EP0692989A1 - Dispositif d'administration par voie intradermique - Google Patents

Dispositif d'administration par voie intradermique

Info

Publication number
EP0692989A1
EP0692989A1 EP94912055A EP94912055A EP0692989A1 EP 0692989 A1 EP0692989 A1 EP 0692989A1 EP 94912055 A EP94912055 A EP 94912055A EP 94912055 A EP94912055 A EP 94912055A EP 0692989 A1 EP0692989 A1 EP 0692989A1
Authority
EP
European Patent Office
Prior art keywords
piston
vacuum
skin
penetrating
medicament
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Withdrawn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
EP94912055A
Other languages
German (de)
English (en)
Inventor
Joseph Gross
John Gerard Kelly
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.)
Elan Medical Technologies Ltd
Original Assignee
Elan Medical Technologies Ltd
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 Elan Medical Technologies Ltd filed Critical Elan Medical Technologies Ltd
Publication of EP0692989A1 publication Critical patent/EP0692989A1/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Withdrawn legal-status Critical Current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
    • A61M5/42—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 having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/425—Protruding skin to facilitate piercing, e.g. vacuum cylinders, vein immobilising means
    • 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • 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
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3295—Multiple needle devices, e.g. a plurality of needles arranged coaxially or in parallel
    • A61M5/3298—Needles arranged in parallel
    • 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
    • A61M5/46—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 having means for controlling depth of insertion

Definitions

  • This invention relates to a device for administering intradermally a medicament in liquid form.
  • intradermal herein is intended to embrace subcutaneous.
  • medicaments Many drugs, active ingredients or medications, hereinafter referred to collectively as medicaments, require administration by injection. This mode of administration tends to be inconvenient and also painful. Patients may be required to self-administer a medicament, such as insulin in the case of diabetics, and various attempts have been made to make this mode of administration more convenient, thereby, increasing patient compliance. Thus, "pen” type injectors have been proposed.
  • Such a device should ideally include a needle or needles which enter the skin to a predetermined depth and allow precise penetration of the skin by the patient.
  • the invention provides a device for administering intradermally a metered dose of a medicament in liquid form, said device comprising means for creating a vacuum so as to secure the device to the skin during medicament delivery, means for penetrating one or more skin layers and delivering said metered dose and means for releasing said vacuum for removal of the device following delivery of the metered dose.
  • the device according to the invention can be used with a minimum of trauma by patients as well as by medical and nursing staff, to administer a range of medicaments, including peptides and polypeptides, by the intradermal route as hereinbefore defined.
  • the means for creating the vacuum comprises a piston arrangement and an associated system of air channels.
  • the means for penetrating the or each skin layer comprises a plurality of hollow needles in communication with a reservoir for the medicament.
  • the creation of the vacuum can cause the skin to be drawn towards, and penetrated by, said penetration means.
  • the vacuum is created circumferentially of the penetrating means.
  • the vacuum can be generated circumferentially of a housing for the device.
  • the penetrating means comprises a plurality of hollow needles
  • a vacuum can be created circumferentially of each needle defining said penetrating means.
  • the piston arrangement when such is present, is preferably actuated by a plunger mechanism integral with the piston.
  • the piston impinges on a displaceable membrane defining a boundary wall of the reservoir so as to expel the contents of the reservoir through the penetrating means when the piston is depressed.
  • the plunger has an internal air duct which is open to the atmosphere.
  • the penetrating means can be movable within the device, such that when the vacuum is generated, said penetrating means is simultaneously or sequentially displaced towards the skin for penetration thereof.
  • actuation of the device simultaneously creates the vacuum and causes movement of the skin penetrating means for penetration of the skin.
  • the vacuum generated can draw the skin against a plate structure in the device disposed on a skin-contacting surface thereof.
  • the plate structure then maintains the skin in position while a set of needles is caused to descend and pass through a plurality of apertures in said plate structure and enter the skin to a predetermined depth.
  • a set of needles is fixed in position on such a plate structure and the act of drawing the skin against the plate causes the needles to penetrate the skin.
  • the medicament is then delivered as a single dose through the set of needles.
  • the withdrawal of the needles from the skin can release the vacuum or vice versa.
  • the device according to the invention is preferably in the form of a disposable pre-filled product for once-off use, although the device can be readily adapted for continued use by the provision of filling means for replenishing the reservoir.
  • the device is suitably provided with means for indicating when a quantity, corresponding to one or more metered doses, has been inserted therein.
  • the medicament can have almost any viscosity, provided that it can be dispensed through the penetrating means at a rate which is pharmaceutically effective and acceptable.
  • the penetrating means will suitably be manufactured from medical-grade stainless steel.
  • the penetrating means can also be composed of a suitable inert plastics material.
  • the device according to the invention is suitable for the administration, including self-administration, of a wide range of medicaments, including peptides and polypeptides.
  • the device according to the invention is especially suitable for the administration of insulin.
  • the device according to the invention is also suitable for the administration of vaccines in methods of vaccination.
  • the device according to the invention can be used to inject a medicament intradermally or subcutaneously automatically as desired by suitable adjustment of the length of the needles or the extent to which the needles or other penetrating means are movable relative to or within the device.
  • the device according to the invention allows for precise penetration of the skin which is an advantage over currently available automatic injection devices.
  • the device according to the invention can also be used to inject controlled release formulations, suitably in a lipophilic base, allowing for convenient subcutaneous injection of depot formulations.
  • the device may be enclosed in a sterilised package until required for use.
  • the needles or other penetrating means will normally be either covered by a peel-off strip or stuck in an impermeable pad to prevent the medicament from leaking out of the device while in storage.
  • Fig.l is a front elevation in section of a first embodiment of the device according to the invention.
  • Fig. 2 is a plan view of the device of Fig. 1 taken on the line II-II;
  • Fig. 3 is a front elevation in section of a second embodiment of the device according to the invention.
  • Fig. 4 is a plan view of the device of Fig. 3 in the direction of the arrow.
  • a device for administering intradermally to a patient a metered dose of a medicament in liquid form comprising a housing 11 and a piston arrangement, indicated generally at 12, comprising a piston 13 movable in sealing engagement within a hollow chamber 14 disposed internally of the housing 11.
  • the piston 13 is provided with an integral plunger mechanism 15 for actuation by the person administering the medicament.
  • the plunger 15 has an internal airway 16 which is substantially L-shaped and which communicates with the atmosphere via an outlet 17.
  • End 18 of the piston 13, which travels within the chamber 14, serves to close the end of the chamber 14 distal from the skin, in use, apart from a second outlet 19 of the airway 16.
  • the end of the chamber 14 proximal to the skin, in use is defined by an elastomeric membrane 20 defining a boundary wall 21 of a reservoir 22 for the medicament 23.
  • the piston arrangement 12 is similar to that used in a conventional hypodermic syringe and thus end 18 of piston 13 which travels within chamber 14 has a circumferentially extending flexible grooved sealing means.
  • the housing 1 1 has a cap 24 with an aperture 25 through which shaft 26 of the plunger mechanism 15 passes in sealing engagement therewith.
  • An air chamber 27 which communicates via extension 28 with the space above end 18 of the piston 13 when the piston is depressed is disposed intermediate walls 29 of the housing 11 and the walls of the chamber 14 and is continuous within a skin-contacting part 30 of the housing 11 containing penetrating means 31 comprised of a plurality of needles 32.
  • the air chamber 27 is also in communication with an aperture 33 surrounding each needle 32.
  • the air chamber 27 can be replaced by a plurality of narrow bore air chambers, typically four, spaced equidistantly about the circumference of the device 10 and being continuous with the space above end 18 of the piston 13 when the piston is depressed and with the skin-contacting part 30.
  • the device 10 is provided with a circumferentially extending elastomeric sealing ring 34 for engagement with the skin in use.
  • the person administering the medicament who may be the patient, selects the site on the skin at which the medicament is to be administered.
  • the device 10 is applied to the skin, the plunger mechanism 15 is depressed in the direction of the skin, causing the piston 13 to move towards the membrane 21.
  • the hollow chamber 14 is open to the atmosphere via outlet 17. Depression of the piston 13 causes a reduction in pressure in space 28 and causes air to be sucked into said space via the air chamber 27, resulting in the creation of a vacuum at the site of application of the device 10.
  • the creation of the vacuum causes the skin to be drawn towards and penetrated by the needles 32.
  • the medicament 23 is delivered through the needles 32 in response to the action of the piston 13 depressing the membrane 20 which forces the medicament 23 out of the reservoir 22 and into the needles 32 followed by intradermal delivery.
  • the piston 13 is retracted releasing the vacuum and thereby releasing the device 10.
  • FIG. 3 and 4 of the Drawings there is illustrated a modification of the device 10 depicted in Fig. 1 and wherein like parts are accorded like reference numerals.
  • the hollow chamber 14' and the skin-contacting part 30' each has a slightly different shape relative to the hollow chamber 14 and the skin-contacting part 30, respectively, of the embodiment depicted in Fig. 1.
  • the membrane 20' in situ has a shape dictated by the interengaging parts 14' and 30'.
  • a peripherally-extending flange 35 which, in use, rests on the skin (not shown).
  • An air chamber 27' is formed intermediate walls 29' of the housing 1 1 and externally of the hollow chamber 14' and the skin- contacting part 30'.
  • the needles 32 are not each provided with an aperture in contact with the air chamber 27'. Rather, when the flange 35 engages the skin, in use, and the piston 13 is depressed, air is sucked from the air chamber 27' into space 28 above piston 13, so as to create a vacuum circumferentially and externally of the part of the device 10 housing the needles 32. The creation of the vacuum causes the device 10 to be held firmly in contact with the skin during delivery of the medicament. To release the device 10, the piston 13 is retracted in the same manner as for the embodiment depicted in Fig. 1.

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Dermatology (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)
  • Fuel-Injection Apparatus (AREA)

Abstract

L'invention concerne un dispositif (10) pour administrer par voie intradermique ou sous-cutanée, éventuellement à soi-même, une dose mesurée d'un médicament liquide (23). Ce dispositif comporte des moyens (12, 27', 30', 35) pour créer un vide permettant de faire adhérer le dispositif (10) à la peau durant l'administration du médicament, des moyens (32) pour pénétrer une ou plusieurs couches de peau à une profondeur souhaitée et introduire le médicament et des moyens (12, 27', 30', 35) pour couper ensuite le vide et permettre d'enlever le dispositif (10). Le dispositif (10) peut se présenter sous la forme d'un article déjà rempli à usage unique, c'est-à-dire qui est jeté après son utilisation. Le dispositif (10) permet d'administrer un médicament d'une manière commode qui améliore l'acceptation du traitement par les patients.
EP94912055A 1993-04-08 1994-04-07 Dispositif d'administration par voie intradermique Withdrawn EP0692989A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IE930274 1993-04-08
IE930274A IE68890B1 (en) 1993-04-08 1993-04-08 Intradermal delivery device
PCT/IE1994/000020 WO1994023777A1 (fr) 1993-04-08 1994-04-07 Dispositif d'administration par voie intradermique

Publications (1)

Publication Number Publication Date
EP0692989A1 true EP0692989A1 (fr) 1996-01-24

Family

ID=11039936

Family Applications (1)

Application Number Title Priority Date Filing Date
EP94912055A Withdrawn EP0692989A1 (fr) 1993-04-08 1994-04-07 Dispositif d'administration par voie intradermique

Country Status (7)

Country Link
EP (1) EP0692989A1 (fr)
JP (1) JPH08508901A (fr)
AU (1) AU6436794A (fr)
CA (1) CA2159588A1 (fr)
IE (1) IE68890B1 (fr)
NZ (1) NZ263619A (fr)
WO (1) WO1994023777A1 (fr)

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US6890553B1 (en) 1999-07-08 2005-05-10 Johnson & Johnson Consumer Companies, Inc. Exothermic topical delivery device
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US7133717B2 (en) 1999-08-25 2006-11-07 Johnson & Johnson Consumer Companies, Inc. Tissue electroperforation for enhanced drug delivery and diagnostic sampling
US8465468B1 (en) 2000-06-29 2013-06-18 Becton, Dickinson And Company Intradermal delivery of substances
US6494865B1 (en) 1999-10-14 2002-12-17 Becton Dickinson And Company Intradermal delivery device including a needle assembly
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JP6327852B2 (ja) 2010-05-04 2018-05-23 コリウム インターナショナル， インコーポレイテッド 微小突起アレイを使用した副甲状腺ホルモンの経皮送達のための方法及びデバイス
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Also Published As

Publication number Publication date
IE930274A1 (en) 1994-10-19
WO1994023777A1 (fr) 1994-10-27
JPH08508901A (ja) 1996-09-24
CA2159588A1 (fr) 1994-10-27
IE68890B1 (en) 1996-07-24
AU6436794A (en) 1994-11-08
NZ263619A (en) 1997-06-24

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