+

WO2009031144A1 - Enveloppe contenant une aiguille stérile - Google Patents

Enveloppe contenant une aiguille stérile Download PDF

Info

Publication number
WO2009031144A1
WO2009031144A1 PCT/IL2008/001192 IL2008001192W WO2009031144A1 WO 2009031144 A1 WO2009031144 A1 WO 2009031144A1 IL 2008001192 W IL2008001192 W IL 2008001192W WO 2009031144 A1 WO2009031144 A1 WO 2009031144A1
Authority
WO
WIPO (PCT)
Prior art keywords
sne
needle
distal
envelope
num
Prior art date
Application number
PCT/IL2008/001192
Other languages
English (en)
Inventor
Zeev Bronfeld
Original Assignee
Sindolor Medical 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 Sindolor Medical Ltd filed Critical Sindolor Medical Ltd
Publication of WO2009031144A1 publication Critical patent/WO2009031144A1/fr

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
    • A61M5/32—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
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • 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
    • A61M2005/3117—Means preventing contamination of the medicament compartment of a syringe
    • A61M2005/3118—Means preventing contamination of the medicament compartment of a syringe via the distal end of a syringe, i.e. syringe end for mounting a needle cannula
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/195—Avoiding coring, e.g. preventing formation of particles during puncture by the needle tip shape
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/19—Constructional features of carpules, syringes or blisters
    • A61M2205/192—Avoiding coring, e.g. preventing formation of particles during puncture
    • A61M2205/197—Avoiding coring, e.g. preventing formation of particles during puncture by the seal material
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • 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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion

Definitions

  • Rebiject and Rebiject II autoinjectors for Rebif the drug for interferon beta- Ia used to treat Multiple Sclerosis.
  • Other autoinjectors exist for diabetics.
  • a long felt need exists for an easily fitted sterile needle suitably packaged for an autoinjector which, when presented to the body of the patient for injection, pierces the patient whilst maintaining it's sterility up to the moment of penetration.
  • a surprising object of the invention is to provide a sterile needle envelope (SNE) enclosing a sharp ended needle wherein the r ⁇ edle is adapted' and disposed to pierce the envelope whilst the needle is penetrating the body of the patient.
  • SNE sterile needle envelope
  • Another object of the invention is to disclose an SNE as defined above, further
  • Another object of the invention is to provide an SNE as defined above, wherein the envelope is made at least in part from an essentially flexible material.
  • the material is selected from the group consisting of rubber, latex, plastic, synthetic material, metal, glass, glass-like material, plexiglass, rubber, rubber-like material and any composition thereof.
  • Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for connecting the needle to an external needle urging means
  • Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for directly connecting said needle to external reciprocating needle injecting means.
  • Another object of the invention is to provide an SNE as defined above, wherein the SNE further comprises means for indirectly connecting said needle to external reciprocating needle injecting means.
  • Another object * of the invention is to provide an SNE as defined above, wherein at least a section of a distal portion of the SNE is at least one of the following: frangible, perforatable, and pierceable.
  • Another object of the invention is to provide an SNE as defined above, wherein the section is frangible, perforatable and pierceable in a predetermined manner.
  • Another objective of the invention is to provide an SNE as defined above, wherein a distal end of the needle is adapted so as to prevent blocking by envelope fragments and debris during piercing of the SNE by the needle.
  • a yet further object of the invention is to provide an SNE as defined above, wherein said
  • NUM is part of an autoinjector.
  • a still further object of the invention is to provide an SNE as defined above wherein said
  • a still further object of the invention is to provide an SNE as defined above wherein the
  • NUM is part of a syrette.
  • a further object of the invention is to provide an SNE as defined above wherein the NUM is part of a standard hypodermic syringe.
  • FIG. 1 is a schematic block diagram illustration of an syringe device comprising a needle that is sealingly enclosed by a sterile needle envelope, according to some embodiments of the invention; ⁇ • ⁇ ⁇
  • FIG. 2B is another schematic block diagram illustration of the syringe device, wherein the distal end of the sterile needle envelope is being perforated by the distal needle edge, according to some embodiments of the invention
  • the needle is adapted and disposed to pierce the envelope whilst the needle is penetrating the body of the patient.
  • the SNE comprises means for connecting the needle to an external liquid reservoir (ELR).
  • ELR external liquid reservoir
  • a further disclosure is made of an SNE as defined above, wherein the SNE further comprises means for connecting the needle to an external needle urging means (NUM).
  • NUM an external needle urging means
  • SNE as defined above, wherein the SNE further comprises means for connecting the needle to an.external reciprocating needle injecting means.
  • SNE as defined above, wherein at least a section of a distal portion of the SNE is characterized by at least one of the following: frangible, perforatable, and pierceable.
  • autoinjector refers to a device designed to deliver a single dose of a particular drug, often by self administration.
  • the SNE is configured to be . fitted to an injection device such as an autoinjector, syrette or hypodermic syringe.
  • the envelope may be frangible and/or perforatable by the needle.
  • the needle may be suitably engaged with the patient's skin and the needle may be urged into the body.
  • a syringe device 100 may include- an external liquid reservoir (ELR) 110 having an opening
  • ELR 110 is configured to securely contain therein substances such as, for example, and insulin.
  • ELR 110 may further include means and/or may be configured to enable varying the volumetric capacity -of ELR llO.F ⁇ r example, ELR 110, may be .embodied by a receptacle wherein means that enable varying the receptacle's volumetric capacity may include a plunger (e.g., plunger 120) that is slidably coupled within the receptacle, whereby the plunger may be configured such to abut against the inner wall of the receptacle.
  • plunger 120 provides a substantially sealed seal. It should be noted that the term "substantially sealed seal" includes “sealed"seal”.
  • Syringe device 100 further includes a sharp ended needle (hereinafter referred to as "needle") 130, e.g., as known in the art, comprising a bore (not shown).
  • the bore may have a diameter of, for example, about 0.1mm to about 0.3 mm
  • Other embodiments of the invention may have needle bores of about 10 microns to about 500 microns.
  • Needle 130 is mechanically coupled to ELR 110 such that a proximate opening 132 of the bore of needle 130 is positioned relative to outlet 111 of ELR 110.
  • the mechanical coupling may be substantially sealed or sealed.
  • ELR 110 in association with needle 130 and the corresponding mechanical coupling constitute a sealed cavity having one opening, which is the distal opening 131 of the bore of needle 130.
  • an increase in the volumetric capacity of ELR 110 generates a vacuum at distal opening 131, thereby enabling suction of a substance into ELR 110.
  • a decrease in the volumetric capacity of ELR 110 causes the ejection of the substance from ELR 110 through distal opening 131.
  • the mechanical coupling of needle 130 to ELR 110 may be embodied, for example, by integrally forming needle 130 with ELR 110.
  • SNE 140 comprises means, e.g., as known in the art, for connecting needle 130 to ELR 110.
  • needle 130 may be mechanically coupled to ELR 110 by means of a Luer Lock.
  • Needle 130 may be embodied, for example, by an anti-coring needle (e.g., a Tuohy needle); hypodermic needles and other needles, e.g., as known in the art. Further, needle 130 may have a distal needle edge 133, which may have various shapes.
  • Distal needle edge 133 may be, for example, a sharp pointed tip embodied, for example, by a standard bevel, by a short bevel or by a true short bevel, e.g., as known in the art. Further, needle 130 may be configured to enable intermuscular injection, subcutaneous injection or other injection types.
  • syringe device 100 may include a sterile needle envelope (SNE) 140, which sealingly encloses at least the portion of needle 130 that may be engaged with' substance transfer site 160.
  • SNE sterile needle envelope
  • SNE 140 may sealingly enclose all of needle 130, and in some embodiments of the invention, SNE 140 may sealingly enclose needle 130 as well as other elements of syringe device 100 such as, for example, ELR 110.
  • ELR 110 elements of syringe device 100
  • the above-mentioned embodiments are hereinafter referred to by the term “sealingly enclosing" and by grammatical variations thereof.
  • SNE 140 may have distal SNE end 141 that is positioned in front of distal opening 131, whereby SNE 140 may be made of any suitable packaging material, e.g., as known in the art, such as, , for example, synthetic material (e.g., plastic, latex), metal, glass or glass-like material (e.g., plexiglass), rubber or rubber-like material or any composition thereof.
  • suitable packaging material e.g., as known in the art, such as, , for example, synthetic material (e.g., plastic, latex), metal, glass or glass-like material (e.g., plexiglass), rubber or rubber-like material or any composition thereof.
  • Needle 130 as well as at least the inner side of SNE 140 that sealingly encloses needle 130 may be sterile or substantially sterile.
  • sterile needle envelope and grammatical variations thereof as used herein may refer to any type of covering, layer, coating, envelop, wrapping, enclosure, sleeve, shell or membrane adapted to protect needle 130 from contamination or substantial contamination.
  • distal opening 131 of needle 130 is adapted so as to prevent blocking by envelope fragments and debris during piercing and/or perforation and/or fraction Of SNE 140 by needle 130:-
  • syringe device 100 is adapted or includes a needle urging means (NUM) causing a relative longitudinal displacement of distal -needle edge 133 against distal SNE end 141, -when operation of syringe 100 is initiated by, e.g., a user of syringe device 100.
  • NUM needle urging means
  • distal edge 131 may perforate or fracture distal SNE end 141.
  • SNE 140 may is adapted to be connected to reciprocating needle injecting means
  • needle 130 may be operatively coupled to plunger 120 in a manner such that longitudinal displacement of plunger 120 (which is schematically illustrated with arrow Q) results in a longitudinal displacement of distal needle edge 133 towards distal SNE end 141.
  • Longitudinal displacement of distal needle edge 133 towards distal SNE end 141 may be accomplished, for example, by telescopically lengthening needle 130; by longitudinally displacing needle 130 towards distal SNE end 141 or by other suitable NUM.
  • the longitudinal displacement causes the engagement of distal needle edge 133 with distal SNE end 141, whereby distal needle edge 133 and/or distal SNE end 141 may be configured such that said engagement results in a perforation of distal SNE end 141.
  • the perforation may be a result of pressure applied by distal needle edge 133 against distal SNE end 141, whereby the pressure causes tearing of distal SNE end 141.
  • the perforation may be a result of an incision operation performed by distal needle edge 133 during its engagement with distal SNE end 141.
  • distal needle edge 133 may have a beveled tip that extends towards cutting edges terminating in the wall of needle 130.
  • distal needle edge 133 During engagement of distal needle edge 133 with distal SNE end 141, the beveled tip punches a hole in distal SNE end 141, whereby ongoing longitudinal displacement causes the 1 cutting edges to cut out and/or perform an incision in distal SNE end 141.
  • traversing of at least some portion of needle 130 towards fluid transfer site 160 is enabled, as is schematically illustrated in FIG. 2B.
  • distal SNE end 141 may be configured to facilitate its perforation by, e.g., distal needle edge 133.
  • distal SNE end 141 may have a pierced boundary; or may have a weakened boundary.
  • distal needle edge 133 and/or distal SNE end 141 may be configured to avoid insertion and/or clogging of the bore of needle 130 by material of SNE 140.
  • Syringe device 100 is configured and/or adapted such suitable operation thereof causes longitudinal displacement of distal needle edge 133 towards injection site 160, as well as insertion of needle 130 into injection site 160.
  • needle 130 may engage with the substance transfer site by, e.g., hypodermically introducing the needle into the body.
  • operation of the syringe device may be initiated for, e.g., withdrawing a substance from the body, into the syringe device and/or, e.g., for transferring substance from the syringe into the body.
  • syringe device 100 may be embodied by, for example, a patient, healthcare personnel (e.g., a nurse, a physician) and the like.
  • syringe device may be embodied by mechanisms as known in the art and/or by syringe devices that are not yet known in the art.
  • SNE 140 enclosing needle 130 is adapted and/or disposed alone to pierce the SNE when needle 130 is penetrating a body via, e.g., liquid transfer site 160.
  • NUM may be a part of an automjector and/or a needle cartridge.

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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne une enveloppe d'aiguille stérile (SNE) (140) renfermant une aiguille à bout pointu (130). L'aiguille mentionnée ci-dessus est conçue et placée de façon à percer l'enveloppe lorsque l'aiguille pénètre dans le corps du patient.
PCT/IL2008/001192 2007-09-05 2008-09-04 Enveloppe contenant une aiguille stérile WO2009031144A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IL185741A IL185741A0 (en) 2007-09-05 2007-09-05 Envelope containing sterile needle
IL185741 2007-09-05

Publications (1)

Publication Number Publication Date
WO2009031144A1 true WO2009031144A1 (fr) 2009-03-12

Family

ID=39942407

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IL2008/001192 WO2009031144A1 (fr) 2007-09-05 2008-09-04 Enveloppe contenant une aiguille stérile

Country Status (2)

Country Link
IL (1) IL185741A0 (fr)
WO (1) WO2009031144A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9682222B2 (en) 2013-05-31 2017-06-20 3M Innovative Properties Company Microneedle injection apparatus comprising an inverted actuator
US9872975B2 (en) 2013-05-31 2018-01-23 3M Innovative Properties Company Microneedle injection and infusion apparatus and method of using same
US9895520B2 (en) 2013-05-31 2018-02-20 3M Innovative Properties Company Microneedle injection apparatus comprising a dual cover
WO2022033783A1 (fr) 2020-08-13 2022-02-17 Novo Nordisk A/S Canule d'aiguille revêtue
WO2022175256A1 (fr) 2021-02-16 2022-08-25 Novo Nordisk A/S Aiguille hypodermique dotée d'un élément d'étanchéité

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0288443A1 (fr) * 1987-04-14 1988-10-26 Astra Meditec AB Seringue automatique à deux compartiments, procédé de mélange et d'injection et cartouche pour seringue
US5685256A (en) * 1995-01-20 1997-11-11 Gas Research Institute Set pressure sensing and verifying device
US5885255A (en) * 1994-12-20 1999-03-23 Jaeger, Jr.; Cletus Wilfred Protective needle cover
DE19856167C1 (de) * 1998-12-05 2000-05-04 Vetter & Co Apotheker Nadelschutzanordnung für Spritzen, Karpulen und dergleichen Injektionsinstrumente
WO2006083876A2 (fr) * 2005-02-01 2006-08-10 Intelliject, Llc Dispositifs, systemes et procedes pour administrer un medicament

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0288443A1 (fr) * 1987-04-14 1988-10-26 Astra Meditec AB Seringue automatique à deux compartiments, procédé de mélange et d'injection et cartouche pour seringue
US5885255A (en) * 1994-12-20 1999-03-23 Jaeger, Jr.; Cletus Wilfred Protective needle cover
US5685256A (en) * 1995-01-20 1997-11-11 Gas Research Institute Set pressure sensing and verifying device
DE19856167C1 (de) * 1998-12-05 2000-05-04 Vetter & Co Apotheker Nadelschutzanordnung für Spritzen, Karpulen und dergleichen Injektionsinstrumente
WO2006083876A2 (fr) * 2005-02-01 2006-08-10 Intelliject, Llc Dispositifs, systemes et procedes pour administrer un medicament

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9682222B2 (en) 2013-05-31 2017-06-20 3M Innovative Properties Company Microneedle injection apparatus comprising an inverted actuator
US9872975B2 (en) 2013-05-31 2018-01-23 3M Innovative Properties Company Microneedle injection and infusion apparatus and method of using same
US9895520B2 (en) 2013-05-31 2018-02-20 3M Innovative Properties Company Microneedle injection apparatus comprising a dual cover
US10391290B2 (en) 2013-05-31 2019-08-27 3M Innovative Properties Company Microneedle injection apparatus comprising a dual cover
US10695547B2 (en) 2013-05-31 2020-06-30 3M Innovative Properties Company Microneedle injection apparatus comprising an inverted actuator
US10716926B2 (en) 2013-05-31 2020-07-21 Kindeva Drug Delivery L.P. Microneedle injection and infusion apparatus and method of using same
US11771878B2 (en) 2013-05-31 2023-10-03 Kindeva Drug Delivery L.P. Microneedle injection and infusion apparatus and method of using same
WO2022033783A1 (fr) 2020-08-13 2022-02-17 Novo Nordisk A/S Canule d'aiguille revêtue
WO2022175256A1 (fr) 2021-02-16 2022-08-25 Novo Nordisk A/S Aiguille hypodermique dotée d'un élément d'étanchéité

Also Published As

Publication number Publication date
IL185741A0 (en) 2008-01-06

Similar Documents

Publication Publication Date Title
CN100551455C (zh) 皮内注射器和针头组件
US10166346B2 (en) Bruiseless cannula
JP2008522754A (ja) 後装式固定針シリンジ及びそれを有する自動注入装置
MX2007011239A (es) Sistema y metodo de llenado para jeringas con agujas cortas.
AU2021261871B2 (en) Connector for aseptic transfer of fluid
JP2013514113A (ja) 注射器
US20080119797A1 (en) System with a syringe device and a needle device
EP1514565A1 (fr) Impulsion séquentielle / Injecteur de distribution de médicament fluide
WO2009031144A1 (fr) Enveloppe contenant une aiguille stérile
AU2011261226A1 (en) Systems and methods for a medical syringe
JP2011510719A (ja) 人体の皮膚を経由しあるいはその内部に流体を注射するシステム
CN111032126B (zh) 用于具有较少防腐剂的药物的多次使用药物递送装置
JP2024528678A (ja) ウェアラブル注射器用の針シールドリムーバアセンブリ
WO2004052430A2 (fr) Appareil de perfusion perfectionne
US8454564B2 (en) Applicator and method for applying lock solution in a catheter
US8439891B1 (en) IV start device and method
EP1248657A1 (fr) Ensemble stylo a aiguille et adaptateur
RU2289427C1 (ru) Одноразовое устройство для введения лекарственного препарата "аэрс"
US20210260275A1 (en) Multi-use drug delivery device for drugs with insufficinet level of preservatives
JPH0131908B2 (fr)
KR20070062002A (ko) 치과용 주사바늘
JP2024161321A (ja) 可動式注射針及び偽装痛点針を有する注射器
WO2025106336A1 (fr) Prévention de colmatage de dispositifs d'administration à aiguille
RU160804U1 (ru) Устройство для введения лекарственных препаратов
GB2388032A (en) Medical Agent Delivery

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08789863

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 08789863

Country of ref document: EP

Kind code of ref document: A1

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载