EP4363009A1 - Auto-injecteur pourvu d'un module électronique - Google Patents
Auto-injecteur pourvu d'un module électroniqueInfo
- Publication number
- EP4363009A1 EP4363009A1 EP22743784.5A EP22743784A EP4363009A1 EP 4363009 A1 EP4363009 A1 EP 4363009A1 EP 22743784 A EP22743784 A EP 22743784A EP 4363009 A1 EP4363009 A1 EP 4363009A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- housing
- engagement
- signal
- auto
- propulsion
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 229940090047 auto-injector Drugs 0.000 title claims abstract description 139
- 239000003814 drug Substances 0.000 claims abstract description 13
- 239000012263 liquid product Substances 0.000 claims abstract description 8
- 239000000047 product Substances 0.000 claims description 59
- 230000011664 signaling Effects 0.000 claims description 53
- 238000009826 distribution Methods 0.000 claims description 47
- 230000008878 coupling Effects 0.000 claims description 13
- 238000010168 coupling process Methods 0.000 claims description 13
- 238000005859 coupling reaction Methods 0.000 claims description 13
- 229940079593 drug Drugs 0.000 claims description 8
- 238000006073 displacement reaction Methods 0.000 claims description 6
- 238000004891 communication Methods 0.000 claims description 4
- 230000001960 triggered effect Effects 0.000 claims description 3
- 238000005259 measurement Methods 0.000 abstract description 3
- 238000007599 discharging Methods 0.000 abstract 1
- 230000036961 partial effect Effects 0.000 description 30
- 238000002347 injection Methods 0.000 description 29
- 239000007924 injection Substances 0.000 description 29
- 230000001681 protective effect Effects 0.000 description 11
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- 240000001973 Ficus microcarpa Species 0.000 description 2
- 102000004877 Insulin Human genes 0.000 description 2
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- 101710198884 GATA-type zinc finger protein 1 Proteins 0.000 description 1
- 102400000322 Glucagon-like peptide 1 Human genes 0.000 description 1
- DTHNMHAUYICORS-KTKZVXAJSA-N Glucagon-like peptide 1 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](C)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](C(C)C)C(=O)N[C@@H](CCCCN)C(=O)NCC(=O)N[C@@H](CCCNC(N)=N)C(N)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](C)NC(=O)[C@H](C)NC(=O)[C@H](CCC(N)=O)NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC=1C=CC(O)=CC=1)NC(=O)[C@H](CO)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](C)NC(=O)[C@@H](N)CC=1N=CNC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 DTHNMHAUYICORS-KTKZVXAJSA-N 0.000 description 1
- 108091034117 Oligonucleotide Proteins 0.000 description 1
- JLCPHMBAVCMARE-UHFFFAOYSA-N [3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[3-[[3-[[3-[[3-[[3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-[[5-(2-amino-6-oxo-1H-purin-9-yl)-3-hydroxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxyoxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(5-methyl-2,4-dioxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(6-aminopurin-9-yl)oxolan-2-yl]methoxy-hydroxyphosphoryl]oxy-5-(4-amino-2-oxopyrimidin-1-yl)oxolan-2-yl]methyl [5-(6-aminopurin-9-yl)-2-(hydroxymethyl)oxolan-3-yl] hydrogen phosphate Polymers Cc1cn(C2CC(OP(O)(=O)OCC3OC(CC3OP(O)(=O)OCC3OC(CC3O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c3nc(N)[nH]c4=O)C(COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3COP(O)(=O)OC3CC(OC3CO)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3ccc(N)nc3=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cc(C)c(=O)[nH]c3=O)n3cc(C)c(=O)[nH]c3=O)n3ccc(N)nc3=O)n3cc(C)c(=O)[nH]c3=O)n3cnc4c3nc(N)[nH]c4=O)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)n3cnc4c(N)ncnc34)O2)c(=O)[nH]c1=O JLCPHMBAVCMARE-UHFFFAOYSA-N 0.000 description 1
- 230000003213 activating effect Effects 0.000 description 1
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- 238000003780 insertion Methods 0.000 description 1
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- 229940125396 insulin Drugs 0.000 description 1
- 239000004026 insulin derivative Substances 0.000 description 1
- 230000000670 limiting effect Effects 0.000 description 1
- 108700021021 mRNA Vaccine Proteins 0.000 description 1
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- 230000000007 visual effect Effects 0.000 description 1
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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
- A61M5/3157—Means providing feedback signals when administration is completed
-
- 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
- A61M5/2033—Spring-loaded one-shot injectors with or without 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
- A61M5/31—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
- A61M5/3202—Devices for protection of the needle before use, e.g. caps
-
- 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
- A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards
-
- 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
- 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
- A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's 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
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/50—General characteristics of the apparatus with microprocessors or computers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/58—Means for facilitating use, e.g. by people with impaired vision
Definitions
- the invention relates to an auto-injector, which is often also referred to as an auto-injection device, with which a product contained in a product container can be poured out automatically after it has been triggered.
- the liquid product is in particular a medicament.
- the invention relates to an auto-injector with an electronic module with a sensor for measuring the axial movement of a signaling device from a position at the start of dispensing to a position at the end of dispensing. This electronics module can be used to record the start and/or end of the injection.
- the term "medicament” includes any flowable medicinal formulation suitable for controlled administration through a means such as a cannula or hollow needle, for example comprising a liquid, solution, gel, or fine suspension containing one or more medicinally active ingredients contains.
- Medicament may be a single active ingredient composition or a premixed or co-formulated multiple active ingredient composition from a single container.
- Medicament includes drugs such as peptides (e.g.
- insulins insulin-containing drugs, GLP-1-containing and derived or analogous preparations
- proteins and hormones proteins and hormones
- biologically derived or active substances substances based on hormones or genes
- nutritional formulations enzymes and other substances in both solid (suspended) or liquid form but also polysaccharides, vaccines, DNA or RNA or oligonucleotides, antibodies or parts of antibodies as well as suitable basic, auxiliary and carrier materials.
- Autoinjectors are known from the prior art, such as from EP2742962A2, in order to deliver an injection simply and safely with a preloaded spring. It is also desirable for the patient or the medical staff if the start and/or the end of the distribution of such an injection can be registered. Thus, the effectiveness of a therapy can be determined by noting the timing of each injection. In addition, it is desirable to automate this logging and dose monitoring. For auto-injectors, it is also desirable that automated logging and dose monitoring be simple and safe, while also keeping costs low.
- WO2020/016313A1 discloses an auto-injector which has an electronics module for logging and dosing monitoring of the injection.
- the auto-injector according to the invention has a housing and a product container arranged in the housing.
- the product container can in particular be a syringe which has a syringe body on whose distal end an injection needle is fixedly arranged.
- the preferably cylindrical syringe body surrounds a plunger, which is displaceable in relation to the syringe body and is pushed towards the distal end for the dispensing of the product, whereby the liquid product, in particular medication, arranged between the plunger and the injection needle is dispensed from the product container through the injection needle will.
- the syringe body can at its proximal, i. H.
- a flange which can also be referred to as a finger flange.
- a syringe designed in this way is available as a standard syringe, so that a specially adapted syringe does not necessarily have to be developed for the autoinjector.
- the plunger sealingly abuts the inner diameter of the syringe body.
- the housing is preferably elongated and forms the longitudinal axis of the auto-injector.
- the housing is preferably sleeve-shaped and/or cylindrical, in particular circular-cylindrical.
- the product container is arranged in the housing.
- the container can be slidably arranged in the housing, ie can be slid in the distal direction relative to the housing for automatic lancing, so that the needle tip protrudes from an opening at the distal end of the autoinjector and can be automatically lancing into the patient.
- the needle tip can optionally be moved into the distal end of the device after the product has been dispensed, in particular the product container can be moved in the proximal direction relative to the housing.
- the product container is immovably accommodated in the housing along the longitudinal axis, in particular by means of a product container holder or syringe holder, which holds the product container in an axially fixed manner and is connected, in particular latched, to the housing in an axially fixed manner.
- the needle tip preferably projects beyond the distal end of the housing in the distal direction. As a result, the needle can be pierced into the puncture site by moving the housing towards the patient.
- a needle protection sleeve is preferably provided, which forms the distal end of the autoinjector and has an opening for the injection needle, the needle being able to pass through the opening.
- the needle guard can be arranged in its initial position relative to the needle tip such that the needle guard projects distally over the needle tip or that the needle tip projects distally over the distal end of the needle shield.
- the needle guard can be moved relative to the housing from its starting position in the proximal direction by an actuating stroke into an actuated position, in particular into the housing, so that the needle emerges or further emerges from the distal end or through the opening of the needle guard.
- the needle guard can be displaced by one needle guard stroke from the actuated position relative to the housing in the distal direction into a needle guard position in which the distal end of the needle guard protrudes distally over the needle tip in order to prevent the device or after the product has been dispensed, there is a risk of injury from an exposed needle tip.
- the needle guard can z. B. against the force of a spring, which can be referred to as a needle guard spring, in the proximal direction, the spring z. B. is the second spring described below or a spring separate therefrom that can move the needle guard from the actuated position in the distal direction, ie into the needle guard position.
- the auto-injector can be a z. B.
- the locking member locks the needle guard in its needle guard position in particular with respect to the housing and blocks a retraction of the needle guard in the proximal direction or in the housing.
- the locking member locks the needle guard at least in such a way that the needle cannot protrude from the distal end of the needle guard.
- the needle guard can z. B. from the needle protection position only so far in the proximal direction that the needle tip does not protrude from the distal end of the needle guard.
- the auto-injector also includes a propulsion member, which acts on the piston at least during the dispensing of the product, in particular rests against the piston, and a first spring, which acts on the propulsion member such as, for. B. is supported in particular with its distal end on the propulsion member.
- the propulsion member can, for. B. be sleeve-shaped.
- the propulsion member can be a rib or ribs, e.g. B. is arranged in the region of the distal end of the propulsion member, include.
- the distal end of the first spring can be supported on the rib.
- the rib can extend in the proximal direction.
- the rib may be provided inside the propulsion member.
- the rib of the propelling member may be provided on an inner side of the propelling member.
- the first spring is preferably located within the sleeve-shaped propulsion member.
- the rib of the driving member can be used to adjust the spring tension of the first spring. For example, a longer rib can produce a higher spring preload.
- the rib can be designed in such a way that the spring tension of the first spring is or is pretensioned in such a way that the liquid product, in particular the entire medication in the product container, can be poured out.
- the catches of the ribs or the rib can determine a prestressing of the first spring in such a way that it can pour the product out of the product container by displacing the propulsion member by a pouring stroke.
- the rib can also serve to reinforce the propulsion member, in particular that part of the propulsion member on which the first spring is supported. This can prevent the propulsion member from being damaged, in particular being broken, by the spring force of the first spring.
- different first springs with different spring tensions can be used inside the propulsion member, depending on requirements. By selecting a corresponding first spring, the spring tension can be selected in such a way that the liquid product, in particular the entire medication in the product container, can be poured out.
- the first spring is preferably a helical spring acting as a compression spring, which is preferably made of metal.
- the first spring is pretensioned to such an extent, particularly when the autoinjector is delivered, that it or the energy stored in it is sufficient to essentially completely pour out the product from the product container by moving the propulsion member by one delivery stroke.
- the displacement of the propulsion element by the discharge stroke also causes the piston to be displaced. If there is a distance between the piston and the propulsion member when delivered, the delivery stroke of the piston is smaller than the delivery stroke of the propulsion member, which is preferred since the piston remains unloaded until use, thereby avoiding unwanted premature product delivery. In principle, however, it is also possible for the propulsion member to rest against the piston in the delivery state and not only when the product is dispensed.
- the delivery stroke of the piston corresponds to the delivery stroke of the propulsion element.
- the proximal end of the first spring which due to its function can also be referred to as a dispensing spring, can be supported on the housing or on an element fixed to the housing, in particular also on an element which is only temporarily fixed axially to the housing.
- the auto-injector has a signal element, a signal stop and a second spring.
- the second spring can act on the signal member against the pouring direction or in exert spring force acting in the proximal direction.
- the second spring z. B. with its proximal end on the signal member.
- the second spring can, for. B. be a coil spring acting as a compression spring, which is supported with its proximal end on the signal element.
- the second spring is preferably made of metal.
- the second spring can with its distal end z. B. on the housing or an element fixed to the housing.
- the second spring is supported with its distal end on the needle protection sleeve or an element which is displaced with the needle protection sleeve, in particular when the needle protection sleeve is displaced relative to the housing.
- the element can be a switching module or a switching sleeve, as will be described further below.
- the element can be arranged kinematically and/or geometrically between the needle guard and the distal end of the second spring.
- the advantage here is that the needle protection sleeve can be moved from its actuated position into the needle protection position by means of the second spring.
- the spring can thus preferably fulfill a dual function, since it also exerts the above-mentioned force on the signal element.
- the signaling element can be coupled to the propulsion element in an axially fixed manner, so that the signaling element can be displaced with the propulsion element along the longitudinal axis and in particular relative to the housing, in particular in the distal direction.
- the axially fixed coupling with the propulsion element has the effect that the signal element is carried along during the displacement of the propulsion element in the delivery direction, in particular during the execution of the first partial stroke of the delivery stroke, and the second spring is tensioned.
- the axially fixed coupling between the signal element and the propulsion element can thus be released.
- the signaling element is positioned counter to the dispensing direction and relative to the Propulsion member and / or the housing accelerated.
- the second spring can accelerate the signaling element to this distance, causing the signaling element to strike the signaling stop at a speed such that an impulse is delivered to the signaling element, which produces an acoustic (audible) and/or tactile (tactile) signal.
- the signal member at a speed on the Hit the signal stop without an impulse, so that no acoustic (audible) and/or tactile (tactile) signal is generated.
- the signal stop can be formed by the housing or by an element that is connected to the housing at least in an axially fixed manner, preferably also in a rotationally fixed manner.
- this element can be a closure cap at the proximal end of the housing and/or form the proximal end of the autoinjector.
- the closure cap can be designed in one piece or in several pieces.
- the closure cap can particularly preferably be connected to the housing in a form-fitting manner, alternatively in a force-fitting or material-fitting manner.
- the element is preferably latched to the housing.
- a separate closure cap has the advantage that assembly of the device is made easier, with at least some of the components being introduced into the housing via the proximal end, which is then closed with the closure cap, for the purpose of assembly.
- the closure cap can form a resonance body when the signal stop is arranged on the cap, with the auditory impression of the acoustic signal being able to be changed within certain limits by the design of material thicknesses and shapes of the closure cap.
- the closure cap may not form a resonator.
- the signaling element has a first engagement element, which is in particular resilient and/or arranged on a resilient arm and which detachably engages in the propulsion element, in particular in a recess of the propulsion element.
- the propulsion element is axially fixedly coupled to the signaling element, the axially fixed coupling between the propulsion element and the signaling element being released when the signaling element, in particular the first engagement element, is disengaged or pushed out of engagement with the propulsion element, in particular the recess of the propulsion element.
- the first engagement member is disengaged from the propulsion member at the end of the first partial stroke of the propulsion member.
- the signal stop is preferably arranged along the longitudinal axis of the autoinjector in such a way that it is arranged in alignment with the signal element. The result of this is that the signal element strikes the signal stop with a movement along the longitudinal axis of the autoinjector.
- the needle protection sleeve acts on the second spring, with the needle protection sleeve being displaceable from its initial position relative to the housing and along the longitudinal axis of the autoinjector in the proximal direction, i.e. counter to the dispensing direction, to trigger the product dispensing , especially the actuation stroke.
- the second spring is tensioned and preferably also the product discharge, in particular the movement of the propulsion element in the discharge direction, triggered.
- the needle guard is preferably moved from its starting position to its actuated position by the actuating stroke in that its distal end is pressed against the puncture site of the patient, with the housing being displaced relative to the needle guard in the direction of the puncture point, so that the needle guard completes the actuating stroke relative to the housing.
- the needle protruding from the distal end of the needle guard is also inserted into the puncture site.
- the auto-injector is removed from the puncture site, whereby the needle protection sleeve is displaced relative to the housing from its actuated position by the needle protection stroke into the needle protection position, in particular by means of the in the second spring stored spring energy. Removing the auto-injector from the puncture site also pulls the needle out of the puncture site.
- a switching module can be arranged kinematically between the second spring and the needle guard, the switching module being carried along by the needle guard in the proximal direction when the needle guard is displaced from its initial position in the proximal direction or into the actuated position, and the Needle guard shifts in the distal direction when the spring acting on the switching module moves the switching module in the distal direction.
- the switching module or a part thereof, such as e.g. B. a switching sleeve can be in one piece with the needle guard or z. B. positively connected such. B. snapped, or be loosely attached to the needle guard.
- the switching module can be a single part or comprise several parts, whereby a multi-part switching module can have at least the switching sleeve and a locking sleeve.
- the locking sleeve can relative to the needle guard and / or switching sleeve z. B. along the longitudinal axis.
- the second spring can be supported on the switching sleeve and the switching sleeve on the needle guard.
- the switching sleeve and the needle guard sleeve can be connected in an axially fixed and preferably non-rotatable manner, it being possible for the second spring to be supported on the switching sleeve.
- the switching sleeve and the needle guard sleeve can be designed in one piece, with the second spring being able to be supported on the switching sleeve.
- a z. B. unidirectionally acting locking member which preferably the above locking member, which locks the needle guard in its needle guard position, may be provided, the z. B. is formed by the locking sleeve and engages in the switching sleeve, in particular in a recess.
- the locking member is preferably designed in such a way that the switching sleeve entrains the locking sleeve via the locking member during its movement relative to the housing in the proximal direction, in particular during the movement of the needle protective sleeve from its starting position into the actuated position, and is displaced relative to the locking sleeve into a locking position during its movement relative to the housing in the distal direction, in particular during the displacement of the needle protecting sleeve from its actuated position into the needle protecting position, wherein in the locking position the or another locking member , such as B. the above, a movement of the switching sleeve relative to the locking sleeve in the proximal direction blocks. This advantageously prevents the needle protection sleeve from being able to be pushed back from its needle protection position into the housing in order to release the needle tip again.
- the switching sleeve can have a first recess in which the locking member of the locking sleeve releasably engages when the needle guard is shifted from its initial position to its actuated position.
- the switching sleeve can have a second recess into which the locking member or possibly the other locking member engages when the needle protection sleeve is in its needle protection position.
- the first and second recesses can preferably be arranged at a distance from one another along the longitudinal axis that corresponds approximately to the needle protection stroke.
- the switching sleeve can have a first recess into which the locking member or locking members of the locking sleeve engages releasably when the needle guard is shifted from its initial position to its actuated position.
- the locking member of the locking sleeve can abut the proximal end of the switch sleeve when the needle guard is in its needle guard position.
- reversing the arrangement of the recess and the locking member is also possible.
- the locking member and possibly the other locking member can be resiliently arranged, in particular each on a resilient arm.
- the switching sleeve can preferably surround and/or guide the locking sleeve.
- the signaling element can have a second engagement element, which can be moved into an, in particular axially fixed, engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, by the disengagement movement of the first engagement element, with which the first engagement element disengages from the propulsion element.
- the first engagement element and the second engagement element of the signal element are preferably matched to one another in such a way that the second engagement element is already, preferably axially fixed, in the needle guard or the switching module engages when the first engagement member is not yet fully disengaged from the propulsion member.
- the needle guard or the switching module in particular the locking sleeve, a z. B. further recess into which the second engagement member of the signal member, z. B. for the axially fixed coupling between the signal element and the switching module, in particular the locking sleeve, or the needle guard engages.
- the propulsion element can have a recess into which the first engagement element engages for the axially fixed coupling between the propulsion element and the signal element.
- the first engaging member and the second engaging member are formed on a common resilient arm, the first engaging member, e.g. B. radially towards the longitudinal axis and the second engagement member, z. B. radially, point away from the longitudinal axis.
- the first and second engagement members can be arranged, preferably radially, between the propulsion member and the needle guard sleeve or the switching module, in particular the locking sleeve.
- the first engagement element of the signaling element is disengaged from the propulsion element and, preferably at the same time, the second engagement element of the signaling element is brought into engagement with the switching module or the needle guard, in particular with a movement transverse to the longitudinal axis.
- the propulsion member can push the first engagement member out of the recess of the propulsion member and the second engagement member into the recess of the needle guard or the switching module, in particular the locking sleeve, by moving in the dispensing direction.
- the needle guard or the switching module in particular the locking sleeve, can hold the first engagement member of the signaling member in engagement with the recess of the propulsion member, with the recess for the second engagement member of the signaling member being occupied by moving the needle guard from its home position to its actuated position relative to the longitudinal axis towards the second engagement element, the recess in the actuated position of the needle guard, in particular at the moment when the delivery stroke is released, at a distance along the longitudinal axis which corresponds approximately to the first partial stroke of the signal element , is arranged to the second engagement member.
- the propulsion member released for the dispensing stroke by actuating the needle guard can then be moved by the first partial stroke in the dispensing direction.
- the first engagement member is engaged with the propulsion member by the inner periphery of the needle guard or the Switching module, in particular the locking sleeve held on or against which the second engagement member rests.
- the second engagement member is at the end of the first partial stroke at the same position relative to the longitudinal axis as the recess, allowing the second engagement member to engage in its recess and the first engagement member to disengage from its recess.
- the delivery stroke of the propulsion member can in particular include two phases, namely the first partial stroke and the second partial stroke.
- the first engagement element of the signaling element is in axially fixed engagement with the propulsion element and the second engagement element of the signaling element is out of axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve.
- the second engagement member is in axially fixed engagement with the needle guard or the switching module, in particular the locking sleeve, with the first engagement member being out of engagement with the propulsion member, which advantageously causes the propulsion member to be relatively can be moved in the distal direction in relation to the signal element and/or the signal element for triggering the signal has not yet been released.
- the delivery stroke can comprise three phases, in particular a further partial stroke.
- the propulsion member moves axially relative to the signal member.
- the signal element is not loaded during the first partial stroke.
- the second partial stroke the first engagement element of the signaling element is in axially fixed engagement with the propulsion element and the second engagement element of the signaling element is out of axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve.
- the signal element is loaded during the second partial stroke.
- the second engagement member is in axially fixed engagement with the needle guard or the switching module, in particular the locking sleeve, wherein the first engagement member is out of engagement with the propulsion member, which advantageously causes the propulsion member to be relatively can be moved in the distal direction in relation to the signal element and/or the signal element for triggering the signal has not yet been released.
- the propulsion member can be moved by the first spring relative to the signal member, in particular by the second partial stroke, in the distal direction when the first engagement member of the signal member is disengaged from the propulsion member and the second engagement member of the signal member is engaged with the needle guard or the switching module.
- the second engagement member of the signal member and the recess for the second engagement member in the delivery state of the auto-injector along the Longitudinal axis can be arranged approximately at a distance from one another which is approximately the sum of the actuating stroke of the needle guard and the first partial stroke of the propulsion member, which corresponds approximately to the stroke of the signal member away from the signal stop.
- the propelling member can prevent the second engagement member of the signaling member from disengaging from axially fixed engagement with the needle guard or the switching module when the propelling member is moving relative to the signaling member in the distal direction, particularly during the second partial stroke of the propelling member.
- the propulsion member allows the second engagement member to disengage from the needle guard or switch module at the end of the dispensing stroke or the second partial stroke.
- the signal element is accelerated by the second spring in the opposite direction to the dispensing direction and strikes the signal stop.
- the second engaging member is maintained in engagement with the needle shield or switch module by the outer periphery of the driving member against which the first engaging member abuts.
- the auto-injector can have a holding element on which z. B. one end of the first spring, in particular the proximal end of the first spring, is supported.
- the spring can be supported with its proximal end on the housing or on an element fixed to the housing.
- the holding element itself can be fixed to the housing or can be arranged so that it can be displaced in relation to the housing.
- the holding element can have a first engagement element which engages in the propulsion element before the product is poured out, as a result of which the propulsion element is prevented from moving in the pouring direction relative to the holding element and/or the housing. The engagement of the first engagement element in the propulsion element can be released for product dispensing.
- the propulsion member When disengaged, the propulsion member is free to move in the dumping direction.
- the first spring can move the propulsion member relative to the holding element and/or the housing by the delivery stroke in the delivery direction.
- the propulsion element can have a recess for the first engagement element of the holding element, this coupling between the propulsion element and the holding element being released when the holding element, in particular the first engagement element, is disengaged from the engagement with the propulsion element, in particular the recess of the propulsion element.
- the first engagement element can be disengaged from the propulsion element by displacing the needle guard from the starting position by the actuating stroke into the actuated position.
- the first engagement element can be held by the needle guard or the switching module, in particular the locking sleeve, in the axially fixed engagement with the propulsion member when the needle guard is not in its actuated position or in its starting position is.
- an inner circumference of the needle guard or of the switching module, in particular the locking sleeve can hold the first engagement element in engagement with the propulsion member, e.g. B.
- a second engagement element which is described below, can abut against the inner circumference.
- the needle guard or the switching module in particular the locking sleeve
- the needle guard or the switching module can allow the first engagement element of the holding element to disengage from the propulsion element, in particular with a movement transverse to the longitudinal axis of the autoinjector.
- a recess in particular for the second engagement element of the holding element, which is formed on the needle guard or the switching module, in particular the locking sleeve, can be arranged in the same position in relation to the longitudinal axis as the first and/or second engagement element, so that the first engagement element can disengage from engagement with the propulsion member.
- the propulsion member may force the first engagement member out of engagement with the propulsion member when the needle shield is in its actuated position.
- the first engagement element of the holding element can e.g. B. point radially to the longitudinal axis and / or be arranged on a resilient arm of the holding element.
- the retaining element can have a second engagement element which can be moved into axially fixed engagement with the needle protection sleeve or the switching module, in particular the locking sleeve, by the disengagement movement of the first engagement element from the propulsion element.
- the second engaging element can, for. B. on the arm on which the first engagement element is arranged, be arranged and / or z. B. point radially away from the longitudinal axis.
- the first engagement element and the second engagement element can be matched to one another in such a way that the second engagement element already engages axially firmly in its recess, which is formed by the needle guard sleeve or the switching module, in particular the locking sleeve, when the first engagement element is not yet fully disengaged is released with the drive member.
- This advantageously means that the axially fixed connection between the holding element and the needle guard or the switching module is first established before the axially fixed connection between the holding element and the propulsion member is released, thus blocking renewed or further pushing back of the needle guard.
- the propulsion element when the second engagement element of the holding element is in its recess, the propulsion element can move in the distal direction relative to the holding element, in particular due to the energy stored in the prestressed spring.
- the propulsion member can do the second Prevent the engagement member from disengaging from axially fixed engagement with the needle guard or the switching module, particularly the locking sleeve, when the propulsion member moves relative to the signal member in the distal direction. This preferably also applies at the end of the delivery stroke, in particular when the second engagement element of the signaling element is released from its recess in order to be accelerated by the second spring counter to the delivery direction.
- the second engagement element disengages from its recess at the end of the dispensing stroke in order to release the needle guard after administration of the product from the actuated position to be able to move into the needle guard position.
- the propulsion member can have a recess into which the first engagement element can engage, with the second engagement element simultaneously disengaging from its recess in order in particular to release the movement of the needle protective sleeve in the distal direction.
- the second engagement element also remains at the end of the delivery stroke in such a way that the second engagement element prevents the locking sleeve from moving relative to the housing and/or the second engagement element to be moved in the distal direction, the switching sleeve and/or the needle protection sleeve being displaceable in the distal direction relative to the locking sleeve, in particular due to the energy stored in the second spring, as a result of which the needle protection sleeve is moved in particular into its needle protection position.
- the locking member can engage between the locking sleeve and the switching sleeve, which prevents the switching sleeve from being displaceable in the proximal direction relative to the locking sleeve.
- movement of the locking sleeve in the proximal direction is prevented in that the locking sleeve is either attached to the housing or an element fixed to the housing, such as. B. on a mechanism holder, or the signal element abuts.
- a further aspect of the invention relates to the design of a product container holder, in particular a tip holder for an auto-injector, in particular for an auto-injector in which the product container cannot be displaced in relation to the housing, or for an auto-injector of the type described above.
- the invention is based on a syringe module which is intended in particular for use in an autoinjector.
- an auto-injector can be provided that is such a Has syringe module.
- the syringe module includes a syringe and a syringe holder.
- the syringe has a syringe body, a plunger and a needle, the needle e.g. B. is undetachably attached to a needle holding portion of the syringe and the plunger is slidably disposed in a cylindrical portion of the syringe body, the syringe body having a tapered portion or region located between the needle holding portion and the cylindrical portion.
- the syringe also has a needle cap which z. B. can be a so-called soft needle shield or preferably a rigid needle shield.
- a soft needle shield is preferably formed from a rubber-elastic plastic, with a rigid needle shield being formed from a sleeve made from hard plastic, in which a sleeve made from a rubber-elastic plastic is arranged.
- the sleeve made of rubber-elastic plastic and the sleeve made of hard plastic together form the rigid needle shield.
- the needle protective cap which covers the needle and is fastened to the needle holding section, which in particular extends conically in the direction of the needle tip, keeps the needle preferably protected from dirt and sterile.
- a gap is formed between the tapered portion and the needle guard, particularly the hard plastic sleeve.
- the syringe holder has at least one engagement element, in particular a shoulder, on which the tapered section of the syringe is supported in the distal direction and which engages in the gap between the needle protective cap and the tapered section.
- the contact of the tapering section on the at least one shoulder prevents the syringe from being able to move in the distal direction relative to the syringe holder.
- the syringe body may include a finger flange at its proximal end, with a gap being formed between the finger flange and the syringe body when the tapered portion abuts the shoulder, leaving the finger flange substantially unstressed. This advantageously prevents the finger flange from being overloaded and breaking the syringe body.
- the syringe holder has at least one holding element, in particular an outwardly directed projection, with which the syringe holder can be or is connected, in particular snapped or can be snapped on, to a housing of the autoinjector in an axially fixed manner.
- the syringe holder can have at least one cam, which is arranged resiliently, in particular on an arm and z. B. is arranged distally of the holding member.
- the at least one cam can inhibit or prevent a needle guard from moving from its initial position to its actuated position in such a way that when a limit force exerted on the needle guard along the longitudinal axis L of the autoinjector is exceeded, the at least one cam is pressed out of engagement with the needle guard, whereby the needle guard can be displaced abruptly into its actuated position relative to the housing.
- the housing of the auto injector can, for. B. have a holding portion which abuts against the syringe holder, in particular on an outer surface or an outer periphery of the syringe holder and which prevents at least one engagement member of the syringe holder from moving transversely to the longitudinal axis away from the longitudinal axis.
- the holding section can be cylindrical and surround the at least one engagement member, preferably two or three or four engagement members, so that the at least one engagement member is arranged within the holding section.
- the syringe holder is outside of the engagement with the holding section of the housing.
- the syringe module or the syringe holder When the syringe is fully inserted into the syringe holder, in particular when the at least one engagement member engages in the gap between the tapered section and the needle protective cap, the syringe module or the syringe holder is brought into engagement with the holding section, so that it is prevented that moving the at least one engagement member out of engagement with the tapered portion transverse to the longitudinal axis, in particular away from or outward from the longitudinal axis.
- the at least one engagement element can be resilient, in particular on an arm on the syringe holder, with the syringe being pushed into the syringe holder, which is preferably sleeve-shaped, via the proximal end with the needle first, with the needle protective cap protecting the at least one engagement member outwardly transverse to the longitudinal axis, ie, away from the longitudinal axis, wherein when the needle shield has been moved fully past the at least one engagement member, the at least one engagement member snaps into the gap between the tapered portion and the needle shield.
- the syringe holder with the syringe is then moved into engagement with the holding section of the housing of the autoinjector, as a result of which the at least one engagement element is held in engagement with the gap between the needle protective cap and the tapered section and can no longer spring out of this engagement.
- the housing includes a holding portion.
- the holding section of the housing can be designed in the form of a sleeve and can be arranged inside the housing.
- a stop for limiting the axial movement of the needle guard in the proximal direction can be provided between the sleeve-shaped holding section of the housing and the sleeve-shaped housing.
- the holding section of the housing preferably protrudes beyond the distal end of the housing in the distal direction.
- the holding section can have one or more grooves which, in conjunction with the rail or rails provided on the needle protection sleeve, form an anti-twist device between the housing and the needle protection sleeve.
- the rail of the needle guard is preferably provided on an inner surface of the needle guard.
- the groove of the holding section is preferably arranged on an outer surface of the holding section.
- the needle guard can preferably be moved axially between the holding section of the housing and the housing in a rotationally fixed manner.
- the one or more grooves may be provided on the needle shield and the one or more rails may be provided on the retaining portion of the housing to provide insurance between the housing and the needle shield.
- the groove of the needle guard is preferably provided on an inner surface of the needle guard.
- the rail of the holding section is preferably arranged on an outer surface of the holding section.
- the auto-injector has an electronic module with a sensor.
- the sensor is configured to measure the axial movement of the signal member from a position at the start of dumping, where the signal member is carried along in the dumping direction, to a position at the end of dumping, where the signal member strikes the signal stop.
- the electronics module is built into the autoinjector by the manufacturer at the moment of delivery to the user or patient. The user does not have to assemble the electronic module himself and cannot use the latter more than once.
- the injection can be carried out directly by monitoring the positions, in particular the position at the start of distribution and the position at the end of distribution of the signal member. Two position changes can be recorded or detected.
- This monitoring of the positions of the signal element via the electronics module can be viewed as a supplement or as an alternative to the acoustic and/or tactile signal generation already mentioned, in order to improve the patient's therapy.
- the positions of the signal element can only be monitored via the electronics module, with the acoustic and/or tactile signal generation mentioned not being implemented in the auto-injector or being actively suppressed or at least dampened. Instead, a feedback signal is generated electronically for the user.
- the senor of the electronics module includes a switch or a button that records or detects the position shift of the signal element.
- the sensor can preferably be designed as a switching detector.
- the auto-injector can include a switch actuator in order to actuate the switch or the button of the switch detector.
- the switching detector can be fixed to the electronic module, in particular fixed axially and in a rotationally fixed manner.
- the switching actuator can be designed as a separate element or alternatively be provided on the signal element or alternatively the signal element can be designed as a switching actuator or alternatively be provided on the closure cap of the auto-injector, on the housing of the auto-injector, on the electronics module or on another housing of the electronics module or alternatively the sealing cap of the auto-injector, the housing of the auto-injector, the electronic module or the other housing of the electronic module can be designed as a switching actuator.
- the switching actuator can be accommodated in the autoinjector in a movable, in particular axially movable, particularly preferably axially movable and non-rotatable manner.
- the switching actuator can particularly preferably be arranged such that it can move, slide or slide axially relative to the housing of the autoinjector, the closure cap of the autoinjector, the electronics module or other housing of the electronics module.
- the switching actuator can be accommodated in the housing of the auto-injector, the closure cap of the auto-injector, the electronics module or other housing of the electronics module in an axially movable, displaceable or slidable manner.
- the switching actuator is preferably a separate element, in particular a pin-shaped element, wherein the switching actuator can be taken along by the signaling element in the proximal direction during the movement of the signaling element, whereas the switching actuator during the movement of the signaling element in the distal direction due to gravity, which is greater than the frictional force between the switching actuator and the housing of the auto-injector, the cap of the auto-injector, the electronic module or other housing of the electronic module is in the can move distal direction.
- the switching actuator is also in a proximal position.
- the switch actuator is also in a distal position. The axial movement of the signal element in the distal direction at the start of the distribution and the axial movement of the signal element in the proximal direction at the end of the distribution can thus be transmitted from the switching actuator to the switching detector.
- the switch detector is configured to measure the axial movement of the switch actuator from a position at the start of the payout, wherein the switch actuator is movable, slideable or slidable in the direction of the payout, to a position at the end of the payout.
- the switching detector can thus sense or detect the position of the signal member.
- the switching detector can have a prestressing force, in particular a spring force, or can be designed to be prestressing, in particular resilient.
- this force can thus cause the switching actuator to be moved or to move in the distal direction during the movement of the signal element in the distal direction.
- the biasing force is preferably greater than the gravitational force of the switching actuator, so that no gravity-driven proximal movement of the switching actuator in the event of an injection against the force of gravity leads to premature detection of the start of the dispensing movement.
- this separation movement can also be detected by the switch detector, provided that the switch actuator itself does not remain in its proximal position relative to the switch detector on the electronic module.
- a bayonet-like separating movement can include a movement of the switching detector radially or tangentially away from the axis or the switching actuator.
- the switching actuator can be lever-shaped.
- a fulcrum of the lever-shaped shift actuator or a pivot joint of the lever-shaped The switching actuator can be accommodated at least partially in the housing of the auto-injector, in the closure cap of the auto-injector, in the electronics module or in the other housing of the electronics module.
- the switching actuator is arranged axially fixed and rotatable relative to the housing of the auto-injector, the closure cap of the auto-injector, the electronics module or other housing of the electronics module.
- the other part of the lever-shaped switching actuator is arranged between the signaling element and the switching detector in such a way that at least the axial movement of the signaling element in the distal direction at the start of distribution and the axial movement of the signaling element in the proximal direction at the end of distribution via the movement of the switching actuator can be transferred to the switching detector.
- the switching actuator can suitably deflect or redirect a movement of the signal element that is to be detected.
- the switching actuator in particular the lever-shaped switching actuator, can be designed to be at least partially preloaded, in particular elastically preloaded or resilient.
- the switching actuator can be accommodated, at least partially, in the housing of the auto-injector, in the closure cap of the auto-injector, in the electronics module or in the other housing of the electronics module.
- the switching actuator is arranged or fastened axially and rotationally fixed relative to the housing of the auto-injector, the closure cap of the auto-injector, the electronics module or other housing of the electronics module.
- the other part of the prestressable, in particular the elastically prestressable or resilient switching actuator is arranged between the signaling element and the switching detector in such a way that the axial movement of the signaling element in the distal direction at the start of the distribution and the axial movement of the signaling element in the proximal direction at the end of the distribution can be transferred to the switching detector via the movement of the switching actuator.
- the switching actuator can be pretensioned before the start of the distribution and at the end of the distribution, in particular elastically pretensioned, between the switching detector and the signaling element, the stored energy of the switching actuator being released during the movement of the signaling element in the distal direction in such a way that during the start the release of the switching actuator is relaxed and/or moved in the distal direction.
- the switching actuator in particular the pretensionable, particularly preferably the elastically pretensionable or the resilient switching actuator, can suitably forward or pass on a movement of the signal element to be detected.
- the switching actuator and the housing of the auto-injector, the closure cap of the auto-injector or the other housing of the electronic module can be designed in one piece.
- a part of the housing of the autoinjector, the closure cap of the autoinjector or the other housing of the electronics module can be prestressed, in particular elastically prestressed or resilient, or have a prestressable arm, in particular a spring arm.
- the switching actuator is arranged in the tensionable, in particular in the elastically pretensionable or in the resilient part of the housing of the auto-injector, the closure cap of the auto-injector or other housing of the electronics module in such a way that it suitably deflects or redirects the movement of the signal element to be detected to the switching detector can.
- the prestressable, in particular the elastically prestressable or resilient part of the housing of the autoinjector, the closure cap of the autoinjector or the other housing of the electronic module can be prestressed before the start of the distribution and at the end of the distribution, in particular elastically pretensioned, between the switching detector and the signal element .
- the stored energy of the pre-tensioned, in particular the elastically pre-tensioned part of the housing of the auto-injector, the closure cap of the auto-injector or the other housing of the electronic module can be released during the movement of the signal element in the distal direction in such a way that the switching actuator relaxes during the start of the distribution and/or is moved in the distal direction.
- the switching actuator can thus suitably forward or pass on a movement of the signal element to be detected to the switching detector.
- the senor is designed as an optical sensor, force sensor, magnetic sensor, inductive sensor or electrically passive sensor. This depends on the object that is to be captured or detected.
- an electrically conductive switch actuator can be provided.
- the switching actuator can be designed to be completely or only partially electrically conductive.
- the electrically conductive part of the switching actuator can be applied, for example, by means of a coating process or can be produced as a two-component part.
- the electrically conductive switching actuator can be axially connected to the signaling element, formed in one piece with the signaling element, or the switching actuator and the signaling element can be separate parts be, wherein the switching actuator and the signal member are axially movable or displaceable at the same time or the movement of the signal member is transmitted to the switching actuator.
- the electronics module can have at least two electrical contact points, with contact between the electrically conductive switch actuator and the two electrical contact points, a circuit can be closed and with a distance between the electrically conductive switch actuator and the two electrical contact points, the circuit can be opened.
- the electronics module can thus suitably record or detect the position of the signal element.
- the electrically conductive switching actuator can be designed as an electrically conductive contact sheet or have an electrically conductive contact sheet.
- the electronic module can have at least one electrical contact. One end of the electrical contact sheet can always be connected to the at least one electrical contact of the electronics module, with the other end of the electrical contact sheet being able to form a closed or an open electrical circuit depending on the axial position of the switching actuator or the signal element.
- the electrical circuit can be closed when the signaling element and/or the switching actuator are in the proximal position, whereas the electrical circuit is open when the signaling element and/or the switching actuator are in the distal position.
- the electrical contact plate can preferably be prestressed, in particular elastically prestressed or resilient.
- the auto-injector has an electronics module with a suitable sensor for measuring the axial movement of the signal element from a position at the start of the delivery to a position at the end of the delivery.
- the electronics module can thus be used to record the start of injection and/or the end of injection.
- the electronics module can be designed as a separate electronics module and can be releasably connected to the housing and/or closure cap of the autoinjector, in particular by means of a bayonet catch to the housing and/or closure cap of the autoinjector. It can also be other detachable connection, such as snap lock or twist lock between the Electronic module and the housing and / or cap of the auto-injector can be provided. It is advantageous that the electronics module can be designed to be reusable and the auto-injector to be designed to be used once. In addition, the electronic module and the auto-injector can be disposed of separately to ensure environmentally friendly disposal. For this purpose, a separating disk can be provided particularly preferably between the electronics module and the housing and/or closure cap.
- the separating disc is used for safe separation and/or to prevent premature separation of the electronics module from the housing and/or sealing cap.
- the electronics module is firmly, in particular non-detachably, connected to the housing and/or closure cap of the autoinjector. It is advantageous that operating errors by the patient are avoided, thus ensuring safe use of the auto-injector.
- the electronics module can preferably be accommodated by an electronics module housing.
- the above-mentioned other housing of the electronics module can particularly preferably be designed as an electronics module housing.
- the electronics module housing serves to protect the electronics module.
- the electronics module housing can be designed in such a way that the electronics module can be easily and safely removed from the housing and/or sealing cap.
- a bayonet lock or another detachable connection can be provided between the electronics module housing and the housing and/or closure cap.
- a separating disk can be provided particularly preferably between the electronics module housing and the housing and/or closure cap. The separating disc is used for safe separation and/or to prevent the electronics module housing from being separated prematurely from the housing and/or sealing cap.
- the separating disc can be mounted in the housing and/or the closure cap in such a way that the electronics module and/or the electronics module housing can only be removed from the housing and/or closure cap after the triggering and/or at the end of the distribution.
- the electronics module includes an energy source and a processor, the processor being coupled to the sensor and the energy source and configured in such a way that the start and/or end of the dispensing of the auto-injector can be registered by means of a sensor. The axial movement of the signal member is recorded or detected from a position at the start of the distribution to a position at the end of the distribution.
- the energy source can be designed as a battery. It can be a disposable battery or a rechargeable battery or an accumulator.
- the electronics module can particularly preferably include a switch for activating the electronics module. This means that the electronics module must be switched off before the injection and only switched on during the injection. Thus, energy of the power source can be saved.
- the processor can have evaluation electronics which are configured to identify processes in or states of the injection device during an injection process based on measurements by the sensor. For example, axial movements can be filtered and compared to a threshold value in a comparator or a comparison circuit. If a pattern determined in this way matches a predetermined pattern, the axial movement is identified as belonging to the specific event.
- the electronics module can particularly preferably include a timer which measures the duration of the release of the auto-injector.
- the processor of the electronics module can preferably be configured to operate the timer.
- the processor of the electronic module can be configured to register the elapsed time since the last distribution and/or to register after a specified period after the registered end of the distribution and/or to register after the registered start of the distribution.
- the electronic module can contain a wireless communication unit for communication with an external electronic device and/or a status display for displaying at least one position of the signal element.
- the status indicator can be activated after a specified period of time after the registered end and/or after the registered start of the distribution.
- the status indicator can be designed as an electric light source, for example as an LED. However, another visual signal generator and/or an acoustic signal generator for generating noises or melodies and/or a tactile signal generator for generating movements can also be provided.
- the health indicator can display information about the health of the auto-injector. The start and/or end of the distribution can be displayed. In addition or as an alternative, the end of a holding time or a waiting time can also be displayed, with the patient being able to remove the auto-injector from the skin after this time has elapsed.
- the electronics module housing can particularly preferably comprise a light source housing, for example an LED housing, in order to better indicate the patient's condition.
- the electronics module housing can form the light source housing, for example the LED housing.
- the light source housing can be designed as a light guide.
- the time recording function and/or the status indicator can take place through a real-time event transmission to the external electronic device.
- the external electronic device can be a computer, a cloud and/or a mobile device including a smartphone or a smartwatch.
- the auto-injector can have an additional or an alternative electronic module with an additional or alternative sensor, configured to measure axial movement of the needle guard and/or propulsion member and/or indexing sleeve and/or locking sleeve.
- This electronic module can be embodied as a separate electronic unit or as an electronic unit integrated in the autoinjector.
- a first and a second auto-injector can be provided, with the first electronics module of the first auto-injector being different from the second electronics module of the second auto-injector, and with the auto-injectors otherwise being identical.
- FIG. 1 exploded view of an auto-injector according to a particularly preferred embodiment, Figures 2a-2c the auto-injector from Figure 1 in a delivery state, the figures
- 2a to 2c are sectional views through the longitudinal axis of the device, the sectional views being angularly offset about the longitudinal axis;
- Figures 3a-3c the device and the views of Figures 2a-2c, with a
- Needle guard is in its actuated position, with a signal which signals the start of product distribution is generated.
- Figures 4a-4c show the device and the views from Figures 2a-2c, with a signal signaling the end of product distribution being generated
- Figures 5a-5c show the device and the views from Figures 2a-2c, with the
- Figure 6 is a side and perspective view of the electronics module (16) of Figure
- FIGS. 7a-7c are preliminary sectional representations of an alternative embodiment of an autoinjector according to the invention. Referring to Figures 1-7c, the structural features and function of preferred auto-injectors will now be described.
- the auto-injector has a sleeve-shaped, elongated housing 2 with a longitudinal axis L, which has a closure cap 12 at its proximal end, which can be rotated and rotated in a form-fitting manner with the housing 2 is axially connected.
- the closure cap 12 is firmly connected to the housing 2, for example via a snap-in connection.
- a detachable electronics module housing 17 can particularly preferably be provided at the proximal end of the closure cap 12 .
- a bayonet lock is preferably provided between the housing 2 and/or the closure cap 12 and the electronics module housing 17 in order to remove the electronics module housing 17 from the autoinjectors.
- Other detachable connections for example a snap closure or a rotary closure, can also be provided between the electronic module housing 17 and the housing and/or sealing cap of the autoinjector.
- the electronics module housing 17 can be permanently connected to the housing 2 and/or the closure cap 12, with the electronics module housing 17 not being able to be removed from the housing 2 and/or the closure cap 12 of the autoinjector.
- An electronic module 16 is preferably provided in the electronic module housing 17 .
- the electronic module 16 can be detachably or non-detachably connected to the housing 2 and/or the closure cap 12 .
- the electronic module can be arranged in a detachable or non-detachable manner at a different location in the autoinjector. The arrangement depends on the object to be detected by the autoinjector.
- the electronics module 16 includes a sensor 16a, a battery 16b, a processor 16c and a light source 16d.
- the light source 16d can be in the form of an LED.
- a pull-off cap 4 is arranged at the distal end of the auto-injector, which is pulled off or twisted off and removed before the auto-injector is used.
- a product container 13 in the form of a syringe is accommodated in the housing 2 so that it cannot be displaced along the longitudinal axis L in relation to the housing 2—apart from the assembly of the autoinjector.
- the product container 13 has a sleeve-shaped syringe body which surrounds a plunger 13b which rests sealingly against the inner circumference of the syringe body.
- the syringe body has an injection needle 13a which is in particular permanently connected to the syringe body and whose distal end is formed by the needle tip.
- a liquid product, in particular medication, is arranged inside the syringe body between the injection needle 13a and the plunger 13b 13a pours out of the product container 13.
- the syringe body has what is known as a finger flange, which projects radially outwards over the outer circumference of the cylindrical syringe body.
- the product container 13 is accommodated in a product container holder, referred to as the syringe holder 1, in such a way that it is secured at least against movement along the longitudinal axis L in the distal direction relative to the syringe holder 1.
- the syringe holder 1 is positively connected to the housing 2, in particular latched.
- the housing 2 has recesses into which the latching elements, which are formed here at the proximal end of the syringe holder 1, engage.
- the syringe holder 1 has at least one inwardly projecting shoulder 1b on which a tapered section of the product container 13, which is distal to the cylindrical syringe body section which guides the plunger 13b, is supported.
- the product container 13 is pressed at its proximal end into engagement with the shoulder 1b by a holder acting on the syringe body.
- the holder is formed by a retaining spring section 5c of a mechanism holder 5.
- the mechanism holder 5 is arranged in relation to the housing 2 along the longitudinal axis L, in particular in a non-displaceable and/or non-rotatable manner.
- the sleeve-shaped mechanism holder 5 can be snapped onto the housing 2 .
- the retaining spring section 5c allows differences in the length of the product container 13, which can arise due to manufacturing tolerances, to be compensated for, with the firm seat of the product container 13 on the shoulder 1b being ensured.
- the product container 13 is arranged in relation to the housing 2 in such a way that the needle tip protrudes distally beyond the distal end of the housing 2 .
- a needle protective cap 14 which in the example shown is designed as a so-called rigid needle shield known to those skilled in the art, alternatively as a soft needle shield, in order to protect the needle 13a from contamination or the needle 13a and the medication to keep sterile.
- the rigid needle shield 14 is arranged at a needle holding portion of the syringe body with the tapered portion of the syringe body located between the needle holding portion and the cylindrical portion of the syringe body.
- the shoulder lb is arranged between the syringe body and the proximal end of the rigid needle shield 14, in particular so that between the rigid needle shield 14 and the shoulder lb a - albeit small - gap is created to prevent the shoulder lb a Force exerts on the rigid needle shield 14, whereby z. B. the sterility of the needle 13a or the liquid product could be compromised.
- the peel-off cap 4 is releasably snapped onto the housing 2 or a needle guard 3, this snap-fit being released when the peel-off cap 4 is removed from the housing 2 or the needle guard 3.
- the pull-off cap 4 has a snap hook 4a which engages in a gap between the syringe body, in particular its tapering area, and the proximal end of the rigid needle shield 14.
- the snap hook 4a hooks into the proximal end of the rigid needle shield 14, whereby the rigid needle shield 14 is detached from the product container 13 and removed together with the cover cap 4 from the auto-injector.
- the snap hook 4a can hook into a lateral surface of the rigid needle shield 14 or into a lateral surface of the soft needle shield.
- the auto-injector has a needle protection sleeve 3, which can be displaced relative to the housing 2 and along the longitudinal axis L by an actuating stroke H B in the proximal direction into an actuated position in order to trigger product dispensing.
- a needle protection sleeve 3 which can be displaced relative to the housing 2 and along the longitudinal axis L by an actuating stroke H B in the proximal direction into an actuated position in order to trigger product dispensing.
- the needle guard 3 By moving the needle guard 3 by the actuating stroke H B , the needle guard 3 is pushed far enough in the proximal direction that the needle 13a protrudes from the distal end of the needle guard 3, in particular with a length that corresponds to the injection depth of the needle into the puncture site.
- the needle 13a should preferably protrude beyond the distal end of the needle protection sleeve 3 to such an extent that a subcutaneous injection can take place.
- the housing 2 can form an actuation stop 2b against which the needle guard 3 rests in the actuated position.
- the needle guard 3 can relative to the housing 2 from the actuated position along the longitudinal axis L by a Nadelschutzhub H N in the distal direction in a Needle guard position ( Figures 5a-5c) are moved.
- the needle protection position the distal end of the needle protection sleeve 3 protrudes distally beyond the needle tip, so that access to the needle tip is prevented and the risk of injury is reduced.
- the needle guard 3 can be blocked from being pushed back out of the needle guard position again.
- the syringe holder 1 has a projection 1a which points radially outwards, the projection 1a engaging in a slot-shaped recess in the needle protective sleeve 3 which is arranged between the housing 2 and the syringe holder 1 .
- the needle guard 3 in particular the proximal end of the slot-shaped recess, rests against the projection la, causing the needle guard to move 3 in the distal direction is prevented.
- a cam 1c which is arranged resiliently on the syringe holder 1 and is formed by the syringe holder 1, can engage in this slot-shaped recess, alternatively in another recess of the needle protective sleeve 3.
- the cam lc is designed so that when attempting to shift the needle guard 3 from the home position to the actuated position, the cam lc initially prevents the shifting of the needle guard 3, with the cam lc being pushed out when the needle guard 3 moves to the Pushing back applied force exceeds a certain threshold, whereby the needle guard 3 is suddenly pushed back into the actuated position. As a result, the needle 13a can suddenly be pierced into the puncture site.
- the distal end of the needle guard 3 is placed in the puncture site, with the housing 2 then being pressed in the direction of the puncture site, and if the pressing force exceeds the above-mentioned threshold value, the Housing 2 abruptly to the puncture site and the needle guard 3 is moved relative to the housing 2 in the actuated position.
- the housing 2 has a cylindrical holding section 2a, which in particular surrounds the distal end of the syringe holder 1 in a cylindrical manner and bears against it, as a result of which the at least one shoulder lb is held in engagement with the tapering area of the syringe body. Furthermore, the housing 2 has in the area of the holding section 2a a translation stop in the form of a holding shoulder 2c, which prevents the syringe holder 1 from being displaceable relative to the housing 2 in the distal direction when the syringe holder 1 rests against the holding shoulder 2c. This also applies advantageously to the variants described.
- the cylindrical holding section 2a can have a groove 2d which, in conjunction with a rail 3c which is attached to the inside of the needle guard 3, provides an anti-twist device for the Form the needle guard 3.
- a plurality of grooves 2d and a plurality of rails 3c can also be provided.
- the autoinjector also has a sleeve-shaped propulsion member 7, which has at its distal end a rib 7c projecting inwards and in the longitudinal direction, on which a first spring 9, which can also be referred to as a dispensing spring, is supported.
- the first spring 9 is arranged inside the sleeve-shaped propulsion member 7 .
- the length of the rib 7c is designed in such a way that the installation space for the first spring 9, which is a helical spring acting as a compression spring, is reduced and thus the spring 9 in the initial or delivery state ( Figures 2a-2c) of the autoinjector with so much energy is biased so that it can pour out the product contained in the product container 13, in particular completely by moving the propulsion member 7 by a delivery stroke H A from the product container 13.
- the rib 7c forms a reinforcement of the bottom of the propulsion element 7, so that the distal region of the propulsion element 7 does not break through due to the high forces of the dispensing spring 9.
- the length of the rib 7c can vary in different auto-injectors, with the corresponding length of the rib 7c of the propulsion member 7 being able to serve to adjust the spring tension of the first spring, which is identical in the different auto-injectors. For example, longer ribs can generate a higher spring preload for dispensing a more viscous liquid.
- the first spring 9 is supported with its proximal end on a holding element 6, which in this example has two arms 6c, with a first engagement element 6a and a second engagement element 6b being arranged on each arm 6c.
- the first engagement element 6a points radially toward the longitudinal axis L, with the second engagement element 6b pointing radially away from the longitudinal axis L.
- the first engagement element 6a engages in a first recess 7a formed by the propulsion element 7, as a result of which movement of the propulsion element 7 relative to the holding element 6 in the distal direction or in the dispensing direction is prevented. As a result, the first spring 9 is held in its tensioned state.
- the holding element 6 has a guide pin 6d which is inserted through the proximal end of the first spring 9 into the core of the spring 9 .
- the guide pin 6d prevents lateral buckling of the first spring 9 during and at the end of the delivery stroke H A of the propulsion member 7.
- the auto-injector has a switching module 8 , 15 which has a switching sleeve 15 and a locking sleeve 8 surrounded by the switching sleeve 15 .
- the switching sleeve 15 is connected to the proximal end 3a of the needle guard 3 or at least rests against the proximal end 3a of the needle guard 3 .
- the second spring 10 is a metal spring that acts as a compression spring and is designed as a helical spring.
- the second spring 10 is supported with its proximal end on a signal element 11, in particular on a projection 11c, which engages in the housing 2 in an axially displaceable and non-rotatable manner and which engages through a slot-shaped groove 5b of the mechanism holder 5.
- the second spring 10 thus also surrounds the mechanism holder 4 at least partially, preferably completely.
- the switching element 15 has a recess 15a, in which a locking element 8a of the locking sleeve 8 engages.
- the locking member 8a is sawtooth-shaped and protrudes radially from the longitudinal axis L away.
- the locking member 8a is arranged resiliently on an arm which is formed by the locking sleeve 8.
- the switching sleeve 15 is also carried along by the actuating stroke H B , as a result of which the second spring 10 is tensioned. If the needle guard 3 is not fully moved into the actuated position, the second spring 10 can move the switch sleeve 15 and the needle guard 3 back to the starting position, with the locking sleeve 8 also being taken along by the switch sleeve 15 via the engagement of the locking element 8a.
- the in particular sleeve-shaped signaling element 11 is in the delivery state ( Figures 2a-2c) or before the release of the product in an axially fixed engagement with the propulsion element 7.
- the signaling element 11 has a first engagement element 11a, which engages in a recess 7b of the propulsion element 7, and a second engagement member 11b.
- the first engagement member 11a and the second engagement member 11b are resiliently mounted at the end of an arm 11d.
- the signal link 11 has two such arms 11d with a first engaging member 11a and a second engaging member 11b.
- the first engagement member 11a faces radially toward the longitudinal axis L, while the second engagement member 11b faces radially away from the longitudinal axis L.
- the first engagement member 11a is held in axially fixed engagement with the propulsion member 7 by the inner circumference of the locking sleeve 8.
- the recess 7b can be designed in such a way, in particular a recess 7b extending in the longitudinal direction, that during a first partial stroke of the delivery stroke there is an axial relative movement between the propulsion element 7 and the signal element 11 and during a second partial stroke of the delivery stroke the first engagement element 1 1 a is held in the axially fixed engagement with the propulsion member 7 at least in the distal direction.
- the second engaging member 11b rests against the inner circumference of the shift sleeve 8 .
- the closure cap 12 has a signal stop 12a against which the signal element 11 can strike to generate a signal and preferably against which the signal element 11 rests in the delivery state (FIGS. 2a-2c) of the device.
- the pull-off cap 4 is removed from the auto-injector together with the rigid needle shield 14.
- the distal end of the needle guard 3 is applied to the puncture site of a patient, with the housing 2 being displaced towards the puncture site, as a result of which the needle guard 3 moves from its initial position by the actuation stroke H B in the proximal direction relative to the housing 2 in the actuated position moved.
- the second spring 10 is tensioned, with the switching sleeve 15 being carried along by the needle guard 3 by the actuating stroke H B .
- the locking sleeve 8 has a first recess 8b, which is brought to the position of the second engagement element 6b by moving the locking sleeve 8 by the actuating stroke H B along the longitudinal axis L.
- the first engagement element 6a is moved out of engagement with the propulsion member 7 with a movement transversely to and away from the longitudinal axis L, while at the same time the second engagement element 6b is moved into engagement with the locking sleeve 8, in particular its first recess 8b.
- the propulsion member 7 is released for movement by the delivery stroke H A in the delivery direction.
- the holding element 6 which can be moved at least a little relative to the housing 2 and along the longitudinal axis L, can be moved in the proximal direction by the first spring 9 , whereby the retaining element 6 takes the locking sleeve 8 with it by a start signal lift H K via the engagement of the second engagement element 6b in the recess 8b, as a result of which the locking sleeve 8 strikes a start signal stop 5a, which is formed by the mechanism holder 5, and as a result an acoustic and/or or emits a tactile signal which indicates to the user of the device that that the product distribution has started ( Figures 3a-3c).
- the locking sleeve 8 and/or the start signal stop 5a can be designed in such a way that no acoustic and/or tactile signal is generated.
- the locking member 8a is released for movement transversely and towards the longitudinal axis L, since the mechanism holder 5 has a recess 5d which allows such a movement of the locking member 8a when the locking sleeve 8 is rotated the actuating stroke H B has been displaced or when the needle guard 3 is in its actuated position.
- the signal member 11 Since the signal member 11 is still axially fixed to the propulsion member 7, it is carried along by a first partial stroke Hs of the delivery stroke H A in the delivery direction, with the signal member 11 being moved away from the signal stop 12a by approximately the first partial stroke Hs.
- the first engaging member 11a is pushed out of engagement with the propelling member 7, at the same time the second engaging member 11b being pushed into the second recess 8c the locking sleeve 8 is moved away from the longitudinal axis L with a movement transverse to the longitudinal axis L and radially.
- the second engagement member 11b is held in engagement with the second recess 8c by the outer periphery of the propulsion member 7 when the propulsion member 7 is moved by its second partial stroke of the discharge stroke H A .
- the outer peripheral surface of the propelling member 7 holds the second engaging element 6b in engagement with the first recess 8b of the locking sleeve 8, as best seen in Figure 4b.
- the propulsion member 7 releases the second engagement member 1 lb from engagement with the locking sleeve 8, whereby the second engagement member 11b is moved out of engagement with the recess 8c, in particular towards the longitudinal axis L, so that the second Spring 10 accelerates the signal element 11 against the distribution direction, ie in the proximal direction, so that when the signal element 11 hits the signal stop 12a, an acoustic and/or tactile signal is generated (FIGS. 4a-4c).
- the signal element 11 and/or the signal stop 12a can be designed in such a way that no acoustic and/or tactile signal is generated.
- the second spring 10 can move the switching sleeve 15 and the needle guard 3 from the actuated position to the needle guard position ( Figures 5a- 5c) by the needle guard stroke H N , forcing the locking member 8a out of engagement with the recess 15a, with the switch sleeve 15 moving relative to the locking sleeve 8 in the distal direction.
- the locking element 8a snaps onto the switching sleeve 15, in particular on a proximal edge of the switching sleeve 15 or alternatively in a further recess in the switching sleeve 15, with the locking element 8a preventing the needle protection sleeve 3 from being pushed back into its actuated position.
- the switching member 15 strikes the locking member 8a, which prevents movement of the needle guard 3 into the actuated position.
- the locking sleeve 8 is supported axially on the start signal stop 5a of the mechanism holder 5 .
- the electronic module 16 with a sensor 16a is used to measure the axial movement of the signal element 11 from a position at the start of the distribution, in which case the signal element 11 is carried along in the direction of distribution, to a position at the end of the distribution, in which case the signal element 11 is attached to the signal stop 12a strikes, configured.
- the injection can be carried out directly by monitoring the positions, in particular the position at the start of the distribution and the position at the end of the distribution of the signal member 11.
- the sensor 16a of the electronic module 16 is designed as a switching detector in order to detect the positional shift of the signal element 11 or.
- the auto-injector also includes a switching actuator 18 in order to actuate the sensor 16a, in particular the switching detector.
- the switching actuator 18 can be provided on the signaling element 11 or the signaling element 11 can be designed as a switching actuator 18 .
- the switching actuator 18 can suitably deflect or redirect a movement of the signal element 11 to be detected and can be designed in one or more parts for this purpose.
- the switching actuator can also include a joint or a gear mechanism for conveying the movement of the signal element to the detector.
- the position or a movement of the holding element 6 can also be detected. This is due to the first spring 9 at Triggering moves at least a little way relative to the housing 2 and along the longitudinal axis L in the proximal direction, whereby by means of the switching actuator 18, or by means of a further switching actuator 19, one or the sensor 16a is also actuated.
- the processor 16c is coupled to the sensor 16a and to the battery 16b of the electronic module 16 and configured in such a way that the start and/or the end of the dispensing of the auto-injector can be registered by means of the sensor 16a.
- the axial movement of the signal element 11 from a position at the start of the distribution to a position at the end of the distribution is recorded or detected.
- the processor 16c includes evaluation electronics which are configured to identify processes in or states of the injection device during an injection process based on measurements by the sensor 16a.
- Processor 16c may preferably be configured to operate a timer.
- the processor 16c of the electronics module 16 may be configured to record the elapsed time since the last payout and/or to record after a specified period of time after the registered end of the payout and/or after the registered start of the payout.
- the light source 16d can be activated after the start position of the signal element 11 and/or the end position of the signal element 11 has been detected or detected, or alternatively after a defined period of time after the registered end and/or after the registered start of the distribution.
- the light source 16d is housed in a light source case 10 .
- This case can be used for protection and better viewing.
- the light source 16d displays information about the status of the autoinjector.
- the light source 16d indicates the start and/or the end of the delivery of the auto-injector.
- the end of a holding time or waiting time can also be displayed, with the patient being able to remove the auto-injector from the skin after this time has elapsed.
- FIGS. 7a-7c show a different embodiment than the embodiments of the invention already disclosed above, only the proximal end of the auto-injector being visible.
- This embodiment differs from the embodiments already disclosed by the construction and the function of the electronics module.
- the sensor 16a′ of the electronics module 16′ is designed as a switching detector in order to detect or detect the positional displacement of the signal element 11′.
- the auto-injector includes a switch actuator 18' in order to actuate the sensor 16a', in particular the switch detector.
- the sensor 16a' is arranged in an axially and rotationally fixed manner in an electronics module housing 17' of the electronics module 16' or alternatively in a housing 2' of the autoinjector.
- the switching actuator 18' has a pretensioning force, in particular a spring force, or can be pretensioned, in particular in a resilient manner.
- the switching actuator 18' is preferably designed in the form of a pin.
- the switching actuator 18' can be arranged in an axially movable, displaceable or slidable manner in a closure cap 12' of the auto-injector or alternatively in the housing 2' of the auto-injector.
- the signal element moves in the distal direction. Due to the released spring force and/or the force of gravity, the switching actuator 18' also moves in the distal direction
- this force can cause the switching actuator 18' to move or move in the distal direction during the movement of the signal element 11' in the distal direction, as can be seen in FIG. 7b.
- the signal element 11' is moved back into the proximal position, with the signal element 11' taking the switching actuator 18' with it and also being moved into the proximal position, as shown in FIG. 7c.
- the axial movement of the signal element 11' in the distal direction at the start of the distribution and the axial movement of the signal element 11' in the proximal direction at the end of the distribution can thus be transmitted from the switching actuator 18' to the sensor 16a', in particular to the switching detector .
- the sensor 16a' in particular the switching detector, is used to measure the axial movement of the switching actuator 18' from a position at the start of the distribution, with the switching actuator 18' being movable or displaceable in the distribution direction, to a position at the end of the distribution, with the switching actuator 18' is configured to be movable or slidable in the proximal direction.
- the sensor 16a' in particular the switching detector, can thus record or detect the position of the signal element 11'.
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- Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Hematology (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Vascular Medicine (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 auto-injecteur destiné à distribuer un produit liquide, en particulier un médicament, cet auto-injecteur comprenant : un module électronique pourvu d'un capteur conçu pour mesurer le mouvement axial d'un élément de signalisation (11) d'une position au début de la distribution, où l'élément de signalisation (11) est entraîné dans la direction de distribution, à une position à la fin de la distribution, où l'élément de signalisation (11) bute contre une butée de signalisation (12a).
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CH70001/21A CH717352A2 (de) | 2021-06-30 | 2021-06-30 | Autoinjektor mit einem Elektronikmodul. |
PCT/EP2022/068113 WO2023275273A1 (fr) | 2021-06-30 | 2022-06-30 | Auto-injecteur pourvu d'un module électronique |
Publications (1)
Publication Number | Publication Date |
---|---|
EP4363009A1 true EP4363009A1 (fr) | 2024-05-08 |
Family
ID=78289409
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP22743784.5A Pending EP4363009A1 (fr) | 2021-06-30 | 2022-06-30 | Auto-injecteur pourvu d'un module électronique |
Country Status (5)
Country | Link |
---|---|
US (1) | US20240123150A1 (fr) |
EP (1) | EP4363009A1 (fr) |
CN (1) | CN117897190A (fr) |
CH (1) | CH717352A2 (fr) |
WO (1) | WO2023275273A1 (fr) |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP4414006A1 (fr) * | 2023-02-08 | 2024-08-14 | Ypsomed AG | Dispositif d'injection comprenant un capuchon de fermeture |
EP4438083A1 (fr) * | 2023-03-27 | 2024-10-02 | Ypsomed AG | Module électronique |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
EP3590568A1 (fr) | 2013-03-22 | 2020-01-08 | TecPharma Licensing AG | Dispositif de distribution de la substance pourvu de dispositif de signal |
EP3199188A1 (fr) * | 2016-01-29 | 2017-08-02 | Carebay Europe Ltd. | Dispositif d'information électrique pour communication d'information concernant la livraison d'un médicament |
CH713114A2 (de) * | 2016-11-09 | 2018-05-15 | Tecpharma Licensing Ag | Elektronisches Zusatzmodul für Injektionsgeräte. |
EP3326671A1 (fr) * | 2016-11-29 | 2018-05-30 | Carebay Europe Ltd. | Ensemble d'activation pour dispositif d'administration de médicaments |
EP3823696A1 (fr) | 2018-07-20 | 2021-05-26 | Novo Nordisk A/S | Dispositif d'auto-injection à enregistrement de dose |
-
2021
- 2021-06-30 CH CH70001/21A patent/CH717352A2/de not_active Application Discontinuation
-
2022
- 2022-06-30 WO PCT/EP2022/068113 patent/WO2023275273A1/fr active Application Filing
- 2022-06-30 EP EP22743784.5A patent/EP4363009A1/fr active Pending
- 2022-06-30 CN CN202280058846.3A patent/CN117897190A/zh active Pending
-
2023
- 2023-12-27 US US18/396,968 patent/US20240123150A1/en active Pending
Also Published As
Publication number | Publication date |
---|---|
US20240123150A1 (en) | 2024-04-18 |
CH717352A2 (de) | 2021-10-29 |
CN117897190A (zh) | 2024-04-16 |
WO2023275273A1 (fr) | 2023-01-05 |
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