EP1827563A1 - Vorrichtung zur injektion eines pharmazeutischen wirkstoffs - Google Patents

Vorrichtung zur injektion eines pharmazeutischen wirkstoffs

Info

Publication number
EP1827563A1
EP1827563A1 EP05803763A EP05803763A EP1827563A1 EP 1827563 A1 EP1827563 A1 EP 1827563A1 EP 05803763 A EP05803763 A EP 05803763A EP 05803763 A EP05803763 A EP 05803763A EP 1827563 A1 EP1827563 A1 EP 1827563A1
Authority
EP
European Patent Office
Prior art keywords
needle
injection device
retaining means
injection
insert
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Withdrawn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
EP05803763A
Other languages
English (en)
French (fr)
Inventor
Christophe Aubert
Roland Cherif-Cheikh
Thierry Rimlinger
Fabrice Bonacci
Serge Barneaud
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.)
Ipsen Pharma SAS
Original Assignee
Societe de Conseils de Recherches et dApplications Scientifiques SCRAS SAS
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 Societe de Conseils de Recherches et dApplications Scientifiques SCRAS SAS filed Critical Societe de Conseils de Recherches et dApplications Scientifiques SCRAS SAS
Priority to EP05803763A priority Critical patent/EP1827563A1/de
Publication of EP1827563A1 publication Critical patent/EP1827563A1/de
Withdrawn legal-status Critical Current

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M37/00Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069Devices for implanting pellets, e.g. markers or solid medicaments

Definitions

  • the present invention relates to an injection device and, in particular, a device for the intramuscular or subcutaneous injection of a pharmaceutical active ingredient.
  • Another disadvantage of administering drugs dissolved or suspended in a liquid medium is that the drugs are often unstable in the liquid.
  • the drug and fluid should be mixed shortly before injection. This can be particularly disadvantageous when it is necessary, for example, to treat hundreds of people in a short period of time to stop an epidemic (administration of a vaccine).
  • solid rather than liquid medications have been used to develop sustained-release or controlled release formulations.
  • the preparation is in the form of an implant or a rod which is directly injected by means of a trocar.
  • Such an implant should contain the daily dose of drug multiplied by the number of days of activity, and the amount of media sufficient to control the release rate of the drug for the period of time considered. Therefore, these solid injection preparations require a much larger needle than the needles usually used with syringes, which leads to painful injections.
  • the injection device shown in FIG. 1 comprises a body 2 which is fixed to a needle 4 by means of coupling means 6.
  • a rod 8 is guided in translation at the end of FIG.
  • the interior of the needle 4 abuts against a dose of drug disposed within said needle 4.
  • a hollow sheath 12 surrounds the needle 4 so that it is not exposed prior to use.
  • the rod 8 has a bulge 14 which limits its path in the body 2.
  • the body 2 comprises a flange 16 to facilitate removal of the device 1 after injection.
  • a piston 18 is attached to the proximal end of the rod 8 and is arranged to slide in a proximal end of the body 2. It has a collar 20.
  • the hollow sheath 12 is slidably positioned at the distal end of the body 2 to lock the needle 4 when in the extended position.
  • the operation of the injection device 1 briefly described above is as follows. When this device is pressed against the skin of the patient, the sheath 12 slides on the body 2, thus exposing the needle 4 and allowing it to penetrate into the skin, while the piston 18 and the rod 8, slidably arranged, maintain the drug under the skin when needle 4 is removed.
  • the solid drug to be injected is intended to be immediately assimilated by the cops.
  • the quantities injected being only those necessary to obtain an immediate effect, the needle can be as fine as those of conventional syringes.
  • the injection is less painful insofar as the volume injected is considerably less than the volume required for an injection in liquid form.
  • the needle of the injection device is not exposed to the external elements. In this way, the needle will not be able to collect contaminants present in the atmosphere nor to scrap someone inadvertently. Similarly, it will not be possible to inadvertently inject a fraction of the drug or the blood of the patient to a member of the hospital staff.
  • a seal 22 can seal the opening 24 through which the needle 4 emerges from the injection device 1 in order to preserve the sterility of said needle 4 and the medicinal dose 10.
  • This seal 22 can be made of a friable material such that of Biocompatible and biodegradable wax.
  • the closure of the opening 24 can be achieved by means of a cap completely covering the sleeve 12.
  • the present invention provides a device for injecting a solid drug called implant that can be handled without exaggerated caution while being assured that the implant is not likely to fall.
  • a device for injecting a solid drug called implant that can be handled without exaggerated caution while being assured that the implant is not likely to fall.
  • the open end of the injection device through which the needle leaves is closed by a cap, it is possible, at the moment when it is about to proceed with the injection, to remove this cap without fearing that the implant does not fall.
  • the retaining means do not interfere with the proper functioning of the injection device.
  • the retaining means temporarily seal the bevel of the needle in the rest position, thereby preventing the implant from coming out of the needle and falling.
  • the retaining means make it possible to off-center the opening through which the needle leaves relative to the axis of general advance of said needle inside the injection device. . - AT -
  • the retaining means comprise an elastic tongue which temporarily bears against the bevel of the needle.
  • FIGS. 2A and 2B are cross-sectional views of the distal end of an injection device provided with means making it possible to prevent the fall of the drug according to a first embodiment of the invention, the needle being respectively in the rest position and in the extended position;
  • FIGS. 4A and 4B are sectional views of the distal end of an injection device provided with means making it possible to prevent the fall of the medicament according to a third embodiment of the invention, the needle being respectively in the rest position and in the extended position.
  • the present invention proceeds from the general inventive idea of providing an injection device with a solid drug, also called an implant, with means for preventing the fall of the drug during storage periods or just before injecting. .
  • a solid drug also called an implant
  • these means do not require the user to engage in complicated manipulations to make said device operational.
  • the retaining means according to the invention do not interfere with the exit of the needle and the overall smooth operation of the injection device.
  • FIG. 2A and 2B A first embodiment of the retaining means according to the invention is illustrated in Figures 2A and 2B.
  • the injection device 1 described in connection with Figure 1 is an example given purely by way of illustration and not limited to the type of injection device to which the present invention can be applied.
  • the distal end 26 of the body 2 of the injection device is provided with an insert 28.
  • This insert 28 is made of a biocompatible plastic material and sterilizable for example by irradiation such as a polycarbonate. It is introduced inside the body 2 through the opening 24 through which the needle 4 comes out.
  • the insert 28, of generally cylindrical shape has an outside diameter adapted to the inside diameter of the body 2, so that the friction forces between these two parts are sufficient to avoid any risk of inadvertent falling of said insert 28.
  • the insert 28 comprises at its base an opening 30 through which the needle 4 leaves.
  • This opening 30 is eccentric with respect to the general axis of advance XX of the needle 4.
  • the insert 28 has, on its face facing said needle 4, an inclined plane 32 which, from top to bottom, approaches the axis of advance of this needle 4 until to intercept and lead to the opening 30.
  • the needle 4 in the rest position ( Figure 2A), the needle 4 is supported by its beveled opening 34 against the inclined plane 32, which prevents the dose 10 of drug substance to fall.
  • Figure 2B During the movement of the output of the needle 4 ( Figure 2B), it slides on the inclined plane 32 by deforming. This movement is made possible by the flexibility of the needle 4.
  • the tapered opening 34 which constitutes the cutting part of the needle 4 is inclined at an angle ⁇ relative to the axis X-X.
  • This tapered opening 34 is preceded by a sliding surface 36 inclined relative to the axis XX by an angle ⁇ less than the angle ⁇ by which said needle 4 slides on the inclined plane 32.
  • the inclined plane 32 of the insert 28 is inclined relative to the axis XX by an angle ⁇ 'substantially equal to the angle ⁇ . In this way, it avoids the contact between the cutting portion of the needle 4 and the inclined plane 32 of the insert 28 which could lead to the tearing of a piece of plastic.
  • a second embodiment of the retaining means according to the invention is shown in FIGS. 3A and 3B.
  • the distal end 26 of the body 2 of the injection device is provided with an insert 38.
  • the insert 38 is made for example of a plastic material such as polycarbonate and is introduced to the inside the body 2 through the aperture 24 through which the needle 4 exits.
  • the insert 38 is firmly retained within the body 2 through the frictional forces between said insert 38 and the inner wall of said body 2 .
  • the insert 38 has two through openings 40 and 42 aligned on the general axis of advance XX of the needle 4 inside the body 2.
  • the first of these openings 40 allows the exit of the needle 4 out of the body 2 of the injection device at the time of the injection (see Figure 3B).
  • the second opening 42 makes it possible to thread the insert 38 onto the needle 4 at the time of mounting of said insert 38.
  • the needle 4 just move an elastic tongue 44 from its rest position. Under the effect of the elastic restoring force, the tongue 44 bears against the beveled face 34 of said needle 4, preventing the dose of drug 10 from falling.
  • the needle 4 advances relative to the insert 38 and pushes the elastic tongue 44 (see Figure 3B).
  • FIGS 4A and 4B are sectional views of an alternative embodiment of the insert 38 described above.
  • the elastic tongue 44 is articulated pivotally on said insert 38 by means of a hinge 46 and is held in abutment against the beveled face 34 of the needle 4 under the The effect of the elastic restoring force of a spring 48.
  • the tongue 44 is erased, which causes the compression of the spring 48.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Dermatology (AREA)
  • Medical Informatics (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)
  • Media Introduction/Drainage Providing Device (AREA)
EP05803763A 2004-12-01 2005-11-15 Vorrichtung zur injektion eines pharmazeutischen wirkstoffs Withdrawn EP1827563A1 (de)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP05803763A EP1827563A1 (de) 2004-12-01 2005-11-15 Vorrichtung zur injektion eines pharmazeutischen wirkstoffs

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP04028411A EP1666084A1 (de) 2004-12-01 2004-12-01 Injektionsvorrichtung für einem pharmazeutischen Wirkstoff
EP05803763A EP1827563A1 (de) 2004-12-01 2005-11-15 Vorrichtung zur injektion eines pharmazeutischen wirkstoffs
PCT/EP2005/012248 WO2006058614A1 (fr) 2004-12-01 2005-11-15 Dispositif pour l’injection d’un principe actif pharmaceutique

Publications (1)

Publication Number Publication Date
EP1827563A1 true EP1827563A1 (de) 2007-09-05

Family

ID=34927595

Family Applications (2)

Application Number Title Priority Date Filing Date
EP04028411A Withdrawn EP1666084A1 (de) 2004-12-01 2004-12-01 Injektionsvorrichtung für einem pharmazeutischen Wirkstoff
EP05803763A Withdrawn EP1827563A1 (de) 2004-12-01 2005-11-15 Vorrichtung zur injektion eines pharmazeutischen wirkstoffs

Family Applications Before (1)

Application Number Title Priority Date Filing Date
EP04028411A Withdrawn EP1666084A1 (de) 2004-12-01 2004-12-01 Injektionsvorrichtung für einem pharmazeutischen Wirkstoff

Country Status (11)

Country Link
US (1) US8348881B2 (de)
EP (2) EP1666084A1 (de)
JP (2) JP4954084B2 (de)
CN (1) CN101098729B (de)
BR (1) BRPI0518747A2 (de)
CA (1) CA2589852C (de)
HK (1) HK1111368A1 (de)
IL (1) IL183503A0 (de)
MX (1) MX2007006481A (de)
RU (1) RU2396990C2 (de)
WO (1) WO2006058614A1 (de)

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JP2015519103A (ja) 2012-04-17 2015-07-09 ドクター ピー インスティチュート エルエルシー 自閉式コネクタ
US10351271B2 (en) 2012-05-01 2019-07-16 Dr. Py Institute Llc Device for connecting or filling and method
CA2910803C (en) 2012-05-01 2019-04-23 Dr. Py Institute Llc Connector for aseptic filling and transfer of fluids
US10080877B2 (en) 2014-07-25 2018-09-25 Warsaw Orthopedic, Inc. Drug delivery device and methods having a drug cartridge
US9775978B2 (en) 2014-07-25 2017-10-03 Warsaw Orthopedic, Inc. Drug delivery device and methods having a retaining member
US10327862B2 (en) 2014-09-17 2019-06-25 Covidien Lp Fiducial marker deployment system
US10485583B2 (en) 2015-10-07 2019-11-26 Covidien Lp Endoscopic ultrasound fine needle fiducial system
US10076650B2 (en) 2015-11-23 2018-09-18 Warsaw Orthopedic, Inc. Enhanced stylet for drug depot injector
US10549081B2 (en) 2016-06-23 2020-02-04 Warsaw Orthopedic, Inc. Drug delivery device and methods having a retaining member
US10434261B2 (en) 2016-11-08 2019-10-08 Warsaw Orthopedic, Inc. Drug pellet delivery system and method
WO2020245448A1 (en) * 2019-06-07 2020-12-10 Novo Nordisk A/S Ingestible device with delivery member detachment
BE1027526B1 (fr) * 2019-08-26 2021-03-29 Novalon Sa Système d'injection pour la délivrance d'un implant médical
CN115120858B (zh) * 2022-05-12 2024-03-29 肖龙 用于纹身装置的针组件

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Also Published As

Publication number Publication date
HK1111368A1 (en) 2008-08-08
MX2007006481A (es) 2008-01-11
WO2006058614A1 (fr) 2006-06-08
RU2396990C2 (ru) 2010-08-20
EP1666084A1 (de) 2006-06-07
BRPI0518747A2 (pt) 2008-12-02
IL183503A0 (en) 2007-09-20
JP2008521527A (ja) 2008-06-26
US8348881B2 (en) 2013-01-08
CN101098729A (zh) 2008-01-02
JP4954084B2 (ja) 2012-06-13
JP2012020189A (ja) 2012-02-02
CN101098729B (zh) 2012-12-05
US20090270797A1 (en) 2009-10-29
CA2589852A1 (en) 2006-06-08
RU2007124602A (ru) 2009-01-10
CA2589852C (en) 2012-10-23

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