TWI816639B - Needlestick prevention device - Google Patents

Abstract

A needlestick prevention device (1, 100) for an injection needle carried by a needle-bearing member (2, 102) of a syringe (102) is formed as a one-piece moulding and comprises a first part (3, 103) adapted to be attached to the needle-bearing member (2, 101) and a second part (4, 104) providing a shield for the needle and pivotally movable relative to the first part to expose the needle for use. The device is adapted to adopt a first position in which the needle is protected for transport of the device prior to use, a second position in which the needle is exposed for filling of the syringe and injection, a third position in which the needle is protected after filling of the syringe but before injection and a fourth position in which the needle is locked in the device following injection.

Description

Needle stick prevention device

The present invention relates to a needlestick prevention device for use with an injection device such as a syringe.

Needlestick injuries commonly occur in medical settings, particularly during the use of syringes or other injection devices, when the user accidentally sticks the needle into themselves or others. This kind of acupuncture injury is the main cause of spreading infection and disease. It not only causes pain but may also lead to disability, so it is important to prevent it.

There are a variety of conventional approaches to attempting to prevent needle stick injuries. Injection needles are usually provided with a protective needle cap that is removed when used and then discarded, as it is not recommended to replace the needle cap on the needle. In fact, the act of repositioning the needle cap is thought to be the cause of a large number of needlestick injuries.

The needle itself can be mounted on a cylindrical ring at the end of the syringe barrel. Alternatively, it can be mounted on a separate hub, which is then attached to the syringe barrel. The connection between the hub and the syringe barrel is typically via a Luer connection, which includes a conical male connector on the barrel and a complementary female connector on the hub. The cone is standard 6°. The connection may be of the Luer slip type, which is a simple friction fit, or of the Luer lock type, in which the male connector is surrounded by an internally threaded ring and the hub has external radial lugs to engage the threads. In fact, the hub is screwed to the column. A further alternative is to engage the radial lug from behind in a cutout in the ring at the end of the syringe. The hub then acts as a push-fit seat on the syringe, held in place by a lug behind the cutout.

One way to prevent needle stick injuries is to provide a safety shield mounted on the needle carrying component, that is, the syringe or hub, to protect the needle when the disposable needle cap is removed. When in use, the cover pivots away from the needle and is then pivoted back and locked in a position covering the needle. This configuration increases the complexity and cost of the finished product by requiring additional parts.

Another suggestion is to mold the safety cover integrally with the needle and hub. The protective strip ensures that the needle is not exposed until use, and when used, the strip is removed. Likewise, when in use, the cover pivots away from the needle and is pivoted back and locked in a position covering the needle. This configuration may be difficult to model and is not suitable for syringes with an integral needle.

There are also suggestions to replace disposable needle caps with safety covers. In this case, the safety shield must of course not be removable in the same way as a disposable needle cap. Thus, it is relatively easy to provide a detachment-proof connection between the injection device and the safety cover, but may result in the cover being unable to be oriented on the device. This is disadvantageous because the user usually needs to orient the needle "bevel up" for injection, lest the shield become an obstruction. If the cover cannot rotate on the device, the orientation of the cover and needle cannot be guaranteed, whereas if it can rotate freely, it can rotate naturally into the blocking position.

Most needlestick injuries occur after an injection has been given. Typically, the user fills the injection device and injects immediately. Increasingly, however, injections are made up of many different medications, and injection devices are filled in places such as pharmacies and then delivered to recipients for injection. To remove the risk of needle stick injury, the needle must be shielded again in the delivery position but not locked so that it is exposed when injecting. It is important that the transport position is clearly distinct from the locked position and that the safety cover cannot be accidentally moved into the use position or the locked position during transport.

According to a first aspect of the invention, a needlestick prevention device for an injection needle carried by a needle-carrying element of a syringe is formed as an integral mould, and includes a first part adapted to be attached to the needle-carrying element, and a second portion providing a cover for the needle and pivotably movable relative to the first portion to expose the needle for use; the device is adapted to assume a first position for transporting the device while protecting the needle prior to use in which the second position is for filling the syringe and injecting with the needle exposed therein, the third position is for protecting the needle after filling the syringe but before injecting, and the fourth position is for the device Locking the needle in during subsequent injections.

This configuration provides a defined delivery position and a fourth position for locking the needle therein. Preferably, the first and second parts can assume three stable positions to define the four positions of the device. In the first stable position, the needle is accommodated in the second part and the relative positions of the first and second parts remain unchanged. This is the initial position, where the device is assembled with the needle-carrying element and can be transported prior to use. If the needle-carrying element is a hub, the hub and device will be attached to the syringe with the device in this initial position. In the second stable position, the securing means are removed and the second part is pivoted away from the first part to expose the needle. This is the operating position where the syringe can be filled and injections can be made. If the injection is not to be performed immediately, the second part can be moved back to the first stable position and maintained there to shield the needle. In this position, the syringe can be safely carried if necessary, so it is in a temporary delivery position. Then, when ready to inject, the second part can be moved into the operating position again. After injection, the device is placed in the third stable position by moving the second part back there via the first stable position to initiate the permanent locking configuration. This is the locked position, which is used to prevent needle stick injuries and to cover the needle again. The second part can be moved between operating and transport positions as required.

In one embodiment, the cover has a delivery recess and a locking recess connected by a gate located at least at the base of the needle, configured such that in the third position, the needle is in the delivery recess and is moveable into the second position, and in the fourth position , the needle moves into the locking recess through the gate device, and is prevented from moving out from the fourth position by the gate device.

This arrangement provides a clearly defined delivery position and a fourth position in which the needle is locked in a simple and secure manner. The locking recess securely houses the needle, and since it is held by a gate device that engages the base of the needle, it is virtually impossible to remove the needle from the locking recess without causing serious damage. This provides the required protection against needle stick injuries.

The first and second parts of the device are preferably connected by a living hinge. Once the user initiates movement, the hinge provides the force to move the second portion between the first and second positions, and between the second and third positions. Further manpower is required to move the second section into the fourth position. The hinge also holds the second part in the first and third positions. This provides a particularly simple construction since no further means are required to hold the second part in various positions.

Conveniently, the first and third positions are identical so that the needle is initially located in the delivery recess. The second part can be moved between the second and third positions as needed.

Conveniently, gate means are provided for the entire length of the needle. The gate device preferably includes a protrusion formed in the second portion for defining the boundary between the delivery recess and the locking recess, and a curved or labyrinth path connecting the delivery recess and the locking recess. When the needle moves from the second position into the third position, it remains in the delivery recess due to the protrusion, but when further force is applied, it can follow the labyrinth path into the locking recess. Once in the locking recess, the base of the needle will not be elastic enough to follow the labyrinthine path around the protrusion.

The second part preferably has an extension that is led out from the delivery recess and faces away from the locking recess to cover the needle when it is in the first and third positions. The extension may be a funnel to guide the needle into the delivery recess.

The second portion may be shaped in any suitable manner so as to be grasped and moved by a user between the first and second, and second and third positions. The second part can also be moved into the locked position by grasping or applying human force. The second part may have an enlargement located on the opposite side of the delivery recess. The enlarged portion accommodates the locking recess. Alternatively, the second portion may have a reduced width extension located in the delivery recess the opposite side. The enlarged portion and the extended portion can each be formed with axially extending outer ribs for ease of use. A further alternative is to provide a finger plate on the second part for manual application, or on a tip or extension at the axial end of the second part.

In another embodiment, the first and second parts of the device are preferably connected by living hinges and fastening means. In the first position, the needle is received in the second part and the securing means are engaged to maintain the relative position of the first and second parts. In the second position, the fixing means are removed and the second part is pivoted away from the first part with the aid of the hinge to expose the needle. The second part can be moved back to the first position and maintained there by fixation means to cover the needle, which is the third, delivery position. Then, when ready for injection, the second part can be moved into the operating position again. After injection, the second part is moved back here via the first position so that the securing means engage in a position that activates the permanent locking configuration.

The securing means may comprise a pair of detents on one of the first and second parts, adapted to engage in recesses of the other part in the third and fourth positions respectively. Alternatively, the securing means may comprise a cooperating pin and hole arrangement having a pin provided in one of the first and second parts and a hole provided in the other part, wherein the pin is engaged in the fourth position.

Conveniently, the device is initially closed by a removable strip extending along the open face of the second part. The strip may be flexible, such as a foil, or a rigid plastic part. The strip is snugly attached to the second part. The second portion may have a flat flange for snugly attaching the strip thereto. The first portion may also have a flat surface to which the proximal end of the strip fits. Alternatively, the strip and the second portion may have a releasable snug engagement. Conveniently, the strip has a free end which can be grasped by the user for removal. Undoing the strap also allows the second part to be moved into the operating position. Once the second part has moved through a predetermined angle, the hinge assists this movement.

The hinge also acts to assist return movement of the second portion to the first position. Further labor may be required to move the second section into the locked position. The second part may also include a needle for the locking position auxiliary locking mechanism. The secondary locking mechanism may include at least one pair of opposing hooks configured such that the needle can pass through them in one direction but not back.

According to a second aspect of the invention, a needle stick prevention device for an injection needle carried by a needle carrying element of a syringe is formed as an integral mould, and includes a first part adapted to be attached to the needle carrying element, and a second part which provides a cover for the needle and is pivotably movable relative to the first part to expose the needle for use, a device adapted to assume at least an open position for filling the syringe and injecting with the needle exposed therein , and a locking position for locking the needle therein during subsequent injections of the device, the cover having a locking device at least at the base of the needle leading to a locking recess, configured such that in the locking position, the needle is moved in via the locking device The recess is locked, and the gate mechanism prevents the needle from moving out of the locked position.

The locking recess securely houses the needle, and since it is held by a gate device that engages the base of the needle, it is virtually impossible to remove the needle from the locking recess without causing serious damage. This provides the required protection against needle stick injuries.

Conveniently, gate means are provided for substantially the entire length of the needle. The gate device preferably includes a protrusion formed in the second portion to define a curved or labyrinth path to the locking recess. When the needle moves into the locking position, it follows the labyrinth path and is held in the locking recess by the protrusion. Once in the locking recess, the base of the needle will not be elastic enough to follow the labyrinthine path around the protrusion.

The third and fourth aspects of the present invention describe the use of a needlestick prevention device to replace disposable needle caps.

According to a third aspect of the invention, a needlestick prevention device for an injection needle carried by a needle-carrying element of a syringe is formed as an integral mould, and includes a first part adapted to be attached to the needle-carrying element, and a second part which provides a cover for the needle and is pivotably movable relative to the first part to expose the needle for use, the first part being attached to the needle-carrying element by attachment means and which provides a needlestick prevention device It can rotate relative to the needle-carrying element between at least 90° and less than 180° in all directions, but prevents the device from falling off.

This configuration ensures that the device cannot be removed from the self-contained needle element, but can be oriented so that the needle is in a bevel-up position so as not to obstruct injection.

Preferably, the first part is not free to rotate on the needle carrying element. Rather, the engagement therebetween is configured to rotate when a torque is artificially applied, and the elements maintain their relative positions when the torque is removed. This configuration may be provided by frictional engagement between the first part and the needle carrying element.

Conveniently, the attachment means comprise a protrusion on one of the needle-carrying element or the needle-stick prevention device, and a groove on the other. Preferably, protrusions are provided on the needle stick prevention device and grooves are provided on the needle carrying element. The protrusion is configured to have an inclined surface for assembly of the needle stick prevention device on the needle carrying element, and an abutment surface that engages the groove to prevent separation of the device and the needle carrying element.

Conveniently, the groove extends around two separate arcs of the circumference of the needle-carrying element, the adjacent ends of the arcs being separated by any desired distance. The needle stick prevention device is formed with a pair of diametrically opposite protrusions, and each protrusion is accommodated in each arc portion of the groove.

According to a fourth aspect of the present invention, a needlestick prevention device for an injection needle carried by a needle-carrying element of a syringe is formed as an integral molding and includes a first portion adapted to be attached to a cylinder or cylinder of the needle-carrying element. a conical portion, and a second portion that provides a shield for the needle and is pivotably movable relative to the first portion to expose the needle for use, the engagement between the first portion and the needle-carrying member being configured to have an enlarged The friction coefficient is to prevent the axial separation of the needle-stick prevention device and the needle-carrying element, and the directional configuration is used to define the annular relative position of the needle-stick prevention device and the needle-carrying element.

Configuring the engagement to have an increased coefficient of friction increases the axial force required to remove the device, meaning it cannot be removed as with a standard disposable needle cap. In addition, it is simply made into a one-piece mold and is easy to assemble, thus reducing costs. An oriented configuration means that the device can assume the desired orientation relative to the needle for injection.

Conveniently, the first part of the device has a substantially cylindrical ring which engages the cylindrical or conical portion of the needle carrying element. The ring may have at least one axial slit extending from its free end. The slits provide radial restoring force to the ring to ensure easy disassembly and assembly of the needle-carrying component.

Preferably, the inner surface of the ring is not smooth, but at least a portion is configured to have an increased friction coefficient to increase the friction between the first portion and the needle-carrying element. This ensures that the device engages the cylindrical or conical portion with sufficient force to prevent axial separation. The increase in coefficient of friction may be provided by a defined pattern of roughening, or the like, or by a random configuration. For example, a smooth modeling surface may be patterned with a defined pattern of annular ridges, or may be provided with a random configuration by a suitable post-modeling process. In various examples, it can be found that the resistance to relative rotation of the first part and the needle-carrying element is less than that of axial separation, so that the device can be removed by a helical movement if necessary. The axial extent of the area of increased coefficient of friction is preferably limited and does not extend over the entire length of the joint between the parts. Attachment may also require protrusions provided on the needle stick prevention device and grooves provided on the needle carrying element.

Conveniently, the peripheral surface of the ring has a reduced diameter to facilitate its engagement in the luer lock connection. The peripheral surface may also have one or more external ribs corresponding to lugs on the hub to engage the threads of a Luer lock connection.

Standard hubs and syringes have guide ribs to assist in orienting the bevel of the needle upward. The first part of the device conveniently includes grooves for receiving the ribs.

A further aspect of the present invention relates to the combination of a needle stick prevention device and a needle carrying element.

According to a fifth aspect of the present invention, in the combination of the needle stick preventing device and the needle carrying element, the needle carrying element has a cylindrical or conical outer surface portion to be joined to the inner surface portion of the needle stick preventing device, and the needle carrying element The puncture prevention device and the needle-carrying element are attached by a protrusion on one of the needle-punch prevention device and the needle-carrying element, which is engaged with a groove on the other of the needle-punch prevention device and the needle-carrying element, and are configured to form a needle puncture The prevention device and the needle-carrying element can rotate relative to each other, but the separation of the needle-stick prevention device and the needle-carrying element is prevented.

Preferably, protrusions are provided on the needle stick prevention device and grooves are provided on the needle carrying element. The protrusion is configured to have an inclined surface for assembly of the needle stick prevention device on the needle carrying element, and an abutment surface that engages the groove to prevent separation of the device and the needle carrying element.

According to a sixth aspect of the present invention, in the combination of the needle stick preventing device and the needle carrying element, the needle carrying element has a cylindrical or conical outer surface portion to be joined to the inner surface portion of the needle stick preventing device, and at least One surface has an increased coefficient of friction to prevent axial separation of the device and needle-carrying element.

Conveniently, only one surface has an increased coefficient of friction, which may be the outer surface or the inner surface. Generally, it is easier to provide an increased coefficient of friction on the outer surface. However, it is also possible for both surfaces to increase the friction coefficient.

Preferably, the increased coefficient of friction is provided by roughening the surface. Roughening can be patterned or randomly configured. A given pattern can consist of annular ridges. Random patterns can be produced by applying appropriate treatments to an initially smooth surface. The increased coefficient of friction may extend throughout the axial length of the engagement between surfaces, or may be limited.

The following is only an example, and the embodiments of the needle stick prevention device according to the viewpoint of the present invention are described with reference to the drawings, wherein:

1:Device

2: hub

3:Part one

4:Part 2

5: hinge

6: Fixed means

7: Strip

8: Rectangular outline part

9: Ring

10: side

11: Side

12:Flat surface

13: Free end

14: side

15: Recess or groove

16: Central Amplification Department

17: Diameter reduction part

18: Free end

19: slit

20: ribs

21: Ridge

22: ditch

23:Protrusion

25: Rectangular outline part

26: cover element

27:side

28: side

29:Opening

30: Edge part

31:Latch

32:Latch

35: Lips

36:Flat surface

37: Auxiliary locking mechanism

38: Tongue

39:Side wall

40: Hollow cone-shaped component

41:Lug

42:Protrusion

43: Needle

44: ribs

45: Incline

46:Outer cone surface

48:Shallow annular ridge

50:Thread

51: Internal thread ring

52:Syringe

100:Device

101: hub

102:Syringe

103:Part One

104:Part 2

106:Cylinder part

107: Free end

108:End

109:Arm

110: Peripheral end

111:Hinge spring

112: ribs

113:Protrusion

114: Contact surface

115:One place

116:Open side

117: closed part

118:Arm

120:Hinge

121: Free end

122:End

123:Funnel

124:Conveying recess

125: Locking recess

126:Gate device

127:Protrusion

128: Curved or maze path

129: Smaller diameter part

130: Needle

131:Drilling

132: Nosed edge

133: ditch

134: arc part, groove part, groove part

140: ribs

141:Central opening

142:petals

145:Extension

146:Extension

Figure 1 is a side view of a needle stick prevention device according to the invention; Figure 2 is similar to Figure 1 but showing the device in an open configuration; Figure 3 is similar to Figure 2 but showing the device in a locked position; Figure 4 is the device of Figure 2 The end view; Figure 5 is a perspective view of the device of Figure 2; Figure 6 is a detail of the device; Figure 7 is similar to Figure 1 but shows the device attached to a hub for carrying an injection needle; Figure 8 is similar to Figure 7 but shows the device in an open configuration; Figure 9 is part of Figure 7 Figure 10 is a plan view of the device of Figure 7; Figure 11 is a perspective view of the device of Figure 7; Figure 12 is a perspective view of the device of Figure 7 mounted on a syringe barrel; Figure 13 is a side view of the device of Figure 7 in the locked position ; Figure 14 is a perspective view of the device of Figure 7 in the locked position; Figure 15 is a perspective view of a further needle stick prevention device according to the present invention; Figure 16 is a side view of the device of Figure 15; Figure 17 is an end view of the device of Figure 15 ; Figure 18 is a cross-sectional view of Figure 17 along line 18-18; Figure 19 is a cross-sectional view of Figure 16 along line 19-19; Figure 20 is a detail of a portion of Figure 19; Figure 21 is a cross-sectional view of Figure 16 along line 21 -21 is a cross-sectional view; Figure 22 is a cross-sectional view of the connection between the device of Figure 15 and the needle hub; Figure 23 is a perspective view of the device of Figure 15 mounted on a syringe barrel; Figure 24 shows the device on the syringe barrel in the operating position; Figure 25 is similar to Figure 24, but showing the device in the locked position; Figure 26 is similar to Figure 15, but showing further modifications; Figure 27 is an end view of the device of Figure 26; Figure 28 is through the needle hub and the device of Figure 26 Cross-sectional view showing the connection between the two; Figure 29 is a perspective view of the needle hub; Figure 30 is similar to Figure 26, but showing further modifications; and Figure 31 is an end view of the device of Figure 28.

Figures 1 to 6 show a needle stick prevention device 1 for an injection needle carried by a needle carrying element such as a syringe barrel or a needle hub. Figures 7 to 14 show the device 1 attached to the needle hub 2. The purpose of Device 1 is to replace the standard disposable needle cap that is typically used to cover the needle before use and provide a safety device that can be used with standard syringes and hubs and is easy and cheap to manufacture and assemble.

The device 1 of Figures 1 to 6 is a one-piece mold made of plastic such as polypropylene. It consists of a first part 3 suitable for attachment to a needle-carrying element (not shown in Figures 1 to 6), and a second part 4 which provides a cover for the needle and is pivotably movable relative to the first part 3, Expose the needle for use. The engagement between the first part 3 and the needle-carrying element is configured such that a greater force is required to remove the needle-carrying element 1 from the device 1 than the axial force alone required to remove a standard needle cap. For example, force above 20N.

The first and second parts 3 and 4 are connected by a hinge 5 and a fixing means 6 . In this way, the first and second parts 3 and 4 can take three stable positions. As shown in Figure 1, after manufacturing and assembly, the first position is the initial position. In the initial position, the removable foil strip 7 is in close contact with the second part 4 . As shown in Figure 2, the second position is the open or operating position where the needle is exposed for use. As shown in Figure 3, the third position is the locked position, where the two parts 3, 4 are held stably and the needle is trapped in the second part 4.

The first part 3 consists of a substantially rectangular profile 8 and a substantially cylindrical ring 9 . The hinge 5 is attached to the edge of one side 10 of the rectangle, while the opposite side 11 is formed with a flat surface 12 so that the removable foil strip 7 initially fits tightly against it. The strip 7 has a free end 13 which can be grasped by the user for removal. The remaining portions of the sides 14 of the portion 8 each form portions of the fixing means 6 . This includes an open axial recess or groove 15 formed with microprojections 23 located at its opening.

The ring 9 has a stepped profile with a central enlarged portion 16 and a reduced diameter portion 17 adjacent to the rectangular portion 8 and also with a free end portion 18 of reduced diameter. Figures 5 and 6 clearly show that the free end portion 18 and the central portion 16 are formed with a pair of opposing axial slits 19 having a keyhole profile. The outer surface of the free end 18 is formed with a pair of opposite axially extending ribs 20 . The inner surface is formed with shallow annular ridges 21 that increase the friction coefficient of the inner surface. The ridge 21 may be formed by moulding, as the slit 19 allows the free end 18 to expand for removal. The slit 19 also provides a free end 18 with radial restorability to assist assembly on the needle carrying element.

Figures 4 and 6 clearly show that the first part 3 can be provided with axial grooves 22 adapted to cooperate with the axial ribs of the needle-carrying element to provide a defined position of the device 1 on the needle-carrying element. It is important that the bevel at the free end of the needle must be oriented towards the user when the device 1 is in the operating position. This is often called a "slope-up" orientation.

The second part 4 includes a substantially rectangular profile 25 , and a substantially U-shaped cover element 26 . The hinge 5 is attached to one side 27 of the rectangular portion 25 . The opposite side 28 has an opening 29 for the passage of the needle, while the edge portion 30 of the side 28 forms a mating portion for the fixing means 6 . Each edge portion 30 has two outwardly facing detents 31,32. Each detent 31 , 32 is adapted to engage in a corresponding recess 15 . If the catch 31 passes the protrusion 23 and engages the recess 15, the fixing means 6 hold the parts 3, 4 in the initial position, where they are aligned. However, if the second part 4 is pivoted further, the detent 32 will pass the projection 23 and enter the recess 15 to place the device in the locked position of Figure 3, where the parts 3, 4 are not aligned. . Relatively little force is required to pivot the second part 4 away from the initial position into the open position, but a greater force is required to move it out of the locked position since the detent 32 is more protruding than the detent 31 . The arrangement of protrusions 23, recesses 15 and detents 31, 32 ensures that the initial and locking positions are well defined.

The U-shaped cover element 26 has an open face through which a needle can pass. It is formed with a lip 35 at the free end and a flat surface 36 for the strip 7 to fit snugly against it. The cover element 26 also has an auxiliary locking mechanism 37 for the needle, which is formed as a tongue 38 projecting inwardly from the side wall 39 of the cover element 26 . The figure shows three tongues 38, two provided on one side of the needle and one provided on the other side. Must have at least two opposing tongues; and More are available depending on the length of the needle. The tongues are available in various lengths to ensure that the needle is held securely. It will be appreciated that in the initial position the needle can contact the tongue but is free to move out of the cover element 26 . In the locked position, the needle contacts and deflects the tongues 38 , which then return to their original position and trap the needle in the cover element 26 .

As mentioned above, the device 1 is a one-piece plastic mold, which is simple and cheap to manufacture. Once the mold is completed, the removable strip 7 is applied and tightly fitted to it. In an alternative configuration, the strap 7 is replaced by a removable strap attached to the second part. Next, the device 1 can be assembled with the needle-carrying element. As mentioned above, this may be a syringe barrel or needle hub 2.

Syringe barrels with an integral needle (not shown) usually have a cylindrical ring at the end of the barrel and a cross-shaped protrusion that receives and secures the needle therein. If the syringe barrel does not have an integral needle, it normally has a hollow, conical protrusion at the end of the barrel for attachment of the needle hub. The hub has an inner conical surface to engage the conical protrusion, forming a so-called Luer connection. Standard taper is 6°. The hub can be a push-fit seat that pushes the protrusion in and holds it in place through friction, called a Luer slip connection. Alternatively, the conical projection may be surrounded by an internally threaded ring to provide a luer lock connection. To this end, the free end of the hub is provided with radially extending lugs to engage threads on the ring to which the hub is attached by rotation.

Figures 7 to 14 show the device 1 of Figures 1 to 6 attached to a hub 2 as a needle carrying element. Figure 12 shows the hub 2 attached to the syringe by a Luer lock connection. For clarity of illustration, the needles are only shown in Figures 10, 11 and 14. The device is identical to that of Figures 1 to 6 except that the cover element 26 is provided with four tongues 38 instead of three.

The hub 2 is a hollow conical element 40 as standard construction. The hub has a pair of radially outwardly extending lugs 41 at the larger proximal end adapted to engage the threads of a Luer lock connection. The opposite end has a cylindrical protrusion 42 into which the needle 43 is inserted, and an axial rib 44 aligned with a bevel 45 at the tip of the needle 43 .

The device 1 is assembled with the hub 2 and needle 43 by aligning the axial rib 44 with the groove 22 of the first part 3 of the device 1 and pushing the two together so that the needle 43 enters the cover element 26 and the ring 9 engages Yu Hub 2's Outer cone 46. Since the inner surface of the ring 9 is cylindrical, the free end 18 expands slightly and the ridges 21 engage the outer surface 46, holding the device 1 securely on the hub 2 due to an increased coefficient of friction. The ridge 21 creates a large amount of resistance to the removal device 1 using axial force alone. In fact, a force of at least 30N needs to be used. However, due to the annular configuration of the ridges 21, the resistance to rotational movement is not great, so the device 1 can be removed using rotational or axial force. In this position, the needle 43 rests on the tongue 38 but is free to move out of the cover element 26, as shown in Figures 10 and 11. If a stronger connection is required, the friction coefficient can also be increased on the outer surface 46 of the hub 2, as shown in Figure 9, by forming similar shallow annular ridges 48 in a limited axial extent.

Once the device 1 is assembled on the hub 2, the hub 2 can be attached to the syringe barrel with a luer connection. If it is a Luer lock connection, as shown in Figure 12, the axial ribs 20 corresponding to the lugs 41 on the hub 2 can enter the threads 50 on the internally threaded ring 51 of the syringe 52. The reduced diameter of the free end 18 ensures that the Luer lock connection is unobstructed.

When using the syringe, the user removes the strip 7 by grasping the free end 13 and pulling toward the distal end. The fixing means 6 can be removed in this way so that the second part 4 pivots away from the first part 3 to expose the needle 43 . Once the second part 4 has moved through a certain angle, the hinge 5, which is a living or spring hinge, assists in moving to the open position of Figure 8. The syringe can then be filled in the usual manner.

Injections can be administered immediately. However, if this is not possible, the needle 43 can be covered again by moving the second part 4 back to the original position. This is a stable neutral position, so there is no risk of needle stick injury while the user is carrying the syringe. Then, when ready for injection, the second part 4 can be moved back to the open position.

Since the ribs 44 and the grooves 22 are aligned, the needle 43 is in the "incline upward" orientation and is ready for injection.

After the injection user moves the second part 4 back to the first part 3, the hinge 5 will assist in the movement. The user then applies force to the cover element 26 until it reaches the locked position of Figures 13 and 14. The user will have an auditory indication based on the movement of the detent 32 through the protrusion 23 into the recess 15, and will also have a visual indication based on the movement of the detent 32 through the protrusion 23 into the recess 15. Parts 3 and 4 are not aligned. In the locked position, the needle 43 moves through the tongues 38 and becomes trapped in them. The syringe can then be safely discarded.

If the device 1 is for a syringe with an integral needle, the assembly and use methods are very similar. The difference is that the device 1 is attached to the cylindrical ring of the syringe instead of the conical surface 46 of the hub 2 . This provides a secure connection since when the free end 18 is pushed it will tend to expand and then contract around the emitter ring.

In various instances, it will be understood that during use, the user's hands will be close to or further away from the needle to comply with safety regulations.

This embodiment shows annular ridges 21 molded into the device 1 to provide an increased coefficient of friction. However, the effect may be achieved in any other suitable way, such as by post-processing the smoothly molded inner surface of the ring 9 to create a random or set pattern to roughen the surface. This also applies to providing a needle-carrying element with an area of increased friction coefficient.

In modifications (not shown), the securing means may include a cooperating pin and hole arrangement having a pin provided in one of the first and second portions and a hole provided in the other, wherein the pin engages in locked position.

Figures 15 to 21 show a needle stick prevention device 100 for use with an injection needle carried by a needle carrying element such as a syringe barrel or needle hub. Figures 22 to 25 show device 100 attached to needle hub 101 and syringe 102. The purpose of device 100 is to replace the standard disposable needle caps typically used to cover needles before use and provide a safety device that can be used with syringes and hubs that is easy and inexpensive to manufacture and assemble.

The device 100 is a one-piece mold made of plastic such as polypropylene. It consists of a first part 103 suitable for attachment to a needle carrying element (not shown in Figures 15 to 21), and a second part 104 which provides a cover for the needle and is pivotably movable relative to the first part 103, Expose the needle for use.

The first and second parts 103, 104 are connected by a hinge 105. In this way, the first and second parts 103 and 104 can take three stable positions. The first position is the initial position and conveying position, please see Figure 23. As shown in Figures 15, 16 and 24, the second position is the open or operative position where the needle is exposed for use. As shown in Figure 25, the third position is the locked position, where the two parts 103, 104 are held stably and the needle is trapped in the second part 104.

The first portion 103 includes a cylindrical portion 106 having a free end 107 suitable for connection to the needle-carrying element 101 or 102 . The other axial end 108 has a pair of laterally projecting arms 109 . The peripheral end 110 of each arm 109 is attached to the second part 104 to form two hinges. The arm 109 also supports one end of the hinge spring 111 .

The free end 107 ends in a smaller diameter portion 129 that can be received in a standard attachment of a syringe. The first portion 103 has a pair of diametrically opposed axial ribs 112 , a short portion extending from the end 108 and the trailing end of the free end 107 . Figures 19 and 20 clearly show that each rib 112 has an inner protrusion 113, which is used to attach the device 100 to the needle-carrying element, which will be described in detail below with reference to Figure 22. Each protrusion 113 has a substantially triangular profile with a face inclined to the axis and an abutment face 114 perpendicular to the axis.

The second portion 104 is a substantially U-shaped cover element. Figure 17 clearly shows that the shape is depressed at a point 115 adjacent the open side 116, while the closed portion 117 is microbulb-like. This makes the second portion 104 easier for the user to grasp.

At the end of the second portion 104 adjacent the first portion 103, a pair of arms 118 project laterally and are attached at a hinge 120 to each arm 109 of the first portion. The arm 118 supports the other end of the hinge spring 111 . The free end 121 of the second portion 104 is closed to the end 122 .

The open side 116 allows the needle to travel between the initial position and the open position, and between the open position and the delivery position. The open side 116 is formed with a funnel 123 which leads to a transport recess 124 and thus to a locking recess 125 via a gate device 126 . Delivery recess 124 extends along the axis of device 100 so that the needle is received in the initial and delivery position. The gate device 126 includes a protrusion 127 that defines the location between the recesses 124 and 125, and a curved or labyrinth path 128 therebetween. The protrusion extends all the way along the axial length of the second part 104, but may be provided only at one end adjacent the first part 103, ie adjacent the base of the needle.

Device 100 may be made purely by injection molding.

Once fabricated, device 100 is assembled to a needle-carrying component such as needle hub 101 as shown in Figure 22. Hub 101 is also typically polypropylene and made by injection molding.

The needle 130 can be molded into the hub 101 or assembled afterwards. The hub 101 is of standard construction with a conical bore 131 for attachment to the syringe 102 and an exposed flange 132 at its proximal end. Since device 100 is intended to replace a standard disposable needle cap, it is important that it is not removable in the same manner as a standard needle cap. Therefore, the hub 101 is formed with an outer groove 133 formed by two arcuate portions 134 extending through approximately 100°, so that their adjacent ends are separated by an arcuate distance of approximately 80°. The hub 101 is assembled with the device 100 by introducing the hub 101 into the free end of the first portion 103 until the protrusions 113 engage the groove portions 134 . The protrusions 113 slide into the groove portion 134 along their inclined surfaces, but the abutment surfaces 114 engage the groove portion 134 to prevent separation of the device 100 and the hub 101 . However, the device 100 is rotatable about 100° in each direction on the hub 101 . The engagement between the first part 103 and the hub 101 has sufficient friction so that when a user manually applies a torque, the first part 103 can rotate relative to the hub 101, but the position remains unchanged when the torque disappears. When the device 100 and hub 101 are assembled, the needle 130 can be received in the delivery recess 124 and the device 100 will be maintained in the original position by the hinge 105 .

When used, the assembled device 100 and hub 101 are separated from any packaging and attached to the syringe 102, as shown in Figure 23. The user then moves the second portion 104 back to the open position of Figure 24 by grasping the bulbous portion 117 and applying force in a direction that causes the needle 130 to begin moving out of the open side 116. The hinge 105 then operates to pivotally move the second portion 104 to the open position. The user may then fill syringe 102 in the usual manner.

Injections can be administered immediately. However, if this is not possible, the needle 130 can be covered again by moving the second portion 104 back into the delivery position. Similarly, the user only needs to exert a small amount of manpower to start moving, because the hinge 105 will continue to move until the needle 130 is located in the delivery recess 124 . when user When carrying the syringe, since the hinge 105 holds the second portion 104 in this stable delivery position, there is no risk of needlestick injury. When ready to inject, the second portion 104 is again moved into the open position.

Since the device 100 can be rotated through approximately 100° in each direction on the hub 101, the second portion 104 can always be moved out of the way to avoid obstructing the user and can be moved by The frictional engagement between the first part 103 and the hub 101 is maintained in a stable position.

After the injection, the user again moves the second part 104 back to the first part 103 and ensures that it reaches the delivery position due to the action of the hinge 105 . The user then applies further force in the same direction to move the needle 130 into the locking recess 125 via the gate device 126 . It will be appreciated that the needle 130 moves along the path 128 around the protrusion 127 and into the locking recess 125 . The locked position is shown in Figure 25. The needle 130 is securely held, particularly because the base of the needle 130 has no elasticity to return along the path 128 . It can also be noted that the free end of the needle 130 is twisted as it engages the back of the locking recess 125, causing it to fail. The syringe 102 can be safely discarded.

When needle 10 moves into the delivery position, it is guided by funnel 123. If the needle becomes twisted during injection, for example by accidentally poking bone, the funnel 123 will guide it back and may even remove at least some of the twist to ensure that it enters the locking recess 125 .

Figures 26-28 also show modifications of the device of Figures 15-35, with corresponding reference numerals used for corresponding parts. Figures 26 to 28 show that the second portion 104 has a similar shape to the bulbous closure portion 117, which also has external axial ribs 140 to facilitate gripping by the user. Figure 26 also shows how the closed end 122 of the second portion is formed. The second part 104 has a central opening 141 surrounded by three petals 142 whose dimensions are chosen such that they close the central opening 141 to the same plane of the end 122 . When the device is removed from the mold, the flaps 142 can be raised as shown and sealed to complete the end 122 as a post-molding step.

Figures 26 to 28 also show modifications of the gate device 126. A barrier is also formed between the transport recess 124 and the locking recess 125, but the acute angle as shown in FIG. 21 has been smoothed, so the path of the needle has become gentle. needle The positions in the transport recess (first and third positions) are also displayed. The locking recess 125 is modified with extensions 145 which face the transport recess 124 on each side of the gate device 126 . This enhances safety because if the needle in the locked position enters one of these extensions, its return via the gate device 126 will be more difficult, if not impossible.

Figures 28 and 29 also show the connection of device 100 and hub 101. Figure 29 shows the formation of trench 133. In Figure 29, there is a relatively small distance between adjacent ends of groove 134, but the radial depth of the groove increases. Figures 26 to 28 also show the modification of each protrusion 113. The protrusion 113 has a larger annular extension and a larger radial depth. The separation distance between the adjacent ends of the groove portion 134 and the annular extension of the protrusion 113 is selected to ensure that when filling the syringe, and when injecting, the device 100 can be rotated a sufficient distance to avoid obstruction. The rotation should be at least 90° and clearly less than 180°. The preferred value is about 115°, but may be any value within the range, such as 100°, 110°, 120°, 130°. This modification provides a more secure attachment. Especially when the hub 101 is attached to the syringe via a Luer lock connection, it is ensured that the connection will remain secure. Otherwise, the structure and operation of the embodiment of FIGS. 26 to 29 are the same as those of FIGS. 15 to 25 .

Figures 30 and 31 show further modifications of the closed portion 117 of the second portion 104. Otherwise, this embodiment is the same as that of FIGS. 26 to 29 , and corresponding reference numerals are used for corresponding parts. In Figures 30 and 31, the closed portion 117 of the second portion 104 is provided with an extension 146 of reduced width rather than being bulbous. The extension 145 also has axial ribs 140 . Although the enlarged portion of Figures 15 to 29 is easier for the user to grasp, in some cases the reduced width extension of Figures 30 and 31 may be better. In a further modification (not shown), a finger plate may be provided on the second portion 104, such as relative to the open side 116, for the user to grasp to move the second portion 104 to the open position. If desired, an axial tip can also be provided at the free end 121 . In a further modification (not shown), the gate device 126 can be modified by changing the profile of the protrusion 127 adjacent the base of the needle to ensure that the needle cannot return from the locked position.

The above embodiments provide a simple structure of the needlestick prevention device, which is simple to manufacture and use, and ensures safe transportation.

It can be understood that the above embodiments not only describe the first four aspects of the present invention, but also describe the fifth and sixth aspects of the present invention, that is, the combination of a needle stick prevention device and a needle carrying element, wherein the needle carrying element has a conical shape. Or a cylindrical outer surface portion to be joined to the inner surface portion of the needle stick preventing device, and the needle stick preventing device and the needle carrying element are formed by protrusions on one of the needle stick preventing device and the needle carrying element, and are joined to The needle-stick prevention device and the needle-carrying element are attached through a groove on the other of the needle-carrying element, and are configured such that the needle-punch prevention device and the needle-carrying element can rotate relative to each other, but prevent the device and the needle-carrying element from being separated, or at least one surface has an enlarged The friction coefficient is to prevent the axial separation of the device and the needle-carrying element. An increased coefficient of friction can be provided in one or both of the device and the needle-carrying element in the manner described above.

1:Device

3:Part One

4:Part 2

5: hinge

6: Fixed means

7: Strip

8: Rectangular outline part

9: Ring

12:Flat surface

13: Free end

16: Central Amplification Department

17: Diameter reduction part

18: Free end

25: Rectangular outline part

26: cover element

35: Lips

38: Tongue

Claims (7)

A needle stick prevention device for an injection needle carried by a needle carrying element of a syringe, wherein the device is formed as a one-piece molding and includes a first portion adapted to be attached to the a needle-carrying element, and a second portion that provides a cover for the needle and is pivotably movable relative to the first portion to expose the needle for use, the first portion being attached to the needle by attachment means The needle-carrying element provides that the needle-stick prevention device can rotate circularly relative to the needle-carrying element at an angle of at least 90° and less than 180° in each direction, but prevents the device from falling off, the first part and the needle-carrying element The engagement therebetween is configured to permit circumferential rotation when a torque is artificially applied, and when the torque is removed, the first portion and the needle-carrying element are maintained in their relative positions. The needle stick prevention device according to claim 1, wherein the attachment means includes a protrusion located on one of the needle carrying element and the needle stick preventing device, and a protrusion located on one of the needle carrying element and the needle stick preventing device. A ditch of the other. The needle stick prevention device as claimed in claim 2, wherein the protrusion is provided on the needle stick prevention device, and the groove is provided on the needle carrying element. The needlestick prevention device of claim 2 or 3, wherein the groove extends around two separate arcs of the circumference of the needle-carrying member, adjacent ends of the arcs being separated by any desired distance. , and the needle puncture prevention device is formed with a pair of diametrically opposite protrusions, and each protrusion is accommodated in each arc portion of the groove. The needle stick prevention device as claimed in claim 1, wherein the needle stick prevention device rotates through an angle of about 110° relative to the needle carrying element. The needle stick prevention device according to claim 2 or 3, wherein the or each protrusion is provided with an inclined surface so that the needle stick prevention device is assembled on the needle carrying element, and an abutment surface engaged with the groove to facilitate Prevent separation of the device and the needle-carrying component. The needlestick prevention device of claim 1, wherein the engagement is a frictional engagement between the first part and the needle-carrying element.