EP0113713A1 - Cylindres de dosage injectables a liberation entretenue - Google Patents

Cylindres de dosage injectables a liberation entretenue

Info

Publication number
EP0113713A1
EP0113713A1 EP19820902430 EP82902430A EP0113713A1 EP 0113713 A1 EP0113713 A1 EP 0113713A1 EP 19820902430 EP19820902430 EP 19820902430 EP 82902430 A EP82902430 A EP 82902430A EP 0113713 A1 EP0113713 A1 EP 0113713A1
Authority
EP
European Patent Office
Prior art keywords
needle
pellet
obturator
patient
cylindrical
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Withdrawn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
EP19820902430
Other languages
German (de)
English (en)
Inventor
Mitchell Harman
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.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of EP0113713A1 publication Critical patent/EP0113713A1/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Withdrawn legal-status Critical Current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
    • A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
    • A61M37/0069—Devices for implanting pellets, e.g. markers or solid medicaments

Definitions

  • This invention relates generally to the field of surgical instrumentation, and more particularly to an improved means and method for administering certain solid form medicaments in subcutaneous applications.
  • a typical example of this procedure is the treat ⁇ ment of menopausal estrogen deficiency in women using 17 beta-estradiol pellet implants. Such replacement has a number of important salutory effects.
  • the implanted does is in the form of compressed, cylindrical pellets containing 25 mg. of 17 beta- estradiol without excipient.
  • the pellets measure appro ⁇ ximately 3.2 mm. in diameter and are 3.5 mm. long.
  • Implantation is effected using a cannula with the same inside diameter as that of the pellet (3.2 mm.) and provided with two trocars. A first trocar 'is pointed for introducing the cannula, and a second trocar is blunt for inserting the pellet thereafter.
  • a small incision is made through the skin with a pointed scalpel blade.
  • the cannula with the pointed trocar is inserted several cm. into the subcutaneous fat, and nearly parallel to the skin, after which the implant pellet is inserted into the cannula and pushed there through using the blunt trocar, following which the cannula is withdrawn.
  • One or two sutures may be re ⁇ quired to close the incision. While a skilled physician can often complete the procedure in a few minutes, the cannula and the trocars must be sterilized for each use, and the procedure can hardly be considered convenient.
  • the known pellet is of such a size that the continued administration of estrogen lasts approximately three months.
  • the alternative parenteral method for supplying estrogen directly to the systemic circulation results in prolonged exposure to unopposed and continuous exposure to unopposed and continuous estrogen.
  • Such unopposed and continuous exposure to estrogens, by either the oral or parenteral route, has been shown to result in an increased risk of uterine cancer. Therefore the ideal method would use a small pellet, lasting only three-four weeks, provide for progestin administration to mature the uterine lining, and be convenient and painless enough that monthly repetition would be feasible for most patients.
  • the other parenteral alternative utilizing intramuscular injection of estradiol in oil, results in transient very high estrogen levels, slowly decreasing in an unpre ⁇ dictable fashion, and is painful.
  • the invention des ⁇ cribed herein is designed to overcome the objections and side effects of such replacement therapy.
  • An elongated cylindrical pellet con ⁇ taining a drug suitable for subcutaneous release into the tissue of a patient for systemic effect, said cylin ⁇ drical pellet containing a sufficient quantity of said drug for sustained systemic effect to a patient, the diameter of said cylindrical pellet being less than about one millimeter, said cylindrical pellet addition ⁇ ally being adapted to fit inside a hollow sleeve of a hypodermic needle.
  • Figure 3 is a central sectional view of a needle cartridge element in detached condition.
  • Figure 4 is a central longitudinal sectional view of a pellet element.
  • Figure 5 is an end elevational view of the pellet element shown in Figure 4.
  • Figure 6 is a central longitudinal sectional view thereof, with needle cartridge attached, and showing the device in "discharged” or post-injection configuration.
  • the invention contemplates the provision of an improved device for the subcutaneous implantation of a solid elongated composite pellet in a manner somewhat resembling the administration of of a liquid drug using a conventional hypodermic syringe.
  • the device includes a hollow cylinder slidably mounting a pair of arms having a cartridge engaging terminal at a distal end thereof.
  • a disposable sealed, pre-sterilized cartridge element includes a hollow needle with means at the base or hub thereof for engaging said terminal.
  • a pellet of cylindrical configuration is positioned in the needle, and a blunt obturator extends through the base of the needle.
  • the pellet may be of either of two types.
  • a single composition pellet such as a pure estradiol pellet delivers estrogen only which may be supplemented at the end of a cycle by orally administering progestin.
  • a second type of pellet with a core of a different drug might contains a 0.2 mm core of progesterone estradiol mixture to release progestin during the last one third of the cycle. The exact size and proportional mix of the core may be varied to suit specific requirements.
  • O PI abut ent 21 and second end 46 which extends into the base of needle member 40 at 47.
  • threaded end wall 20 or cap may first be removed from the barrel 16 with its sliding arms 33-34 and cylinder-lock 37.
  • Disposable cartridge 12 is then attached to cylinder-lock 37 so that obturator 44 passes through the cylinder and comes to rest with its free end 15, in abutment 21 of cap 20.
  • the cartridge is then passed down barrel 16 to emerge through the central opening 26 and the cap rethreaded into place on barrel 16.
  • Figure 2 shows assembled device 10 with the needle inserted into the subcutaneous fat of a patient.
  • the pellet is positioned in the desired implant location, and the device is then removed by leaving guide element 11 in the location shown, and while holding barrel grips 18, slide grip 32 is moved outwardly to result in withdrawing needle member 40 while maintaining obturator 44 in place. This results in uncovering the pellet, in situ in a progressive fashion until slide member 30 has reached its outermost position, at which point end 46 of the obturator has passed the free end of the needle.
  • the pellet at this
  • index means is provided on the outer surface of the obturator to indicate when the needle member has been completely withdrawn.
  • a hypodermic syringe contemplated for use with the above pellet must have a relatively narrow needle in order to be relatively painless for a patient and pro ⁇ vide so minimal a wound as to not require suturing.
  • Perhaps the largest interior bore diameter that could be remotely contemplated for injection into a patient would be 17 gauge (1.06) mm, and even that gauge would not be considered sufficiently small for most patients.
  • Such a large gauge bore would cause the patient much pain, no matter how skillful the physician or nurse that would make the injection, so that a maximum interior bore for a needle of the present invention when defined in terms of the bore of a hypodermic syringe would not be greater than about 1 mm (i.e., an 17 gauge maximum bore would be 1.06 mm) .
  • Anti-hypertensive delivery over a period of 30 days is also contemplated in accordance with this invention, which would typically include from about 1 mg to about 15 mg of Clonidine, and preferably about 3 mg.

Abstract

Dispositif (10) permettant d'administrer des comprimés médicinaux allongés (13) dans des applications sous-cutanées. Le dispositif comprend un élément de guidage manuel (11) comprenant un cylindre creux (16) renfermant un organe coulissant (30) à une extrémité duquel est aménagé un organe d'attache d'aiguille. Un élément de cartouche jetable (12) comprend une aiguille creuse (40) contenant un comprimé destiné à être implanté et un obturateur (44) quelque peu plus long que l'aiguille. Lors de l'utilisation, une extrémité de l'élément de cartouche s'engage dans l'élément de guidage. L'extrémité libre de l'aiguille est insérée dans le gras sous-cutané du patient, et l'organe coulissant est déplacé en sens inverse pour extraire l'aiguille du cylindre creux. Pendant ce mouvement, l'obturateur est maintenu relativement stationnaire en engageant un élément d'appui sur l'élément de guidage, à une extrémité de celui-ci, l'extrémité opposée de l'obturateur s'engageant dans une extrémité du comprimé, de sorte que lorsque l'aiguille est retirée, le comprimé reste dans la position d'implantation. Un comprimé composite possèdant un noyau formé d'un premier ingrédient et d'un enrobage composé d'un deuxième ingrédient est également décrit.
EP19820902430 1982-07-08 1982-07-08 Cylindres de dosage injectables a liberation entretenue Withdrawn EP0113713A1 (fr)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US1982/000927 WO1984000304A1 (fr) 1982-07-08 1982-07-08 Cylindres de dosage injectables a liberation entretenue

Publications (1)

Publication Number Publication Date
EP0113713A1 true EP0113713A1 (fr) 1984-07-25

Family

ID=22168080

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19820902430 Withdrawn EP0113713A1 (fr) 1982-07-08 1982-07-08 Cylindres de dosage injectables a liberation entretenue

Country Status (2)

Country Link
EP (1) EP0113713A1 (fr)
WO (1) WO1984000304A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102013226039A1 (de) 2013-12-16 2014-04-10 Henkel Ag & Co. Kgaa Pflegende Färbe- und Blondiermittel
DE102013226144A1 (de) 2013-12-17 2014-04-10 Henkel Ag & Co. Kgaa "Pflegende Färbe- und Blondiermittel mit verbessertem Volumen"

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE3867759D1 (de) * 1987-08-18 1992-02-27 Akzo Nv Injektionsvorrichtung fuer ein implantat.
US5487739A (en) 1987-11-17 1996-01-30 Brown University Research Foundation Implantable therapy systems and methods
US5106627A (en) * 1987-11-17 1992-04-21 Brown University Research Foundation Neurological therapy devices
GB2240718A (en) * 1990-02-09 1991-08-14 Hundon Forge Ltd Implanting device with needle cover
KR930701209A (ko) * 1991-06-28 1993-06-11 윌리암 엠. 잭슨 신경 이식 시스템
AU2004240186B2 (en) * 1991-08-16 2007-11-01 Societe De Conseils De Recherches Et D'application Scientifiques Scras Device for local administration of solid or semi-solid formulations and delayed-release formulations for parenteral administration and preparation process
US20020111603A1 (en) 1996-12-02 2002-08-15 Societe De Conseils De Recherches Et D'application Device for local administration of solid or semi-solid formulations and delayed-release formulations for proposal parental administration and preparation process
FR2756493B1 (fr) * 1996-12-02 2001-04-13 Delab Dispositif d'administration locale de formulations solides ou semi-solides
DE19734385C1 (de) * 1997-08-08 1999-02-18 Gaplast Gmbh Implantatspritze
DE102011116973A1 (de) 2011-10-26 2013-05-02 Amw Gmbh Implanter
GB201317641D0 (en) * 2013-10-05 2013-11-20 Chowdhury Dewan F H Novel solid dosage form

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA455838A (fr) * 1949-04-12 American Cystoscope Makers Dispositif chirurgical a implanter
US1262732A (en) * 1916-08-08 1918-04-16 George F Andrews Pill-injector.
US3137631A (en) * 1959-12-01 1964-06-16 Faberge Inc Encapsulation in natural products
US3800038A (en) * 1972-04-21 1974-03-26 Biolog Concepts Inc Uterine administraton of eutectic solid solutions of steroid hormones in a steroidal lipid carrier
GB1379358A (en) * 1973-07-04 1975-01-02 Syntex Corp Implanter having a cartridge ejector
US3921632A (en) * 1974-08-16 1975-11-25 Frank M Bardani Implant device
US4077406A (en) * 1976-06-24 1978-03-07 American Cyanamid Company Pellet implanter for animal treatment
US4086914A (en) * 1977-02-11 1978-05-02 Edwin Bailey Moore Implant injector

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See references of WO8400304A1 *

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102013226039A1 (de) 2013-12-16 2014-04-10 Henkel Ag & Co. Kgaa Pflegende Färbe- und Blondiermittel
DE102013226144A1 (de) 2013-12-17 2014-04-10 Henkel Ag & Co. Kgaa "Pflegende Färbe- und Blondiermittel mit verbessertem Volumen"

Also Published As

Publication number Publication date
WO1984000304A1 (fr) 1984-02-02

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