Safety device for a needle and safety needle system comprising a safety device

Abstract

The invention relates to a safety device (1000) for a needle having a housing (200) with a passage (201) having a proximal opening (210) and a distal opening (212) for a shaft of a needle (100) to pass through, wherein the housing (200) is configured to slide over the shaft of the needle (100) such that the needle (100) is movable relative to the housing (200) between a first needle position, in which a needle tip (101) protrudes from the distal opening of the housing (200), and a second needle position, in which the needle tip (101) is located within the passage (201); and having a closing device configured to close the distal opening of the housing (200) when the needle tip (101) is in the second needle position, wherein the closing device comprises a protective flap (8), wherein the protective flap (8) closes the distal opening when the protective flap (8) is in a first protective flap position, wherein the closing device comprises a securing element, wherein the securing element is configured to block a movement or a deformation of the protective flap (8) out of the first protective flap position towards an inner side of the passage (201). The invention further relates to a safety needle system comprising a needle (100) and the safety device (1000), and to a method of manufacturing the safety device (1000).

Description

Technical Field

[0001] The present invention relates to a safety device for a needle and a safety needle system including a needle and a safety device, and to a method of manufacturing the safety device. Background Technology

[0002] Needles are used in medicine to inject and / or extract fluids from a patient's body, as well as to suture muscles, fascia, and other materials. Needles have sharp tips and pose a significant risk of injury to healthcare professionals, especially when they become contaminated with blood after use.

[0003] US2013 / 0172825A1 discloses a safety needle system including a needle with a safety device. The needle has a distal end, a proximal end, and a bar extending between the distal and proximal ends, and a needle tip at the distal end of the needle. The safety device is configured to slide on the bar of the needle between a first position in a proximal region of the bar and a second position at the distal end of the bar. The safety device has a channel having a proximal opening and a distal opening for the needle bar to pass through, wherein, when the safety device is in the second position, the needle tip is inside the channel. The safety device includes a closing device that closes the distal opening of the recess when the needle tip is inside the channel. Summary of the Invention

[0004] The object of this invention is to provide a safety device for needles and a safety needle system including such a safety device, which is cost-effective in production and allows for reliable protection against injury to the needle tip. Another object of this invention is to provide a method for manufacturing the safety device.

[0005] This objective is achieved by a safety device, a safety needle system, and a method for manufacturing the safety device, having the features of claims 1, 9, and 11. Preferred embodiments are defined in the dependent claims.

[0006] According to a first aspect, a safety device for protecting against injury from a needle tip is provided, the safety device comprising a housing and a closing device, the housing having a channel having a proximal opening and a distal opening for a needle shaft to pass through therethrough, wherein the housing is configured to slide on the needle shaft such that the needle can move relative to the housing between a first needle position and a second needle position, wherein in the first needle position the needle tip protrudes from the distal opening of the housing, and in the second needle position the needle tip is located inside the channel, wherein the closing device is configured to close the distal opening of the housing when the needle tip is in the second needle position, wherein the closing device includes a protective flap, wherein when the protective flap is in a first protective flap position, the protective flap closes the distal opening, wherein the closing device further includes a retaining element configured to prevent movement or deformation of the protective flap away from the first protective flap position toward the inside of the channel.

[0007] Throughout this specification and claims, the indefinite articles “a” or “an” mean “one or more”. Reference to “first element” does not imply the existence of a “second element.” Furthermore, the expressions “first” and “second” are used only to distinguish one element from another and do not indicate any order of elements.

[0008] In the first needle position, the needle tip protrudes from the safety device, and the needle is usable, for example, by inserting it into the patient's body. When the needle is removed, the safety device moves relative to the needle toward the needle tip. When the needle reaches the second needle position, the protective flap moves into the first protective flap position and closes the distal opening of the housing. Thus, the housing is sealed, and any injury to healthcare personnel due to a contaminated needle tip is prevented.

[0009] According to the present invention, a retaining element is provided, wherein the retaining element prevents unintentional movement or deformation of the protective flap toward the inside of the channel, which may result in exposure of the needle tip.

[0010] In one embodiment, the protective flap is elastically bendable and compelled by its restoring force into or toward a first protective flap position, wherein, when the protective flap is not obstructed by a fastening element, the protective flap is elastically bendable against its restoring force into a second protective flap position, in which the protective flap protrudes into the channel. In other words, the restoring force acts on the protective flap to hold it in the first protective flap position, in which the protective flap closes the distal opening of the channel. In one embodiment, when in the first needle position, the needle loads the protective flap to hold it in the second protective flap position against the restoring force of the protective flap. When the housing is moved relative to the needle, the protective flap is released and moves into or toward the first protective flap position by its restoring force. In one embodiment, when unloaded, the protective flap presents the first protective flap position. In other words, in the embodiment of the protective flap, the first protective flap position is its neutral position.

[0011] In one embodiment, the safety element is a safety latch located on the side wall of the channel, which is, for example, tapered to allow the protective flap to move unidirectionally from a second protective flap position inside the channel to a first protective flap position, and to block movement in the opposite direction.

[0012] In another embodiment, the fixing element is a flexible and / or rotatable fixing flap with a free end extending into the movement path of the protective flap between a first protective flap position and a second protective flap position, wherein the protective flap and the fixing flap are configured to interact to allow unidirectional movement of the protective flap from the second protective flap position toward the first protective flap position. The rotatable or flexible fixing flap allows for unidirectional movement using only the restoring force of the protective flap and blocks movement in the opposite direction.

[0013] In one embodiment, the fixed flap is elastically bendable, wherein the fixed flap in a stable position is arranged in a first fixed flap position, in which the fixed flap prevents the protective flap from moving away from the first protective flap position toward a second protective flap position, and wherein the fixed flap is elastically bendable against its restoring force into the second fixed flap position, thereby allowing the protective flap to move from the second protective flap position toward the first protective flap position.

[0014] In one embodiment, the retaining flap extends into the movement path of the protective flap between a first protective flap position and a second protective flap position, wherein, when the protective flap is moved from the second protective flap position toward the first protective flap position, the protective flap acts on the retaining flap and forces the retaining flap to bend against its restoring force into the second retaining flap position. The protective flap and the retaining flap are formed and arranged such that when the protective flap moves toward the first protective flap position due to its restoring force, the free end of the protective flap acts on the retaining flap. Once the free end of the protective flap has been moved beyond the free end of the retaining flap, the protective flap no longer loads the retaining flap, and the retaining flap returns to the first retaining flap position.

[0015] In one embodiment, a protrusion is provided on the sidewall of the housing opposite the retaining flap. This protrusion is configured to force the retaining flap into a first retaining flap position during assembly of the housing and the closing device. Specifically, the retaining flap is provided with a beveled flap configured to ensure that the retaining flap slides on the protrusion during assembly. In this embodiment, the protrusion is a ramp protrusion, especially if the beveled flap is not provided to the retaining flap. During the introduction of the safety device into the housing, the ramp on the ramp protrusion facilitates sliding of the corresponding edge of the beveled flap or the retaining flap on the protrusion.

[0016] In the first fixed-fitting flap position where the ramp protrusion forces the fixed-fitting flap into place, the fixed-fitting flap extends from the sidewall at an acute angle. Therefore, the fixed-fitting flap has low bending stiffness to resist the force acting on it that forces the fixed-fitting flap toward the sidewall, and high bending stiffness to resist the force acting in the axial direction of the channel.

[0017] Before the closure device and housing are assembled, the retaining flaps do not move to the first retaining flap position, but are arranged in a position that does not impede the movement of the protective flaps. This allows the introduction of the pin and / or the hollow cylinder for subsequent pin introduction.

[0018] In one embodiment, the abutment portion is disposed at the distal opening, wherein the protective flap in the first protective flap position abuts against the abutment portion. The abutment portion reliably prevents the protective flap from moving beyond the distal opening. Therefore, the protective flap in the first protective flap position is clamped between the abutment portion and the fixing element (particularly the fixing flap).

[0019] In one embodiment, the closing device is a one-piece structure formed from a metal sheet. This allows for manufacturing with low costs. Furthermore, such a structure can be mounted onto a housing formed as a single plastic component, further reducing manufacturing costs.

[0020] According to a second aspect, a safety pin system is provided, comprising a pin and a safety device having a housing and a closing mechanism. The pin is housed in the safety device such that it is movable relative to the housing of the safety device between a first pin position and a second pin position. In the first pin position, the pin tip protrudes from a distal opening in the housing, and in the second pin position, the pin tip is located inside a channel. Prior to use of the safety pin system, the pin, inserted into the channel, extends between the proximal and distal ends of the channel, forcing a protective flap away from a first protective flap position. A portion of the pin held inside the channel in the second pin position and the protective flap of the closing mechanism are adapted to each other such that when the pin moves relative to the housing into the second pin position, the protective flap is released and moves into the first protective flap position.

[0021] In embodiments of the invention, the needle is deformed to provide a stop that prevents the needle from being withdrawn from the safety device. In particular, in one embodiment, the needle is pressed in two opposite radial directions, resulting in radial expansion in a direction orthogonal to it.

[0022] According to a third aspect, a method for manufacturing a safety device is provided, wherein a closing device is formed by bending a metal sheet into a U-shape at three bending lines. The U-shape has a central portion, a first sidewall and a second sidewall extending orthogonally from the central portion, and a first base segment extending parallel to the central portion at the distal end of the first sidewall. Prior to bending, a protective flap cutout is cut from the metal sheet at the first sidewall, the protective flap cutout defining a protective flap extending in the extension of the first base segment after bending. In an embodiment, the protective flap cutout is U-shaped. The protective flap in the embodiment is designed to have a length equal to or slightly shorter than the length of the central portion, such that the protective flap closes the opening of the U-shape opposite the central portion after bending.

[0023] Furthermore, in embodiments of the invention, the closing device includes a retaining flap, wherein a retaining flap slit is cut from a metal plate at a second sidewall, the retaining flap slit defining the retaining flap, which has an axis at a bend between a central portion and the second sidewall. In the embodiments, the retaining flap is designed to extend along the entire length of the second sidewall. Before the metal plate is inserted into the housing, the retaining flap is arranged flush with the second sidewall and does not obstruct the installation of the pin in the safety device. The pin forces the protective flap into a second protective flap position. When the closing device is inserted into the housing, the retaining flap is forced into a first retaining flap position by a protrusion provided on the sidewall of the housing opposite the retaining flap.

[0024] In one embodiment, the fixed flap is provided with a beveled flap notch to form a beveled flap having a free end pointing toward the axis of the fixed flap. When the safety device is manufactured, the beveled flap is inelasticly bent toward the inside of the U-shape, such that the free end points toward the opposing first sidewall. As described above, the fixed flap interacts with a protrusion (particularly a ramp protrusion) located on the sidewall of the housing opposite the fixed flap, which forces the fixed flap into the first fixed flap position during assembly. The beveled flap acts as a running ramp, ensuring that the fixed flap slides on the protrusion.

[0025] In one embodiment, the metal sheet is bent at four bend lines, wherein a second base segment is provided extending parallel to the central portion at the distal end of the second sidewall, wherein an abutment portion cut is made from the metal sheet at the second sidewall, the abutment portion defining the abutment portion extending in the extension of the second base segment after bending. In such an embodiment, the second base segment is provided before the first base segment is provided.

[0026] The cuts in the embodiment are formed by laser cutting. The cuts are formed before bending, thereby allowing for a cost-effective manufacturing method of the closure device, which is inserted into the housing after being bent at four bend lines. Attached Figure Description

[0027] In the following description, embodiments of the invention will be illustrated in detail with reference to the accompanying drawings. Throughout the drawings, the same elements will be indicated by the same reference numerals.

[0028] Figure 1 The safety system, including the safety device and the needle, is shown in cross-sectional view;

[0029] Figure 2 A cross-sectional view is shown. Figure 1 The housing of the safety device;

[0030] Figure 3 A cross-sectional view is shown. Figure 1 The needle and the safety device's closing mechanism, wherein the needle is in the first needle position;

[0031] Figure 3A Perpendicular to Figure 3 The cross-sectional view shows the details of the needle;

[0032] Figure 4 It shows the process of forming before bending. Figure 1 Metal plate of the closing device of the safety device;

[0033] Figure 5 shows the method used for... Figure 4 The metal sheet shown is formed Figure 4 Manufacturing steps of the closing device;

[0034] Figure 6 Details of the closing device and housing during assembly are shown;

[0035] Figure 7 This illustrates the introduction of a hollow cylinder into the closing device during the assembly of the safety system;

[0036] Figure 8 The safety device incorporating a hollow needle is shown.

[0037] Figure 9 The cross-sectional view shows the scene shortly after the needle is moved to the second needle position. Figure 1 The needle and the closing device of the safety device;

[0038] Figure 9A Perpendicular to Figure 9 The cross-sectional view shows the details of the needle;

[0039] Figure 10 This illustrates a process similar to the movement of the protective flap of the closing device to the first protective flap position. Figure 9 The needle and the closing device of the safety device; and

[0040] Figure 11 This shows a similar effect after the protective flap moves to the first protective flap position. Figure 10 The needle and the safety device closing device, wherein the protective flap is fixed by a fixed flap. Detailed Implementation

[0041] Figure 1 A safety system 1000 is shown, comprising a needle 100 for insertion into a patient's body and a safety device. The safety device is configured to protect the needle 100 from injury at its tip 101 during or after it is withdrawn from the patient's body. The device includes a housing 200 and a closing device housed within the housing 200.

[0042] The housing 200 has a channel 201 having a proximal opening 210 and a distal opening 212 for the shank of the needle 100 to pass through. The needle 100 is capable of... Figure 1 The first needle position and the second needle position shown (see Figure 5) are movable relative to the housing 200. In the first needle position, the needle tip 101 protrudes from the distal opening 212, and in the second needle position, the needle tip 101 is located inside the housing 200.

[0043] The closing device is housed in channel 201. This device includes a resiliently bendable protective flap 8, wherein in an unloaded or neutral position (referred to as the first protective flap position), the protective flap 8 closes the distal opening 212. The protective flap 8 bends against its restoring force to... Figure 1The second protective flap position is shown, where the needle 100 holds the protective flap in the second protective flap position. When the needle is withdrawn, the restoring force causes the protective flap 8 to move back to the first protective flap position, as indicated by... Figure 1 As indicated by the arrow in the image.

[0044] Figure 1 The closing device shown also includes a retaining flap 10 and an abutment portion 14, wherein, as will be explained in more detail below, after the needle 100 moves to the second needle position, the protective flap 8 can be clamped between the retaining flap 10 and the abutment portion 14, thereby blocking the movement of the protective flap 8 into or away from the channel 201 to the outside.

[0045] The closing device also includes a sloping flap 12, the function of which will be explained in more detail below.

[0046] Figure 2 A housing 200 of an isolated safety device is shown. In one embodiment, the housing 200 is made of plastic. The housing 200 has a channel 201 that connects to a channel 208 disposed in a top wall 205. In the illustrated embodiment, a receiving section 209 is provided in the top wall.

[0047] The channel 201 has left and right sidewalls 202. A ramp protrusion 203 is formed in one of the sidewalls 202. The channel 201 extends from the top wall 205 to the bottom wall 204.

[0048] On both sides of the channel 201, inclined walls 206 protrude from the bottom wall 204, wherein undercuts 207 are formed in the transition area between the bottom wall 204 and the inclined walls 206.

[0049] Reference Figure 3 The closing device to be inserted into the housing 200 is described in more detail in Figure 5.

[0050] In the illustrated embodiment, the closing device is a metal plate 1 formed by laser cutting and bending.

[0051] Figure 3 The metal plate 1 is shown together with the needle 100, with the needle in the first needle position.

[0052] To prevent the needle 100 from being pulled out of the safety device, a stop portion 102 is formed on the needle 100 above the needle tip 101.

[0053] In the illustrated embodiment, the stop portion 102 of the needle 100 is formed by pressing the needle 100 from two opposing sides in the radial direction. Therefore, the diameter of the needle 100 decreases in the pressing direction, and as... Figure 3AThe cross-section of the needle 100, shown in the diagram, increases in a direction orthogonal to the pressing direction, wherein the diameter of the needle through-hole 2 is smaller than the increased diameter of the needle 100. Therefore, the increased diameter forms a stop portion 102, which prevents the needle 100 from being pulled out through the needle through-hole 2 of the metal plate 1 by the safety device.

[0054] Figure 4 The metal sheet 1 is shown before bending. The metal sheet 1 is inelastically bent around two bending lines 21 to form a central portion 3 and two parallel sidewalls 4, 5 extending orthogonally to the central portion 3. A first base portion 6 and a second base portion 7 are provided at the distal ends of the sidewalls 4, 5, which are inelastically bent relative to the sidewalls 4, 5 around bending lines 22, 23 to extend parallel to the central portion 3.

[0055] The pinhole 2 is located in the central part 3.

[0056] like Figure 4 As shown, laser cutting provides protective flap slits 9, 11, 13, and 15 for the protective flap 8, the fixed flap 10, the beveled flap 12, and the abutment portion 14, respectively. Protective flap slit 9 is shaped to form the protective flap 8, which has an axis coinciding with the bend line 22, a free end facing the central portion 3, and a length slightly shorter than the length of the central portion. The fixed flap slit is shaped to form a flap having an axis coinciding with the bend line 21 between the central portion 3 and the second sidewall 5. The fixed flap 10 is formed to extend along the entire length of the sidewall 5. The beveled flap 12 is disposed on the fixed flap 10, wherein the free end of the beveled flap 12 points towards the bend line 21 between the central portion 3 and the second sidewall 5. The abutment portion slit 15 is shaped to form the abutment portion 14 in the extension of the second base portion 7.

[0057] After cutting, the metal plate 1 with cuts 9, 11, 13, and 15 is bent along bending lines 21, 22, and 23 to form a three-dimensional shape of the metal plate 1 used as a closing device.

[0058] The bending process is described in more detail with reference to Figure 5.

[0059] In the first step shown in Figure 5(A), the inclined flap 12 is bent along the inclined flap bending line 20, such that the distal end of the inclined flap 12 of the final product protrudes toward the inside of the metal plate 1 facing the central portion 3.

[0060] In the second step shown in Figure 5(B), the metal plate 1 is inelastically bent along the central portion bending line 21 to form a first sidewall 4 and a second sidewall 5 on both sides of the central portion 3, thereby protruding orthogonally to the central portion.

[0061] In the third step shown in Figure 5(C), the second sidewall 5 is inelastically bent along the second base portion bending line 23 to form the second base portion 7. As a result, since the abutting portion 14 is an extension of the second base portion 7, the abutting portion 14 rotates toward the first sidewall 4 and extends into the inside of the safety sheet 1.

[0062] In the fourth and final bending step shown in Figure 5(D), the first sidewall 4 is bent along the first base portion bending line 22 to form the first base portion 6. Therefore, since the protective flap 8 is an extension of the first base portion 6, the protective flap 8 extends toward the second sidewall 5, and the lower surface of the distal end of the protective flap 8 abuts against the upper side of the abutting portion 14.

[0063] The bent safety sheet 1 is installed to Figure 2 The housing 200 shown.

[0064] When the bent metal plate 1 is installed into the housing 200, the center portion 3 of the safety plate 1 is inserted into the channel 201, and the metal plate 1 is pushed into the channel 201 of the housing 200 from below until the center portion 3 of the metal plate 1 abuts against the top wall 205 and the first base portion 6 and the second base portion 7 of the metal plate 1 abut against the bottom wall 204.

[0065] like Figure 6 As schematically shown, during the insertion of the metal plate 1 into the channel 201 of the housing 200, the fixed flap 10 with the beveled flap 12 abuts against the ramp protrusion 203. The beveled flap 12 facing the ramp protrusion 203 slides on the ramp protrusion 203. Then, as the beveled flap 12 slides on the ramp protrusion 203, the fixed flap 10 bends 21 around the central portion of the second sidewall 5 toward the central axis of the channel 201.

[0066] At the end of the introduction of the metal plate 1 into the channel 201 of the housing 200, the side edges of the first base portion 6 and the second base portion 7 slide along the inclined wall 206 of the housing 200. Therefore, the side walls 4 and 5 can also be elastically rotated into the channel 201. An undercut 27 is formed at the end of the inclined wall 206, and when the first base portion 6 and the second base portion 7 abut against the bottom wall 204, the side edges of the first base portion 6 and the second base portion 7 respectively enter the undercut. Thus, the metal plate 1 is fixed within the housing 200, and the positions of the side walls 4 and 5 are restored.

[0067] As an alternative to the inclined wall 206 and the undercut 207, in one embodiment, the metal plate 1 is fixed to the housing 201 by form-fitting, for example, by thermally or plastically deforming certain portions of the housing.

[0068] In order to introduce the needle 100 into the housing 200, the protective flap 8 of the metal plate 1 is elastically bent from below toward the side wall 4. As in the illustrated embodiment, since the bending is blocked by the fixed flap 10 after the metal plate 1 is inserted into the housing 200, the insertion of the needle 100 must be performed before the metal plate 1 is installed into the channel 201 of the housing 200.

[0069] like Figure 7 and Figure 8 As shown, in one embodiment, before the metal plate 1 is installed into the housing 200, the hollow mounting cylinder 30 is used to bend or push the protective flap 8 toward the second protective flap position, so that the needle 100 can be introduced from above into the central cavity of the mounting cylinder. After the hollow mounting cylinder 30 is introduced into the bent metal plate 1, the metal plate 1 is installed into the housing 200 together with the hollow mounting cylinder 30, as shown. Figure 8 As shown, the needle 100 is introduced. After the needle 100 is introduced into the housing 200, the mounting cylinder can be removed, and then the protective flap 8 rests against the outer wall of the needle 100. Thus, the needle 100 prevents the protective flap 8 from moving rearward to the first protective flap position.

[0070] Reference Figures 9 to 11 A more detailed description of how the safety needle works.

[0071] In order to pull the needle 100 out of the patient's body, the housing 200 is held in place on the patient's skin. Then, the needle 100 is pulled out of the patient's body relative to the housing 200.

[0072] like Figure 9A As shown, the movement of the needle 100 relative to the housing is restricted by a stop portion 102 formed on the needle 100.

[0073] As the needle 100 moves relative to the housing 200, the needle tip 101 passes the free end of the protective flap 8 and releases the protective flap 8.

[0074] After its release, the protective flap 8 moves to the first protective flap position due to its restoring force, i.e., in the illustrated embodiment, it rotates toward a horizontal position in the plane of the figures (i.e., at least substantially parallel to the patient's skin). During this movement, the free end of the protective flap 8 abuts against the fixed flap 10. The restoring force of the fixed flap 10 forces the fixed flap 10 into position. Figure 9The first fixed flap position is shown, in which its free end is away from the sidewall 5 and protrudes into the movement path of the protective flap 8. The restoring force of the protective flap 8 is greater than that of the fixed flap 10. Therefore, when the free end of the protective flap 8 contacts the inner surface of the fixed flap 10, the fixed flap 10 is elastically pushed towards the sidewall 5 of the safety sheet 1. As the fixed flap 10 moves to the sidewall 5, the free end of the protective flap 8 slides along the inner surface of the fixed flap 10 toward the first protective flap position.

[0075] The lengths and rotation axes of the protective flap 8 and the fixed flap 10 are configured such that shortly before reaching the position of the first protective flap, the free end of the protective flap 8 passes through the free end of the fixed flap 10. At this time, as... Figure 10 and Figure 11 As shown, the fixed flap 10 is no longer pushed by the protective flap 8 and returns to its original position, i.e. Figure 1 , Figure 3 and Figure 6 The position of the first fixed connecting flap shown.

[0076] The aforementioned movement of the protective flap 8 and the fixed flap 10 provides the practitioner with clear acoustic and tactile feedback that the safety device is effective and that injury to the needle tip is impossible even before the safety needle is removed from the patient's skin. This offers a significant benefit to the practitioner compared to other safety devices used for needles, in which activation is mostly only visually perceptible after the safety needle has been removed from the patient's skin.

[0077] In the illustrated embodiment, the safety device further includes an abutment portion 14, wherein when the protective flap 8 is in the position as shown... Figure 11 When the first protective flap is in the position shown, the protective flap 10 abuts against the abutting portion 14.

[0078] Therefore, as Figure 11 As shown, when the fixed flap 10 is in the first fixed flap position and the protective flap 8 is in the first protective flap position, the protective flap 8 can neither be pushed into the channel 201 nor pushed outward to protrude from the channel 201, but is fixedly held in the first protective flap position between the fixed flap 10 and the abutment portion 14.

[0079] In an embodiment not shown, an additional undercut is provided at the top wall 205 of the channel 201 in a direction transverse to the longitudinal direction of the safety plate 1. The undercut allows the safety plate 1 to be more securely fixed within the channel 201 of the housing 200 when the needle 100 pushes the retaining flap 8 downward, thus preventing the central portion 3 of the safety plate 1 from separating from the top wall 205 of the channel 201.

[0080] Alternatively or additionally, in another embodiment (not shown), a valve or diaphragm is placed in the receiving section 209 of the housing. This valve or diaphragm prevents blood adhering to the outer surface of the needle from being exposed in areas where a practitioner might come into contact with it. In one embodiment, to further secure the valve or diaphragm within the receiving section 209, the sidewall 210 of the receiving section 209 is sloped such that the receiving section has a truncated conical shape with a smaller diameter on the outer side. In another embodiment, steps are provided in the sidewall for securing the valve or diaphragm.

[0081] In the illustrated embodiment, the housing is a one-piece design, wherein the safety plate 1 is held within the housing 200 using an undercut 207. In an alternative embodiment, a housing with a two-piece design, similar to US2013 / 0172825A1, is provided, in which the safety plate 1 is clamped.

Claims

1. A safety device for protecting against injury from a needle tip, comprising: A housing (200) having a channel (201) having a proximal opening (210) and a distal opening (212) for a rod of a needle (100) to pass through, wherein, The housing (200) is configured to slide on the rod of the needle (100), such that the needle (100) is movable relative to the housing (200) between a first needle position and a second needle position, in which the needle tip (101) protrudes from the distal opening of the housing (200), and in the second needle position, the needle tip (101) is located inside the channel (201), and A closing device is configured to close the distal opening of the housing (200) when the needle tip (101) is in the second needle position, wherein the closing device includes a protective flap (8) and a retaining element, wherein the protective flap (8) closes the distal opening when the protective flap (8) is in the first protective flap position. The protective flap (8) is elastically bendable and forced into or toward the first protective flap position by its restoring force, characterized in that the retaining element is configured to prevent the protective flap (8) from moving or deforming away from the first protective flap position toward the inside of the channel (201). Furthermore, when the protective flap (8) is not blocked by the fixing element (10), the protective flap (8) can elastically bend to the second protective flap position against its restoring force, in which the protective flap (8) protrudes into the channel (201).

2. The safety device according to claim 1, characterized in that, The fixing element is a flexible and / or rotatable fixing flap (10) with a free end extending into the movement path of the protective flap (8) between the first protective flap position and the second protective flap position, wherein the protective flap (8) and the fixing flap (10) are configured to interact to allow the protective flap (8) to move unidirectionally from the second protective flap position toward the first protective flap position.

3. The safety device according to claim 2, characterized in that, The fixed flap (10) is elastically bendable, wherein the fixed flap (10) in a stable position is arranged in a first fixed flap position, in which the fixed flap (10) prevents the protective flap (8) from moving away from the first protective flap position toward the second protective flap position, and wherein the fixed flap (10) is elastically bendable against its restoring force into the second fixed flap position, thereby allowing the protective flap (8) to move from the second protective flap position toward the first protective flap position.

4. The safety device according to claim 3, characterized in that, The fixed flap (10) extends into the movement path of the protective flap (8) between the first protective flap position and the second protective flap position, wherein, when the protective flap moves toward the first protective flap position, the protective flap (8) acts on the fixed flap (10) and forces the fixed flap (10) to move toward the second fixed flap position against the restoring force of the fixed flap (10).

5. The safety device according to claim 4, characterized in that, A protrusion is provided on the sidewall (202) of the housing (200) opposite to the retaining flap (10), the protrusion being configured to force the retaining flap (10) into the first retaining flap position during assembly of the housing (200) and the closing device, wherein, in particular, the retaining flap (10) is provided with a beveled flap (12) configured to ensure that the retaining flap (10) slides on the protrusion during assembly.

6. The safety device according to any one of claims 1 to 5, characterized in that, An abutting portion (14) is provided at the distal opening, wherein the protective flap (8) located at the first protective flap position abuts against the abutting portion (14).

7. The safety device according to any one of claims 1 to 5, characterized in that, The closing device is an integral structure formed from a metal plate (1).

8. The safety device according to claim 5, characterized in that, The protrusion is a slope protrusion (203).

9. A safety needle device comprising a needle (100) and a safety device according to any one of claims 1 to 8.

10. The safety needle device according to claim 9, characterized in that, The needle is deformed to provide a stop that prevents the needle from being pulled out of the safety device.

11. A method for producing a safety device according to any one of claims 1 to 8, wherein, The closing device having the protective flap (8) is formed by bending a metal plate (1) into a U-shape at three bending lines (21, 22, 23), the U-shape having a central portion (2), a first sidewall (4) and a second sidewall (5) extending orthogonally from the central portion (2), and a first base segment (6) extending parallel to the central portion (2) at the distal end of the first sidewall (4), wherein, before bending, a protective flap cutout (9) is cut from the metal plate (1) at the first sidewall (4), the protective flap cutout defining the protective flap (8), the protective flap (8) extending in the extension of the first base segment (6) after bending.

12. The method according to claim 11, characterized in that, A connecting flap cutout (11) is cut from the metal plate (1) at the second sidewall (5), the connecting flap cutout (11) being a connecting flap (10) with an axis defined at the bend line (21) between the central portion (2) and the second sidewall (5).

13. The method according to claim 12, characterized in that, The fixed flap (10) is provided with a beveled flap cutout (13) for forming a beveled flap having a free end pointing to the axis of the fixed flap (10).

14. The method according to any one of claims 11 to 13, characterized in that, The metal plate (1) is bent at four bending lines (21, 22, 23), wherein the second base segment (7) extends parallel to the central portion (2) at the distal end of the second sidewall (5), wherein an abutment portion cut (15) is cut from the metal plate (1) at the second sidewall (5), the abutment portion cut (15) defining an abutment portion (14), the abutment portion (14) extending in the extension of the second base segment (7) after bending.

15. The method according to claim 11, characterized in that, The protective flap slits are formed by laser cutting.

16. The method according to claim 12, characterized in that, The fixed folding plate cut is formed by laser cutting.

17. The method according to claim 13, characterized in that, The beveled fold cut is formed by laser cutting.

18. The method according to claim 14, characterized in that, The cut in the contact area is formed by laser cutting.

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