TW201726198A - 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 prevention device

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

Acupuncture injuries typically occur in a medical setting, particularly during the use of a syringe or other injection device, when the user accidentally pierces the needle into himself or others. This kind of acupuncture injury is the main cause of spreading infections and diseases, which not only causes pain, but also causes disability, so it is important to prevent it.

There are a variety of conventional methods that attempt to prevent needle stick injuries. The needle is usually provided with a protective needle cap that is removed when used and then discarded, as it is not recommended to place the needle cap on the needle again. In fact, the action of placing the needle cap again is considered to be the cause of a large number of needle stick 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 that is then attached to the syringe barrel. The connection between the hub and the syringe barrel is typically through a Luer connection that 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 a Luer slip type, i.e., a simple friction fit, or a Luer lock type, wherein the male joint is surrounded by an internally threaded ring and the hub has an outer radial lug to engage the thread. In fact, the hub is screwed onto the column. A still further alternative is to insert the radial lugs from the rear into a slit on the ring at the end of the syringe. Next, the hub acts as a push-fit seat on the syringe and is held by the lugs behind the slit.

One method of preventing needle stick injury is to provide a safety shield that is mounted on a needle member, i.e., a 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 place to cover the needle. This configuration adds complexity and cost to the finished product due to the extra portion required.

Another suggestion is to integrally mold the safety cover to the needle and hub. The protective strip ensures that the needle will not be exposed before use and will be removed when in use. Likewise, when in use, the cover pivots away from the needle and is pivoted back and locked in place to cover the needle. This configuration may be difficult to mold and is not suitable for syringes with integral needles.

It is also recommended to replace the disposable needle cap with a safety cover. In this case, the safety shield must of course not be removed as a disposable needle cap. As such, it is relatively easy to provide a connection that prevents detachment between the injection device and the safety shield, but may result in the cover being unorientable on the device. This is disadvantageous because the user typically needs to orient the needle "beveled up" for injection so that the mask does not become obstructed. If the cover is not rotatable on the device, the orientation of the cover and the needle cannot be guaranteed, and if it is free to rotate, it can naturally rotate to the obstructed position.

Most acupuncture injuries occur after the injection is completed. Typically, the user fills the injection device and the injection is performed immediately. However, gradually, the injection is composed of many different medications, and the injection device is filled at a place such as a pharmacy, and then delivered to the drug-collecting person for injection. In order to remove the risk of needle stick injury, the needle must be masked again in the delivery position, but not locked so that it is exposed when injecting. It is important that the delivery position is distinct from the locked position and that the safety cover cannot be accidentally moved into the use position or the locked position during delivery.

According to a first aspect of the present invention, a needling device for an injection needle provided in a needle-loading member for a syringe is formed as an integral mold, and includes a first portion adapted to be attached to the needle-loading member, and A second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the device being adapted to assume a first position for use in transporting the device prior to use In the second position, the needle is used to fill the syringe and the injection to expose the needle therein, the third position is to protect the needle after filling the syringe but before the injection, and the fourth position is in the device The needle is locked in the subsequent injection.

This configuration provides a configuration for a given delivery position and a fourth position in which the needle is locked. Preferably, the first and second portions can take three stable positions to define four positions of the device. In the first stable position, the needle is received in the second portion and the relative positions of the first and second portions are unchanged. This is the initial position where the device is assembled with a needle-loaded element and can be delivered before use. If the needle member is a hub, the hub and device are attached to the syringe and the device is in this initial position. In the second stable position, the securing means is removed and the second portion is pivoted away from the first portion to expose the needle. This is the operating position where the syringe can be filled and injected. If the injection is not taken immediately, the second portion can be moved back to the first stable position and held there to shield the needle. In this position, the syringe can be safely carried as needed, so it is in a temporary delivery position. Next, when the injection is ready for injection, the second portion can be moved into the operating position again. After injection, the device is placed in a third stable position by moving the second portion back through the first stable position to initiate a 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 the operating and transport positions as needed.

In one embodiment, the cover has a delivery recess and a locking recess that is connected by a gate device at least at the base of the needle, configured to be in the third position, the needle being located in the delivery recess and movable into the second position, and in the fourth position The needle is moved into the locking recess via the gate device, and the transmission gate device prevents removal from the fourth position.

This configuration provides a distinctly defined delivery position and a configuration that locks the needle in a fourth position that is both simple and safe. The locking recess securely receives the needle, and since it is held by the shutter attached to the base of the needle, it is virtually impossible to remove the needle from the locking recess without causing serious damage. In this way, the need for needlestick damage provides the protection you need.

The first and second portions of the device are preferably joined by a living hinge. Once the user has moved, the hinge will provide a 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 part into the fourth position. The hinge also holds the second portion in the first and third positions. This provides a particularly simple construction since no further means are required to hold the second portion in various positions.

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

Conveniently, the brake device is provided over the entire length of the needle. The gate device preferably includes a protrusion formed in the second portion for defining a boundary between the conveying recess and the locking recess, and a curved or labyrinth path connecting the conveying recess and the locking recess. When the needle is moved from the second position into the third position, it remains in the delivery recess due to the protrusion, but it can enter the locking recess as the labyrinth path is applied when further manpower is applied. Once in the locking recess, the base of the needle will not have sufficient resilience to return along the labyrinth path that bypasses the protrusion.

The second portion preferably has an extension that emerges 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 can be a funnel to guide the needle into the delivery recess.

The second portion can be shaped by any suitable method for the user to grasp and move it between the first and second, and the second and third positions. It can also be grasped or manually applied to move the second portion into the locked position. The second portion may have an enlarged portion that is located on the opposite side of the delivery recess. The enlarged portion can accommodate the locking recess. Alternatively, the second portion may have a reduced width extension located on the opposite side of the delivery recess. The amplifying portion and the extending portion may be respectively formed with axially extending outer ribs for use. A still further alternative is to provide a finger plate in the second portion for applying manpower or a tip or extension at the axial end of the second portion.

In another embodiment, the first and second portions of the device are preferably joined by living hinges and securing means. In the first position, the needle is received in the second portion and the securing means are engaged to maintain the relative positions of the first and second portions. In the second position, the securing means is removed and the second portion is pivoted away from the first portion with the aid of the hinge to expose the needle. The second portion can be moved back to the first position and held there by a securing means to shield the needle, i.e., the third, delivery position. Then, when ready for injection, the second portion can be moved into the operating position again. After the injection, the second portion is moved back there via the first position so that the securing means engages the position in which the permanent locking configuration is activated.

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

Conveniently, the device is initially closed by a removable strip that extends along the open face of the second portion. The strip can be flexible, such as a foil, or a rigid plastic part. The strip is attached to the second portion in close fitting. The second portion can have a flat flange to attach the strip to it snugly. The first portion may also have a flat surface that is closely attached to the proximal end of the strip. Alternatively, the strip and the second portion may have a releasable adhesive bond. Conveniently, the strap has a free end that can be grasped by a user for removal. Unwinding the strip also moves the second portion into the operating position. Once the second portion has moved past a predetermined angle, the hinge will assist in this movement.

The hinge also acts to assist the second portion to return to the first position. Further manpower may be required to move the second part into the locked position. The second portion may also include an auxiliary locking mechanism for the needle in the locked position. The auxiliary locking mechanism can include at least one pair of opposing hooks configured to pass the needles in one direction but not back.

According to a second aspect of the present invention, a needling device for an injection needle provided in a needle carrying member for a syringe is formed as an integral mold, and includes a first portion adapted to be attached to the needle member, and a second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the device being adapted to at least take an open position for filling the syringe and injecting the needle to expose the needle And a locking position for locking the needle therein in a subsequent injection of the device, the cover having a gate device at least at the base of the needle that leads to the locking recess, configured to move the needle through the gate device in the locked position The recess is locked and the gate device prevents the needle from moving out of the locked position.

The locking recess securely receives the needle, and since it is held by the shutter attached to the base of the needle, it is virtually impossible to remove the needle from the locking recess without causing serious damage. In this way, the need for needlestick damage provides the protection you need.

Conveniently, the gate device is provided over substantially the entire length of the needle. The gate device preferably includes a protrusion formed in the second portion for defining a curved or labyrinth path to the locking recess. As the needle moves into the locked position, it follows the labyrinth path and remains in the locking recess due to the protrusion. Once in the locking recess, the base of the needle will not have sufficient resilience to return along the labyrinth path that bypasses the protrusion.

The third and fourth aspects of the invention illustrate the use of a needling prevention device in place of a disposable needle cap.

According to a third aspect of the present invention, a needling device for an injection needle provided in a needle carrying member for a syringe is formed as an integral mold, and includes a first portion adapted to be attached to the needle member, and a second portion that provides a cover for the needle and that is pivotally movable relative to the first portion to expose the needle for use, the first portion being attached to the needle member by an attachment means that provides a needling device It is rotatable relative to the needle element at an angle of at least 90° and less than 180° in each direction, but prevents the device from falling out.

This configuration ensures that the device is not removable from the loading needle element, but can be oriented such that the needle is in a beveled upward position to prevent obstruction of the injection.

Preferably, the first portion is not free to rotate on the needle member. Conversely, the engagement between them is configured to be rotatable when the moment is manually applied, and when the torque is lost, the elements can be maintained in their relative positions. This configuration may be provided by a frictional engagement between the first portion and the needle member.

Conveniently, the attachment means comprises a projection located in one of the needle-loading elements or the needling prevention means, and a groove in the other. Preferably, the protrusion is provided to the needling device and the groove is provided to the needle member. The protrusion is configured to have an inclined surface so that the needling device is assembled to the needle member and the abutting surface is engaged with the groove to prevent separation of the device and the needle member.

Conveniently, the grooves extend around two separate arcs of the circumference of the needle element, the adjacent ends of which are separated into any desired distance. The needling preventing device is formed with a pair of diametrically opposed protrusions, and each of the protrusions is accommodated in each arc of the groove.

According to a fourth aspect of the present invention, a needling device for an injection needle provided in a needle carrying member for a syringe is formed as an integral mold and includes a first portion adapted to be attached to a cylinder of the needle member or a conical portion, and a second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the engagement between the first portion and the needle member being configured to have an enlarged The coefficient of friction is such as to prevent the axial separation of the needling device and the needle-carrying element, and the directional arrangement for defining the annular relative position of the needling device and the needle-carrying element.

Configuring the joint to have an increased coefficient of friction increases the axial force required to remove the device, which means that it cannot be removed as a standard disposable needle cap. In addition, it is simple to manufacture in one piece and is easy to assemble, thus reducing costs. The directional configuration means that the device can take the desired orientation relative to the needle for injection.

Conveniently, the first portion of the device has a substantially cylindrical ring that engages a cylindrical or conical portion of the needle member. The ring may have at least one axial slit extending from its free end. The slit provides a radial restoring force to the ring to ensure that it is easily removed and assembled to the needle member.

Preferably, the inner surface of the ring is not smooth, but at least a portion is configured to have an increased coefficient of friction to increase the friction between the first portion and the needle member. This ensures that the device engages the cylinder or cone and has sufficient force to prevent axial separation. The increase in the coefficient of friction can be provided by a roughened predetermined pattern, or the like, or a random configuration. For example, the smooth mold surface may be molded with a predetermined pattern of annular ridges or may be provided with a random configuration by suitable post-forming processes. In various examples, it has been found that the resistance of the relative rotation of the first portion and the needle member is less than that of the axial separator, so that the device can be removed by helical motion as desired. The axial extent of the increased coefficient of friction region is preferably limited and does not extend over the entire length of the joint between the portions. Attachment may also require protrusions provided to the needling device and grooves provided to the needle member.

Conveniently, the peripheral surface of the ring has a reduced diameter portion so that it fits into the Luer lock connection. The peripheral surface may also have one or more outer ribs and corresponding to the lugs on the hub to engage the threads of the luer lock connection.

The standard hub and syringe have guiding ribs to assist in the upward orientation of the bevel of the needle. The first portion of the device conveniently includes a groove that engages the ribs.

A further aspect of the invention relates to a combination of a needling device and a needle-carrying element.

According to a fifth aspect of the present invention, in the combination of the needling preventing device and the needle carrying member, the needle carrying member has a cylindrical or conical outer surface portion to be joined to the inner surface portion of the needling preventing device, and the needle The lance prevention device and the stylus element are protrusions formed by one of the needling prevention device and the stylus element, and are attached to the groove of the other of the needling prevention device and the stylus element, and are attached to the needle. The preventing device and the needle-carrying member are relatively rotatable, but the separation of the needling preventing device and the needle-carrying member is prevented.

Preferably, the protrusion is provided to the needling device and the groove is provided to the needle member. The protrusion is configured to have an inclined surface so that the needling device is assembled to the needle member and the abutting surface is engaged with the groove to prevent separation of the device and the needle member.

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

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

Preferably, the increased coefficient of friction is provided by roughening the surface. Roughening can be a given pattern or a random configuration. The predetermined pattern can be composed of annular ridges. The random pattern can be created by suitable processing of the initially smooth surface. The increased coefficient of friction may extend over the entire axial length of the joint between the surfaces or may be limited.

Hereinafter, an embodiment of the needling prevention device according to the viewpoint of the present invention will be described by way of example only, with reference to the drawings, wherein:

Figures 1 to 6 show a needling device 1 for an injection needle carried by a needle-loading element such as a syringe barrel or a needle hub. 7 to 14 show that the device 1 is attached to the needle hub 2. The purpose of the device 1 is to replace the standard disposable needle cap that is typically used to cover the needle prior to use, and to provide a safety device that can be used in standard syringes and hubs and that is both easy and inexpensive to manufacture and assemble.

The apparatus 1 of Figs. 1 to 6 is an integral mold made of a plastic such as polypropylene. It comprises a first portion 3 adapted to be attached to a stylus element (not shown in Figures 1 to 6), and a second portion 4 which provides a cover for the needle and which is pivotally movable relative to the first portion 3, To expose the needle for use. The engagement between the first portion 3 and the needle member is configured to require a greater force to self-load the needle member removal device 1 than is required to remove the standard needle cap. For example, a force of 20 N or more.

The first and second portions 3, 4 are connected by a hinge 5 and a fixing means 6. Thus, the first and second portions 3, 4 can take three stable positions. As shown in Figure 1, the first position is the initial position after manufacture and assembly. In the initial position, the removable foil strip 7 is in close contact with the second portion 4. As shown in Figure 2, the second position is an open or operational position where the needle is exposed for use. As shown in Fig. 3, the third position is the locked position, where the two portions 3, 4 are stably held while the needle is trapped in the second portion 4.

The first portion 3 includes a substantially rectangular contour portion 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 face 12 so that the removable foil strip 7 initially fits into it. The strip 7 has a free end 13 which can be grasped by a user for removal. The remaining portions of the sides 14 of the portion 8 are each formed with a portion of the securing means 6. This includes an open axial recess or groove 15 formed with a microprojection 23 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 having a reduced diameter free end portion 18. 5 and 6 clearly show that the free end portion 18 and the central portion 16 are formed with a pair of opposed axial slits 19 having a keyhole profile. The outer surface of the free end portion 18 is formed with a pair of opposed axially extending ribs 20. The inner surface is formed with a shallow annular ridge 21 that increases the coefficient of friction of the inner surface. The ridge 21 can be formed by molding because the slit 19 allows the free end 18 to expand for removal. The slit 19 also provides a free end 18 with a radial restoring force to assist in assembly on the needle member.

4 and 6 clearly show that the first portion 3 can be provided with an axial groove 22 adapted to engage the axial rib of the needle member to provide a predetermined position of the device 1 on the needle member. Importantly, when the device 1 is in the operative position, the bevel at the free end of the needle must be oriented towards the user. This is often referred to as the "beveled up" orientation.

The second portion 4 includes a substantially rectangular contour portion 25, and a substantially U-shaped cover member 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 needle to pass, while the edge portion 30 of the side 28 is formed with a mating portion of the securing means 6. Each edge portion 30 has two outwardly facing detents 31,32. Each of the detents 31, 32 is adapted to be joined to a corresponding recess 15. If the catch 31 passes through the projection 23 and is joined to the recess 15, the securing means 6 holds the portions 3, 4 in the initial position, where the portions 3, 4 are aligned. However, if the second portion 4 is pivoted further, the catch 32 will pass through the projection 23 and into the recess 15 to place the device in the locked position of Figure 3, where the portions 3, 4 are not aligned. . A relatively small force is required to pivot the second portion 4 away from the initial position to the open position, but requires more force to move it out of the locked position because the catch 32 is more prominent than the catch 31. The configuration of the projections 23, recesses 15 and detents 31, 32 ensures that the initial and locked positions are well defined.

The U-shaped cover element 26 has an open face through which the needle can pass. It is formed with a lip 35 at the free end and a flat surface 36 so that the strip 7 is in close contact with it. The cover element 26 also has an auxiliary locking mechanism 37 for the needle that is formed as a tongue 38 that projects inwardly from the side wall 39 of the cover element 26. The figure shows three tongues 38, two on one side of the needle and one on the other side. There must be at least two opposing tongues; more depending on the length of the needle. The tongues are of different lengths to ensure that the needle is held securely and the length is somewhat acceptable. It will be appreciated that in the initial position, the needle can contact the tongue but can be freely removed from the cover member 26. In the locked position, the needles contact and deflect the tongues 38, which then return to their original position and trap the needles in the cover element 26.

As mentioned above, the device 1 is a one-piece plastic mold that is both simple and inexpensive to manufacture. Once the molding is completed, the removable strip 7 will be applied and adhered to it. In an alternative configuration, the strip 7 is a removable strip that is replaced by a second portion. Next, the device 1 can be assembled with a carrier element. As mentioned above, it can be a syringe barrel or hub 2.

A syringe barrel having an integral needle (not shown) typically has a cylindrical ring at the end of the barrel and a cross-shaped projection that receives and secures the needle therein. If the syringe barrel does not have an integral needle, it normally has a hollow conical projection at the end of the barrel for attaching the needle hub. The hub has an inner tapered surface to engage a conical projection that joins into a so-called Luer connection. The standard taper is 6°. The hub can be a push-fit seat to push in the protrusion and hold it by friction, called a Luer slip connection. Alternatively, the conical projections 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 the threads on the ring, while the hub is attached for rotation.

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

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

The device 1 is assembled with a hub 2 and a needle 43 by aligning the axial ribs 44 with the grooves 22 of the first portion 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 On the outer tapered surface 46 of the hub 2. Since the inner surface of the ring 9 is cylindrical, the free end portion 18 is slightly expanded, and the ridge 21 is engaged with the outer surface 46 to securely hold the device 1 on the hub 2 based on the increased coefficient of friction. The ridge 21 exerts a large amount of resistance to the removal device 1 with a separate axial force. In fact, it is necessary to use a force of at least 30N. However, due to the annular configuration of the ridge 21, the resistance to rotational movement is not large, 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 member 26, as shown in Figures 10 and 11. If a stronger connection is desired, a coefficient of friction can also be added to the outer surface 46 of the hub 2, as shown in Figure 9, by forming a similar shallow annular ridge 48 in a limited axial extent.

Once the device 1 is assembled on the hub 2, the hub 2 can be attached to a syringe barrel with a luer connection. If it is a Luer lock connection, as shown in FIG. 12, the axial rib 20 corresponding to the lug 41 on the hub 2 can enter the thread 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 unimpeded.

When a syringe is used, the user removes the strip 7 by grasping the free end 13 and pulling it toward the end. The securing means 6 is thus detachable such that the second portion 4 pivots away from the first portion 3 to expose the needle 43. Once the second portion 4 has moved past a particular angle, the hinge 5, which is a living hinge or spring hinge, will assist in moving to the open position of FIG. The syringe can then be filled in the usual way.

The injection can be taken immediately. However, if this is not possible, the needle 43 can be covered again by moving the second portion 4 back to the initial position. This is a stable intermediate position, so there is no risk of needle stick injury during the user carrying the syringe. Next, when the injection is ready for injection, the second portion 4 can be moved back to the open position.

Since the ribs 44 and the grooves 22 are aligned, the needles 43 are oriented "beveled upward" to prepare for injection.

After the injection user moves the second portion 4 back to the first portion 3, the hinge 5 will assist in the movement. The user then applies force to the cover member 26 until it reaches the locked position of Figures 13 and 14. The user will have this audible indication that entering the recess 15 based on the movement of the catch 32 through the projection 23 will also have a visual indication based on the misalignment of the portions 3, 4. In the locked position, the needles 43 move through the tongue 38 and are trapped in them. The syringe can then be safely discarded.

If the device 1 is for a syringe with an integral needle, the method of assembly and use is very similar. The difference is that the device 1 is a cylindrical ring attached to the syringe, rather than the tapered surface 46 of the hub 2. This provides a secure connection because when the free end 18 is pushed it will tend to expand and then contract around the ejector ring.

In various examples, it will be appreciated that in use, the user's hand will approach the needle or be away from it to comply with safety regulations.

This embodiment shows that the annular ridge 21 is molded to the device 1 to provide an increased coefficient of friction. However, the effect can be produced by any other suitable method, such as by post-processing of the smoothly contoured inner surface of the ring 9 to create a random or predetermined pattern to roughen the surface. This also applies to the provision of a needle element with an increased area of friction coefficient.

In a modification (not shown), the securing means can include a mating pin and hole arrangement having a pin provided to one of the first and second portions and a hole provided to the other, wherein the pin engages In the locked position.

15 to 21 show a needling prevention device 100 for an injection needle carried by a needle-loading member such as a syringe barrel or a needle hub. 22 through 25 show that the device 100 is attached to the needle hub 101 and the syringe 102. The purpose of device 100 is to replace the standard disposable needle cap that is typically used to cover the needle prior to use, and to provide a safety device that can be used in syringes and hubs and that is both easy and inexpensive to manufacture and assemble.

The device 100 is an integral mold made of a plastic such as polypropylene. It includes a first portion 103 adapted to be attached to a needle carrying member (not shown in Figures 15 to 21), and a second portion 104 that provides a cover for the needle and that is pivotally movable relative to the first portion 103, To expose the needle for use.

The first and second portions 103, 104 are connected by a hinge 105. Thus, the first and second portions 103, 104 can take three stable positions. The first position is the initial position and the conveying position, see Figure 23. As shown in Figures 15, 16, 24, the second position is an open or operational position where the needle is exposed for use. As shown in Fig. 25, the third position is a locked position where the two portions 103, 104 are stably held while the needle is trapped in the second portion 104.

The first portion 103 includes a cylindrical portion 106 having a free end 107 adapted to be coupled to the stylus element 101 or 102. The other axial end 108 has a pair of arms 109 that project laterally. The peripheral end 110 of each arm portion 109 is attached to the second portion 104 to form two hinges, and the arm portion 109 also supports one end of the hinge spring 111.

The trailing end of the free end 107 is a smaller diameter portion 129 that can be received by 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. 19 and 20 clearly show that each rib 112 has an inner protrusion 113 for attaching the device 100 to the stylus element, as will be described in more detail below in connection with FIG. Each protrusion 113 has a substantially triangular profile with a face that is inclined to the axis and an abutment surface 114 that is perpendicular to the axis.

The second portion 104 is a substantially U-shaped cover element. Figure 17 clearly shows that the shape is recessed at a location 115 adjacent the open side 116 and the closed portion 117 is microsphere-like. It is thus easy for the user to grasp the second portion 104.

At the end adjacent to the second portion 104 of the first portion 103, a pair of arms 118 project laterally and are attached at the hinge 120 to the arms 109 of the first portion. The arm portion 118 supports the other end of the hinge spring 111. The free end 121 of the second portion 104 is enclosed at 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 transport position. The open side 116 is formed with a funnel 123 that leads to the delivery recess 124 and thus to the locking recess 125 via the gate device 126. The delivery recess 124 extends along the axis of the device 100 such that the needle is received in the initial and delivery position. The gate device 126 includes a protrusion 127 that defines a location between the recesses 124 and 125 and a curved or labyrinth path 128 therebetween. The projection extends all the way along the axial length of the second portion 104, but may be provided only adjacent to the first portion 103, i.e., adjacent one end of the base of the needle.

The device 100 can be made solely by injection molding.

Once manufactured, the device 100 will be assembled to a needle-carrying element such as the needle hub 101 as shown in FIG. The hub 101 is also typically polypropylene and is 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 the device 100 is intended to replace a standard disposable needle cap, it is important that it cannot be removed as a standard needle cap method. Therefore, the hub 101 is formed with an outer groove 133 which is formed by two curved portions 134 extending through about 100° so that their adjacent ends are separated by an arcuate distance of about 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 each projection 113 engages the respective groove portion 134. The projections 113 slide along their inclined faces into the groove portion 134, but the abutment faces 114 engage the groove portions 134 to prevent separation of the device 100 and the hub 101. However, the device 100 can be rotated about 100° in all directions on the hub 101. The engagement between the first portion 103 and the hub 101 has sufficient friction so that when the user manually applies a moment, the first portion 103 can rotate relative to the hub 101, but when the torque disappears, the position does not change. When the device 100 and the hub 101 are assembled, the needle 130 can be received in the delivery recess 124 and the device 100 will be maintained in the initial position by the hinge 105.

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

The injection can be taken immediately. However, if this is not possible, the needle 130 can be again covered by moving the second portion 104 back to the delivery position. Similarly, the user only needs to apply a small amount of manpower to start moving because the hinge 105 will continue to move until the needle 130 is in the delivery recess 124. When the user carries the syringe, there is no risk of needle stick injury due to the hinge 105 holding the second portion 104 in this stable delivery position. When the injection is ready for injection, the second portion 104 is again moved into the open position.

Since the device 100 can be rotated about 100° in all directions on the hub 101, the second portion 104 can always be removed to avoid obstructing the user when the needle 130 is oriented with the desired bevel facing upwards for injection. The frictional engagement between the first portion 103 and the hub 101 is maintained in a stable position.

After the injection, the user again moves the second portion 104 back to the first portion 103 and ensures that it reaches the delivery position due to the action of the hinge 105. The user then applies a 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 is along the path 128, bypassing the protrusion 127 and moving 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 does not have resilience along the path 128. It is also noted that the free end of the needle 130 is distorted by engagement with the back of the locking recess 125, causing it to fail. The syringe 102 can be safely discarded.

When the needle 10 is moved into the delivery position, it is guided by the funnel 123. If during the injection the needle is twisted by, for example, accidentally puncture the bone, the funnel 123 will direct it back and even remove at least some of the distortion to ensure it enters the locking recess 125.

26 to 28 also show modifications of the apparatus of Figs. 15 to 35, and corresponding element symbols are used for the corresponding parts. Figures 26 through 28 show the second portion 104 having a contour similar to the bulbous closure portion 117, which also has an outer axial rib 140 for the user to grasp. Figure 26 also shows how the closed end 122 of the second portion is formed. The second portion 104 has a central opening 141 surrounded by three petals 142 that are sized such that they can enclose the central opening 141 in the same plane of the end 122. When the device is removed from the mold, the petals 142 can be erected as shown and can be closed to complete the end 122 for use as a later molding step.

Figures 26 through 28 also show the modification of the brake device 126. A barrier is also formed between the conveying recess 124 and the locking recess 125, but the acute angle shown in Fig. 21 has become smooth, so that the path of the needle is relaxed. The position (first and third positions) of the needle in the conveying recess is also displayed. The locking recess 125 is modified to have an extension 145 that faces the delivery 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, it returns via the gate device 126, which is more difficult, if not impossible.

28 and 29 also show the connection of the device 100 and the hub 101. Figure 29 shows the formation of the grooves 133. In Figure 29, there is a relatively small distance between adjacent ends of the groove 134, but the radial depth of the groove increases. Figures 26 through 28 also show the modification of each protrusion 113. The protrusion 113 has a large annular extension and a large radial depth. The separation distance between the adjacent ends of the groove portion 134 and the annular extension of the projection 113 is selected to ensure that the device 100 can be rotated a sufficient distance to avoid obstruction when filling the syringe. The rotation should be at least 90° and obviously less than 180°. The value is preferably about 115°, but can be any value in the range, such as 100°, 110°, 120°, 130°. This modification provides a safer attachment. In particular, when the hub 101 is attached to the syringe through the Luer lock connection, it is ensured that the connection will remain safe. Except for this, the construction and operation of the embodiment of Figs. 26 to 29 are the same as those of Figs.

Figures 30 and 31 show further modifications of the closed portion 117 of the second portion 104. Except for this, the present embodiment is the same as those of Figs. 26 to 29, and corresponding element symbols are used for the corresponding portions. In Figures 30 and 31, the closed portion 117 of the second portion 104 is provided with a reduced width extension 146 rather than a bulbous shape. The extension 145 also has an axial rib 140. Although the enlarged portions of Figures 15 through 29 are easy 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 can be provided to 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. An axial tip can also be provided at the free end 121 if desired. In a further modification (not shown), the shutter device 126 can be modified by changing the contour of the protrusion 127 adjacent the base of the needle to ensure that the needle is not returnable from the locked position.

The above embodiment provides a simple structure of the needling prevention device which is simple to manufacture and use, and ensures safe transportation.

It will be understood that the above embodiments describe not only the first four aspects of the present invention, but also the fifth and sixth aspects of the present invention, namely the combination of the needling prevention device and the needle-carrying element, wherein the needle-bearing member has a conical shape. Or a cylindrical outer surface portion for engaging the inner surface portion of the needling preventing device, wherein the needling preventing device and the needle supporting member are protrusions on one of the needling preventing device and the needle supporting member, and are joined to The needling device and the other of the needle-clamping elements are attached to the groove, and the needle-neetting preventing device and the needle-carrying element are relatively rotatable, but the separation of the device and the needle-carrying element is prevented, or at least one surface is enlarged. The coefficient of friction to prevent axial separation of the device and the needle member. The increased coefficient of friction can be provided by one or both of the device and the needle member as described above.

1‧‧‧ device
2‧‧‧ hub
3‧‧‧Part 1
4‧‧‧Part II
5‧‧‧ Hinges
6‧‧‧Fixed means
7‧‧‧ strips
8‧‧‧Rectangular outline
9‧‧‧ Ring
10‧‧‧ side
11‧‧‧ side
12‧‧‧flat surface
13‧‧‧Free end
14‧‧‧ side
15‧‧‧ recesses or slots
16‧‧‧Central Amplification
17‧‧‧Drop reduction
18‧‧‧Free end
19‧‧‧Slit
20‧‧‧ ribs
21‧‧‧ Ridge
22‧‧‧ditch
23‧‧‧Outstandings
25‧‧‧Rectangular outline
26‧‧‧ cover elements
27‧‧‧ side
28‧‧‧ side
29‧‧‧Opening
30‧‧‧Edge section
31‧‧‧掣子
32‧‧‧掣子
35‧‧‧Lip
36‧‧‧flat surface
37‧‧‧Assisted locking mechanism
38‧‧ ‧Tongue
39‧‧‧ side wall
40‧‧‧ hollow conical components
41‧‧‧ 耳耳
42‧‧‧Overhang
43‧‧‧ needle
44‧‧‧ ribs
45‧‧‧Bevel
46‧‧‧ outer cone
48‧‧‧ shallow annular ridge
50‧‧‧ thread
51‧‧‧ internal thread ring
52‧‧‧Syringe
100‧‧‧ device
101‧‧‧ hub
102‧‧‧Syringe
103‧‧‧Part 1
104‧‧‧Part II
106‧‧‧Cylinder
107‧‧‧Free end
108‧‧‧
109‧‧‧arms
110‧‧‧ peripheral end
111‧‧‧Hinged spring
112‧‧‧ ribs
113‧‧‧ Outstandings
114‧‧‧Abutment
115‧‧‧One place
116‧‧‧ open side
117‧‧‧closed section
118‧‧‧arms
120‧‧‧Histor
121‧‧‧Free end
122‧‧‧
123‧‧‧ funnel
124‧‧‧Transport recess
125‧‧‧Lock recess
126‧‧‧ gate device
127‧‧ ‧ protrusions
128‧‧‧Bend or labyrinth path
129‧‧‧Small diameter section
130‧‧ needle
131‧‧‧Drilling
132‧‧‧Front
133‧‧‧ditch
134‧‧‧Arc, groove, groove
140‧‧‧ ribs
141‧‧‧Central opening
142‧‧‧ petals
145‧‧‧Extension
146‧‧‧Extension

Figure 1 is a side view of a needling device according to the present invention; Figure 2 is similar to Figure 1, but the display device is in an open configuration; Figure 3 is similar to Figure 2, but the display device is in a locked position; Figure 4 is the device of Figure 2. 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 the display device is attached to a hub for use with an injection needle; Figure 8 is similar to Figure 7, Figure 9 is a perspective view of the device of Figure 7; Figure 11 is a plan view of the device of Figure 7; Figure 11 is a perspective view of the device of Figure 7; Figure 13 is a side elevational view of the device of Figure 7 in a locked position; Figure 14 is a perspective view of the device of Figure 7 in a locked position; Figure 15 is a perspective view of a further needling device in accordance with the present invention; Figure 17 is a cross-sectional view of Figure 17 taken along line 18-18; Figure 19 is a cross-sectional view of Figure 16 taken along line 19-19; Figure 20 is a cross-sectional view of Figure 17; Figure 21 is a cross-sectional view of Figure 16 taken along line 21-21; Figure 22 is a cross-sectional view of Figure 16 Figure 23 is a perspective view of the device of Figure 15 mounted on the syringe barrel; Figure 24 is a perspective view of the device on the syringe barrel; Figure 25 is similar to Figure 24, but the display device Figure 26 is a view similar to Figure 15 but showing further modifications; Figure 27 is an end view of the device of Figure 26; Figure 28 is a cross-sectional view through the needle hub and the device of Figure 26 showing the connection therebetween 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.

1‧‧‧ device

3‧‧‧Part 1

4‧‧‧Part II

5‧‧‧ Hinges

6‧‧‧Fixed means

7‧‧‧ strips

8‧‧‧Rectangular outline

9‧‧‧ Ring

12‧‧‧flat surface

13‧‧‧Free end

16‧‧‧Central Amplification

17‧‧‧Drop reduction

18‧‧‧Free end

25‧‧‧Rectangular outline

26‧‧‧ cover elements

35‧‧‧Lip

38‧‧ ‧Tongue

Claims (37)

A needle stick preventing device is an injection needle for a needle member of a syringe, wherein the device is formed as an integral mold and includes a first portion adapted to be attached thereto a needle carrying member, and a second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the device being adapted to assume a first position, Is used to transport the device before use to protect the needle therein, a second position for filling the syringe and injecting the needle to expose the needle, a third position is filling the syringe but at The needle is protected therein prior to injection, and a fourth position is in which the needle is locked during subsequent injection of the device. The needling prevention device of claim 1, wherein the first and second portions are capable of taking three stable positions to define four positions of the device. The needling device of claim 1 or 2, wherein the cover has a delivery recess and a locking recess, the two being connected by a gate device at least at the base of the needle, configured to be in the third position The needle is located in the delivery recess and is movable into the second position, and in the fourth position, the needle is moved into the locking recess via the gate device, and the gate device is prevented from being removed from the fourth position. A needling prevention device according to any of the preceding claims, wherein the first and second portions of the device are connected by a living hinge provided in the first and second positions once the user moves to move And moving the force of the second portion between the second and third positions. The needling device of claim 4, wherein the hinge also holds the second portion in the first and third positions. A needling prevention device according to any one of claims 3 to 5, wherein the first and third positions are the same such that the second portion is initially located in the delivery recess. The needling device of any one of claims 3 to 6, wherein the gate device is for substantially the entire length of the needle. The needling device of any one of claims 3 to 7, wherein the gate device comprises a protrusion formed in the second portion for defining a boundary between the conveying recess and a locking recess, And a curved or labyrinth path connecting the conveying recess and the locking recess. A needling prevention device according to claim 8, wherein the needle is held in the third position in the conveying recess by the protrusion, but when the manual force is applied, it enters the locking along the labyrinth path The fourth position of the recess. The needling device of any one of claims 3 to 9, wherein the second portion has an extension portion that is drawn from the delivery recess and faces away from the locking recess to allow the needle to be located Cover the first and third positions. The needling device of claim 10, wherein the extension is a funnel to guide the needle into the delivery recess. A needling prevention device according to any one of the preceding claims, wherein the second portion is shaped so that the user grasps and moves between the first and second, and the second and third positions. And applying a manpower to move the second portion into the locked position. A needling prevention device according to claim 12, wherein the second portion has an enlarged portion located on an opposite side of the conveying recess. A needling preventing device according to claim 12, wherein the second portion has an extended portion having a reduced width, which is located on an opposite side of the conveying recess. A needling prevention device according to claim 13 or 14, wherein the amplifying portion or the extending portion is formed with a plurality of axially extending outer ribs. A needling prevention device according to claim 12, wherein a handful of cardboard is provided in the second portion. The needling device of claim 1 or 2, wherein the first and second portions of the device are connected by a living hinge and a fixing means. The needling device of claim 17, wherein in the first position, the needle is received in the second portion, and the fixing means is engaged to maintain a relative position of the first and second portions, In the second position, the securing means is removed and the second portion is pivoted away from the first portion with the aid of the hinge to expose the needle, and in the third, transport position, the second portion is moved into the The third position is maintained there by the securing means to shield the needle, and in the fourth position the securing means engages a position in which a permanent locking configuration is activated. The needling device of claim 17 or 18, wherein the fixing means comprises a pair of detents on one of the first and second portions, each tweezers being adapted to be in the third and fourth positions A recess is joined to the other portion, respectively. The needling device of claim 17 or 18, wherein the fixing means comprises a matching pin and hole arrangement having a pin provided in one of the first and second portions, and provided in A hole in the other portion, wherein the pin is engaged in the fourth position. A needling prevention device according to any one of claims 17 to 20, wherein the second portion includes an auxiliary locking mechanism for the needle in the locked position and includes at least one pair of opposing hooks, the configuration The needles can pass through them in one direction, but they cannot be returned. A needling prevention device according to any of the preceding claims, wherein the device is initially adhered by a strip extending along an open face of the second portion. A needle stick preventing device is an injection needle for a needle member of a syringe, wherein the device is formed as an integral mold and includes a first portion adapted to be attached thereto a needle carrying member, and a second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the device being adapted to assume at least one open position, Is used to fill the syringe and the injection to expose the needle therein, and a locking position in which the needle is locked during subsequent injection of the device, the cover having at least a base at the base of the needle, leading to A locking recess configured to move the needle into the locking recess via the gate device in the locked position, and the gate device prevents the needle from moving out of the locked position. A needling prevention device according to claim 23, wherein the gate device is for the entire length of the needle. The needling device of claim 23 or 24, wherein the brake device includes a protrusion formed in the second portion to define a curved or labyrinth path to the locking recess. A needle stick preventing device is an injection needle for a needle member of a syringe, wherein the device is formed as an integral mold and includes a first portion adapted to be attached thereto a needle carrying member, and a second portion that provides a cover for the needle and is pivotally movable relative to the first portion to expose the needle for use, the first portion being attached by attachment means The needle unit provides that the needling device is rotatable relative to the needle member at an angle of at least 90° and less than 180° in each direction, but prevents the device from falling out. The needling device of claim 26, wherein the attachment means comprises a protrusion located in one of the needle member and the needling prevention device, and a groove in the other. A needling preventing device according to claim 27, wherein the protrusion is provided to the needling preventing means, and the groove is provided to the needle carrying member. A needling prevention device according to any one of claims 27 to 28, wherein the groove extends around two separate arcs of the circumference of the needle member, the adjacent ends of the arc portions being separated into any The required distance, and the needling prevention device is formed with a pair of diametrically opposed protrusions, and each protrusion is accommodated in each arc of the groove. A needling prevention device according to any one of claims 26 to 29, wherein the needling prevention device is rotated by an angle of about 110 with respect to the needle member. The needling device of any one of claims 26 to 30, wherein the engagement between the first portion and the needle member is configured to be rotatable when a moment is manually applied, and when the moment disappears The first portion and the needle member are maintained in their relative positions. The needling device of claim 31, wherein the engagement is a frictional engagement between the first portion and the needle member. A needle stick preventing device and a combination of a needle member, wherein the needle member has a cylindrical or conical outer surface portion for engaging an inner surface portion of the needling preventing device, and the needle punching The preventing device and the needle-loading element are a protrusion on one of the needling preventing device and the needle-carrying element, and are attached to a groove of the other of the needling preventing device and the needle-carrying element, and are attached to each other. The needling device and the needle-carrying member are relatively rotatable, but the separation of the needle-neetting preventing device and the needle-carrying member is prevented. The combination of claim 33, wherein the protrusion is provided to the needling prevention device, and the groove is provided to the needle-carrying member. The combination of claim 33 or 34, wherein the protrusion is configured to have an inclined surface such that the needling device is assembled to the needle member, and an abutment surface that engages the groove to block the Separation of the device and the stylus element. A needling prevention device is used for the combination as described in claim 33. A needle-carrying element for use in combination as claimed in claim 33.