WO2017016987A1 - Dispositif d'injection et procédé utilisant un entraînement électrique régulé pour l'introduction d'une aiguille - Google Patents

Dispositif d'injection et procédé utilisant un entraînement électrique régulé pour l'introduction d'une aiguille Download PDF

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Publication number
WO2017016987A1
WO2017016987A1 PCT/EP2016/067456 EP2016067456W WO2017016987A1 WO 2017016987 A1 WO2017016987 A1 WO 2017016987A1 EP 2016067456 W EP2016067456 W EP 2016067456W WO 2017016987 A1 WO2017016987 A1 WO 2017016987A1
Authority
WO
WIPO (PCT)
Prior art keywords
injection
injection part
housing
needle
injection device
Prior art date
Application number
PCT/EP2016/067456
Other languages
German (de)
English (en)
Inventor
Tobias Kistler
Original Assignee
Vetter Pharma-Fertigung GmbH & Co. KG
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 Vetter Pharma-Fertigung GmbH & Co. KG filed Critical Vetter Pharma-Fertigung GmbH & Co. KG
Publication of WO2017016987A1 publication Critical patent/WO2017016987A1/fr

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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
    • A61M5/46—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for controlling depth of insertion
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • 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
    • A61M2005/206—With automatic needle insertion
    • 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
    • A61M5/2066—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically comprising means for injection of two or more media, e.g. by mixing
    • 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
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/422—Desensitising skin
    • 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
    • A61M5/42—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for desensitising skin, for protruding skin to facilitate piercing, or for locating point where body is to be pierced
    • A61M5/427—Locating point where body is to be pierced, e.g. vein location means using ultrasonic waves, injection site templates

Definitions

  • the invention relates to an injection device for medical purposes and a method for operating such an injection device.
  • a needle guard serves to prevent a user of the injection device from accidental contact with an injection needle
  • the needle guard Prior to using the injection device, the needle guard is manually displaced or removed by the user from an injection member to expose the injection needle. Usually, the displacement of the needle guard against the pressure of a
  • the disadvantage here is a risk of injury by the movable needle guard, for example by pinching, a possible ejection of parts from the injection device in case of failure of parts and a reduced life by failure of wearing parts. Also difficult
  • the invention is therefore based on the object to provide an injection device for medical purposes and a method for operating such an injection device, said disadvantages do not occur.
  • the object is achieved by providing the subject matters of the independent claims. Advantageous embodiments will become apparent from the dependent claims and the description.
  • an injection device for medical purposes which has an injection part and a housing.
  • the injection part is arranged to dispose an injection needle on the injection part.
  • the housing surrounds the injection part at least partially.
  • the injection part is displaceable relative to the housing.
  • the injection device has a drive device which is set up to effect a controlled and / or regulated relative displacement of the injection part relative to the housing.
  • the drive device has an electrical force generating device, which is operatively connected to the injection part at least in an operating state.
  • taxes is used synonymously for taxes and rules with the aim of simplifying comprehensibility.
  • the axial direction denotes a longitudinal direction of the injection device and preferably also of the housing, wherein the longitudinal direction preferably coincides with an axis of symmetry of the preferably cylindrical injection device.
  • a circumferential direction concentrically surrounds the axial direction.
  • a radial direction is perpendicular to the axial direction.
  • One at an injection intended end of the injection device facing the body of a patient is referred to as a front part. This points in the distal direction.
  • An end of the injection device arranged opposite to one another in the axial direction is referred to as the rear part and points in the proximal direction.
  • the injection part has a guide sleeve for receiving a primary packaging means.
  • the primary packaging means is preferably a carpule, in particular a Doppelschkarpu- le, or a syringe, each preferably made of glass or plastic.
  • the injection part therefore particularly preferably has the guide sleeve on the one hand and the primary packaging means arranged in the guide sleeve, in particular the carpule or the syringe, which is guided and held by the guide sleeve, on the other hand.
  • the primary packaging material which typically consists of a fragile or easily damaged material, is protected by the guide sleeve.
  • an embodiment of the injection device is preferred as an alternative, which is characterized in that the injection part is designed as a primary packaging.
  • the injection part is particularly preferably designed as a carpule or as a syringe.
  • the injection device can be constructed cheaper and easier.
  • the injection device has advantages over the prior art.
  • the relative displacement of the injection part can be effected controlled to the housing, it is possible in particular, the injection part automated or parameter- controls to relocate, so that a manual relocation is no longer necessary.
  • the controlled relative displacement of the injection part relative to the housing can be used to realize an added benefit.
  • the injection part is preferably displaceable relative to the housing, at least into a protective position and into an injection position.
  • the injection part can be displaced into a plurality of intermediate positions, particularly preferably into a continuum of intermediate positions between the protective position and the injection position.
  • the protective position is characterized in that the housing completely overlaps the injection needle in such a way that accidental contact with the injection needle and, in particular, injury due to it are precluded, whereby the injection position is characterized in that the injection needle is exposed so far that an injection can be performed with the injection device.
  • the injection part can be moved to an intermediate position which is suitable so that a user of the injection device can remove a protective cap from the injection needle without being able to injure himself.
  • the controlled relative displacement includes the ability to actively hold the injection member in a predetermined position. Furthermore, the controlled relative displacement includes an active displacement of the injection part, for example in order to shift this from the protective position into the injection position.
  • the relative displacement is preferably parameter-dependent controllable, wherein in particular displacement path, displacement speed, displacement acceleration, displacement force and / or displacement direction of the injection part can be specified. Furthermore, a controlled proximal displacement of the injection part is preferred in order to prevent conclusion of the injection to pull the hypodermic needle out of the patient's skin.
  • an autoinjector is, in particular, an injection device which is set up to completely inject a medicament dose encompassed by the injection part into the body of the patient as part of a single injection.
  • a pen is an injection device which can inject individual doses of a medicament encompassed by the injection part into the body of the patient in the course of a plurality of injections.
  • An embodiment of the injection device is preferred, which is characterized in that the force required for the relative displacement of the injection part is provided by the electric force generating device.
  • the electrical power generating device obtains its energy required for operation from an energy store, preferably a battery or an accumulator, which is arranged on the injection device, preferably integrated therein.
  • the electrical force generating device is characterized in that it is operatively connected to the injection part in at least one operating state. In this case, an operative connection is preferred which encompasses the relative displacement of the injection part both in the proximal direction and in the distal direction, as well as an active holding of the injection part in a predetermined position.
  • the holding of the injection member in a predetermined position can also be realized by a separate holding device is arranged on the injection device, is preferably integrated therein, which is arranged to hold the injection part in a predetermined position. In any case, it is possible to effect the relative displacement of the injection part in a secure and reproducible manner.
  • An embodiment of the injection device is also preferred, which is characterized in that the electric force generating device has an electric motor. It is a cost-effective, technologically mature and space-efficient solution.
  • the electric motor can also be controlled in a parameterizable manner. It is preferably designed as a stepper motor or servomotor.
  • An embodiment of the injection device is also preferred, which is characterized in that the drive device is arranged on the housing, preferably integrated therein.
  • the housing has larger cross-sectional dimensions than the injection part and thus serves the better tangibility and handling of the injection device by the user.
  • the injection part arranged within the housing is protected by the housing from impairment and / or damage.
  • the housing has a rotation lock, which is adapted to prevent a rotation of the injection part relative to the housing. It is preferably characterized in that the housing has on its inner circumferential surface at least one longitudinal groove, preferably a plurality of longitudinal grooves, in which at least one guide projection, preferably a plurality of guide projections or a guide engages ing rail, which is arranged on the injection part.
  • the at least one longitudinal groove can also be provided on the injection part and the at least one guide projection or the guide rail on the inner circumferential surface of the housing.
  • the injection part or an outer casing around the injection part may, for example, have the outer contour of a polygon, which cooperates with a corresponding inner contour of the housing.
  • the drive device has a mechanical transmission which is set up to operatively connect the electrical force-generating device to the injection part, at least in one operating state.
  • the operating state is a state in which the holding and / or the relative displacement of the injection part are required.
  • a mechanical gearbox is particularly preferred because of the low cost, the technological maturity and the compact design.
  • the mechanical transmission is designed as a spur gear. Here meshes a drive-side pinion with a toothing, which is arranged on the injection part.
  • the axis of rotation of the pinion is preferably aligned orthogonal to the axial direction.
  • the pinion meshes with the toothing, preferably a toothed rack, which preferably at least partially represents a line-shaped area, which is located on an outer circumferential surface of the injection part and extending in the axial direction.
  • the toothing is arranged on the guide sleeve. If, however, the injection part is designed as a primary packaging means, the toothing is arranged on the primary packaging means. In principle, it is possible that the toothing extends in the circumferential direction on a sector of the outer circumferential surface of the injection part up to the entire circumference.
  • the toothing is integrally formed with the injection part.
  • the axial length of the toothing corresponds to a maximum translational displacement of the injection part.
  • the arrangement of the mechanical transmission, in particular of the pinion, the length of the toothing and an axial arrangement of the toothing on the injection part are preferably adjusted so that the injection part can be displaced into the protective and injection position.
  • a mechanical gearbox located at the rear end of the housing may require a longer injection part than a mechanical gearbox located at the front end of the housing.
  • individual elements of the drive device are arranged at different locations of the housing.
  • the mechanical transmission is arranged in the front part of the housing, while the electrical force generating device is arranged in the rear part of the housing.
  • the electrical force generating device in addition to its function for Relativverlagern of the injection part other functions such as acting on the primary packaging, for example, activating an active and / or auxiliary by mixing or squeezing the same from the primary packing means, takes over.
  • the teeth in a raised design as a guide rail or in recessed design as a longitudinal groove of the rotation lock.
  • the spur gear is straight teeth.
  • the straight-toothed spur gear can also be designed as a friction gear.
  • the mechanical transmission is designed as a worm gear.
  • a cylindrical screw is in this case arranged radially spaced from the injection part, its axis of rotation is preferably parallel to the longitudinal axis.
  • a worm wheel preferably corresponds to a toothing, preferably a rack.
  • the toothing is arranged on the outer lateral surface of the injection part in the axial direction, preferably integrally formed thereon.
  • the toothing is arranged on the guide sleeve or the primary packaging means.
  • the cylindrical worm meshes with the toothing on the injection part, so that the rotational movement of the cylindrical worm causes the relative displacement of the injection part.
  • the arrangement of the mechanical transmission, in particular the cylindrical screw, on the housing and the length of the cylindrical screw and an axial arrangement of the toothing on the injection part and the axial length of the toothing on the injection part are preferably adjusted so that the required relative movement of the injection part according the intended use can be realized.
  • the axis of rotation of the cylindrical screw is not parallel to the longitudinal axis of the injection part, but at an angle offset thereto.
  • Worm gears can be designed to be self-locking, which is a desired effect in this embodiment.
  • a force on the injection part in the axial direction does not lead to an unwanted displacement of the injection part, that is, a conversion of a longitudinal displacement of the rack in a rotational displacement of the cylindrical screw is prevented.
  • a sufficiently small pitch angle of the cylindrical screw is preferably selected, so that an efficiency of less than 0.5 is preferably realized.
  • the injection part can then be securely held in position. A strong reduction achieved thereby also proves advantageous in terms of a very precise axial positioning of the injection part.
  • An embodiment of the injection device is preferred, which is characterized in that the drive device has a double tappet.
  • a first part of the double tappet is a coupling sleeve which is set up, at least in an operating state, to operatively connect the electrical force-generating device to the injection part.
  • a second part of the double plunger is a piston adapted to act on the primary packaging means having the injection part.
  • the coupling sleeve engages around the piston at least partially.
  • the coupling sleeve and the piston are each carried out separately displaceable.
  • the outer dimensions of the piston are matched to the inner dimensions of the coupling sleeve in such a way that the coupling sleeve at least partially seals the piston.
  • the piston is preferably carried out by the coupling sleeve, wherein the piston in the coupling sleeve is axially relocatable.
  • the outer dimensions of the coupling sleeve and the inner dimensions of the housing are matched to one another in such a way that the housing can embrace the coupling sleeve, preferably at least in sections, in a guiding manner. An axial relative displacement of the coupling sleeve to the housing is possible.
  • the double tappet is located behind the injection part. The coupling sleeve and the injection part are set up to realize an operative connection.
  • a state can be achieved at which the coupling sleeve contacts the injection part in a predetermined manner.
  • the injection part has the guide sleeve which encompasses the primary packaging means, a contacting of the coupling sleeve and the guide sleeve and / or of the primary packaging means is possible.
  • the guide sleeve and / or the primary packaging means are preferably contacted on a rear side surface of the respective lateral surface. This makes it possible to realize the introduction of force as a pressure force introduction into the injection part for relative displacement so that the guide sleeve and / or the primary packaging are not exposed to unacceptable bending forces and material damage is prevented.
  • the coupling sleeve is contacted with the primary packaging means.
  • the coupling sleeve is thus adapted to the relative displacement of the injection part by introducing a compressive force in the injection part in the distal direction, whereby it is possible to shift the injection part from the protective position into the injection position.
  • the contact surface between the coupling sleeve and the injection part, in particular the guide sleeve se and / or the primary packaging, is preferably predetermined and configured, for example by means of positive locking, that a secure guidance of the injection part is realized by the coupling sleeve.
  • the coupling sleeve is guided in the housing to prevent the introduction of a relative rotation in the injection part.
  • at least one longitudinal groove is preferably introduced into the housing on the inside, in which engages at least one guide projection which is arranged on an outer lateral surface of the coupling sleeve. It is also possible that at least one longitudinal groove is arranged on the outer circumferential surface of the coupling sleeve, in which engages at least one guide projection, which is arranged on the inside of the housing.
  • the injection device is also characterized in that a relative displacement of the injection part in the proximal direction can be realized.
  • two solutions are preferred, which can be realized separately or together.
  • a first alternative is an axial coupling of the coupling sleeve with the injection part.
  • a positive and / or non-positive connection which is preferably designed as a releasable connection, such as a latch, between the coupling sleeve and the injection member. It is thereby possible to shift the injection part from the injection position into the protective position.
  • the coupling sleeve is also designed for the transmission of compressive and tensile forces.
  • a second alternative is that a force in the proximal direction is introduced into the injection part by means of a prestressed spring.
  • a spring element is preferably arranged between a front end region of the injection part and a front end region of the housing.
  • the front end region of the housing is preferably designed such that between a Inner peripheral surface of the housing and an opening through which the injection needle is feasible, arranged a first bearing area, preferably formed, which has a nikringför- shaped in the case of a cylindrical housing and a circular opening.
  • a first bearing area preferably formed, which has a nikringför- shaped in the case of a cylindrical housing and a circular opening.
  • a relative displacement of the injection part in the distal direction by introducing pressure force through the coupling sleeve on the injection part this is done against a spring force of the spring element.
  • the pressure force must therefore be greater than the spring force.
  • the relative displacement of the injection member in the proximal direction can be done by the pressure force is reduced below a level of the spring force, so that the proximal relative displacement of the injection part can be effected by the spring force.
  • the control of the proximal relative displacement as well as a holding of the injection part is preferably carried out by controlling the relative displacement of the coupling sleeve in the proximal direction. In this case, it is sufficient if the coupling sleeve is designed for the transmission of compressive forces.
  • the piston the double ram has, is arranged behind the injection part in such a way that it is aligned with the end plug of the primary packaging means.
  • the dimensions of the piston are designed so that an operative connection with the end plug can be realized, so that a relative displacement of the piston in the distal direction causes a relative displacement of the end plug in order to act on the primary packaging means.
  • the electrical force generating device which has the drive device, is preferably arranged in the rear part of the housing, preferably integrated therein.
  • the drive device can also be arranged in another part of the housing. It is operatively connected at least in an operating state with the coupling sleeve, wherein it is thereby operatively connected to the injection part and is adapted to cause a relative displacement of the injection part.
  • a mechanical transmission is arranged between the electrical see force generating device and the coupling sleeve, which is arranged to implement a rotational movement of the electric force generating device in the translational axial relative displacement of the coupling sleeve.
  • the mechanical gear can be constructed so that a drive-side pinion meshes with a rack, which is arranged on the outer lateral surface of the coupling sleeve.
  • the drive device By controlling the drive device, in particular a first drive train, it is possible to effect the controlled relative displacement of the injection part in the proximal and distal directions as well as the holding of the injection part in a predetermined position. It is also conceivable that the drive device has a second drive train, which is set up to realize a relative displacement of the piston. Preferably, the first and the second drive train are each separately controllable.
  • the advantage of this embodiment of the injection device manifests itself inter alia in a particularly slim design of the injection device, which allows a particularly ergonomic design of the housing.
  • An exemplary embodiment of the injection device is preferred, which is characterized in that the drive device has a clutch which is set up to operatively connect the electrical force generating device to the mechanical transmission, at least in one operating state.
  • the coupling may constitute a rigid, elastic, movable and / or releasable connection of the electrical force generating device with the mechanical transmission. It is preferably possible to effect an increase or decrease in the speed of the rotational movement by controlled looping of the clutch during engagement and / or during disengagement.
  • the clutch is configured to block the injection part by blocking preferably the output side power flow of the drive train.
  • an overload protection function can be realized by allowing a slip in the drive train between the electric drive device and the mechanical transmission when a predetermined maximum torque is exceeded.
  • a controlled interruption of the operative connection between the electric drive device and the mechanical transmission can be realized in order to manually realize, for example in the event of a power failure, the force introduction necessary for the displacement of the injection part. It is preferably possible to use a suitable device for this purpose. To introduce a rotary motion on the drive side via a bypass in the mechanical transmission, for example by rotating a handwheel, thereby causing the axial relative displacement of the injection part.
  • An embodiment of the injection device is also preferred, which is characterized in that the drive device has a control device which is set up to control the drive device in order to control the relative displacement of the injection part.
  • the control device is set up for a position determination of the injection part relative to the housing. The position determination can be used in particular to check in which position the injection part is arranged, and / or to define a maximum release length and thus in particular a maximum penetration depth of the injection needle into the body of the patient.
  • the position determination is preferably realized by measuring the revolutions of the electric motor, in particular a stepping motor, and / or by reading a rotary encoder on a suitable element on the drive train, wherein the position of the injection part is determined and confirmed.
  • the maximum penetration depth of the injection needle is particularly preferably parameter-dependent and / or parameterizable depending on an injection type, wherein, for example, different penetration depths for patients with different body measurement index (BMI) as well as for different injection types, in particular a subcutaneous, intracutaneous, intradermal, intraarterial, intravenous, intramuscular or other injection.
  • control device can preferably be operated, in particular parameterized, by a physician, medical staff or the user of the injection device via a man-machine interface. Furthermore, it is preferably possible that the control device is set up to actively displace the injection part during the penetration of the injection needle into the body tissue of the patient in the distal direction, to actively shift in the proximal direction after completion of the injection, around the injection needle from the skin of the patient to pull, and / or to keep the Injekti- on part at a predetermined position.
  • a further exemplary embodiment of an injection device is preferred, which is characterized in that the injection device has at least one sensor which is set up to record operating data, position data and / or further data.
  • the at least one sensor is operatively connected to the control device, wherein the control device is configured to process sensor data for controlling, in particular, the displacement of the injection part relative to the housing. It is also conceivable to control the piston for acting on the primary packaging.
  • a first sensor is in particular configured to detect a placement of the housing on the skin of the patient, wherein the first sensor in this case is preferably designed as a pressure sensor, touch sensor or distance sensor.
  • a second sensor which is designed as a distance sensor
  • the distance of the injection device from an intended puncture site on the skin of the patient can be detected.
  • the first and second sensors may be the same sensor. Using data obtained in this way is particularly effective and certainly possible to monitor the relative displacement between the injection device and the skin of the patient, for example to monitor the penetration depth of the injection needle.
  • the object is also achieved in particular by providing a method for operating an injection device for medical purposes, whereby a relative displacement of an injection part having an injection needle is controlled and / or regulated to a housing. This is done by driving a drive device which is operatively connected to the injection part at least in one operating state.
  • an injection device according to one of the embodiments described above is particularly preferably operated.
  • the advantages that have already been explained in connection with the injection device arise.
  • the term tax is used synonymously for taxes and rules with the aim of better understanding and simplicity in connection with the relative shift.
  • the control of the relative displacement between the injection part and the housing in particular includes that the injection part is held in a predetermined position relative to the housing.
  • An embodiment of the method is preferred, which is characterized in that the injection part is moved to a position in which the injection needle is exposed in a predetermined section.
  • a protective cap is provided, which is still arranged inside the housing on the injection needle, so that it is also displaced in the proximal direction injection part - so in particular. the same in the injection position of the same - is not yet freely accessible. Rather, then first the protective cap must be removed from the injection needle. By displacing the injection member to a predetermined position and thus exposing the injection needle in the predetermined portion, it is certainly possible for a user to grasp the protective cap and withdraw it from the injection needle.
  • An embodiment of the method is preferred, which is characterized in that it is checked whether the injection needle has traveled a predetermined insertion path.
  • it can be checked whether the injection needle has penetrated into the body of a patient with a penetration depth, which can preferably be parameterized.
  • the penetration depth can be parameterized in particular as a function of a specific patient and / or of an injection type.
  • a position of an end face of the housing is known precisely at the level of a tip of the injection needle or preferably slightly above, wherein the injection part is displaced in such a way that, at the beginning of an injection, the tip of the injection needle is in a plane of an opening of the housing, thus congruent with the face, lies.
  • the injection device is then placed with the end face on the skin of the patient.
  • the position determination of the injection part is preferably realized by means of measuring the revolutions of an electric motor, which has an electrical force generating device which has the drive device, and / or by reading a rotary encoder on a suitable element on the drive train, whereby a position of the injection part is determined and confirmed becomes.
  • the injector tion needle are displaced into the body of the patient, wherein the injection member is displaced relative to the housing in the distal direction.
  • the reaching of a predetermined end position of the injection part can be detected, wherein the path between the known position at the level of the tip of the injection needle and the predetermined end position corresponds to the predetermined insertion path.
  • the injection member is actively held or locked at the predetermined end position.
  • a specific signal can preferably be generated by the control device.
  • the holding or locking of the injection part is preferably effected by stopping, in particular blocking, the motor, by blocking by means of the coupling and / or another device.
  • the injection part is already displaced to the predetermined end position at the beginning of the injection, in which case the injection takes place such that the injection device with the injection needle from the user until reaching a skin contact with the end face of the housing in the body the patient is guided.
  • An embodiment of the method is also preferred, which is characterized in that a placement on a puncture site is detected by means of at least one sensor. In particular, this assists in checking whether the injection needle has actually traveled the predetermined puncture path.
  • the placement of the end face of the housing on the skin of the patient can be detected by a first sensor, which is preferably designed as a pressure, contact or distance sensor.
  • a specific signal can be generated, alternatively or additionally in the absence of feedback from the first sensor with respect to the contact of the end face of the housing with the skin a preferably different specific signal generated ,
  • a second sensor which is designed as a distance sensor, can be set up to detect a distance of the injection device from the intended puncture site on the skin of the patient. This is for example at already displaced before the injection in the distal direction injection part to detect the achievement of the predetermined penetration depth of the injection needle into the skin of the patient.
  • a continuous measurement of the distance of the injection device with the intended puncture site on the skin of the patient and thus the achievement of the predetermined penetration depth can be checked.
  • the first and second sensors may be the same sensor.
  • the housing for at least a predetermined period of time to vibrations, preferably by means of the drive means, is excited. This may be done, for example, to indicate the end of a predetermined injection period.
  • the housing is caused to vibrate in order to facilitate the penetration of the injection needle when the housing rests on the skin of the patient.
  • the housing can in particular be excited to high-frequency oscillations in order to influence the properties of the body tissue and the skin in a manner favorable to the penetration of the injection needle.
  • a similar approach is known, for example, for razor blades, which can be excited to vibrate to facilitate shaving or to make it more thorough.
  • the housing is already stimulated before the penetration of the injection needle into the body tissue of the patient to vibrate to distract the patient and thereby overcome any fear of injection and additionally or alternatively to reduce perception of the puncture by the patient in that the perception of the puncture with the perception of vibration superimposed.
  • An embodiment of the method is also preferred, which is characterized in that the injection part is actively displaced in the proximal direction after injection, in order to shift the injection needle back out of the injection position.
  • the injection part is moved away from the body of the patient by proximal relative displacement, wherein at the same time the injection needle is withdrawn from the body tissue of the patient.
  • the user and in particular the patient who operates the injection device itself, then does not have to pull the injection needle out of the body tissue by its own power after the end of the injection, but rather it is pulled out by active displacement of the injection part. Also, a too long residence time of the injection needle in the body of the patient can be avoided.
  • a timing for the duration of the injection may be provided within the scope of the method. It is possible that the achievement of the maximum penetration depth of the injection needle is detected in the body tissue, after which the injection is started or at least a start of the injection is assumed. After a predetermined, in particular parameterizable period of time, the injection part can then be displaced in the proximal direction in order to preferably immediately extract the injection needle from the body tissue. The end of the injection can also be indicated by a brief movement, in particular vibration, of the housing.
  • the description of the injection device on the one hand and the method on the other hand are to be understood as complementary to one another.
  • Features of the injection device that have been explained explicitly or implicitly in connection with the method are preferably individually or combined with one another
  • Features of a preferred embodiment of the injection device are preferably individually or combined with one another
  • Method steps which have been explained explicitly or implicitly in connection with the injection device are preferably individually or combined with one another Steps of a preferred embodiment of the method.
  • This is preferably characterized by at least one method step, which is caused by at least one feature of the injection device.
  • the injection device is preferably characterized by at least one feature, which is due to at least one step of a preferred embodiment of the method.
  • Figure 1 is a sectional view of a first embodiment of an injection device in a first functional position
  • FIG. 2 shows the exemplary embodiment of the injection device according to FIG. 1 in a second functional position
  • FIG. 3 is a sectional view of a second exemplary embodiment of the injection device in a first functional position
  • FIG. 4 shows the exemplary embodiment of the injection device according to FIG. 3 in a second functional position
  • Figure 5 is a sectional view of a third embodiment of the injection device in a first functional position
  • Figure 6 shows the embodiment of the injection device according to Figure 5 in a second functional position
  • FIG. 7 shows the exemplary embodiment of the injection device according to FIGS. 5 and 6 in a third functional position.
  • the injection device 1 shows a representation of a first embodiment of an injection device 1 in longitudinal section.
  • the injection device 1 has an injection part 3 which has an injection needle 5.
  • the injection device 1 also has a drive device 7.
  • the drive device 7 is set up to effect a controlled relative displacement of the injection part 3 to a housing 9 in the axial direction, that is to say vertically in FIG.
  • the drive device 7 in this case has an electrical force generating device 1 1, which preferably has an electric motor, which is not shown in Figure 1.
  • the electrical force generating device 1 1 is operatively connected to the injection part 3 at least in an operating state.
  • the operative connection between the electrical force generating device 1 1 and the injection Part 3 is preferably realized by a mechanical transmission, which is designed as a spur gear 13.
  • the toothing 17 is preferably designed as a rack and arranged on the injection part 3. It is conceivable that a predetermined end point of the relative displacement of the injection part 3 is determined by a Endanschlagselement, which is arranged on the injection part 3, which is not shown in Figure 1, however.
  • the end stop member is adapted to prevent axial displaceability of the injection member 3 beyond the predetermined end point by the end stop member meeting, at the predetermined end point, an end stop counterpart member fixedly attached to the housing 9. It is conceivable that the axial range of motion of the injection part 3 is defined in proximal and in the distal direction by two such devices.
  • the injection device 1 has the housing 9, which surrounds the injection part 3.
  • the housing 9 increases the ease of use of the injection device 1 and at the same time protects the injection part 3 from damage.
  • the injection part 3 is guided in the housing 9, wherein preferably a non-illustrated in Figure 1 rotation of the type described in the preceding text is provided.
  • the injection part 3 in a defined rotational position - seen in the axial direction - are held relative to the housing 9.
  • a specific position of the housing 9 a certain position of an opening plane of a tip of the injection needle 5 can be assigned to a Users to facilitate the handling of the injection device 1.
  • the drive device 7 is arranged in the housing 9, preferably integrated in the housing 9.
  • the injection device 1 preferably has a control device, which is preferably set up to control the drive device 7 in order to control the relative displacement of the injection part 3.
  • the control device is preferably set up to determine a position of the injection part 3 relative to the housing 9.
  • the position of the injection part 3, or a corresponding position of the pinion 15 and the end points of the injection part 3 in the proximal and distal directions are preferably stored in the control device.
  • the relative displacement can be controlled so that the injection part 3 is not unintentionally displaced beyond the specific end points.
  • the injection device 1 preferably has at least one sensor, which is preferably arranged on the housing 9 and / or at another point of the injection device 1, preferably integrated in a component. It is not shown in FIG.
  • the at least one sensor is preferably set up to detect a placement of the housing 9 on an intended puncture site and / or to determine a distance of the injection device 1 to a puncture site. It is operatively connected to the control device, wherein the control device is adapted to process sensor data for controlling in particular the relative displacement of the injection part 3.
  • the injection part 3 is formed as a primary packaging 19, more preferably as a carpule 21, such as shown in Figure 1, or as a syringe.
  • the carpule 21 is a double chamber carpule.
  • the injection needle 5 is preferably detachable for multiple use of the carpule 21 connected to the primary packaging means 19 and pierces a septum 23 of the carpule 21, when the injection needle 5 is placed as intended on the carpule 21.
  • the injection part 3 has a guide sleeve, in which the primary packaging means 19 is guided and held.
  • the injection part 3 is displaced so far in the axial direction from its protective position shown in Figure 1 in the distal direction, which can be deducted by the user manually from the injection needle 5 a protective cap 25.
  • This position of the injection part 3 is then preferably also a position which occupies the injection part 3 at the beginning of an injection.
  • the opening 27 and in particular an end face 29 are then arranged just at the level of a tip of the injection needle 5.
  • a predetermined puncture path can be ensured and / or checked if the injection part 3 is arranged at the beginning of the injection in a defined predetermined relative position to the housing 9.
  • the injection device 1 after deduction of the protective cap 25 in just that position of the injection part 3 with the end face 29 on the skin of the patient sets up the tip of the injection needle 5 is in the plane of the opening 27. A measured from this position relative displacement of the Injection part 3 in the distal direction then also indicates the insertion path of the injection needle 5 into the body tissue of the patient, so that a penetration depth is determined and the certain puncture route can be tested. It is important that in the injection device 1, the injection part 3 relative to the housing 9 in a controlled manner displaced or even at a predetermined position festhaltbar by the drive means 7 is driven in a suitable manner.
  • FIG. 2 shows the exemplary embodiment of the injection device 1 according to FIG. 1 in a second functional position. Identical and functionally identical elements are provided with the same reference numerals, so that reference is made to the preceding description.
  • the injection part 3 in the functional position shown in FIG. 2, the injection part 3 is displaced maximally far in the distal direction so that, starting from the opening 27, a maximum injection length of the injection needle 5 is released.
  • the protective cap 25 is removed.
  • the injection needle 5 protrudes beyond the opening 27, so that it can penetrate into the body tissue of the patient or may have already penetrated.
  • the drive means 7 a maximum penetration depth of the injection needle 5 is limited in the body tissue of the patient by an intermediate position between the Abziehdian, wherein the protective cap 25 is withdrawn, and the position shown in Figure 2 is taken.
  • the injection part 3 can then be held by means of the drive device 7 in a predetermined position, for example, corresponding to the maximum penetration depth, so that further penetration of the injection needle 5 into the body tissue can be prevented.
  • the maximum penetration depth of the injection needle 5 is preferably parameterizable and can be stored in particular in the control device.
  • the penetration depth, and thus the predetermined stichweg are limited by means of a suitable control of the drive means 7, in particular in a parameterizable manner.
  • a residence time of the injection part 3 can be parameterized in a predetermined injection position, in particular, a predetermined holding time and / or injection time can be programmed.
  • the housing 9, preferably by means of the drive means 7, is excited to vibrate. This may be used, for example, to indicate an end of the predetermined injection or hold time.
  • the housing 9 it is also possible for the housing 9 to be impressed with vibrations during the penetration of the injection needle 5 into the body tissue, as a result of which the penetration of the injection needle 5 into the body tissue is made easier, if necessary, and a reduction in pain is possible.
  • FIG. 3 shows a sectional view of a second embodiment of the injection device 1 in a first functional position.
  • the same and functionally identical elements are provided with the same reference numerals, so that reference is made to the previous description.
  • FIG. 3 differs from FIGS. 1 and 2 essentially in that the mechanical transmission is designed as a snow Kenkegetriebe 31 is formed.
  • the worm gear 31 is used to transmit the force from the electric force generating device 1 1 and the injection part 3.
  • a power transmission via a drive-side cylindrical screw 33 is realized, which meshes with the toothing 17 'on the injection part 3, in this illustration, the primary packaging 19.
  • the cylindrical screw 33 is self-locking.
  • the toothing 17 ' is at least partially disposed on the outer circumferential surface of the injection part 3, preferably formed integrally therewith.
  • a rotation lock according to the described type is preferably realized. It is preferably provided to arrange a coupling, which is not shown in FIG. 3, between the worm gear 31 and the electrical power generating device 1 1 with the functionality already described.
  • FIG. 4 shows the exemplary embodiment of the injection device according to FIG. 3 in a second functional position. Identical and functionally identical elements are provided with the same reference numerals, so that reference is made to the preceding description.
  • FIG. 4 differs from FIG. 3 essentially in that the injection part 3 is largely displaced in the distal direction and the protective cap 25 is pulled off. The injection part 3 is not yet in, in the distal direction, the maximum extended state. It is therefore possible to displace the injection part 3 with the injection needle 5 still further in the distal direction, thereby further increasing the penetration depth of the injection needle 5. However, it may also be provided, the injection part 3 in just that position, because the maximum penetration depth of the injection needle 5 is already reached in the body tissue of the patient.
  • FIG. 5 shows a sectional illustration of a third exemplary embodiment of the injection device 1 in a first functional position.
  • This embodiment of the injection device 1 is characterized in that the drive device 7 has a double tappet 35.
  • a first part of the double tappet 35 is designed as a coupling sleeve 37.
  • the coupling sleeve 37 is set up, at least in an operating state, to electrically connect the electrical force-generating device 11, which is not shown in FIG. 5, to the injection part 3.
  • the double plunger 35 also has a second part, namely a piston 39.
  • the piston 39 is adapted to act on the primary packing means 19.
  • the coupling sleeve 37 is arranged such that it contacts the rear side surface of the lateral surface of the primary packaging means 19, in particular the carpule 21, at its front end.
  • the coupling sleeve 37 is at least partially encompassed by a housing part 9 ', wherein the housing part 9' is detachably connected to the housing 9.
  • the coupling sleeve 37 is preferably guided in the housing part 9 ', preferably in the manner of the rotation lock already described.
  • the coupling sleeve 37 surrounds at least partially the piston 39, preferably this is guided in the coupling sleeve 37.
  • the front end of the piston 39 is operatively connected to the rear side surface of the end plug 40 of the primary packing means 19, which is here designed as a double-chamber carpule.
  • the injection part 3 is also distinguished by the fact that it has a guide sleeve 41, which the primary packaging means 19, in particular the carpule 21 surrounds.
  • the guide sleeve 41 is seated with its rear end on a flange 43 of the housing part 9 ', which also serves the connection with the housing 9 here.
  • the flange 43 thus forms a rear end stop element, which limits an axial displacement of the injection part 3 in the proximal direction.
  • FIG. 6 shows a sectional illustration of the exemplary embodiment of the injection device according to FIG. 5 in a second functional position. Identical and functionally identical elements are provided with the same reference numerals, so that reference is made to the preceding description.
  • the injection part 3 in the illustrated functional position, is displaced in the distal direction relative to the position in FIG. This displacement can preferably be effected by the coupling sleeve 37 exerting a pressure force in the distal direction on the injection part 3.
  • the relative displacement of the injection part 3, in particular the relative displacement of the coupling sleeve 37 is preferably controlled by the control device.
  • the control device is set up to receive signals from the at least one sensor that can be processed in the control device.
  • the sensor is in turn set up to record operating data, position data, and / or further data of the injection device 1, for example placing the housing 9 with the end face 29 on the skin of a patient or a distance of the injection device 1, in particular the end face 29, from the intended puncture site.
  • the sensor is preferably operatively connected to the control device.
  • the relative displacement of the coupling sleeve 37 is preferably effected by the drive means 7, which is not shown in Figure 6, and which is controlled by the control device.
  • the injection tion part 3 is displaced so far in the distal direction that the injection needle 5 already projects beyond the opening 27 with its tip.
  • the injection needle 5 is enveloped by the protective cap 25.
  • the piston 39 In the functional position shown here, in comparison to FIG. 5, the piston 39 is displaced distally in the axial direction in synchronism with the coupling sleeve 37. Consequently, there has been no relative displacement of the end stopper 40 of the primary packaging means 19 relative to the guide sleeve 41.
  • FIG. 7 shows the exemplary embodiment of the injection device 1 according to FIG. 5 and FIG. 6 in a third functional position.
  • This functional position differs from the functional position shown in FIG. 6 by the withdrawn protective cap 25 and a piston 39 displaced in the distal direction, the displacement being relative to the coupling sleeve 37 and relative to the guide sleeve 41 and to the primary packaging means 19, in particular the carpule 21. is done.
  • the end plug 40 has been pressed by the piston 39 in the distal direction, whereby an action on the primary packaging means 19, in particular the carpule 21, has been completed.
  • the tip of the injection needle 5 projects beyond the opening 27 in the distal direction.
  • the injection needle 5 is not yet displaced maximally in the distal direction.
  • two solutions are preferred, which are realized together or alternatively preferably in the exemplary embodiment.
  • a contact region 44 is set up for the transmission of tensile forces.
  • a prestressed spring element is arranged between the housing 9, in particular a first support region 45 and the injection part 3, in particular an additional element 47, on which a second support region 49 is arranged, which is not shown in FIG.
  • both the safety and the injection comfort when using an injection device can be increased by the injection device 1 proposed here as well as the method for using an injection device. It is particularly advantageous that the length of the injection device remains constant. In particular, by avoiding shortening of the injection device when inserting the injection needle into the body tissue of the patient, tracking of the injection device by the user is not necessary, which increases the user-friendliness. The injection can thus be actively controlled without the patient, apart from the puncture perceives.
  • a further advantage with regard to the robustness of the injection device is that the housing assumes the function of a needle guard and thus avoids damage of a separate needle guard that is easier to damage than the housing.

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

Abstract

L'invention concerne un dispositif d'injection (1) à usage médical, comportant une partie d'injection (3) qui est conçue pour la mise en place d'une aiguille d'injection (5) sur la partie d'injection (3), et un boîtier (9,9') qui entoure au moins partiellement la partie d'injection (3), la partie d'injection (3) pouvant se déplacer par rapport au boîtier (9,9') et comportant un dispositif d'entraînement (7) conçu pour provoquer un déplacement relatif commandé et/ou régulé de la partie d'injection (3) par rapport au boîtier (9,9'), et le dispositif d'entraînement (9) comprenant un dispositif de génération de force électrique (11) qui est en liaison fonctionnelle avec la partie d'injection (3), au moins à l'état de fonctionnement.
PCT/EP2016/067456 2015-07-24 2016-07-21 Dispositif d'injection et procédé utilisant un entraînement électrique régulé pour l'introduction d'une aiguille WO2017016987A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102015214088.1A DE102015214088A1 (de) 2015-07-24 2015-07-24 Injektionseinrichtung und Verfahren zum Betreiben einer Injektionseinrichtung
DE102015214088.1 2015-07-24

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Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0302278A1 (fr) * 1987-08-05 1989-02-08 VEB Transformatoren- und Röntgenwerk "Hermann Matern" Dispositif d'injection
US20140330203A1 (en) * 2011-06-02 2014-11-06 Ucb Pharma Sa Auto-injector

Family Cites Families (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0239721A3 (fr) * 1986-04-03 1987-12-23 VEB Transformatoren- und Röntgenwerk "Hermann Matern" Dispositif pour injection et méthode pour introduire une canule
US8517992B2 (en) * 2009-07-15 2013-08-27 Sanofi-Aventis Deutschland Gmbh Drive mechanism for an injection device and an injection device with such a drive mechanism
US9308321B2 (en) * 2013-02-18 2016-04-12 Medtronic Minimed, Inc. Infusion device having gear assembly initialization

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0302278A1 (fr) * 1987-08-05 1989-02-08 VEB Transformatoren- und Röntgenwerk "Hermann Matern" Dispositif d'injection
US20140330203A1 (en) * 2011-06-02 2014-11-06 Ucb Pharma Sa Auto-injector

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