WO2018034660A1 - Ensemble adaptateur universel d'injection de médicament destiné à être utilisé avec une seringue pharmaceutique sans aiguille - Google Patents

Ensemble adaptateur universel d'injection de médicament destiné à être utilisé avec une seringue pharmaceutique sans aiguille Download PDF

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Publication number
WO2018034660A1
WO2018034660A1 PCT/US2016/047389 US2016047389W WO2018034660A1 WO 2018034660 A1 WO2018034660 A1 WO 2018034660A1 US 2016047389 W US2016047389 W US 2016047389W WO 2018034660 A1 WO2018034660 A1 WO 2018034660A1
Authority
WO
WIPO (PCT)
Prior art keywords
cannula
hub
coupling
distal end
needle
Prior art date
Application number
PCT/US2016/047389
Other languages
English (en)
Inventor
Shlomi BEN-SASSON
Original Assignee
Sid Technologies, Llc
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 Sid Technologies, Llc filed Critical Sid Technologies, Llc
Priority to PCT/US2016/047389 priority Critical patent/WO2018034660A1/fr
Publication of WO2018034660A1 publication Critical patent/WO2018034660A1/fr

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
    • A61M5/31—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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150015—Source of blood
    • A61B5/15003—Source of blood for venous or arterial blood
    • 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
    • A61M5/3287—Accessories for bringing the needle into the body; Automatic needle insertion
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/15—Devices for taking samples of blood
    • A61B5/150007—Details
    • A61B5/150748—Having means for aiding positioning of the piercing device at a location where the body is to be pierced
    • 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
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3216—Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • 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

Definitions

  • the present invention is generally directed to a medication injection adaptor assembly for use with a needleless pharmaceutical syringe and, more particularly, to a universal female intradermal adapter having disposed therein a needle hub with a needle cannula projecting therefrom.
  • Intradermal injections are used for delivering a variety of diagnostic and treatment compositions into a patient.
  • Intradermal injections are typically injections of a relatively small amount of medicament into the dermis, the dermal layer or even into a lower portion of the epidermis of a patient's skin. Administering an intradermal injection can be difficult and generally requires an experienced nurse or medical professional.
  • a preferred intradermal injection technique typically requires a healthcare professional to attach an adapter with a needle safety shield to the hub of the syringe prior to administration of the medication.
  • the procedure for attaching the adapter exposes the healthcare professional to the additional risk of a needle stick prior to the injection of the medication.
  • incorrect assembly of the intradermal injection device may lead to misalignment of the needle cannula in the adapter resulting in incorrect placement of the tip of a needle cannula at the injection site, which, in turn, may lead to a failed injection.
  • the syringe is pushed distally in a longitudinal direction until the distal end of the syringe barrel contacts a latch attached to the adapter body and the forward tip of the needle cannula is enclosed in a conical section of the adapter having a needle opening.
  • an axial force applied to the syringe barrel causes the latch to deflect extending the tip of the needle cannula through the needle opening.
  • WO 201 1/01 1697 entitled “Intradermal Injection Device” discloses an intradermal adapter configured for side insertion of a syringe having a needle cannula projecting therefrom.
  • the adapter includes a side opening that extends along an entire length of the adapter, generally parallel to the longitudinal axis.
  • the side opening permits insertion of the syringe into the adapter such that the cannula is disposed in a cannula channel extending through a central portion of the adapter generally parallel to the longitudinal axis of the adapter.
  • the exposed tip of the cannula is spaced distally relative to the cannula channel edge of the adapter, and is generally fixed in this position in the assembled configuration.
  • WO 201 1/01 1697 Figs. 1 1 and 12 disclose the general concept of longitudinally inserting a hub with a cannula projecting therefrom in an adapter, mounting the cannula thereto and attaching the proximal end portion of the body of the adapter to a needleless syringe using a conventional Luer connector.
  • the manner in which the hub is attached to the adapter body is not disclosed. Further, the adapter body does not include a side opening for receipt of the syringe.
  • a universal medication injection adaptor assembly attachable to a needleless syringe by a standardized Luer connector and having fixedly disposed therein a needle hub with a needle cannula projecting therefrom; thereby allowing a healthcare professional to provide a relatively simple and safe intradermal injection device, that is relatively easy to use.
  • one embodiment of the present invention is directed to a universal medication injection adaptor assembly for use with a needleless pharmaceutical syringe having a syringe barrel with a syringe-barrel distal end terminating in a male Luer connector.
  • the universal injection adaptor assembly comprises a generally cylindrical coupling having a coupling distal end and a coupling proximal end.
  • a coupling cavity is provided in the coupling.
  • the coupling cavity extends between the coupling distal end and the coupling proximal end.
  • a cannula hub has a cannula-hub distal end and a cannula-hub proximal end.
  • the cannula-hub distal end is disposed in the coupling cavity.
  • the cannula-hub proximal end is configured as an exposed female Luer connector compatible with the male Luer connector of the syringe-barrel distal end.
  • a mount is in the coupling cavity. The mount is configured to support the cannula- hub distal end thereon.
  • An ultrasonic energy director is in the coupling cavity.
  • a needie- cannula safety shield extends from the distal end of the coupling.
  • a needle cannula has a needle-cannuia proximal end and a needie-cannula distal end. The needle-cannuia proximal end extends from the cannula-hub distal end.
  • the needie-cannula safety shield at least partially surrounds the needle cannula.
  • the needle-cannuia distal end terminates in an exposed needle tip.
  • the cannula hub has a hub melting temperature and the ultrasonic energy director has an energy-director melting temperature.
  • the hub melting temperature is less than the energy- director melting temperature.
  • the ultrasonic energy director is embedded in the cannula-hub distal end fixedly attaching the cannula-hub distal end to the coupling.
  • FIG. 1 is a left-side, elevation view, partially in cross section, of an intradermal syringe assembly including a first preferred embodiment of a needleless-syringe adapter in accordance with the present invention
  • Fig. 2 is a left-side, bottom-perspective view of an enlargement of the distal portion of the needleless-syringe adapter of Fig. 1 showing in transparency the distal portion of the syringe barrel to which the needleless-syringe adapter is attached;
  • FIG. 3 is an exploded left-side, bottom-perspective view of the needleless-syringe adapter of Fig. 2;
  • Fig. 4 is a left-side, perspective elevation view of the needleless-syringe adapter of Fig. 1 showing the distal portion of the syringe barrel in cross section;
  • Fig. 5 is a left-side, cross-sectional elevation view of the needleless-syringe adapter of Fig. 1 ;
  • Fig. 6 is a right-side, perspective elevation view of the cover of the needleless- syringe adapter of Fig. 1 ;
  • Fig. 7 is a front cross-sectional view of the cover of the needleless-syringe adapter of Fig. 6;
  • Fig. 8 is an enlarged front cross-sectional view of the needleless-syringe adapter of Fig. 1 along line 8-8 in Figure 5, showing the position of the cover relative to the base of the adapter prior to initiation of sonic welding;
  • Fig. 9 is an enlarged front cross-sectional view of the needleless-syringe adapter of Fig. 1 along line 9-9 in Figure 5, showing the position of the cover relative to the base of the adapter upon completion of sonic welding;
  • Fig. 10 is a flow diagram of a preferred embodiment of a method for manufacturing a needleless-syringe adapter in accordance with the present invention.
  • first, second, etc. are used herein to describe various elements, these elements should not be limited by these words. These words are only used to distinguish one element from another. For example, a first surface could be termed a second surface, and, similarly, a second surface could be termed a first surface, without departing from the scope of the present invention.
  • Figs. 1 -9 a first preferred embodiment of a universal medication injection adaptor assembly, generally designated 10, and hereinafter referred to as the
  • needleless-syringe adapter * in accordance with the present invention. While reference is made herein specifically to a pre-filled needleless syringe, it is understood that the present invention is not so limited.
  • the needleless-syringe adapter 10 described in detail below may also be used with nearly any type of needleless syringe, such as those to be filled by a patient or user, for example.
  • the needleless-syringe adapter 1 0 is preferably designed for intradermal injection.
  • the needleless-syringe adapter 10 is not limited to use only for intradermal injections.
  • the needleless-syringe adaptor 10 is for use with a needleless pharmaceutical syringe 1 having a syringe barrel 2 with a syringe-barrel distal end 3 terminating in a male Luer connector 4.
  • the needleless-syringe adaptor 10 has a generally hollow cylindrical coupling 12 having a coupling distal end 14 and a coupling proximal end 16.
  • a coupling cavity 1 8 extends between the coupling distal end 14 and the coupling proximal end 16.
  • the coupling 12 has a coupling melting temperature.
  • the coupling 12 is made from polycarbonate material and the coupling melting temperature is the temperature at which polycarbonate melts, namely. 155°C.
  • a cannula hub 20 has a cannula-hub distal end 22 disposed in the coupling cavity 18 and a cannula-hub proximal end 24 configured as an exposed female Luer connector 26 compatible with the male Luer connector 4 of the syringe-barrel distal end 3.
  • the cannula hub 20 has at least one radially outwardly projecting hub bar 28 having a generally rectangular cross-section and extending a length of the distal end-portion 30 of the cannula hub 20.
  • the cannula hub 20 has a plurality of diametrically opposed hub bars 28 projecting from the cannula hub 20.
  • the cannula hub 20 has a cannula-hub melting temperature.
  • the cannula hub 20 is made from a polypropylene material and the cannula-hub melting temperature is the temperature at which polypropylene melts, namely, at 130 °C.
  • the coupling 12 has a first coupling portion 32 partially surrounding the cannula-hub distal end 22.
  • a first coupling-portion lateral opening 34 extends longitudinally in the first coupling portion 32.
  • the first coupling-portion lateral opening 34 provides transverse access to the coupling cavity 18.
  • a second coupling portion 36 is configured to cover the first coupling- portion lateral opening 34.
  • the coupling 12 circumscribes the coupling cavity 1 8 when the first coupling-portion lateral opening 34 is covered by the second coupling portion 36.
  • the coupling 12 has a radially inwardly extending bulkhead 38 with a bulkhead lateral opening 40 extending generally parallel to a longitudinal axis "A " of the needleless-syringe adapter 10.
  • the bulkhead 38 serves as a stop preventing longitudinal movement of the cannula hub 20 beyond the cannula-hub distal end 22.
  • the cannula-hub distal end 22 abuts the bulkhead 38.
  • the cannula-hub distal end 22 may extend into the bulkhead lateral-opening 40.
  • a mount 42 in the coupling cavity 18 is configured to support the cannula-hub distal end 22.
  • the mount 42 extends radially inwardly from the first coupling portion 32 and directly supports the hub bars 28 on a rib-like surface extending longitudinally.
  • a needle cannula 44 has a needle-cannula proximal end 46 extending from the cannula-hub distal end 22 and a needle-cannula distal end 48 terminating in an exposed needle tip 50.
  • a needle-cannula safety shield 52 extends from the coupling distal end 14 at least partially surrounding the needle cannula 44.
  • the needle-cannula safety- shield 52 further comprises a safety-shield distal section 54 configured to orient the needleless- syringe adapter 10 at an angular position relative to the skin of the patient during intradermal administration of the medication.
  • the safety-shield distal section 54 has a first safety-shield surface 56 and a second safety-shield surface 58 different than the first safety- shield surface 56.
  • the first safety-shield surface 56 lies entirely in a first plane generally parallel to the longitudinal axis of the needleless-syringe adapter 10 and is configured to contact a first skin-area (not shown) of a patient.
  • the second safety-shield surface 58 is spaced from the needle-cannula 44, lies entirely in a second plane at a predetermined angle ⁇ relative to the first plane and is also configured to contact a second skin area (not shown) of the patient.
  • the coupling cavity 18 has two opposite ultrasonic energy directors 60 each having an energy-director melting temperature that is greater than the melting temperature of the cannula hub 204.
  • the ultrasonic energy director 60 extends radially inwardly from the second coupling portion 36.
  • the radially inwardly most extending portion of the ultrasonic energy director 60 terminates in an ultrasonic energy concentrator 62.
  • the coupling cavity 18 preferably also has a leading ultrasonic energy concentrator 62 and a trailing ultrasonic energy concentrator 62 disposed between the two opposite ultrasonic energy directors 60 along the cylindrical coupling 12.
  • the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 are intended to be embedded in the distal end-portion 30 of the cannula hub 20 fixedly attaching the cannula-hub distal end 22 to the coupling 12. ⁇ see, Fig. 9).
  • a preferred method for solving the following problems:
  • manufacturing the needleless-syringe adapter assembly 10 and hereafter referred to as the "method 100" in accordance with the present invention comprises at least the steps described below.
  • the cannula-hub distal end 22 is inserted through the first coupling-portion lateral opening 34 into the coupling cavity 18 such that the first coupling portion 32 partially surrounds the cannula-hub distal end 22, the needle-cannula safety shield 52 at least partially surrounds the needle cannula 44, and the needle-cannula distal end 48 terminates in an exposed needle tip 50.
  • a supporting step 1 10 the cannula-hub distal end 22 is supported on the mount 42 extending radially inwardly from the first coupling portion 32.
  • a closing step 1 15 the first coupling-portion lateral opening 34 is closed with the second coupling portion 36 such that the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 are in direct contact with the cannula-hub distal end 22 (Fig. 8).
  • ultrasonic energy is applied to the coupling 12 in an amount which is sufficient to soften the polypropylene cannula hub 20 but not the polycarbonate ultrasonic energy directors 60 and the polycarbonate ultrasonic energy concentrators 62 such that the pressure applied to the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 embed the ultrasonic energy directors 60 and the ultrasonic energy concentrators 62 in the cannula-hub distal end 22.
  • the second coupling portion 36 is bonded to the first coupling portion 32 using ultrasonic welding (Fig. 9).

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Veterinary Medicine (AREA)
  • Animal Behavior & Ethology (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Environmental & Geological Engineering (AREA)
  • Physics & Mathematics (AREA)
  • Biophysics (AREA)
  • Pathology (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Surgery (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

Un ensemble adaptateur d'injection de médicament universel destiné à être utilisé avec une seringue pharmaceutique sans aiguille ayant une extrémité distale se terminant dans un connecteur Luer mâle. Une embase de canule ayant une température de fusion d'embase a une extrémité distale disposée dans une cavité d'un raccord cylindrique et une extrémité proximale configurée comme un connecteur Luer femelle pour s'accoupler avec le connecteur Luer mâle de la seringue. Un support dans la cavité supporte l'extrémité distale de la canule-embase. Des directeurs d'énergie ultrasonore dans la cavité interne présentent une température de fusion de directeur d'énergie supérieure à la température de fusion de l'embase. Un blindage de sécurité s'étendant à partir de l'extrémité distale de couplage entoure au moins partiellement une canule d'aiguille ayant une extrémité proximale s'étendant à partir de l'extrémité distale de l'embase et une extrémité distale se terminant dans une pointe d'aiguille exposée. Les directeurs d'énergie ultrasonore sont intégrés dans l'extrémité distale de l'embase de canule pour attacher de manière fixe l'extrémité distale de l'embase-canule dans le connecteur.
PCT/US2016/047389 2016-08-17 2016-08-17 Ensemble adaptateur universel d'injection de médicament destiné à être utilisé avec une seringue pharmaceutique sans aiguille WO2018034660A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2016/047389 WO2018034660A1 (fr) 2016-08-17 2016-08-17 Ensemble adaptateur universel d'injection de médicament destiné à être utilisé avec une seringue pharmaceutique sans aiguille

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2016/047389 WO2018034660A1 (fr) 2016-08-17 2016-08-17 Ensemble adaptateur universel d'injection de médicament destiné à être utilisé avec une seringue pharmaceutique sans aiguille

Publications (1)

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WO2018034660A1 true WO2018034660A1 (fr) 2018-02-22

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021074417A1 (fr) * 2019-10-16 2021-04-22 Novosanis Nv Adaptateur d'aiguille et ensemble pour former un dispositif d'injection servant à administrer un fluide à un sujet
WO2023086088A1 (fr) * 2021-11-11 2023-05-19 Becton, Dickinson And Company Dispositif d'accès vasculaire avec ajustement de longueur d'aiguille efficace

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011011697A1 (fr) * 2009-07-23 2011-01-27 Sid Technologies, Llc Adaptateur d'injection intradermique

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2011011697A1 (fr) * 2009-07-23 2011-01-27 Sid Technologies, Llc Adaptateur d'injection intradermique

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2021074417A1 (fr) * 2019-10-16 2021-04-22 Novosanis Nv Adaptateur d'aiguille et ensemble pour former un dispositif d'injection servant à administrer un fluide à un sujet
WO2023086088A1 (fr) * 2021-11-11 2023-05-19 Becton, Dickinson And Company Dispositif d'accès vasculaire avec ajustement de longueur d'aiguille efficace

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