The subject of the invention is a safety protective sheath for forehead vein assembly, which safety protective sheath has a purpose of providing protection against injury during the use of needles, particularly when a so called forehead vein assembly is used that can be fastened to the body.

Dangerous infections could be contracted from needles used in medical activities, when a needle gets into contact with blood, therefore, it gets an increasingly important role to ensure comprehensive safety in the medical practice.

According to the state of art, the patent TW200817058 of Taiwan makes known a solution, where a coupler is attached to the needle, which can be connected to a receiving component having a butterfly shape. There are two hooks on the side of the coupler, which can be engaged into the holes of the receiving component. When the needle is retracted after use, the coupler travels on a rail, and it prevents the reuse of the needle after it hooks into a tongue that prevents back movement.

The drawback of the solution described here is the rail, which is installed for preventing reuse, presents an obstacle during use, and the rail can bend, the fixing joint cannot be seen, and the joining might not happen at all. A further disadvantage of this solution is that it cannot provide permanent closing simultaneously, therefore, yet another component is to be used.

The international patent publication WO2011055287 is also makes known according to the state of art, which describes a solution, where an outward protruding node is connected to the needle, which moves in a split pipe which is integrated with a butterfly handle, where the split allows the introduction of a node at one end, but it dos not prevent falling out, then a split is available that allow pushing the needle forward, which is terminated towards one end with a fastening part aligned in perpendicular direction. By turning the node to this location it is possible to fix the needle in order to prevent the needle from sliding back. The reuse of the needle is prevented by a tongue, which jumps in front of the retracted node. The drawback of this solution is that the node might get disengaged during use, and the protecting sleeve can slide forward, thus interfering with the placing.

For eliminating the deficiencies of the solutions known according to the state of art and used in practice, we had the following objectives when developing the invention:

- The protecting sheath of the needle should be usable in a simple and straightforward manner.

- The protecting sheath shall be on the assembly continuously, so that it would be available after using the assembly.

- The protecting sheath must not present an obstacle during the use of the assembly, and it must not occupy too much space between the butterfly shaped fastener and the operator, because this would make the use of the assembly difficult.

- The protecting sheath must ensure appropriate safety even in its condition preceding the use. An inadvertent opening is not acceptable.

- The protecting sheath must not be openable after closing.

- The protecting sheath must separate the needle from the environment entirely after closing. We developed the geometry of the safety protecting sheath according these aspects, so that it can be used for a forehead vain assembly or for similar assemblies.

While developing the solution according to the invention we realized that if a safety protecting sheath is used for the forehead vein assembly that has a needle at one of its ends, a fluid conducting pipe is connected to its other end, and to this a butterfly shaped fastened is connected, and a ring is attached to the middle part between the needle and the fluid conducting pipe, which has a flexible serrated branch and a flexible curved branch, with outward protruding node at its end; the freely moving ends of the double fastening tongue are aligned in a direction opposite to the needle; a protecting sheath is installed in the ring in a movable manner, the end of the protecting sheath toward the needle is closed, there is a slit up to its end to allow pushing the needle forward; the protecting sheath covers the needle before and after use; a closed terminating ring is located on the protecting sheath at its end opposite to the point of the needle, and a gate is created on this terminating ring, and the gate has a reducing shape, through the narrowest part of which both branches of the fastening tongue can pass together with the protruding node at their ends, then the set aim can be achieved. The invention is a safety protective sheath for forehe.

middle part having a needle at one of its end, a fluid conducting pipe connected to its other end, and a butterfly shaped fastener is connected to this pipe. It is characterised by that, the a ring is connected to the middle part located between the needle and the fluid conducting pipe, there is a double fastening tongue created on the outside of ring, which has a flexible serrated branch and a flexible curved branch, on the end of which there is an outward protruding node; the freely moving ends of the double fastening tongue are aligned in a direction opposite to the point of the needle; a protecting sheath is installed in the ring in a movable manner, the end of protecting sheath towards the needle is closed, a slit is created up to the other end to allow pushing of needle forward; the protecting sheath covers the needle before and after use; on the end of the protecting sheath being opposite to the point of the needle a closed terminating ring is mounted, on which a gate is created, this gate has a reducing shape and a size, so that both branches of the double fastening tongue together with the protruding nodes at its ends can pass through its narrowest part.

In a preferred embodiement of the solution according to the invention the butterfly shaped fastener is installed between the protecting sheath and the body, and it is fixed to the middle part by means of a connector.

In another preferred embodiement of the solution according to the invention the butterfly shaped fastener is installed on the centre of the protecting sheath, and it is fixed to the middle part by means of two connectors.

In a further preferred embodiement of the solution according to the invention the ring and the terminating ring are made of a material that has a different flexibility relative to the protecting sheath.

The invention is furthermore set forth on the base of the enclosed figures:

The Fig. 1 shows the top view of the safety protecting sheath according to the invention, as configured before use.

The Fig. 2 shows the top view of the safety protecting sheath according to the invention, as configured after use. The Fig. 3 shows the perspective view of an embodime:

according to the invention, in partially retracted condition.

The Fig. 4 shows the perspective view of the protecting sheath belonging to an embodiment of the safety protecting sheath according to the invention.

The Fig. 5 shows Section A-A of an embodiment of the safety protecting sheath according to the invention, where the fastener is located at the bottom.

The Fig. 6 shows Section B-B of an embodiment of the safety protecting sheath according to the invention, where the fastener is located at the bottom.

Fig. 7 shows Section A-A of an another embodiment of the safety protecting sheath according to the invention, where the fastener is located at the middle.

Fig. 8 shows Section B-B of an another embodiment of the safety protecting sheath according to the invention, where the fastener is located at the middle.

Fig. 9 is an enlarged Section C-C of the safety protecting sheath according to the invention, showing the double fastening tongue in a position after use.

The Fig. 1 shows the safety protecting sheath according to the invention in a position before use. The essential part of the invention, the double fastening tongue 5 can be well visible in the figure, which is fixed to the ring 4. The serrated branch 6 of the double fastening tongue 5 is aligned within the gate 10, and its node 8 engages into the rear edge of the gate 10 in order to prevent inadvertent movement. The gate is designed preferably with reducing section partly to guide the double fastening tongue 5 into the gate 10 when it is moved in a position after the use. In a position before the use, the protecting sheath 9 covers the needle 2 entirely. In a position before use, the curved branch 7 of the double fastening tongue 5 embraces and fixes the gate 10 from the outside as a result of its flexible nature. The entire safety protecting sheath can be fixed to the body by means of the butterfly shaped fastener 3. The fluid is delivered to the needle 2 through the fluid conducting pipe 1.

The Fig. 2 shows the top view of the safety protecting sheath according to the invention in a position after use. The difference between the two positions of the double fastening tongue 5 can be seen here. While the curved branch 7 of the double fastening tongue 5 embraces the gate 10 from the outside in the former figure, here both branches of the double fastening tongue 5 are inside the gate 10, and the outward protruding node 8 on it springs out at the rear end of the gate 10 to fix it pern

gate 10 allows to pass through both branches of the double fastening tongue 5 together with the node 8. The shape of the node 8 facilitate the travel into the gate 10, that is why its front edge is inclined, but it prevents pulling back, therefore, its rear edge is nearly perpendicular. The curved branch 7 of the double fastening tongue 5 is made of resilient material, and its thickness is reduced toward its end.

The Fig 3. shows the perspective view of an embodiment of the safety protecting sheath according to the invention. In this embodiment design the butterfly shaped fastener 3 is located beneath the needle 2 at the side towards the body. There is a space for the protecting sheath 9, that protects the needle 2, between the ring 4 and the fluid conducting pipe 1.

The Fig. 4 shows the perspective view of the protecting sheath 9 belonging to the embodiment of the safety protecting sheath according to the invention as described above. The protecting sheath 9 is closed at its end towards the needle 2 along a length not longer then the end of the needle 2, then there is a slit 13 up to its other end. A terminating ring 11 is shaped at the other end of the protecting sheath 9, and a gate 10 is placed on it.

The Fig. 5 shows the longitudinal section of the embodiment of the invention described above. It can be seen in the figure, that the ring 4 is attached to the middle part 14 with another connecting component 12 independently of the butterfly shapes fastener 3. This solution allows to produce the ring 4 from a material different from that of the butterfly shaped fastener 3.

The Fig. 6 shows the cross sectional view of the embodiment of the invention described above. It can be seen in the figure, that in case of this embodiment, the butterfly shaped fastener 3 is fixed to the middle part 14 in the shaft through the slit 13 created at the bottom of the protecting sheath 9 with the help of a connecting component 12.

The Fig. 7 and Fig. 8 show the longitudinal section of another embodiment of the safety protecting sheath according to the invention, where the butterfly shaped fastener 3 is located at the middle. In this version, the butterfly sh

axis of the needle 2. Here, the connecting component 12 joins the ring 4 and the butterfly shaped fastener 3 together to the middle part 14. As can be seen in Fig. 8, a slit 13 is created at each side of the protecting sheath 9.

The Fig. 9 shows the enlarged image of section C-C of the double fastening tongue 5 of the safety protecting sheath according to the invention in a position after use. As can be seen in the figure, the front end is inclined on the node 8 located on both branches of the double fastening tongue 5, which prevents the reuse, while the rear edge is engaged in the edge of the gate 10, thus preventing retraction of the protecting sheath 9. The joint can be easily opened after bending the serrated branch 6, therefore, the protecting sheath

9 can be pulled back before use, when the curved branch 7 is located next to the gate 10 at the outside.

The protecting sheath according to the invention can be assembled very easily. During the production phase the part integrated with the needle 2 shall be assembled with the protecting sheath 9 in a way, that the serrated branch 6 of the double fastening tongue 5 is located within the gate 10, but the flexible curved branch 7 remains outside. The butterfly shaped fastener 3, which is attached to the middle part 14, and connected to the needle 2 and the fluid conducting pipe 1, is to be positioned in the slit 13 of the protecting sheath 9, then the terminating ring 11 is to be adhered onto the protecting sheath 9.

For the purpose of using, the needle 2 is to be released by ^' manually bending the serrated branch 6 towards the inside of the gate 10, and the protecting, sheath 9 is to be pulled back, as a result of which the temporary connection between the gate 10 and both branches of the double fastening tongue 5 is ceased.

After use, the protecting sheath 9 is to be simply pushed forward until both branches of the double fastening tongue 5 are within the gate 10, and the node 8 springs out at the rear end of the gate 10, thus fixing the protecting sheath 9 above the needle 2. The gate

10 and both branches of the double fastening tongue 5 are dimensioned in a way, that the repeated pulling back of the protecting sheath 9 is prevented. The advantage of the solution is that the protecting sheath 9 does not present an obstacle during the use of the assembly, and it does not occupy excessive space between the butterfly shaped fastener and the operator. The protecting sheath guarantees the adequate safety even when it is in a state before use. The inadvertent opening is excluded. After closing, the protecting sheath cannot be opened again.

After closing, the safety protecting sheath fully separates the needle from the environment.

List of referrences:

1 fluid conducting pipe

2 needle

3 butterfly shaped fastener

4 ring

5 double fastening tongue

6 serrated branch

7 curved branch

8 node

9 protecting sheath

10 gate

11 terminating ring

12 connector

13 slit

14 middle part