A safety needle assembly

(12) PATENT DESCRIPTION (19) PL (11) 196617 (13) B1 (21) Application number: 368987 ⁽¹³⁾ (22) Date of notification: 28/11/2002 ^{(51) Int.Cl.}

A61M 5/32 (2006.01) (86) Date and number of the international application:

28.11.2002, PCT / DK02 / 00799 (87) Date and publication number of the international application:

June 5, 2003, WO03 / 045480 PCT Gazette No. 23/03 (54)

Safety needle assembly

<td>(30) Priority: 2001-11-30, DK, PA200101772</td><td>(73) The right holder of the patent: NOVO NORDISK A / S, Bagsvaerd, DK</td>

<td>(43) Application was announced: 04/04/2005 BUP 07/05</td><td>(72) Inventor (s): Karsten Jensen, Hjorring, DK Niels Nymark, Hjorring, DK</td>

<td>(45) The grant of the patent was announced: 31.01.2008 WUP 01/08</td><td>(74) Representative: Słomczyńska Elżbieta, POLSERVICE, Kancelaria Rzeczników Patentowych Sp. z o. o</td>

(57) 1. A safety needle assembly comprising a cylindrical housing having an upper surface with an aperture and a lower surface and having means for mounting the housing to a medical injection device, a needle cannula mounted on the lower surface and having a distal end disposed on the distal side of the lower surface, and a telescopically movable guard extending through the aperture. relative to the housing between a remote position where the sheath covers the distal end of the needle cannula and the proximal position, wherein at least a portion of the distal end of the needle cannula is exposed, a spring disposed within the housing biasing the shield in the distal direction, and a closure member disposed within the housing having at least one outwardly projecting closure projection characterized by that the closure element (16, 44) is a separate part positioned between the spring (25) and the shell (2.43) and longitudinally slidably attached to the shell (2.43) with respect to the housing (1.40) guiding the closure lip (17.49) ) on the closure member (16) from a first position, where the closure (2.43) is in a distant position by the second position, where the closure (2.43) is in a close position to the third position, where the closure (2.43) is in position. remote location and, in which at least one of the locking projections (17.49) is blocked by the locking surface (15.55) ..........

<img file="PL196617B1_D0001.tif" />

PL 196 617 B1

Description of the invention

The invention relates to a safety needle assembly that reduces the risk of accidental needle stick injuries, and in particular to a safety needle assembly in which a needle cannula is mounted in a hub.

Needle assemblies are commonly used either to inject substances into or out of the body of humans or animals. Such needle assemblies are typically disposable and are only discarded after one use. The problem posed by the disposal of the needle assembly, and indeed any use of the needle assembly, is the potential risk of being injured by the sharp end of the needle cannula. This is especially dangerous when it follows penetration of the skin of patients as the needle cannula may become contaminated and therefore transmit diseases such as hepatitis and HIV.

A large number of safety needle assemblies have been developed in which the needle cannula is covered by a telescopically movable shield during injection.

One such prior art needle shield system is disclosed in WO 01.76665. This safety needle includes a hub with a centrally located needle cannula. The telescopically movable cover is placed on the outer surface of the hub. The shield is telescopically movable between a first position where it fully covers the needle cannula and a second position where a portion of the needle cannula is left shielded for injection. The cam element rotatably attached to the hub is provided with at least one cam which is guided in a cam curve provided on the inner surface of the shell. The guard is pushed in the distant direction by a spring that stretches between the hub and the guard. The curvature of the cam is adapted to lock the cam in a locking position as the guard returns to the first position following injection.

The safety needle assembly disclosed in WO 01.76665, however, is rather bulky and consists of a large number of parts that must be formed and then fit together very precisely in order to obtain correct cam follower movement.

It is also a fact that the various plastic parts of the composite structure tend to change their relative dimensions when the structure is sterilized with steam or gas. This is especially troublesome when the tolerances have to be very tight, such as in the needle safety assembly disclosed in WO 01.76665.

Rather a strong spring is needed to ensure that the cam element of WO 01.76665 actually moves into the closed position when the protective cap returns to its starting position after injection has been performed. This is inconvenient for the user as he has to literally push the protective cap in a near direction as he or she uses his or her skin when giving an injection.

The object of the present invention is to provide a safety needle assembly which is easy to use, in particular which is made of fewer parts and whose parts are not subject to very strict tolerances.

Additionally, it is an object of the present invention to provide a safety needle assembly having a spring of limited force, thus offering the user maximum comfort.

A safety needle assembly comprising a cylindrical housing having upper surface with an aperture and a lower surface and having means for mounting the housing to a medical injection device. a needle cannula mounted in the lower surface and having a distal end disposed on the distal side of the lower surface and extending through the aperture a sheath telescopically movable relative to the housing between the distal position where the sheath covers the distal end of the needle cannula and a proximal position where at least a portion of the distal end of the needle cannula is exposed, spring located inside the housing, pushing the cover in a distant direction, and a closing element located inside the housing and having at least one closing projection, according to the invention, is characterized in that the closing element is a separate part arranged between the spring and the cover and longitudinally slidably connected with the cover in relation to the housing by guiding the closing projection on the closing element from the first the position where the guard is in the remote position by the second position, wherein the cover is in a close position to a third position, wherein the cover is in a remote position, and wherein at least one of the locking projections is blocked by a locking surface fitted with the inner surface of the housing irreversibly restraining additional movement of the cover.

PL 196 617 B1

Preferably, the closing projection of the closing element in the first position abuts a post on the shell and a tab on the inner surface of the housing.

Preferably, the closure member and the closure projection are rotatably connected to the housings and covers and are pivoted to align with the inclined surface of the post and the inclined surface of the tab.

Preferably, the closing projection of the closing element in the second position abuts a gear located at the proximal end of the shell.

Preferably, the closing projection of the closing element in the third position is trapped in an opening defining the locking surface in an elongated rib provided on the inner surface of the housing.

Preferably, the guiding means for guiding the closing projection of the closing element comprises ribs and tabs situated on the inner surface of the housing, the ribs and tabs extending only in the horizontal direction.

Preferably, the cover is mounted inside the housing and extends through an opening at the upper surface of the housing.

Preferably, a spring connects the closure member and the lower surface of the housing.

Preferably, the housing is provided with a window through which the closing projection is visible in its third position.

When the closure member is provided as a separate element between the spring and the sheath and moves simultaneously with the sheath, the closure projection can be guided during the longitudinal movement of the closure member, thereby eliminating the need for tracks or cams thereby allowing the safety needle assembly to be constructed with only three parts as hub add-on.

Since there are no tracks or cams as such, the internal tolerances are not so critical and the friction can be kept rather low which allows a somewhat soft spring to be used which increases the comfort of the user.

By blocking the pivoting movement of the closure lip with a tab provided on the inner surface of the housing, it is possible to determine when the pivoting movement of the closure lip should start simply by specifying a specific length of the tab.

When the closing projection on the locking element has moved to the end of the tab, it will be possible to slide the locking projection backwards. The length of the protrusions may be such that when the sheath is actuated and the needle cannula emerges from the opening in the sheath, the injection can be removed and the needle retained for later use.

When the closure projection engages the shield gear, the shield can be moved an entire length rearward in an approximate direction, thereby exposing the needle cannula.

Once the injection is complete and the locking lip is trapped in the slot in the longitudinal rib, it is practically impossible to slide the needle cannula back by pressing the sheath back in approximately direction.

The guiding means for guiding the locking lip comprises only horizontally defined ribs and tabs. This makes both the molding of the parts and the assembly of the parts very easy.

By mounting the cover inside the housing it is ensured that the cover cannot be separated from the housing.

When a spring stretched between the closing member and the hub connects both the closing member and the lower surface of the housing, it is ensured that the spring can be added to the assembly in a very simple manner.

By providing the housing with a window through which the closure projection can be viewed when in the captive position, it is ensured that the user can visually check whether or not the safety needle assembly has already been used before.

The portion of the shield and / or closure member that is visible through the window when the safety needle assembly is unused may also be painted a color indicating that the safety needle assembly is ready for use.

The window can be either transparent or simply a hole in the side wall of the housing.

In the present context, the term "moving simultaneously, which is used to describe the relationship between the movement of the cover and the closure member, does not necessarily mean that the cover and the closure projection are moving at the same speed. Relative speed of the motion delimited by

The different inclined surfaces thereby vary. The term "moving simultaneously only means that both the cover and the closing projection are moving at the same time.

The subject of the invention in an exemplary embodiment is shown in the drawing, in which fig. 1 shows a perspective view of the safety needle assembly according to the invention, fig. 2 shows an exploded view of the safety needle assembly according to the invention, fig. 3 shows a perspective view of the needle shield, fig. 4. shows a perspective view of the closure member, fig. 5 shows a perspective view of the housing body, fig. 6 shows a schematic view of the casing body, fig. 7 shows a schematic view of the safety needle assembly according to the invention, fig. 8 shows a schematic view of the safety needle assembly according to the invention with part of the housing cut away, fig. 9 shows the locking projection in its first position, fig. 10 shows the locking projection in or moving in towards its first position, Fig. 11 shows the movement of the locking lip passing from the second position to the third position, Fig. 12 shows the locking projection in a third position, fig. 13 shows a perspective view of an embodiment of a safety needle assembly according to the invention, fig. 14 shows a housing part of an embodiment of a safety needle assembly according to the invention, fig. 15 shows an exploded view of a safety needle assembly according to the invention, fig. Fig. 16 is a perspective view of a needle safety device stored in a container.

The figures are schematic and simplified for the sake of clarity, and just show details which are essential for understanding the invention, while other details are left aside. As a whole, the same numeric reference numerals are used for identical or corresponding parts.

Initially, it may be convenient to specify that the term "distal end is intended to refer to the end of the safety needle assembly inserted into the patient's body, while the term" near end is intended to refer to the end connected to the injection device.

Figure 1 shows a safety needle assembly comprising a housing 1 and a sheath 2, the housing 1 is made of a hub 3 and a body 4. The hub 3 and body 4 are normally glued or welded together.

The interface 5 between the hub 3 and the body 4 is shown in a specific position in the figures, but could of course be positioned as desired. The hub 3 and body 4 could even be welded as one piece closed at the top surface 6 by a lid. The upper surface 6 is provided with an opening 8 through which the cover 2 passes.

The shield 2 is provided with a needle outlet 7 through which the needle cannula 30 can pass. The proximal end of the shield 2 is, as shown in Figure 2, provided with eight outwardly extending posts 10, which posts 10 have a flat front face 11 and an inclined underneath. angle of the rear face 12.

Housing 1 has a lower surface 9 in the center of which a needle cannula 30 is mounted. The needle cannula 30 can either be mounted so that a portion of the cannula 30 extends from the lower surface 9 in a proximal direction which is preferred for use with inserts or can be mounted without this so-called back needle, which is beneficial for hypodermic syringes. Adjacent to the lower surface 9, at the proximal end of the housing 1, means are provided for mounting the safety needle assembly on the injection device. These means would normally be a thread such that the safety needle assembly can be screwed onto the syringe.

Figure 3 shows the shield 2 seen from the near end. The eight posts 10 are separated from each other by eight equally measured intervals 26. The angular rear face 12 of the posts 10 together with the shell 2 form a gear 13 in which the center of the posts 10 forms apexes and the shell 2 at the spacing of the armpits 26 forms recesses.

The closure element 16 seen in Fig. 2 is provided on its near outer surface with four closure projections 17. These closure projections 17 have, as shown in Fig. 4, an angled front face 18 and a flat rear face 19.

The housing 4 of the housing 1 is shown in perspective in FIG. 5 and in a sectional view in FIG. 6. The body 4 is provided with four windows 20 and one longitudinal rib 21 for each window 20. The ribs 21 are disposed on the inner surface of the body 4. These longitudinal ribs 21 extend the entire length of the body 4, but are divided into two parts (21a, 21b). ) through the windows 20. A distal part of this rib 21 is formed uniformly with a flange 24 provided at the distal end of the body 4 and ends in a flat surface 14 at the distal end of the window 20. A proximal portion of the rib 21 ends at the proximal end of the window 20 on the locking surface 15, the use of which will be explained later. Four protrusions 22 are provided at the distal end of the body 4. These protrusions 22 are uniformly formed with a collar 24 at the distal end of the body 4.

They have an angled surface 23 at the proximal end which ends approximately adjacent the center of the windows 20.

Although the embodiment described herein has eight posts 10, four locking projections 17 and four windows 20, these parts could be provided in a different number as shown in Fig. 15.

When the safety needle assembly shown in Fig. 2 is assembled, the spring 25 extends between the bottom surface 9 of the housing 1 and the closure member 16 pushing the closure member 16 and the shield 2 in the remote direction. The flat front surface 11 of the pillars 10 rests against the flange 24 such that the cover 2 is connected to the body 4 of the housing 1.

The assembled safety needle assembly is shown in Figs. 7 and 8; Fig. 8 illustrates the inside of the safety needle assembly with the body 4 cut out.

The cover 2 is positioned in the body 4 of the housing 1 such that each rib 21 and each tab 22 are located at a distance 26 between the two posts. The upper portion 21a of the ribs 21 is not shown in Fig. 8, however, since the upper rib 21a is not completely necessary. The locking element 16 is then mounted such that the angled front side 18 on each locking projection 17 abuts a rear angled side 12 on the four pillars 10 of the cover 2, whereby the lateral surface of the locking lip 17 and the lateral surface of the studs 10 form a straight line. which rests on the side surface of the tabs 22 of the body 4 of the housing 1.

When the shield 2 and the closure member 16 are properly mounted in the body 4 of the housing 1, the spring 25 is positioned around the needle cannula 30 and the body 4 and hub 3 are welded together making the safety needle assembly ready for use.

The movement of the closure lip 17 is schematically shown in Figs. 9-12, showing the relative position of one of the closure tabs 17 on the closure element 16, two posts 10 on the cover 2, one of the tabs 22 on the inner surface of the body 4 of the housing 1 and one of the ribs. 21 also placed on the inner surface of the body 4 of the housing 1.

Figure 9 illustrates the safety needle assembly in its initial position as shown in Figure 8 with the shield 2 in its distant position where the shield 2 covers the needle cannula 30. When the shield 2 is pressed towards the user's skin, the shield 2 and the posts 10 are pressed against the user's skin. displaced in the proximal direction as indicated by the arrow 27. This movement also moves the locking lip 17 on the obturator 16 in the proximal direction against the force F of the spring 25.

When the locking tabs 17 are released from the tabs 22 as shown in Fig. 10, the angled front side 18 of the locking tabs 17 will slide along the angled rear side 12 of the posts 10 and the angled front side 23 of the tabs 22 as shown by the arrow. 28. This movement will bring the closure projections 17 into contact with the recesses of the gear 13. The additional movement of the cover 2 and thus the posts 10 in the direction of the arrow 27 will only move the locking lugs 17 further in the near direction. The injection is then performed with the cover 2 in its closest direction. The position of the tabs 22 and the ribs 21 is such that the posts 10 are always guided either by the tabs 22 or by the ribs 21.

When the injection is complete, the needle cannula 30 exits the skin of the user, causing the shield 2 with the posts 10 and the closure member 16 with the closure lip 17 to move in the distant direction under the force F applied by the spring 25. The arrow 29 in Fig. 11 shows this move.

Figure 12 illustrates how the force F of the spring 25 pushes the closure member 16 with the closure lip 17 and the shell 2 with pillars 10 in the distant direction. When the angled front side 23 on the tabs 22 is aligned with the angled back side 12 of the posts 10 such that the two angled front sides 23, 12 form a diagonal line, the angled front side 18 of the locking lip 17 will move along this line to the position where the closure projection 17 is positioned between the upper portion 21a and the lower portion 21b of the ribs 21, that is, between the flat surface 14 of the upper portion 21a of the ribs 21 and the locking surface 15 of the lower portion 21b of the ribs 21. In this position, the locking projection 17 and hence the locking element 16 and the cover 2 are irreversibly closed.

At the proximal end of the closure projection 17, the flat rear side 19 will abut or at least be blocked by the locking surface 15 on the ribs 21 of the body 4 of the housing 1, making it impossible to move the cover 2 in the close direction. At the distal end, the angled front side 18 of the closure lip 17 will abut the gear 13 of the cover 2 and since the flat front side 11 of the pillars 10 on the cover 2 abuts the flange 24 of the body 4 of the cover 1, it will not be possible to slide the cover 2 in the distant direction. . Sideways

The posts 10 of the cover 2 will be trapped between the top 21a of the ribs 21 and the tabs 22. As a result, it will be impossible to move the cover 2 in any direction.

Instead of positioning the sloping front face 18 of the closure lip 17 adjacent to the shield gear 13 when the injection is complete, the front end 36 of the closure member 16 may be arranged to abut the inner upper end 37 of the closure 2 when the closure lip 17 is in position. closure. This will in fact make it impossible to compress the angled front side 18 of the closure lip 17 by pushing the cover 2 in the near direction.

The body 4 of the housing 1 is provided with four windows 20, which windows 20 divide each of the four ribs 21 into an upper portion 21a and a lower portion 21b. When the safety needle assembly is used, the closure projection 17 on the closure member 16 will be positioned between the upper portion 21a and the lower portion 21b of the ribs 21, and will therefore be visible through the window 20. The closure protrusion 17, or part of it, could be painted a bright color or provided with some other indicator that would make it very easy for the user to visually check whether or not the safety needle assembly has been used by looking at the window 20. The windows 20 could, for example, be conceived of as openings in the body wall 4.

Prior to use, the safety needle assembly is provided to the user sterilized and packaged as shown in Figure 7. The container 31 is closed at the distal surface 32 and open at the proximal surface 33. The proximal surface 33 is sealed by a removable seal, not shown. The container 31 has ribs on its inner surface, not shown, which cooperate with ribs 34 located on the outer surface of the housing 1, preferably on the hub 3, so that the safety needle assembly can be screwed on and unscrewed from the syringe without removing the container 32 from the safety needle assembly. Additionally, the container 31 could be provided with a number of, not shown, raised points supporting the safety needle assembly in a slightly variable position to assist the steam or gas to fully surround the safety needle assembly during sterilization in the event that this type of sterilization is used.

The spring 25 pushing the closure member 16 and the skirt 2 in the distal direction is preferably made of non-corrosive stainless steel so that the spring 25 will not be damaged during the steam sterilization process. A spring 25 particularly suitable for this purpose is a spring. 1.4462 / SAF2205.

Another embodiment of a safety needle assembly according to the invention is disclosed in Fig. 13 and Fig. 14.

Figure 13 shows housing 40 including hub 41 and body 42. Inside housing 40 are a housing 43 and a closure member 44. Housing 43 exits housing 40 through an opening 45 located at the distal end of housing 40.

The cover 43 is provided with four posts 46 and ends at the near end in the gear 38.

This gear wheel 38 engages a second gear wheel 39 arranged on the closing element 44. The closing element 44 is additionally provided with a closing projection 49 arranged at its proximal end.

The needle cannula 30 is in this Fig. 13 mounted in the lower surface 50, which surface 50 is provided with a housing 40, preferably a hub 41.

Figure 13 shows the safety needle assembly with the shield 43 in a closed position, and Figure 4 illustrates the inner surface of the housing 40 by showing a portion of the housing 40 cut out in Figure 13 viewed from the rear.

The four posts 46 on the cover 43 are routed in the first horizontal tracks 51 provided on the inner surface of the housing 40. The locking projection 49 on the locking element 44 abuts the flat surface 48 in its initial position and is guided in the second horizontal track 52 when the covers 43 are moved in the near direction. When the cover 43 is moved all the way back to its nearest position and the injection is completed, a spring not shown disposed between the bottom surface 50 and the closure member 44 will push the closure member 44 and hence the guard 43 in the distant direction. During this movement, the angled front side 47 of the locking lip 49 will engage an oblique track 53 also provided in the inner surface of the housing 40. As the cover 43 returns to its original position, the closure member 44 and hence the closure lip 49 will rotate approximately 180 degrees in the oblique track 53 and engage the closure chamber 54 provided at the distal end of the oblique track 53, which closure chamber 54 is has a locking surface 55, the flat back side 56 of which will abut the locking projection 49 making additional movement of the cover 43 impossible. The first gear 38 of the shield 43 and the second gear 39 of the closure element 44 support this movement by engaging the angled surfaces of the two wheels 38, 39 with each other.

The cover 43 cannot be rotated with respect to the housing 40 due to the engagement of the posts 46 with the first horizontal tracks 51. Since the rotation of the cover 43 is stopped, it is impossible to rotate the locking projection 49 of the locking element 44 backwards in the oblique track 53, and the locking projection 49 will thus be remained in the closure chamber 54 thereby securing the safety needle assembly.

A window could be provided within the housing 40 through which the closure chamber 54 can be seen so that a user can obtain a visible indication of whether or not the safety needle assembly has been used.

The improved embodiment of the safety needle assembly disclosed in Figures 1 to 12 is shown in Figures 15 and 16.

In the following numbers relating to the same element as in the previous figures, the same number plus one hundred is given.

The safety needle assembly shown in Fig. 15 includes both a housing made of a needle hub 103 and a suitable injection body 104 formed of PP. Both the hub 103 itself and the hub column 103 are slightly taller than that shown in Fig. 2, while the body 104 is slightly shorter. A needle cannula 130 is inserted into the hub 103 and glued to the hub 103 with a drop of adhesive 160.

The body 104 is in this embodiment provided with three windows 120 and the closure member 116 is also provided with three closure projections 117. When the closure member 116 closes the safety needle assembly prior to reuse, the three closure projections 117 will be visible in the three windows 120 as previously explained. .

The shield 104, which is preferably made of TPX, may be transparent so that the tip of the needle cannula 130 is visible for viewing by a user prior to injection having six posts 110 at its proximal end. The gear 113 formed between these posts 110 is thus in this example. versions only provided with six recesses.

The closure member 116, which is preferably made of POM or PP, is provided on the distal end face with a serrated ring 161 which is used during the manufacturing process. When the safety needle assembly is mounted, the tool can enter the safety needle assembly through the needle outlet 107 in the shield 102 and engage the serrated ring 161 to rotate the closure member 116 to correct position before the shield 102 and the closure member 116 are permanently closed. in the housing. For this purpose, the needle outlet 107 must be large enough for the tool that passes through the needle outlet 107.

In the embodiment shown in Fig. 10 there is little possibility of rotation of the cover 2 when the posts 10 are longitudinally positioned between the tabs 22 and the lower part 21b of the ribs 21. In order to prevent such accidental rotation, the posts 110 of the embodiment shown in Fig. 15 are provided with an additional guide rib 162 which are guided in a number of paths, not shown, provided on the inner surface of the housing body 104. Therefore, no rotation between shield 102 and body 104 is possible.

When the safety needle assembly is mounted the entire unit is packaged in a container 131 which is sealed with a movable seal 163 and sterilized. Removable seal 163 is preferably made of paper.

The distal portion of the container 131 may be formed as a cup 164 maintaining a predetermined level as shown in FIG. 16. The dispensing of the injection device to be used with the safety needle assembly can therefore be controlled by dispensing a predetermined number of doses into the cup 164 and checking the amount expelled. This can be done either by filling the cup completely or by placing indicators printed on the cup.

Parts List 1 Housing 2 Cover

4 Body Hub

Connecting surface 6 Top surface

PL 196 617 B1

Needle outlet 8 Hole

Lower surface 10 Post

Flat front surface (10 pillars)

Rear surface inclined at an angle (bars 10)

Gear

Flat surface 15 Locking surface 16 Locking element

Closing lug

Angled side of the closing projection 19 Flat rear side of the closing projection 20 Window

Rib

21a Upper rib 21b Lower rib 22 Tab

Inclined surface

Collar

Spring

Clearances on the cover

Directional arrow

Directional arrow

Directional arrow

Needle cannula

Container

Distant surface of container 33 Near surface of container 34 Ribs on outer surface of housing 35 Thread

Front end of closure projection 37 Inner top end of cover 38 Cover gear

Second gear of closing element 40 Housing 41 Hub

Body 43 Cover

Closing element 45 Hole 46 Posts

The angled front side of the closing lip

Flat surface

Closing lug

Lower surface

The first horizontal track

Second horizontal track

Diagonal track

Closing chamber 55 Locking surface 56 Flat rear side

102 Cover

103 Hub

104 Body

107 Needle outlet

PL 196 617 B1

110 Post

113 Gear

116 Locking element 117 Locking projection 120 Window

125 Spring

130 Needle cannula

131 Container

160 Glue

161 Serrated ring 162 Guide rib 163 Gasket

164 Cup