+

WO2001068167A1 - Appareil et procede d'adaptation des caracteristiques d'une seringue sans aiguille - Google Patents

Appareil et procede d'adaptation des caracteristiques d'une seringue sans aiguille Download PDF

Info

Publication number
WO2001068167A1
WO2001068167A1 PCT/GB2001/001144 GB0101144W WO0168167A1 WO 2001068167 A1 WO2001068167 A1 WO 2001068167A1 GB 0101144 W GB0101144 W GB 0101144W WO 0168167 A1 WO0168167 A1 WO 0168167A1
Authority
WO
WIPO (PCT)
Prior art keywords
syringe
mode
nozzle
combination
deployed
Prior art date
Application number
PCT/GB2001/001144
Other languages
English (en)
Inventor
Brian John Bellhouse
Mark Anthony Fernance Kendall
Nathan John Quinlan
Original Assignee
Powderject Research Limited
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 Powderject Research Limited filed Critical Powderject Research Limited
Priority to AU40853/01A priority Critical patent/AU4085301A/en
Publication of WO2001068167A1 publication Critical patent/WO2001068167A1/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
    • A61M5/30—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
    • A61M5/46—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

  • This invention relates to the field of particle acceleration and the delivery of particles by entraining them in high speed gas, particularly to modifying a needleless syringe to alter the velocity at which the particles exit the syringe.
  • US-A-5 630 796 discloses a device for accelerating small particles in a supersonic gas flow.
  • This so-called “needleless syringe” can be used for the transdermal delivery of powdered drug compounds and compositions, for delivery of genetic material into living cells (eg gene therapy) and for the delivery of biopharmaceuticals to skin, muscle, blood or lymph.
  • One needleless syringe described in US-A-5 630 796 (the disclosure of which is hereby incorporated by way of reference) comprises an elongate tubular converging-diverging nozzle disposed downstream of a supply of powdered drug which itself is located downstream of a source of gaseous energy.
  • the gaseous energy source typically takes the form of a reservoir of helium or air pressurised to 60 bar. Upon activation, the gaseous energy source creates a high velocity flow in the nozzle which has the drug particles entrained therein. The particles are accelerated into a target surface to elicit a desired pharmacologic, immunogenic and/or physiologic effect by local and/or systemic action.
  • a single needleless syringe is able to be used on differing target surfaces on the body to deliver particles thereto safely and efficiently.
  • varying skin thicknesses at different sites on the body and differences in skin thickness and structure between different persons contributes to the difficulty in developing a needleless syringe having a single configuration that can be used in widely varying applications.
  • a low pressure device on thin skin areas and a higher pressure device on thicker skin areas This has the disadvantage that substantially different devices are required for different body areas If a single device is used, it is necessary to change the amount of gas initially in the reservoir which is not convenient for the operator of the device Further, if the adjustment method comprises releasing gas from the reservoir, the method is not easily reversible Another method is to vary the size of the particles according
  • a needleless sy ⁇ nge for delivering particles to a target surface, and a particle velocity reducing device, the sy ⁇ nge comprising an elongate tubular nozzle having upstream and downstream ends, the nozzle being for the passage therethrough, on operation of the syringe, of a gas flow in which particles are entrained and accelerated prior to exiting the downstream end of the nozzle,
  • the sy ⁇ nge has an exit opening at its downstream end for the delivery therethrough of the particles This exit opening is defined by the spacer in the first mode of operation of the syringe In the second mode of operation of the sy ⁇ nge this opening is defined by the deployed device
  • the device and syringe could initially be provided separately, with the device needing to be attached to the syringe to deploy it and so as to convert the sy ⁇ nge from its first mode of operation to its second mode of operation
  • the device could be provided initially attached to the sy ⁇ nge, with the device needing to be separated from the sy ⁇ nge to convert the syringe from its second mode of operation to its first mode of operation
  • a method of reducing the exit velocity of particles from a needleless syringe for use in delivering particles to a target surface comprising increasing in mean thickness a layer of high density gas of low velocity next to the target surface when the syringe is operated
  • the laver of high density gas is created or increased in thickness by modifying the syringe by the
  • Figure 1 is a schematic part side elevational and part sectioned view of the downstream portion of a needleless syringe in a first mode of operation, without the deployment of a particle velocity reducing device,
  • Figure 2 is a view corresponding to that of Figure 1, but additionally showing a first embodiment of particle velocity reducing device deployed on the syringe in accordance with the present invention
  • Figure 3 is a view similar to that of Figure 1, but additionally showing a second embodiment of particle velocity reducing device deployed on a syringe in accordance with the present invention
  • Figure 4 is a view corresponding to that of Figure 1, but additionally showing a third embodiment of particle velocity reducing device deployed on the syringe in accordance with the present invention
  • Figure 5 is a view corresponding to that of Figure 1, but additionally showing a fourth embodiment of particle velocity reducing device deployed on the sy ⁇ nge in accordance with the present invention.
  • the left hand portion of the Figure shows (in side elevation) the downstream portion of a needleless sv ⁇ nge 1 of the general sort disclosed in US-A-5 630 796
  • the right hand half of the Figure shows the sy ⁇ nge in sectional side elevation
  • the syringe may have a gas reservoir, drua cassette and conversent-diversent nozzle arranged in that order in the downstream direction.
  • the divergent portion of nozzle 2 is visible in Figure 1.
  • the nozzle 2 is shown divergent, it may be substantially cylindrical, or any other suitable shape
  • a syringe cover 3 is provided around the nozzle 2.
  • a spacer 4 is provided in the vicinity of the downstream end 2a of the nozzle 2 .
  • This spacer is advantageously made .of a material which is substantially non-porous to the gas stored in the gas reservoir (not shown).
  • the axially directed annular end surface 4a of the spacer is intended to be placed in contact with the target surface, for example with the back of a patient's hand, so that the spacer 4 allows the downstream end 2a of the nozzle 2 to be spaced from the target surface by a predetermined amount.
  • the particles contained in the particle cassette (not shown) are entrained in the high velocity (preferably supersonic) gas flow passing down the nozzle 2, and are accelerated down the nozzle to pass through a downstream exit opening 10a defined by the annular spacer 4 to impact the target surface at high velocity, for example a velocity of the order of 350 - 400 m/s
  • the particles may be lidocaine particles.
  • a passage 5 is provided between the downstream end 2a of the nozzle 2 and the upstream lip 4b of the spacer 4 to allow the particle- propelling gas to be exhausted into a silencing chamber 9.
  • This passage 5 may be of the order of 4 mm in axial extent, with the diameter of the downstream end 2a of the nozzle 2 having a diameter of about 13 mm and the exit opening 10a defined by the annular spacer 4 being slightly larger
  • the silencing chamber 9 may, as shown, be empty or it may be at least partly filled with silencing material, for example an open pore material such as reticulated polyurethane foam
  • an annular, generally radially inwardly facing surface 4c of the spacer 4 is presented to the gas to radially contain it immediately upstream of the target surface.
  • the above described first mode of operation is intended for the syringe to be used in applications requiring a higher power of administration, for example thicker skinned areas such as on the back of the hand and/or when very small particles are being administered.
  • Figure 2 illustrates a first embodiment of the present invention in which the syringe of Figure 1 is modified by having deployed on it a first design of particle velocity reducing device 6.
  • Figure 2 represents a second mode of operation of the syringe, in which the syringe operates in a lower power mode, which is useful for thinner skinned target surfaces, such as the anticubital fossa, and/or when the particles to be delivered are relatively large.
  • like parts have been allocated like reference numbers.
  • the first design of particle velocity reducing device 6 illustrated in Figure 2 comprises a main, generally cylindrical section 6a, together with a generally radial flange portion 6b.
  • the device is attached to the syringe 1 (for example by a push fit), with the upstream portion of the main section 6a extending into the exit opening 10a previously defined by the spacer 4.
  • the interior cylindrical surface of the main section 6a thus forms a new exit opening 10b of a reduced diameter (for example 14 mm) relative to the opening 10a (see Figure 1) previously formed by the spacer 4.
  • the diameter of the newly formed exit opening 10b is, in this arrangement, reduced to being generally similar to the diameter of the nozzle 2 at its downstream end 2a.
  • the downstream portion of the main generally cylindrical section 6a of the device 6 extends in the downstream direction beyond the axially directed annular end surface 4a of the spacer 4. Consequently, when in the second mode of operation the downstream end face 7 of the device 6 is placed against the target surface, the distance between the downstream end 2a of the nozzle and the target surface is increased relative to the first mode of operation of the syringe. In the illustrated embodiment, the increase in length is approximately 6 mm.
  • the axial length of the annular, radially inwardly facing surface 6c presented to the gas immediately upstream of the target surface is increased in length relative to the Figure 1 arrangement
  • the length of this surface 6c, represented by the cylindrical inner surface of the main generally cylindrical section 6a, is approximately twice the length of the surface 4c of the spacer 4 defining the exit opening 10a in the first mode of operation (Figure 1)
  • the stagnant layer at the skin surface will be approximately 1 or 2 mm thick, with particles of 20 ⁇ m diameter impacting the target surface at approximately 400 m/s and particles of 50,um impacting the target surface at approximately 350m/s
  • the stagnant layer is increased in thickness leading to a substantial reduction in the velocities of particles impacting the target surface Larger particles are thought to be less affected by the increase in thickness of the stagnant gas layer
  • Figure 3 illustrates a syringe 1 with a second design of particle velocity reducing device 6 deployed thereon
  • the syringe is slightly different to that illustrated in Figures 1 and 2 in that it has a shorter nozzle 2 to enable the device 6 to be made longer without increasing the overall length of the apparatus
  • a main difference between the device 6 illustrated in Figure 3 and that illustrated in Figure 2 is that when deployed, the device 6 does not extend beyond the axially directed end face 4a of the spacer 4 Consequently, in both the first and second modes of operation, the annular end surface 4a of the spacer 4 will be in contact with the target surface and the downstream end 2a of the nozzle 2 will thus be positioned at a constant distance from the target surface
  • the inside diameter of the device 6 is approximately 14 mm and the inside diameter of the downstream end 2a of the nozzle 2 is approximately 1 1 mm, such that the exit openings 10a, 10b defined by the spacer 4 and device 6 in the first and second modes of operation respectively are both greater than the internal diameter of the downstream end 2a of the nozzle 2 This need not, however, be so. as will become apparent from the device design illustrated in Figure 4.
  • the axial length of the device 6 is approximately 19 mm, which is longer than the overall length of the device 6 illustrated in Figure 2. It is thought that this increased length for the device 6 makes the device more effective at creating a thicker layer of stagnant gas adjacent the target surface, this thicker layer being more effective at decelerating the particles having to pass through it to penetrate the target surface.
  • Figure 4 shows a syringe 1 similar to that of Figures 1 and 2, with a third design of particle velocity reducing device 6 deployed thereon.
  • This third design is generally similar to the first design illustrated in Figure 2, except that the radial thickness of the main generally cylindrical section 6a is increased.
  • the inside diameter of the main section 6a is 12 mm, rather than 14 mm as in Figure 2.
  • the inside diameter of the downstream end 2a of the nozzle 2 is approximately 13 mm. Consequently, in the Figure 4 arrangement the exit opening 10b formed by the device 6 in the second mode of operation is slightly smaller than the downstream diameter of the nozzle 2.
  • FIG. 5 shows a syringe similar 1 to that shown in Figure 3, with a fourth design of particle velocity reducing device 6 deployed thereon.
  • This device 6 is virtually identical to that illustrated in Figure 3, the main difference being a radially thicker main generally cylindrical section 6a, to provide an inside diameter for the device 6 in Figure 5 of 12 mm, as opposed to 14 mm in Figure 3. This consequently reduces the size of the exit opening 10b.
  • particle velocity reducing device 6 defines on exit opening 10b of constant circular cross-section, this is simply the preferred configuration. Furthermore, it is not essential that the particle velocity reducing device 6 restricts the effective exit area of the syringe when fitted thereon. Any shape for the device 6 that will cause a thickening of the layer of stagnant gas adjacent the target surface when fitted to the downstream end of the syringe will be satisfactory and is intended to be covered by the following claims.
  • the most important aspect of the device 6 is its axial length, in particular the increase in axial length of the annular, radially inwardly facing surface 4c, 6c etc positioned immediately upstream of the target surface, to assist in containing radially the stagnant layer of gas, brought about by deploying the device 6.
  • deploying a device 6 to cause an increase in thickness of the stagnant layer of 1 to 2 mm may be sufficient to cause a reduction in velocity of particles exiting the apparatus of between 25 and 50%, with a consequent reduction in the possibility of damaging the target surface.
  • the particle velocity reducing device 6 is made of a similar material to the syringe itself, for example a plastics material.
  • the devices 6 are intended to be push or snap- fitted into the opening of the spacer 4.
  • the devices may, however, be attached by other means, for example by the provision of the spacer 4 and devices 6 with cooperating screw threads.
  • the operator of the syringe could be provided with a plurality of particle velocity reducing devices 6 of different configurations and different velocity reducing effects.
  • the operator could then select the most appropriate firing configuration for the syringe, whether this be the first mode of operation (with no particle velocity reducing device deployed thereon) or a second mode of operation (with one of the differing construction devices 6 deployed thereon). In this way the operator will be able to tailor a basic syringe design to a wider range of particle delivery applications.
  • the device 6 is shown as being a separate item from any component of the syringe itself, the device 6 could be formed as part of the syringe.
  • the device 6 might be a unitary molding with the spacer element 4 (not shown), but be only weakly attached to the main body of the spacer element 4, for example by thin webs of plastics material. This would enable the device 6 to be snapped or sheared off from the spacer element 4 by the operator of the syringe in the event that higher power particle delivery is required, i.e. if it is desired to operate the syringe in its first mode of operation rather than in its reduced power second mode.
  • the devices 6 are physically separable from the syringe 1. When the devices 6 are deployed on the syringe, they are attached to the syringe in the vicinity of the syringe's spacer. When the devices are not deployed, they are physically removed from the syringe.
  • the device 6 may be provided permanently on the syringe, but be adjustable in position relative to the spacer 4. For example, the device 6 may be movably mounted on the spacer 4, to enable the device to be moved to at least two distinct positions, each corresponding to one of said first and second modes of operation.
  • the present invention makes it possible to use a single syringe design in a wider range of applications than previously.
  • the syringe may be used in different ways without changing its fundamental and proven parameters.
  • the effect of the device is easy to determine and accurate and reproducible payload administration may be provided. Furthermore, attaching the particle velocity reducing device does not disturb payload entrainment.
  • the resultant needleless syringe is thus easy and convenient to adjust in accordance with the area of the body the device is to be used on. Furthermore, since the invention does not involve the adjustment of any of the major device parameters (such as the gas pressure, particle size, nozzle geometry etc), predictable and accurate operation can be ensured.
  • the major device parameters such as the gas pressure, particle size, nozzle geometry etc

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

Une seringue sans aiguille (1) peut être munie d'un dispositif (6) permettant de réduire la vitesse des particules expulsées de ladite seringue. En déployant sélectivement ce dispositif (6) situé sur la seringue, il est possible de modifier l'épaisseur d'une couche de gaz haute densité sur la surface cible de manière à modifier la vitesse d'impact des particules sur ladite surface cible. Ceci permet de modifier de manière simple la seringue sans aiguille conformément à son utilisation envisagée, par exemple en réduisant la vitesse d'impact des particules lorsque le site cible est plus mince ou moins souple tel que cela est souvent le cas avec la peau des jeunes enfants ou des personnes âgées.
PCT/GB2001/001144 2000-03-15 2001-03-15 Appareil et procede d'adaptation des caracteristiques d'une seringue sans aiguille WO2001068167A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU40853/01A AU4085301A (en) 2000-03-15 2001-03-15 Apparatus and method for adjusting the characteristics of a needleless syringe

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0006263A GB0006263D0 (en) 2000-03-15 2000-03-15 Apparatus and method for adjusting the characteristics of a needleless syringe
GB0006263.8 2000-03-15

Publications (1)

Publication Number Publication Date
WO2001068167A1 true WO2001068167A1 (fr) 2001-09-20

Family

ID=9887687

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2001/001144 WO2001068167A1 (fr) 2000-03-15 2001-03-15 Appareil et procede d'adaptation des caracteristiques d'une seringue sans aiguille

Country Status (3)

Country Link
AU (1) AU4085301A (fr)
GB (1) GB0006263D0 (fr)
WO (1) WO2001068167A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD519633S1 (en) 2003-11-12 2006-04-25 Powderject Research Limited Syringe
US10279113B2 (en) 2013-05-17 2019-05-07 Socpra Sciences Et Genie S.E.C. Needleless syringe and method for delivering therapeutic particles

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3605743A (en) * 1968-10-14 1971-09-20 Raul Olvera Arce Hypodermic syringe
US5026343A (en) * 1988-11-21 1991-06-25 Walter Holzer Device for needleless hypodermic injection of medications
US5141496A (en) * 1988-11-03 1992-08-25 Tino Dalto Spring impelled syringe guide with skin penetration depth adjustment
US5190523A (en) * 1991-08-16 1993-03-02 Idee International R & D Inc. Disposable syringe and injector
US5630796A (en) * 1993-04-08 1997-05-20 Oxford Biosciences Limited Method of delivering powder transdermally with needless injector
US5865796A (en) * 1994-01-21 1999-02-02 Powderject Vaccines, Inc Gas driven gene delivery instrument
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

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3605743A (en) * 1968-10-14 1971-09-20 Raul Olvera Arce Hypodermic syringe
US5141496A (en) * 1988-11-03 1992-08-25 Tino Dalto Spring impelled syringe guide with skin penetration depth adjustment
US5026343A (en) * 1988-11-21 1991-06-25 Walter Holzer Device for needleless hypodermic injection of medications
US5190523A (en) * 1991-08-16 1993-03-02 Idee International R & D Inc. Disposable syringe and injector
US5630796A (en) * 1993-04-08 1997-05-20 Oxford Biosciences Limited Method of delivering powder transdermally with needless injector
US5865796A (en) * 1994-01-21 1999-02-02 Powderject Vaccines, Inc Gas driven gene delivery instrument
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

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
USD519633S1 (en) 2003-11-12 2006-04-25 Powderject Research Limited Syringe
US10279113B2 (en) 2013-05-17 2019-05-07 Socpra Sciences Et Genie S.E.C. Needleless syringe and method for delivering therapeutic particles

Also Published As

Publication number Publication date
AU4085301A (en) 2001-09-24
GB0006263D0 (en) 2000-05-03

Similar Documents

Publication Publication Date Title
DE69432021T2 (de) Pulver-inhalator
RU2150298C1 (ru) Способ ожижения порошкообразного лекарственного препарата для ингаляции, ингалятор
CA2208590C (fr) Administration de particules
JP5114515B2 (ja) エアロゾル化薬剤の送出方法と装置
DE69401651T2 (de) Nadellose spritze unter anwendung eines gasstroms mit überschallgeschwindigkeit zur verabreichung von partikeln
CA2377566C (fr) Systeme d'atomisation a faible force de pulverisation et faible faible retention de particules de medicament
US6397839B1 (en) Dispensing device for fluid product activated by inhaling
JP2010005411A (ja) 針無しシリンジ
EP0892649A1 (fr) Seringue sans aiguille dans laquelle les particules d'agent therapeutique sont entrainees dans un flux supersonique de gaz
DE69830658T2 (de) Spritze und dafür geeignete kapsel
JPH10504214A (ja) 粒子供給装置
US6911015B2 (en) Needleless syringe functioning by shock-tube effect, with prior lateral retention of the active principle
DE60005938T2 (de) Nadellose spritze
US20080262417A1 (en) Needleless syringe
US20030178440A1 (en) Dispensing Apparatus for Delivering Powdered Product
KR20050000496A (ko) 분말 에어 레이저 형성 장치
US6835187B2 (en) Needleless syringe provided with an inner seal containing the active principle
WO2001068167A1 (fr) Appareil et procede d'adaptation des caracteristiques d'une seringue sans aiguille
EP3159030A1 (fr) Inhalateur de poudre sèche
CA2247142C (fr) Seringue sans aiguille
CS269282B1 (cs) Zařízení pro výrobu aerosolu

Legal Events

Date Code Title Description
AK Designated states

Kind code of ref document: A1

Designated state(s): AE AG AL AM AT AU AZ BA BB BG BR BY BZ CA CH CN CO CR CU CZ DE DK DM DZ EE ES FI GB GD GE GH GM HR HU ID IL IN IS JP KE KG KP KR KZ LC LK LR LS LT LU LV MA MD MG MK MN MW MX MZ NO NZ PL PT RO RU SD SE SG SI SK SL TJ TM TR TT TZ UA UG US UZ VN YU ZA ZW

AL Designated countries for regional patents

Kind code of ref document: A1

Designated state(s): GH GM KE LS MW MZ SD SL SZ TZ UG ZW AM AZ BY KG KZ MD RU TJ TM AT BE CH CY DE DK ES FI FR GB GR IE IT LU MC NL PT SE TR BF BJ CF CG CI CM GA GN GW ML MR NE SN TD TG

121 Ep: the epo has been informed by wipo that ep was designated in this application
DFPE Request for preliminary examination filed prior to expiration of 19th month from priority date (pct application filed before 20040101)
122 Ep: pct application non-entry in european phase
NENP Non-entry into the national phase

Ref country code: JP

点击 这是indexloc提供的php浏览器服务，不要输入任何密码和下载