WO2003000320A1 - Injecteur sans aiguille jetable a faible cout - Google Patents

Injecteur sans aiguille jetable a faible cout Download PDF

Info

Publication number
WO2003000320A1
WO2003000320A1 PCT/GB2002/002633 GB0202633W WO03000320A1 WO 2003000320 A1 WO2003000320 A1 WO 2003000320A1 GB 0202633 W GB0202633 W GB 0202633W WO 03000320 A1 WO03000320 A1 WO 03000320A1
Authority
WO
WIPO (PCT)
Prior art keywords
skin
spring
jet injector
injector according
nozzle
Prior art date
Application number
PCT/GB2002/002633
Other languages
English (en)
Inventor
William Denne
Original Assignee
William Denne
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
Priority claimed from GB0115086A external-priority patent/GB0115086D0/en
Priority claimed from GB0117963A external-priority patent/GB0117963D0/en
Priority claimed from GB0200923A external-priority patent/GB0200923D0/en
Priority claimed from GB0205756A external-priority patent/GB0205756D0/en
Application filed by William Denne filed Critical William Denne
Publication of WO2003000320A1 publication Critical patent/WO2003000320A1/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
    • A61M5/20—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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/281—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle using emptying means to expel or eject media, e.g. pistons, deformation of the ampoule, or telescoping of the ampoule
    • A61M5/282—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle 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
    • A61M5/28—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle
    • A61M5/285—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened
    • A61M5/288—Syringe ampoules or carpules, i.e. ampoules or carpules provided with a needle with sealing means to be broken or opened by piercing without internal pressure increase

Definitions

  • Jet injectors have been in use for more than fifty years.
  • a high velocity jet of liquid drug passes through the skin and into the underlying tissue without need for a hypodermic needle.
  • the procedure may be painless and far less intrusive than a standard injection.
  • disposable jet injectors have been devised which are driven by a small canister of compressed gas. These, however, are still more expensive than most injectable drug shots.
  • a low cost jet injector that may be used for a number of shots from a single drug ampoule.
  • a jet injector in which one or more end thrust beams may impact and depress corresponding flexible portions in the wall of a rigid chamber filled with liquid drug where the flexible portions of wall are sited between a nozzle and an extended constriction.
  • the end thrust beam or end thrust beams are driven by an over centre spring which is preferably made of elastomeric material.
  • the spring is compressed by pressing the injector against the skin of the patient. On passing through the central unstable equilibrium position, the spring accelerates the end thrust beam to impact with the flexible portion of wall.
  • the geometry of the spring and flexible portion of wall may be adjusted so that the line of force of the spring lies approximately through the centre of the flexible portion of wall at impact.
  • the spring is preferably in the form of two coplanar rigid end thrust beams, which bear on the rigid chamber at one end and are joined at their outer ends by two parallel leaf springs.
  • Extended end surfaces on the end thrust beams at the rigid chamber end provide both a rotational bearing and a thruster element.
  • the central gap between the end thrust beams is less than the spacing provided by the rigid chamber so that at rest the spring assembly is concave to the skin of the patient.
  • the end thrust beams rotate about an axis approximately perpendicular to the skin of the patient axis so stretching the leaf springs until the spring assembly assumes the planar configuration of unstable equilibrium.
  • the end thrust beams then accelerate rotationally to a configuration convex to the skin of the patient until the end thrust beams impact on the flexible portion of the rigid chamber wall.
  • the impact force and residual spring tension raise the hydraulic pressure within the rigid chamber which accelerates a high speed liquid jet through the nozzle. Acceleration of fluid though the extended constriction is so slow that little fluid escapes through the constriction during the high pressure transient.
  • the jet cuts a track through the skin of the patient and the main dose of drug may be delivered via the unoccluded rigid chamber and track through the skin with a conventional piston and cylinder arrangement. Load need only be applied to the piston.
  • the pressure of the nozzle on the skin will provide a higher pressure hydraulic seal than the hydraulic pressure generated by the piston. If the spring tips press against the skin before the nozzle, any air in the pump may be preferentially expelled, prior to the formation of the hydraulic seal, due to the lower density of air compared with liquid drug. A pressure raising feature around the nozzle may pump away any extraneous lubricating fluid from the local nozzle skin interface and the resultant high frictional forces may retain the alignment of nozzle and track throughout the drug delivery.
  • Portable power sources are relatively expensive and complex. Power sources that may be used more than once, even more so. To reduce cost, this injector uses the pressure of the device against the skin of the patient to energise it. To reduce the power requirement, the main dose may be delivered manually with a piston and cylinder in the conventional fashion. This provides slow delivery which reduces soft tissue damage. The jet injector need only generate a single fast drop to cut a track through the skin.
  • the device comprises an over centre spring connected to one or more end thrust beams.
  • the spring is stretched by pressure against the patient then on passing through the position of unstable equilibrium, accelerates the end thrust beams to impact with flexible portions within the wall of a rigid chamber.
  • the impact and residual stress of the springs generate a high hydraulic pressure transient within the drug filled chamber.
  • the chamber tapers to a fine nozzle so that the pressure accelerates fluid through this nozzle to form a high speed liquid jet. This jet may cut a track through the skin.
  • At the other end of the chamber is an elongated constriction. The high pressure transient will accelerate fluid through the constriction, but the fluid inertia is so great that liquid loss will be negligible for the duration of the transient.
  • the constriction offers no significant resistance at all.
  • the depression of the flexible portions of chamber is insufficient to occlude the chamber, so there is no need to retract the end thrust beam ends after firing.
  • the main dose of liquid drug may be fed through the jet injector by a piston and cylinder arrangement in the usual manner, then on through the track in the skin to the subcutaneous tissue.
  • the device may be held by the piston and pressed against the skin of the patient to actuate it.
  • the force exerted on the piston will then also be exerted on the skin of the patient. If the cross sectional area of the piston is greater than the effective area of the nozzle, the hydraulic seal pressure against the skin must always be greater than that generated by the piston. A wet shot, in which drug flows partially over the outer skin of the patient, is therefore fundamentally impossible.
  • the track must clearly be kept accurately aligned with the nozzle throughout the drug delivery. Since the pressure on the skin will be continuous during delivery, there will be a continuous frictional force between the skin and the nozzle. If the nozzle is in the form of a truncated cone, tension in the skin will provide a very high and localised pressure loading along the circular locus of truncation. The localisation will ensure that any lubricating liquid film on the skin, such as drug or sweat, will rapidly be pumped away. The high pressure against dry skin will provide a localised high frictional retaining force which will maintain accurate registration of the nozzle and mouth of the track during drug delivery.
  • the conical form of the nozzle will produce a radially decreasing stress pattern in the underlying tissues of approximately spherical symmetry.
  • the compression of the soft tissues will tend to close the capillaries and the drug will be preferentially deposited at the end of the track.
  • the depth of shot can be precisely engineered.
  • the initial jet will aggressively cut though the outer skin, but as the track develops, boundary layers will form in the flow pattern that will effectively progressively remove fluid from the jet.
  • the boundary layer flow will be laminar due to the small scale and so may be very accurately predicted.
  • By varying the cross section and duration of the jet it will be possible to control the depth of the shot very accurately, irrespective of the toughness or thickness of the outer skin.
  • the base of the end thrust beam against the rigid chamber wall may be an extended surface that pivots. As the spring rotates, the line of action of the spring steadily moves away from the pivot point. It may be arranged the impact of the end thrust beam end surface with the flexible portion of chamber wall occurs when the line of action is approximately at its centre. In this manner, the residual spring force is instantaneously switched from the pivot point to the point of impact. In practice, this force will probably be double the impact loading, so is very significant.
  • the end thrust beam ends may be retained by sockets within the rigid chamber wall. By appropriately designing these sockets, they may set defined limits to the rotational travel of the end thrust beam, provide a land for the pivot action and control the movement of the flexible material.
  • the syringe may be flushed of air bubbles in the usual manner, prior to use, but the working volume of the effective injector pump is small and a slight spring back of the rubber syringe piston can induce inflow of air. Clearly bubbles within the pump will prevent correct operation. If it is arranged that the spring tips load the skin of the patient before the nozzle touches down, the syringe piston will flush any air from the pump chamber. Because the density of air is roughly one thousandth that of a liquid drug, acceleration of air through the nozzle will be rapid and escape of liquid drug will be negligible.
  • FIG. 1 shows the spring in plan and elevation.
  • Figure 2 shows the injection process in axial cross section through the rigid chamber.
  • Figure 3 shows the external attachment.
  • Figure 4 indicates retention of the end thrust beam in its socket.
  • FIG. 1 shows a typical spring, 1, in plan and elevation.
  • the end thrust beams have extended central surfaces, 5, one corner of which, 6, acts as a rotational bearing and the surface, 5, provides the impact thrust.
  • FIG. 2 shows a series of axial cross sections of the device during the injection cycle.
  • the device is shown prior to use.
  • an injector body, 10, which comprises a rigid chamber, 11, a tapered section, 12, leading to a nozzle, 13, an elongated constriction, 14, which may lead to a piston and cylinder drug storage and delivery system.
  • the elongated constriction is a length of fine bore steel hypodermic chamber, which terminates in a sharp tip, 15, that may pierce the septum of a drug ampoule.
  • the threaded end cap, 28, is provided to facilitate this.
  • the constriction may be cold formed or a welded constriction against a pin former.
  • the rigid chamber, 11, also contains two flexible windows, 16, preferably moulded from silicone rubber and reference lands, 17.
  • the spring is shown in the initial configuration of concave to the skin of the patient.
  • the end thrust beams, 18, bear on the reference lands, 17, and the front and rear walls, 19 and 20 respectively of a retaining channel, 21.
  • the leaf springs, 22, are shown in dotted outline.
  • Figure 2a shows the assembly touching the skin of the patient, 23.
  • the end thrust beam tips touch first the skin first and pressure on the piston expels any air from the pump chamber.
  • the density of air is roughly one thousandth that of water, acceleration of air through the nozzle is approximately a thousand times greater and requires very little pressure. Conversely, there will be minimal escape of liquid during the brief period.
  • Figure 2b shows upward deflection of the spring by pressure from the skin of the patient.
  • the leaf springs flatten under load and extend elastically.
  • the frusto conical nozzle embeds in the skin to form a hydraulic seal and registration device.
  • Figure 2c indicates the planar metastable configuration of the leaf springs, 22. There is still clearance between the thrust surfaces, 5, and the flexible windows, 16.
  • Figure 2d shows the moment after impact.
  • the leaf springs, 22, are now convex with respect to the skin of the patient, 23.
  • the extended end thrust beam surfaces, 5, have impacted with the flexible windows, 16, resulting in protrusion, 24, of the silicone rubber into the rigid chamber, 11. This results in the expulsion of a high speed jet, 25, through the skin of the patient, 23.
  • the outer tips of the end thrust beams, 26, have moved sufficiently beyond the pivot point, 6, that the line of force, 27, lies approximately through the centre of the flexible windows, 16.
  • the spring load is therefore transferred very rapidly from the pivot to the flexible window providing a very fast pressure rise time.
  • the main chamber is unrestricted by the displaced rubber so drug may now flow freely from the ampoule under the action of the piston to the end of the track cut in the skin of the patient.
  • the device may be simply re-cocked by manually pushing the spring forward to its initial position. In this manner, the device can be re-fired in the unlikely event of a misfire. Such an event would be obvious to the user, as the piston would stay stationary. No leakage would occur as a wet shot, as explained above.
  • the injector may be used for multiple metered deliveries from the same ampoule. This will have considerable significance for insulin delivery.
  • the frusto conical nozzle, 30, is shown with the high pressure seal and frictional alignment retention along the locus of truncation, 31.
  • the radially decreasing compressive stress distribution in the soft tissue is indicated by dotted lines, 32.
  • Figure 3 shows retention of the leaf springs, 22, by external detents on the injector body, 41.
  • the position and profile of these detents may have a profound influence on the operation of the device.
  • the mechanical advantage of the system can be engineered to produce a more linear force displacement curve for the spring, which may provide a lower skin loading for a given system energy. To obtain maximum residual pressure from the spring at impact requires, minimum distension of a very stiff spring.
  • the mean mechanical advantage of the system can be increased by appropriate design of the detents.
  • a modicum of pre tension in the spring will assist in retaining the end thrust beams in their sockets. With careful design, it may be ensured that a displaced spring tip will return automatically to the symmetrical disposition. It may even be arranged that both spring tips are automatically reset even if only one is pushed forward after firing.
  • Figure 4a shows the forces acting on the end thrust beams in regard to retention of the end thrust beam in its socket.
  • the reaction, 50 from the rear face, 20, to an applied load on the spring tip, 51, has a component along the strut, 52.
  • the reaction, 53 from the forward wall has no such component.
  • the strut will pop out of its retaining socket, 21.
  • a feature, 55 is added to provide a point or line contact with the forward wall, so that the line of the reaction force, 53, becomes parallel with reaction force, 50, it will cancel the pop-out component.
  • the mechanical advantage of the leverage system ensures that reaction 53 is always greater than reaction 50, ensuring that the end thrust beam will stay in it socket..
  • the preferred material for the injector body and spring is polysulphone. It has medical certification, is highly stable, low mechanical loss, high yield strain, relatively low cost, is mouldable with mechanical properties that are substantially independent of the direction of melt flow. It is also very resistant to radiation damage which facilitates radiation sterilisation.
  • the preferred material for the rubber windows is medical grade silicone rubber, which is also very radiation resistant.
  • Conventional silane primers are relatively ineffective on polysulphone but it is found that a 30% chlorobenzene addition does not affect the silanes but partially dissolves the polysulphone surface giving excellent adhesion. Any remaining solvent may be dispelled by heating before moulding.
  • a silicone non return valve may be moulded across the nozzle during the moulding of the flexible windows. Pierced silicone rubber tends to re-bond to itself with time. This problem may be circumvented by adding 20% silicone oil to the rubber before moulding. This does not impair the bonding of the flexible windows but it does permanently inhibit rebonding of a non return valve.
  • the nozzle may be in the form of a slot rather than the conventional circular nozzle. This offers the possibility of cutting a larger diameter track with less fluid energy which is desirable in terms of reducing skin loading.
  • the membrane may be controllably burst with the high hydraulic pressure of the first firing.
  • Forming a depression in the rubber with a triangular prism mould tool predisposes the membrane to burst in a controlled fashion, forming a jet along the mid plane of the prism.

Abstract

L'invention porte sur un injecteur sans aiguille dont un ou plusieurs supports de poussée terminaux donnent une impulsion à des parties flexibles d'une chambre rigide située entre une canule et une constriction étendue. Ces supports de poussée terminaux sont actionnés par un ressort à lames passant au-dessus du centre et fonctionnant grâce à la pression de l'injecteur contre la peau du patient.
PCT/GB2002/002633 2001-06-20 2002-06-19 Injecteur sans aiguille jetable a faible cout WO2003000320A1 (fr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
GB0115086.1 2001-06-20
GB0115086A GB0115086D0 (en) 2001-06-20 2001-06-20 A simple jet injector
GB0117963A GB0117963D0 (en) 2001-07-24 2001-07-24 Peristaltic jet injector
GB0117963.9 2001-07-24
GB0200923A GB0200923D0 (en) 2001-06-20 2002-01-16 Micropump jet injector
GB0200923.1 2002-01-16
GB0205756A GB0205756D0 (en) 2001-06-20 2002-03-12 Improved jet injector
GB0205756.0 2002-03-12

Publications (1)

Publication Number Publication Date
WO2003000320A1 true WO2003000320A1 (fr) 2003-01-03

Family

ID=27447957

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2002/002633 WO2003000320A1 (fr) 2001-06-20 2002-06-19 Injecteur sans aiguille jetable a faible cout

Country Status (1)

Country Link
WO (1) WO2003000320A1 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004039438A1 (fr) * 2002-11-01 2004-05-13 Novo Nordisk A/S Injecteur sans aiguille a ressort bistable
WO2005058393A2 (fr) 2003-12-18 2005-06-30 Novo Nordisk A/S Dispositif de type a buse avec systeme d'etirement de la peau
WO2005070482A1 (fr) * 2004-01-26 2005-08-04 Novo Nordisk A/S Chambre a impulsions pour dispositif de distribution de jets
WO2008116688A1 (fr) * 2007-03-23 2008-10-02 Shl Medical Ab Auto-injecteur
WO2009053464A1 (fr) * 2007-10-24 2009-04-30 Novo Nordisk A/S Unité d'injection par jet à chambre de liquide élastique
US8608684B2 (en) 2003-11-27 2013-12-17 Novo Nordisk A/S Impulse chamber for jet delivery device
US8652095B2 (en) 2005-12-20 2014-02-18 Novo Nordisk A/S Skin retention device for a medical jet injection kit

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5034003A (en) * 1988-11-21 1991-07-23 Raymond Denance Injection device having a stabilizing sight which actuates a safety valve for the needle
WO1996018425A1 (fr) * 1994-12-17 1996-06-20 Bailey, William, John Injecteur
WO1998013085A1 (fr) * 1996-09-26 1998-04-02 Akzo Nobel N.V. Injecteur sans aiguille
WO2001030419A2 (fr) * 1999-10-28 2001-05-03 William Anthony Denne Pistolet a injection a usage unique

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5034003A (en) * 1988-11-21 1991-07-23 Raymond Denance Injection device having a stabilizing sight which actuates a safety valve for the needle
WO1996018425A1 (fr) * 1994-12-17 1996-06-20 Bailey, William, John Injecteur
WO1998013085A1 (fr) * 1996-09-26 1998-04-02 Akzo Nobel N.V. Injecteur sans aiguille
WO2001030419A2 (fr) * 1999-10-28 2001-05-03 William Anthony Denne Pistolet a injection a usage unique

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2004039438A1 (fr) * 2002-11-01 2004-05-13 Novo Nordisk A/S Injecteur sans aiguille a ressort bistable
US8608684B2 (en) 2003-11-27 2013-12-17 Novo Nordisk A/S Impulse chamber for jet delivery device
WO2005058393A2 (fr) 2003-12-18 2005-06-30 Novo Nordisk A/S Dispositif de type a buse avec systeme d'etirement de la peau
WO2005058393A3 (fr) * 2003-12-18 2005-08-04 Novo Nordisk As Dispositif de type a buse avec systeme d'etirement de la peau
JP2007514489A (ja) * 2003-12-18 2007-06-07 ノボ・ノルデイスク・エー／エス 皮膚引き伸ばし手段を有するノズルデバイス
WO2005070482A1 (fr) * 2004-01-26 2005-08-04 Novo Nordisk A/S Chambre a impulsions pour dispositif de distribution de jets
US8652095B2 (en) 2005-12-20 2014-02-18 Novo Nordisk A/S Skin retention device for a medical jet injection kit
WO2008116688A1 (fr) * 2007-03-23 2008-10-02 Shl Medical Ab Auto-injecteur
JP2010521260A (ja) * 2007-03-23 2010-06-24 エス・ホー・エル・グループ・アクチボラゲット 自動注射器
WO2009053464A1 (fr) * 2007-10-24 2009-04-30 Novo Nordisk A/S Unité d'injection par jet à chambre de liquide élastique

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