EP2190507A1 - Dispositif de canule équipé d'une protection d'aiguille pivotante - Google Patents

Dispositif de canule équipé d'une protection d'aiguille pivotante

Info

Publication number
EP2190507A1
EP2190507A1 EP08786690A EP08786690A EP2190507A1 EP 2190507 A1 EP2190507 A1 EP 2190507A1 EP 08786690 A EP08786690 A EP 08786690A EP 08786690 A EP08786690 A EP 08786690A EP 2190507 A1 EP2190507 A1 EP 2190507A1
Authority
EP
European Patent Office
Prior art keywords
cannula
cannula device
protective
base body
latching
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Withdrawn
Application number
EP08786690A
Other languages
German (de)
English (en)
Inventor
Hans Haindl
Reinhard Kruse
Michael Kaufmann
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
SFM Medical Devices GmbH
Original Assignee
Sueddeutsche Feinmechanik GmbH
Sueddeutsche Feinmechanik GmbH
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority claimed from DE102008002796A external-priority patent/DE102008002796A1/de
Priority claimed from DE200810002858 external-priority patent/DE102008002858A1/de
Application filed by Sueddeutsche Feinmechanik GmbH, Sueddeutsche Feinmechanik GmbH filed Critical Sueddeutsche Feinmechanik GmbH
Publication of EP2190507A1 publication Critical patent/EP2190507A1/fr
Withdrawn legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—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
    • A61M5/3216—Caps placed transversally onto the needle, e.g. pivotally attached to the needle base
    • 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
    • A61M5/3245—Constructional features thereof, e.g. to improve manipulation or functioning
    • A61M2005/3247—Means to impede repositioning of protection sleeve from needle covering to needle uncovering position
    • 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
    • A61M5/50—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile
    • A61M5/5086—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for preventing re-use, or for indicating if defective, used, tampered with or unsterile for indicating if defective, used, tampered with or unsterile

Definitions

  • the invention relates to a cannula device with a base body made of plastic, on which a cannula is held with a cannula tip, and with a protective element, which is preferably formed integrally with the base body and in particular hingedly connected thereto and relative to the base body from a first position, in the delivery state of the cannula device, the cannula tip is covered for protection of a user from injury, in a second position in which the cannula tip is released for use of the cannula device is movable, the protective element after use of the cannula device back to the first position or in a third position is movable, covered in the protection of a user from injury, the cannula tip and the protective element is irreversibly locked to the base body by third fixing means.
  • Such cannula devices are generally known as so-called safety cannulas and are used to inject or remove fluids from the body into the human or animal body.
  • a separate protective element - also called protective body or cap - can be covered, z.
  • GB-A-2 277 685 US-A-5 423 765
  • WO-A-2006/041 442 WO-A-2005/030290
  • WO-A No. 2006/074121 US-A-2006/0149188
  • US-A-2006/0 129 126 US-A-2006/0100576, GB-A-2 277 685 (US-A-5 423 765), WO-A-2006/041 442, WO-A-2005/030290, WO-A No. 2006/074121 (US-A-2006/0149188) or US-A-2006/0 129 126.
  • WO-A-90/01348 discloses a generic cannula device which consists of a basic body surrounding a cannula made of plastic and a protective cap formed integrally therewith, which can be pivoted.
  • the cap after use of the cannula in a third position irreversibly lock with the body.
  • one or more fingers of the indoor Side of the protective cap which engage in recesses of the body. So that an uncontrolled swinging back is excluded, the recesses must be relatively deep and thus the body have an undesirably thick wall thickness. This in turn results in a rather voluminous protective cap in the region of the base body.
  • EP-A-I 384 439 and US-A-5,490,841 provide a protective cap integrally formed with a base body surrounding a cannula, by means of which the cannula can be covered.
  • the protective cap can surround the cannula such that an uncontrolled pivoting of the protective cap is no longer possible.
  • a protective cap is displaced longitudinally of a cannula with complete removal from the cannula for use. Then the protective caps are replaced.
  • a disadvantage of the relevant construction is that the protective cap is removed during the use of the cannula and put away, so that often a restart does not occur.
  • a protective body or protective cap connected in one piece with the main body surrounding the cannula can be found in US Pat. No. 5,807,351. Disadvantage of the relevant construction is that the cannula locked both in the delivery state, ie before use, as well as after use in the same position with the body, so that consequently the cap is easily removable even from a used cannula.
  • the invention has the object of providing a cannula device of the type mentioned in such a way that with simple measures the possibility of easy use and protection for a user after using the cannula is given, especially after using the cannula unwanted removal of the as well Protective cap to be designated protective body of the cannula is not possible. Another object of the invention is to ensure that during use of the cannula the protective body can not pivot uncontrollably. Also, according to one aspect of the invention should be easily detectable, whether the cannula is still unused.
  • the third fixing means comprise at least one protruding from the base body first locking projection and at least one latching projection associated with the first latching receptacle in at least one side wall of the protective element.
  • the protective element is in this state of delivery in the first position, in which the cannula tip is covered to protect a user from injury.
  • the user moves the protective element into the second position, in which the cannula tip is exposed.
  • the user places the protection element in a third position, in which the cannula tip is covered to protect a user from injury.
  • a user of the cannula device according to the invention is reliably protected against needlestick injuries both in the delivery state and after the use of the cannula device.
  • the protective cap locks irreversibly on the Body.
  • the third fixing means comprise at least one protruding from the base body first locking projection and at least one latching projection associated with the first latching receptacle in at least one side wall of the protective element.
  • the basic body can be compactly formed, without having to compromise on latching and thus safety for the user.
  • the latching projection barb-like engages in the locking receptacle, in particular opening a secure and therefore irreversible locking is given - under the condition of normal handling.
  • a self-invented proposal provides that the protective element is connected to the base body via a tamper-evident closure or that the protective element before use of the cannula device is fixed by first fixing means in the first position. In this way, the risk is reduced that a user accidentally moves the protection element in the second position and a pinch injury to the then exposed needle tip.
  • the protective element - also called protective body or cap - in the delivery state connected to the main body via a tamper-evident closure it must be destroyed when the cannula exposed, so the protective body is pivoted to the cannula.
  • the tamper-evident closure virtually constitutes a sealing of the protective body to the main body receiving the cannula, which is compulsorily destroyed when the protective body has been pivoted to the cannula.
  • the protective cap is caulked to the base body, wherein in particular a hot caulking takes place.
  • the protective cap can be selectively ultrasonically welded to the base body.
  • Another solution age native provides that for the formation of the tamper-evident closure, the protective cap is connected to the body via an adhesive strip such as label.
  • the protective cap or at least one of its side walls may be connected to the body via a type of film or thin skin formed during spraying, which must be destroyed when the cannula is exposed, ie when the protective cap is to be pivoted ,
  • the film or the skin may be present in addition to or as an alternative to the previously described embodiments of the tamper-evident closure.
  • this should extend at a distance from at least one articulation point, via which the protective body is connected to the base body.
  • locking of the protective element or body with the base body can take place in the first position, ie in the delivery state.
  • first latching projections extend symmetrically to a plane from the base body, each latching projection being assigned a first latching receptacle in one of the side walls.
  • the cannula runs in the plane itself.
  • the two first latching projections project from a web-shaped section of the base body extending along the cannula and preferably penetrated therefrom.
  • the latching projections should merge into each other and have a trapezoidal geometry with a proximally extending larger base leg in section.
  • the dimensioning of the latching projection and the wall thickness of the side wall should preferably be matched to one another such that, when the latching projection is latched in the latching receptacle, this outer edge region, which extends completely with its free perimeter transverse to the cannula body longitudinal axis, extends within the first latching receptacle as through opening.
  • the transverse leg of the T-shaped section forms the Rastvor jumps.
  • the opposite side of the cannula go from the web-shaped longitudinal leg laterally projecting portions, via which the cannula body is connected via film hinges with the protective body.
  • the cannula passes through the base body and is glued or encapsulated in this.
  • the main body should transition proximally into a section which is preferably in the form of a Luer cone or Luer connection body, in order to provide a connection, e.g. to allow with a syringe body or a hose connection.
  • a protection against accidental release in the third position located in the protective cap can be achieved in particular by the fact that the fixation by the fixing means can not be solved by hand, but only using tools. For example, and in particular may occur in the third position, a locking of the protective element with the body, which can not be canceled without tools.
  • the protective element between the first and the second position can perform any suitable movement.
  • An advantageous development of fiction, contemporary teaching provides that the protective element is pivotally connected to the body.
  • the structure of the cannula device according to the invention is further simplified, since a pivotal connection between the protective element and the base body can be realized in a particularly simple manner, in particular during injection molding of the protective element and the base body made of plastic.
  • the protective element is hingedly connected, in particular via at least one film hinge, to the base body.
  • film hinges can be produced in a particularly simple manner by injection molding in the one-piece production of the protective element with the base body.
  • the protective body is caulked with the distal portion, in particular with the transverse leg of the distal portion of the basic body, or punctured z. B. is connected by means of ultrasonic welding.
  • each side wall of the protective body is caulked with an obvious latching projection outside the latching receptacle or selectively connected in particular by means of ultrasonic welding.
  • the connection between the protective body and the basic body forming the tamper-evident closure should be made in the area of the end faces of the side walls and the transverse leg.
  • a tamper-evident closure is realized by at least one adhesive strip such as a label
  • this or this should be placed along at least one outer surface of one of the side walls. Walls of the protective body run and lead to the body. To ensure that the tape can not be removed without destruction, appropriate perforations are provided. Regardless of this, a perforation should run between the main body and the protective body, so that the adhesive strip or the label does not hinder a desired pivoting of the protective body. In particular, an adhesive strip or a label emerges from each side wall, which leads to the main body.
  • the fixing means may be releasable fixing agents.
  • the first fixing means may comprise latching means by which the protective element is latched in the first position with the main body of the cannula device, wherein the latching connection can be solved for the preparation of the cannula device on the use of hand.
  • the locking means may be covered, for example by an adhesive tape or the like.
  • the first fixing at least one when moving the protective element from the first position to the second position having severable fixation element.
  • the protective element is first fixed in the first position on the fixing element on the base body. After severing and thus the destruction of the fixing element, the protective element can then be moved to the second position in which the needle tip is released.
  • Shape and size of the fixing element can be selected within wide limits according to the respective requirements. The same applies to the number of fixing elements, if more than one fixing element is present.
  • An advantageous development of the teaching according to the invention provides that the fixing element is formed like a film. In this way, the fixing element is particularly simple and can be produced with only a small amount of material. By appropriate choice of the thickness of the film, it can be ensured that, on the one hand, the protective element is sufficiently fixed to the main body in the first position, and element, however, is severed reliably when moving the protective element in the second position.
  • the fixing element may be designed according to the Invention as a separate component, which is manufactured separately from the base body and the protective element and connected by suitable connecting means with the protective element and the base body.
  • the fixing element may in particular also be formed in one piece both with the main body and with the protective element.
  • An advantageous development of the teaching according to the invention provides that the fixing element is integrally formed at its one end with the base body or the protective element and is connected at its other end by connecting means with the protective element or the base body.
  • the fixing element is formed integrally with one of the components, while being connected by connecting means with the other component.
  • This embodiment has the particular advantage that a unit of base body, protective element and fixing element are manufactured in one piece and open and the cannula can be glued into the base body. After gluing the cannula, the unit can then be closed, wherein the fixing element can be connected by connecting means with the component with which it is not integrally formed.
  • the connecting means have locking means.
  • the protective element can be fixed in the second position by second fixing means.
  • the protective element is prevented from undesirably moving from the second position to the first position and thus interfering with the use of the cannula device, for example during an injection.
  • the second fixing means may in this case be in particular releasable fixing means, so that the protective element can be moved after use of the cannula device back to the first position or in another position in which the cannula tip is covered to protect a user from injury.
  • a development of the aforementioned embodiment provides that the protective element is connected to the main body via a dead center arrangement, which has a dead center in the second position of the protective element.
  • the protective element for holding the cannula device is stably held in the second position, but can be easily moved by the user by overcoming the dead center back to the first or in another position, in order to protect the user from injury, the cannula tip is covered.
  • a dead center arrangement can be formed in particular in that the film hinge has two or more individual hinges which lie in different planes.
  • the protective body In order to allow trouble-free pivoting of the protective body while simultaneously guiding it, the protective body should preferably be articulated to the basic body via film hinges via two articulation points or regions spaced apart from one another.
  • a holding hinge connecting the base body to the protective body should then run with the dead center position in the use position as the second position between the two spaced-apart articulation points or areas.
  • the retaining hinge is therefore designed in the manner of a snap hinge such that when the protective body is pivoted in a circumference to the cannula, the retaining hinge automatically pivots the protective cap in an end position corresponding to a dead center of the hinge. This ensures that in the use position, ie the second position, an unintentional pivoting of the protective body is omitted, so that undisturbed handling of the cannula is made possible.
  • another embodiment of the inventive teaching provides that the second fixing means and / or the third fixing means are integrally formed with the protective element or the base body.
  • the base body is formed together with the protective element as an injection molded part made of plastic, as provided by another embodiment of the teaching of the invention.
  • the latching between the first and third position should be arranged in a positionally arranged such that the inside of the rear side wall of the protective body in the third position of the protective cap is closer to the cannula than in the first position.
  • At least one second latching projection protrudes from the longitudinal leg of the distal section of the base body having the T-shape in the area of the cannula in the side wall of the protective body extending second latching receptacle is associated, which extends closer to the base body side extending transverse edge of the side wall than the first latching receptacle.
  • the second latching projection protrudes from the base body, in particular from the longitudinal section of a T-shaped distal section in a region which is closer to the pivot axis than the first latching projection or below the first latching projection, so that due to the arrangement of the first and it is ensured that the inside of the rear side wall of the protective body in the first position (delivery state) is further spaced from the cannula than in the third position, that is, after the cannula has been used, the second locking projection and the associated first and second locking receptacle.
  • each second locking projection is associated with a second locking receptacle in one of the side walls.
  • the second locking projections do not cause them to rest against the inner sides of the side walls and thus could push them outward, it is provided that in the side wall between the first and second locking receptacle extends a third locking receptacle in which the second locking projection protrudes when the protective body is in the third position.
  • the second latching projection has in particular the geometry of a cylinder, so that the second and / or third latching receptacle in the plane of the side wall has a circular geometry, wherein the cross section of the third latching receptacle in the plane of the side wall is greater than the cross section of the second latching receptacle.
  • the first latching receptacle in the plane of the side wall has a rectangular geometry in order to receive the first latching projection, which exhibits a rectangular geometry in the cross-sectional plane running parallel to the longitudinal leg of the distal section of the basic body.
  • An alternative embodiment for locking the protective body in the first position, ie in the delivery state provides that of at least one side of the longitudinal leg of the T-shaped distal portion of the base body a receptacle for a ver along the side of the pivotable side wall of the protective body and with this projection connected via a predetermined breaking point starts, which is fixed in the first position in the receptacle as locked.
  • a secure holding of the protective body is ensured in the first position, wherein due to the forces occurring during pivoting the projection is separated from the side wall, so that consequently the protective body from the first position to the second position, ie in the position in the cannula is to be used, can be easily pivoted.
  • the separation from the side wall is facilitated by a predetermined breaking point.
  • the proposed solution proposes a tamper-proof closure with simultaneous locking.
  • each side of the longitudinal leg is a receptacle for each one with a side wall connected via a predetermined breaking point projection. It is provided that the projection is connected via a pivotable web-shaped the predetermined breaking point having portion with the side wall.
  • the projection may have a cylindrical shape with reinforcement provided at the free end, such as a bead, which engages under the receptacle when the positioning is fixed in the receptacle.
  • the receptacle can be delimited by two webs running parallel to one another and in particular also parallel to the cannula longitudinal axis and protruding from the longitudinal leg of the T-shaped distal section of the main body.
  • the web-shaped portion In the mounting position, ie before the protective body is pivoted to the first position for covering the cannula, the web-shaped portion extends in plane spanned by the side wall, from which the projection protrudes vertically.
  • the projection is pivoted about the predetermined breaking point in order to engage in the receptacle as it locks in place. It lies the reinforced end such as knob-like bead-like extension below the lower edges of the recording limiting web-shaped sections.
  • the webs forming the receptacle delimit a receiving channel, which is flared endwise.
  • a further embodiment for locking the protective body in the delivery state, ie first position, provides for a two-armed leg which pivots toward the side wall towards the side wall, starting from the base side and extending in the direction of the longitudinal leg of the T-shaped distal section of the basic body extending holding portion comprises, wherein from the longitudinal leg a spaced apart from the first latching projection and to the proximal portion of the base body offset second latching projection emanates, which in the first position of the protective body of the holding portion is under.
  • the pivotable leg such as wing is aligned in such a way to the outside of the side wall, that assumes a diverging to the side wall in the absence of force on the pivotable leg of these starting from the articulation region.
  • a simple pivoting of the wing is made possible. If the wing is adjusted in the direction of the side wall, the holding section extending beyond the connecting region with the side wall is brought into engagement with the second catch projection, so that consequently the protective body can be pivoted.
  • a pivotable leg such as wings and from each side of the longitudinal leg of the T-shaped distal portion of the body should emanate from each side wall or its transverse edge region, a second latching projection, wherein the second latching projections extend symmetrically to the plane in which the Long give! lies.
  • the pivotable leg as the wing has a recess such as opening, which is aligned at a side wall of an approximate or abutting position of the wing to the first latching receptacle.
  • FIG. 1 is a side view of a first embodiment of a cannula device according to the invention, attached to a syringe,
  • FIG. 1A in an enlarged scale a detail of FIG. 1,
  • FIG. 2 shows another side view of the cannula device according to FIG. 1, FIG.
  • FIG. 3 is a top view of the cannula device of FIG. 1,
  • FIG. 4 is a partially sectioned side view of the cannula device of FIG. 1, 5 in the same representation as FIG. 1, the cannula device according to FIG. 1, wherein the protective element is in the third position, FIG.
  • FIG. 6 shows the cannula device according to FIG. 5 during use during an injection
  • FIG. 7 in the same representation as FIG. 1, the cannula device according to FIG. 1, wherein the protective element is in the third position, FIG.
  • FIG. 8 is a top view of the cannula device of FIG. 7,
  • FIG. 9 is a partially sectioned side view of the cannula device of FIG. 7,
  • FIG. 10 shows a further embodiment of a cannula device or cannula protection device
  • FIG. 11 shows the cannula protection device according to FIG. 10 with a first embodiment of a tamper-evident closure
  • FIG. 12 shows the cannula protection device according to FIG. 10 as delivered in rear view
  • FIG. 13 shows the cannula protection device according to FIG. 10 in the disposal position (third position)
  • FIG. 14 shows the protective device according to FIG. 10 with a second embodiment of a tamper-evident closure
  • FIG. 13 shows the cannula protection device according to FIG. 10 in the disposal position (third position)
  • FIG. 14 shows the protective device according to FIG. 10 with a second embodiment of a tamper-evident closure
  • FIG. 15 shows a modification of the cannula protection device according to FIG. 10, FIG.
  • FIG. 16 shows a further embodiment of a cannula protection device in the assembly position
  • FIG. 17 shows the cannula protection device according to FIG. 16 in the delivery state (first position), FIG.
  • FIG. 18 the cannula protection device according to FIG. 13 in disposal position (third position) and
  • FIG. 19 shows a further embodiment of a cannula protection device.
  • a first embodiment of a cannula device 2 which has a base body 4 made of plastic, on which in Fig. 1 only partially visible cannula 6 is held with a not visible in Fig. 1 cannula tip.
  • the main body 4 may be formed, for example, as a female Luer connector.
  • the cannula device 2 further comprises a protective element 10 - hereinafter also referred to as a protective body or cap - which between a first position shown in Fig. 1, in which the cannula tip is covered to protect a user from injury, and one explained in more detail below second position, in which the cannula tip is released for use of the cannula device 2, is movable relative to the base body 4.
  • the protective element 10 is made of plastic and is in particular integrally formed with the base body 4.
  • the unit of base body 4 and protective element 10 is formed as an injection molded injection molded gus steep.
  • the protective element 10 is pivotally connected and hinged about a in Fig. 1 in the plane extending into pivot axis, namely via a film hinge 12, with the base body 4. Since the film hinge 12 connects the main body 4 with the protective element 10, it is also formed integrally with the base body 4 and the protective element 10.
  • FIG. 1A shows a detail from FIG. 1 in the region of the film hinge 12.
  • FIG. 2 shows the cannula device 2 in another side view, wherein the cannula 6 with its cannula tip 14 can be seen. From Fig. 2 it is further apparent that the protective element 10 is formed in Fig. 2 open towards the user. However, in other embodiments of a cannula device 2 according to the invention, the protective element 10 may also be designed in the manner of a cap.
  • first fixing means are provided which have a fixing element 16 which is formed in this embodiment as a film-like thin web which connects the opposing free axial ends of the base body 4 and the protective element 10 together.
  • the fixing element 16 extends into the plane of the drawing, that is to say essentially in the circumferential direction of the cannula 6 for a short distance. It has a material weakening, for example in the form of a notch, such that the severing of the fixing element 16 when moving the protective element from the position shown in FIG.
  • the fixing element 16 is integrally formed at its two relative to the cannula 6 axial ends with the base body 4 and the protective element 10.
  • a further fixing element 16 ' is provided, which is constructed correspondingly symmetrical to the fixing element 16 and therefore will not be explained here.
  • Fig. 2A shows an enlarged detail of Fig. 2, in which the fixing element 16 is particularly well recognizable.
  • FIG. 3 shows a top view of the cannula device 2.
  • FIG. 4 shows a partially sectioned side view of the cannula device 2 in the first position of the protective element 10.
  • second fixing means are provided, which in this embodiment locking means having two hook-like locking projections 18, 20, of which Detent projection 18 is arranged on the protective element 10 and the latching projection 20 on the base body 4.
  • the protective element is pivoted from the first position shown in FIG. 4 in the direction of an arrow 22 about the hinge axis of the film hinge 12.
  • the user applies so much force that the fixing elements 16, 16 ', promoted by the material weakening provided on them, are severed, so that the opposite ends of the protective element 10 and the main body 4 free from each other and the protective element 10 is further pivoted clockwise can be until the second position is reached.
  • Fig. 5 shows the cannula device in the second position of the protective element 10, in which the cannula tip 14 of the cannula 6 is exposed for use of the cannula device.
  • the latching projections 18, 20 are locked together in the second position, as shown in Fig. 5 and in Fig. 5A, the one enlarged detail of Fig. 5 in the region of the locking projections shows, better recognizable.
  • the protective element 10 is pivoted about the hinge axis of the film hinge 14 by approximately 180 ° relative to the first position.
  • the fixing element 16 ' is cut through, wherein on both sides of the dividing line, ie on the protective element 10 and / or on the main body 4, remains of the fixing element 16' may remain, in this embodiment in each case a substantially triangular web part.
  • the cannula device 2 can be used and punctured by means of the cannula 6, as indicated in FIG. 6, for example an injection of a liquid into human or animal tissue
  • the protective element 10 can be pivoted in Fig. 5 in the direction of an arrow 24 in Fig. 5 in the counterclockwise direction back towards the first position.
  • first the second fixing means formed by the latching projections 18, 20 are unlocked, namely under elastic deformation of the latching projections 18, 20th
  • the protective element 10 is pivoted beyond the first position into a third position shown in FIG. 7, which in turn corresponds to a protective position in which the cannula tip 14 is covered to protect a user from injury.
  • third fixing means are provided, which arranged at the free axial end of the base body 4, in the radial direction of the main body 4 projecting locking projection 26 - hereinafter also called the first locking projection - which in the third position in a in the region of the base body 4 facing the free axial end of the protective element 10 formed window-like recess 28 - hereinafter also called first Rastausneh- tion or -aufnähme, snaps.
  • the latching between the latching projection 26 and the latching recess 28 is chosen so that a permanent fixation of the protective element 10 is achieved in this position and accidental, in particular tool-free unlatching is prevented. In this way, a user is prevented from accidentally moving the protective element 10 back to a position in which the cannula tip 14 is exposed.
  • the cannula device 2 After completion of the use of the cannula device 2 and moving the protective element 10 in the third position shown in Fig. 7, the cannula device 2 can be disposed together with the syringe 8 or separately from this.
  • Fig. 7A shows a detail of Fig. 7 in the region of Rastvor jump 26 and the recess 28th
  • FIG. 8 shows a view from above of the cannula device 2 in the third position of the protective element 10 according to FIG. 7.
  • Fig. 9 shows a partially sectioned side view of the cannula device 2 in the third position of the protective element 10, wherein it can be seen that the cannula tip 14 of the cannula 6 can be easily bent in this third position.
  • FIGS. 10 to 16 A further embodiment of a cannula device or cannula protection device 510 can be seen in FIGS. 10 to 16, which consists of a base or base body 514 penetrated by a cannula 512 and a pivotable protective body 516 preferably integrally formed therewith, ie protective element or cap , both in the delivery state (first position) and in a third Position forming disposal position covers the cannula 512.
  • the protective body 516 in the third position, the protective body 516 is latched to the base body 514 in such a way that unintentional release and, thus, renewed pivoting are no longer possible.
  • the cannula protection device 510 in the use position (second position), the cannula protection device 510 remains in a pivoted position, so that obstruction in the use of the cannula 512 can not take place. Furthermore, the position of the cannula protection device 510 in the delivery state (1st position) should deviate from the disposal position (3rd position).
  • the protective body 516 having a U-shaped geometry will be explained.
  • Other geometries such as in section a C-shape are also covered by the invention.
  • the cannula 512 may be directly surrounded by the body 514 as overmolded or connected to a conventional cannula attachment.
  • the main body 514 is composed of a proximal portion 518 and a distal portion 520.
  • the proximal portion 518 immediately surrounds the cannula 512.
  • the main body 518 is designed in particular as a Luer connector or connection to connect z. B. with a syringe body or hose to allow.
  • the distal section 520 comprises a web-shaped section 522 which is penetrated by the cannula 512 and which merges into a section 524 extending perpendicularly to the latter and forming the web-shaped section 522 so as to give rise to a T-geometry in which the web-like section 522 is the longitudinal leg and the transverse to this section 524 of the transverse leg.
  • the protective cap 516 is hollow cuboid-shaped in the exemplary embodiment and has side walls 526, 528 and a rear side wall 530 connecting them. On the front side, the protective cap 516 is open in order to place the cannula 512 in the cavity formed by the side walls 526, 528 and the rear wall 530 both in the delivery state (1st position, FIG. 11) and in the disposal position (3rd position). Position, Fig. 13). Furthermore, in the exemplary embodiment, the protective cap 516 is closed on the head side by a top wall 532. However, this is just as little a mandatory feature as the hollow cuboid shape of the cap 516, the z. B. also hollow cylindrical or at least partially hollow cylindrical may be formed.
  • the protective cap 516 is connected to the main body 514 via hinges such as film hinges 534, 536.
  • the film hinges 534, 536 start from sections 538, 540, which in turn laterally protrude from the web-shaped section or longitudinal leg 522 of the distal section 520 and are side legs of a U-section.
  • the hinge joint 546 is integral with the protective cap 516 and the base body 514, for example. B. formed by injection molding.
  • the hinge joint 546 has outer sections 549, 551, which adjoin the transverse edge region 550 of the rear side wall 530 and the transverse leg 542 of the distal section 522, and between which a flexible section 552 extends, through which the hinge joint 546 then pivots when the protective cap 516 is pivoted is held when it is in the position pivoted away from the cannula 512, in the on application position (2nd position) (Fig. 10).
  • the hinge 546 acts more or less like a folding hinge in such a way that is adjusted by the relative movement between the articulation points on the distal portion 520 of the main body 514 and the protective body 516 such that in the use state on the cap 516 via the hinge 546 a force acts, the Protective cap 516 holds in the open position.
  • the film hinges 534, 536 and the articulation region of the hinge joint 546 on the distal section 520 of the main body 514 must also extend in mutually offset, but mutually parallel, planes.
  • the side walls 526, 528 delimit V-shaped pockets 560, 562, which provide a problem-free gripping of the protective cap 516 for pivoting it.
  • the side walls 526, 528 which are parallel to each other in opening side portions 564, 566, are inwardly offset in their rearward portions 568, 570 from the opening side portions 564, 566.
  • the rear side wall 530 also is wing-like Edge portions 572, 574 across, which are extensions of the backside wall 530.
  • the transverse leg 524 of the distal section 520 of the main body 514 is trapezoidal in its region extending relative to the cannula 512 opposite the articulation region of the protective cap 516, each extending to one side of the longitudinal leg 522 Area forms a first latching projection 576, 578.
  • the larger base 580 of the trapezoid thus formed faces the proximal region or section 518 of the main body 514 and may optionally have a curved concave profile relative to the latter, as can be seen in particular from FIG. 10.
  • the first latching projections 576, 578 are assigned first latching receptacles 604, 606, into which the first latching projections 576, 578 engage in the disposal position (3rd position) if necessary.
  • the protective cap 514 is fixed in the first position, ie in the delivered state to the main body 514 by a tamper-evident closure, which makes it possible to visually and also physically check whether the protective cap 516 is closed the main body 514 was pivoted so that a re-use is not allowed.
  • this connection which also forms a seal and forms a tamper-evident seal, is realized by tightening the side walls 526, 528 of the protective cap 516 with the transverse leg 524 of the distal section 520 of the main body 514
  • FIG. 12 illustrates that caulking takes place directly in the region of the ends of the transverse limb forming the first latching projections 576, 578. Irrespective of this, it is additionally possible to provide a film which can be cut through and produced during spraying between the main body 514 and the protective cap 516, as was explained in the first exemplary embodiment according to FIGS. 1 to 9. The same applies to the other embodiments.
  • the symbolized by the solid circles 605, 607 and formed by particular stemming in particular compounds Verify thus ensure that pivoting of the cap 516 can only take place when the compounds 605, 607 are destroyed.
  • a resistance must be overcome, so that a physical check can be made whether the cannula 512 has already been used or has been exposed.
  • a check is also possible because the connections 605, 607 are destroyed by the pivoting of the protective cap.
  • caulkings (links 605, 607) are spaced apart from the hinges 534, 536, it is ensured that a targeted force must be applied to the protective cap 516 to destroy the caulkings.
  • the protective cap 516 with the main body 514 in the region of the transverse leg 524 z. B. be selectively connected by means of ultrasonic welding. It is also possible to provide other connections such as adhesive connections, which must be designed such that a targeted separation NEN of protective cap 516 and body 514 is possible without functional parts are damaged.
  • the protective cap 516 is connected to the main body 514 via an adhesive strip 609, 611 such as a label.
  • the protective cap 516 is in the first position, ie in the delivery state of the cannula 512.
  • the adhesive strip or the label 609, 611 is also an optical as well as physical verification possible, whether the protective cap 516 already to the cannula 512th was swung or not.
  • a corresponding adhesive strip 609, 611 which should extend in the axial direction of the cannula 512. In order to rule out a targeted loosening and Wiederankleben the adhesive strip 609, 611, this should have nominal perforations that do not allow re-sticking together.
  • a perforation not shown, be introduced so as not to unnecessarily complicate the pivoting of the protective cap 516 when the cannula 512 is to be used.
  • the protective cap 516 is pivoted in the illustrations clockwise about the film hinges 534, 536, into the use position (2nd position) (FIG. 10), in which the protective cap 516 due to the hinge joint 546 is held.
  • the tamper-evident closure in the form of the heat staking in FIG. 11 or the label or adhesive strip 609, 611 according to FIG. 14 is destroyed.
  • the cannula 512 is freely accessible and can therefore be inserted.
  • the protective cap 516 is pivoted in the direction of the cannula 512-in the drawings, thus counterclockwise-to an extent such that the first latching projections 576, 578 engage in the latching receivers 604, 606. This is the In addition, pivoting is limited in that the lower transverse edges 600, 602 of the side walls 526, 528 abut against the stops 596, 598.
  • the latching receptacles 604, 606 in the plane of the side walls 526, 528 likewise have a rectangular geometry.
  • the respective underside of the first latching projections 576, 578 bears against the lower edge of the first latching receptacles 604, 606, so that pivoting is prevented when force is exerted on the protective cap 516.
  • the latching projections 576, 578 should be positioned with respect to the latching receivers 604, 606 to the hinge joints 534, 536 such that when the latching projections 576, 578 engage in the latching receptacles 604, 606, the cannula 512 is bent.
  • a pivoting of the protective cap 516 from the disposal position (3rd position) should take place, optically visible that the cannula 512 has already been used.
  • the main body 514 surrounds the cannula 512 directly.
  • a connection can be made by gluing or by injection molding.
  • the teaching of the invention is not abandoned when the cannula protection device according to the invention is sold independently of a cannula to then z. B. pushed onto the neck of a cannula or with a syringe body, z. B. to be connected to a pre-filled syringe, from which in turn emanates a cannula.
  • the protective cap 516 not only has a tamper-evident closure, as is the case in principle from FIGS. 2, 11, 14, but additionally a latching in the delivery state (first position) with the main body 514 can be connected.
  • second latching projections 582, 584 can laterally protrude from the longitudinal leg 522, which, running symmetrically to the plane defined by the longitudinal leg 522, have a cylindrical shape.
  • the second locking projections 582 extend approximately in Center region between the longitudinal edges 586, 588 of the web-like portion 522, that is, the longitudinal Schenkeis of the T-geometry having distal portion 520 of the body 514 and below the first locking projections 576, 578th
  • the first and second latching projections 576, 578 and 582 are associated with first and second latching receptacles 604, 606 and 608, 610, wherein the second latching projections 582 engage in the second latching receptacles 608, 610 when the cannula protection device 510 is in the delivery condition, ie. H. located in the first position.
  • the first locking receptacles 604, 606 in the plane of the side walls 526, 528 also have a rectangular geometry.
  • the latching receptacles 608, 610, 620, 622 are circular in cross-section, the third receptacles 620, 622 having a larger cross-section than the second receptacles 608, 610.
  • the second locking receptacles 608, 610 are adapted to the cross-sectional geometry of the second latching projections 582 such that a relatively low clearance exists.
  • FIGS. 16 to 18 A further embodiment of a cannula protection device 200 is shown in FIGS. 16 to 18, wherein for elements which correspond to those in the embodiment of the cannula protection device 510 according to FIGS. 10 to 15, basically the same reference numerals are used.
  • the cannula protection device 710 likewise consists of the base body 514 and the protective cap 516, which with respect to the articulation to the main body 514, the formation of the protective cap 516 and the first latching projections 576, 578 and the first latching receptacles 604, 606 with the embodiment of FIG 10 to 15 Right.
  • the protective cap 516 in the delivery state (1st position) is not fixed via second locking projections, which engage in second locking receptacles of the protective cap 516, but the following construction is selected. Regardless of this, a tamper-evident closure should be provided, as long as the fixing via the second latching projections (FIG. 15) or the construction described below is self-discovery.
  • the protective cap 516 is pivoted in the exemplary embodiment in a clockwise direction.
  • the cylindrical projections 206, 208 which are clamped in the channels 218, 220 between the webs 222, 224, 226, separated from the flachstegartigen sections 202, 204, that is, demolished.
  • predetermined breaking points 234, 236 are formed in the web-like sections 202, 204. Since the cylindrical projections 206, 208 are clamped between the web-like projections 222, 224, 226, they remain in the cage. nalen 218, 220, which thus record for the cylindrical projections 206, 208 form.
  • the protective cap 516 is pivoted in the counterclockwise direction in the direction of the cannula 512 to such an extent that the first latching projections 576, 578 engage in the first latching receptacles 604, 606 in the side walls 526, 528.
  • the main body 514 of the protective device 710 has the same structure as that of the cannula protection device 510.
  • FIG. 19 shows a further embodiment of a cannula protection device 810 which, with regard to the connection of the main body 514 with the protective cap 516, the film hinges 534, 536, the hinge joint 546 and the locking of the protective cap 516 after use of the cannula 512, ie in the disposal state (3rd position) realized the same constructive features, as they have been illustrated with reference to the previously described embodiments of FIGS. 1 to 18.
  • the web-like projections 314, 316 extend symmetrically to the plane defined by the longitudinal leg 522 plane and sloping in the direction of the articulation region of the protective cap 516. This is to ensure that in the delivery state (FIG. 19), the inner surfaces of the L-shaped sections 307, 309 of the wings 302, 304 lie flat against the lower sides of the latching projections 314, 316.
  • a tamper-evident closure can likewise be provided. Also, locking takes place in the 3rd position, as has been explained in detail previously.
  • the cannula devices or protective devices 2, 510, 710, 810 explained with reference to embodiments in which the base body 4, 514, the cannula 6, 512 immediately surrounds, ie z. B. is connected to this by gluing or injection molding, the teaching of the invention is of course not left, when the cannula protection device according to the invention is sold independently of a cannula to then z. B. pushed onto the neck of a cannula or with a syringe body, z. B. to be connected to a pre-filled syringe, from which in turn emanates a cannula.

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

Abstract

La présente invention a pour objet un dispositif de canule (510, 710) doté d'un corps de base (514) en matière plastique, sur lequel est maintenue une canule (512), et doté d'un élément de protection (516), qui peut passer, par rapport au corps de base, d'une première position dans laquelle, dans l'état de livraison du dispositif de canule, la pointe de la canule est recouverte pour protéger un utilisateur de toute blessure, à une deuxième position dans laquelle la pointe de la canule est libérée pour utiliser le dispositif de canule. L'élément de protection peut être ramené dans une troisième position après l'utilisation du dispositif de canule, dans laquelle la pointe de la canule est recouverte pour protéger un utilisateur de toute blessure et l'élément de protection est encliqueté de manière irréversible avec le corps de base par des troisièmes moyens de fixation, qui comprennent au moins une première saillie d'encliquetage (576, 578) dépassant du corps de base (514) ainsi qu'au moins un premier logement d'encliquetage (604, 606) affecté à la saillie d'encliquetage dans au moins une paroi latérale (526, 528) de l'élément de protection (516).
EP08786690A 2007-08-01 2008-07-31 Dispositif de canule équipé d'une protection d'aiguille pivotante Withdrawn EP2190507A1 (fr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
DE102007036507 2007-08-01
DE102008002796A DE102008002796A1 (de) 2008-03-06 2008-03-06 Kanülenschutzeinrichtung
DE200810002858 DE102008002858A1 (de) 2008-05-21 2008-05-21 Kanülenschutzeinrichtung
PCT/EP2008/060065 WO2009016234A1 (fr) 2007-08-01 2008-07-31 Dispositif de canule équipé d'une protection d'aiguille pivotante

Publications (1)

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EP2190507A1 true EP2190507A1 (fr) 2010-06-02

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EP08786690A Withdrawn EP2190507A1 (fr) 2007-08-01 2008-07-31 Dispositif de canule équipé d'une protection d'aiguille pivotante

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US (1) US8827955B2 (fr)
EP (1) EP2190507A1 (fr)
WO (1) WO2009016234A1 (fr)

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US8827955B2 (en) 2014-09-09
US20100198152A1 (en) 2010-08-05

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