Protective device for an injection needle

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DESCRIPTION

Protection device for an injection needle

The present invention relates to a protection device for an injection or infusion needle comprising a protective member surrounded by a tube.

Document DE 20315872 U1 describes a protection device with low manufacturing costs, where the protection member as described in one of the preferred embodiments as a spring clip is surrounded by a shrinkable tube which is attached to the protection member thanks to to radial stress. Because of this, the mobility of the guard member along the needle post is affected, especially when the guard member has two opposing elastic arms whose angled distal ends bear against the needle post, where the arms of the shield member are forced against the needle by the shrink tube.

US 2008/0243086 A1 (Hager et al.) Describes an apparatus for preventing exposure or contamination of blood after removal of a hypodermic needle that includes a needle having a tip and a cap configured to trap the tip of the needle. the needle during the removal of the needle. The cap of the hypodermic needle may include a protective device and / or housing to wrap the tip of the needle.

The invention is based on the object of designing a protection device with low manufacturing costs in such a way that the protection member is easily displaceable along the needle.

This object is achieved by means of a protection device, where the tube surrounding the protection member has a diameter that is only locally reduced or deformed such that the protection member is confined within the tube.

Preferably the tube is a shrinkable tube that is locally deformed by the action of heat. The shrink tube thus does not apply radial stress to the arms of the shield member and the shield member can easily move together with the shrink tube along the needle post. The shrink tube mounted on the shield member limits the possible relative axial movement of the shield member and the shrink tube within the shrink tube.

Advantageous embodiments of the invention will be found in the dependent claims.

The protection device comprises a tube, preferably a shrink tube, which is deformed not completely but only locally in one position or in a plurality of positions, for example at the ends or distal and proximal end portions of the shrink tube projecting overhead. from the ends of the guard member. Here, the diameter of the shrink tube is locally reduced, or modified, by the action of heat such that the shield member is reliably confined within the shrink tube or the shrink tube is reliably mounted and retained in the member. protection due to these diametrically reduced or modified areas of the shrink tube.

Thus, the tube may have an internal diameter, for example between the diametrically reduced end portions, which is greater than the maximum radial dimension of the shield member, so that the shield member is confined and thus retained in the tube shrinkable only by axial support at the ends or diametrically reduced end portions thereof.

Due to the only local deformation of the shrink tube, a protection device is achieved which is very cost-effective to manufacture and in which the protection member is not adversely affected by the assembled shrink tube and the shrink tube forms a gripping part for handle the protection member. The shrink tube can also be considered a protection tube that protects the protection member from contact with the fingers of an operator.

Instead of a tube consisting of a material that shrinks due to the action of heat, a tube consisting of another material, plastic or metallic material, can also be used, this material being then locally deformable by various known methods. The material can, for example, be plastically deformable under pressure.

Other objects, advantages, characteristics and possible applications of the present invention are apparent from the following description of the embodiments with reference to the drawing. Thus, all the features described and / or shown schematically form the subject matter of the present invention in themselves or in any meaningful combination, and independently of their summary in the claims and in the dependencies of the claims.

The invention is explained in greater detail hereinafter with reference to the drawing, where reference is made to the preferred embodiment of a shrink tube.

Fig. 1 shows a side view of a needle mount with a needle and the protection device mounted thereto in a mounting position in longitudinal section,

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Fig. 1a Fig. 2

Fig. 3

Figs. 4a-c Figs. 5a-b Figs. 6 Fig. 7

Figs. 8a-8b

Fig. 9 shows the shrink tube in its initial position in longitudinal section, shows a side view of a needle mount with a needle with another protection device arranged therein in a prepared position in longitudinal section, shows a side view of a needle mount with a needle and the protection device arranged therein with the protection member in the protection position, shows different designs of the shrink tube in longitudinal section, shows two more embodiments of protection members in longitudinal section, shows another design of the shrink tube in a side view, shows another design of the shrink tube in longitudinal section, shows sectional views of the shrink tube having a protection member therein without show the needle, and shows another embodiment of the deformed shrink tube.

In the figures, reference numeral 1 designates a needle mount to which a hollow needle 2 is attached. On the needle post 2, there is a movable guard member 3 which, in the embodiment shown, is formed in the form of a spring clip with crossed arms, one arm of which rests on one side and the other arm of the arms. which are supported on the opposite side of the needle post by means of non-angled end portions 3a. Near the tip of the needle 2 a diametral widening 2a is formed, for example by a slight undulation of the hollow needle, so that during the displacement of the guard member 3, the opening formed in the proximal transverse wall 3b thereof does not it can move past this radial projection 2a and the guard member is kept in the guard position of Fig. 3 such that it cannot move beyond the tip of the needle.

On the needle mount 1, projecting ribs 1a may be formed, to which a protective cap 4 shown in Fig. 2 can be attached. Reference numeral 1b designates a distally projecting mount portion on the needle mount 1 , which has a diameter smaller than the needle mount 1 and protrudes above the ribs 1a in a distal direction. A syringe or infusion device can be inserted into the needle mount 1.

The protection member 3 is surrounded by a shrinkable tube 5, which before assembly has essentially the same diameter and the same wall thickness over its entire length, as shown in Fig. 1a. The shrink tube can be easily placed over the protection member 3. To this end, in its initial position in Fig. 1a the shrinkable tube 5 advantageously has an internal diameter that is greater than the maximum radial dimension of the protection member 3.

During the assembly of the shrink tube 5, the protection member 3 may be located on the needle post 2, for example, approximately in the intermediate position shown in Fig. 1, so that after displacement of the shrink tube 5 heat is applied radially from the outside to the ends or end portions 5a and 5b of the shrink tube projecting over the ends of the shield member 3, so that only those portions 5a and end 5b projecting over the shield member are reduced in diameter.

Due to the specific action of heat on the circumference of the shrink tube 5 only in the end portions 5a and 5b, the middle area 5a of the shrink tube maintains its original diameter, so that in the mounting position of Fig. 1 the Shrinkable tube 5 may have radial play relative to protection member 3. The shield member is only restricted in its axial movement within the shrink tube 5 by axial bearing at the distal and proximal ends in the shrink tube 5 so that it is free to move back and forth within the shrink tube 6 to while it is confined and reliably retained therein, as it cannot move out of the shrink tube 5.

It is also possible to dimension the shrink tube relative to the shield member such that the shrink tube rests slightly on the circumference of the shield member or only on a part of the circumference of the shield member and does not exert any radial stress on the shield member. same. Such a shrink tube design is indicated in Fig. 2. In the embodiment according to Fig. 2, the proximal transverse wall 3b of the protection member has a rectangular shape, while the shrink tube may have a circular diameter so that the shrink tube can rest only on the corners of the rectangular transverse wall 3b, as shown in Fig. Fig. 8a. If the shrink tube rests only on the four corners of the rectangular transverse wall 3b the protection member under a certain tension, this results in a protection against twisting of the protection member 3 relative to the shrink tube 5 without the function the protection member is adversely affected otherwise, because the arms of the guard member are held unrestricted due to radial play within the shrink tube and the shrink tube does not exert any radial stress

ES 2 598 960 T3 on the arms of the protection member.

Fig. 8b shows an embodiment in which, in contrast to the embodiment of Fig. 8a, the diameter of the shrink tube 5 deformed in the area of ​​the proximal transverse wall 3b is greater than the maximum radial dimension of the protection member o of the proximal transverse wall 3b thereof. The sectional view in Fig. 8a corresponds to the intersection line AA given in Fig. 2 without a representation of the needle.

Therefore, the protection member can be completely unrestricted in the deformed shrink tube 5 as indicated in Fig. 6 and Fig. 8, or partially supported on the shrink tube in the radial direction, as shown in Fig. 7 and Fig. 8a. However, it is also possible for the guard member to rest on the shrink tube along the guard member or at the ends thereof, albeit without radial tension, as indicated in Fig. 1.

Preferably, the shrink tube 5, which is made of plastic, has a wall thickness or consistency due to which it is relatively rigid, so that the middle area 5c of the shrink tube maintains its shape even when the shrink tube is grasped by the fingers. of one hand and the guard member is moved by means of the shrink tube towards the guard guard of Fig. 3.

The shrinkable tube 5 can be elastic; however, it preferably has a sufficient rigidity so that the circumference of the shrink tube in the middle area 5c does not compress when touched during handling.

Especially in the proximal area, the end portion 5b of the shrink tube 5 is diametrically reduced to have a longitudinal section such that the end portion 5b of the shrink tube holds the protection member at a predetermined distance from the front end of the ribs 1a. Thus, the end portion 5b forms a distance maintainer between the protection member 3 and the needle mount 1, said distance maintainer preventing that part of the adhesive could possibly reach the protection member 3 during the setting of the adhesive that Holds needle 2 in needle mount 1. Fig. 1 shows an adhesive coating 6 on the circumference of needle 2. If the adhesive hardens on the circumference of the needle as a sheet and some of the adhesive could reach the area between the opening in the proximal transverse wall of the shield member and the circumference of the needle, this could cause the shield member to get stuck. The distance maintainer in the shape of the end portion 5b prevents such jamming of the guard member from occurring, because the proximal transverse wall 3b thereof has sufficient distance from the distal end of the needle mount.

In the representation of Fig. 2, the diametrically reduced end portion 5b of the shrink tube can be arranged with radial play over the mounting portion 1b of the needle mount 1. Alternatively, a supported arrangement without radial clearance is possible. In the case of a large reduction in the diameter of the end portion 5b, as shown in Fig. 4b, this end portion can also rest on the front end of the mounting portion 1b.

For such an embodiment, a shrink tube is used having a correspondingly small diameter in its initial shape, since during the manufacture of a shrink tube it is expanded by means of an expansion process from its extruded shape. Under the action of heat, the tube thus expanded then shrinks back to its extruded shape.

In Figs. 1-3, the diametrically reduced end portions of the shrink tube are depicted as longitudinal sections 5a and 5b. However, it is also possible to reduce only the ends of the shrink tube radially inward, so that the result is essentially a transverse wall 5a 'or 5b' at the distal and proximal ends of the shrink tube 5, between which ends the member is clamped. 3 protection. Fig. 4a shows such a shape of the shrink tube that it can be formed by bending the end of the tube inward to shape it by heat.

It is also possible to reduce the diameter of the distal and proximal ends of the shrink tube 5 in various ways and through various methods so that, for example, at the proximal end, an end portion 5b is formed as the distance maintainer and is form around the protection member 3 at the distal end a sleeve essentially closed by a transverse wall 5a ', as shown in Fig. 4b. Thus, the end portion 5b is formed by a shrinkage process and the transverse wall 5a 'is formed by shaping.

The diametrically reduced ends or portions 5a, 5a ', 5b and 5b' can be designed in such a way that they surround the needle 2 and the diametrical enlargement 2a thereof with sufficient clearance, where the very diametrically reduced distal end of the shrink tube simultaneously serves as protection against the emergence of blood adhering to the tip of the needle.

Fig. 4c shows another embodiment of the shrink tube which also shrinks in its middle area by the annular action of heat, such that a constriction 5d arises in the middle area. Such a 5d constriction is useful especially when using a protection member 3 with intersecting arms, where, in the middle area between the proximal and distal ends, a free 3d space appears into which the 5d constriction can extend.

ES 2 598 960 T3 for holding the shrinkable tube 5 axially relative to the protection member 3. In such an embodiment with a constriction 5d in the middle area, it is possible to omit a diametrical reduction at the ends of the shrink tube or only at one end of the shrink tube, because due to the narrowing 5d, a sufficient axial fixation of the shrink tube 5 occurs with relation to member 3 of protection.

According to another embodiment, a shrink tube shown in Fig. 6 may be provided with an annular radial constriction 5d 'and 5d "in the area of ​​its ends, between which the protection member is clamped in the axial direction, possibly also with a play in the axial direction.

Fig. 7 shows a modified embodiment in which the proximal end of the shrink tube is diametrically reduced and the shrink tube remains unchanged in diameter at its distal end, so that the protective tube 5 thus deformed forms a clamping part. for the guard member 3, by means of which the guard member can be moved forward towards the distal guard position.

In such an embodiment according to Fig. 7, it is useful to form the radial deformation in the proximal end portion of the shrink tube so that an approximately funnel-shaped transition 5e appears between the diametrically reduced end portion 5b and the undeformed portion 5c, where during assembly this portion The funnel-shaped 5e may engage or wedge with the proximal transverse wall 3b of the guard member to prevent the guard member from moving out of the representation of Fig. 7, clockwise in a distal direction relative to the shrink tube. The nesting or wedging of the proximal transverse wall 3b takes place in the partially shrunk portion 5e and thus forms a retaining element in the shrinkable tube 5.

The protection member 3 can be formed in different ways. For example, arms may be provided extending from a proximal rear wall 3b approximately parallel to the needle post 2, where at least one of the arms is provided with an angled end portion 3a to lock the needle tip at the protection position, said end portion 3a preventing displacement of the protection member 3 out of the protection position in the proximal direction. Fig. 5a shows such an embodiment. Furthermore, it is also possible to design the protection member 3 as a sleeve with a proximal transverse wall 3b, where for such an embodiment, on the proximal side of the protection member 3 in the protection position, a retention means must be arranged on the abutment of the needle so that the sleeve, which is open on the distal side and surrounds and covers the tip of the needle in the protective position, cannot be displaced from the protective position in the proximal direction. Such an embodiment of a sleeve-shaped protection member with a retaining element on the proximal side is known, for example, from EP 1 513 578.

Other embodiments of protection members that can be surrounded by a shrink tube as described are represented in different variants in WO 99/08742. Another embodiment of a shield member may be formed from a single arm, which extends parallel to the needle post from a proximal transverse wall 3b having an opening through which the needle extends, and having a Angled end to lock the needle tip, as shown in Fig. 5b.

Other embodiments of guard members can be taken from US7637887. This type of shield member has a sleeve at its proximal end and arms or an arm attached to, and extending distally from, the sleeve. This type of guard member can be used not only with a needle with a curved tip but also with straight needles as described below.

In a means of engagement with the radial projection of the needle post, this radial projection may be in the form of an undulation of the needle post which is indented on two sides and protrudes on the other two sides. According to another embodiment, this radial projection may also have the shape only of a needle post widening having a predetermined distance from the needle tip. Another embodiment may also have only one protrusion or curl only on one side of the needle post, or be formed by a metallic coating on the needle post.

Furthermore, protective members having a gripping means can be used instead of the described means of engagement with the radial protrusion 2a on the needle post, so that a needle 2 with a smooth continuous surface without any protrusion can be used. 2nd radial. Such protection members are described, for example, in US 5 053 017 and US 4 929 241.

The mounting of the shield member preferably takes place in the position of the shield member 3 shown in Fig. 1, so that heat can be applied to the proximal end portion 5b of the shrink tube in the radial direction without hindrance by the needle mount 1. Here, a mechanical distance maintainer (not shown) can be provided, which determines the distance between the proximal end of the shield member and the proximal end of the shrink tube during the shrinking process. After the shrink tube 5 has been assembled, it can be moved with the guard member 3 to the ready position shown in Fig. 2, in which the proximal end portion 5b abuts against the mount portion 1b projecting axially from the needle mount 1 or at the front end of the ribs 1a. After removal of the protection plug 4, an injection can be carried out and then the shrink tube 5 can be moved with the protection member 3 to the protection position of Fig. 3.

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Various modifications of the described construction are possible. For example, the outer circumference of the shrink tube 5 may also be structured, for example, with ribs or corrugations that extend transversely or longitudinally. It is also possible to apply letters or information on the outer circumference of the shrink tube. The shrink tube may also have a cross-sectional shape other than a circle.

Since the middle area of ​​the shrink tube 5 does not change under the action of heat, in this area it is also possible to form, for example, openings in the circumference of the shrink tube, through which the protection member 3 located inside the shrink tube may have an effect outside the shrink tube, for example by means of the elbow shaped portions at the distal ends of the spring clip in Fig. 1, which can be attached to a catheter mount (not shown) in such an embodiment. In such an embodiment, a protection against twisting is provided between the shrink tube 5 and the protection member 3, for example in the form that the corners of the proximal transverse wall 3b of the spring clip are held by the material of the shrink tube. , or radially projecting members are provided in the shield member 3, preferably in the proximal end portion of the shield member, which serve as protection against twisting and can be attached to the shrink tube.

In the disclosed embodiments, radial constrictions or reduced diameter portions are formed in the shrink tube in an annular shape continuously around the circumference thereof. However, it is also possible to form circumferentially shrunk portions only at one position or at individual positions, for example by applying heat by means of opposite heating plates only at opposite positions of the shrink tube. By means of a constriction arranged locally on the circumference in such a way, a retaining portion for the protection member can be formed, which holds the protection member within the shrinkable tube 5 in the axial direction.

The local deformation of the shrink tube 5 should be interpreted as a deformation in one or a plurality of positions along the shrink tube and / or along a circular line of the shrink tube, where along the length of the shrink tube the deformation can also be provided only at individual positions on the circumference. In other words, for example, an annular diameter reduction can be provided, as shown in 5a, 5b or 5d, and in combination with this, a local constriction 5f of the shape of the section can be achieved by deformation in a position individual on the circumference at a distance from the annular deformation, as shown in Fig. 9, in which the area 5f is extended to the cross section of the protection tube by the action of heat.

The present invention further relates to the following aspects:

Aspect 1: Protection device for an injection or infusion needle (2), comprising a needle mount (1) at the proximal end of the needle, on the post of which a protection member (3) for the tip of the needle is movable, the guard member having a mating section (3b) that engages with the needle post to prevent the guard member (3) from moving past the tip of the needle, where the protection member (3) is surrounded by a tube (5) whose diameter is locally reduced or deformed so that the protection member (3) is confined in the tube (5).

Aspect 2: Protection device according to aspect 1, where the protection member (3) remains axially displaceable relative to the tube (5) when the tube (5) is mounted thereto.

Aspect 3: Protection device according to aspect 1, where the protection member (3) is held and axially fixed inside the tube (5).

Aspect 4: Protection device according to aspect 1, wherein the tube (5) has a reduced diameter at its ends or end portions (5a, 5b) extending over the protection member.

Aspect 5: Protection device according to aspect 1, where the tube (5) has an internal diameter between the ends or end portions (5a, 5b) that have a reduced diameter, where said internal diameter is greater than the radial dimension of the protection member (3).

Aspect 6: Protection device according to aspect 1, where by means of a diametrically reduced constriction (5d), the tube is coupled to a radial free space (3d) of the protection member, and with a radial play between the member (3) and the tube (5), the tube being thus axially clamped relative to the guard member.

Aspect 7: Protection device according to one of the preceding aspects, where in a prepared position, the diametrically reduced proximal end portion (5b) forms a stop on the needle mount (1), by means of which the member ( 3) guard is held at a distance from the needle mount (1) or in a mount portion (1b) of the mount (1b) formed so that it protrudes axially from the needle mount.

Aspect 8: Protection device according to one of the preceding aspects, where the tube (5) is locally deformed on the circumference of the tube.

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Aspect 9. Protection device according to one of the preceding aspects, wherein at least one end of the tube (5) is provided with an annular radial constriction (5d) in the area of ​​its end.

Aspect 10. Protection device according to one of the preceding aspects, wherein a radial opening, through which a part of the protection member (3) can act radially outside the tube, is arranged in an undeformed portion of the tube (5).

Aspect 11. Protection device according to one of the preceding aspects, wherein the protection member (3) is formed as a spring clip.

Aspect 12. Protection device according to aspect 11, wherein the spring clip has at least one elastic arm with an angled distal end that rests on the needle post and remains inside the tube (5) in position prepared without being constrained by the tube (5).

Aspect 13. Protection device according to aspect 12, where the at least one elastic arm of the spring holder has a radial play within the tube (5) without being constrained.

Aspect 14: Protection device according to one of the preceding aspects, where the tube (5) is a shrinkable tube deformable by the action of heat.

Aspect 15: Protection device according to aspect 14, where the shrinkable tube (5) has a stiffness in its undeformed area (5c) that resists compression of the shrinkable tube (5) during handling.

Aspect 16: Protection device according to aspect 14, where at least one end of the shrinkable tube (5) has a reduced diameter so that it essentially results in a transverse wall (5a ', 5b').

Aspect 17: Protection device according to aspect 14, where the shrinkable tube (5) rests on the 20 corners of the rectangular transverse proximal wall (3b) of the protection member (3)

Aspect 18: Protection device according to one of the preceding aspects, where the tube (5) and the protection member (3) there are movable together along the needle post.