Improved safety needle assembly and drug delivery device

Abstract

An improved safety needle assembly includes a needle / cannula mounted in a tubular housing. The needle is provided with a patient end and a non-patient end, and the purpose of the utility model is to provide passive acupuncture protection at the non-patient end. A further object is to increase reliability and reduce fatigue on the resilient mechanism prior to use. The sleeve is located in the needle seat, and the needle seat is located in the tubular shell. The concealing sleeve provides a blocking mechanism that maintains alignment of the cannula along the longitudinal axis of the tubular member. In particular, the blocking mechanism is arranged to counteract the pivoting force of the spring or the ability of the sleeve to rotate freely so as to hold the sleeve in the operational position. According to the safety needle assembly, the spring and the needle seat are arranged at set positions, and the safety needle assembly and the medical injector are used to cause displacement from the set positions. This displacement enables the spring to rotate the needle to a hidden position when the safety needle assembly is detached from the medical syringe. The utility model further relates to a corresponding medicine delivery device.

Description

Technical Field

[0001] The utility model relates to a safety needle assembly used with a medical syringe, comprising a drug delivery device of the safety needle assembly and the medical syringe and a method for hiding a non-patient end of a needle in the safety needle assembly. Background Art

[0002] Needlestick injuries from drug delivery devices / safety engineering devices can be prevented by active systems and / or passive systems that provide two different types of safety feature activation methods. In active systems, the user is required to activate the safety mechanism, and these may require one-handed or two-handed activation by a healthcare professional after use. However, in passive systems, the user does not need to intervene, and the safety system is automatically activated, and specifically does not require any action / step from the user. In particular, in passive systems, the safety features are automatically initiated and activated during use of the device.

[0003] The needle safety assembly may include a spring to cause the needle to move from the operating position to the shielding position. The spring is assembled directly into the load position, and a blocking mechanism is arranged to prevent the needle from moving from the operating position to the shielding position until the needle has been used and injection preformed. Therefore, the spring can be kept in the load position for an extended period of time. Such a spring can be formed of an elastic material that is deformed from an unbiased position to provide the required thrust for the needle and the spring is thereby preloaded. Therefore, the material must have the property of ensuring that the spring capacity does not significantly decrease before the assembly is used. In addition, the material of the spring must have such an inherent property that the spring cannot fail in any way while remaining in the deflected position for an extended period of time. Such a property can dictate the cycle in which the assembly must be used, or can limit the thrust that can be initially preloaded.

[0004] In metal springs, the material is able to maintain a preloaded force. However, metal springs cause problems during assembly, which is a significant problem for devices that are assembled during high-speed assembly processes. For example, coiled metal springs can nest and cause other problems during assembly. Springs formed from plastic materials offer advantages because they can be reliably and accurately manufactured, and these springs can also be used in high-speed assembly processes. However, any preload of such elastic materials can gradually decrease over time.

[0005] It is an object of the present invention to overcome at least one of the problems associated with the prior art, whether in this context or otherwise. Utility Model Content

[0006] According to a first aspect of the utility model, there is provided a safety needle assembly for a medical syringe, comprising:

[0007] a tubular housing removably attached to the medical syringe, the tubular housing extending in a longitudinal direction from a proximal end to a distal end, the proximal end being arranged for attachment to the medical syringe;

[0008] a needle hub disposed within the tubular housing for directly or indirectly supporting a double-ended needle having a patient end and a non-patient end, said needle hub being arranged to allow said needle to be moved from an operative position to a concealed position;

[0009] An elastic mechanism, used for causing the needle to move to the hidden position;

[0010] a releasable blocking mechanism arranged to prevent movement of the needle from the operative position in which the needle extends in a direction along the longitudinal axis of the tubular housing and whereby release of the blocking mechanism allows movement of the needle to the concealed position;

[0011] The needle hub is a unitary component inserted into the tubular housing and positioned to rotate about an axis, and the resilient mechanism is arranged to urge the needle to rotate about the axis; and

[0012] the blocking mechanism engages the needle hub to retain the needle in the operative position prior to use, after which the safety needle assembly is attached to the medical syringe, and use thereof causes the blocking mechanism to disengage from the needle hub and allow the resilient mechanism to rotate the needle to the concealed position and move the non-patient end of the needle toward the distal end of the tubular housing where the needle extends at an oblique angle relative to the longitudinal axis of the tubular housing to place the non-patient end of the needle adjacent to the inner wall of the tubular housing;

[0013] Features:

[0014] The elastic mechanism is integral with the mounting member, and

[0015] In the operating position before use, the mounting member and the needle seat are arranged at a set position relative to each other, and thereafter use of the safety needle assembly with a medical syringe causes displacement from the set position; the displacement causes one of the mounting member or the needle seat to move relative to the other, so that the elastic mechanism can rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

[0016] The mounting member may be arranged to move proximally relative to the needle holder so that the displacement preloads the elastic mechanism from the set position to generate a force sufficient to enable the elastic mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe. The mounting member may be arranged to move distally relative to the needle holder so as to cause a displacement from the set position to preload the spring to generate a force sufficient to enable the elastic mechanism to rotate the needle to the hidden position when the safety needle assembly is separated from the medical syringe. The needle holder may be positioned to rotate around an axis intersecting the longitudinal axis of the tubular housing. The mounting member may be arranged to move axially along the longitudinal axis of the tubular housing. The mounting member may include a tubular housing. The mounting member may include an inner sleeve portion slidably mounted in the tubular housing.

[0017] Preferably, in the operating position before use, the elastic mechanism and the needle seat are arranged in a set position, after which use of the safety needle assembly with a medical syringe causes a displacement from the set position; said displacement enables the elastic mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

[0018] The needle hub may be arranged to rotate about an axis intersecting the central longitudinal axis of the tubular housing. The needle hub may be arranged to rotate about an axis intersecting the longitudinal axis of the tubular housing, the axis being offset from the central longitudinal axis of the tubular housing. The longitudinal axis of the tubular housing may be central or center offset.

[0019] Preferably, the element is slidably mounted in the tubular housing for movement between an inactivated position and an activated position;

[0020] including a verification member to audibly verify that the elements of the safety needle assembly are properly attached to the medical syringe;

[0021] The verification member includes a resilient member resiliently flexible between a first configuration and a second configuration; a deflection member for bending the verification member during relative movement of the verification member on the deflection member in a distally extending direction;

[0022] wherein the resilient member projects axially from the element and attaches the safety needle assembly to the medical syringe such that a portion of the medical syringe moves the element distally in the tubular housing, and the movement causes a portion of the resilient member to move on the deflection member from a first configuration to a second configuration and then back to the first configuration; and

[0023] The verification member is arranged to generate an audible signal when the verification member moves from the second configuration back to the first configuration when the element moves to the activated position to verify that the safety needle assembly is correctly attached to the medical syringe.

[0024] Preferably, the needle hub comprises an integral component, an integral mounting element or a mounting element in the form of a shaped surface or an axial member located on the outer surface. The shaped outer surface may provide a spherical surface and may enable the needle hub to be fixed by a ball and socket arrangement and may achieve a click fit (ball and socket) arrangement. The axial member may provide a hemispherical surface and may enable the needle hub to be fixed by a ball and socket arrangement and may achieve a click fit (ball and socket) arrangement.

[0025] Preferably, the resilient means is preloaded from displacement to the set position to ensure movement of the needle to the concealed position when the safety needle assembly is detached from the medical injector.

[0026] Using the safety needle assembly with a medical syringe may include attaching the safety needle assembly to the medical syringe and / or its use and / or detaching the safety needle assembly from the medical syringe.

[0027] Using the safety needle assembly with a medical syringe may cause the resilient mechanism and the needle hub to move relative to each other so that the resilient mechanism can rotate the needle to the hidden position when the safety needle assembly is separated from the medical syringe.

[0028] Preferably, the resilient means is preloaded from displacement to the set position to ensure movement of the needle to the concealed position (when the safety needle assembly is removed from the medical injector).

[0029] Preferably, the displacement from the set position causes the elastic mechanism to generate a force sufficient to cause the needle to move to the hidden position. Preferably, the use of the safety needle assembly with the medical syringe causes a change in position of the elastic mechanism relative to the needle holder. Preferably, the use of the safety needle assembly with the medical syringe causes a change in position of the needle holder relative to the elastic mechanism. Preferably, the use of the safety needle assembly with the medical syringe causes the elastic mechanism and the needle holder to shift apart. Preferably, the use of the safety needle assembly with the medical syringe causes the elastic mechanism and the needle holder to move closer together. Preferably, said elastic mechanism and said needle holder are arranged to move from said set position to an active position.

[0030] Preferably, in the set position, the needle seat is held in the tubular housing with the needle in the operating position. Preferably, in the set position, the elastic mechanism is not fully loaded and may be unloaded. In the set position, the elastic mechanism may be partially loaded or completely unloaded.

[0031] Preferably, in the active position, the needle holder is held in a pivoted position so as to be rotatable about an axis intersecting the longitudinal axis of the tubular housing, and the elastic mechanism is arranged to promote rotation of the needle about said axis.Preferably, in the active position, the elastic mechanism is fully loaded.

[0032] The needle hub may be in a pivoted position, wherein the resilient mechanism and the needle hub are in a set position. The resilient mechanism may be arranged to move from the set position to an active position relative to the needle hub during attachment of the safety needle assembly to the medical syringe. The resilient mechanism may be arranged to move with the control member.

[0033] Before moving to the pivot position, the needle seat can initially (operating position before use) remain in a non-pivoted position. The non-pivoted position can be defined by a first pair of axial members on the tubular housing. The pivot position can be defined by a second pair of axial members on the tubular housing. The needle seat can be arranged to move from a first pair of recesses to a second pair of recesses so as to displace the elastic mechanism and the needle seat from a set position. The needle seat may include axial members located on an outer surface. The axial members may each provide a hemispherical surface. The axial members may be arranged to move from a first pair of recesses to a second pair of recesses.

[0034] The axial member of the needle hub may comprise recesses, and wherein the needle hub may comprise an axial member providing a hemispherical surface on an outer surface, and wherein the axial member of the needle hub may be arranged to move from said first pair of recesses to said second pair of recesses.

[0035] The resilient mechanism may be mounted to the tubular housing. The resilient mechanism may include a leaf spring, which may be in the form of a resilient finger. The leaf spring may protrude inwardly from the inner surface of the tubular housing. The leaf spring may protrude inwardly perpendicularly relative to the inner surface of the tubular housing. The leaf spring may protrude inwardly at an acute angle relative to the inner surface of the tubular housing. The leaf spring may protrude inwardly at an acute angle relative to the longitudinal inner axis of the tubular housing in a distal or proximal direction. The leaf spring may have a curved or arcuate or straight form. The leaf spring may have curved and / or arcuate and / or straight portions.

[0036] Movement of the tubular housing relative to the needle hub may displace the resilient mechanism and the needle hub from a set position and may preload the resilient mechanism.

[0037] The tubular housing can be moved proximally (relative to the needle seat) to displace the elastic mechanism and the needle seat from a set position. The tubular housing can be moved toward the medical syringe to displace the elastic mechanism and the needle seat from a set position. The tubular housing can be moved distally (relative to the needle seat) to displace the elastic mechanism and the needle seat from a set position.

[0038] The elastic mechanism may be integral with the mounting member, comprising: an inner sleeve portion and / or (part of) a tubular housing and the combination of the elastic mechanism (leaf spring) and the mounting member may comprise an integral component. Movement of the mounting member relative to the needle seat may displace the elastic mechanism and the needle seat from a set position. The mounting member may be moved proximally (relative to the needle seat) so as to displace the elastic mechanism and the needle seat from a set position. The mounting member may be moved distally (relative to the needle seat) so as to displace the elastic mechanism and the needle seat from a set position.

[0039] The blocking mechanism may include a control member slidably displaceable along the longitudinal axis of the tubular housing from a set position. The control member may be slidably displaceable along the longitudinal axis of the tubular housing from a set position in which the control member engages the needle hub to hold the needle in the operative position. The control member may be arranged to move away from the set position to disengage the needle hub.

[0040] The blocking mechanism may include a portion of the elastic mechanism that engages with the needle seat to prevent rotation / pivoting movement of the needle seat in the set position, and preferably, the spring is in an unloaded position. The end of the elastic mechanism (leaf spring) may be positioned in a recess defined on the outer surface of the needle seat. The non-pivoting position may be defined by a first pair of axial members on the tubular housing, and the recess may be positioned in the same plane as the first pair of axial members. The depth of the recess and / or the length of the elastic finger (elastic mechanism) may cause the elastic mechanism to be partially loaded in the set position. The depth of the recess and / or the (relative) length of the elastic finger (elastic mechanism) may cause the elastic mechanism to be completely unloaded in the set position.

[0041] The releasable blocking mechanism may be arranged to prevent rotational / pivotal movement of the needle from the operative position in which the needle extends in a direction along the longitudinal axis of the tubular housing and thereby release of the blocking mechanism allows rotational / pivotal movement of the needle to the concealed position.

[0042] The elastic mechanism may comprise a leaf spring. The elastic mechanism may comprise a plastic material. The elastic mechanism may comprise a non-metallic material.

[0043] The end of the leaf spring may contact the outer surface of the needle seat. Preferably, the end of the leaf spring is arranged to move along the outer surface of the needle seat when the elastic mechanism and the needle seat are displaced from the set position.

[0044] The needle hub may include a flange on the outer surface. The flange may be arranged to contact the elastic mechanism so as to transmit the spring force to the needle hub.

[0045] The leaf spring may initially be spaced apart from the flange. The leaf spring may be moved into contact with a flange defined on the needle hub so as to displace the elastic mechanism and the needle hub from a set position and preferably to an active position and to move the spring to a loaded position. The leaf spring may be moved into contact with a proximal surface of the flange so as to displace the elastic mechanism and the needle hub from a set position and preferably to an active position and to move the spring to a loaded position. The leaf spring may be moved into contact with a distal surface of the flange so as to displace the elastic mechanism and the needle hub from a set position and preferably to an active position and to move the spring to a loaded position.

[0046] Preferably, the rotational axis is statically fixed relative to the tubular housing and the non-patient end moves from the operative position to the stowed position in a circumferential path about the rotational axis.

[0047] The axis of rotation may be radial relative to the longitudinal axis of the tubular housing. The axis of rotation may be perpendicular relative to the longitudinal axis of the tubular housing. The axis of rotation may be at an oblique angle relative to the longitudinal axis of the tubular housing. The axis of rotation may extend across the inner diameter of the tubular housing.

[0048] The axis of rotation may extend along a chord through the interior region of the tubular shell.

[0049] Preferably, the needle hub is coaxial with the tubular housing when the needle is in the operative position.

[0050] In the hidden position, the non-patient end of the needle may contact or be adjacent to the inner peripheral wall of the tubular housing.In the hidden position, the elastic mechanism may push the non-patient end of the needle against the inner peripheral wall of the tubular housing.

[0051] Preferably, in the operative position, the resilient mechanism stores energy therein.

[0052] In the operating position, the elastic mechanism may be latched by a latch mechanism. Preferably, the displacement from the set position causes the latch mechanism to latch the elastic mechanism in a preload position to ensure movement of the needle to the hidden position when the safety needle assembly is removed from the medical syringe. Preferably, the latch mechanism latches the elastic mechanism in a loaded position to ensure movement of the needle to the hidden position when the safety needle assembly is removed from the medical syringe. The displacement from the set position to the active position may be permanent, and this may ensure movement of the needle to the hidden position when the safety needle assembly is removed from the medical syringe. Preferably, the latch mechanism maintains and / or holds the elastic mechanism and the needle holder in the active position.

[0053] The resilient mechanism may be mounted (or positioned adjacent) to the inner wall of the tube at a first side / portion, and wherein the non-patient end of the cannula is positioned adjacent to a second side / portion of the inner wall of the tubular housing. The first side / portion may be an opposite side portion disposed on the tubular housing relative to the second side portion. The first side / portion may be offset 180 degrees around the tubular housing relative to the second side / portion. The first side / portion may be longitudinally aligned with the second side / portion.

[0054] The elastic mechanism may contact the needle hub at a position distal to the rotation axis.The elastic mechanism may contact the needle hub at a position proximal to the rotation axis.

[0055] Preferably, the control member includes an engagement hole, and a portion of the needle hub is arranged in the set position to be positioned in the engagement hole to prevent the needle from rotating from the operating position. The control member may include an annular member, and the engagement hole is located in the center of the annular member. The needle hub may include a collar, and the collar is positioned in the hole of the control member in the set position.

[0056] Preferably, the distal end of the needle hub provides an outer surface complementary to the engagement aperture of the control member.

[0057] The control member may comprise an end face having a complementary end face of the hidden sleeve.Preferably, the distal end face of the control member is complementary to the proximal end face of the hidden sleeve.

[0058] Preferably, the elastic mechanism comprises an elastic member extending inwardly from the tubular housing and contacting an outer surface of the needle hub at a position offset from the rotation axis, and preferably applying a rotational force to rotate said needle hub.

[0059] Preferably, the resilient mechanism comprises a leaf spring, the leaf spring protruding inwardly from the tubular housing, and the leaf spring is in a preloaded state and deflectable from a neutral / relaxed position when the needle is in the operating position. Preferably, the leaf spring has energy stored therein when the needle is in the operating position. An end surface of the leaf spring can contact an outer longitudinal surface of the needle hub to generate a torque about the rotation axis.

[0060] Preferably, the needle seat comprises an integral component having an axial member located on the outer surface. The axial member can provide a hemispherical surface, and can enable the needle seat to be fixed by a ball-and-socket arrangement, and can be realized by a click-fit (ball-and-socket) arrangement. The tubular housing may include an axial member located on the inner surface for cooperating with the axial member provided on the needle seat. Preferably, the axial member of the needle seat and the tubular housing can push the needle seat into a pivot position in the axial member of the tubular housing. The axial member of the tubular housing and the needle seat may include a first pair of axial members and a second pair of axial members, the first pair of axial members including a protrusion, and the second pair of axial members including a corresponding recess. The protrusion may include a hemispherical protrusion. The axial member may provide a ball-and-socket joint. Preferably, the axial member provides a first ball-and-socket joint on one side of the needle seat and a second ball-and-socket joint on the opposite side of the needle seat for connecting to a joint of a complementary ball-and-socket joint provided in the tubular housing.

[0061] Preferably, the control member is mounted to move away from the proximal end of the tubular housing (and / or towards the distal end) to disengage the needle hub.The control member may be mounted to move towards the proximal end of the tubular housing (and / or away from the distal end) to disengage the needle hub.

[0062] Preferably, the safety needle assembly comprises a needle hiding sleeve, and wherein the control member may comprise a distal face of the needle hiding sleeve providing an engagement aperture or engagement holes to prevent rotation of the needle from said operative position while said control member is in said set position.

[0063] The control member may include a disc located within a needle hiding sleeve of the safety needle assembly, and wherein the disc is slidably displaceable from the set position in the needle hiding sleeve, and wherein the control member is frictionally engaged in the needle hiding sleeve and maintained in a position adjacent to the distal end of the needle hiding sleeve, and is moved by the tubular housing to the needle hiding sleeve during injection.

[0064] The control member may include a distal face and a skirt extending therefrom, the distal face including a hole for engaging an outer surface of the needle hub in the set position, and the skirt provides a contact surface for contact by a portion of the medical syringe, and the control member is moved from the set position to attach the needle safety assembly to the medical syringe.

[0065] The control member may be mounted to move toward the proximal end of the tubular housing so as to disengage the needle hub. The needle hiding sleeve may surround and hide the patient end of the needle in the non-injection configuration, and wherein the needle hiding sleeve is coaxial with the tubular housing and may be arranged to slidably move longitudinally relative thereto. The needle hiding sleeve may surround and hide the patient end of the needle in the non-injection configuration, and wherein the needle hiding sleeve includes a release device to slidably displace the control member from the set position.

[0066] According to a second aspect of the present utility model, a drug delivery device is provided, which comprises a safety needle assembly and a medical syringe. The safety needle assembly is according to the first aspect of the present utility model.

[0067] Preferably, the medical syringe comprises a rubber seal and the safety needle assembly is attached to the medical syringe such that the non-patient end of the needle pierces and penetrates the rubber seal and wherein the non-patient end holds the needle in an operative position by the position of the rubber seal after the control member has been moved from the set position.

[0068] According to a third aspect of the present invention, a method for hiding the non-patient end of a needle in a safety needle assembly used with a medical syringe is provided, the safety needle assembly being the first aspect of the present invention, wherein the method is characterized in that:

[0069] Using the safety needle assembly with a medical syringe, the mounting member and the needle hub are displaced from a set position, the displacement causing the mounting member to move relative to the needle hub so that the resilient mechanism can rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe, and

[0070] The safety needle assembly is separated from the medical syringe, and the needle is rotated together with the elastic mechanism to the hidden position.

[0071] The method may include moving one of the mounting member or the needle hub relative to the other to enable the resilient mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

[0072] According to another aspect of the utility model, there is provided a safety needle assembly for a medical syringe, comprising:

[0073] a tubular housing removably attached to the medical syringe, the tubular housing extending in a longitudinal direction from a proximal end to a distal end, the proximal end being arranged for attachment to the medical syringe;

[0074] a needle hub, located within the tubular housing, for directly or indirectly supporting a double-ended needle having a patient end and a non-patient end;

[0075] an element slidably mounted in the tubular housing for movement between an inactivated position and an activated position;

[0076] An element including a verification member to audibly verify that the safety needle assembly is properly attached to the medical syringe;

[0077] The verification member includes a resilient member that is resiliently flexible between a first configuration and a second configuration;

[0078] a deflection member for bending the verification member during relative movement of the verification member on the deflection member in a distally extending direction;

[0079] wherein the resilient member projects axially from the element and attaches the safety needle assembly to the medical syringe such that a portion of the medical syringe moves the element distally in the tubular housing, and the movement causes a portion of the resilient member to move on the deflection member from a first configuration to a second configuration and then back to the first configuration; and

[0080] Wherein when the element moves to the activated position to verify that the safety needle assembly is correctly attached to the medical syringe, the verification member is arranged to generate an audible signal when the verification member moves from the second configuration back to the first configuration.

[0081] Preferably, the acoustic signal is generated at a position coinciding with the element reaching the activation position.

[0082] Preferably, the verification member is arranged to generate an audible signal when the verification member moves back from the second configuration to the first configuration when the element reaches the activated position to verify that the safety needle assembly is correctly attached to the medical injector.

[0083] The auditory signal may include a single auditory signal. The single auditory signal may include a click.

[0084] The auditory signal may include a series of auditory signals. The series of auditory signals may include a series of clicks.

[0085] The resilient member may protrude axially from the element in a proximal direction.The resilient member may protrude axially from the element in a distal direction.

[0086] Preferably, the audible signal provides a dual function when providing the audible signal, to verify that the safety needle assembly is correctly attached to the medical syringe (the non-patient end of the cannula is correctly positioned in the medical syringe), and also to verify that the resilient mechanism is preloaded. Preferably, the audible signal provides a dual function when providing the audible signal, to verify that the safety needle assembly is correctly attached to the medical syringe and to verify displacement from the set position to the active position, which may be permanent.

[0087] The element may comprise a disc member. The element may comprise an annular member. The element may comprise a circular member. The element may comprise a sleeve portion or a tubular portion.

[0088] The element may be arranged to move axially along the longitudinal axis of the tubular housing. Preferably, the element is arranged to move distally along the longitudinal axis of the tubular housing. Preferably, the element is arranged to move slidably without any rotational movement.

[0089] Preferably, the element comprises a proximal surface arranged to be in contact with a (distal) part of the medical injector, such that (distal) movement of the medical injector relative to the tubular housing causes a corresponding movement of the element relative to the tubular housing.

[0090] Preferably, the verification member comprises a resilient member, which may include a resilient finger or a resilient skirt. Preferably, the resilient member extends axially in the proximal or distal direction. The verification member may protrude / extend (axially) forwardly / distally from the front surface of the element. The verification member may protrude / extend (axially) backwardly / proximally from the rear surface of the element. The verification member may include a head at its end. The head may provide a shaped surface to cooperate with the surface of the deflection member. The mating surface may allow unidirectional movement of the verification member relative to the deflection member, thereby forming a latching device.

[0091] Preferably, the deflection member is defined on the inner surface of the tubular housing. The deflection member may include a lug or rib protruding inwardly from the inner surface of the tubular member. The deflection member may have a distal surface, which may include an inclined surface. The deflection member may include a proximal surface, which may include an abutment surface. The abutment surface may provide an abutment surface extending directly radially inwardly in a generally vertical direction.

[0092] The auditory signal may include a click.

[0093] Preferably, the verification member latches the element in a latched position relative to the tubular housing. Preferably, in the latched position, the spring pushes the needle from the operating position to the hidden position. Preferably, the attachment of the safety needle assembly to the medical syringe causes the spring to move from the unloaded position to the loaded position. Preferably, the position of the spring moving from the unloaded position to the loaded position coincides with the position of the element latching, and preferably this also coincides with the generation of the audible signal. Thus, the audible signal can warn the user to correctly attach the safety needle assembly to the medical syringe and latch the element in the tubular housing (and the spring is loaded).

[0094] After injection has been performed, the latched position of the element maintains the loaded position of the spring, which continues to push the needle to the hidden position. After the medical syringe is disassembled from the safety needle assembly, the latched position of the element maintains the loaded position of the spring, which continues to push the needle to the hidden position. BRIEF DESCRIPTION OF THE DRAWINGS

[0095] The present invention will now be described by way of example only, with reference to the following drawings, in which:

[0096] Figure 1 It is a schematic diagram of an embodiment of a safety needle assembly and a medical syringe.

[0097] Figure 2 A perspective view of a tubular housing, a needle hub, and a needle of an embodiment of a safety needle assembly.

[0098] Figure 3 A partial view of a first preferred embodiment of a safety needle assembly with the spring and needle hub in a set position.

[0099] Figure 4 A partial cross-sectional view of a first preferred embodiment of a safety needle assembly detached from a medical syringe in a use configuration.

[0100] Figure 5 It is a partial cross-sectional view of a second preferred embodiment of the safety needle assembly, wherein the spring and the needle seat are in the set position.

[0101] Figure 6 It is a partial cross-sectional view of a third preferred embodiment of a safety needle assembly, wherein the spring and the needle seat are in a set position.

[0102] Figure 7 A partial cross-sectional view of a third preferred embodiment of a safety needle assembly connected to a medical syringe ready for an injection.

[0103] Figure 8 A partial cross-sectional view of a third preferred embodiment of a safety needle assembly connected to a medical syringe after injection.

[0104] Fig. 9A partial cross-sectional view of a third preferred embodiment of a safety needle assembly detached from a medical syringe in a use configuration.

[0105] Fig.10 A partial cross-sectional view of a sixth preferred embodiment of a safety needle assembly, wherein the spring and the needle hub are in a set position and include a first embodiment of a pre-activation verification mechanism.

[0106] Fig.11 A partial cross-sectional view of a seventh preferred embodiment of a safety needle assembly, wherein the spring and the needle hub are in a set position and include a second embodiment of a pre-activation verification mechanism.

[0107] Fig.12 A partial cross-sectional view of a seventh preferred embodiment of a safety needle assembly for connection to a medical syringe, including a second embodiment of a pre-activation verification mechanism.

[0108] Fig.13 A partial cross-sectional view of an eighth preferred embodiment of a safety needle assembly separated from a medical syringe, including a third embodiment of a post-activation verification mechanism.

[0109] Fig.14 is a partial cross-sectional view of a ninth preferred embodiment of a safety needle assembly, before the needle hub is connected / incorporated into the tubular housing.

[0110] Fig.15 It is a partial cross-sectional view of a ninth preferred embodiment of a safety needle assembly, wherein the needle hub is connected / integrated into the tubular housing.

[0111] Fig.16 A partial cross-section of the tenth preferred embodiment of the safety needle assembly, wherein the spring and the needle seat are in a set position.

[0112] Fig.17 A cross-section of a portion of a tenth embodiment of a safety needle assembly separated from a medical syringe in a use configuration.

[0113] Fig.18 It is a cross-sectional view of the eleventh embodiment of the safety needle assembly. DETAILED DESCRIPTION

[0114] As shown in the figures and as will be described, the proximal end of the safety needle assembly is attached to the distal end of a medical syringe 11. The distal end of the safety needle assembly 10 will be pressed against the patient's skin during an injection, and the distal end of the medical syringe 11 is positioned away from the patient.

[0115] In this specification, references to use and using the safety needle assembly include attaching the safety needle assembly to a medical syringe and / or injecting a patient and delivering a liquid drug and / or detaching the safety needle assembly from a medical syringe.

[0116] The pen needle 12 is a double ended needle 12 and includes a patient end 14 or a distal end including a sharp tip for insertion into a patient. The double ended needle 12 also includes a non-patient end 15 or a proximal end including a sharp tip for insertion into a vial or cartridge 16 provided by the pen injector 11. The proximal / non-patient end 15 of the needle must typically pierce a rubber seal 18, which may include a septum or stopper disposed on the end of the vial or cartridge 16, to access the liquid drug or medication contained within the cartridge.

[0117] refer to Figure 1 , the safety pen needle assembly 10 and the medical syringe 11 are shown in an exploded view. The safety needle assembly 10 generally includes a hub or tubular housing 20, a needle 12, and a hidden sleeve 30. The tubular housing 20 includes a body 21 extending from a proximal end 24 to a distal end 22 in a longitudinal direction. The proximal end 24 is formed with an open face and is shaped to receive a portion of the syringe 11 to allow the safety needle assembly 10 to be attached to the syringe 11. For the description of the utility model, the term sleeve 12 will now be used to specifically refer to the double-ended needle of the safety needle assembly 10. The sleeve 12 includes a distal end 14 formed for insertion into a patient's body and a proximal end 15 for communicating with a liquid drug located in a reservoir. As shown in the figure, the distal end 14 of the sleeve 12 protrudes distally beyond the distal end 22 of the tubular housing 20. The proximal end 15 of the sleeve 12 can be inside the tubular housing 20 adjacent to the proximal end 24, or can protrude / extend proximally from the proximal end 24. The cannula 12 is mounted within the needle hub 60 and may be secured therein using any known technique, such as being adhesively secured thereto.

[0118] like Figure 1 As shown, the drug delivery device in the form of a medical pen or syringe pen comprises a safety needle assembly 10 which, in use, is arranged to be attached to a medical syringe 11. The medical syringe 11 comprises a barrel 16 containing a medicament / liquid, and in particular, the barrel 16 contains a volume of liquid medicament.

[0119] The present invention provides a safety needle assembly 10 that can be attached to a medical syringe 11. The safety needle assembly 10 provides a cannula 12 through which a liquid medicament is delivered from a barrel 16 to a patient. The cannula 12 includes a double-ended needle having a sharp tip at a patient end (distal end) 14 and also having a sharp tip at a non-patient end (proximal end) 15. However, it should be understood that the terms needle and cannula can be used interchangeably, and the present invention can also be applied to other types of drug delivery devices 8.

[0120] For delivering liquid medicament, the sleeve 12 is held in the operating position. In this operating position, the linear sleeve 12 directly protrudes out of the end of the drug delivery device, and in particular, the sleeve 12 extends along the (central) longitudinal axis 50 of the tubular housing 20. Thus, in this operating position, the sleeve 12 is located in a central coaxial position within the tubular housing 20. This coaxial position enables the sleeve 12 to protrude vertically from the front surface 31 of the needle safety assembly 10.

[0121] The safety assembly 10 provides a front surface 31 having a central window or hole 32 through which the cannula 12 protrudes or can be protruded. The safety needle assembly 10 is provided with an end cap in the form of a hidden sleeve 30, which includes the central window 32. The hidden sleeve 30 or end cap acts as a blocking mechanism in the form of a control member 80 to maintain the position of the cannula 12 and release the cannula 12.

[0122] The control member 80 or the hidden sleeve 30 is mounted on the tubular housing 20. The control member 80 or the hidden sleeve 30 is located on and held on the outer surface 23 of the tubular housing 20. However, the control member 80 or the hidden sleeve 30 is slidably movable relative to the tubular housing 20 in the longitudinal direction.

[0123] The housing 17 of the syringe 11 has a distal end that provides external threads 36 to engage with internal threads provided on the safety needle assembly 10. Specifically, the proximal end 24 of the tubular housing 20 provides internal threads for attaching the safety needle assembly 10 to the housing 17.

[0124] The cannula 12 is fixed in the needle hub 60. The needle hub 60 is arranged to be fixed in the tubular housing 20 so as to fix the cannula 12 in the safety needle assembly 10. The needle hub 60 is provided with two axial members in the form of lugs 64, 65 for engaging in two corresponding axial members in the form of recesses 28, 29, which are provided in the interior of the tubular housing 20. In particular, the tubular housing 20 defines a rotation axis, which can be a fixed rotation axis around which the cannula 12 can rotate (or pivot). This movement is functionally important and enables the cannula 12 to rotate from the operating position to the hidden position. In the hidden position, the non-patient end 15 of the cannula 12 is hidden to prevent and / or inhibit rear end needle stick injuries. The fixed rotation axis can be provided by an axial element, which is engaged in the corresponding recess to allow the needle hub 60 to rotate / pivot relative to the tubular housing 20. In alternative embodiments, the rotation / pivot functionality may be provided by a flexible portion, such as a living hinge arrangement, whereby the axis of rotation may not be statically fixed to merely provide an axis of rotation about a static rotation.

[0125] The sleeve 12 is arranged to rotate (or pivot) about a fixed axis 52 (or fixed point) in the tubular housing 20. In the operating position, the sleeve 12 extends along the central longitudinal axis of the tubular housing 20. The fixed axis 52 for rotation extends vertically and intersects the central longitudinal axis 50. The fixed axis 52 extends diametrically through the tubular housing 20 and extends radially from the central longitudinal axis 50. This creates a fixed axis 52 or a fixed pivot point or a fixed rotation point for the sleeve 12, which is located on the central longitudinal axis 50.

[0126] The sleeve 12 is arranged to rotate about the fixed axis 52 from an operating position in which the sleeve 12 extends along the central longitudinal axis 50 to a concealed position in which the sleeve 12 extends at an angle to the central longitudinal axis 50. In particular, in the concealed position, the sleeve 12 extends in a direction inclined to the central longitudinal axis 50.

[0127] Due to the fixed axis 52 and the fixed rotation point of the cannula 12, the movement from the central longitudinal axis 50 to the inclined position causes the non-patient end 15 of the cannula 12 to move toward the inner wall 26 of the tubular member 20. In this position, the non-patient end 15 of the cannula 12 is toward and adjacent to the inner wall 26 of the tubular housing 20, the non-patient end 15 is more concealed and the risk of needle stick injury is significantly reduced. In addition, due to the fixed axis 52, the pivoting action of the needle about the fixed point located on the central longitudinal axis 50 means that the non-patient end 15 of the cannula 12 also moves forward (in the distal direction) and away from the open end 24 of the tubular housing 20. This movement of the non-patient end 15 of the cannula 12 in the distal direction of the longitudinal axis 50 of the tubular housing 20 thereby increases the distance between the open end 24 of the tubular housing 20 and the non-patient end 15 of the cannula 12. This increases the level of protection provided by increasing the distance the fingertip needs to be inserted into the open end 24 of the tubular housing 20 to contact the non-patient end 15 of the cannula 12. The increased separation distance coupled to the non-patient end 15 is also located adjacent the wall 26 of the tubular housing 20, providing the user with increased safety from needle stick injuries.

[0128] The cannula 12 is fixed in a needle hub 60 which provides two shaft lugs 64, 65 on opposite sides. The shaft lugs 64, 65 are received in two corresponding recesses 28, 29 in the tubular housing 20 so that the cannula 12 can rotate about a fixed axis 52 in the tubular housing 20.

[0129] The safety needle assembly 10 is attached to the pen injector 11 using threads 36 provided on the end of the pen injector 11 and also provided on the tubular housing 20. When the safety needle assembly 10 is engaged with the pen injector 11, the non-patient end 15 of the cannula 12 abuts, pierces and then protrudes through the rubber seal 18. During this attachment, the cannula 12 is held along the central longitudinal axis 50 to assist in smooth movement of the cannula 12 through the rubber seal 18.

[0130] The tubular housing 20 comprises a resilient means in the form of a leaf spring in the form of a resilient finger, which protrudes inwardly from the inner surface 26 of the tubular housing 20. The resilient finger comprises a contact tip which contacts or abuts the outer surface of the needle hub 62 at a position offset from the fixed axis 52 of rotation defined by the axial members 28, 29, 64, 65. Thus, in the operative position, the resilient finger is in such a configuration that the tip exerts a force, in particular a moment or torque, on the outer surface of the needle hub 60. Thus, in the operative position, the resilient finger is not in a neutral position and is in a deflected state relative to a neutral relaxed state / state / position. In particular, in the operative position, the leaf spring / resilient finger is preloaded so that energy is stored in the leaf spring / resilient finger. This stored energy is used to urge the cannula 12 away from the operative position and away from alignment with the longitudinal axis of the tubular housing 20. Before the needle hub 60 is assembled in the tubular housing 20, the leaf spring / resilient finger is in a neutral state without stored energy. When the needle hub 60 is installed in the tubular housing 20, the leaf spring / elastic finger deflects and moves to store energy, which acts to urge the needle hub 60 away from the operating position. When the cannula 12 / needle hub 60 is released by both the control member 80 and the rubber seal 18, the non-patient end 15 of the cannula 12 is positioned adjacent to the inner wall 26 of the tubular housing 20. In this configuration, the leaf spring / elastic finger is generally not in a neutral position, and energy is still stored, so that the leaf spring / elastic finger continues to press and push the non-patient end 15 of the cannula 12 against the inner wall 26 of the tubular housing 20.

[0131] The needle hub 60 is held in the operative position by a control mechanism that engages a portion of the needle hub 60 and holds the cannula 12 in the operative position. In the first preferred embodiment, the blocking mechanism is provided by a hidden sleeve 30 that includes a central hole 32. The central hole 32 engages around the front end of the needle hub 60. In addition, the hidden sleeve 30 is fixed around the tubular housing 20 and can only move longitudinally in the distal direction relative to the tubular housing 20. Therefore, in the set position, the front end of the needle hub 60 is fixed within the hole 32 of the hidden sleeve 30, so that any force applied by the resilient fingers is offset and does not cause rotation of the needle hub 60 or the cannula 12 around the fixed axis 52.

[0132] In this set position, it can be seen that the patient end 14 of the needle protrudes outwardly from the drug delivery device and is thereby able to inject the patient and deliver liquid drug from the pen injector 11. Once the injection is completed, the hidden sleeve 30 is moved forward to the hidden position. Specific details of the arrangement of the front hidden sleeve 30 are not provided in this specification, and there are many suitable detailed arrangements available, such as those described in WO2011 / 092518. In this position, the needle holder 60 is no longer engaged in the hole 32 of the hidden sleeve 30, and the elastic mechanism can no longer be prevented from rotating the needle holder 60 about the fixed axis 52. However, the non-patient end 15 of the sleeve 12 remains engaged in the rubber seal 18 along the longitudinal axis 50, so that the arrangement still prevents the needle holder 60 from rotating about the fixed axis 52.

[0133] After use, the safety needle assembly 10 needs to be disposed of and is therefore disassembled from the medical syringe 11 by using the threaded surface 36 to disassemble and unscrew the safety needle assembly 10. When disengaged, the non-patient end 15 of the cannula 12 is retracted through the rubber seal 18 and disengaged from the rubber seal 18, and is therefore no longer held by the rubber seal 18 along the longitudinal axis 50 of the tubular member 20. In this configuration, there is no limiting mechanism to prevent the rotation of the needle hub 60 due to the torque applied by the elastic fingers, and therefore, the needle hub 60 automatically rotates around the fixed axis 52.

[0134] The energy stored in the resilient fingers rotates the needle hub 60 about the fixed axis 52 until the non-patient end 15 of the cannula 12 is positioned adjacent to and preferably adjacent to the inner sidewall 26 of the tubular housing 20. The length of the cannula 12 ensures that the non-patient end 15 abuts the inner sidewall 26. Due to the fixed axis 52 of the needle hub 60, the non-patient end 15 of the cannula 12 moves circumferentially in the distal direction and in an arcuate direction around the axis 52, so that the distance between the non-patient end 15 and the open face 24 of the tubular housing 20 along the longitudinal extent increases. Therefore, not only is the non-patient end 15 positioned adjacent to the inner wall 26 of the tubular housing 20, but the non-patient end 15 is also retracted / retracted into the tubular housing 20, which significantly increases the protection provided against needle stick injuries. The lateral, radial movement of the non-patient end 15 and the retraction / withdrawal movement of the non-patient end 15 in the distal direction are automatically performed and simultaneously provide improved passive needle stick protection, which does not require user intervention. Furthermore, in the stowed position, the leaf spring may continue to exert a pivoting / rotational force on the needle hub 60 , and this will press the non-patient end 15 of the cannula 12 against the inner wall 26 of the tubular housing 20 .

[0135] The operation and use of further embodiments of suitable safety needle assemblies are shown and described in GB2104342.7, which is incorporated herein by reference.

[0136] The first embodiment of the utility model is Figure 3 and Figure 4 . The safety needle assembly comprises a needle / cannula 112 mounted in a tubular housing 120, which provides a mounting member for a spring 170. The cannula 112 is located in a needle seat 160, which is located in the tubular housing 120. In this embodiment, the hidden sleeve 130 provides a blocking mechanism that prevents the cannula 110 from being aligned along the longitudinal axis of the tubular member 120. In particular, the blocking mechanism is configured to counteract the pivoting force of the spring or the ability of the cannula to rotate freely so as to maintain the cannula 112 in the operating position. In this embodiment, the spring 170 (leaf spring) is integral with the tubular housing 120 (mounting member), and the tubular housing 120 moves relative to the needle seat 160. The spring 170 and the tubular housing 170 form an integral component.

[0137] The spring 170 and the needle seat 160 are arranged at a set position relative to each other, and the use of the safety needle assembly 110 with the medical syringe 111 causes a displacement from the set position, and the displacement causes one of the mounting member or the needle seat to move relative to the other to enable the elastic mechanism to rotate the needle to the hidden position when the safety needle assembly is disassembled from the medical syringe. In some embodiments, both the needle seat and the mounting member can actually / physically move, although this is covered by using the term relative movement. When the safety needle assembly 110 is disassembled from the medical syringe 111, the displacement enables the spring 170 to subsequently rotate the needle 112 to the hidden position. In the first, second and third embodiments, the displacement is caused by attaching the safety needle assembly 110 to the medical syringe 111. In the fourth and fifth embodiments, the displacement is caused by using the device, that is, the action of injecting the patient. As will be understood, the displacement can also be caused by the disengagement (specifically, the initial part of the disengagement sequence) of the safety needle assembly 110 from the medical syringe 111.

[0138] Figure 3 The safety needle assembly 110 is shown in an initial position, wherein the spring 170 and the needle hub 160 are in a set position before being attached to the medical syringe 111. The tubular housing 120 provides an axial member for engaging the axial member of the needle hub 160. The axial members 191a, 191b, 192a, 192b of the tubular housing 120 include recesses 191a, 191b, 192a, 192b and the axial member of the needle hub includes axial lugs 164, 165. In particular, the tubular housing 120 provides a first pair of recesses 191a, 191b to mount the needle hub 160 in the first position ( Figure 3 ) and a second pair of recesses 192a, 192b to mount the needle hub 160 in a second position.

[0139] The needle hub 160 is arranged to move from a first (set) position to a second (active) position relative to the spring 170 during attachment of the safety needle assembly 110 to the medical syringe 111. In the set position, the spring 170 may be in an unloaded position by which the spring 170 is unable to pivot the needle hub 160. For example, the spring 170 may be completely unloaded, with no stored force applied to the needle hub 160, or the spring 170 may be only partially loaded and / or combined with a contact position on the needle hub 160, which results in the spring 170 being unable to pivot the needle hub. In the active position, the load in the spring 170 and / or the contact position on the needle hub 160 are arranged such that the spring 170 is able to pivot the needle 112, although such movement may not actually occur until the blocking mechanism is disengaged and / or the non-patient end 115 of the cannula 112 is withdrawn from the rubber seal 118.

[0140] As previously described, the safety needle assembly 110 is attached to the medical syringe 111 by means of mating threaded surfaces 136, 137 or similar arrangements. During this attachment, the non-patient end 115 of the cannula 112 pierces the rubber seal 118. This penetration ultimately causes the proximal end 168 of the needle hub 160 to contact the rubber seal 118 or the area surrounding the rubber seal 118. This stops and prevents further proximal movement of the needle hub 160 relative to the medical syringe 111.

[0141] Further engagement of the threaded surfaces 136, 137 continues the movement of the tubular housing 120 toward the medical syringe 111. Thus, this movement causes the tubular housing 120 to move relative to the needle hub 160, which prevents further movement of the end of the medical syringe 111. In particular, the shaft lugs 164, 165 are moved out of the first pair of recesses 191a, 191b and into the second pair of recesses 192a, 192b. In addition, the distal end 169 of the needle hub 160 extends into the hole 132 of the hidden sleeve 130 to provide a blocking mechanism.

[0142] The safety needle assembly 110 includes a resilient mechanism 170 in the form of a resilient finger 172, including a tip 174 that contacts and abuts against the outer surface of the needle hub 160. In the first embodiment, the resilient finger 172 is disposed on the inner surface 126 of the tubular housing 120 and protrudes inwardly therefrom. Therefore, since the needle hub 160 moves relative to the tubular housing 120 during attachment, the needle hub 160 also moves relative to the resilient finger 172 during attachment of the safety needle assembly 110 to the medical syringe 111. Specifically, the contact point between the needle hub 160 and the resilient finger 170 moves along the (proximal) outer surface of the needle hub 160 from a first contact position ( Figure 3 ) moves to a second contact position.

[0143] like Figure 3As shown, the needle hub 160 provides a first contact position in the form of a shaped surface, including a recess or notch 190. In the first position, the end 174 of the resilient finger 172 is positioned within the notch 196. The depth of the notch 190 can result in no or only minimal transmission of any spring force from the resilient finger 170 to the needle hub 160. In addition, the notch 190 is located diametrically along the support axis provided by the first pair of recesses 191a, 191b. Thus, when the shaft lugs 164, 165 are located within the first pair of recesses 191a, 191b, this prevents the resilient finger 172 from pushing the needle hub 160 to rotate relative to the tubular housing 120, as set in the first (set) position before attachment. Therefore, this prevents fatigue of the resilient finger before use.

[0144] Additionally, the shape of the recess 190 is arranged to maintain the needle hub 160 aligned with the longitudinal axis of the tubular housing 120. Figure 3 As shown, it can be seen that the needle hub 160 is prevented from rotating / pivoting by the end 174 of the resilient finger 172. Specifically, if the needle hub 160 attempts to rotate within the tubular housing 120, the end 174 will generate an anti-rotation force.

[0145] As described above, when the safety needle assembly 110 is attached to the medical syringe 111, the needle hub 160 is arranged to move relative to the tubular housing 120. Specifically, a force is generated by the contact of the proximal end 168 of the needle hub 160 with the distal end of the medical syringe 111. This pushes the needle hub forward relative to the tubular housing 120 and moves the tip 174 of the resilient finger away from the notch 190. The tip 174 will then travel proximally along the outer surface of the needle hub 160 until the movement stops and the shaft lugs 164, 165 remain in the second pair of recesses 192a, 192b in the second (active) position.

[0146] In this position, the resilient fingers 172 generate a force on the needle hub 160. The contact point is now offset from the diametric axis created by the second pair of recesses 192a, 192b and this causes the resilient fingers 172 to generate a rotational or pivoting force on the needle hub 160. However, the distal end of the needle hub 160 is now located within the aperture 132 of the hidden sleeve 130, thereby counteracting this rotational force and maintaining the cannula 112 in the operative position.

[0147] The subsequent operation of the utility model is basically the same as that of the above reference Figure 1 and Figure 2 The operation described is the same and as further described in GB2104342.7. Therefore, the present invention provides an improved safety needle assembly 110 by removing any fatigue on the elastic mechanism 170 before attaching the safety needle assembly 110 to the medical syringe 111. In addition, the activation of the elastic mechanism automatically attaches the safety needle assembly 110 to the medical syringe 111.

[0148] In short, subsequent operation and use of the safety needle assembly 110 after attachment includes injecting a patient, after which the hidden sleeve 130 moves or is moved to the outer distal position. At this position, the distal end 169 of the needle hub 160 is no longer retained within the hole 132 (blocking mechanism) of the hidden sleeve 130. Therefore, the engagement / penetration of the non-patient end 115 of the sleeve 112 in the rubber seal 118 is the only mechanism for preventing the spring action of the resilient fingers 172 from rotating the needle hub 160 about the axis between the second pair of recesses 192a, 192b.

[0149] The safety needle assembly 110 is then removed from the medical syringe 111 by using the threads 136, 137 to Figure 4 Thus, when the non-patient end 115 of the cannula 112 is disengaged from the rubber seal 118 and removed from the rubber seal 118, the spring force of the resilient fingers 172 automatically and immediately rotates the cannula 112 to the hidden position. In this position, the non-patient end 115 moves to the inner surface 126 of the tubular housing 120 and is also further retracted into the tubular housing 120 away from the proximal open end 124.

[0150] exist Figure 5 A second embodiment of the improved safety needle assembly 210 is shown in FIG. In this embodiment, the tip 274 of the resilient finger 272 is initially positioned distally relative to the axis of the shaft lugs 264, 265 passing through the needle hub 260. In addition, the resilient finger 272 extends directly and radially inwardly toward the central longitudinal axis of the tubular housing 220. In the first embodiment, the resilient finger 272 does not extend directly radially inwardly, but extends at an inner acute angle relative to the tubular housing 220. In the second embodiment, the resilient finger 272 forms an inner right angle with the tubular housing 220. In this embodiment, the spring 270 (leaf spring) is integral with the tubular housing 220 (mounting member), and the tubular housing 220 moves relative to the needle hub 260. The spring 270 and the tubular housing 270 form an integral component.

[0151] In this embodiment, the distal end 269 of the needle hub 260 is engaged by the hidden sleeve 230 prior to attaching the safety needle assembly 210 to the medical syringe 211. This maintains the cannula 212 aligned with the longitudinal axis of the tubular housing 220. This operating position of the cannula prevents any damage to the cannula and also maintains the non-patient end 215 in an optimal position for subsequent piercing of the rubber seal 218.

[0152] The safety needle assembly 210 is attached to the medical syringe 211 using threads 236, 237, and this causes the proximal end 268 of the needle seat 260 to contact the distal end of the medical syringe 211. Subsequent use of threads 236, 237 causes the tubular housing 220 to keep moving proximally and the needle seat 260 to move relative to it. This relative movement causes the shaft lugs 264, 265 to move away / disengage from the first pair of recesses 291a, 291b. The outer ends of the shaft lugs 264, 265 are shaped to cause / assist this disengagement and subsequent reengagement in the second pair of recesses 292a, 292b. In particular, the outer ends of the lug shafts 264, 265 are substantially hemispherical. The lug shafts 264, 265 reengage in the second pair of recesses 292a, 292b to provide an operating position for the device. Thus, attachment of the safety needle assembly 210 to the medical syringe 211 causes the spring 270 and the needle hub 260 to be displaced from the set position.

[0153] During the relative movement between the needle hub 260 and the tubular housing 220, the resilient mechanism 270 moves proximally with the tubular housing 220 relative to the needle hub 260. The needle hub 260 provides a flange 267 for engaging with the resilient finger 272. In particular, the tip 274 of the resilient finger 272 contacts and abuts the distal surface of the flange 267. This contact exerts a force on the flange 267 because the resilient finger 272 is in a deformed and loaded position when the shaft lugs 264, 265 are engaged in the second pair of recesses 292a, 292b. The load provides a rotational force for the needle hub 260 because the force is offset relative to the axis of rotation created by the pair of recesses 292a, 292b. However, the distal end 269 of the needle hub 260 is engaged in the hidden sleeve 230, and the non-patient end 215 of the cannula 212 is also engaged in the rubber seal 218. Therefore, the needle seat 260 cannot rotate, but the elastic mechanism 270 is loaded. In this embodiment and in some other described embodiments, the spring 270 is shown as being completely unloaded in the set position. However, it should be understood that the spring 270 can be partially semi-preloaded in the set position. In the set position, it is advantageous to avoid fully preloading the spring, but zero or a small or partial preloading spring 270 still provides the utility model with the advantages of extending and extending the material properties of the spring 270.

[0154] The patient end 214 of the cannula 212 is ready to perform an injection. After the injection, the hidden sleeve moves or moves to the distal position. In this position, the distal end 269 of the needle hub 260 is no longer engaged with the hidden sleeve 230. However, the non-patient end 215 of the cannula 212 remains engaged in the rubber seal 218, so that the cannula 212 is still maintained in a position aligned with the longitudinal axis of the tubular housing 220.

[0155] The disengagement of the safety needle assembly 210 from the medical syringe 211 causes the non-patient end 215 to be released from the rubber seal. The load of the resilient fingers 272 then rotates the needle hub 260 about the axis formed between the second pair of recesses 292a, 292b. The non-patient end 215 of the cannula 212 is withdrawn into the tubular housing 220 and also moves to the inner surface 226 of the tubular housing 220 to prevent needle stick injuries.

[0156] The third embodiment of the safety needle assembly 310 is Figures 6 to 9 370 is shown in FIG. 371 . In this embodiment, the elastic mechanism 370 is again provided by an internally protruding elastic finger 372 having a tip 374. However, the elastic finger 372 is located proximally relative to the recesses 328, 329 and the axis of rotation. In the initial position, since the distal end 369 of the needle seat 360 is engaged in the hole 332 of the hidden sleeve 330, the elastic mechanism 370 is not loaded and the needle seat 360 is held in place. In this embodiment, the spring 370 (leaf spring) is integral with the inner sleeve part 395 (mounting member), which moves relative to the needle seat 360. The spring 370 and the tubular housing 370 form an integral component. The inner sleeve part 395 is axially slidable in the tubular housing 320.

[0157] In this embodiment, the resilient fingers 372 are mounted on an inner sleeve portion 395 which is a separate and distinct component from the tubular housing 320. The inner sleeve portion 395 is positioned and slides internally relative to the tubular housing 320. The inner sleeve portion 395 may have an incomplete cross-section and may be substantially C-shaped or may have cut-out portions to allow for mounting of internal protrusions of the recesses 328, 329.

[0158] In this embodiment, the resilient finger 372 moves distally from an unloaded position (set position) to a loaded position (active position). Figure 6In the embodiment of the present invention, the elastic finger 372 is shown as protruding vertically inward relative to the inner surface of the tubular housing 320. However, it should be readily understood that the elastic finger 372 (leaf spring) can protrude vertically or at an acute angle inward relative to the longitudinal inner axis of the tubular housing 320 in the distal or proximal direction. In particular, the elastic finger 372 (leaf spring) can protrude inward, "pointing" to the front (distal) or rear (proximal) of the housing. In addition, the elastic finger 372 can have a curved or arcuate or straight form, or can have curved and / or arcuate and / or straight portions (in order to best perform as a spring). The needle seat 360 is provided with a flange 367, and the end 374 of the elastic finger 372 is arranged to contact the proximal surface of the flange 367 and generate a force on the proximal surface of the flange 367. The force is offset from the rotation axis of the needle seat 360 provided by the recesses 328, 329, thereby forcing the needle 312 to move to the hidden position.

[0159] In use, the safety needle assembly 310 is provided separated from the elastic mechanism 370 in an unloaded position, such as Figure 6 As shown. In some embodiments, in the set position, the elastic mechanism is partially or semi-preloaded or completely unloaded. Although in this disassembled configuration, it will be readily appreciated that the inner sleeve portion 395 is held in place relative to the tubular housing 320 so as to retain the inner sleeve portion 395 within the tubular housing 320. Any suitable arrangement may be used to maintain this positional arrangement, such as frictional resistance between the inner sleeve portion 395 and the tubular housing 320 (e.g., Figure 6 395, and the reciprocating protrusions / recesses on the inner sleeve portion 395 and the tubular housing 320, etc. The safety needle assembly 310 is attached to a medical syringe 311, such as Figure 7As shown. The attachment causes the elastic mechanism 370 to move distally relative to the needle seat 360 so as to load the elastic mechanism 370. Specifically, the attachment of the safety needle assembly 310 to the medical syringe 311 causes the spring 370 and the needle seat 360 to shift from the set position (to the active position). The mounting member and the needle seat are arranged at the set position relative to each other. Thereafter, the use of the safety needle assembly with the medical syringe causes a shift from the set position; and the shift causes one of the mounting member or the needle seat to move relative to the other, so that when the safety needle assembly is removed from the medical syringe, the elastic mechanism can rotate the needle to the hidden position. In particular, when partially attached, the proximal end 397 of the inner sleeve portion 395 abuts and contacts the distal end of the medical syringe 311. The inner sleeve portion 395 is then prevented from moving further toward the medical syringe 311, but further attachment moves the tubular housing 320 toward the medical syringe 311. Therefore, the tip 374 of the resilient finger 372 moves toward and abuts the flange 367, and the resilient mechanism 370 is loaded, thereby generating a rotational force on the needle hub 360. In particular, the resilient mechanism is preloaded to generate a force sufficient to enable the resilient mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

[0160] After attachment and loading of the elastic mechanism 370 (e.g., from a partially or semi-preloaded or fully unloaded state to a (fully) preloaded state), the injection is performed and the hidden sleeve 330 is moved or distally moved to the hidden position, as shown. Figure 8 In this position, the resilient fingers 372 push the needle hub 360 to rotate, but this is counteracted by the engagement of the non-patient end 315 with the rubber seal 318.

[0161] Subsequent disengagement of the safety needle assembly 310 from the medical syringe 311 releases the reactive engagement. Specifically, the non-patient end 315 is released from the rubber seal 318 and the needle hub 360 is immediately rotated due to the load of the resilient fingers 372. The non-patient end 315 is withdrawn into the tubular housing 320 and is positioned / adjoined against the inner surface 326 of the tubular housing in a safe condition. It will be readily appreciated that the inner sleeve portion 395 is held in place relative to the needle hub 360 so as to maintain the urging force exerted by the resilient fingers on the flange 367. Any suitable arrangement may be used to maintain this force, such as frictional resistance between the inner sleeve portion 395 and the tubular housing 320 (e.g., Fig. 9395 and the reciprocating projection / recess on the tubular housing 320, etc. By way of confirmation, when the safety needle assembly 310 is separated from the medical syringe 311, the offset from the set position (to the active position) is permanent to ensure that the needle 312 moves to the hidden position. Therefore, friction contact (as shown in the drawings) or some other means will be required to hold and maintain the inner sleeve portion 395 in the tubular housing 320 in an effective position.

[0162] In a fourth embodiment of the safety needle assembly, the elastic finger is positioned distally relative to the flange on the needle seat and moves proximally from the unloaded position to the loaded position. The load of the elastic mechanism is caused by the movement of the hidden sleeve, and the attachment of the safety needle assembly to the medical syringe does not displace the spring and the needle seat from the set position. In this embodiment, the spring is integrated with the inner sleeve portion and forms an integral component. When the hidden sleeve moves proximally, the inner distal surface of the hidden sleeve contacts the distal end of the inner sleeve portion, and the inner sleeve portion and the elastic finger move proximally relative to the needle seat, and the needle seat is statically retained in the recess of the tubular housing. This relative movement causes the end of the elastic finger to contact the flange provided on the needle seat so as to load the elastic mechanism. Specifically, the action of using and injecting the patient displaces the spring and the needle seat from the set position. Then, the hidden sleeve moves to the outer distal position of the distal end of the needle seat. In this position, the engagement of the sleeve at the non-patient end only offsets the rotational force applied to the needle seat by the elastic mechanism. Finally, the safety needle assembly is separated from the medical syringe and the non-patient end is positioned on the inner surface of the tubular housing.

[0163] In the fifth embodiment, it is again the subsequent movement of the hidden sleeve that displaces the spring and needle holder from the set position and activates the load of the elastic mechanism. In addition, in this embodiment, the load is due to the provision of two pairs of recesses. The lug shaft engages in the first pair of recesses and the distal collar on the needle holder. In this embodiment, the spring is integrated with the tubular housing and forms an integral component. Therefore, the movement of the hidden sleeve by the patient's skin causes the hidden sleeve to contact and move the distal collar, and thus moves the needle holder from the first (distal) pair of recesses to the proximal pair of recesses, thus backward toward the medical syringe. In this position, the elastic mechanism is loaded, but the needle holder is constrained. As previously described, the hidden sleeve moves or moves to an external hidden position and releases the needle holder, but the sleeve is still engaged with the rubber seal to prevent the rotation of the needle holder. Finally, the safety needle assembly is separated from the medical syringe, the syringe releases the sleeve from the rubber seal, and the elastic fingers of the load cause the needle holder to rotate immediately.

[0164] The sixth embodiment of the present invention is Fig.10. This embodiment provides a verification mechanism or verification system that verifies that the safety needle assembly 610 is correctly positioned on the medical syringe 611. Specifically, the verification mechanism provides feedback to the user who manually attaches the safety needle assembly 610 to the medical syringe 611. The safety needle assembly 610 can be the same as the safety needle assembly described in embodiments one to five. Even, the verification system can also be used with other safety needle assemblies and medical syringes.

[0165] In the sixth embodiment, the verification mechanism provides an audible signal or an audible mark to warn the user that the correct attachment position of the safety needle assembly 610 on the medical syringe 611 has been reached. The audible alarm may include a click or another suitable audible signal. In particular, the safety needle assembly 610 is screwed onto the medical syringe 611 using a corresponding thread. This moves the safety needle assembly 610 toward the attachment position, and in the correct attachment position, the non-patient end 615 of the sleeve 612 is safely positioned and located in the chamber of the medical syringe 611. Therefore, this verifies to the user that the device is ready for use and prevents any risk that the safety needle assembly 610 is only positioned in the attachment position, but the non-patient end of the sleeve 612 is not in the desired position.

[0166] The verification mechanism comprises an element 645 (axially) movably located within the tubular housing 620. In particular, the element 645 is arranged to slidably move between an unactivated position and an activated position within the tubular housing 620, at which an audible signal is generated. The element 645 comprises a proximal end 642, which is arranged to contact the distal side 639 of the medical syringe 611 during the attachment of the safety needle assembly 610 to the medical syringe 611.

[0167] like Fig.10 As shown, the medical syringe 611 has a boss 640 having an outer thread 636 (threaded surface) arranged around the periphery. The tubular housing 620 provides a corresponding inner thread 637 (threaded surface) so that the medical syringe 611 can be attached to the safety needle assembly 610.

[0168] The medical syringe 611 is screwed relative to the safety needle assembly 610, and this action causes the distal end face 639 to initially contact and abut the proximal end 642 of the element 645. Further tightening action thereby causes the element 645 to move together with the distal end 639, such that this causes the element 645 to slidably move within the tubular housing 620 toward the distal end of the tubular housing 620.

[0169] In this embodiment, element 645 provides a verification member, which is an elastic member. The elastic member extends axially from element 645. This enables a greater force to be generated in the elastic finger 641 to produce a reliable and / or louder audible noise compared to a radially extending wing, which may not produce an audible signal at all due to the available deflection amount. This small deflection distance will not reliably produce enough force to produce an audible signal to be relied upon. The elastic member can extend from element 645 in a proximal direction or a distal direction. In this embodiment, the elastic member is in the form of a distal / forwardly extending latch finger 641, which has a distal latch head 644. The latch finger 641 has a proximal end 643, which fixes the latch finger 641 to the element 645. The latch finger 641 is integrated with the element and forms an integral component. The latch finger 641 includes an elastic material that enables the latch finger 641 to be flexed inwardly.

[0170] The tubular housing 620 provides a deflection member on the inner surface in the form of a lug 649 or rib or other suitable latching surface. The lug 649 includes an inclined / angled proximal surface arranged to deflect the latch finger 641 inwardly. The lug 649 includes a distal surface arranged to engage with the latch head 644 so as not to deflect the latch finger 641, which prevents the latch finger 641 from disengaging from the lug 649 when engaged.

[0171] When the element 645 moves distally due to the relative screwing action, the latch head 644 reaches the inclined surface and this causes the latch finger 641 to bend inwardly. The additional tightening action then causes the latch finger 641 to move on the top edge of the lug 649, and the latch finger 641 naturally bends outwardly back to the latched position. Due to the contact of the latch finger 641 with the tubular housing 620, this movement of the latch finger 641 causes an audible signal to be emitted. This audible signal is sufficient to warn the user of the engagement of the latch finger 641. Due to the relative position of the lug 649 in the safety needle assembly 610, the position where the latch finger 641 engages coincides with the correct relative position of the safety needle assembly 610 and the medical syringe 611. In this correct attachment position, the non-patient end of the sleeve 615 is optimally located in the medical syringe 611.

[0172] The audible signal provides confirmation that the safety needle assembly 610 is properly attached to the medical syringe 611, and prevents the user from over-tightening / positioning and under-tightening / positioning the safety needle assembly 610 and the medical syringe 611. It should be understood that, as will be appreciated, an under connection may result in the non-patient end 615 of the cannula 612 being incorrectly positioned in the medical syringe 611. Similarly, an over connection may create unnecessary stress and result in failure / fracture in the material of the safety needle assembly 610 or the medical syringe 611. Thus, the audible alarm (which may include a click or similar noise) reliably notifies the user of the properly connected safety needle assembly 610, which is then ready for use as previously described.

[0173] In some embodiments, the latch movement may also provide a tactile sensation that provides feedback to the user to reconfirm and verify / confirm the auditory signal heard by the user. For example, the vibration will resonate through the safety needle assembly 610 held by the user's fingertips. This feedback can help confirm the auditory signal to the user.

[0174] In some embodiments, element 645 may include or be integrated with or connected to an inner sleeve portion 395, 495 as described in previous embodiments, and may include an integral leaf spring mounted thereon. Fig.10 The components shown can be formed Figures 6 to 9 In this arrangement, the verification mechanism will provide dual functions to provide an audible signal to demonstrate the correct attachment position, and will also form a retention mechanism to maintain / retain the inner sleeve portion 395 in an active position (such as Fig. 9 shown).

[0175] exist Fig.11 and Fig.12 The seventh embodiment of the present invention is shown in FIG. This embodiment again provides a verification mechanism or verification system, which verifies that the safety needle assembly 710 is correctly positioned on the medical syringe 711. In particular, the verification mechanism provides feedback to the user who manually attaches the safety needle assembly 710 to the medical syringe 711 in the form of an auditory signal (e.g., a click). The safety needle assembly 710 can be the same as the safety needle assembly described in relation to embodiments one to five. In particular, the seventh embodiment is effectively similar to Figures 6 to 9 The third embodiment is shown.

[0176] In this embodiment, the verification mechanism includes a latch mechanism disposed at the proximal end 742 of a proximally extending latch finger 741. Compared to the sixth embodiment, the latch finger extends axially and specifically proximally relative to the element 745. In particular, the latch finger 741 extends backward (toward the proximal side) rather than forward (toward the distal side). The tubular housing 720 provides a lug 749 or other suitable latching surface on the inner surface. The lug 749 includes an inclined / angled proximal surface that is arranged to deflect the latch finger 741 inwardly. The lug 749 includes a distal surface that is arranged to engage with the latch head 744 so as not to deflect the latch finger 741 inwardly, and this prevents the latch finger 741 from disengaging from the lug 749 once engaged.

[0177] Element 745 is initially positioned in tubular housing 720 with head 744 positioned adjacent to the proximal inclined surface of lug 749 so that head 744 does not move on thread 737 during attachment of safety needle assembly 710 to medical syringe 711. Lug 749 is positioned so that latching of head 744 coincides with proper engagement of safety needle assembly 710 and proper loading of needle hub 760 with resilient mechanism (resilient finger 772). Movement of head 744 to latched position on lug 749 creates / generates an audible signal (e.g., click) to demonstrate attachment of medical syringe 711 to safety needle assembly 710. A tactile signal that can be sensed (by the touch of the user) can also be generated simultaneously and naturally with the audible signal.

[0178] The verification mechanism also forms a retaining mechanism to maintain / retain the inner sleeve portion 795 in an effective position within the tubular housing 720 (see Fig. 9 741 and / or the corresponding profile of the head 744 of the lug 749 causes the latch mechanism to retain the inner sleeve portion 795 in the active position only, wherein the head or end 774 of the resilient finger 772 presses against the flange 767 to retain the non-patient end of the cannula 715 in the tubular housing 720 and locate / adjoin the inner surface 726 of the tubular housing 720 in a safe condition. In this embodiment, the spring 772 is integral with the inner sleeve portion 795 and forms a one-piece component.

[0179] The verification mechanism comprises an inner sleeve portion 795 which provides the element 745 movably located within the tubular housing 720. In particular, the element 745 / inner sleeve portion 795 is arranged to be slidably movable within the tubular housing 720. The element 745 / inner sleeve portion 795 comprises a proximal end 797 (provided by the head 744) arranged to be retracted with the distal face 739 of the medical syringe 711 during attachment of the safety needle assembly 710 to the medical syringe 711.

[0180] The medical syringe 711 is relatively screwed onto the safety needle assembly 710, and this action causes the distal end face 739 to initially contact and abut against the proximal end 797 of the element 745 / inner sleeve portion 795. Further screwing action thereby causes the element 745 / inner sleeve portion 795 to move together with the distal end 739, so that this causes the element 745 / inner sleeve portion 795 to slidably move within the tubular housing 720 toward the distal end of the tubular housing 720.

[0181] As described above, in this embodiment, the element 745 / inner sleeve portion 795 has a latch finger 741 extending proximally, with a latch head 744 defined at the proximal end. The latch head 744 includes an outwardly shaped portion having an outer peripheral surface to cooperate with the lug 749. The latch finger 741 is integral with the element 745 / inner sleeve portion 795 and forms a one-piece component. The latch finger 741 includes a resilient material that enables the latch finger 741 to bend inwardly. The lug 749 provides a suitable latching surface on the inner (distal) surface to prevent the latch finger 741 from moving proximally once engaged / latched.

[0182] When the element 745 / inner sleeve portion 795 moves distally due to the relative screwing action, the distal surface of the head 744 reaches the inclined surface of the lug 749, which causes the latch finger 741 to bend inwardly. Then, further screwing action causes the latch finger 741 to move on the lug 749, wherein the latch finger 741 naturally bends outwardly after moving over the lug 749. This movement of the latch finger 741 causes an audible signal to be emitted due to the sudden contact of the latch finger 741 with the lug 749 / outer tubular member 720. The audible signal is sufficient to alert the user to the engagement process of the latch finger 741. Due to the relative position of the lug 749 within the safety needle assembly 710, the position where the latch finger 741 engages with the lug 749 coincides with the correct relative position of the safety needle assembly 710 and the medical syringe 711. In this correct attachment position, the non-patient end of the sleeve 715 is optimally located within the medical syringe 711. The user will know when the correct connection has occurred because the latching movement will emit an audible signal or click. In this position, the proximal end 724 of the tubular housing 720 is located adjacent to the shoulder 748 of the medical syringe 711, or in some embodiments, the tubular housing 720 can abut the shoulder 748 of the medical syringe 711. The verification mechanism provides a dual function in providing an audible signal to prove the correct attachment position (the non-patient end of the sleeve 715 positioned in the medical syringe 711), and also proves that the elastic mechanism (elastic finger 772) is preloaded against the flange 767.

[0183] Eighth embodiment ( Fig.13) again provides a verification mechanism for verifying that the safety needle assembly 810 is correctly positioned on the medical syringe 811. The verification mechanism includes a latch mechanism that is fixed around and / or integral with the inner sleeve portion 895. The inner sleeve portion 895 has a latch skirt 841 extending therefrom, which will deflect / bend inwardly on the threads 837 when the medical syringe 811 is attached to the safety needle assembly 810. The latch skirt 841 is provided for contacting the proximal end of the medical syringe 811 during attachment. When the latch skirt 841 moves on the threads 837, an audible signal (e.g., a click) or a series of audible signals (such as clicks) is generated to demonstrate that the medical syringe 811 is attached to the safety needle assembly 810. The latch skirt 841 extends axially from the element / inner sleeve portion 895, and in particular extends proximally from the inner sleeve portion 895. The spring 872 is integral with the inner sleeve portion 895 and forms a one-piece component.

[0184] In this embodiment, the inner sleeve portion 895 has a proximal skirt 841 having a latching edge 844 defined around the proximal edge. The latching edge 844 includes an outwardly shaped portion having an outer peripheral surface that cooperates with the threads 837. The latching skirt 841 is integral with the inner sleeve portion 895 and forms a one-piece component. The latching skirt 841 includes an elastic material that enables the latching skirt 841 to flex inwardly.

[0185] The threads 837, and in particular the final threads of the tubular housing 820, provide a suitable latching surface on the inner surface to prevent or at least hinder the latch skirt 841 from moving proximally. The threads 837 provide a generally sinusoidal surface that is arranged to deflect the latch skirt 841 inwardly during movement of the inner sleeve in the distal direction. However, the latching edge 844 provides a proximal surface that is arranged to engage with the threads 837 so as not to deflect the latch skirt 841 inwardly, and this prevents the latch skirt 841 from disengaging from the final threads 837 once engaged.

[0186] When the inner sleeve portion 895 moves distally due to the relative screwing action, the distal surface of the latch edge 844 reaches the inclined surface of the first thread 837, and this causes the latch skirt 841 to bend inward. Then, further threading action causes the latch skirt 841 to move the subsequent thread 837, wherein the latch skirt 841 naturally folds back outward after moving over each peak of the thread 837. Due to the sudden contact of the latch skirt 841 with the groove of the thread 837, this movement of the latch skirt 841 causes an audible signal to be emitted. The audible signal is sufficient to remind the user of the engagement process of the latch skirt 841. Due to the relative position of the thread 837 in the safety needle assembly 810, the position where the latch skirt 841 engages in the thread 837 is consistent with the correct relative position range of the safety needle assembly 810 and the medical syringe 811. In this correct attachment position, the non-patient end of the sleeve 815 is optimally located in the medical syringe 811. Since the threads 837 will emit multiple audible signals or clicks, the user can know to screw in the medical syringe 811 until multiple clicks are heard and further screwing in is blocked due to the end of the threads. In this position, the proximal end 824 of the tubular housing 820 is positioned adjacent to the shoulder 848 of the medical syringe 811, or, in some embodiments, the tubular housing 820 can abut the shoulder 848 of the medical syringe 811.

[0187] The ninth preferred embodiment of the safety needle assembly 910 is as follows: Fig.14 and Fig.15 The needle seat 940 is positioned in a fixed position within the tubular housing 930, and the spring 950 is positioned on an inner sleeve portion 952 that is movable within the tubular housing 930. Fig.14 ), it can be easily understood that the inner sleeve portion 952 is held in position relative to the tubular housing 930 so as to retain the inner sleeve portion 952 within the tubular housing 930. Any suitable arrangement can be used to maintain this positional arrangement, such as friction resistance between the inner sleeve portion 952 and the tubular housing 130, a latch mechanism, reciprocating protrusions / recesses on the inner sleeve portion 952 and the tubular housing 930, detents, etc. The tubular housing provides two axially opposed recesses 942 (mounting members) that hold the needle hub 940 in a fixed longitudinal position but allow the needle hub 940 to articulate within the mounting member 942. This mounting arrangement provides a ball and socket type joint. The needle is initially retained along the central longitudinal axis by the blocking member 944. The spring 950 is integral with the inner sleeve portion 952.

[0188] The attachment of the safety needle assembly 910 to the medical syringe causes the spring 950 (mounted on the inner sleeve portion 952) to move distally relative to the needle seat 940 so as to load the spring 950. The end of the spring 950 moves toward and against the flange 936, and the spring 950 is loaded to generate a rotational force on the needle seat 940. The injection is performed, and the shield 914 (outer shield) moves distally or moves back to the hidden position. During the injection process, the blocking mechanism 944 (control member) moves distally and remains at the distal end of the shield 914. In this position, the blocking mechanism 944 no longer holds the needle 916 along the central longitudinal axis. In this position, the spring 950 pushes the needle seat 940 to rotate, but this is offset by the engagement of the non-patient end 918 with the rubber seal. The subsequent separation of the safety needle device 910 from the medical syringe releases this reaction engagement, and the needle seat 940 rotates immediately due to the load of the spring 950. It will be readily appreciated that the inner sleeve portion 952 is held in position relative to the needle hub 940 so as to maintain the urging force exerted by the spring on the flange 936. Any suitable arrangement may be used to hold the inner sleeve portion 952 in position, such as frictional resistance between the inner sleeve portion 952 and the tubular housing 930, a latch mechanism, mutually complementary protrusions / recesses / detents or cam profiles on the inner sleeve portion 952 and the tubular housing 930, etc. By way of confirmation, the displacement from the set position (to the active position) is permanent to ensure that the needle 916 moves to the hidden position when the safety needle device 910 is separated from the medical syringe 912.

[0189] In the tenth embodiment of the present invention, the needle hub 1060 includes a spherical outer surface, and the integral leaf spring 1070 acts / contacts the front / distal portion of the needle hub 1060, such as Fig.16 and Fig.17 In this embodiment, the non-patient end 1015 of the cannula 1012 is again moved to the hidden position. In the hidden position, the non-patient end 1015 of the cannula 1012 is positioned along the same side of the tubular housing as the leaf spring 1070. It will be appreciated that if the leaf spring 1070 contacts the needle hub 1060 in the distal / forward position of the axis, the leaf spring 1070 (integral to the tubular housing) will cause the needle hub 1060 to move in the counterclockwise direction 1002, referring to FIG. Fig.16 and Fig.17 Conversely, if the leaf spring 1070 does contact the needle hub 1060 at a proximal / rearward position relative to the axis of rotation, the needle hub 1070 is urged in a clockwise direction. In this embodiment, the non-patient end 1015 of the cannula 1012 travels around the circular / arc-shaped path 1002, and the separation distance increases from the first distance 1096 to the second distance 1098.

[0190] Finally, the eleventh embodiment of the present invention is Fig.18 As shown, Fig.18 The needle hub 1160 is shown arranged to rotate about an axis 1104 that is offset from the central longitudinal axis 1107 of the tubular housing 1120, which has an integral spring. The outer surface 1161 of the front of the needle hub 1160 can again be arranged to engage with the control member 1180. The axis of rotation 1104 is still located along the longitudinal axis 1105 of the tubular member, but the longitudinal axis is not the central longitudinal axis of the tubular housing 1120. In this embodiment, it can be seen that the offset position of the axis or rotation 1104 can increase the retraction distance 1196, 1198 of the non-patient end 1115 of the cannula 1112 when moving to the hidden position. This is due to the increase in the length of the arcuate travel path 1102 of the non-patient end 1115, thereby increasing the final separation distance 1198.

Claims

1. An improved safety needle assembly for use with a medical syringe, comprising: a tubular housing removably attached to the medical syringe, the tubular housing extending in a longitudinal direction from a proximal end to a distal end, the proximal end being arranged for attachment to the medical syringe; a needle hub, located within the tubular housing, for directly or indirectly supporting a double-ended needle having a patient end and a non-patient end, the needle hub being arranged to allow the needle to be moved from an operative position to a concealed position; An elastic mechanism for pushing the needle to move to the hidden position; a releasable blocking mechanism arranged to prevent movement of the needle from the operative position in which the needle extends in a direction along the longitudinal axis of the tubular housing, and whereby release of the blocking mechanism allows movement of the needle to the concealed position; The needle hub is a one-piece component, the one-piece component is inserted into the tubular housing and is positioned to rotate about an axis, and the elastic mechanism is arranged to urge the needle to rotate about the axis; as well as the blocking mechanism engaging the needle hub to retain the needle in the operative position prior to use, after which the safety needle assembly is attached to the medical syringe and use thereof causes the blocking mechanism to disengage the needle hub and allow the resilient mechanism to rotate the needle to the concealed position and move the non-patient end of the needle toward the distal end of the tubular housing where the needle extends obliquely at an angle relative to the longitudinal axis of the tubular housing to position the non-patient end of the needle adjacent to the inner wall of the tubular housing; Features: The elastic mechanism is integrated with the mounting member, and In the operating position before use, the mounting member and the needle seat are arranged at a set position relative to each other, and thereafter use of the safety needle assembly with the medical syringe causes a displacement from the set position; the displacement causes one of the mounting member or the needle seat to move relative to the other, so that when the safety needle assembly is separated from the medical syringe, the elastic mechanism can rotate the needle to the hidden position.

2. The safety needle assembly according to claim 1, characterized in that: The mounting member is arranged to move proximally relative to the needle hub so that displacement from the set position preloads the resilient mechanism to generate sufficient force to enable the resilient mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

3. The safety needle assembly according to claim 1, characterized in that: The mounting member is arranged to move distally relative to the needle hub so that displacement from the set position preloads the resilient mechanism to generate sufficient force to enable the resilient mechanism to rotate the needle to the hidden position when the safety needle assembly is removed from the medical syringe.

4. The safety needle assembly according to claim 1, characterized in that: The needle hub comprises a one-piece component having an integral mounting element in the form of a shaped surface on an outer surface, and wherein the shaped outer surface provides a spherical surface.

5. The safety needle assembly according to claim 4, characterized in that: The spherical surface enables the needle seat to be fixed by a ball and socket structure.

6. The safety needle assembly according to claim 4 or 5, characterized in that: The spherical surface enables a click-fit arrangement.

7. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The needle hub comprises a one-piece component having an integral mounting element in the form of a shaped axial member on the outer surface and wherein the axial member provides a hemispherical surface and enables the needle hub to be secured by a ball and socket arrangement.

8. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The use of the safety needle assembly and the medical syringe causes the position of the elastic mechanism to change relative to the needle seat.

9. The safety needle assembly according to any one of claims 1 to 3, characterized in that: In the set position, the elastic mechanism is partially or semi-preloaded or completely unloaded.

10. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The needle hub is positioned to rotate about an axis that intersects the longitudinal axis of the tubular housing.

11. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The mounting member is arranged to move axially along the longitudinal axis of the tubular housing.

12. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The elastic mechanism comprises a leaf spring, and an end of the leaf spring contacts the outer surface of the needle seat, and wherein the end of the leaf spring is arranged to move along the outer surface of the needle seat when the elastic mechanism and the needle seat are displaced from the set position.

13. The safety needle assembly according to any one of claims 1 to 3, characterized in that: The needle hub comprises a flange on an outer surface, and wherein the flange is arranged to contact the elastic mechanism so as to transmit the spring force to the needle hub.

14. A drug delivery device, characterized in that: The invention comprises a safety needle assembly and a medical syringe, wherein the safety needle assembly is any one of claims 1 to 13.

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