EP1225939A1 - Cartouche de medicament - Google Patents

Cartouche de medicament

Info

Publication number
EP1225939A1
EP1225939A1 EP00980229A EP00980229A EP1225939A1 EP 1225939 A1 EP1225939 A1 EP 1225939A1 EP 00980229 A EP00980229 A EP 00980229A EP 00980229 A EP00980229 A EP 00980229A EP 1225939 A1 EP1225939 A1 EP 1225939A1
Authority
EP
European Patent Office
Prior art keywords
stopper
medicament
needle
tubular member
medicament cartridge
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Withdrawn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
EP00980229A
Other languages
German (de)
English (en)
Other versions
EP1225939A4 (fr
Inventor
Peter L. Sadowski
Paul R. Lesch, Jr.
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.)
Antares Pharma Inc
Original Assignee
Antares Pharma Inc
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 Antares Pharma Inc filed Critical Antares Pharma Inc
Publication of EP1225939A1 publication Critical patent/EP1225939A1/fr
Publication of EP1225939A4 publication Critical patent/EP1225939A4/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Withdrawn legal-status Critical Current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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/286—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened upon internal pressure increase, e.g. pierced or burst
    • 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
    • A61M2005/31516—Piston or piston-rod constructions, e.g. connection of piston with piston-rod reducing dead-space in the syringe barrel after delivery
    • 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
    • A61M5/30—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules
    • 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

Definitions

  • the present invention is directed to a device for delivery of medicament, and in particular to a medicament cartridge for use with a medicament injector, such as a syringe or needle assisted jet injector.
  • a medicament injector such as a syringe or needle assisted jet injector.
  • Medicament cartridge having three stoppers are useful for a number of applications, including separation of the needle from a colloid or particulate drug until injection to prevent needle clogging.
  • Three stopper designs can be used in any situation in which there is reason not to have the needle bearing stopper in contact with the drug prior to the injection. This could be required for drug stability reasons - either because the drug was inherently unstable or because stability data existed for the drug but without a needle.
  • the second stopper can include a first section with a wall defining a cavity having an opening and the first stopper has a medicament contacting surface configured and dimensioned to mate with the opening of the cavity to minimize volume of medicament remaining in the lumen after the first stopper has reached the second end of the tubular member.
  • the shape of the cavity can be frustroconical or any other suitable configuration.
  • the second stopper can also include a second section extending beyond the tubular member and a shoulder located between the first and second sections of the second stopper and contacting the second end of the tubular member.
  • the needle can have an injecting tip opposite the piercing end and the medicament cartridge can include a needle guard covering this injecting tip.
  • the needle guard has an enlarged end larger than the opening of the cavity of the second stopper or the needle guard is configured and dimensioned to be insertable in the opening without contacting the needle.
  • the flexible member comprises a cap and a base with a collapsible portion that flexes upon compression of the flexible member.
  • the first stopper has a medicament contacting surface and the cap has a surface with a dimple configured and dimensioned to mate with at least a portion of the medicament contacting surface to minimize volume of medicament remaining in the lumen after the first stopper has reached the second end of the tubular member.
  • the piercing end of the needle pierces the dimpled surface of the cap.
  • Figure 1 is a cross sectional view of an embodiment of the medicament cartridge according to the present invention.
  • Figure 2 is a cross sectional view of the medicament cartridge of Figure 1 upon activation of an energy mechanism to commence an injection
  • Figure 3 is a cross sectional view of the medicament cartridge of Figure 1 near completion of the injection
  • Figure 4 is a cross section view of a portion of the medicament cartridge of Figure 1 prior to completion of assembly (e.g. without a flexible member covering the needle) and fill;
  • Figure 5 is a cross sectional view of another embodiment of the medicament cartridge according to the present invention.
  • Figure 6 is a cross sectional view of the medicament cartridge of Figure 5 upon activation of an energy mechanism to commence an injection
  • Figure 7 is a cross sectional view of the medicament cartridge of Figure 5 near completion of the injection.
  • a medicament cartridge 10 comprises a tubular member 12 having a distal or first end 14 and a proximal or second end 16.
  • proximal and distal are used with respect to the injection site so that distal or first end 14 is the end of tubular member 12 farthest from the injection site and the proximal or second end 16 is nearest to the injection site.
  • Tubular member 12 defines a lumen 18 that has a cylindrical shape with a longitudinal axis.
  • lumen 18 will be in contact with the medicament. Therefore, tubular member 12 should be made of a material compatible with the medicament.
  • the walls of lumen 18 could be coated with such a material.
  • An example of a material known to be compatible with most medicaments is borosilicate glass and other examples of suitable materials are well known to those of ordinary skill in the art.
  • a needle 20 is operatively associated with second end 16 of tubular member 12. Needle 20 has a piercing end 22 that extends into lumen 18 and, in an exemplary embodiment, an injecting tip 24 extending beyond second end 16 of tubular member 12 and inserted into the person receiving the injection.
  • the length of injecting tip 24 can be selected based on the injection device and particular application that cartridge 10 is intended for use with. For example, if the injection device is a conventional auto-injector, the length of injecting tip 24 should be at least about 5 mm. If the injection device is a needle-assisted jet injector, the length of injecting tip 24 is about 5 mm or less. If the injection device is a jet injector, then injecting tip 24 does not extend substantially beyond second end 16.
  • needle 20 is located in a second stopper 30 with piercing end 22 extending from second stopper 30 and at least a portion of the second stopper 30 inserted in lumen 18 near second end 16 of tubular member 12. Injecting tip 24 extends beyond second end 16 of tubular member 12.
  • Second stopper 30 comprises a first section 32 with a wall 34 defining a cavity 36. Cavity 36 is shown having a frustroconical shape, although other shapes are envisioned within the scope of the current invention.
  • Piercing end 22 of needle 20 extends into cavity 36.
  • the sliding of first stopper 28 in lumen 18 toward second end 16 of tubular member 12 expels medicament from lumen 18 through needle 20, i.e. injection of the medicament.
  • first stopper 28 has a medicament contacting surface 38 that mates with cavity 36 as best seen in FIG. 3.
  • needle cap 25 is configured and dimensioned so that even prior to placement of flexible membrane 26 to cover piercing end 22, there is no risk of contact with piercing end 22.
  • needle cap 25 has an enlarged end 44 that has a width or diameter (w) that is larger than the width or diameter (o) of cavity 36 shielding piercing end 22 of needle 20.
  • the depth (d) that needle 20 is recessed in cavity 36 is chosen so that enlarged end 42 cannot contact any part of needle 20.
  • the other dimensions of cartridge 10 have also been selected such that protruding features cannot extend deep enough into cavity 36 to damage or impinge piercing end 22.
  • the width and length of wall 34 and shoulder 42 are selected such that neither wall 34 or shoulder 42 can extend into cavity 36 to come in contact with any part of needle 20.
  • first stopper 28 is located in lumen 18 near first end 14 of tubular member 12.
  • the medicament is contained in lumen 18 of tubular member 12.
  • the boundaries of the medicament are defined by tubular member 12 in the longitudinal axis and first stopper 28 at first end 14 and membrane 26 at second end 16.
  • the portion of membrane 26 covering piercing end 22 of needle 20 has a dome-like shape.
  • Medicament cartridge 10 is contained in an injection device (not shown) so that second stopper 30 at second end 16 cannot be pushed away from medicament cartridge 10. Shoulder 42, which contacts second end 16 of tubular member 12 when anchored in the injection device, prevents second stopper 30 from detaching from tubular member 12 as the result of the movement of first stopper 28.
  • first stopper 28 continues to slide within lumen 18 until surface 38 of first stopper 28 contacts second stopper 30.
  • the present invention encompasses any manner of causing compression of the medicament. Relative movement between first and second stoppers 28, 30 would result in compression of the medicament. Compression could be caused, for example, by movement of second stopper 28 toward first end 14 of tubular member 12. One mechanism that could cause this movement is twisting or pushing second stopper 30 toward first stopper 28 to further "seat" second stopper 30.
  • Figures 5-7 show another embodiment of a medicament cartridge according to the present invention in which the flexible member is a cap 46 with a base 48 extending therefrom.
  • Base 48 has a collapsible portion 50 that flexes upon application of a pressure.
  • the compression of medicament in lumen 18 between first stopper 28 and cap 46 causes collapsible portion 50 to flex sufficiently so that piercing end 22 of needle 20 pierces cap 46 to create a fluid pathway for the medicament through needle 20.
  • Cap 46 has a dimple 52 that mates with medicament contacting surface 38 of first stopper 28 to minimize volume of medicament remaining in lumen 18 after completion of the injection.
  • Dimple 52 also reduces the cross section of cap 46 that must be pierced by piercing end 22.
  • a number of materials, including polymers and elastomers, can be used for the flexible member (membrane 26 or cap 46 and base 48) as long as: (1) the flexible member can be punctured by piercing end 22; (2) the flexible member has the desired flexibility; (3) the flexible member is compatible with the medicament; and (4) possesses the appropriate barrier properties required for a drug container.
  • piercing end 22 of needle 20 is shown having a beveled end, any geometry capable of piercing membrane 26 can be used.

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

La présente invention concerne une cartouche de médicament (10) qui est destinée à un dispositif d'injection, tel qu'une seringue ou un pistolet à injection. La cartouche de médicament (10) selon cette invention comprend un élément tubulaire (12), présentant une lumière (18), une aiguille (20), connectée de manière opérationnelle à une extrémité dudit élément tubulaire (12) et pourvue d'une extrémité de perforation (22) qui s'étend dans la lumière (18), un premier élément d'arrêt (28), situé à l'intérieur de la lumière, à côté de l'autre extrémité de l'élément tubulaire (12), pouvant glisser à l'intérieur de la lumière (18), ainsi qu'un élément souple (26), situé à l'intérieur de la lumière (18) et couvrant l'extrémité de perforation (22) de l'aiguille (20). Des modes de réalisation d'éléments souples adaptés comprennent une membrane souple (26), un capuchon (46) présentant une base (48) pourvue d'une partie souple (50) et des éléments similaires. La compression du médicament pousse l'élément souple (26) en contact avec l'extrémité de perforation (22) de l'aiguille (20), de façon que l'extrémité de perforation perce l'élément souple (26) et crée ainsi une voie de passage fluidique qui permet au médicament de traverser l'aiguille (20).
EP00980229A 1999-10-22 2000-10-20 Cartouche de medicament Withdrawn EP1225939A4 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US16087699P 1999-10-22 1999-10-22
PCT/US2000/029111 WO2001030423A1 (fr) 1999-10-22 2000-10-20 Cartouche de medicament
US160876P 2009-03-17

Publications (2)

Publication Number Publication Date
EP1225939A1 true EP1225939A1 (fr) 2002-07-31
EP1225939A4 EP1225939A4 (fr) 2003-03-19

Family

ID=22578841

Family Applications (1)

Application Number Title Priority Date Filing Date
EP00980229A Withdrawn EP1225939A4 (fr) 1999-10-22 2000-10-20 Cartouche de medicament

Country Status (3)

Country Link
EP (1) EP1225939A4 (fr)
AU (1) AU1752101A (fr)
WO (1) WO2001030423A1 (fr)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE10137962A1 (de) * 2001-08-07 2003-02-20 Roesch Ag Medizintechnik Ampulle für eine Injektionseinrichtung
FR2832080B1 (fr) 2001-11-15 2004-09-24 Valois Sa Dispositif de distribution de produit fluide
AT500941A1 (de) * 2004-11-09 2006-05-15 Arrowmind Patententwicklungs U Injektionsvorrichtung mit einer karpule zur aufnahme eines medikamentes, sowie karpule zum einsatz in eine injektionseinrichtung
US9504816B2 (en) 2008-03-17 2016-11-29 Syringetech Llc Multi-mode syringe

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1288174A (en) * 1918-06-28 1918-12-17 H K Mulford Company Package and hypodermic syringe.
DE882600C (de) * 1951-12-04 1953-07-09 Alfons Kiesl Spritzampulle
US3308821A (en) * 1964-03-23 1967-03-14 Walter A Shields Disposable hypodermic syringes
US4051850A (en) * 1975-11-21 1977-10-04 Tischlinger Edward A Disposable medicament injector
US4072149A (en) * 1976-08-09 1978-02-07 Tischlinger Edward A Nose cap and diaphragm assembly for injector
US4171698A (en) * 1977-08-15 1979-10-23 Abbott Laboratories Prefilled two-compartment syringe

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL8802106A (nl) * 1988-08-26 1990-03-16 Abraham Van Den Haak Naaldbeveiliging voor een injectiespuit.
FR2733687B1 (fr) * 1995-05-04 1997-10-03 Brunel Marc Procede de fabrication d'un dispositif d'injection du type pre-rempli renfermant une dose de liquide a injecter, et dispositif d'injection realise

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US1288174A (en) * 1918-06-28 1918-12-17 H K Mulford Company Package and hypodermic syringe.
DE882600C (de) * 1951-12-04 1953-07-09 Alfons Kiesl Spritzampulle
US3308821A (en) * 1964-03-23 1967-03-14 Walter A Shields Disposable hypodermic syringes
US4051850A (en) * 1975-11-21 1977-10-04 Tischlinger Edward A Disposable medicament injector
US4072149A (en) * 1976-08-09 1978-02-07 Tischlinger Edward A Nose cap and diaphragm assembly for injector
US4171698A (en) * 1977-08-15 1979-10-23 Abbott Laboratories Prefilled two-compartment syringe

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO0130423A1 *

Also Published As

Publication number Publication date
EP1225939A4 (fr) 2003-03-19
WO2001030423A1 (fr) 2001-05-03
AU1752101A (en) 2001-05-08

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