DESC:FIELD

[0001] The present disclosure relates to needle assemblies. More particularly, but not exclusively, the present disclosure relates to a needle assembly with a safety mechanism against inadvertent needle-stick injuries and related methods. In particularly, the present disclosure relates to a needle assembly for example a huber needle assembly having an automatic safety mechanism against inadvertent needle-stick injuries and related methods for subcutaneous injections.

BACKGROUND

[0002] Needle-stick injuries are a great concern in today’s health care industry. For example, in case of a Huber needle, an implanted port requires a special needle to be inserted through the skin of the patient and into the port. The most common type of such a needle includes a ninety degree bend and this type of needle is called a Huber needle. A vast majority of such injuries occur while withdrawing conventional huber needles from implanted ports after administering medications such as medical fluid or medicines, for example antibiotics, anti-viral or anti-fungal drugs.
[0003] A substantial force is required when pulling the Huber needle in order to get it out of the implanted port in that it may cause the needle to bounce-back which comprises a rebounding effect. In some instances, the use of substantial force may also lead to the Huber needle moving out of its protected position and in some instances the needle hub may also detach thereby exposing the needle. Because of a specific configuration of the needle, removing the Huber needle at the end of infusion therapy is, thus, particularly dangerous exposing the medical practitioner to a high degree of risk of inadvertent needle stick injury. A needle stick injury may expose the medical practitioner to serious transferable disease, such as hepatitis, HIV.
[0004] A need, therefore, exists to provide a needle assembly with a safety mechanism against accidental needle pricks.

SUMMARY AND OBJECTS

[0005] According to the apparatus, and method, described herein, there is provided a needle assembly with a safety mechanism comprising: a needle hub; a needle connected to the needle hub; a wing holder; a safety member being movable connected to the needle hub and the wing holder; and an integral locking mechanism for the needle. The needle, the needle hub, the wing holder, and the safety member each having a proximal end and a distal end. The proximal end of wing holder is hingedly connected to the proximal end of the needle hub. The needle hub and the wing holder each having a top surface and a bottom surface. The wing holder also acts as a base of the needle assembly.
[0006] An object and advantage of the present disclosure is to provide a needle assembly that is simple in construction and use, providing effective protection reducing the risk of needle stick injuries.
[0007] Another object and advantage of the present disclosure is to provide a needle assembly, for example a Huber needle assembly having an automatic safety mechanism and related methods. The needle assembly includes a safety mechanism that automatically retracts and locks the needle when the needle is withdrawn from the port of the wing holder, thereby eliminating the risk of bounce-back or any movement of the needle from its protected position. The disclosed assembly significantly reduces the likelihood of needle stick injuries.
[0008] Another object and advantage of the present disclosure is to provide a user-friendly and cost-effective needle assembly, as well as related methods.
[0009] Another object and advantage of the present disclosure is to provide an integrated needle locking mechanism for the needle assembly. The locking mechanism secures the needle in a protected position, preventing reuse of the needle after use.
[0010] Yet another object and advantage of the present disclosure is to provide a cover for the safety mechanism of the needle assembly.
[0011] A still further object and advantage of the present disclosure is to provide a safety mechanism that prevents both anti-rebound of the needle and its movement beyond a designated position i.e. a locked position, thereby preventing the needle from breaking out of the safety mechanism.
[0012] In some examples, the needle has a bent tip at the delivery end. The needle is fabricated from medical grade metal, such as stainless steel. The needle has two ends defining a length in that one end is securely connected to the needle hub, while the other end of the needle is the bent tip. The needle may be constructed as a single, one-piece component, ensuring structural integrity and reliability during use. The needle may comprise a bend (curvature) located approximately midway the length of the needle, which allows for optimal angling during insertion. Further, the distal end of the needle comprises a secondary bend near the bent tip.
[0013] The needle comprises both an exposed and an un-exposed portion. The exposed portion refers to the segment of the needle that is visible and accessible outside of the needle hub, while the unexposed portion is contained within the needle hub.
[0014] The needle has an effective length which is substantially equal to the exposed portion of the needle. The effective length of the needle is defined as the portion or length of the needle which is exposed outside of the needle hub.
[0015] The safety member has at least two ends defining a length wherein one end thereof is fixed with the needle assembly, and the other end thereof is free and movable.
[0016] In some examples, both the ends of the safety member are connected to or fixed with components of the needle assembly. For example, both ends of the safety member are connected to or fixed with the needle assembly, wherein one end of the safety member being movable is connected to or fixed with the needle hub and the other end being movable is connected to or fixed with the wing holder.
[0017] The needle assembly of the present disclosure is designed with a robust locking mechanism, including a back lock feature that enhances safety during medical procedures. The integral locking mechanism provided in the needle assembly comprises a back lock that securely engages with the needle tip when the needle hub is lifted away from the wing holder. The back lock is positioned adjacent to a through hole in the needle hub to facilitate seamless engagement with the needle tip once retracted. The needle assembly allows for a two-handed approach to safely retract the needle from a patient, ensuring controlled lifting of the needle hub. As the user elevates the needle hub, a safety member guides the needle tip into a designated back lock. The back lock securely captures the needle tip, preventing any unintended movement or dislodgement, even when subjected to external forces. Once engaged, the back lock ensures that the needle remains in a protected position, effectively eliminating risks associated with accidental needlestick injuries during use or disposal. The locking mechanism comprising the back lock is designed to engage automatically upon lifting the needle hub, ensuring immediate locking of the needle tip in the back lock. The configuration of the back lock prevents any backward movement of the needle tip once it is engaged, thereby eliminating risks of accidental exposure. Thus, the back lock significantly improves the safety and reliability of needle assembly handling in medical applications. The back lock includes a tapered design that facilitates smooth engagement and secure retention of the needle tip during retraction. The back lock mechanism may include an audible click feature that signals successful engagement of the needle tip into the locked position. The back lock mechanism is integrally constructed from a durable material that withstands repeated use and maintains locking integrity under various handling conditions.
[0018] In some examples, the needle assembly incorporates a unique U cut feature at the proximal end of the wing holder, which significantly enhances the maneuverability of the needle hub. The U cut design provides an extended length for the needle hub, creating a dedicated space that allows for unobstructed movement during medical procedures. The U cut configuration prevents kinking or bending of the extension tube attached to the needle hub, thereby ensuring optimal fluid delivery and administration. The enhanced flexibility afforded by the U cut is particularly advantageous in dynamic clinical settings, where precise positioning of the needle hub is crucial. The U cut is formed with a curvature that enhances the flexibility of the needle hub while ensuring stability during use. The dimensions of the U cut are adjustable to accommodate different lengths and configurations of needle hubs for enhanced compatibility with various medical applications. It is to be understood that the shape of cut is not limited only to U shape and may be in the form of other alternative shapes, for example, rectangular, oval, square etc.
[0019] In some examples, the safety member has at least one free end. The end other than the free end of the safety member is connected to or fixed with the wing holder being in movable connection with the needle hub. Alternatively, the end other than the free end of the safety member is connected to or fixed with the needle hub being in movable connection with the wing holder. The two ends of the safety member define a length.
[0020] In some examples, the length between the two ends of the safety member may vary depending on the effective length of the needle. The length of the safety member facilitates the activation of the safety mechanism viz-a-viz the effective length of the needle in that the length of the safety member creates a limiting force on the needle during the transition of the needle assembly from a ready position to a protected position thereby effectively locking the needle in place and minimizing the risk of accidental needle stick injuries.
[0021] In some examples, the length between the two ends of the safety member may be equal to the effective length of the needle. Such a configuration ensures a precise match between the safety member’s length and the exposed portion of the needle, allowing for optimal activation of the safety mechanism and effective locking of the needle the protected position.
[0022] In some examples, the length between the two ends of the safety member may be less than the effective length of the needle.
[0023] In some examples, the length between the two ends of the safety member may be more than the effective length of the needle.
[0024] In some examples, the safety member, not being limited to, may be a wire and/or a rope and/or a thread and/or a T shaped rod.
[0025] In some examples, the safety member, not being limited to, may be configured in the form of a hoop or loop.
[0026] In some examples, the safety member may be flexible and/or rigid and/or both i.e. flexible as well as rigid.
[0027] In some examples, the safety member has at least one change in profile.
[0028] In some examples, the safety member has at least one change in profile at only one end thereof.
[0029] In some examples, the safety member has at least one change in profile at both the ends thereof.
[0030] In some examples, the safety member has at least one change in profile in between both the ends thereof.
[0031] In some examples, the safety mechanism includes a cover for the safety member. The cover may be a movable cover or alternatively a fixed cover.
[0032] The change in profile may be formed in the form of a shoulder, bulge formed as an annular widening and by adding material onto the outer surface of the safety member or by adding a sleeve to the safety member for example, by welding, gluing, insert molding, flattening or soldering etc. The added material may include a metal material, a plastic material, adhesive, resin or the like. In the case of the added material being metal material, the change in profile may, for example, be formed by build-up welding or by soldering of the additional material onto the safety member. Alternatively, the additional material could be glued to the safety member. The change in profile in the form of an enlargement may be referred to as a crimp, a sleeve, an annular sleeve, part annular sleeve, a bulge, a section of the safety member with added material or combinations thereof. The change in profile may also be made in a manner wherein two components are joined by press fitting e.g. plastic creating a T shape or other shape in the form of a change in profile.
[0033] In some examples, the needle hub has a channel through which a portion of the needle passes through. The un-exposed portion of the needle is received within the needle hub and passes through the channel, which in turn is connected to a flexible extension tube, thereby establishing a fluid connection. The exposed portion of the needle, which constitutes the effective length, remains outside of the needle hub. The channel may be sized and adapted to provide a tight fit around the needle and the tube, ensuring stability and proper alignment during operation of the assembly.
[0034] In some examples, a taper angle is provided in at least one of the two i.e. the needle hub or the wing holder. The taper angle acts as a safety mechanism. In some examples, the taper angle is provided at the proximal end of the wing holder. When the needle is retracted, the taper angle functions as a stopping mechanism for the needle, effectively preventing the needle from retracting or moving beyond a designated position i.e. a locked position once the needle is secured in the protected position. The taper angle may vary depending on the size and dimension of the needle hub and/or the needle. For example, the taper angle may vary depending on the length or height of the needle hub or length of the needle. The taper angle acts as a safety mechanism and in aid to locking mechanism of the needle to prevent bounce-back of the needle or prevent the needle from retracting or moving beyond the designated locked position. The taper angle, thus, works in tandem with other safety mechanisms discussed herein thereby locking the needle in place in the locked position. The taper angle further facilitates immovable locking of one end of the needle hub and the wing holder when in the protected position. In some examples, the taper angle immovably locks the proximal ends of the needle hub and the wing holder in the protected position.
[0035] In some examples, the proximal end of the needle is connected to a tube for administration of medications such as medical fluid or medicines. As such, one end of the tube being connected to the proximal end of the needle is connected to the proximal end of the needle hub and other end of the tube is connected to a joining member, for example a luer lock such as a luer lock having female luer in order to make a leak free connection between two parts/components. One or more clamp(s) are movably connected to the tube to regulate the flow of liquid or fluid through the tube.
[0036] In some examples, at least one through hole is provided in at least one of the two i.e. the needle hub or the wing holder or both. The through hole acts as a stopping element for the safety member. The through hole may also act as a guiding means for the safety member ensuring proper positioning and operation of the safety member within the assembly.
[0037] In some examples, the wing holder at its distal end has a port having a through hole. The hole in the port allows the needle to slidably pass therethrough, enabling the needle to extend out of the wing holder for use during medical procedures. The through hole in the port is adapted to facilitate a smooth and controlled movement of the needle as it is inserted and retracted.
[0038] In some examples, the wing holder has at least two wings attached on the two sides of the wing holder opposing each other. The wings provide additional stability and ease of handling during the insertion and removal of the needle assembly. Alternatively, the wing holder may be without wings.

BRIEF DESCRIPTION OF THE DRAWINGS

[0039] The above and other objects and advantages of the disclosure will be apparent upon consideration of the following detailed description, taken in conjunction with the accompanying drawings, in which like reference characters refer to like parts throughout, and in which:
[0040] FIGS. 1A, 1B & 1C illustrate a side, front and top views respectively of a needle assembly, for example a huber needle assembly in a ready position, in accordance with some examples of the present disclosure;
[0041] FIGS. 1D, 1E, 1F & 1G illustrate various perspective views respectively of the needle assembly as shown in Fig. 1A in the ready position, in accordance with some examples of the present disclosure;
[0042] FIGS. 2A & 2B illustrate side and front views respectively of the needle assembly as shown in Fig. 1 in a protected position, in accordance with some examples of the present disclosure;
[0043] FIGS. 2C, 2D, 2E & 2F illustrate various perspective views respectively of the needle assembly as shown in Fig. 1A in the protected position, in accordance with some examples of the present disclosure;
[0044] FIG. 2G illustrates a cross-sectional side view of the needle assembly as shown in Fig. 1A in the protected position, in accordance with some examples of the present disclosure;
[0045] FIG. 3 illustrates a cross-sectional side view of the needle assembly in the protected position, in accordance with some examples of the present disclosure;
[0046] FIGS. 4A – 4D illustrate various perspective views respectively of the needle assembly in the protected position, in accordance with some examples of the present disclosure;
[0047] FIG. 5 illustrates the needle assembly with a cover for the safety member, in accordance with some examples of the present disclosure; and
[0048] FIG. 6 illustrates a side view of the needle assembly with connected components.

DETAILED DESCRIPTION

[0049] The present disclosure relates to needle assembly 10, such as a Huber needle assembly with a safety mechanism that substantially minimizes the risk of injury and user exposure to blood borne pathogens, and any other undesirable elements, living or non-living that may be transported through air or by direct contact while using the device. As shown in FIGS. 1A, 1B & 1C, a Huber needle assembly 10 is depicted in various orientation, including a side, front and top views respectively, in a ready position in accordance with some examples of the present disclosure. Reference is also made to FIGS. 1D, 1E, 1F & 1G which illustrate various perspective views respectively of the huber needle assembly 10 as shown in Fig. 1A. Further reference is made to Figs. 4A-4D which illustrate various perspective views respectively of the needle assembly in the protected position, in accordance with some examples of the present disclosure. The safety mechanism is designed to cover the sharp needle tip at the distal end of the needle and securely lock the sharp distal tip within the assembly 10 after use, thereby reducing the likelihood of accidental needlestick injuries during needle removal, transport and disposal.
[0050] As shown in the referenced figures, the huber needle assembly 10 is provided with a safety mechanism designed to enhance user safety and operational efficiency. The assembly 10 comprises a needle hub 12, a huber needle 14 connected to the needle hub 12, a wing holder 16 which enhances the ease of handling and maneuverability of the assembly 10 during use. The assembly 10 further comprises a safety member 18 which is movably connected to both the needle hub 12 and the wing holder 16. The assembly 10 further includes an integral locking mechanism for the needle 14, which ensures that the needle 14 remains securely locked in a retracted position once the procedure is completed.
[0051] In the assembly 10, as illustrated in the referenced figures, each of the components, namely the needle 14, the needle hub 12, the wing holder 16 and the safety member 18 having a proximal 20 and a distal 22 end.
[0052] The assembly 10 as shown in Figs. 1A & 2A comprises a hinged connection 24 that securely links the proximal end 20 of the wing holder 16 to the proximal end 20 of the needle hub 12. The hinged connection 24 serves as a pivotal point, allowing for the pivotability of the needle hub 12 in relation to the wing holder 16. The hinged connection 24 enables the user to adjust orientation of the needle hub 12 and the attached needle 14 relative to the wing holder and the patient’s skin, facilitating optimal positioning and insertion angle during the procedure. As such, the hinged connection 24 is configured to provide smooth and controlled range of motion, ensuring that the needle hub 12 can be pivoted with precision and stability. The hinged connection 24 is designed in a manner to maintain its integrity throughout the procedure, withstanding the forces exerted during insertion, use, and retraction of the needle 14.
[0053] As depicted in Figs. 1E and 1F, both the needle hub 12 and the wing holder 16 having distinct top surface(s) 26 and bottom surface(s) 28 which contribute to the overall functionality and user interaction with the assembly 10. The top surfaces 26 of these components are oriented towards the user, facilitating easy handling during procedures, while the bottom surfaces 28 are positioned against the patient’s skin, providing stability and support during needle 14 insertion. The wing holder 16 serves a dual purpose by functioning not only as a handle for the user but also as a base of the needle assembly 10. The wing holder 16 at its distal end 22 has a port 40 having a through hole 42 as shown in Fig. 2G. The through hole 42 is configured to allow the needle 14 to slidably pass through, enabling smooth and controlled movement of the needle 14 during insertion and retraction. The profile of the port 40 and the hole 42 integrally made therein ensures that the needle 14 can be accurately positioned within the port 40, thereby facilitating precise access to vascular sites while minimizing the risk of misalignment.
[0054] The needle 14 having a length has a bent tip 48 i.e. a delivery end which serves to facilitate precise access to implanted ports and vascular sites. The needle 14 is formed of metal, such as medical grade stainless steel, ensuring durability, strength, and biocompatibility. The needle 14 can be one-piece construction which contributes to its structural integrity, minimizing the risk of component failure during use. Further, the needle 14 is configured with a bend or curvature 50 located approximately midway the length of the needle 14 thereon as shown in Fig. 2G. The needle hub 12 of the assembly 10 comprises a channel 36 configured to accommodate a portion of the needle 14. The bend 50 in the needle 14 effectively divides the needle 14 into two distinct segments: a proximal part and a distal part. The proximal part, located anterior to the bend 50, being connected to is securely received within the channel 36 of the needle hub 12. The channel 36 ensures a secure and stable connection between the needle hub 12 and the proximal portion of the needle 14, facilitating effective transfer of forces during needle insertion and manipulation. Whereas the distal part of the needle 14, situated posterior to the bend, is exposed and slidably received within the through hole 42 that is integrally formed in the port 40 of the wing holder 16.
[0055] As depicted in Fig. 2G, the distal end 22 of the needle 14 includes another bend 52 nearing the bent tip 48., the entire bend portion of the needle, which encompasses both the bent tip 48 and the adjacent straight portion at the distal end, is configured to enter the through hole 42 of the port in a manner that aligns the centerline of the hole 42. Such an alignment ensures that the needle 14 can be smoothly and accurately inserted into the port 40 without obstruction or misalignment, thereby enhancing the ease of use for the medical practitioner. Further such an alignment, allows for a degree of tolerance during the insertion process, accommodating slight variation in angle or positioning while still maintaining effective engagement with the hole 42 while transitioning from the ready to the protected position.
[0056] The assembly 10 further comprises a pair of opposing wings 38 that are integrally connected to the wing holder 12. Constructed from a soft, flexible material, the wings 38 provide a comfortable grip for the medical practitioner, allowing for easy manipulation and control during insertion and stabilization of the needle 14. The configuration and design of the wings 38 permits them to be pivoted in various directions, enabling the user to hold the wings 38 securely with their fingers for optimal leverage and precision. The wings 38 can be pivoted to be applied on the skin of a patient. The connection of the wings 38 to the wing holder 16 at the base allows for a wide range of motion, permitting the wings to be bent, rotated, pivoted, flapped, or otherwise adjusted up or down as needed.
[0057] The assembly 10 is configured to include a flexible tube 62 that is integrally connected to the proximal end of the needle 14 as depicted in Fig. 6, facilitating the administration of medications, medical fluids or other therapeutic agents through the needle 14. One end of the tube 62 is securely connected to the proximal end 20 of the needle 14, which is in turn integrated with the needle hub 12, ensuring a stable and reliable connection that withstands the pressure associated with fluid administration. The tube 62 is constructed from materials that can withstand repeated flexing and pressure variations without compromising its integrity. The opposite end of the tube 62 is integrally connected to a joining member 64, for example a luer lock fitting such as a female luer lock configured to create a leak-fee connection between the assembly 10 and other medical devices or fluid delivery systems. Further, one or more clamp(s) 66 is movably connected to the tube 62, allowing the medical practitioner or user to regulate the flow of liquid or fluid through the tube 62. One or more Y connectors 68 are also integrally connected with the tube 62 providing connection points enabling multiple connections to different fluid sources or delivery pathways.
[0058] As shown in Figs. 1A-1G, the safety member 18 of the assembly 10 has at least one free end 30. The end of the safety member 18 that is opposite the free end 30 is fixedly connected to the wing holder 16 at a predetermined connection point 60. Such a fixed connection secures the safety member 18 to the wing holder 16, while the free end 30 remains movable being in engagement with the needle hub 12. The connection point 60, at which the safety member 18 is fixedly attached to the wing holder 16, is strategically positioned at the distal end of the wing holder 16. The proximity of the connection point 60 to the port 40, through which the needle 14 passes, enhances the effectiveness of the safety member 18 in covering the needle tip upon retraction. While such a location is not intended to be limiting, it has been selected to optimize the functionality and safety of the needle assembly 10. It is to be understood that the connection point 60 can be located at any other location in the wing holder 16. In some examples, the connection point may be a through hole.
[0059] The free end 30 of the safety member 18 is configured to transverse through at least one through hole 44 that is provided in the distal end of the needle hub 12. The through hole 44 has a dimension defining the hole. The safety member 18, thus being connected to the wing holder 16 is in a movable connection with the needle hub 12 through said hole 44. Said at least one through hole 44 may be provided in at least one of the two i.e. the needle hub 12 or the wing holder 14 or both. Further, the safety member 18 has at least one change in profile 32 at only one end thereof, in particularly at the proximal end of the free end 30. The change in profile 32 is configured to interact with the through hole 44. The change in profile 32 acts as a stopping element once it interacts with the through hole 44 once the needle 14 is retracted. As shown in Figs. 2A-2G, when the needle 14 is retracted, the change in profile 32 interacts with the through hole 44, ensuring that the safety member 18 is securely positioned and preventing any unintended movement. The combination of through hole 14 and change in profile act as a limiting mechanism for the retraction of the needle 14 thereby preventing the needle 14 from moving backward or beyond a designated position i.e. a locked position 54 in the protected position as shown in Fig. 2G. In this protected position, the change is profile 32 is firmly abutted against the through hole 44, effectively locking the needle in place. Furthermore, the through hole 44 not only functions as a stopping point but also serves as a guiding means, allowing the safety member 18 to slide smoothly therethrough. Such a mechanism not only enhances safety by ensuring that the needle 14 is safely retracted but also allows for a controlled and smooth needle retraction process, ensuring that the needle 14 moves in a predictable manner.
[0060] The safety member 18, not being limited to, may be a wire and/or a rope and/or a thread and/or a T shaped rod or member. In some examples, the safety member 18 has at least one change in profile 32 at only one end thereof. In some examples as depicted in Fig. 3, the safety member 18 may have at least one change in profile 32 at both the ends thereof. In some examples, the safety member 18 may have at least one change in profile 32 in between both the ends thereof. The change in profile 32 has a dimension bigger than the dimension of the through hole 44.
[0061] Referring to Fig. 2A & 2B, these figures depict side and front views, respectively, of the needle assembly 10, as illustrated in Fig. 1, in a protected position. Additionally, Figs. 2C, 2D, 2E & 2F depict various perspective views respectively of the needle assembly 10 as shown in Fig. 1 in the protected position. Referring further to FIG. 2G which illustrates a cross-sectional side view of the huber needle assembly in the protected position, a taper angle 46 in at least one of the two i.e. the needle hub 12 or the wing holder 14 is provided which acts as a safety mechanism. As depicted in Fig. 2G, the taper angle 46 is provided at the proximal end 20 of the wing holder 16. When the needle 14 is retracted, the taper angle 46 functions as a stopping mechanism for the needle 14, effectively preventing the needle 14 from retracting or moving beyond a designated position i.e. a locked position 54 once the needle is secured in the protected position as depicted in Fig. 2G. The taper angle 46 may be in a range of 0 to 180 degrees, with its specific value being contingent upon the size and dimensions of the needle hub 12 and/or the needle 12. For example, the taper angle 46 may vary depending on the length or height of the needle hub 12 or length fot the needle 14. The taper angle 46 acts as a safety mechanism and in aid to the locking mechanism of the needle 14 in the protected position. The taper angle 46 effectively prevents the needle 14 from experiencing bounce-back or moving beyond a designated position i.e. the locked position 54 upon retraction. The taper angle 46 thus ensures that upon retraction the needle 14 remains securely locked in a designated position i.e. the locked position 54, working in conjunction with other safety features described herein to maintain the locked position 54 of the needle 14 in the protected position. Furthermore, the taper angle 46 enhances the stability of the assembly 10 by facilitating the immovable locking of one end of the needle hub 14 and the wing holder 16 when in the protected position. In some examples, the taper angle 46 immovably locks the proximal ends of the needle hub 14 and the wing holder 16 in the protected position.
[0062] Referring further to Figs. 2G & Fig. 3, the operation of the needle assembly 10, including its protected position, locking mechanism, and safety mechanism will be described in detail. To safely remove the needle assembly 10 from a patient, the user begins by applying pressure to the two wings 38 attached to the wing holder 16 using one hand. Concurrently, the user grips the distal portion of the needle hub 12 using the other hand. Such a two hand approach provides the necessary leverage and control to lift the needle hub 12 away from the wing holder 16. As the needle hub 12 is lifted away from the wing holder 16, the change in profile 32 of the safety member 18 moves toward the through hole 44 of the needle hub 12, facilitating the retraction of the needle 14. During such lifting up action, the needle hub 12 is adapted to be elevated to a specific point where the change in profile 32 of the safety member 18 abuts the through hole 44 provided in the needle hub 12. Upon abutment of the change in profile 32 with the thorough hole 44, the needle tip 48 of the needle 14 is securely and immovably locked in a back lock 72 situated in an upper portion 56 adjacent to the hole 42 of the port 40 in the wing holder 16. This locking mechanism is designed to ensure that once the needle tip 48 engages with the back lock 72, it remains firmly in place, preventing any unintended movement or dislodgement from its locked position even under use of intentional or unintentional force including a pulling or pushing force by a user against the needle 14. The safety member 18 ensures that as the needle hub 12 is lifted, the bent tip 48 is guided into the back lock 72, effectively preventing any backward movement of the needle 14. Once the bent tip 48 is received in the back lock 72, it becomes immovably locked, thereby securing the needle 14 in a protected position. The back lock 72 thus provides a reliable anchoring point for the needle 14. At this point, the needle assembly 10 is rendered ready for safe disposal, as the locking mechanism ensures that the needle 14 cannot inadvertently extend or become exposed during further handling for disposal eliminating the risk of accidental needlestick injuries.
[0063] Furthermore, during the aforementioned pulling up action, the taper angle 46 facilitates the elevation of the needle hub 12, allowing the needle hub 12 to be pulled upward until the change in profile 32 of the safety member 18 abuts against the through hole 44 provided in the needle hub 12. Thus, the combination of the effect of the taper angle 46 and the abutment of the change in profile 32 of the safety member 18 with the through hole 44 brings the bent tip 48 of the needle 14 securely and immovably locked within the back lock 72 in the upper portion 56 adjacent to the hole 42 of the port 40 of the wing holder 16. Once received in the back lock 72, the bent tip 48 of the needle 14 is immovably locked rendering the needle assembly 10 ready for safe disposal.
[0064] Referring to Figs. 4A-4B, in addition to the features discussed above, in some examples, the proximal end of the wing holder 16 is configured with a U cut 70. The design of U cut 70 allows the needle hub 12 even longer in length a dedicated maneuverability space while maintaining unobstructed movement, thereby preventing any kinking or bending of the extension tube 62 attached to the needle hub 12. The U cut 70 effectively creates a dedicated maneuverability space for the needle hub 12, facilitating a greater range of motion during medical procedures. Such enhanced flexibility is particularly beneficial in dynamic clinical environments where precise positioning of the needle hub 12 is essential for effective fluid delivery and administration.
[0065] Referring now to Fig. 5, the illustrated example except for the above discussed features/components, includes a cover 34 for the safety member 18 as shown in Fig. 1A. The cover 34 has a proximal end 20 and a distal end 22, and it is connected to the needle hub 12. The cover 34 protects and covers the safety member 18 being arranged movably within an inner space provided in the cover 34. The cover 34 thus prevents the exposure of the safety member 18 to a user. The cover 34 further comprises a cap 58 integrally formed in the distal end region of the cover 34 which facilitates the pulling up and pushing down of the needle 14 during the operation of the needle assembly 10. The cover 34 could be integrally formed with the needle assembly 10, forming a unitary structure. It is to be understood, though, that the cover 34 could be a separate component and connected or joined either temporarily or permanently, whether mechanically attached adhered or joined or welded or by other connecting/joining means or mechanism with the needle assembly 10. The cover 34 may be formed of any material suitable for medical use, such as elastomer, silicon, steel, plastic, glass, thermoplastic material, and/or a combination thereof.
[0066] As used herein, the term “proximal”, “bottom”, “down” or “lower” refers to a location on the device that is closest to the medical practitioner using the device and farthest from the patient in connection with whom the device is used when the device is used in its normal operation. Conversely, the term “distal”, “top”, “up” or “upper” refers to a location on the device that is farthest from the clinician using the device and closest to the patient in connection with whom the device is used when the device is used in its normal operation. For example, the distal region of a needle will be the region of the needle containing the needle tip which is to be inserted e.g. into a patient's vein.
[0067] The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the present disclosure. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. As used herein, the term "and/or" includes any and all combinations of one or more of the associated' listed items.
[0068] It can be further understood that the terms "comprises" "comprising," "includes" and/or "including" when used herein, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this present disclosure belongs. It will be further understood that terms used herein should be interpreted as having a meaning that is consistent with their meaning in the context of this specification and the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.
[0069] It can be further understood that the terms "protected position" or “post use position” when used herein, refers to the state of the needle when it is locked and/or shielded, minimizing the risk of accidental needlestick injuries. When the needle is in the protected position, it is ready to be disposed of ensuring the safety of healthcare professionals and patients.
[0070] It can be further understood that the terms "ready position" or “pre use position” when used herein, refers to the state of the needle when it is ready to be inserted, for example into the septum of a subcutaneously implanted port.
[0071] It can be further understood that the terms “locked position” when used herein, refers to the state wherein the needle/huber needle is safely guarded once the needle is retrieved from the subcutaneously implanted port.
[0072] The components of the needle assembly 10 can be fabricated from a variety of suitable materials, including plastic, metal, or composites, depending on the specific design requirements and intended use. In some examples, needle assembly 10 may be constructed as a unitary structure, with the needle hub 12, needle 14, wing holder 16, wings 38, and the cover 34 integrally formed as a single piece. This can simplify the manufacturing process and enhance the structural integrity of the assembly. It is to be understood, though, that the individual components of the needle assembly 10 could be separate components and connected or joined either temporarily or permanently. The connection methods can include mechanical attachment, adhesive bonding, welding, or other suitable joining techniques. The needle assembly 10 may be fabricated of any material suitable for medical use, such as elastomers, silicone, stainless steel, plastic, glass, thermoplastic material, and/or a combination thereof.
[0073] The above-stated descriptions are merely example implementations of this application but are not intended to limit the protection scope of this application. A person with ordinary skills in the art may recognize substantially equivalent structures or substantially equivalent acts to achieve the same results in the same manner or a dissimilar manner; the exemplary embodiments or examples should not be interpreted as limiting the disclosure to one embodiment.
[0074] While aspects of the present disclosure have been described in detail with reference to the illustrated examples, those skilled in the art will recognize that many modifications may be made thereto without departing from the scope of the present disclosure. The present disclosure is not limited to the precise construction and compositions disclosed herein; any and all modifications, changes, and variations apparent from the foregoing descriptions are within the spirit and scope of the disclosure as defined in the appended claims. Moreover, the present concepts expressly include any and all combinations and sub combinations of the preceding elements and features. The description is provided for clarification purposes and is not limiting. Words and phrases are to be accorded their ordinary, plain meaning unless indicated otherwise. More generally, the above disclosure is meant to be illustrative and not limiting. Only the claims that follow are meant to set bounds as to what the present invention includes. Furthermore, it should be noted that the features and limitations described in any one example may be applied to any other example herein, and features relating to one example may be combined with any other example in a suitable manner, done in different orders, or done in parallel. It should also be noted that the devices and/or methods described above may be applied to, or used in accordance with, other devices and/or methods.
,CLAIMS:
1. A needle assembly (10) with a safety mechanism comprising: a needle hub (12); a needle (14) connected to the needle hub (12); a wing holder (16); a safety member (18) being movable connected to the needle hub (12) and the wing holder (16); and an integral locking mechanism for the needle (14), wherein the needle (14), the needle hub (12), the wing holder (16), and the safety member (18) each have a proximal end (20) and a distal end (22); the proximal end (20) of the wing holder (16) is hingedly connected through a hinged connection (24) to the proximal end (20) of the needle hub (12).

2. The needle assembly (10) as claimed in claim 1, wherein the wing holder (16) includes a port (40) at its distal end (22), the port (40) having a through hole (42) allowing the needle (14) to slidably pass therethrough.

3. The needle assembly (10) as claimed in claim 1, wherein the needle hub (12) includes a channel (36) through which a portion of the needle (14) passes.

4. The needle assembly (10) as claimed in claim 1, wherein the safety member (18) has at least one free end (30).

5. The needle assembly (10) as claimed in claim 1, wherein an end of the safety member (18), other than the free end (30), is connected to the wing holder (16) being in a movable connection with the needle hub (12).

6. The needle assembly (10) as claimed in claim 5, wherein the movable connection of the safety member (18) provided through at least one through hole (44) provided in at least one of the two i.e. the needle hub (12) or the wing holder (14).

7. The needle assembly (10) as claimed in claim 1, wherein the safety member (18) comprises a wire and/or a rope and/or a thread and/or a T shaped rod.

8. The needle assembly (10) as claimed in claim 1, wherein the safety member (18) is in a form of hoop or loop.

9. The needle assembly (10) as claimed in claim 1, safety member (18) is flexible and/or rigid and/or both.

10. The needle assembly (10) as claimed in claim 1, wherein the safety member (18) has at least one change in profile (32).

11. The needle assembly (10) as claimed in any of the preceding claims, wherein the safety member (18) has at least one change in profile (32) at one end thereof.

12. The needle assembly (10) as claimed in any of the preceding claims, wherein the safety member (18) has at least one change in profile (32) at both the ends thereof.

13. The needle assembly (10) as claimed in any of the preceding claims, wherein the safety member (18) has at least one change in profile (32) in between both the ends thereof.

14. The needle assembly (10) as claimed in claim 1, wherein a taper angle (46) is provided in at least one of the needle hub (12) or the wing holder (14).

15. The needle assembly (10) as claimed in claim 15, wherein the taper angle (46) varies depending on the size and dimension of the needle hub (12) and/or the needle (14).

16. The needle assembly (10) as claimed in claim 1, further comprising a cover (34) connected to the needle hub (12), the cover having a proximal end (20) and a distal end (22) adapted to cover the safety member (18) being arranged movably within an inner space provided in the cover (34).

17. The needle assembly (10) as claimed in any of the preceding claims, wherein the safety member (18) has at least two ends defining a length.

18. The needle assembly (10) as claimed in claim 17, wherein both ends of the safety member (18) are fixed with the assembly (10), with one end of the safety member (18) being movable is connected to or fixed with the needle hub (12), and the other end being movable is connected to or fixed with the wing holder (16).

19. The needle assembly (10) as claimed in claim 17, wherein one end of the safety member (18) is fixed with the assembly (10), and the other end of the safety member (18) is free and movable.

20. The needle assembly (10) as claimed in claim 1, wherein the needle (14) has an effective length comprising an exposed and an un-exposed portion.

21. The needle assembly (10) as claimed in any of the preceding claims, wherein the length between the two ends of the safety member (18) varies depending on the effective length of the needle (14).

22. The needle assembly (10) as claimed in claim 1, wherein the integral locking mechanism further comprises a back lock (72) that securely engages with the needle tip (14) when the needle hub (12) is lifted away from the wing holder (16).