WO2010010488A1 - Dispositif destiné à être fixé à un ensemble aiguille pour faire varier la longueur de l'aiguille découverte - Google Patents

Dispositif destiné à être fixé à un ensemble aiguille pour faire varier la longueur de l'aiguille découverte Download PDF

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Publication number
WO2010010488A1
WO2010010488A1 PCT/IB2009/053078 IB2009053078W WO2010010488A1 WO 2010010488 A1 WO2010010488 A1 WO 2010010488A1 IB 2009053078 W IB2009053078 W IB 2009053078W WO 2010010488 A1 WO2010010488 A1 WO 2010010488A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle
extender
length
biological material
proximal portion
Prior art date
Application number
PCT/IB2009/053078
Other languages
English (en)
Inventor
Raju Krishnaswamy
Original Assignee
Wockhardt Research Centre
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 Wockhardt Research Centre filed Critical Wockhardt Research Centre
Publication of WO2010010488A1 publication Critical patent/WO2010010488A1/fr

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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
    • A61M5/46—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 having means for controlling depth of insertion
    • 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
    • A61M5/31525—Dosing

Definitions

  • the present invention provides a device for the delivery of biological material across the biological tissue.
  • the device comprises of an extender which when attached to a needle hub of a needle assembly allows protrusion of desired length of needle from the distal end of the extender.
  • Dosed biological material delivery devices often referred to as 'injection pen device' are commonly used for routine injection of biological materials.
  • Dosed biological material delivery devices are a preferred means of delivery wherever the volume of biological material delivered needs to be variable but accurate, critical, small and needs to be administered very frequently.
  • 'injection pen device' may refer generally to any and all free-standing portable device containing a plurality of doses of a biological material liquid which may be operated by a patient for self injection to deliver metered doses of the liquid to the patient's body on a plurality of occasions.
  • US patent No 6,200,296 discloses a needle assembly for a medication delivery pen or hypodermic syringe having a usable length of 5 mm (0.19V) that delivers a dose of medication to a proper location in the tissue 'strata' or subcontinuous layer without the need for the user or patient to 'pinch-up' the skin layer during the injection.
  • USpatent No 7,186,235 discloses an apparatus and method for intradermally administering a pharmaceutical composition or other substance into and through the skin of a mammalian body in a manner that avoids or eliminates excess pain and discomfort normally caused as a result of the microabraders or microneedles entering the epithelial layers beneath the stratum corneum.
  • USpatent No 6,482,176 discloses a method for controlling the introduction depth of an injection needle which is mounted inside a needle introduction device so as to be capable of axial displacement relative to an injection device coupled to said needle introduction device or arranged in the same.
  • US patent no 5,944,700 discloses an extender that is rotatably attached to a hub on the pen needle to set the pen needle to a desired injection length. This injection length serves the purpose of intravaneous, subcutaneous and intra muscular delivery.
  • US patent No 6,554,238 discloses that needle has an injection part extending axially from the hub and terminating in a skin piercing obliquely cut end.
  • the length of the injection part is between 4 and 6 mm, thereby facilitating a proper subcutaneous injection.
  • US patent application No 20070118073 Al relates to an apparatus and method for in- tradermally administering a pharmaceutical composition or other substance into and through the skin of a mammalian body in a manner that avoids or eliminates excess pain and discomfort normally caused as a result of the microabraders or microneedles entering the epithelial layers beneath the stratum corneum.
  • the apparatus is a microdevice with an array of microabraders or microneedles with a manipulating member.
  • EP No 1625870 relates to needle for intradermal delivery of substance into human or animal skin comprises hub to limit penetration of the needle into the skin, and outlet so positioned to prevent leakage of the substance to the skin surface.
  • the present inventors while working for suitable extender design which when attached to a needle hub of a needle assembly the protruded portion of the needle from the distal end of the extender extends to a desired length.
  • the desired length may be between 3 ⁇ m to about 4.5mm which specifically allows dermal/epidermal or transdermal delivery of biological material.
  • Delivery of pharmaceutically active ingredient to dermal layer of the skin has the advantages of (i) fast on set off action and (ii) cost efficient as there is no need to fabricate separate small length needles.
  • the fabrication of small length needles may be expensive and requires precision manufacturing process.
  • One of the aspects of the invention discloses a device which comprises of an extender comprising a proximal portion and a distal portion;
  • the proximal portion of the extender is shaped and has a length sufficient enough to fit on to the needle hub of the needle assembly having a needle length of about 1 mm and more of an injection pen device;
  • the shaped distal portion of the extender has a length such that the protruded portion of the needle from distal end of the extender has a desired length of between 3 ⁇ m to 4.5 mm which specifically allows dermal/epidermal or transdermal delivery of biological material.
  • the conventional hypodermic needle attached to a needle hub will have varying lengths.
  • the projected needle length of the hypodermic needle from the distal portion of the needle hub can be less than 6mm or more than 9mm, more preferably between 6mm to 9mm long.
  • the needle gauge can be anywhere between 22gauge to 34 gauge and more preferably 30 or 31 gauge.
  • the 30 gauge or 31 gauge conventional needles have outer diameters of 305 ⁇ m and 254 ⁇ m and inner diameter of around 200 ⁇ m.
  • microneedle' refers to a device for transdermal or intradermal delivery or removal of fluids without many of the risks associated with standard syringes.
  • Microneedle may be designed to pierce the stratum corneum skin barrier layer in a minimally invasive and pain-free manner to provide transient pathways for the delivery of macromolecules to the underlying skin epidermis. Since the needle may be short, it may not reach the nerve-rich regions of the lower parts of the skin. As a consequence, the stimulus caused by microneedle insertion into the skin may be weak and cause less pain.
  • 26 gage hypodermic needle i.e. upper end for pain perception commencement can be considered as 500 ⁇ m.
  • Biomaterial Storage' may mean a syringe or cartridge containing suitable pharmaceutical substance.
  • proximal portion means the portion which may be towards the dose setting end and the distal portion means the portion which my be towards the needle end.
  • proximal end means towards the dose setting end and distal end means towards the needle end.
  • the term ' biological material ' refers to an agent which possesses therapeutic, prophylactic, or diagnostic properties in vivo, for example when administered to an animal, including mammals, such as humans.
  • the biological material is selected from the group comprising of peptides, proteins, carbohydrates, nucleic acid molecules, lipids and other pharmaceutically active ingredients or combinations thereof.
  • the pharmaceutically active ingredients may be one or more of anesthetics, analgesics, anti bacterials, anti virals, antiadrenergics, antiamebics, antianginals, antiarrhythmics, antibiotics, anticoagulants, anticonvulsants, antidepressants, antidiabetics, antidiuretics, antidyskinetics, antiemetics, antifungals, antihistaminics, antihyper- parathyroids, antihypertensives, antiinflammatories, antimigraines, antineoplastics, antineoplastics, antiprotozoals, antipsychotics, antispasmodics, antithrombotics, antiul- ceratives, anxiolytics, astringents, bone resorption inhibitors, bronchodilators, cardiotonics, cholinergics, diaprostic agents, diuretics, hormones, steriods, hydrochloride as anineoplastic, hypn
  • the pharmaceutically active ingredients may further include one or more ketamine, chloroprocaine hydrochloride, alfentanil, amikacin, abacavir, bretylium tosylate, metronidazole, diltiazem hydrochloride, ciprofloxacin, dextran sulfate sodium, fos- phenytoin sodium, rubidium chloride, insulin, desmopressin acetate, haloperidol lactate, dimenhydrinate, abelcet, diphenhydramine hydrochloride, paricalcitol, diltiazem hydrochloride, ketorolac, dihydroergotamine mesylate, mitoxantrone hydrochloride, leuprolide acetate, metronidazole, aripiprazole, dicyclomine hydrochloride, dipyridamole, cimetidine hydrochloride, diazepam, zinc chloride, zoledron
  • protruded needle length from the distal end of the distal portion of the extender may be less than 1 mm, in which case it would function as a microneedle.
  • the length of the microneedle typically may be between about 10 ⁇ m and 1 mm, preferably between 100 ⁇ m and 500 ⁇ m, and more preferably between 150 ⁇ m and 350 ⁇ m. The length may be selected for the particular application, accounting for both an inserted and un inserted portion.
  • the 'insertion depth' of the microneedle may be preferably less than about 500 ⁇ m, so that insertion of the micro needles into the skin does not penetrate into the dermis, thereby avoiding contacting nerves which may cause pain.
  • the actual length of the microneedle typically may be longer, since the portion of the microneedle distal the tip may not be inserted into the skin; the uninserted length depends on the particular device design and configuration.
  • the actual (overall) height or length of microneedle should be equal to the insertion depth plus the un inserted length.
  • proximal portion may be cylindrical in shape and distal portion may be conical in shape.
  • cylindrical portion has either protrusions or threads on its internal surface.
  • the protrusions on its internal surface results in good frictional contact with outside surface of the needle hub.
  • the suitable material for manufacturing device include one or metals or non biodegradable polymers.
  • Suitable materials for manufacturing needle (8) or extender (9) include one or more metals.
  • the metals can be selected from the group comprising of pharmaceutical grade stainless steel, gold, titanium, nickel, iron, tin, chromium, copper, palladium, platinum, alloys, silicon, silicon dioxide, and combinations thereof.
  • Suitable materials for manufacturing extender (9) also may include one or more nonbiodegradable polymers which include one or more cellulose, polycarbonate, polyester or polyacrylamides.
  • the biological material may be selected from the group comprising of peptides, proteins, carbohydrates, nucleic acid molecules, lipids and other pharmaceutically active ingredients and combinations thereof.
  • Embodiments of the device for attachment to a needle assembly to vary the length of the needle may include one or more of the following features.
  • Figure IA and IB show the injection pen device (1) where in present needle and a cap (5) that would be associated with a pen.
  • Needle hub (7) has an internal thread (6) that mates with the cartridge or syringe (2) and needle (8) extends on both sides of the needle hub (7).
  • the needle (8) which may extend from the distal end of the needle hub may be less than 6mm long or more than 6mm long, more preferably 6 mm to 9mm long.
  • needle (8) On attachment of needle hub (7) to the cartridge or syringe (2) by screw mechanism or any other means, needle (8) which extends on to the internal of the cap pierces the rubber seal (3) of the cartridge or syringe (2) and establishes contact with the biological material in the cartridge or syringe (2). Needle cap (5) may be removed and set dosage of the biological material may be administered to a patient.
  • Figure 2 shows the proposed system wherein a device may comprise an extender (9) which has two portions namely the proximal portion and the distal portion.
  • the extender (9) on attachment to the needle hub (7) of the needle assembly results in a protruded portion of the needle from the distal end of the extender (9) of desired length. It could be possible that that the length of the protruded portion of the needle from the distal end of the extender (9) may be less than lmm or more than 1 mm. More preferably the length of the protruded portion of the needle from the distal end of the extender (9) would be in the range 3 ⁇ m to 4.5 mm.
  • the proximal portion (12) of the extender (9) has the shape and dimension as to correspond and fit on to the needle hub (7) of the needle assembly.
  • the length of the shaped distal portion (11) may be such that the protruded portion of the needle from the distal end of the extender (9) may be of desired length.
  • the desired length may be between 3 ⁇ m to 4.5mm which specifically allows dermal/epidermal or transdermal delivery of biological material.
  • Figure 2 shows the extender (9) with needle cap removed and fitted on to needle hub of the needle assembly.
  • the proximal portion (12) is cylindrical in shape and whose length corresponds to the length of the needle hub. Inside diameter of the proximal portion of the extender would be such that it would tight fit on to the outside diameter of the needle hub.
  • Distal end (11) of the embodiment shown in figure 2 may be so dimensioned as to achieve the protruded portion of the needle of desired length.
  • the proximal and distal portions of the extender (9) may be either separately made and attached or molded as an integral device.
  • the extender (9) shown in Figure 2 is an integral one.

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 un dispositif pour administrer une substance biologique dans un tissu biologique. Le dispositif comprend un élément de prolongement qui, lorsqu'il est fixé à l'embase d'une aiguille d'un ensemble aiguille, permet à une longueur d'aiguille souhaitée d'être en saillie par rapport à l'extrémité distale de l'élément de prolongement.
PCT/IB2009/053078 2008-07-21 2009-07-16 Dispositif destiné à être fixé à un ensemble aiguille pour faire varier la longueur de l'aiguille découverte WO2010010488A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IN1534MU2008 2008-07-21
IN1534/MUM/2008 2008-07-21

Publications (1)

Publication Number Publication Date
WO2010010488A1 true WO2010010488A1 (fr) 2010-01-28

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/IB2009/053078 WO2010010488A1 (fr) 2008-07-21 2009-07-16 Dispositif destiné à être fixé à un ensemble aiguille pour faire varier la longueur de l'aiguille découverte

Country Status (1)

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WO (1) WO2010010488A1 (fr)

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999027986A1 (fr) * 1997-11-27 1999-06-10 Disetronic Licensing Ag Procede et dispositif de commande de la profondeur de penetration d'une aiguille pour injection
WO1999034850A1 (fr) * 1998-01-08 1999-07-15 Fiderm S.R.L. Dispositif de commande de la profondeur de penetration d'une aiguille conçu pour etre utilise avec une seringue d'injection
EP1092444A1 (fr) * 1999-10-14 2001-04-18 Becton Dickinson and Company Dispositif d'administration intradermique et ensemble aiguille
US20050203459A1 (en) * 2004-03-11 2005-09-15 Alchas Paul G. Intradermal syringe and needle assembly
WO2006077466A2 (fr) * 2005-01-18 2006-07-27 Wockhardt Americas Inc Dispositifs d'injection de medicaments en forme de stylo
KR200423638Y1 (ko) * 2006-05-19 2006-08-09 최종수 주사기의 니들 길이조절용 캡

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1999027986A1 (fr) * 1997-11-27 1999-06-10 Disetronic Licensing Ag Procede et dispositif de commande de la profondeur de penetration d'une aiguille pour injection
WO1999034850A1 (fr) * 1998-01-08 1999-07-15 Fiderm S.R.L. Dispositif de commande de la profondeur de penetration d'une aiguille conçu pour etre utilise avec une seringue d'injection
EP1092444A1 (fr) * 1999-10-14 2001-04-18 Becton Dickinson and Company Dispositif d'administration intradermique et ensemble aiguille
US20050203459A1 (en) * 2004-03-11 2005-09-15 Alchas Paul G. Intradermal syringe and needle assembly
WO2006077466A2 (fr) * 2005-01-18 2006-07-27 Wockhardt Americas Inc Dispositifs d'injection de medicaments en forme de stylo
KR200423638Y1 (ko) * 2006-05-19 2006-08-09 최종수 주사기의 니들 길이조절용 캡

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