EP3706832A1 - Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif - Google Patents

Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif

Info

Publication number
EP3706832A1
EP3706832A1 EP18822131.1A EP18822131A EP3706832A1 EP 3706832 A1 EP3706832 A1 EP 3706832A1 EP 18822131 A EP18822131 A EP 18822131A EP 3706832 A1 EP3706832 A1 EP 3706832A1
Authority
EP
European Patent Office
Prior art keywords
liquid
injection device
outlet nozzle
nozzle
housing
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Withdrawn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
EP18822131.1A
Other languages
German (de)
English (en)
Inventor
Fritz Schmitt
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.)
Conzima GmbH
Original Assignee
CC Pharma GmbH
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 CC Pharma GmbH filed Critical CC Pharma GmbH
Publication of EP3706832A1 publication Critical patent/EP3706832A1/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Withdrawn legal-status Critical Current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
    • 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
    • A61M5/3007—Syringes for injection by jet action, without needle, e.g. for use with replaceable ampoules or carpules with specially designed jet passages at the injector's distal end
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M5/31583—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M5/2455—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened
    • A61M5/2466—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase
    • A61M2005/247—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic with sealing means to be broken or opened by piercing without internal pressure increase with fixed or steady piercing means, e.g. piercing under movement of ampoule
    • 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
    • A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
    • A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
    • A61M2005/31588—Constructional features or modes of drive mechanisms for piston rods electrically driven
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8206—Internal energy supply devices battery-operated
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8262—Internal energy supply devices connectable to external power source, e.g. connecting to automobile battery through the cigarette lighter
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/82—Internal energy supply devices
    • A61M2205/8275—Mechanical
    • A61M2205/8287—Mechanical operated by an external magnetic or electromagnetic field
    • 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
    • A61M2250/00—Specially adapted for animals

Definitions

  • the invention relates to a method for the needleless injection of liquid into a substrate, in particular a liquid
  • the invention is further directed to an injection device for needle-less injection of liquid into a substrate, in particular a liquid pharmaceutical or cosmetic preparation in a biological tissue, with a liquid reservoir, an outlet nozzle and with a liquid from the reservoir ejifugden by the outlet nozzle in the form of a liquid jet
  • the invention also relates to a fluid container for use in exercising the
  • a liquid into a substrate for example a liquid pharmaceutical or cosmetic preparation in or under the skin of a human or other animal
  • the liquid is regularly introduced through an injection needle into the substrate, ie the human or animal tissue.
  • Injection needle must first be inserted into the substrate. As a result of the incision made at the needle tip by means of a cutting edge, injuries occur that usually heal quickly in living tissue but regularly result in scarring. In addition, injections with hypodermic needles always carry the risk of infection.
  • hypodermic jet injectors are used to deliver a small amount of fluid, such as a vaccine or other drug, without the use of an injection needle pierceable into the substrate Anesthetic or the like to introduce directly through the skin surface in the tissue.
  • a fluid such as a vaccine or other drug
  • Anesthetic or the like to introduce directly through the skin surface in the tissue.
  • the idea in these efforts was to penetrate the skin of the patient alone by the pressure of the fluid and to bring the injection medium to a desired depth.
  • the devices developed for this purpose could not meet the expectations set in them.
  • the injection devices proposed in the past for the needleless injection of liquids such as medicaments have an energy storage such as a spring accumulator, an accumulator and / or a primer, which causes an increase in pressure in a liquid reservoir contained in the device when triggered to liquid from the supply through an outlet nozzle.
  • the nozzle cross section is as small as possible and the pressure acting on the liquid reservoir pressure as high as possible, to a liquid jet with a small cross-section and large
  • US 2006/0149193 A1 discloses a device with a probe and a liquid applicator, which has a liquid outlet opening for needleless injection of a liquid into a biological tissue and a liquid line leading to the liquid outlet opening.
  • An associated liquid supply device has a drive device and is equipped with a pressure-storing
  • Pressure vessel connectable as energy storage.
  • Liquid supply device includes an expansion chamber having a movable wall surface which encloses the liquid to be injected and which can be acted upon by a pressure fluid.
  • a force-enhancing lever optionally provided.
  • the object of the invention is therefore to provide a method and a
  • Liquid jet is offset at least in its outer region before its impinging on the substrate in rotation about its beam axis. Accordingly, the device according to the invention is characterized by means for causing the liquid jet to rotate about its jet axis before impinging it on the substrate.
  • Liquid particles (molecules) hold together, and not only on the way the liquid jet from the outlet to the
  • Outlet nozzle it comes by the rotation of the jet after its exit from the outlet nozzle even to a cross-sectional reduction and thus to an increase in velocity of the liquid jet, so that it can impinge on the substrate even at a greater velocity than it has when exiting an outlet nozzle .
  • Fluid jet when injected into biological tissue such as e.g. into or under the skin of a human or an animal reliably penetrates into this, even if the outlet nozzle of the device according to the invention at a distance from the
  • Tissue surface is positioned so the liquid jet so the distance between the nozzle and the tissue surface has to bridge as a "free jet", without increasing the distance would have an adverse effect on the injection quality.
  • the rotation imparted to the beam before impinging on the substrate is superimposed by the translatory movement of the liquid in its direction of jet to a helical motion with which the beam, following the observations made, has very little resistance at the surface of the substrate this virtually "drilled” or “screwed in” to form an inlet channel corresponding to the beam cross-section, with practically virtually none of the fluid striking the substrate being lost, ie not penetrating into the substrate.
  • the rotation of the liquid jet is effected by means of at least one aperture or nozzle with at least one helical or helical running fluid channel.
  • the at least one helical or helical fluid channel is first at least a partial flow of the liquid flowing through the outlet nozzle on
  • Rotation of the liquid jet is effected by means of a rotating diaphragm or nozzle, to which the device-wise provided means preferably comprise at least one rotatably driven part de outlet nozzle. Also a combination of the two
  • Rotation-generating measures is conceivable.
  • the injection device according to the invention may preferably be configured such that the liquid reservoir, the outlet nozzle and the Ej ektor adopted in a common housing
  • the device can be made particularly compact in this way, it is for example as
  • Injection device for injecting cosmetic or
  • the at least one fluid channel at a passage in the
  • Exhaust nozzle limiting nozzle wall may be arranged.
  • the arrangement may be made in the injection device such that the outlet nozzle has at least one convergent section, the cross section of which projected in the direction of flow
  • At least one fluid channel extends at least over a partial length of the convergent section.
  • the outlet nozzle can also have at least one section of constant cross section, wherein the at least one fluid channel then preferably (also) extends at least over a partial length of the section with a constant cross-section.
  • Impose screwing consists in several, substantially rotationally symmetrical to the axis of the liquid jet in the
  • Fluid channels obtained a comparatively large, helical or helical extending contact or exchange surface between the nozzle passage and the liquid flowing therethrough, whereby a strong spin or a relatively fast rotation of the liquid at the nozzle exit even at a short axial extent of the nozzle (Nozzle length) is reached.
  • the fluid channels may be arranged adjacent to each other on the passage wall defining the passage of the outlet nozzle.
  • the at least one fluid channel extends in the form of a coiled pipe from the inlet to the outlet side of the outlet through this.
  • Outlet side has decreasing helical radius, this leads in an exceptionally advantageous manner to a cyclone effect, namely to an increase in the flow velocity of the (rotating) liquid jet as it exits the thus designed outlet nozzle.
  • cyclone nozzle Designate cyclone nozzle.
  • the effect described can be further enhanced by two or more coiled tubing are each provided offset by an angular amount to each other in the manner of a double or multiple helix.
  • the effect of such a "cyclone nozzle" can also be with one or more of the Passage wall of a nozzle with a narrowing, in particular conical nozzle passage and arranged on the wall, helically extending fluid channels reach.
  • a likewise expedient design is when the outlet nozzle has a central, preferably straight passage for a partial flow of the liquid and when the at least one fluid channel coaxially surrounds the central passage helically.
  • the outlet nozzle can be rotatably mounted and be set in rotation by means of a drive.
  • it preferably has at least one, in particular preferably a plurality of eccentric to the axis of the eji formen from the outlet nozzle
  • Liquid jet disposed fluid channel (s) on.
  • the rotational movement of the outlet nozzle or of the fluid channel (s) arranged therein about the axis of the fluid jet transmit their rotational movement to it, so that the fluid jet has the rotational movement according to the invention about its jet axis as it exits the nozzle.
  • outlet nozzle has a plurality of aperture disks arranged in the form of a diaphragm stack in the direction of passage of the fluid, each having a slot opening extending over a portion of the disk diameter, the slot openings being consecutive in the diaphragm stack Aperture discs in
  • Slit openings then form a central, substantially rectilinear passage in the axial direction of the nozzle passage and two arranged in the manner of a double helix, spiral staircase-like stepped fluid channels along the forming wall of the central passage.
  • the arrangement is preferably so
  • the injection device as a cosmetic and / or pharmaceutical device, when the liquid supply in a liquid container
  • liquid pharmaceutical preparations of different types as in A vaccine series may be needed by simply
  • the arrangement furthermore has the advantage that the device can be cleaned and / or sterilized in a particularly simple and thorough manner without the liquid reservoir accommodated therein, which is particularly useful in its use in
  • the outlet nozzle is arranged on the liquid container.
  • This arrangement makes it possible in a particularly simple manner, the type and shape of the nozzle, in particular the passage provided therein for the liquid as best as possible to the specific, absorbed in the liquid container and to to adjust the injecting fluid.
  • the injecting fluid For example, it may be necessary in the processing of relatively high viscosity liquids such as
  • Hyaluronic acid preparations used in cosmetic applications e.g. for injection of wrinkles or for modeling of lips and in medicine for injection into arthrosis damaged joints are used, a nozzle with a larger passage cross-section
  • Liquid container then ensures that in each case the appropriate outlet nozzle for the respective liquid received in the container is used.
  • Liquid containers especially those with it
  • the outlet nozzle may have a nozzle outlet extending substantially coaxially with the housing axis of the housing. The liquid then enters a coaxial with the housing axis of the housing
  • the outlet nozzle has a nozzle outlet which extends at an angle to the housing axis, wherein the angle is preferably greater than 45 °. It is particularly advantageous if the nozzle outlet in one
  • Nozzle outlet is then located in this trough-like forming recess below the level of the adjacent substrate and then the liquid can be injected substantially parallel to the substrate surface below it.
  • this or the front end of the housing may be provided with a depth indicator or a depth stop, so that the liquid can be introduced exactly to the desired depth below the substrate surface.
  • Liquid container has.
  • This embodiment has the advantage that the liquid container, together with the liquid received therein, is first accelerated in the housing together with the ejector device before the liquid is expelled from its container through the outlet nozzle. This will be the
  • Liquid container effective stop damper for example, an elastomeric buffer element is provided.
  • a liquid container for use be exercise of the method according to the invention and / or in the
  • Device proposed according to the invention characterized i by at least one receiving space for liquid, a
  • Fluid outlet and a shock introduction element for introduction a pulse burst in the recorded in the receiving space liquid At the shock introduction element, which in principle may basically be a whatsoever means or a configuration of the liquid container, whereby it is possible, a pressure surge (impulse impulse) in the im
  • Liquid introduced liquid to initiate liquid can be provided for this purpose an actuating means of ej ektor adopted which is accelerated to high speed after triggering the device, ie in particular the ejktor ram mentioned above,
  • Liquid container or in the embodiment in which this is accelerated together with the liquid therein and the Ej ektorst Jardinel together to a speed when hitting the liquid container to the for
  • Substrate generates the rotating liquid jet an open at the substrate surface injection channel, which extends into a
  • Injection depth is sufficient. This depth achieved depends essentially on the jet thickness, which results essentially from the cross-section of the outlet nozzle through which the liquid leaves the device, and from the jet velocity with which the first subset impinges on the substrate surface.
  • Velocity is a function of the pressure that is actually reached for a very short time due to the impulse impulse in the fluid. So by the speed the actuator (Ej ektorstumbleel) and thus the size of the impulse imparted this varies, you can influence the injection or penetration into the substrate targeted. It has surprisingly been found that a subsequent injection channel generated by the advance by means of the first subset in the
  • Substrate introduced second subset of liquid which is then usually ejected at significantly lower pressure through the outlet and accordingly injected at low speed into the substrate, in this until the end of the previously generated injection channel, that is up to the penetration depth, and then in this essentially evenly distributed around the channel.
  • a second subset of the liquid can thus be introduced into the desired depth in the manner of a liquid depot.
  • Injection channel passes.
  • the ej ektor offers with electromagnetic drive, which plays an independent inventive performance and the Of course, it is also suitable for methods and apparatuses in which the liquid accelerated to the needleless injection in the form of a thin jet is not set in rotation or screw movement, not only allows the above-described, stepped injection with two or more liquid subsets. It is also very well suited to a series of injection in a short time sequence at different, preferably immediately adjacent sites in the substrate
  • the ej ektorst Jardinel immediately after generating the impulse pulse in the liquid reservoir, preferably by
  • a liquid container forming a cylinder space with a liquid outlet provided on one side and a piston which can be actuated by the ejector tappet and which is in it
  • impinging plunger caused steps in the cylinder space can be inserted, to always a subset of liquid from the
  • the acceleration section which is the EJ ektorst Schemeel between a rear, constant stop in the housing and its front, defined by the piston stop point available. Since the increase in the acceleration distance under otherwise unchanged conditions, in particular constant current, with which the electromagnetic drive is applied, an increasingly greater speed of the plunger would have on its impact on the piston result, which then also the pressure pulse generated in the liquid and the resulting Increasing the jet speed and penetration depth increase, means are preferably provided for adjusting the plunger speed when it hits the piston, which make it possible, regardless of the position of the piston in the liquid container in this repeatable generate at least approximately equal pressure pulses, so that the injections produced in series penetrate each to the same depth into the substrate.
  • the device according to the invention is thus advantageously suitable for the injection of wrinkles in the skin of a patient or else for the production of
  • the electromagnet and / or the energy store (battery / accumulator) provided for its operation may be located on the movable part of the ejector device, that is to say in particular the ejector tappet, and can be removed together with the latter from the housing, For example, in order to clean this before a new use of equipment and / or to sterilize.
  • Fig. 1 is an overview of a
  • FIGS. 2a-c show the handpiece of the injection device according to FIG.
  • FIG. 4 shows a second embodiment of an outlet nozzle for
  • FIG. 5 shows a third embodiment of an outlet nozzle for
  • FIG. 6 shows a fourth embodiment of an outlet nozzle for
  • FIG. 7 shows the aperture disks of the diaphragm stack used in the embodiment according to FIG. 6 in a perspective exploded view (exploded view); FIG. and
  • Fig. 8 shows a fifth embodiment of an outlet nozzle for
  • Fig. 1 10 in its entirety an injection device according to the invention is referred to, which has a handle portion 11 which is connected via a cable connection 12 with an external power supply 13, in the illustrated embodiment, a battery pack.
  • the handpiece 11 of the injection device 10 can from his
  • the handle 11 has a housing 14 which is provided on its outer periphery with a recess 15 in which a magnetic coil 16 is accommodated.
  • the magnetic coil 16 is protected by means of a circumferential cover 17.
  • the magnetic coil 16 is part of a total of 18
  • Ej ektor transplanted with a longitudinally displaceably guided Ej ektorst Schemeel 20, which in the embodiment shown has a rear portion 21 and a front portion 22. While the rear portion of larger diameter is adapted to the inner cross section of the Ejektorrohrs 19 and largely play and friction can slide in this, the front portion 22 has a smaller Diameter up. He forms a pressure piece 23, which from behind into a cylindrical liquid container 24 in the form of a
  • This liquid container 24 is similar to the rear one
  • the liquid container 24 is closed with a piston 26 which holds the liquid 25 in the container 24 and is pushed so far into the cylinder space 27 defined by the container 24, that on its rear side the pressure piece 23 also a Piece far into this cylinder space borders.
  • the liquid container 24 is closed with a membrane 28.
  • the ejector tube 19 is at its front, in Fig.2 left
  • End face provided with a cap 29 having a central opening in which an inwardly in the direction of the
  • Liquid container 24 projecting Aufstechkanüle 30 is added.
  • an elastic buffer element 31 surrounding the piercing cannula 30 is arranged.
  • the Aufstechkanüle 30 projects with its piercing tip 32 opposite, the outlet end a little way over the cap 30 and thereby forms a centering for a
  • Outlet nozzle 33 which is plugged onto this outlet-side end of the cannula 31 and fixed to the housing 14 by means of a union nut 34.
  • the Ej ektorst Schemeel 20 is first with its front, the pressure piece 23 forming portion 22 from the rear in the cartridge-like configured
  • Liquid container 24 is inserted, wherein the end face of the pressure piece 23 rests against the piston 26 in the cylindrical opening of the liquid container.
  • Liquid cartridge and Ej ektorst Jardinel can then with the Liquid cartridge front occlusive membrane 28 are pushed forward from behind into the ejector tube 19 in the housing 16, for which purpose a rear cover arranged on the housing 35 can be opened. After closing the cap, the device is ready. This operating state is shown in Fig. 2a.
  • Fig. 2a shows the starting position of the
  • Ej ektorstwagels 20 in the rearmost position (in the drawing on the right) is located (rear end position).
  • the ektorstShels in this position of the Ej and the front of this attached liquid container before this up to the end cap 29 extending free space in the Ejektorrohr 19 forms a
  • Liquid container 24 existing unit can be accelerated. To from the position shown in Figure 2a a
  • Fig. 2b Operating state is shown in Fig. 2b. As is indicated only schematically in dashed lines in the representations according to FIG. 2a, the free space 36 which is located in the interior of the ejector tube 19 between its front cap 29 and the end of the end of the membrane closed by the membrane
  • Liquid container 24 is present by means of a
  • Overflow 37 connected to the space 38 behind the rear plunger end 21. Due to the overflow line, air can be displaced from the front free space 36 or actually actively sucked through the negative pressure in the space 38 that forms behind the plunger during its forward movement, which ensures that the
  • the overflow can be integrated in the wall of the housing so that it actually does not notice from the outside.
  • the utilized discharge nozzle which is preferably designed as described below, may have a passage 36 for the liquid 25 having a diameter of 80 to 300 inches, so that the first , Due to the pressure surge ejected subset of liquid as very fine
  • Liquid jet with a correspondingly small cross-section hits the substrate at very high speed.
  • Exit velocity of the liquid due to the pressure surge can easily be 1000 m / s.
  • an injection channel is created (shot) in the substrate down to a depth that depends on the jet velocity and its diameter and, ultimately, on the strength of the impulse impulse, that of the jet
  • the magnetic coil 16 can be energized further after reaching the front end position of the liquid container 24 (FIG. 2 b).
  • the ej ektorst Schemeel 20 is pressed with its front portion 22 (pressure piece 23) further from behind against the piston 26 in the liquid container, so that after the degradation of the pressure surge in the container still remaining
  • Liquid (second subset) is pressed through the cannula 31 as in a conventional syringe and then expelled through the outlet nozzle 33. It has surprisingly been found that, despite the then significantly lower pressure with which the second subset is ejected, it reliably and completely penetrates into the injection channel generated in advance in the substrate by means of the first subset and thus into the substrate, ie in the case of the first subset
  • Embodiment gets into or under the skin. This generally results in deposit formation at the end of the injection channel, i. the second subset of liquid is distributed substantially evenly in the tissue around the end portion of the sphere
  • the apparatus may also provide a sequence of more or less densely positioned injections of comparatively small quantities of liquid at short intervals of time. For this purpose, by suitable control (change of the current flow direction) of the
  • Magnetic coil 16 of Ej ektorst Schemeel 20 pulled directly after generating a pulse impulse in the liquid received in the container back to its original position (ie in the drawing to the right). Since the liquid container 24 after the very first, carried out as described above injection process of the piercing tip 32 of the cannula 30 on the membrane is already opened, it remains in this operation appropriately in its left side end position shown in the drawing of Figure 2c, which by a suitable , not shown retaining element
  • a transversely biased radially inwardly transversely to the longitudinal axis of the Ejektorrohrs 19 in a recess in the Ejektorrohr be taken after the Vorbeigang the liquid cartridge after triggering the first injection process under the
  • Liquid container edge of the liquid container seizes and prevents it from moving back.
  • the retracted by short-term reversal of the magnetic coil ej ektorst Schemeel 20 can be held in its retracted position by means of a small permanent magnet or an electromagnet on the rear cap 35 of the housing so that it is not unintentional and / or premature alone due to its own weight against the Shock introducing element (piston 26) falls on the liquid container.
  • the ej ektorst Scheme el can then, if necessary, overcoming the magnetic holding force of said permanent magnet (not shown) or electromagnet, be accelerated again on the acceleration path lying in front of him to high speed, wherein he on the tail of his movement with the front
  • Fluid from the device may (after repositioning it at the next desired injection site) be manually, ie by actuation of a triggering mechanism (not shown)
  • Device as a tattoo machine also can be chosen very short.
  • Magnitude of 35 to 200 Hz is readily possible with suitable dimensioning of the plunger and the acceleration section.
  • this outlet nozzle 33 has a central, coaxial to the cannula 30 extending passage 39 for the liquid to be injected 25 having at its fürlrawdung 40 at least one helical or spiral-shaped fluid channel 41 extending from the nozzle inlet 42 at the side the cannula 30 extends to the nozzle outlet 43, from which the liquid 25 exits for injection.
  • This helical fluid channel 41 causes the liquid flowing through the outlet nozzle 33 to swirl
  • Substrate 46 in the embodiment, the skin of a human or animal is incident.
  • the depth of the resulting injection channel in (human or animal) tissue can thus be adjusted between a few millimeters and a few centimeters.
  • FIG. 4 shows a further embodiment of an outlet nozzle according to the invention, wherein corresponding features with the same
  • the outlet nozzle 33 shown in Fig. 4 is fixed by means of a union nut 34a on the housing, which also forms a spacer or a depth gauge.
  • the outlet nozzle according to FIG. 4 can be pressed somewhat into the substrate 46, namely from its upper side 48 into the skin of a patient, so that it can penetrate into the skin of a patient
  • the outlet nozzle 33 has a passage 39 with an inlet-side approximately cup-shaped nozzle chamber 51, on the wall of two (or more) fluid channels 41 are formed, which wrap helically in the manner of a double (or multiple) helix and as described by the Nozzle flowing liquid impart the twist of the invention (screw movement).
  • the nozzle has two (or more) laterally approximately radially outwardly open nozzle outlets 43, through the liquid jets 44 unlike the first imple mentation of the device, the nozzle not coaxial with the longitudinal direction, but in directions that in the
  • an outlet nozzle 33 shown in FIG. 5 largely corresponds to that of FIG.
  • the passage 39 here has no constant cross section over its entire length, but on the inlet side, it first has a converging section 53 whose cross-section is reduced in the direction of flow 54 of the liquid 25 ejected through the nozzle, and then into a section of constant cross-section 55.
  • both sections 53 and 55 are on the walls itself
  • helical widening fluid channels 41 provided, in the embodiment shown two channels, the manner of a
  • Double helix are arranged.
  • the converging section initially provides for an acceleration of the liquid entering the nozzle from the liquid container.
  • Outlet nozzle 33 a plurality in the forward direction 54 of the liquid arranged one behind the other in the form of a diaphragm stack 57
  • Aperture discs 58 each one extending over part of the
  • successive diaphragm discs 58 are arranged offset in the circumferential direction by an angular amount ß to each other.
  • the amount of this angular displacement ⁇ in the circumferential direction is smaller at the radially outer ends of the slot openings 59 than the width of the slot openings. This results in a helical staircase
  • Fluid channel 41 with a central passage opening.
  • Embodiment with the stacked aperture is even with the smallest dimensions with a passage cross-section, which is in the micrometer range, particularly easy and inexpensive to produce.
  • the invention provides a method for needleless injection of liquid into a substrate, in particular for injecting liquid, pharmaceutical or cosmetic preparation into a biological tissue, in which liquid is ejected from a fluid reservoir through an outlet nozzle and leaves it as a fluid jet, which enters the substrate, this method including characterized in that by means of a with
  • Subset of liquid is a pre-jet is generated, which forms an injection channel in the substrate, and then that at least a second subset of liquid is introduced through the injection channel generated by the pre-jet into the substrate.
  • the first subset of liquid is preferably ejected through the outlet nozzle under high pressure generated by means of a pulse impulse. In an equally advantageous embodiment rotates
  • Fluid jet axis is offset.
  • the pulse pulse is preferably by means of a preferably electro-magnetically on a
  • At least second subset can be by means of the pressure on the
  • Liquid ej edictionsdem Prepareels be eji afford by the outlet nozzle.
  • the ej edictionsst Schemeel to pressure be subjected to the at least second subset with an electromagnetically generated force.
  • the invention further provides an injection device for the needleless injection of a liquid into a substrate, in particular for injecting liquid pharmaceutical or cosmetic preparation into a biological tissue, comprising a housing, a liquid reservoir accommodated or arrangeable in the housing, an outlet nozzle and with an ejection device for Ejifug of liquid from the liquid supply through the outlet, wherein the injection device is characterized in that the ej etations sensible means for generating a force acting on at least a first subset of liquid in the liquid reservoir impulse impulse, which means of Ej etechnischs adopted for generating the impulse pulse preferred one a
  • Impact speed acceleratable Ej edictionsstgolel may include, with its accelerated mass on the impact velocity, the at least first subset of liquid can be acted upon.
  • the arrangement may preferably be made such that the
  • Liquid supply can be acted upon by means of an Ej etechnischs friendship operable ejection piston, which in turn can be acted upon by the EJ etechnischsst Jardinel or formed by this.
  • the ej etechnischs may have an electromagnetic drive for the ej etechnischsst Jardinel.
  • the ej etechnischs preferably has an acceleration section for the Ej edictionsstumbleel.
  • the electromagnetic drive may be disposed at a rear end of the housing spaced from or about the middle of the outlet nozzle, and the acceleration path extending between the outlet nozzle and the rear housing end.
  • the electromagnetic drive can be very much preferred
  • the EJ edictionsst Jardinel be provided with a power storage device to supply the electromagnet mi current.
  • the acceleration section is preferably in the area in front of and behind the Ej edictionsst dealtel with pressure equalization openings in
  • Connection which may be connected to each other via an overflow.
  • the ej edictions strongly has expedient means for generating a pressure increase in the liquid supply in immediate connection to the impulse impulse applied, which means for generating the
  • Pressure increase essentially of the Ej etechnischsst Jardinel can be formed, which acts on the liquid reservoir after the impulse shock by means of a force-exerting drive.
  • the force-exerting drive can be the electromagnetic drive.
  • the liquid supply is preferably received in the invention in a liquid container, which is particularly preferably interchangeable in the housing can be arranged.
  • the embodiment can also be made such that the outlet nozzle is arranged on the liquid container.
  • the outlet nozzle preferably has means for causing the fluid jet to rotate at least in its outer region prior to impinging it on the substrate.
  • the outlet nozzle may have a nozzle outlet extending substantially coaxially with the housing axis of the housing. But it is also possible if the outlet nozzle extending substantially in a normal plane to the housing axis of the housing
  • the outlet nozzle and / or the front end of the housing can with a depth indicator or a
  • Liquid container with the liquid received therein together with the ej etechnischsst Jardinel in the housing or the acceleration path provided therein is movably received un the housing at its front outlet end has a stop for da liquid container.
  • the stop can with a
  • the invention also provides a fluid container for use in practicing the method and / or in the device characterized by at least one, a first, in a substrate to be injected liquid receiving piston chamber having a liquid outlet and a shock introduction element for
  • Pulse thrust has.

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  • 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

L'invention concerne un procédé et un dispositif d'injection sans aiguille d'un liquide dans un substrat, en particulier d'injection d'une préparation pharmaceutique ou cosmétique liquide dans un tissu biologique, permettant de manière particulièrement avantageuse d'injecter de manière fiable et complète un jet de liquide particulièrement fin dans le substrat. A cet effet, le jet de liquide éjecté est mis en rotation autour de son axe de jet avant son impact sur le substrat, de sorte qu'un mouvement hélicoïdal est imprimé au jet et que celui-ci se visse pratiquement dans le substrat, sans provoquer de projection latérale.
EP18822131.1A 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif Withdrawn EP3706832A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102017126493 2017-11-10
PCT/IB2018/058810 WO2019092642A1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif

Publications (1)

Publication Number Publication Date
EP3706832A1 true EP3706832A1 (fr) 2020-09-16

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ID=64744760

Family Applications (3)

Application Number Title Priority Date Filing Date
EP18822132.9A Active EP3706833B1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif
EP18822133.7A Pending EP3706834A1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat
EP18822131.1A Withdrawn EP3706832A1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif

Family Applications Before (2)

Application Number Title Priority Date Filing Date
EP18822132.9A Active EP3706833B1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat et récipient de liquide destiné à être utilisé dans le procédé et le dispositif
EP18822133.7A Pending EP3706834A1 (fr) 2017-11-10 2018-11-09 Procédé et dispositif d'injection sans aiguille d'un liquide dans un substrat

Country Status (3)

Country Link
US (3) US20200360611A1 (fr)
EP (3) EP3706833B1 (fr)
WO (3) WO2019092643A1 (fr)

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Publication number Priority date Publication date Assignee Title
DE112019006596A5 (de) 2019-01-07 2021-12-23 Fritz Schmitt Verfahren zum qualitativen und/oder quantitativen Nachweis von in einer Hanfpflanze enthaltenen Substanzen und Kit zur Verwendung darin

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Publication number Priority date Publication date Assignee Title
US2653604A (en) * 1950-12-19 1953-09-29 Jr George N Hein Injection device
US2762370A (en) * 1954-09-07 1956-09-11 Scherer Corp R P Hypodermic injector
US5569190A (en) * 1987-06-08 1996-10-29 D'antonio; Nicholas F. Hypodermic fluid dispenser
US7025762B2 (en) 1997-05-23 2006-04-11 Crymed Technologies, Inc. Method and apparatus for cryogenic spray ablation of gastrointestinal mucosa
US6132395A (en) * 1998-12-08 2000-10-17 Bioject, Inc. Needleless syringe with prefilled cartridge
US6224567B1 (en) * 1999-09-08 2001-05-01 Cambridge Biostability Limited Modified disposable injector device
DE10340613A1 (de) * 2003-08-29 2005-03-24 Primojex Gmbh Vorrichtung zur Injektion eines injizierbaren Produktes
US20060149193A1 (en) 2005-01-05 2006-07-06 Biomec, Inc. High pressure liquid jet ablation of tissue and apparatus
CA2597561A1 (fr) * 2005-02-11 2006-08-17 Massachusetts Institute Of Technology Dispositif d'injection a travers une surface
DE102005038694A1 (de) 2005-04-11 2006-10-26 Erbe Elektromedizin Gmbh Endoskopisches Chirurgiegerät
JP2006296236A (ja) * 2005-04-18 2006-11-02 Cosmo Libra:Kk 粉末食品及びその製造方法
MX2009002178A (es) * 2006-09-01 2009-03-11 Massachusetts Inst Technology Dispositivo inyector sin aguja con capacidad de autocarga.
WO2013190537A1 (fr) * 2012-06-18 2013-12-27 Michael Tavger Procédé et système d'administration d'une solution à travers les pores de la peau d'un être humain
US20180099140A1 (en) * 2012-06-18 2018-04-12 Michael Tavger Method and system for triggering wound recovery by delivering solution into the pores of recipient
ITRM20130562A1 (it) * 2013-10-11 2015-04-12 Manuele Casale Dispositivo di erogazione di una sostanza in forma di aerosol
CA2928270A1 (fr) * 2013-10-23 2015-04-30 Fluidfile Ltd. Appareil et methode pour traitement endodontique
JP6720167B2 (ja) * 2014-11-12 2020-07-08 ノボ・ノルデイスク・エー／エス ある範囲の自動注射器のうち１つを製造する方法
JP6772175B2 (ja) * 2014-12-22 2020-10-21 サノフィ−アベンティス・ドイチュラント・ゲゼルシャフト・ミット・ベシュレンクテル・ハフツング 電磁駆動ユニットを含む自動注射デバイス
FR3068625B1 (fr) * 2017-07-06 2019-08-09 Aptar France Sas Dispositif de distribution de produit fluide.

Also Published As

Publication number Publication date
US20200353171A1 (en) 2020-11-12
EP3706833A1 (fr) 2020-09-16
EP3706833B1 (fr) 2023-08-16
WO2019092644A1 (fr) 2019-05-16
US20200261653A1 (en) 2020-08-20
WO2019092643A1 (fr) 2019-05-16
EP3706833C0 (fr) 2023-08-16
EP3706834A1 (fr) 2020-09-16
US20200360611A1 (en) 2020-11-19
WO2019092642A1 (fr) 2019-05-16

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