EP0902692A1 - Revetement a faible frottement pour capuchon etanche de cartouche - Google Patents

Revetement a faible frottement pour capuchon etanche de cartouche

Info

Publication number
EP0902692A1
EP0902692A1 EP96905537A EP96905537A EP0902692A1 EP 0902692 A1 EP0902692 A1 EP 0902692A1 EP 96905537 A EP96905537 A EP 96905537A EP 96905537 A EP96905537 A EP 96905537A EP 0902692 A1 EP0902692 A1 EP 0902692A1
Authority
EP
European Patent Office
Prior art keywords
cartridge
needle
seal cap
septum
coating
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Withdrawn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
EP96905537A
Other languages
German (de)
English (en)
Other versions
EP0902692A4 (fr
Inventor
John J. Niedospial
Mark A. Stiehl
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.)
Abbott Laboratories
Original Assignee
Abbott Laboratories
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 Abbott Laboratories filed Critical Abbott Laboratories
Publication of EP0902692A4 publication Critical patent/EP0902692A4/en
Publication of EP0902692A1 publication Critical patent/EP0902692A1/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Withdrawn legal-status Critical Current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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/247—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule
    • 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
    • A61M5/34—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub
    • A61M5/348—Constructions for connecting the needle, e.g. to syringe nozzle or needle hub snap lock, i.e. upon axial displacement of needle assembly

Definitions

  • This invention relates to a low friction coating for a coupling system for transferring liquid medicaments from one flow conduit to another and, more particularly, to a low friction coating for a cartridge seal cap used in conjunction with disposable liquid medicament-containing cartridge-needle units.
  • Disposable medicament-containing cartridge needle units are well known in the art and in widespread commercial use.
  • Such cartridges conventionally feature a cartridge barrel, formed of glass or plastic having a distal end and a proximal end.
  • the proximal end of the cartridge is closed with a slideable plunger, while the distal end has a neck portion which terminates in an opening closed by a diaphragm or septum secured to the cartridge by a crimped-on metal collar, usually aluminum collar.
  • the neck portion of the distal end is adapted to receive and engage a needle-hub-needle-needle guard assembly.
  • the needle-hub portion snaps onto the diaphragm in a mating relationship.
  • untreated elastomer septums offer a high resistance against the exterior surface of the needle as the needle is being inserted into the penetration area.
  • septum fragments are the result of the elastomeric portion of the septum being abraded off the upper surface of the septum as it conforms to the shape of the needle. The fragments then either enter into the needle cannula or the interior of the cartridge as the needle drags the fragments during penetration.
  • Another approach proposed in the prior art to reduce the tendency of the stopper to generate particulate matter is to coat the elastomeric core of the septum with a thermoplastic film on the fluid contacting side thereof.
  • One of the objects of the present invention is to eliminate or at least greatly reduce the tendency of this occurrence.
  • Another object of the present invention relates to the reduction of activating force needed to activate the needle-hub- needle-needle guard assembly when the cartridge content is to be injected into the patient.
  • the cartridge, containing the liquid medicament is packaged separately from the needle-hub-needle guard assembly Prior to injection the assembly is snapped on the cartridge, the proximal end of the needle cannula penetrating the septum, and the needle guard removed to render the device ready for injection.
  • the snap-on step is easy, not requiring excessive force, as well as when the injection is completed and the needle- hub-needle-needle guard assembly is removed from the cartridge, the force of removal is not excessive to the average practitioner
  • both the snap-on and the removal steps tended to be cumbersome for some practitioners
  • a coating during the manufacture of the metal cap or after the cap is crimped on the septum and the cartridge greatly reduces the tendency, or completely eliminates the necessity of applying excessive force by the practitioner to activate and/or deactivate the cartridge containing the liquid medicament.
  • a low friction coating for a coupling system for transferring liquid medicaments from one flow conduit to another and more particularly, to a low friction coating for a cartridge seal cap used in conjunction with disposable, liquid medicament-containing cartridge-needle units to eliminate or at least greatly reduce, the presence of particulate materials originating from the coupling system and to reduce the force of activation and deactivation of the device.
  • the invention provides an improvement m a cartridge-needle assembly wherein said cartridge comprises:
  • a cartridge barrel having a distal end and a proximal end, a plunger axially and reciprocally ⁇ lideable in the cartridge barrel; a septum of a resilient material sealing the distal end of the cartridge barrel; and a cartridge seal cap having an aperturee located at its center for allowing a needle to penetrate the septum, said cartridge seal cap securely holding said septum in place;
  • a needle assembly unit comprising a hub axially holding a needle, said needle having a distal end and a proximal end, said hub comprising a sleeve constructed to be snapped on the distal end of said cartridge while said proximal end of said needle penetrates the septum in the cartridge;
  • a sheath covering the distal end of the needle constructed to be snapped on the hub for protection against injury by the needle to the user; wherein said improvement comprises: a coating of low friction material covering the cartridge seal cap to prevent particulate material originating from the cartridge seal to enter into the needle and to reduce tne f ⁇ ctional force needed to activate and deactivate the cartridge .
  • the coating of the metallic cartridge seal cap may be done during the manufacturing of the cap or after the cap is crimped on the cartridge.
  • Such coating may be: a polyolefin, such as polypropylene and polymethylpentene; a polyvinyl, such as polystyrene, polyvinyl acetate (PVA) , polyvinyl chloride (PVC) , polyvinylidene chloride (PVDC) , a copolymer of polyvinylchloride (PVC) and polyvinylidene chloride (PVDC) , polyvinyl fluoride, and polyvinylidene fluoride; an ether, such as polymethylene oxide, polyphenylene oxide and polyphenylene sulphone; an ester, such as polyethylene terephthalate (PET) , polycarbonate and copolyester,- an ester, such as polycaprolactam (Nylon 6) , polyhexamethylene adipamide (Nylon 66
  • the coating thickness will be in the range of about 0.002 to about 1.0 mm, and preferably about 0.02 to 0.5 mm.
  • the coating may be applied or bonded to the metallic cap material in any suitable manner known in the art, such as, but not limited to, by the use of adhesives, solvents, spray applications, radio waves, infrared, microwaves, ultrasonics and heat.
  • the coating of the seal cap may also cover the central portion of the septum which is exposed by the aperture in the seal cap.
  • FIG. 1 is a plan view of a needle assembly unit showing a hub axially holding the needle;
  • FIG. 2 is a plan view of a cartridge
  • FIG. 3 is a plan view of a sheath to cover the needle shown in FIG. 1;
  • FIG. 4 is plan view of a plunger for use in the cartridge shown in FIG. 2;
  • FIG. 5 is a plan view of a fully assembled cartridge, plunger and hub-needle assembly without the sheath;
  • FIG. 6 is an enlarged, fragmentary, longitudinal cross section of the distal end of the cartridge having the septum in place, the crimped-on seal cap and a portion of the hub and needle prior to the needle piercing the septum;
  • FIG. 7 is an enlarged, fragmentary, longitudinal cross section of the distal end of the cartridge having the septum m place, the crimped-on seal cap and a portion of the hub and needle after the needle has pierced the septum.
  • This invention is useful in conjunction with a wide variety of cartridges activatable by a snap-on needle unit.
  • cartridge 10 comprises: a cartridge barrel 20, formed of glass and plastic, having a distal end 26 and a proximal end 40.
  • Distal end 26 has a neck portion 28 which terminates in an opening (not shown) , closed by a seal or diaphragm cap 30 and a septum or diaphragm 36.
  • Seal cap 30 contains an annular groove 32 to receive a snap-on hypodermic needle assembly 60 shown in FIG. 1.
  • Hypodermic needle assembly 60 comprises a snap-on portion 62 which is to engage seal cap 30 in a mating relationship, and a conical portion 64 which is to receive and engage proximal end 74 of sheath 70.
  • a plunger or piston 50 shown m FIG. 4, which has a forward, liquid-interfacing surface 52 and a rearwardly extending threaded portion 56 for interconnec ion with a plunger rod mot shown) when the cartridge is readied for use.
  • FIG. 6 shows an enlarged, fragmentary, longitudinal cross section of the distal end of cartridge barrel 20, having septum 36 covering the distal opening of the barrel, the crimped-on seal cap 30 and snap-on portion 62 of the hypodermic needle assembly. As shown, at this stage of the process, the proximal end of needle 66 has not pierced septum 36.
  • FIG. " shows the same parts and spacial configuration thereof, except the proximal end of needle 66 has now pierced septum 36.
  • crimped-on seal cap 30 includes aperture 38 in its center portion to expose underlying septum 36 to allow piercing of same by the proximal end of needle 66.
  • Crimped-on seal cap 30 is coated with a low friction polymeric coating 80. The coating may cover the exterior surface of the seal cap or it may cover it both on its exterior and interior surfaces. When the coating is applied after the seal cap is crimped on the cartridge, the coating may also cover the center, exposed surface of the septum.
  • the septum can be made of compliant, rubbery materials capable of resealmg itself after being pierced. Preferred materials possess a Shore A durometer hardness of from about 50 to about 70.
  • the seal cap which holds the septum in place after it is crimped on, is made of any suitable metallic materials, preferably aluminum.
  • the needle unit except the needle which is of stainless steel, is fabricated of plastic. Suitable plastics include polypropylene, polystyrene, nylons, acetals, polyethylene and polyester.
  • the health professional receives the device in a form wherein the cartridge is pre-filled with the liquid medicament and is sealed at both ends: the distal end is sealed by the septum and seal cap, while the proximal end is sealed by the plunger.
  • the plunger rod is not attached to the plunger and neither is the needle unit snapped-on the distal end of the cartridge.
  • the cartridge-needle unit is activated by causing the proximal end of the needle to pierce the septum and the cartridge is moved forward in the hub to reach the snapped position.
  • the snap-on step is convenient and easy since the smooth coated surface of the seal cap exerts little frictional force on the hub of the needle unit.
  • the plunger rod is screwed onto the post of the plunger. Lastly, the sheath covering the exposed portion of the needle is removed. Thereafter, the distal end of the needle is inserted into the injection site and the liquid medication is delivered to the patient by applying an axially directed force to the plunger rod.
  • Cartridge activation force was determined using TEFLON-coated and non-coated seal caps crimped onto cartridges. Instron 4502 equipment was used to determine the maximum load expressed in pounds to activate the needle into the cartridges of 40-samples of each of the coated and uncoated samples. The average forces and standard deviations were as follows:

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)
  • Pens And Brushes (AREA)
  • Closures For Containers (AREA)
  • Coating Apparatus (AREA)

Abstract

L'invention concerne un système de couplage amélioré pour transférer un médicament liquide d'une cartouche (10) vers un unité (60) à aiguille, l'amélioration consistant en un revêtement à faible frottement déposé sur le capuchon d'étanchéité métallique (30) (36).
EP96905537A 1995-03-02 1996-02-20 Revetement a faible frottement pour capuchon etanche de cartouche Withdrawn EP0902692A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US39682995A 1995-03-02 1995-03-02
US396829 1995-03-02
PCT/US1996/002176 WO1996026751A1 (fr) 1995-03-02 1996-02-20 Revetement a faible frottement pour capuchon etanche de cartouche

Publications (2)

Publication Number Publication Date
EP0902692A4 EP0902692A4 (fr) 1999-03-24
EP0902692A1 true EP0902692A1 (fr) 1999-03-24

Family

ID=23568793

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96905537A Withdrawn EP0902692A1 (fr) 1995-03-02 1996-02-20 Revetement a faible frottement pour capuchon etanche de cartouche

Country Status (5)

Country Link
EP (1) EP0902692A1 (fr)
JP (1) JPH11500938A (fr)
AU (1) AU4927096A (fr)
CA (1) CA2214120A1 (fr)
WO (1) WO1996026751A1 (fr)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB9805102D0 (en) 1998-03-10 1998-05-06 Ciba Geigy Ag Device
WO2010047825A1 (fr) * 2008-10-24 2010-04-29 Gvd Corporation Procédés de revêtement, systèmes et articles associés
EP3170526B1 (fr) * 2009-10-30 2021-07-14 Sanofi-Aventis Deutschland GmbH Cartouche pour dispositif d'administration de médicament
CN103025370B (zh) 2010-06-09 2015-08-19 瓦莱里塔斯公司 流体输送装置针收回机构、筒及可扩张液压流体密封件
GB201206766D0 (en) 2012-04-17 2012-05-30 Univ Antwerpen Prefillable intradermal delivery device
US11097055B2 (en) * 2013-10-24 2021-08-24 Amgen Inc. Injector and method of assembly
CA3019486A1 (fr) 2016-04-01 2017-10-05 Novosanis Dispositif d'injection

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2203118A (en) * 1987-04-07 1988-10-12 Fuso Pharmaceutical Ind Plastics transfusion containers

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPS549119B1 (fr) * 1970-09-16 1979-04-21
US5332113A (en) * 1989-11-30 1994-07-26 Elan Pharmaceutical Research Corporation Cap assembly
US5219083A (en) * 1992-04-02 1993-06-15 Sterling Winthrop Inc. Stopper for reduction of particulate matter
US5358491A (en) * 1993-09-13 1994-10-25 Sterling Winthrop Inc. Cartridge-needle unit having retractable needle

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2203118A (en) * 1987-04-07 1988-10-12 Fuso Pharmaceutical Ind Plastics transfusion containers

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO9626751A1 *

Also Published As

Publication number Publication date
JPH11500938A (ja) 1999-01-26
EP0902692A4 (fr) 1999-03-24
CA2214120A1 (fr) 1996-09-06
AU4927096A (en) 1996-09-18
MX9706667A (es) 1998-06-28
WO1996026751A1 (fr) 1996-09-06

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