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WO2007007128A1 - Appareil pour l'administration de substances à un organisme - Google Patents

Appareil pour l'administration de substances à un organisme Download PDF

Info

Publication number
WO2007007128A1
WO2007007128A1 PCT/GB2006/050197 GB2006050197W WO2007007128A1 WO 2007007128 A1 WO2007007128 A1 WO 2007007128A1 GB 2006050197 W GB2006050197 W GB 2006050197W WO 2007007128 A1 WO2007007128 A1 WO 2007007128A1
Authority
WO
WIPO (PCT)
Prior art keywords
skin
substance
base
spikes
patient
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.)
Ceased
Application number
PCT/GB2006/050197
Other languages
English (en)
Inventor
Bruce Roser
Henry Kirby
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.)
Cambridge Biostability Ltd
Original Assignee
Cambridge Biostability 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 Cambridge Biostability Ltd filed Critical Cambridge Biostability Ltd
Priority to GBGB0700944.2A priority Critical patent/GB0700944D0/en
Publication of WO2007007128A1 publication Critical patent/WO2007007128A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/20—Surgical instruments, devices or methods for vaccinating or cleaning the skin previous to the vaccination
    • A61B17/205—Vaccinating by means of needles or other puncturing devices
    • 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
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0023—Drug applicators using microneedles
    • 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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
    • A61M2037/0038—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles having a channel at the side surface

Definitions

  • This invention relates to apparatus for administering substances such as vaccines into a patient.
  • Langerhans cells crucial to the body's immunisation response, are migratory cells located in the Keratinocyte layer of the epithelium located approximately lmm under the surface of the skin. It is well known that vaccines work most effectively when injected into this layer as this causes the greatest amount of stimulation of the Langerhans cells which are the "professional" antigen presenting cells to the immune system. Some vaccines, including those for tuberculosis and rabies, will only produce an effective immune response if injected into this layer.
  • tuberculosis vaccine Bacillus Calmette-Guerin BCG
  • Bacillus Calmette-Guerin BCG
  • the vaccine is then able to enter the body to the level of the Langerhans cells through the holes formed by the gun.
  • a related drug administration technique employs an array of naked spikes, coated with a vaccine and arranged onto an open mount.
  • the mount is adapted to be loaded into an applicator to be 'fired' onto the skin.
  • the mount adheres to the skin, allowing the vaccine on the spikes to dissolve into the body.
  • the mount is limited to administering vaccines which can be coated and dried onto the spikes without losing activity on storage.
  • apparatus for administrating a substance into a patient characterised by a base or base layer adapted to be applied to the surface of a skin of the patient, a collapsible cover attached to the base or base layer to define a container for the substance to be administered and a penetrating means located within the container and arranged so that, when the cover is collapsed, the penetrating means penetrates the base or base layer and the skin allowing the substance to enter into the patient.
  • the invention thus allows the sterile containment of the penetrating means and the substance to be administered and can be used to administer substances including those which are a flowable material such as a liquid or cream.
  • the invention when used to contain and administer a substance comprising a stabilised active ingredient, would provide a single item, which would not require refrigeration, additional applicator apparatus such as a 'gun' or highly trained persons to administer the dose.
  • the apparatus is in the form of an adhesive patch, comprising a container constructed from a cover and base containing the substance to be administered and a penetrating means as a single or an array of projections.
  • the penetrating means is in the form of needles or spikes made from any material providing sufficient strength and rigidity to penetrate the base and skin to the Langerhans layer.
  • the individual needles or spikes may additionally define a groove so as to facilitate the passage of the substance along the needle and thus through the skin.
  • the penetrating means may be formed from a material which dissolves upon entering the body, an example of such a material is sugar glass or other soluble glasses. Once dissolved, the penetrating means would no longer obstruct the holes into the skin, facilitating the administration of the substance into the body.
  • the substance may be contained as a flowable liquid or cream within the container.
  • the penetrating means may be formed so as to comprise the substance to be administered, allowing the substance to be released into the body as the penetrating means dissolves.
  • the substance may be coated onto the penetrating means, and adapted to dissolve once the penetrating means has entered the body.
  • the collapsible cover be shaped so as to define a 'hat' or 'top hat' shape. So as to produce a relatively flat patch, it is desirable that the container has a low profile i.e. the height of the cover is much less than the width of the base.
  • the penetrating means is arranged to lie on the underside of the crown of the hat.
  • the cylinder of the hat is adapted to compress causing the penetrating means to pass through a base and skin. It is desirable that the penetrating means, if in the form of needles or spikes, are of a length that inhibits them from penetrating further than the Langerhans layer.
  • the base is flexible and formed from polymer or a metal and polymer composite laminate and comprises an adhesive on its outer surface so as to adhere to the skin for a sufficient time to allow the required amount of substance to be administered into the body.
  • the adhesive is preferably protected by a release sheet which is removed immediately before use.
  • the base layer may be adhered to the cover by adhesives, crimping, heat sealing or a combination of these.
  • the container may also comprise a protective top which provides protection to the compressible cover before use.
  • This protective top may be in the form of a relatively stiff plastic annulus. Alternatively the protective top may also be adapted to assist in the administration of the contained substance.
  • Figure 1 is an exploded perspective view of a patch for administering a vaccine
  • Figure 2 shows a cross sectional profile view of the patch as shown in Fig 1;
  • Figure 3 is an isometric view of a micro array forming part of the patch shown in Figs 1 & 2;
  • Figure 4 is an exploded perspective view of a patch comprising a protective top adapted to facilitate the administration of a vaccine.
  • a micro array 1 comprising a support IB which supports a number of spikes IA of approximately 2mm in length, fabricated from metal, plastic, silicon or a sugar or other soluble glass and attached to a disk shaped base IB comprised of a plastic, metal sugar or soluble glass material.
  • the micro array 1 is adhered, via an adhesive film 3 onto the underside of a crown 2A of a hat shaped cover 2.
  • the cover 2 further defines a brim 2B and a collapsible cylinder 2C and is preferably fabricated from a flexible polymer or aluminium and polymer composite film laminate.
  • a relatively stiff plastic annulus 8 releasably attached to the topside of the brim 2B acts to protect the cylinder 2C from collapsing unwantedly before the patch 9 is used.
  • the underside of the brim 2B of cover 2 is adhered to a foil base 4 by adhesive film 5 to form a sealed container containing the micro array 1, and a liquid or cream in which an active ingredient such as a vaccine is dissolved or suspended and which is not a solvent for the micro array 1.
  • the underside of the base 4 is permanently adhered to a disk 6 comprising, on its underside, a high tack adhesive and defining a circular orifice 6A.
  • the underside of the disk 6 is releasably adhered to an outer foil cover 7 defining a pull tab 7A. In some cases it may be beneficial to omit the orifice 6A as this would allow stronger adhesion between the patch and the skin.
  • Fig 2 illustrates the components as described in Fig 1 assembled to form a patch 9.
  • the foil cover 7 is separated from the disk 6 using the pull tab 7A, to expose the underside of the disk 6 coated with the high-tack adhesive and part of the base 4 through circular orifice 6A.
  • the patch 9 is placed onto the patient so that the high tack adhesive causes the patch 9 to adhere firmly to the skin.
  • the annulus 8 is removed from the cover 2 and a force, perhaps from a nurses hand, is applied to the crown 2A of the cover 2 causing the collapsible cylinder 2C to collapse.
  • the patch 9 is arranged so that the collapse of the cylinder 2C causes the spikes IA to penetrate the base 4, pass through circular orifice 6A and further penetrate approximately lmm into the skin, where the Langerhans cells are located. Further penetration of the spikes IA ceases, once the support IB of micro array 1 comes in contact with the base 4, the depth of penetration being defined by the length of the spikes IA minus the thickness of the base 4.
  • the spikes IA are made from a soluble sugar or other glass forming material they subsequently dissolved into the body.
  • the vaccine contained within the base 4 and cover 2 is then free to enter the body via the holes formed by the spikes IA.
  • the high-tack adhesive surface of the disk 6 adheres the patch 9 to the skin until removed by the wearer after a prescribed amount of time.
  • the soluble spikes IA have dissolved and the patch 9 can therefore be safely discarded without risk of injury to people who might subsequently come into contact with it. If the spikes are made from a non soluble material, the patch needs to be safely discarded.
  • the spikes IA may be shaped to define grooves as shown at IA on Fig 3. These grooves allow the vaccine to flow more easily through the skin.
  • Figure 4 illustrates a patch with a protective top adapted with a pull-tab slider to facilitate the administration of a vaccine or other substance.
  • the collapsible wall 2C and crown 2A of cover 2 illustrated in Fig 4 has a cuboidal rather than cylindrical shape to facilitate compression by the pull-tab slider.
  • the base 4, adhesive 6 and foil release sheet 7 are shaped to accommodate the different shape of the collapsible cover 2. Additionally, 'disk' 6 has a substantial greater surface area than the base 4 so as to facilitate the adherence of the patch to the skin.
  • the protective top of the embodiment illustrated in Fig 4 has a protective case 9 defining an orifice 9A and a slider 10 defining a ring-pull 1OA hinged to a rectangular frame.
  • the rectangular frame defines two congruent side bars 1OB, one front bar 1OC to which the ring-pull 1OA is hinged, one back bar 1OD and a ball 1OE moulded to form part of the back bar ID.
  • Both the slider 10 and protective cover 9 are made from relatively stiff synthetic plastics material.
  • the rectangular frame When assembled, the rectangular frame is housed within the protective case 9 with the pull-tab 1OA situated outside of orifice 9A.
  • the internal structure of the protective case 9 is shaped so as to inhibit movement of the rectangular frame in any direction other than through orifice 9A.
  • the protective case 9 and slider 10 are connected by a sacrificial tie (not shown) between the moulded ball 1OE and the inside surface of protective case 9. Both the protective case 9 and slider 10 are arranged to fit over and protect the collapsible cover 2 from collapsing until the sacrificial tie is broken by the person administering the vaccine.
  • the patch is adhered to the patient by separating the foil cover 7 from the adhesive layer 6 and adhering layer 6 to the skin.
  • a force is exerted on the ring-pull 1OA away from the protective case 9.
  • the sacrificially tie severs allowing the rectangular frame to slide freely through orifice 9A.
  • the rectangular frame and protective cover 9 are arranged so that as the rectangular frame slides, the back bar 1OC presses against the top of the collapsible cover 2 causing the cover 2 to collapse driving the penetrating means 1 through the base 4 and into the skin.
  • the spikes IA could be formed so as to comprise the vaccine to be administered.
  • the spikes IA are pulled out of the skin by a spring action once the force exerted on the crown 2A of the cover 2 has been removed.
  • the vaccine contained within the cover 2 and base 4 may be in the form of a liquid or cream containing up to approximately 75% solid material.
  • This solid material may be in the form of soluble glass particles comprising the active ingredient as is known per se.
  • Such a composition may be used when slow release of an active ingredient is required
  • the patches may be produced so as to share a common foil cover 7.
  • the patches could be manufactured as sheets, each patch sharing a single large foil cover 7.
  • a spring loaded gun applicator could be used to pick up the patch from the sheet 7 and then used to apply the necessary force required to penetrate the needles or spikes IA into the skin.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Medical Informatics (AREA)
  • Dermatology (AREA)
  • Surgery (AREA)
  • Vascular Medicine (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

L'invention concerne des vaccins dont on sait qu'ils ne produisent de réponse immunitaire que s'ils sont présentés aux cellules de la couche de kératinocytes sous la surface de la peau. Plus particulièrement, l'invention permet d'appliquer le vaccin à une surface cutanée et de le faire pénétrer dans la zone d'application par l'intermédiaire d'un ensemble d'aiguilles constituant généralement une partie d'un applicateur à pistolet. L'invention propose une amélioration de ce procédé en utilisant un dispositif d'administration dans lequel le vaccin est stocké dans un récipient doté d’un couvercle pouvant s’affaisser (2). En vue de l'administration du vaccin, le dispositif est placé sur la peau du patient et par le biais de la pression exercée par la main de l'opérateur, le récipient s'affaisse, permettant à un ensemble de pointes (1) à l'intérieur du dispositif d'administration de percer la peau et d'administrer ainsi le vaccin.
PCT/GB2006/050197 2005-07-08 2006-07-07 Appareil pour l'administration de substances à un organisme Ceased WO2007007128A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
GBGB0700944.2A GB0700944D0 (en) 2005-07-08 2007-01-08 Apparatus for administrating substances into a body

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0513962A GB2428197A (en) 2005-05-16 2005-07-08 Apparatus for administrating a substance into a patient
GB0513962.1 2005-07-08

Publications (1)

Publication Number Publication Date
WO2007007128A1 true WO2007007128A1 (fr) 2007-01-18

Family

ID=36968969

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2006/050197 Ceased WO2007007128A1 (fr) 2005-07-08 2006-07-07 Appareil pour l'administration de substances à un organisme

Country Status (2)

Country Link
GB (3) GB0509863D0 (fr)
WO (1) WO2007007128A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012061556A1 (fr) * 2010-11-03 2012-05-10 Flugen, Inc. Dispositif d'administration de médicament à porter sur soi, avec action par ressort et mécanisme d'actionnement à coulisse
JPWO2010095456A1 (ja) * 2009-02-23 2012-08-23 株式会社 メドレックス 剣山型マイクロニードルのアプリケーター
CN103874518A (zh) * 2011-10-12 2014-06-18 3M创新有限公司 一体化微针阵列递送系统
WO2015005143A1 (fr) * 2013-07-11 2015-01-15 凸版印刷株式会社 Unité de micro-aiguille
JPWO2015129894A1 (ja) * 2014-02-27 2017-03-30 凸版印刷株式会社 マイクロニードルユニット、および、マイクロニードル用容器
WO2017182530A1 (fr) * 2016-04-19 2017-10-26 Philip Douglas Appareil pour administration d'un liquide dans la peau
KR101966050B1 (ko) * 2018-12-20 2019-04-05 이상혁 일체형 마이크로 니들 패치
WO2020076017A1 (fr) * 2018-10-08 2020-04-16 연세대학교 산학협력단 Timbre à microstructures multifonctionnel
US12200519B2 (en) * 2019-09-12 2025-01-14 Zte Corporation Multi-access point joint data transmission method and device, and computer-readable storage medium

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12214346B2 (en) 2021-10-13 2025-02-04 Satio, Inc. Dermal patch with a diagnostic test strip
US12053284B2 (en) 2021-11-08 2024-08-06 Satio, Inc. Dermal patch for collecting a physiological sample
US11877848B2 (en) 2021-11-08 2024-01-23 Satio, Inc. Dermal patch for collecting a physiological sample
US12178979B2 (en) 2021-10-13 2024-12-31 Satio, Inc. Dermal patch for delivering a pharmaceutical
EP4642506A1 (fr) * 2022-12-28 2025-11-05 Satio, Inc. Timbre dermique servant à administrer un produit pharmaceutique

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2974787A (en) * 1960-05-10 1961-03-14 American Cyanamid Co Single use, prepackaged vaccinator
US5320600A (en) * 1993-06-14 1994-06-14 Lambert Wm S Plural content container for simultaneous ejection
US20010011171A1 (en) * 1999-10-14 2001-08-02 Alchas Paul G. Intradermal delivery device including a needle assembly
WO2003020359A2 (fr) * 2001-09-05 2003-03-13 3M Innovative Properties Company Reseaux de microaiguilles et leurs procedes de fabrication
US20040199103A1 (en) * 2002-06-25 2004-10-07 Sung-Yun Kwon Solid solution perforator for drug delivery and other applications

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HU219921B (hu) * 1993-10-20 2001-09-28 Ervin Lipscher Vérvételi eszköz, különösen ujjbegyből történő vérvételre
US6102896A (en) * 1999-09-08 2000-08-15 Cambridge Biostability Limited Disposable injector device
US6821281B2 (en) * 2000-10-16 2004-11-23 The Procter & Gamble Company Microstructures for treating and conditioning skin

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US2974787A (en) * 1960-05-10 1961-03-14 American Cyanamid Co Single use, prepackaged vaccinator
US5320600A (en) * 1993-06-14 1994-06-14 Lambert Wm S Plural content container for simultaneous ejection
US20010011171A1 (en) * 1999-10-14 2001-08-02 Alchas Paul G. Intradermal delivery device including a needle assembly
WO2003020359A2 (fr) * 2001-09-05 2003-03-13 3M Innovative Properties Company Reseaux de microaiguilles et leurs procedes de fabrication
US20040199103A1 (en) * 2002-06-25 2004-10-07 Sung-Yun Kwon Solid solution perforator for drug delivery and other applications

Cited By (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPWO2010095456A1 (ja) * 2009-02-23 2012-08-23 株式会社 メドレックス 剣山型マイクロニードルのアプリケーター
WO2012061556A1 (fr) * 2010-11-03 2012-05-10 Flugen, Inc. Dispositif d'administration de médicament à porter sur soi, avec action par ressort et mécanisme d'actionnement à coulisse
CN103874518A (zh) * 2011-10-12 2014-06-18 3M创新有限公司 一体化微针阵列递送系统
US10864360B2 (en) 2013-07-11 2020-12-15 Toppan Printing Co., Ltd. Microneedle unit
WO2015005143A1 (fr) * 2013-07-11 2015-01-15 凸版印刷株式会社 Unité de micro-aiguille
US20160121092A1 (en) * 2013-07-11 2016-05-05 Toppan Printing Co., Ltd. Microneedle unit
JPWO2015005143A1 (ja) * 2013-07-11 2017-03-02 凸版印刷株式会社 マイクロニードルユニット
JPWO2015129894A1 (ja) * 2014-02-27 2017-03-30 凸版印刷株式会社 マイクロニードルユニット、および、マイクロニードル用容器
WO2017182530A1 (fr) * 2016-04-19 2017-10-26 Philip Douglas Appareil pour administration d'un liquide dans la peau
WO2020076017A1 (fr) * 2018-10-08 2020-04-16 연세대학교 산학협력단 Timbre à microstructures multifonctionnel
US12048771B2 (en) 2018-10-08 2024-07-30 Industry-Academic Cooperation Foundation, Yonsei University Multifunctional microstructure patch
KR101966050B1 (ko) * 2018-12-20 2019-04-05 이상혁 일체형 마이크로 니들 패치
WO2020130240A1 (fr) * 2018-12-20 2020-06-25 이상혁 Timbre à micro-aiguilles intégrées
US12200519B2 (en) * 2019-09-12 2025-01-14 Zte Corporation Multi-access point joint data transmission method and device, and computer-readable storage medium

Also Published As

Publication number Publication date
GB2428197A (en) 2007-01-24
GB0513962D0 (en) 2005-08-17
GB0700944D0 (en) 2007-02-28
GB0509863D0 (en) 2005-06-22

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