the prior art.
  • the driven member 10 has on its flange 11 in the feed direction an attachment part which is designed as a sleeve-shaped component 12.
  • the outer diameter of the flange 11 and the sleeve-shaped component 12 can essentially match.
  • the sleeve-shaped component 12 forms an annular elevation of the end face 4 of the output member, i.e. to form the contact surface, the sleeve-shaped component 12 rests only on the edge of the surface 5 of the stopper 2, so that the central region of the surface 5 remains largely free and does not contribute to the contact surface.
  • the surface 5 of the stopper 2 bulges into the sleeve-shaped component 12 and deforms the shape of the stopper 2 in such a way that the contact pressure of the stopper 2 against an inner wall of the ampoule 1 is reduced ,
  • the rearmost sealing lip 3c easily detaches from the inner wall of the ampoule, so that the contact pressure of the outer surface of the stopper 2 relative to the inner wall of the ampoule 1 decreases relatively and thus the friction when the stopper is advanced is reduced. It is not absolutely necessary to use a plug with three sealing lips, which has a comparatively large height.
  • stoppers with a lower height it is also possible to provide a narrow stopper of low height as long as there is sufficient sealing between the outer surface of the stopper and the inner wall of the ampoule.
  • the bending or curvature of the stopper according to the invention can be used particularly effectively, since these are more flexible than stoppers with a high height.
  • FIG. 3 a shows a second exemplary embodiment of an uneven end face of an output member.
  • An attachment part in the form of a convex component 13 is placed on the flange 11 of the driven member 10 in the feed direction.
  • a conical component 14 can also be used as shown in Figure 3b. If the output member 10 is displaced in the feed direction of the plug 2 in this embodiment, the surface 5 of the plug 2 bulges around the convex end face 4 of the component 13, or around a tip 15 of the conical component 14.
  • the surface with which the surface 5 of the stopper 2 comes to rest on the convex or conical end face 4 forms the contact surface according to the invention and is significantly smaller than the entire surface 5 of the stopper 2.
  • the shape of the stopper 2 is deformed such that the friction between the The outer surface of the stopper 2 and the wall of the ampoule 1 decreases.
  • the rearmost sealing lip 3c can easily detach from the inner wall of the ampoule 1.
  • FIG. 4 shows a third exemplary embodiment of the invention.
  • the output member 10 has a flange 11 which is disc-shaped and on which an additional disc 16 is placed.
  • the diameter d2 of the flange 11 is dependent on the inner diameter of the ampoule 1 (not shown). It is preferably between 5 and 15 mm. In the case of an ampoule with an inner diameter of 9.6 to 9.8 mm, the diameter d2 is preferably 9 mm.
  • the diameter dl of the disk 16 is smaller than the diameter d2 of the flange 11 and is preferably 5 to 10 mm. In the case of an ampoule with an inner diameter of 9.6 to 9.8 mm, the diameter dl is preferably 7 mm.
  • the disc 16 and the flange 11 can have different heights h1 and h2.
  • the height h1 of the disk 16 is preferably 0.5 to 1.0 mm, particularly preferably 0.6 mm.
  • the height h2 of the flange 11 is preferably 0.3 to 0.7 mm, particularly preferably 0.4 mm.
  • the ratio of diameter and height, of flange and washer can differ.
  • Harder plug material leads to the diameter dl of the Disc 16 must be reduced and the height h1 of disc 16 must be maximized to achieve the same bulging or bending effect of the plug as is possible with a soft plug material.
  • the feed force which acts on the stopper 2 can also influence the choice of the diameter and height of the components.
  • This choice is also influenced by the shape of the plug, such as the number of sealing lips, or another shape.
  • dl 9: 7
  • the disc 16 or an attachment part such as the components 12, 13 and 14 can be placed on the output member 10 or the flange 11 and e.g. can be attached by mechanical connection or by an adhesive.
  • the sleeve-shaped component 12, the convex component 13, the cone-shaped component 14, the disk-shaped component 16 or a differently shaped component can also be attached directly to the plug 2 or only to the plug 2. That is to say that an attachment part of the output member 10, which is formed by such a component, can be arranged or fixed opposite one another before the surface 5 of the stopper 2 is administered, and the output member 10 hits e.g.
  • the surface 5 of the stopper 2 in accordance with one of the components described, i.e. corresponding to an end face 4, which is formed by such a component, as an indentation or bulge or elevation.
  • the unevenness of the end face of the output member 10 or its top part, or the choice of the size of the contact area between the surface of the plug and the end face of the output member with a suitable height of the contact-causing component is the cause of minimizing plug friction.
  • Stopper friction can be reduced by reducing the friction surface of the outer surface of the stopper on the inner wall of the ampoule.
  • the at least partial covering of the stopper with a stopper cap is provided, as shown in FIG. 5.
  • the stopper cap 20 is sleeve-shaped and closed on one side and wraps around the rear region of the stopper 2.
  • a front part 21 of the hatch 20 is spirally circumferential on its front, that is to say the edge of the sleeve-like hatch.
  • the edge of the front cap part 21 therefore falls continuously from a foremost point in the circumferential direction.
  • This spiral configuration serves to screw the cap 20 into the ampoule 1 and around the stopper 2.
  • a tool can be inserted into a notch 22 in the closed cap side on the rear part 25 of the cap 20 and the cap 20 can be inserted in a rotating manner between the stopper 2 and the inner wall of the ampoule 1. So that the cap 20 can be arranged in this way in the ampoule 1, the wall of the sleeve-shaped part of the cap must be thin.
  • the outer diameter of the cap 20 is smaller than the inner diameter of the ampoule 1, so that there is no or only minimal sliding friction between the ampoule 1 and the cap 20, or the stopper part covered by the cap. Since an inner circumferential surface of the cap 20 can be pressed airtight against the outer circumferential surface of the stopper 2, or against one or more sealing lips 3b or 3c of the stopper 2, when screwing onto the stopper 2, it should be possible to originally between the stopper 2 and the To be able to vent cap 20 lying cavity.
  • the ventilation holes 24 arranged in the closed rear part 25 of the cap can be used for this.
  • the cap 20 In order not to impair the tightness of the ampoule 1, the cap 20 should be pushed at most up to the second foremost sealing lip 3b, so that at least one sealing lip, such as the sealing lip 3a, can perform its sealing function.
  • the tightness of the ampoule requires that an area of the stopper which is closed in the circumferential direction of the outer circumferential surface of the stopper 2 is not covered by the cap 20.
  • a known output member that is flat on the end face or equipped with a flat flange can be used for advancing the stopper. It is not necessary to take particular account of the size relationships of the surfaces lying against one another. The following features are also to be considered as belonging to the invention:
  • Device according to 1. characterized in that the contact surface of the top part (11, 12, 13, 14) of the output member (10) facing the plug (2) for pushing the plug (2) is uneven.
  • attachment part (16) comprises a disk-shaped flange (11) with a disk (16) projecting therefrom.
  • Medicament container (1) for storing a liquid active substance solution between an outlet and a stopper (2) mounted displaceably in the outlet direction, thereby characterized in that the rear plug part is enclosed in a sleeve-shaped cap (20).
  • Sleeve-shaped cap (20) according to 17, characterized in that the cap (20) can be screwed partially over the stopper (2).

Landscapes

  • 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)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un dispositif pour administrer une substance par déversement d'une solution d'agent actif liquide hors d'un contenant d'agent actif (1), ce dispositif comportant un bouchon (2) logé mobile, ainsi qu'un élément de sortie (10) pour déplacer le bouchon (2). Une surface de contact entre une surface (5) du bouchon (2) et une face frontale (4) de l'élément de sortie (10) ou d'un élément de recouvrement (12; 13; 14; 16) de l'élément de sortie (10) est inférieure à la surface (5) du bouchon (2), la face frontale (4) de l'élément de sortie (10) présentant alors de préférence des aspérités. L'invention concerne en outre un capuchon (20) pour le bouchon (2) d'un contenant d'agent actif (1), ce bouchon étant déplacé par un élément de sortie (10) pour administrer un agent actif à partir du contenant d'agent actif (1). De préférence en forme de douille, le capuchon (20) entoure le bouchon (2) sur sa surface extérieure de telle sorte qu'une zone de cette surface extérieure fermée dans le sens circonférentiel reste libre.
EP02781046A 2001-12-19 2002-12-11 Dispositif pour administrer une substance, pourvu d'un element de sortie et d'un capuchon de bouchon Withdrawn EP1455869A2 (fr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
CH23142001 2001-12-19
CH23142001 2001-12-19
CH612002 2002-01-16
CH612002 2002-01-16
PCT/CH2002/000683 WO2003051434A2 (fr) 2001-12-19 2002-12-11 Dispositif pour administrer une substance, pourvu d'un element de sortie et d'un capuchon de bouchon

Publications (1)

Publication Number Publication Date
EP1455869A2 true EP1455869A2 (fr) 2004-09-15

Family

ID=25699004

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02781046A Withdrawn EP1455869A2 (fr) 2001-12-19 2002-12-11 Dispositif pour administrer une substance, pourvu d'un element de sortie et d'un capuchon de bouchon

Country Status (3)

Country Link
EP (1) EP1455869A2 (fr)
AU (1) AU2002349253A1 (fr)
WO (1) WO2003051434A2 (fr)

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AU2002349253A1 (en) 2003-06-30
WO2003051434A3 (fr) 2003-10-30

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