Source: https://patents.google.com/patent/WO2003045480A1/en
Timestamp: 2018-11-18 13:03:54
Document Index: 761289600

Matched Legal Cases: ['art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21', 'art 21']

WO2003045480A1 - A safety needle assembly - Google Patents
A safety needle assembly Download PDF
WO2003045480A1
WO2003045480A1 PCT/DK2002/000799 DK0200799W WO03045480A1 WO 2003045480 A1 WO2003045480 A1 WO 2003045480A1 DK 0200799 W DK0200799 W DK 0200799W WO 03045480 A1 WO03045480 A1 WO 03045480A1
PCT/DK2002/000799
Needle assemblies are commonly used to either inject substances into or extract substances out of human or animal bodies. Such needle assemblies are typically disposable and are dis- carded after only one use. The problem presented by the disposal of a needle assembly, and indeed, by any handling of the needle assembly, is the potential risk of being injured by the sharp end of the needle cannula. This is particular dangerous when following after the penetration of a patients skin since the needle cannula then may be contaminated and therefore capable of spreading diseases such as hepatitis and HIV.
One such prior art needle protection system is disclosed in WO 01.76665. This safety needle comprises a hub with a centrally located needle cannula. A telescopically movable shield is provided on the outside 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 part or the needle cannula is left free to perform an injection. A cam element, rotatable mounted to the hub is provided with at least one cam, which cam is guided in cam curve provided in the inside surface of the shield. The shield is urged in the distal direction by a spring cocked between the hub and the shield. The cam curve is adapted to block the cam in a blocking position when the shield returns to the first position after an injection has been performed. The safety needle assembly disclosed in WO 01.76665 is however rather cumbersome and consist of a large number of parts that must be moulded and afterwards fitted together very precisely in order to obtain the correct movement of the cam follower.
When the locking element is provided as a separate element located between the spring and the shield and moved simultaneously with the shield, the locking protrusion can be guided during the longitudinal movement of the locking member thereby eliminating the need for tracks or cams thus making it possible to construct the safety needle assembly from only three plastic part in addition to the hub. Since there are no tracks or cams as such the internal tolerances are not that important, and the friction can be kept rather low which renders it possible to utilize a somewhat soft spring, which enhances the user comfort.
When the spring cocked between the locking element and the hub interfaces both the locking element and the bottom surface of the housing as revealed in claim 8, 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 locking protrusion can be viewed when it is in the arrested position, it is ensured that a user can visible inspect whether the safety needle assembly has been used before or not.
In the present context, the term "moving simultaneous" which are used to describe the relationship between the movement of the shield and the locking element, does not necessary mean that the shield and the locking protrusion moves with the same speed. The relative speed of movement is defined by the various angled surfaces, and is therefore variable. The term "moving simultaneously" merely means that both the shield and the locking protrusion move at the same time.
Figure 1 Shows a perspective view of the safety needle assembly according to the invention.
Figure 2 Shows an exploded view of the safety needle assembly according to the invention.
Figure 3 Shows a perspective view of the needle shield.
Figure 4 Shows a perspective view of the locking element.
Figure 5 Shows a perspective view of the body of the housing. Figure 6 Shows a schematically view of the body of the housing.
Figure 7 Shows a schematically view of the safety needle assembly according to the invention.
Figure 8 Shows a schematically view of the safety needle assembly according to the invention, with a part of the housing cut away.
Figure 9 Shows the locking protrusion in its first position.
Figure 10 Shows the locking protrusion in or moving towards its second position.
Figure 11 Shows the movement of the locking protrusion moving from the second to the third position.
Figure 12 Shows the locking protrusion in the third position.
Figure 13 Shows a perspective view of an embodiment of the safety needle assembly according to the invention.
Figure 14 Shows a part of the housing of an embodiment of the safety needle assembly according to the invention.
Figure 15 Shows an exploded view of the safety needle assembly according to the invention.
Figure 16 Shows a perspective view of the safety needle assembly stored in a container.
Detailed Description of Embodiment: Initially it may be convenient to define that, the term "distal end" is meant to refer to the end of the safety needle assembly inserted into the patient, whereas the term "proximal end" is meant to refer to the end connected to the injection device.
Figure 1 shows a safety needle assembly comprising a housing 1 and a shield 2, the housing 1 is made up from a hub 3 and a body 4. The hub 3 and the body 4 is normally glued or welded together.
The shield 2 is provided with a needle outlet 7 through which the needle cannula 30 can penetrate. The proximal end of the shield 2 is, as shown in figure 2, provided with eight outwardly projecting studs 10, which studs 10 has a planar fore front 11 and an angled back front 12.
The housing 1 has a bottom surface 9 in the centre of which the needle cannula 30 is mounted. The needle cannula 30 can either be mounted such that a part of needle cannula 30 projects from the bottom surface 9 in the proximal direction, which is preferred for use with cartridges, or it can be mounted without this so called back needle, which is preferred for hypodermic syringes. Adjacent the bottom surface 9, at the proximal end of the housing 1 , means are provided for mounting the safety needle assembly on to an injection device. These means would normally be a thread 35 such that the safety needle assembly can be screwed onto a pen syringe.
Figure 3 shows the shield 2 seen from the proximal end. The eight studs 10 are separated from each other by eight equally sized spaces 26. The angular back front 12 of the studs 10 forms together with the shield 2 a toothed ring 13 where the centre of the studs 10 forms the tops and the shield 10 within the spaces 26 forms the valleys. The locking element 16 seen in figure 2 is on the proximal outside surface provided with four locking protrusions 17. These locking protrusions 17 have, as shown in figure 4, an angled fore front 18 and a planar back front 19.
The body 4 of the housing 1 is in figure 5 shown in perspective and in figure 6 in a sectional view. The body 4 is provided with four windows 20 and one longitudinal rib 21 for each window 20. The ribs 21 are provided on the inside surface of the body 4. These longitudinal ribs
21 extend through the entire length of the body 4 although divided into two parts (21a, 21b) by the windows 20. The distal part of this rib 21 is moulded uniform with a collar 24 provided at the distal end of the body 4 and terminates in a planar surface 14 at the distal end of the window 20. The proximal part of the rib 21 terminates at the proximal end of the window in a blocking surface 15, the use of which will be explained later. At the distal end of the body 4 there is provided four fins 22. These fins 22 is moulded uniform with the collar 24 at the distal end of the body 4, and has at the proximal end an angled surface 23 which terminates ap- proximately in a position adjacent the middle of the windows 20.
Although the embodiment here described has eight studs 10, four locking protrusions 17 and four windows 20, these parts could be provided in a different number, as shown in figure 15.
When the safety needle assembly shown in figure 2 is assembled, a spring 25 is cocked between the bottom surface 9 of the housing 1 and the locking element 16 urging the locking element 16 and the shield 2 in a distal direction. The planar forefront 11 on the studs 10 abuts the collar 24 such that the shield 2 is connected to the body 4 of the housing 1.
The assembled safety needle assembly is shown in figure 7 and 8. Figure 8 illustrates the inside of the safety needle assembly with the body 4 cut away.
The shield 2 is located such within the body 4 of the housing 1 that each rib 21 and each fin
22 is located in the space 26 between two studs 10. The upper part 21a of the ribs 21 are however not shown in figure 8, since this upper rib 21a is not entirely necessary. The locking element 16 is thereafter mounted such that the angular forefront 18 on each locking protrusion 17 abuts the angled back front 12 on four of the studs 10 of the shield 2, whereby the side surface of the locking protrusion 17 and the side surface of the studs 10 forms a straight line which line abuts the side surface of the fins 22 of the body 4 of the housing 1. Once the shield 2 and the locking element 16 is correctly mounted within the body 4 of the housing 1 , the spring 25 is located around the needle cannula 30 and the body 4 and the hub 3 are sealed together, rendering the safety needle assembly ready for use.
The movement of the locking protrusion 17 is schematically shown in figure 9 - 12, showing the relative position of one of the locking protrusion 17 on the locking element 16, two of the studs 10 on the shield 2, one of the fins 22 on the inside surface of the body 4 of the housing 1 and one of the ribs 21 also located on the inside 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 distal position where the shield 2 covers the needle cannula 30. When the shield 2 is pressed towards the skin of a user, the shield 2 and with it the studs 10, are moved in a proximal direction as indicated with the arrow 27. This movement also moves the locking protrusion 17 on the locking element 16 in the proximal direction against the force F of the spring 25.
Once the locking protrusions 17 is moved free of the fins 22, as shown in figure 10, the angled fore front 18 of the locking protrusions 17 will slide along the angled back front 12 of the studs 10 and the angled fore front 23 of the fins 22 as indicated with the arrow 28. This movement will move the locking protrusions 17 into contact with the valleys of the toothed ring 13. Further movement of the shield 2 and thereby the studs 10 in the direction of the arrow 27 will only move the locking protrusions 17 further in the proximal direction. The injection is then executed with the shield 2 in its most proximal direction. The position of the fins 22 and the ribs 21 is such that the studs 10 are always guided either by the fins 22 or by the ribs 21.
When the injection is over, the needle cannula 30 is retracted from the skin of the user, which will cause the shield 2 with the studs 10 and the locking element 16 with the locking protrusion 17 to move in the distal direction due to the impact of the force F executed by the spring 25. The arrow 29 in figure 11 indicates this movement.
Figure 12 illustrates how the force F of the spring 25 urges the locking element 16 with the locking protrusion 17 and the shield 2 with the studs 10 in the distal direction. When the angled fore front 23 on the fins 22 aligns the angled back front 12 of the studs 10, such that the two angled fore fronts 23, 12 form a diagonal line, the angled fore front 18 of the locking pro- trusion 17 will slide along this line into a position where the locking protrusion 17 is located between the upper part 21a and the lower part 21b of the ribs 21 i.e. between the planar surface 14 of the upper part 21a of the ribs 21 and the blocking surface 15 of the lower part 21b of the ribs 21. In this position the locking protrusion 17 and hence the locking element 16 and the shield 2 is irreversible locked.
At the proximal end of the locking protrusion 17, the planar back front 19 will abut or at least be blocked by the blocking surface 15 on the ribs 21 of the body 4 of the housing 1 , thereby rendering it impossible to move the shield 2 in the proximal direction. At the distal end, the angled fore front 18 of the locking protrusion 17 will abut the toothed ring 13 of the shield 2 and since the planar forefront 11 of the studs 10 on the shield 2 abuts the collar 24 of the body 4 of the housing 1 it will not be possible to move the shield 2 in the distal direction. Sideways the studs 10 of the shield 2 will be arrested between the upper part 21a of the ribs 21 and the fins 22. As a result of this it will be impossible to move the shield 2 in any direc- tion.
The body 4 of the housing 1 is provided with four windows 20 which windows 20 divides each of the four ribs 21 into an upper part 21a and a lower part 21 b. When the safety needle assembly has been used, the locking protrusion 17 on the locking element 16 will be located between the upper part 21a and the lower part 21b of the ribs 21, and will thus be visible through the window 20. The locking protrusion 17, or a part of it, could be coloured in an inflammatory colour, or provided with another indication, which will render it very easy for a user to visibly inspect whether the safety needle assembly has been used or not just by glancing at the windows 20. The windows 20 could e.g. be provided as openings in the wall of the body 4.
Prior to use, the safety needle assembly is delivered to the user sterilized and contained as is 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 not shown removable seal. The container 31 has on the inside surface not shown ribs that mates ribs 34 located on the outside surface of the housing 1 preferably on the hub 3, such that the safety needle assembly can be screwed on and off a pen syringe without removing the container 32 from the safety needle assembly. Further the container could on the inside surface be provided with a num- ber of not shown raised points supporting the safety needle assembly in a somewhat floating position making it easier for the steam or gas to fully surround the safety needle assembly during sterilization in case this type of sterilization is used.
The spring 30 urging the locking element 16 and the shield 2 in the distal direction is prefera- bly made from stainless non-corrosive steel such that the spring 30 will not be damaged during the steam sterilization process. A spring 30 particular suitable for this purpose is a 1.4462/SAF2205 spring.
Another embodiment of the safety needle assembly according to the invention is disclosed in figure 13 and figure 14.
Figure 13 shows a housing 40 comprising of a hub 41 and body 42. Mounted inside the housing 40 are a shield 43 and a locking element 44. The shield 43 penetrates out of the housing 40 through an opening 45 located at the distal end of the housing 40
The needle cannula 30 is in figure 13 mounted in the bottom surface 50, which bottom surface 50 is provided in the housing 40, preferably in the hub 41.
Figure 13 shows the safety needle assembly with the shield 43 in the locked position, and figure 14 illustrates the inside surface of the housing 40 by showing the part of the housing 40 cut away in figure 13 seen from the backside. The four studs 46 on the shield 43 is guided in first horizontal tracks 51 provided on the inside surface of the housing 40. The locking protrusion 49 on the locking element 44 abuts a planar surface 48 in its initiate position and is guided in a second horizontal track 52 as the shield 43 is moved in the proximal direction. Once the shield 43 has been moved all the way back to its most proximal position and the injection is executed, a not shown spring positioned between the bottom surface 50 and the locking element 44 will urge the locking element 44 and hence the shield 43 in the distal direction. During this movement, the angled fore front 47 of the locking protrusion 49 will engage a diagonal track 53 also provided in the inside surface of the housing 40. While the shield 43 moves back to its initiate position, the locking element 44 and hence the locking protrusion 49 will rotate approximately 180 degrees in the diagonal track 53 and engage a locking chamber 54 provided at the distal end of the diagonal track 53, which locking chamber 54 has a blocking surface 55 that a planar back front 56 of the locking protrusion 49 will abut rendering further movement of the shield 43 impossible. The first toothed ring 38 of the shield 43 and the second toothed ring 39 of the lock- ing element 44 support this movement due to mutual engagement of the angled surfaces of the two rings 38, 39.
The shield 43 cannot be rotated relatively to the housing 40 due to the engagement of the studs 46 with the first horizontal tracks 51. Since rotation of the shield 43 is inhibited it is im- possible to rotate the locking protrusion 49 of the locking element 44 backwards in the diagonal track 53, and the locking protrusion 49 will therefore remain in the locking chamber 54 thus rendering the safety needle assembly secured.
An improved embodiment of the safety needle assembly disclosed in figure 1 to 12 is shown in figure 15 and in figure 16.
The safety needle assembly shown in figure 15 comprises a housing made up from a needle hub 103 and a body 104 both preferably injection moulded from PP. Both the hub 103 itself and the tower of the hub 103 is somewhat higher than shown in figure 2, while the body 104 is somewhat shorter. The needle cannula 130 is inserted in the tower of the hub 103 and glued to the hub 103 by a blob of glue 160.
In the embodiment shown in figure 10 there exist a slight possibility of rotating the shield 2 when the studs 10 are longitudinal located between the fins 22 and the lower part 21b of the ribs 21. In order to prevent such accidental rotation, the studs 110 of the embodiment shown in figure 15 is provided with an additional guiding rib 162 which are guided in a number of not shown guiding tracks provided on the inside surface of the body 104 of the housing. Due to this no rotation between the shield 102 and the body 104 is possible,
The distal part of the container 131 can be formed as a cup 164 holding a predetermined volume as shown in figure 16. The dosage of an injection device to be used with the safety needle assembly can thus be controlled by ejecting a predetermined number of doses into the cup 164 and verifying the expelled volume. This can be done either by filling the entire cup or by having indications printed on the cup 164.
2 Shield 3 Hub
7 Needle outlet 8 Opening
12 Angled back front of studs 13 Toothed ring
17 Locking protrusion 18 Angled front of locking protrusion
21a Upper part of rib 21 b lower part of rib
25 Spring 26 Spaces on shield
30 Needle cannula 31 Container distal surface of container proximal surface of container Ribs on outside surface of housing Thread Front end of locking protrusion Inner top end of shield Toothed ring of shield Second toothed ring of locking element Housing Hub Body Shield Locking element Opening Studs Angled fore front of locking protrusion Planar surface Locking protrusion Bottom surface First horizontal track Second horizontal track Diagonal track Locking chamber Blocking surface Planar back front
Shield Hub Body Needle outlet Stud Toothed ring Locking element Locking protrusion Window 125 Spring
A cylindrical housing (1, 40) having a top surface (6) and a bottom surface (9, 50), said housing (1 , 40) having means for mounting said housing (1 , 40) onto a medical injection device,
A needle cannula (30) mounted in the bottom surface (9, 50), said needle cannula (30) having a distal end located at a distal side of the bottom surface (9, 50),
A shield (2, 43) telescopically movable relatively to the housing (1 , 40) for movement between a distal position where the shield (2, 43) covers the distal end of the needle cannula (30) and a proximal position where at least a part of the distal end of the needle cannula (30) is exposed,
A spring (25) located inside said housing (1 , 40) urging the shield (2, 43) in the distal direction,
A locking element (16, 44) provided inside the housing (1, 40) and having at least one out- wardly pointing locking protrusion (17, 49),
said locking element (16, 44) is a separate part provided between the spring (25) and the shield (2, 43) and longitudinal moved simultaneously with the shield (2, 43) relatively to the housing (1 , 40) during use, whereby the locking protrusion (17, 49) provided on the locking element (16) is guided from a first position where the shield (2, 43) is in the distal position, via a second position where the shield (2, 43) is in the proximal position to a third position where the shield (2, 43) is in the distal position and in which third position at least one of the locking protrusions (17, 49) is blocked by a blocking surface (15, 55) provided on the inside surface of the housing (1 , 40) whereby further movement of the shield is irreversible immobilized,
2. A safety needle assembly according to claim 1 , characterized in that, the locking protrusion (17) of the locking element (16) in the first position abuts a stud (10) provided on the shield (1) and a fin (22) provided on the inside surface of the housing (1).
3. A safety needle assembly according to claim 2, characterized in that the locking element
(16) and the locking protrusion (17) rotates relatively to the housing (1) and the shield (2) when an angled surface (12) of the stud (10) aligns an angled surface (23) of the fin (22).
4. A safety needle assembly according to claim 3, characterized in that the locking protrusion (17) of the locking element (16) in the second position abuts a toothed ring (13) provided at the proximal end of the shield (2).
5. A safety needle assembly according to claim 4, characterized in that the locking protrusion
(17) of the locking element (16) in the third position is arrested in an opening in a longitudinal rib (21) provided on the inside surface of the housing (1), which opening defines the blocking surface (15)
6. A safety needle assembly according to claim 5, characterized in that, guiding means for guiding the locking protrusion (17) of the locking element (16) comprises the ribs (21) and the fins (22) provided on the inside surface of the housing (1), which ribs (21) and fins (22) extends only in the horizontal direction.
7. A safety needle assembly according to anyone of the claims 1 to 6, characterized in that the shield (2, 43) is mounted inside the housing (1 , 40) and penetrates through an opening (8, 45) at the top surface of the housing (1 ,40).
8. A safety needle assembly according to claim 7, characterized in that, the spring interfaces the locking element (16, 44) and the bottom surface (9, 50) of the housing (1, 40).
9. A safety needle assembly according to claim 8, characterized in that, the housing (1 , 40) is provided with a window (20) through which window (20) the locking protrusion (17, 49) is visible when the locking protrusion (17, 49) is in its third position.
PCT/DK2002/000799 2001-11-30 2002-11-28 A safety needle assembly WO2003045480A1 (en)
EP20020803754 EP1448256B1 (en) 2001-11-30 2002-11-28 A safety needle assembly
DK05006983T DK1557191T4 (en) 2001-11-30 2002-11-28 A safety needle assembly
DE2002608933 DE60208933T2 (en) 2001-11-30 2002-11-28 A safety needle assembly
AU2002365290A AU2002365290B2 (en) 2001-11-30 2002-11-28 A safety needle assembly
KR20047008072A KR100879498B1 (en) 2001-11-30 2002-11-28 A safety needle assembly
JP2003546977A JP4603262B2 (en) 2001-11-30 2002-11-28 Safe injection needle structure
CA 2468243 CA2468243C (en) 2001-11-30 2002-11-28 A safety needle assembly
DE2002608933 DE60208933D1 (en) 2001-11-30 2002-11-28 A safety needle assembly
PL36898702A PL196617B1 (en) 2001-11-30 2002-11-28 A safety needle assembly
IL16170902A IL161709D0 (en) 2001-11-30 2002-11-28 A safety needle assembly
ZA200403370A ZA200403370B (en) 2001-11-30 2004-05-04 A safety needle assembly
WO2003045480A1 true true WO2003045480A1 (en) 2003-06-05
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KR100879498B1 (en) 2009-01-20 grant
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