WO2009053464A1 - Unité d'injection par jet à chambre de liquide élastique - Google Patents

Unité d'injection par jet à chambre de liquide élastique Download PDF

Info

Publication number
WO2009053464A1
WO2009053464A1 PCT/EP2008/064442 EP2008064442W WO2009053464A1 WO 2009053464 A1 WO2009053464 A1 WO 2009053464A1 EP 2008064442 W EP2008064442 W EP 2008064442W WO 2009053464 A1 WO2009053464 A1 WO 2009053464A1
Authority
WO
WIPO (PCT)
Prior art keywords
coil spring
injection device
jet injection
liquid chamber
spring
Prior art date
Application number
PCT/EP2008/064442
Other languages
English (en)
Inventor
Torben Strøm HANSEN
William Anthony Denne
Original Assignee
Novo Nordisk A/S
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 Novo Nordisk A/S filed Critical Novo Nordisk A/S
Publication of WO2009053464A1 publication Critical patent/WO2009053464A1/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
    • A61M5/178—Syringes
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2006—Having specific accessories
    • A61M2005/2013—Having specific accessories triggering of discharging means by contact of injector with patient body
    • 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
    • A61M2005/3128—Incorporating one-way valves, e.g. pressure-relief or non-return valves
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/204—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically connected to external reservoirs for multiple refilling
    • 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
    • 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
    • A61M5/2422—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/2425—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule by compression of deformable ampoule or carpule wall
    • 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
    • A61M5/3294—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 comprising means for injection of two or more media, e.g. by mixing

Definitions

  • the invention relates to a jet injection unit integrating an actuating mechanism for a jet injector with a pressure chamber and nozzle part into one single compact unit.
  • Jet injectors in general contain a fluid drug which has been transferred into a chamber having a small orifice at one end.
  • a well known principle of jet injectors utilizes a piston to transfer the energy necessary to form a jet beam to the liquid.
  • the piston can be a single or two pressure stage piston energized by a ram under the force of for instance a spring, pressurized gas or an explosive.
  • a flexible liquid pressure chamber which can be influenced by an external ram.
  • the flexible pressure chamber can have at least one or two liquid openings. Most important of course is the outlet which lets the liquid pass out through an orifice of a well defined dimension to form a liquid jet beam when sufficient pressure is exerted on the liquid.
  • a second opening can be applied to the flexible liquid chamber to facilitate the connection to a liquid reservoir. In the latter case, the second opening can advantageously comprise counter flow restriction means, such as a check-valve to ensure correct flow direction out of the orifice when a jet injection is performed.
  • Piercing of the skin by means of a pressurized liquid beam requires a minimum critical pressure impulse.
  • This impulse is for most known needle free jet injector concepts produced by release of an axially pre-stressed mechanical spring or a compressed gas.
  • the mechanical spring based concepts often suffer from a release recoil and sound that gives the user an unintended bad perception of the given device.
  • the recoil stems from the acceleration and deceleration of the mass of the mechanism used to propel the liquid.
  • the compressed gas based concepts has got less accelerated mass and thereby recoil since the density of the compressed gas is much lower than that of the mechanical spring.
  • the compressed gas needs a leak-safe compartment suitable for storage during the shelf life of the device and needs to be changed as an accessory imposing a significant cost and inconvenience on the user. It is therefore desirable to provide a jet injection device having a reduced recoil and release sound without the need for a leak-safe compartment.
  • PCT / GB 02 / 02633 describes a jet injector in which there is a rigid tube terminating at one end in a nozzle and at the other in a constriction which leads to the main drug supply. A portion of the rigid tube is formed as a flexible window. There is an over centre spring and an end thrust beam which may compress the window to cause a high speed flow through the nozzle.
  • the device suffers a number of problems. Priming the pump is unstable, the spring acting in tension stores insufficient energy, the flexible window tears from its mount and causes inefficient energy transfer, the spring and beams carry insufficient momentum, the nozzle form tends to close the entrance to the track through the skin and energising by pressing against the skin of the patient is somewhat uncomfortable.
  • the present specification details radical improvements to this device.
  • WO 2004/039438 discloses an injector comprising a rigid tube with an outlet at one end and a non-return valve at the other end, a hole in the tube wall, an elastomeric liner within the rigid tube and a piston arranged to impact the elastomeric liner through the hole in the tube to produce a high pressure transient.
  • the injector includes a spring member arranged to act upon the piston to cause the piston to impact the liner.
  • the piston is attached to a mass which is capable of being accelerated by the spring member.
  • the spring member is bi- stable. It may be manually energised to a latched position and may then be triggered by pressure against the skin of a patient. Though compact and simple in nature this device still suffers from drawbacks especially regarding energy compactness and technical function of the actuating spring.
  • the present invention aims to overcome these drawbacks.
  • WO 2005/070482 discloses a deformable impulse chamber which can be used for expelling an amount of fluid at a high pressure.
  • the impulse chamber is collapsed by a radially moving piston which is activated upon release of a pre-stressed helical torsion spring.
  • the piston activation mechanism comprises the spring and a number of other elements being arranged along an axle which is positioned on one side of the impulse chamber. This arrangement takes up a considerable amount of space and the unit consisting of the impulse chamber, the piston and the piston activation mechanism therefore appears rather bulky.
  • the jet injection device of the present invention addresses the large recoil of a longitudinally pre-stressed coil spring and the inconvenience of a compressed gas accessory by changing the loading of a coil spring.
  • the device comprises a coil spring which is suited for being rotationally pre-stressed and which is arranged so that upon triggering the spring will rotate and, due to a reduction of its radial dimension, impact a radially translating impulse transferring member, such as a piston, which will then compress a resilient liquid chamber containing a limited amount of liquid representing a sub-portion of the dose.
  • the rotational pre-stressing of a spring allows for a dense storage of energy and thereby less accelerated mass. Furthermore, the accelerated mass rotates instead of moving longitudinally. This significantly reduces the recoil of the device. Additionally, by employing a resilient liquid chamber containing only a sub-portion of the dose, a reduced volume of liquid is actually accelerated to pierce the skin. This requires less pre-stress energy reducing both the device recoil and the force to be triggered by the user.
  • a jet injection device comprising a resilient liquid chamber, an outlet orifice in liquid communication with the resilient liquid chamber, an inlet for establishing a connection between the resilient liquid chamber and a source of liquid drug, a coil spring having a first end and a second end, the first end being essentially fixed and the second end being connected to a load member, spring release means, and an impulse transferring member, wherein the coil spring is suited for being rotationally pre- stressed by manipulation of the load member, and wherein at least a part of the coil spring and/or the load member encircles at least a part of the impulse transferring member so that upon activation of the spring release means the rotation of the coil spring will cause the impulse transferring member to move radially to compress the resilient liquid chamber.
  • a jet injection device of the above type provides for a very compact design which has a significantly reduced recoil and release sound due to the chamber deformation energy being transferred to the impulse transferring member by a rotating coil spring/load member arrangement.
  • the pre-stressing may be carried out by turning the load member clockwise or anti-clockwise in relation to the part of the device which holds the first end of the coil spring in an essentially fixed position.
  • the part of the device which holds the first end of the coil spring in an essentially fixed position may be a base part comprising the impulse transferring member, but any part of the device around which the load member revolves during pre- stressing could in principle be used to essentially fix the first end of the coil spring.
  • the first end and the second end of the coil spring are thereby angularly displaced in relation to the helix axis and the unstressed state.
  • a ratchet and pawl mechanism may be provided to ensure a firm and stable engagement between the load member and the part of the device holding the first end of the coil spring during the pre-stressing.
  • the load member When the load member has been rotated a number of turns it may reach a pre-defined stop and engage with a lock snap which then holds the coil spring in the pre-stressed position until a spring release means is activated. This indicates that the device is ready to be fired.
  • the spring release means Upon activation of the spring release means the second end of the coil spring will rotate with respect to the helix axis and with respect to the first end.
  • the diameter reduction of the coil spring may, due to the coil spring being forced into engagement with the impulse transferring member, result in the impulse transferring member being moved radially to compress the resilient liquid chamber.
  • the reduction of the coil spring diameter causes the part of the coil spring which encircles the impulse transferring member to engage with the impulse transferring member and exert a radial force on it which moves a pair of jaws to compress the resilient liquid chamber.
  • the rotating coil spring may act directly on the resilient liquid chamber causing it to deform and thereby expel a liquid jet beam.
  • a jet injection device comprising a resilient liquid chamber, an outlet orifice in liquid communication with the resilient liquid chamber, an inlet for establishing a connection between the resilient liquid chamber and a source of liquid drug, a coil spring having a first end and a second end, the first end being essentially fixed and the second end being connected to a load member, and spring release means, wherein the coil spring is suited for being rotationally pre-stressed by manipulation of the load member, and wherein at least a part of the coil spring and/or the load member encircles at least a part of the resilient liquid chamber so that upon activation of the spring release means the coil spring will rotate to compress the resilient liquid chamber.
  • the load member may comprise a catch member, e.g. an annular catch member, which is used to guide the rotational movement of the coil spring in the device.
  • the load member may comprise a load mass, e.g. an annular load mass, which is used to guide the rotational movement of the coil spring in the device and to increase the impulse transferred to the resilient liquid chamber, either directly from the rotating coil spring/load mass or via an impulse transferring member.
  • the jet injection device is adapted to be coupled to a source of liquid drug, such as a variable volume cartridge, which may supply the small volume of drug to the resilient liquid chamber for the initial skin penetrating jet beam as well as a bulk amount of drug for when the skin has been pierced by the liquid jet and the remaining part of the dose is to be administered.
  • a source of liquid drug such as a variable volume cartridge
  • the source of liquid drug may be comprised in a drug delivery device, such as a pen-type device, which drug delivery device may provide the means for transferring either the small volume of drug, the bulk amount of drug, or both, from the source of liquid drug to the jet injection device.
  • a drug feed tube may be provided to establish fluid connection between the resilient liquid chamber and the source of liquid drug and thereby serve as an inlet for filling or flushing the resilient liquid chamber.
  • a non-return valve may be provided which may conveniently be a moulding on the drug feed tube. It may simply be a coaxial tube of elastomer, or slightly more complex as a flaps disposed either side of an elastomeric extension of the feed tube.
  • the non-return valve may be provided as an inlet channel between a feed needle, adapted to establish fluid connection between the resilient liquid chamber and the source of liquid drug, and the resilient liquid chamber, said inlet channel having a radial dimension which is smaller than the radial dimension of the outlet orifice and/or an axial dimension which is longer than the axial dimension of the outlet orifice.
  • a jet injector incorporating a substantially helical metal spring as the power source.
  • Rotation of the tip of the helical spring about the helix axis stores energy in the spring.
  • the large displacement involved implies a very low finger pressure for a given energy storage.
  • a rectangular cross section wire may be used to provide more efficient energy storage.
  • the tip of the spring may latch in a fascia between the spring and skin of the patient. Pressure on the skin may then release the spring so that the stored energy is converted into kinetic energy.
  • the helix may taper toward the stationary end of the spring or the injector body may expand, so collapse of the spring about the body is progressive from the stationary end to the free end.
  • the taper may be such that the spring is pre-stressed in its unexcited state.
  • Such pre-stress provides a more uniform excitation load throughout the excitation phase. It also effectively extends the permissible fractional spring over-wind.
  • the helical spring wraps securely around the body. At the moving point of contact, the moving spring is brought to a standstill with respect to the body. This deceleration force acting on the spring, causes it to precess about the body. The energy in the spring is thus conserved and concentrates in the free end of the spring. At the end of the collapse, there is an eccentric relief of the body.
  • An annular load member or load mass connected to the tip of the spring may wrap around this eccentric to linearly displace a radially disposed piston. In this manner, the rotatory motion of the spring may simply and efficiently be converted into a linear radial motion to generate the hydraulic transient.
  • a non return valve may be provided which may conveniently be a moulding on the drug feed tube. It may simply be a coaxial tube of elastomer, or slightly more complex as a flaps disposed either side of an elastomeric extension of the feed tube.
  • the hydraulic transient causes flow through the tube and a lowering of the pressure within it.
  • the pressure profile across the length of the elastomeric tube also causes it to collapse, so very rapidly the tube is closed to flow.
  • a helical steel spring is therefore a very compact means of storing energy around a screw-on cap.
  • Conventionally, helical springs operate in extension or compression, the energy being stored as torsion in a circular cross section wire.
  • the maximum comfortable finger loading is around 10 N and an excitation energy of the order of 0.5 J is required for operation. Under these conditions an extension of 100 mm would be required which is clearly impracticable.
  • the spring may be excited in bending by rotating the free end about the helical axis.
  • a typical effective spring diameter might be 14 mm, in which case, 2.2 turns would provide the 100 mm translation required.
  • Compression and extension springs generally use circular cross section wire. As the wire is under rotational shear, the outer surface is uniformly under maximum stress. The arrangement is very efficient and energy storage is 50% of that possible if the material were uniformly stressed to its maximum permissible strain. In bending, a circular cross section is less efficient. The outer part of the circle is takes maximum stress, but there is very little volume of material to be stressed. The bulk of the material is consequently stressed at a very low level with correspondingly low energy storage. If a rectangular or flattened circular wire is used, the efficiency will rise to 66% of that in a circular wire under shear loading. A rectangular cross section is therefore very desirable.
  • the free tip of the spring may latch against a detente in a fascia placed between the spring and the skin of the patient. In this manner, pressure from the skin of the patient may unlatch the spring tip permitting the potential energy in the spring to convert to kinetic energy that may be used to drive the injection process.
  • the fascia may also protect the skin of the patient from damage from the rapidly rotating spring tip.
  • the helical spring may be tapered toward the stationary end, or the injector body tapered with an increase in diameter toward the stationary end, so that the spring is progressively pre-stressed.
  • This offers three advantages at the cost of slight loss in stored energy. It ensures that the spring collapses uniformly against the injector body from the stationary end to the free tip. This concentrates the kinetic energy in the free tip.
  • the excitation force is proportional to the length of active spring as well as the stress within the spring. The pre- stressing therefore provides a much more uniform excitation force as the effective spring length increases with spring stress.
  • the final advantage is additional protection against overwinding. If the spring is stressed to 75% of its plastic limit, a 25% overrun will cause permanent damage. If the spring is pre-stressed so that the excitation translation is reduced by a third, the maximum overrun will increase to 33% which gives a significant improvement is ruggedness.
  • the helical spring wraps securely around the body. At the moving point of contact, the moving spring is brought to a standstill with respect to the body. This deceleration force acting on the spring, causes it to precess about the body. The energy in the spring is thus conserved and concentrates in the free end of the spring.
  • the spring may wrap around a piston to convert the rotational energy into a linear thrust to generate a hydraulic transient in the axial drug filled tube.
  • the impulse transferring member moves radially to compress the resilient liquid chamber due to a combined reduction of the radial dimension of the coil spring and precession of the coil spring about the impulse transferring member.
  • the impulse is transferred from the coil spring and/or the load member to the impulse transferring member via an eccentric arrangement.
  • an eccentric arrangement could be realised by positioning the coil spring and/or the load member eccentrically to the impulse transferring member or in such a way that a contact face of the load member, suited to facilitate contact with a related contact face of the impulse transferring member, is positioned eccentrically to the impulse transferring member.
  • Figs. 1A - 1 C show contours of constant stress in wires under shear and tension
  • Figs. 2A and 2B show the helical spring according to an embodiment of the invention
  • Figs. 3A and 3B show the load mass and its attachment to the spring according to an embodiment of the invention
  • Figs. 4A - 4C show the injector body according to an embodiment of the invention
  • Figs. 5A - 5C show the feed needle and non return valve according to an embodiment of the invention
  • Fig. 6 illustrates the piston according to an embodiment of the invention
  • Figure 7 shows the complete assembly according to an embodiment of the invention in cross section
  • Figure 8 shows how the rotatory motion is converted to a linear piston stroke according to an embodiment of the invention
  • Figure 9 shows a cross-sectional perspective view of the jet injection device according to another embodiment of the invention
  • Figure 10 shows a perspective view of the load member according to the embodiment of Figure 9
  • Figure 11 shows a perspective view of the impulse transferring member according to the embodiment of Figure 9.
  • distal distal
  • proximal proximal
  • radial radial
  • Figure 1 shows contours of constant stress in wires and illustrates the reaction moment generated.
  • Figure 1A shows a circular wire in torsion.
  • the stress increases linearly with distance from the axis, 1 , as area of each element under stress and its associated moment arm.
  • the moment of each element therefore increases as the cube of radius.
  • the largest area is therefore under greatest stress and has the maximum moment arm. Energy storage is therefore very efficient.
  • Figure 1 B shows a circular cross section wire under bending stress. While the stress and moment arm also increase with distance from the neutral axis, 2, the element cross section decreases. Furthermore, as the outermost element determines the maximum permissible stress, most elements in this configuration are significantly understressed for efficient energy storage.
  • Figure 1C illustrates a rectangular wire cross section under bending.
  • the element cross section is constant to the outer surface, and this represents a good compromise between practicality and efficiency of energy storage.
  • Figure 2a shows the complete helical spring, 27, in axial projection and figure 2b in plan form.
  • the wire, 20, is of rectangular cross section and the spring turns, 21 , are touching in the rest state.
  • the spring tapers from the load mass end, 22, to the stationary end, 23.
  • Figure 3a shows the load mass in axial elevation and figure 3b shows a plan form of the spring attached to the load mass.
  • the load mass, 30, is essentially an annulus of stainless steel.
  • There is an annular relief, 31 which accepts the end of the spring and provides clearance between the spring, 27, and the injector body, 40.
  • a slot, 32 which accepts a peg, 33 which can engage with a slot in the fascia, 52, to retain the excited spring tip.
  • the zig zag, 26, slides into a radial slot, 34, and an axial force is applied locally to upset the slot and rivet the zig zag securely in position.
  • Figure 4a shows the injector body, 40, in plan form.
  • Figure 4b shows the latch actuator 50 in the displaced position.
  • Figure 4c shows the fascia in axial projection, showing the nozzle, 42, and the latch actuator, 50.
  • There is a coaxial tube, 41 running the length of the body. It starts as a nozzle, 42, at one end, which widens conically to a tubular pumping chamber, 43.
  • the continuation of this tube, 44 accepts the feed tube, 55, as an interference fit.
  • the tubular section, 45 is bored out to provide clearance for the feed tube.
  • the tubular section, 46 provides an internal thread for screw fitting to the injector pen.
  • FIG. 47 shows the rectangular hole, 47, which retains the stationary end of the spring
  • the radial cylindrical blind hole, 48 which accepts the piston, 60, the eccentric, 49, machined to facilitate the rotary to linear motion transformation
  • the fascia, 51 which separates the spring from the skin of the patient
  • the notch, 52 which latches the excited spring and the latch actuator, 50.
  • the latter is a low rate spring which accepts pressure from the skin of the patient and transmits it to the tip of the spring, eventually displacing it from the latch notch and initiating collapse of the excited spring.
  • Figure 5a shows the drug delivery needle in plan form.
  • Figure 5b and 5c show a close up section of the tubular elastomeric non return valve and illustrate how it is closed by hydraulic pressure.
  • the drug delivery needle, 55 has a significant diameter of between 1.5-2 mm typically. It has a capillary tube, 57, running its length, typically 0.3 mm diameter. A tubular elastomeric valve, 56, is moulded onto the internal end. The external end, 58, is machined down and sharpened to pierce the drug ampoule.
  • detente 59, which facilitates removal on prototype devices for assessment of the pumping chamber, nozzle cleanliness and other matters.
  • Figure 5b shows the internal end of the drug delivery needle, 55, press fitting into the injector body, 43.
  • the tubular elastomeric valve, 56 is moulded on to the internal tip of the drug delivery needle. There is clearance between the valve, 56, and the wall, 43.
  • the hydraulic pressure starts to build, it operates on the outer surface of the tubular valve.
  • the pressure within the capillary steel drug delivery tube, 57 will remain close to zero.
  • the pressure gradient across the elastomeric valve will cause it to collapse as in figure 5c, so sealing the pumping chamber.
  • Figure 6a and 6b shows the end and side elevations respectively of the simple cylindrical piston, 60.
  • Figure 7 shows the complete assembled injector in axial section.
  • the spring, 27, is in its unexcited state.
  • the load mass, 30, lies within the fascia, 51.
  • the latch peg, 33 also can move freely within the fascia, 51.
  • the piston, 60 is bonded within the piston channel, 48, with highly extensible, high strength elastomer, preferably addition cure silicone rubber.
  • Figure 8 illustrates the conversion of rotary motion to a linear impact.
  • the load mass, 30, is rotating at full speed about the injector body axis when the dog leg, 25, of the last turn of the spring, tightens against the injector body and tethers the load mass. This causes the load mass to precess about the body and in so doing, depresses the piston. Correct matching is required for optimum effect, but pressures of the required magnitude and duration may be obtained.
  • Figure 9 shows a cross-sectional perspective view of an assembled jet injection device according to another embodiment of the invention.
  • a coil spring 127 is in its proximal end connected to a base member 160 and in its distal end connected to a load member 130 via a tail 128 which is accepted in a cavity (not visible) of the load member 130.
  • the connections are arranged so that the coil spring 127 will not undergo any significant axial deformation during use of the device.
  • the base member 160 comprises an outer circumferential part 161 and an inner elongated part 162 which is capable of acting as an impulse transferring member through a pair of radially displaceable jaws 164. In its unstressed state the coil spring 127 encircles and rests upon the inner elongated part 162. A radial clearance 180 between the outer circumferential part 161 and the inner elongated part 162 enables the coil spring 127 to expand radially during pre-stressing.
  • the base member 160 also comprises a circumferentially extending tooted rack 163 which is adapted to engage with a protruberance 138 on flexible arms 137 of the load member 130 to provide a ratchet and pawl mechanism that enables a one-way rotational movement between the base member 160 and the load member 130.
  • a tubular element 141 Centrally positioned in this arrangement is a tubular element 141 which comprises a resilient liquid chamber 143, an outlet orifice or nozzle 142, and an inlet channel 156 which also acts as a non-return valve.
  • the resilient liquid chamber 143 extends axially from the outlet orifice 142 through openings in both the load member 130 and the base member 160 and is engaged in a proximal part of its axial extension by the pair of jaws 164.
  • the proximal end of the tubular element 141 is adapted to receive a feed needle 155 for establishing fluid connection between a source of liquid drug (not shown) and the resilient liquid chamber 143.
  • Figure 10 shows the load member 130 comprising an axially extending annular body 136.
  • a couple of partly circumferential tracks 139 have been cut in the body 136 to provide for the flexible arms 137.
  • Each flexible arm 137 is provided with a radially inwards pointing protruberance 138.
  • Figure 11 shows the base member 160 comprising the outer circumferential part 161 and the inner elongated part 162.
  • the base member 160 is formed in one piece, and the inner elongated part 162 provides for a radially flexible structure which when subjected to a compressive force will move the pair of jaws towards each other in a squeezing action.
  • a source of liquid drug not shown
  • the load member 130 is rotated a number of turns relative to the base member 160.
  • the nozzle 142 is then placed against the skin of the user, and by exerting a force on the device to press it against the skin the base member 160 will move distally a short distance relative to the load member 130, traversing the axial clearance 190. This movement will slide the protruberances 138 out of engagement with the toothed rack 163, thereby releasing the coil spring 127 from its pre-stressed state. The distal end of the coil spring 127 will then rotate about the helix axis due to the conversion of its pre-stressed potential energy to kinetic energy. The elastic relief of the coil spring 127 will result in a decrease of its radial dimension and cause a momentary diameter reduction of up to 30% compared to the unstressed state.
  • the coil spring 127 When the coil spring 127 reduces its diameter beyond the unstressed dimension it will engage with the inner elongated part 162 and exert a radially compressive force on it. Due to the construction of the base member 160, the inner elongated part constitutes a radially flexible structure which, under the compressive force from the coil spring 127, will cause the pair of jaws 164 to move radially inwards to thereby squeeze the resilient liquid chamber 143. The impulse thus transferred to the liquid in the resilient liquid chamber 143 generates a pressure variation along the tubular element 141 which due to the small dimension of the inlet channel 156 forces the liquid out of the device through the nozzle 142.
  • a jet injection device comprising:
  • an impulse transferring member wherein the coil spring is suited for being rotationally pre-stressed by manipulation of the load member, and wherein at least a part of the coil spring encircles at least a part of the impulse transferring member so that upon activation of the spring release means the coil spring will rotate and thereby cause the impulse transferring member to move radially to compress the resilient liquid chamber.
  • a jet injection device comprising:
  • a coil spring having a first end and a second end, the first end being essentially fixed and the second end being connected to a load member, and • spring release means, wherein the coil spring is suited for being rotationally pre-stressed by manipulation of the load member, and wherein at least a part of the coil spring encircles at least a part of the resilient liquid chamber so that upon activation of the spring release means the coil spring will rotate to compress the resilient liquid chamber.
  • a jet injection device according to any of features 1 -2, wherein the jet injection device is suited for connection to a source of liquid drug.
  • a jet injection device wherein the source of liquid drug is a cartridge having a variable volume.
  • a jet injection device according to any of features 1 -4, wherein the jet injection device is suited for connection to a medical drug delivery device. 6.
  • a jet injection device according to feature 5, wherein the medical drug delivery device is a pen-type device comprising a drug containing cartridge.
  • a medical jet injector comprising; • a resilient liquid chamber in liquid communication with
  • the coil spring is suited for being rotationally biased and when released by activation of the spring release means, said coil spring and the impulse mass is accelerated and rotates to engage with the impulse transferring member which upon engagement moves inwards towards the liquid chamber wall, thereby compressing the resilient liquid chamber causing liquid outflow through the orifice forming a liquid jet stream.
  • a medical jet injector according to feature 7, WHEREIN said coil spring has a substantially rectangular cross section.
  • a medical jet injector according to any of features 7-8, WHEREIN said impulse is transferred from the coil spring and the impulse mass to the impulse transferring member via an eccentric arrangement.
  • a medical jet injector WHEREIN the impulse mass has a contact face suited to facilitate contact to a related contact face of the impulse transfer member, said contact face of the impulse mass is rotatably arranged eccentric relative to the impulse transfer member, whereby the impulse transfer member is moved substantially inwards upon rotation of the impulse member when the release member is activated.
  • a medical jet injector according to any of features 7-1 1 , WHEREIN said medical jet injector is suited for connection to a medical drug expelling device.
  • a medical jet injector according to feature 14, WHEREIN said medical drug expelling device is a pen-type device comprising a drug containing cartridge.
  • a medical jet injector according to feature 14 or 15, WHEREIN said medical drug expelling device comprises manual or automatic actuating means for expelling a dose of liquid drug via the liquid passage of said medical jet injector and a passage in the skin of a subject provided by the impulse of the liquid jet stream exerted prior to expelling said dose.
  • a medical jet injector according to any of features 7-16, WHEREIN said medical jet injector comprises skin fixating means to ensure that the position of the orifice relative to a skin surface is maintained during a performing of an impulse jet injection and a following relatively low-pressure injection of a dose of liquid drug.
  • a medical jet injector according to feature 17, WHEREIN said skin fixation means comprise adhesive.
  • a medical jet injector according to any of features 7-18, WHEREIN the injected drug is insulin.

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

L'invention concerne un dispositif d'injection par jet qui comporte un élément de base (160), un élément de charge (130), une chambre de liquide élastique (133) en communication fluidiquee avec un orifice de sortie (142) à une extrémité et avec un canal d'entrée (156) à l'autre extrémité, un élément de transfert d'impulsions (164) et un ressort hélicoïdal (127) approprié pour être précontraint en rotation par manipulation de l'élément de charge (130). Lors de sa libération, le ressort hélicoïdal (127) tournera et subira une contraction radiale qui activera l'élément de transfert d'impulsions (164) pour presser la chambre de liquide élastique (143), ce qui force le contenu de la chambre de liquide élastique (143) à sortir via l'orifice de sortie (142).
PCT/EP2008/064442 2007-10-24 2008-10-24 Unité d'injection par jet à chambre de liquide élastique WO2009053464A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP07119162 2007-10-24
EP07119162.1 2007-10-24

Publications (1)

Publication Number Publication Date
WO2009053464A1 true WO2009053464A1 (fr) 2009-04-30

Family

ID=39032218

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2008/064442 WO2009053464A1 (fr) 2007-10-24 2008-10-24 Unité d'injection par jet à chambre de liquide élastique

Country Status (1)

Country Link
WO (1) WO2009053464A1 (fr)

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2432523A1 (fr) * 2009-05-20 2012-03-28 Sanofi-Aventis Deutschland GmbH Ensemble pour dispositif de distribution de médicament
EP3548117B1 (fr) * 2016-12-01 2021-07-07 Novo Nordisk A/S Dispositif d'administration de médicament avec fonction de ressort de torsion

Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4165739A (en) * 1976-09-02 1979-08-28 Doherty Norman R Inoculator
WO1996018425A1 (fr) * 1994-12-17 1996-06-20 Bailey, William, John Injecteur
WO2003000320A1 (fr) * 2001-06-20 2003-01-03 William Denne Injecteur sans aiguille jetable a faible cout
WO2003105934A1 (fr) * 2002-06-14 2003-12-24 Riemser Arzneimittel Ag Dispositif pour l'injection sans aiguille d'une substance dans un tissu d'un etre humain ou d'un animal, dispositif pour creer sans aiguille un canal d'injection et procede pour l'injection d'une substance dans ledit tissu
WO2004039438A1 (fr) * 2002-11-01 2004-05-13 Novo Nordisk A/S Injecteur sans aiguille a ressort bistable
WO2005070482A1 (fr) * 2004-01-26 2005-08-04 Novo Nordisk A/S Chambre a impulsions pour dispositif de distribution de jets

Patent Citations (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4165739A (en) * 1976-09-02 1979-08-28 Doherty Norman R Inoculator
WO1996018425A1 (fr) * 1994-12-17 1996-06-20 Bailey, William, John Injecteur
WO2003000320A1 (fr) * 2001-06-20 2003-01-03 William Denne Injecteur sans aiguille jetable a faible cout
WO2003105934A1 (fr) * 2002-06-14 2003-12-24 Riemser Arzneimittel Ag Dispositif pour l'injection sans aiguille d'une substance dans un tissu d'un etre humain ou d'un animal, dispositif pour creer sans aiguille un canal d'injection et procede pour l'injection d'une substance dans ledit tissu
WO2004039438A1 (fr) * 2002-11-01 2004-05-13 Novo Nordisk A/S Injecteur sans aiguille a ressort bistable
WO2005070482A1 (fr) * 2004-01-26 2005-08-04 Novo Nordisk A/S Chambre a impulsions pour dispositif de distribution de jets

Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2432523A1 (fr) * 2009-05-20 2012-03-28 Sanofi-Aventis Deutschland GmbH Ensemble pour dispositif de distribution de médicament
EP2432523B1 (fr) * 2009-05-20 2020-01-15 Sanofi-Aventis Deutschland GmbH Ensemble à utiliser dans un dispositif d'approvisionnement de médicament
EP3548117B1 (fr) * 2016-12-01 2021-07-07 Novo Nordisk A/S Dispositif d'administration de médicament avec fonction de ressort de torsion

Similar Documents

Publication Publication Date Title
JP5084825B2 (ja) 注射装置のための機構
US20070049873A1 (en) Impulse chamber for jet delivery device
US11957878B2 (en) Process and autoinjector device for injections with increased patient comfort
JP5203931B2 (ja) 強制ロックアウト機構及び注入速度制限機構を有する注入器装置
AU2004286732B2 (en) Device for the administration of an injectable product
EP2162170B1 (fr) Injecteur "monocoup" et ressorts jumelés
WO2007100899A2 (fr) Amortisseur de chocs pour injecteur automatique
JP2007514489A (ja) 皮膚引き伸ばし手段を有するノズルデバイス
JP2012509097A (ja) 薬物皮内注射用薬物送達ペンのための力付加装置
US20090254026A1 (en) Syringe Device Comprising a Motor Adapted for Filling an Injection Chamber
EP3240594B1 (fr) Dispositif d'administration de médicament doté d'un mécanisme de déclenchement hydraulique
ZA200502901B (en) Syringe with retractable needle assembly.
WO2009053464A1 (fr) Unité d'injection par jet à chambre de liquide élastique
CN201168281Y (zh) 一种卡式瓶全自动注射器
EP3508238B1 (fr) Structure de support
CN220676486U (zh) 一种一次性击发结构

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08841385

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 08841385

Country of ref document: EP

Kind code of ref document: A1