WO2011075320A1

WO2011075320A1 - Needle guard

Info

Publication number: WO2011075320A1
Application number: PCT/US2010/058714
Authority: WO
Inventors: Randy Joe Myers
Original assignee: Cook Incorporated
Priority date: 2009-12-15
Filing date: 2010-12-02
Publication date: 2011-06-23

Abstract

A needle guard assembly (10) is provided with a needle guard (24) pivotally mounted on a hub (12) by a living hinge. The hub may be connected to a needle (20) and a syringe (22). The needle guard may have one side with a mating surface for interaction with the syringe and another side having a longitudinal groove that is configured to fit around at least a portion of the needle. The needle guard is movable between an open position in which the mating surface of the needle guard is adjacent to the surface of the syringe and a closed position in which at least a portion of the longitudinal groove fits around at least a portion of the needle. The longitudinal groove of the needle guard may be positioned over the sharp distal tip of a needle in order to protect medical personnel and patients from accidental needle sticks.

Description

NEEDLE GUARD

BACKGROUND

[0001] The present invention relates generally to medical devices and more particularly to devices for protecting a needle.

[0002] Medical professionals may handle a variety of sharp devices such as scalpels and needles during their work. These devices pose a risk of sharps-related injuries to both medical professionals (e.g., laboratory staff, physicians, nurses) and their patients. One type of sharps-related injury that is particularly common is needle stick injuries. Needle stick injuries occur when an unintended person is accidentally pricked by a needle. Some studies estimate that between 600,000 and 800,000 needle stick accidents occur annually.

[0003] Needle stick injuries may expose medical professionals and their patients to a variety of bloodborne pathogens. Transfer of bloodborne pathogens via a needle stick injury occurs when the needle is contaminated prior to the needle stick accident. Some bloodborne pathogens that may be transmitted through needle stick injuries include Hepatitis B, Hepatitis C, Human Immunodeficiency Virus (HIV), Herpes Virus, Malaria and Tuberculosis. Many of these pathogens are potentially life threatening or incurable. Moreover, screening and treatment for a person who is accidentally pricked by a needle may be very costly. In addition, a victim of a needle stick accident may suffer from anxiety as a result of possible exposure to pathogens. This anxiety may occur even when the needle was not actually contaminated at the time of the accidental needle stick. In addition, because some diseases may not be detectable until weeks or months after a needle stick accident, a victim of a needle stick accident may suffer from such anxiety long after the injury occurred even if the victim did not contract any pathogen.

[0004] Due to the risks and costs associated with needle stick accidents, procedures and devices have been developed to safely dispose of contaminated needles, thereby reducing the occurrence of accidental needle sticks. [0005] One principal method for avoiding an accidental needle stick is to dispose of a used needle immediately after use without recapping it. However, relying solely on being able to dispose of the needle immediately after a procedure has disadvantages. The used needle must be disposed of promptly in order to reduce the risk of injury between use of the needle and disposal. However, prompt disposal may not be possible. In order to avoid potential accidental needle sticks after disposal, needles and other sharps must be disposed of in special puncture resistant containers. Contaminated needles must also be disposed of as biohazards. Suitable disposal containers may not always be immediately available in the vicinity of the location in which a needle is used. Thus, there is a risk of an accidental needle stick occurring between the use of the needle and the time at which it may be properly disposed.

[0006] A second way to reduce the risk of an accidental needle stick is to recap the needle using a one-handed recapping procedure. Needle sticks often occur when a person attempts to recap a needle using two hands, i.e., when holding the needle in one hand and the cap in the other. The person may miss the cap and accidentally stick the hand holding the cap. In some cases, the needle may puncture the cap and subsequently the hand holding the cap. One-handed recapping procedures are designed to avoid such risks. One-handed recapping can be accomplished by the one-handed scoop technique. The one-handed scoop technique requires that the needle cap be placed loose on a flat surface. The needle is then slid into the cap and scooped upwards until the cap slides onto the needle. Only one hand is used to avoid an accidental needle stick. This technique may not be practical for all medical professionals because it requires a flat surface. Thus, the medical professional may have to carry the exposed needle for a distance before reaching a location where the technique may be practiced. Until it is recapped, the exposed needle poses a risk of an accidental needle stick to the medical professional, other personnel, and the patient.

[0007] A third method for preventing accidental needle sticks is the use of specialized recapping devices. However, needle recapping devices may not be immediately available to medical personnel. These devices are not attached to the needle and thus require the medical personnel to carry the capping device with them whenever a needle may need to be capped. It is possible that medical personnel may forget to bring a needle recapping device with them when performing procedures requiring needles, particularly in an emergency situation. In addition, many recapping devices are designed to be set on a flat surface. It may be impractical to have such devices set up in every possible location where medical personnel may use a needle. In addition, a needle recapping device may be located at a distance from the place where the needle is used. Thus, the person holding the needle must move the exposed needle, risking injury to the person, other medical personnel and the patient.

BRIEF SUMMARY

[0008] A needle guard assembly having a needle guard pivotally mounted on a hub by a living hinge is described. The hub may be connected to a needle and a syringe. The needle guard may have a hinged end and protective end. The needle guard may also have a first side having a mating surface for interaction with a syringe and a second side with a longitudinal groove. The needle guard may be capable of moving between an open position and a closed position. In the open position, a portion of the mating surface of the first side of the needle guard is configured to be adjacent to the syringe. In the closed position, at least a portion of the longitudinal groove of the second side of the needle guard is capable of fitting around at least a portion of the needle. The needle guard may be moved from the open position to the closed position after use. In the closed position, the sharp tip of the needle is shielded within the longitudinal groove of the needle guard, thereby protecting medical personnel and patients from accidental needle sticks.

[0009] The invention may include any of the following aspects in various combinations and may also include any other aspect described below in the written description or in the attached drawings. [0010] One embodiment of a needle guard assembly comprises: a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is capable of being attached to a needle and the proximal end of the hub is capable of being attached to a syringe; and a needle guard having a hinged end and a protective end, the hinged end of the needle guard being pivotally mounted on the hub by a living hinge, the needle guard having a first side having a mating surface for interaction with a syringe and a second side having a longitudinal groove, wherein the needle guard is capable of moving between an open position in which a portion of the mating surface of the first side of the needle guard is configured to abut a syringe and a closed position in which at least a portion of the longitudinal groove of the second side of the needle guard is capable of fitting around at least a portion of a needle.

[0011] Another embodiment of a needle guard assembly comprises the living hinge having a default position corresponding to the needle guard being in the closed position.

[0012] Another embodiment of a needle guard assembly comprises a needle guard wherein the longitudinal groove is sealed at the protective end of the needle guard.

[0013] Another embodiment of a needle guard assembly comprises a needle guard wherein the longitudinal groove is sealed by a cap at the protective end of the needle guard.

[0014] Another embodiment of a needle guard assembly comprises a needle connected to the distal end of the hub.

[0015] Another embodiment of a needle guard assembly comprises a syringe connected to the proximal end of the hub.

[0016] Another embodiment of a needle guard assembly comprises a needle guard wherein the longitudinal groove has a greater depth near the hinged end of the needle guard than at the protective end of the needle guard. [0017] Another embodiment of a needle guard assembly comprises a needle guard wherein the proximal end of the hub is removably connected to the syringe by mated threading.

[0018] Another embodiment of a needle guard assembly comprises a needle guard wherein the first side of the needle guard is integral with the hub.

[0019] Another embodiment of a needle guard assembly comprises a needle guard wherein the needle guard is integral with the hub.

[0020] Another embodiment of a needle guard assembly comprises a needle guard that is pivotally mounted on the center portion of the hub.

[0021] Another embodiment of a needle guard assembly comprises a needle guard that is pivotally mounted on the proximal end of the hub.

[0022] Another embodiment of a needle guard assembly comprises a tab extending from the protective end of the needle guard, wherein the tab may be used to grasp the needle guard when it is in the open position and move the needle guard toward the closed position.

[0023] Another embodiment of a needle guard assembly comprises:

a needle connected to the hub, the needle having an outer diameter; an opening formed by the longitudinal groove of the needle guard, the opening being generally at least as wide as the outer diameter of a needle; and at least one narrow section along the opening that is slightly narrower than the outer diameter of the needle, wherein the opening is sized to allow at least a portion of the needle to pass into the longitudinal groove as the needle guard is moved into the closed position and the at least one narrow section is sized to keep the needle from slipping out of the longitudinal groove absent pressure.

[0024] Another embodiment of a needle guard assembly comprises:

a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is capable of being attached to a needle and the proximal end of the hub is capable of being attached to a syringe; a needle guard pivotally mounted on the hub by a living hinge, the needle guard having a back side and a front side; and a longitudinal groove in the front side of the needle guard, wherein the needle guard is capable of moving between an open position in which a portion of the back side of the needle guard is capable of being adjacent to the surface of a syringe and a closed position in which at least a portion of the longitudinal groove of the front side of the needle guard is capable of fitting around at least a portion of a needle.

[0025] Another embodiment of a needle guard assembly comprises: at least one pair of curved arms extending from the needle guard, wherein the arms are capable of fitting around at least a portion of a syringe when the needle guard is in an open position.

[0026] Another embodiment of a needle guard assembly comprises:

a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is capable of being attached to a needle; a syringe having a proximal end and a distal end; a connector ring between the distal end of the syringe and the proximal end of the hub; a needle guard pivo tally mounted on the connector ring by a living hinge, the needle guard having a back side and a front side with a longitudinal groove; wherein the needle guard is capable of moving between an open position in which a portion of the back side of the needle guard is capable of being adjacent to the surface of a syringe and a closed position in which at least a portion of the longitudinal groove of the front side of the needle guard is capable of fitting around at least a portion of a needle.

[0027] Another embodiment of a needle guard assembly comprises a needle guard wherein the living hinge has a default position corresponding to the needle guard being in the closed position.

[0028] Another embodiment of a needle guard assembly comprises a needle guard with a back side that has a mating surface for interaction with the syringe.

[0029] Another embodiment of a needle guard assembly comprises a needle guard with a connector ring that is removably connected to the distal end of the syringe and the proximal end of the hub by threading. [0030] Another embodiment of a needle guard assembly comprises a needle guard assembly wherein the distal end of the syringe is connected to the proximal end of the hub and the connector ring rests between the distal end of the syringe and the proximal end of the hub.

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] Figure 1 is a side view of a needle guard assembly;

[0032] Figure 2 is a side view of the needle guard of Figure 1;

[0033] Figure 3 is a cross-sectional view of the needle guard of Figure 2 taken along the line 2A-2A;

[0034] Figure 3(a) is a cross-sectional view of an alternative embodiment of the needle guard of Figure 3.

[0035] Figure 4 is a cross-sectional view of the needle guard of Figure 2 taken along the line 2B-2B;

[0036] Figure 5 is a top view of the second side of the needle guard of Figure 2;

[0037] Figure 6 is a top view of the first side of the needle guard of Figure 2;

[0038] Figure 7 is a side view of a needle guard;

[0039] Figure 8 is a top view of the second side of the needle guard of Figure 7;

[0040] Figure 9 is a side view of a needle guard;

[0041] Figure 10 is a top view of the second side of the needle guard of Figure 9;

[0042] Figure 11 is a side view of a needle guard assembly;

[0043] Figure 12 is a side view of a needle guard assembly;

[0044] Figure 13 is a side view of the needle guard of Figure 12;

[0045] Figure 14 is a cross-sectional view of the needle guard of Figure 13 taken along the line 13A-13A;

[0046] Figure 15 is a top view of the front side of the needle guard of Figure 13; [0047] Figure 16 is a side view of a needle guard assembly;

[0048] Figure 17 is a cross-sectional view of the needle guard assembly of

Figure 16 taken along the line 16A-16A;

[0049] Figure 18(a) is a side view of a needle guard assembly in the open position;

[0050] Figure 18(b) is a side view of the needle guard assembly of Figure 18(a) in the closed position;

[0051] Figure 19(a) is a top view of a needle guard assembly in the open position;

[0052] Figure 19(b) is a side view of the needle guard assembly of Figure 19(a) in the closed position; and

[0053] Figure 19(c) is a side view of the needle guard assembly of Figure 19(a) in the open position.

DETAILED DESCRIPTION OF THE DRAWINGS AND THE PRESENTLY PREFERRED EMBODIMENTS

[0054] Referring now to the drawings, and particularly to Figure 1, a needle guard assembly 10 is shown. In the present application, the term "proximal" refers to the direction that is generally toward a physician during a medical procedure, while the term "distal" refers to a direction that is generally towards a target site within a patient's anatomy during a medical procedure.

[0055] The needle guard assembly 10 includes a hub 12, which has a proximal end 14, a center portion 16, and a distal end 18. The distal end 18 of the hub 12 is shaped and structured to be attached to the proximal end 64 of a needle 20. The proximal end 14 of the hub 12 is shaped and structured to be attached to the distal end of a syringe 22. Figure 1 shows the hub 12 attached to a needle 20 and a syringe 22.

[0056] As shown in Figure 1, the needle guard assembly 10 also includes a needle guard 24 pivotally mounted on the hub 12. The needle guard 24 has a hinged end 26 and a protective end 28. The hinged end 26 of the needle guard 24 is pivotally mounted on the hub 12. The needle guard 24 has a first side 30 (see e.g., Figures 3 and 4) and second side 32. The first side of the needle guard 24 has a mating surface 40 for interaction with a syringe 22. The second side 32 of the needle guard 24 has a longitudinal groove 42.

[0057] The needle guard 24 is capable of moving between the open position 50 and a closed position 52. When in the open position 50, a portion of the mating surface 40 of the first side 30 of the needle guard 24 abuts the syringe 22. When in the closed position 52, at least a portion of the longitudinal groove 42 of the second side 32 of the needle guard 24 is capable of fitting around at least a portion of a needle 20. When the needle guard 24 is in the open position 50, the distal tip 54 of the needle 20 is exposed to allow a person to use the needle 20. After the needle 20 has been used, the needle guard 24 may be moved into the closed position 52. Figure 1 shows that when in the closed position 52, the needle guard 24 fits over the sharp distal tip 54 of the needle 20, thereby protecting the person using the needle 20, other medical personnel, and the patient from accidental needle sticks.

[0058] The needle guard 24 shown in Figure 1 is connected to the hub 12 by a living hinge 34. The living hinge 34 may be a weakened portion that is capable of bending without breaking as the needle guard 24 is moved between the open position 50 and the closed position 52. The living hinge 34 may be designed to have a default position that corresponds to the needle guard 24 being in the closed position 52. In an embodiment having this default position, the needle guard 24 will naturally move toward the closed position 52. This may help to ensure that the needle 20 will be covered within the protective end 28 of the needle guard 24 when the needle 20 is not in use. In other embodiments, the living hinge 34 may have a default position corresponding to the needle guard 24 being in the open position 50 or at an intermediate position between the closed position 52 and the open position 50. In still other embodiments, the living hinge 34 may be designed not to have a default position at all. It should be understood that the living hinge of the needle guard it not limited thereto, and other conventional hinges as known in the art are also contemplated. [0059] As shown in Figure 1, the shape of the living hinge 34 may be designed to allow the first side 30 of the needle guard 24 to abut a syringe 22 when the needle guard 24 is in the open position 50. This may allow the needle guard 24 to be fitted against the syringe 22 during use of the needle 20. In other embodiments, the needle guard 24 may be adjacent to the syringe 22 when the needle guard 24 is in the open position 50, but will not abut or contact the syringe 22. Having the needle guard 24 abutting or adjacent to the syringe may minimize the risk that the needle guard 24 may unintentionally catch on something during the time when the needle 20 is exposed.

[0060] The living hinge 34 may be attached to the hub 12 at the distal end 18 of the hub 12 as shown in Figure 1. In the alternative, the living hinge 34 may be attached at the proximal end 14 of the hub 12 or along the center portion 16 of the hub 12. Depending on the location of the attachment of the living hinge 34 in relation to the hub 12, the angle of the hinged end 26 of the needle guard 24 may be varied in order to ensure that the needle guard 24 will rest adjacent to the syringe 22 when the needle guard 24 is in the open position. Note that while the living hinge 26 is shown attached to the distal end of the hub 12, it is not limited thereto, and the living hinge may be attached to any position along the length of the hub. In such embodiments, the shape of the needle guard 24 extending away from the hinge 26 will be such that the needle guard 24 is able to move between the open and closed positions 50, 52 without or with minimal interference with the syringe 22 or hub 12, as shown in, for example, the embodiment 1800 of Figure 18.

[0061] Figure 2 shows the needle guard 24 of Figure 1. Figures 3 and 4 illustrate how the first side 30 of the needle guard 24 may be shaped to form a mating surface 40. The mating surface 40 may be shaped to lie adjacent or abut a syringe 22. The mating surface 40 of the first side 30 in the embodiment shown in Figures 4 and 5 is rounded and smooth. However, the mating surface 40 may have any shape or texture suitable for allowing the first side of the needle guard 24 to lie adjacent or abut a syringe 22. For example, the mating surface 40 may have a knob designed to mate with a groove on a syringe 22. Any type of mating surface known in the art may be used.

[0062] As shown in Figure 3, the longitudinal groove 42 may be formed of two side members 56 that extend from the second side 32 of the needle guard 24. In some embodiments, the sharp angle at which the side members 56 rise from the second side 32 of the needle guard 24 may create a visible juncture 66 between the side members 56 and the surface of the second side 32 of the needle guard 24. The side members 56 may be slightly curved such that the opening 58 of the longitudinal groove 42 is narrower than its base 60. It may be beneficial to have a groove 42 with a narrower opening 58 because this may help to retain the needle 20 inside the groove 42 when the needle guard 24 is in the closed position 52. Other embodiments may have side members 56 that are not curved. In these alternate embodiments, the opening 58 of the groove 42 and the base 60 of the groove 42 may have the same width. As shown in Figure 3(a), the first side 30 may also include inwardly projecting protrusions 41 that are configured to engage the external surface of the syringe 22 thereby frictionally holding the first side 30 of the needle guard 24 against or adjacent the external surface of the syringe 22 in a releasable manner. The second side 32 may also include walls 43 that extend away from the surface of the second side 32 beyond the groove 42 to add additional protection from the needle 20. Note that while the protrusions 41 and the walls 43 are shown only as being present on the embodiment of Figure 3, the protrusions 41 and walls 43 may be present on any of the embodiments described in this specification. Both the protrusions 41 and the walls 43 may be integrally formed with the needle guard 24, or may be separate components that are attached to the needle guard 24.

[0063] As shown best in Figures 4 and 5, the longitudinal groove 42 of the embodiment of a needle guard 24 shown in Figure 2 may be sealed at the protective end 28 by a cap 48. It may be advantageous to seal the protective end 28 of the needle guard 24 because when the needle guard 24 is in the closed position 52, the sealed end 28 will be distal to the distal tip 54 of needle 20, thereby protecting the user and others from the distal tip 54 of the needle 20. The cap 48 may be integral with the side members 56 forming the longitudinal groove 42 of the needle guard 24. In the alternative, the cap 48 may be a separate piece. In embodiments lacking side members 56, the cap 48 also may be integral with the needle guard 24 or a separate piece. Rather than using a cap, in some embodiments having a sealed end, the longitudinal groove 42 may get gradually narrower at the protective end 28 of the needle guard 24 until the two side members 56 of the longitudinal groove 42 join at the protective end 28. Still other embodiments may not be sealed at all. In embodiments lacking a sealed protective end 28, the longitudinal groove 42 will extend distally to the distal end 54 of the needle 20 when the needle guard 24 is in the closed position 52 and thereby protect the user from the sharp distal tip 54 of the needle 20.

[0064] As shown in Figure 2, the hinged end 26 of the needle guard 24 may be connected to the side members 56 forming the longitudinal groove 42. In other embodiments the hinged end of the needle guard 24 may not be connected to the side members 56, but rather be connected along the mating surface 40 of the first side 30 of the needle guard 24. In still other embodiments, the connection between the hinged end 26 of the needle guard 24 and the rest of the needle guard 24 may be along both the side members 56 and the mating surface 40.

[0065] In the embodiment of a needle guard 24 shown in Figures 1-6, the longitudinal groove 42 extends the full length of the needle guard 24. This may be advantageous because it insures that as much of the length of the needle 20 as possible is enclosed within the longitudinal groove 42 when the needle guard 24 is in the closed position 52. However, due to the difference in the diameter of the needle 20 and the syringe 22, it may not be possible in some embodiments for the needle guard 24 to rest adjacent to the syringe 20 when the needle guard 24 is in the open position 50 and also rest flat against the needle 20 when the needle guard 24 is in the closed position 52. This is illustrated in Figure 1, which shows the needle guard 24 not resting flat against the needle 20 when in the needle guard 24 in the closed position 52. Instead, when the needle guard 24 is in the closed position 52, it sits at a slight angle and a gap 62 is formed between the needle 20 and the hinged end 26 of the needle guard 24. Thus, a portion of the proximal end 64 of the needle 20 may be exposed when the needle guard 24 is in the closed position 52. Because the proximal end 64 of the needle 20 is not sharp, the gap 62 does not affect the ability of the needle guard assembly 10 to prevent accidental needle sticks.

[0066] In order to ensure that the entire needle 20 is covered when the needle guard 24 is in the closed position 52, the side members 56 of the longitudinal groove 42 may be lengthened in some embodiments. In these embodiments, the side members 56 of the longitudinal groove 42 may be longer at the hinged end 26 of the needle guard 24 than at the protective end 28 of the needle guard 24. In embodiments having elongated side members 56, the depth of the longitudinal groove 42 is greater near the hinged end 26 of the needle guard 24. In these embodiments, when the needle guard 24 is in the closed position 52, the elongated side members 56 will extend past the gap 62 to enclose the proximal end 64 of the needle 20. The use of elongated side members 56 that allow the entire length of the needle 20 to be contained within the longitudinal groove 42 may be advantageous because contaminated needles may have blood or other potentially hazardous fluids on them. Containing the entire length of the needle 20 within the longitudinal groove 42 may minimize the risk that unintended persons are exposed to such fluids.

[0067] The needle guard may optionally include a tab 80 to allow a user to easily grip the needle guard 70. Figures 7 and 8 shows an embodiment of a needle guard 70 having a hinged end 72 and a protective end 74. The needle guard 70 also has a first side and a second side 78. As shown in Figure 7, a tab 80 is located at the protective end 74 of the needle guard 70. The a tab 80 may be disposed at the protective end 74 of the needle guard 70 such that the tab 80 serves to further shield the sharp distal tip of the needle when the needle guard 70 is in the closed position. The tab 80 may be used by a user to grip the needle guard 70 when it is in the open position 50 and move the needle guard toward the closed position 52. The tab 80 shown in Figure 7 is exemplary only. The tab 80 may have any shape known in the art suitable for gripping with a human hand. The location of the tab 80 may also vary. It may be located at any suitable position along the length of the second side 78 needle guard 70. In some embodiments, the tab 80 may be disposed in a position on the needle guard 70 such that the tab 80 is proximal of the distal end of the needle when the needle guard 70 is in both the open and closed positions 50, 52.

[0068] As best seen in Figure 8, some embodiments of the needle guard 70 may have at least one narrow section 84 along the length of the longitudinal groove 82. In these embodiments, the hub may be attached to a needle having an outer diameter. The longitudinal groove 82 in the second side 78 of the needle guard 70 forms an opening 86. The opening 86 is generally at least as wide as, and may be wider than the outer diameter of the needle to which the hub is connected. However, in these embodiments, there is at least one narrow section 84 along the opening 86 that is slightly narrower than the outer diameter of the needle. Thus, the opening 86 is sized to allow at least a portion of the needle to pass into the longitudinal groove 82 as the needle guard 70 is moved into the closed position. Because the narrow section 84 is only slightly narrower than the outer diameter of the needle, the narrow section 84 will flex outwardly, thereby allowing the needle to slide past the narrow section 84 when pressure is applied. Once in the groove 82, the narrow section 84 is sized to engage and exert force against the needle 20, thereby frictionally restraining the needle 20 within the groove 82 and preventing the needle from slipping out of the longitudinal groove 82 absent pressure. The use of a narrow section 84 in the longitudinal groove 82 may be advantageous because it serves to "lock" the needle within the protective groove 82. This ensures that the sharp tip of the needle remains protected and reduces the risk of needle stick accidents.

[0069] The embodiment shown in Figure 8 has one narrow section 84 that is nearer to the protective end 74 of the needle guard 70 than to the hinged end 72 of the needle guard 70. It may be advantageous to locate the narrow section 84 near the protective end 74 of the needle guard 70 because the sharp tip of the needle will be located at the protective end 74 of the needle guard 70 when the needle guard 70 is in the closed position. Having a narrow section 84 near the sharp tip ensures that the sharp tip will not be exposed. In other embodiments, the narrow section 84 may be located even closer to the protective end 74 than shown in Figure 8. Alternately, the narrow section 84 may be located closer to the hinged end 72 of the needle guard 70. In still other embodiments, there will be more than one narrow section 84. The number and location of the narrow sections 84 along the longitudinal groove 82 may vary depending on the size and type of needle and its length. For example, it may be advantageous to have multiple narrow sections 84 for long needles in order to keep the entire length of the needle secured in the groove. Conversely, only one narrow section may suffice for a relatively short needle.

[0070] Figures 9 and 10 show another embodiment of a needle guard 114. Figure 11 illustrates the operation of the needle guard 114 of Figures 9 and 10 in a needle guard assembly 100. The needle guard assembly 100 includes a hub 102, which has a proximal end 104, a center portion 106, and a distal end 108. As shown in Figure 11, the distal end 108 of the hub 102 may be attached to the proximal end 128 of a needle 110. The proximal end 104 of the hub 102 is attached to a syringe 112. The needle guard 114 is pivotally mounted on the hub 102 by a living hinge 124 or the like.

[0071] The needle guard 114 shown in Figures 9-11, has a hinged end 116 and a protective end 118. The needle guard 114 has a first side and second side 122. The first side of the needle guard 114 has a mating surface for interaction with a syringe 112. The second side 122 of the needle guard 114 has a longitudinal groove 126. The longitudinal groove 126 of the needle guard 114 shown in Figures 9-11 does not run the entire length of the needle guard 114. Instead, the longitudinal groove 126 runs from the protective end 118 of the needle guard 114 over a portion of the center portion of the needle guard 114. As shown in Figure 11, the longitudinal groove 126 in this embodiment does not cover the entire length of the needle 110 when the needle guard 114 is in the closed position 130. Nonetheless, the distal tip of the needle 110 is protected within the longitudinal groove 126 when the needle guard 114 is in the closed position 130. The use of a longitudinal groove 126 that does not run the full length of the needle guard 114 may be advantageous for some uses because a section of the second side 122 of the needle guard will have a smooth outer surface with no side members or longitudinal groove 126. This section of the needle guard assembly 100 may facilitate gripping the needle guard 114 when it is in the open position 132.

[0072] Figure 12 shows another embodiment of a needle guard assembly 140. The needle guard assembly 140 includes a hub 142 having a proximal end 144, a center portion 146, and a distal end 148. The distal end 148 of the hub 142 is capable of being attached to a needle 150. The proximal end 144 of the hub 142 is capable of being attached to a syringe 152. Figure 12 shows the hub 142 attached to both a needle 150 and a syringe 152. A needle guard 154 is pivotally mounted on the hub 142 by a living hinge 168 or the like.

[0073] As shown in Figure 13, the needle guard 154 of Figure 12 has a back side 156 and a front side 158. A longitudinal groove 160 is formed in the front side 158 of the needle guard 154. The needle guard 154 is capable of moving between an open position 162 adjacent to the surface of the syringe 152 and a closed position 164 in which at least a portion of the longitudinal groove 160 of the front side 158 of the needle guard 154 is capable of fitting around at least a portion of the needle 150.

[0074] The back side 156 of the needle guard 154 rests adjacent to the syringe 152 when in the closed position 164. The hinged end 170 of the needle guard 154 is angled to allow the needle guard 154 to rest adjacent to the syringe 152. As best seen in Figure 14, the longitudinal groove 160 in the front side 158 of the needle guard 154 may result in a rounded protrusion 178 forming on the back side 156 of the needle guard 154. In other embodiments, the back side 156 of the needle guard 154 will have no protrusion, which may allow it to conform to the curvature of the syringe 152. This may allow the back side 156 of the needle guard 154 to rest against the surface of the syringe 152 when the needle guard 154 is in the open position 162. In still other embodiments, the back side 156 of the needle guard 154 may be substantially flat.

[0075] The needle guard assembly 140 may optionally also include at least one pair of arms 166 extending from the needle guard 154. In embodiments having arms 166, the arms 166 may be capable of fitting around at least a portion of a syringe 152 when the needle guard 154 is in the open position 162. The embodiment depicted in Figure 12 includes a pair of arms 166. As shown in Figure 14, the arms 166 may be curved to allow them to grip or clasp onto the syringe 152 when the needle guard 154 is in the open position 162. These curved arms 166 may secure the needle guard 154 to the syringe 152 when the needle 150 is in use, thereby reducing the risk that the needle guard 150 will get in the way during use of the needle 150. It also minimizes the risk of the needle guard 150 snagging unintentionally on clothing or another item when the needle 150 is exposed and thus reduces the risk of accidental needle sticks.

[0076] In embodiments having arms 166, the longitudinal groove 160 may be recessed in the front side 158 of the needle guard 154 such that the curvature of the front side 158 is flush with the arms 166 as shown in Figure 14. In other embodiments, the longitudinal groove 160 may be formed of a pair of side members that extend from the front side.

[0077] The location and width of the arms 166 on the needle guard 154 may vary. The embodiment shown in Figures 12-15 has a pair of arms 166 near the protective end 172 of the needle guard 154. In other embodiments, a pair of arms 166 may be located at the protective end 172, along the center portion 174, or near the hinged end 170 of the needle guard 154. Other embodiments may include multiple pairs of arms 166 at several different locations along the length of the needle guard 154. Still other embodiments will not have any arms 166.

[0078] The ends 176 of the curved arms 166 may be tapered and rounded as shown in Figure 14. In the alternative, the ends 176 may be blunt. The ends 176 of the curved arms 166 may have any other shape known in the art. The cross- sectional shape of the curved arms may be round, rectangular, tapered, or have any other shape known in the art.

[0079] Figures 16 and 17 show another embodiment of a needle guard assembly 200. The needle guard assembly 200 includes a hub 202 having a proximal end 204, a distal end 206, and a center portion 208 and a syringe 212 having a proximal end 230 and a distal end 232. This embodiment includes a connector ring 228 located between the distal end 232 of the syringe 212 and the proximal end 204 of the hub 202. A needle guard 214 is pivotally mounted on the connector ring 228 by a living hinge 234 or the like. The needle guard 214 includes a back side 216 and a front side 218 having a longitudinal groove 220. The needle guard 214 is capable of moving between an open position 224 in which a portion of the needle guard 214 is capable of being adjacent to the surface of a syringe 212 and a closed position 226 in which at least a portion of the longitudinal groove 220 of the front side 218 of the needle guard 214 is capable of fitting around at least a portion of a needle 210.

[0080] As shown in Figure 17, the back side 216 of the needle guard 214 may include a mating surface for interaction with the syringe 212. This may allow the back side 216 of the needle guard 214 to rest adjacent to or to abut the surface of the syringe 212 when the needle guard 214 is in the open position 224.

[0081] As shown in Figure 16, the connector ring 228 may sit between the syringe 212 and the hub 202. In some embodiments the connector ring 228 may be removably connected to the distal end 232 of the syringe 212 and the proximal end 204 of the hub 202 by threading. In other embodiments, the connector ring 228 may be removably connected to the distal end 232 of the syringe 212 and the proximal end 204 of the hub 202 by another type of removable connection, such as pieces designed to snap together, luer fittings, a tight fit, or adhesives. Any other type of removable connection known in the art may be used. In some embodiments, the type of removable connection used between the syringe 212 and connector ring 228 may be the same type of connection as between the connector ring 228 and the hub 202. In other embodiments, a different type of removable connection may be used for the connection between the syringe 212 and connector ring 228 than between the hub 202 and connector ring 228. In still other embodiments, one or both of the connections between the syringe 212 and the connector ring 228 and the connector 228 ring and the hub 202 may be nonremovable.

[0082] In some embodiments having the configuration shown in Figure 16, the connector ring 228 will rest between the syringe 212 and the hub 202, but will not serve to connect the two together. In these embodiments, the distal end 232 of the syringe 212 and the proximal end 204 of the hub 202 may be connected together through threading, luer fittings, a snap fit, a tight fit, adhesives, or any other mechanism known in the art. The proximal end 204 of the hub 202 may be recessed to allow the connector ring 228 to fit around this recessed portion of the hub 202. When the proximal end 204 of the hub 202 and the distal end 232 of the syringe 212 are connected together, the connector ring 228 in this embodiment will be held in place between the non-recessed portion of the hub 202 and the syringe 212. In the alternative, the syringe 212 may feature a recessed portion that the connector ring 228 may fit over or the syringe 212 and the hub 202 may each feature a recessed portion.

[0083] The embodiment shown in Figures 16 and 17 features a longitudinal groove 220 having a greater depth 240 near the hinged end 236 of the needle guard 214 than at the protective end 238 of the needle guard 214. As shown in Figure 16, this enables the needle guard 214 to enclose virtually the entire length of the needle 210 when the needle guard 214 is in the closed position 226.

[0084] Figures 18(a) and (b) illustrate another embodiment of the needle guard 1824. As shown in Figure 18(a) and (b), the hub 1812 may have a tapered, semi-conical shape. The hinge 1826, which may be a living hinge or the like, is attached to the proximal end of the hub 1814 near the distal end of the syringe 22 such that when the needle guard 1824 is in the open position 50, the needle guard 1824 is substantially parallel and adjacent to or contacting the outer surface of the syringe 22. The longitudinal groove 1832 may be closed at one end 1828 and extend partially along the length of the needle guard 1824. A retaining arm 1880 may extend outward from the body of the needle guard 1824 and extend at least partly around the circumference of the syringe 22. The arm 1880 may have an inwardly projecting nub or the like to frictionally engage the syringe and restrain and maintain the needle guard 1824 in the open position 50 (Figure 18(a)) until sufficient force is applied to release the needle guard 1824 from the syringe 22 and allow it to move to the closed position covering the distal end of the needle 20 (Figure 18(b).

[0085] Figure 19 (a)-(c) illustrate an alternative embodiment of Figure 18(a) and (b), in which the hinge 1926 is disposed at the distal end of the hub 1912 and the longitudinal groove 1932 includes a plurality of protrusions or nubs 1941 extending toward the center of the longitudinal groove 1932 such that the distance between the innermost surface of the protrusion is slightly less than the width of the needle 20. The protrusions 1941 may be disposed on opposite sides of the longitudinal groove 1932 in pairs and create narrowed sections 84 as in Figure 8. That is, as the needle 20 is inserted into the groove 1932 when the needle guard 1924 moves from the open position 50 to the closed position 52, the protrusions 1941 engage the needle 20 thereby frictionally restraining needle guard 1924 against the needle 20 and ensuring the needle guard 1924 remains in the closed position 52. In other embodiments, the protrusions 1941 may be disposed at staggered longitudinal positions on opposite sides of the longitudinal groove 1932 in a non-paired arrangement. In the case of staggered protrusions 1941, when used with a small gauge, flexible needle, the needle 20 may flex around the protrusions 1941, thereby securing the needle 20 to the needle guard more securely. The needle guard 1924 may also include one or more slits 1901 disposed along the groove 1932. The slits 1901 may extend transverse to the longitudinal groove 1932 and may increase the flexibility of the needle guard 1924 by introducing flex points along the length of the needle guard 1924. These flex points allow the needle guard 1924 to better adapt to the shape of the needle along its length, thereby securing the entirety of the needle in a more complete manner. The slits 1901 may be particularly beneficial in embodiments such as those shown in, for example, Figures 1, 11, and 12, where the needle guard is not substantially parallel to or contact the needle 20 along the length of the longitudinal groove.

[0086] Some embodiments may also include a fastening mechanism that secures the needle guard to the syringe when the needle guard is in the open position. In these embodiments, the first side of the needle guard may include one or more snaps, clasps or any other fastener known in the art. Likewise, the surface of the syringe may also feature a corresponding fastener. When the needle guard is moved into the open position, the fastener on the first side of the needle guard may interact with the corresponding fastener on the syringe to secure the needle guard to the syringe. The fastener may be designed to release when pressure is applied to the needle guard to move it into the close position. The use of a fastener may ensure that the needle guard will not unintentionally come loose before desired. This reduces the risk of the needle guard being snagged on something when in the open position and causing an accidental needle stick.

[0087] The needle guard may be formed integrally with the hub. The point of connection between two separate pieces is often the weakest point in a structure. An integral needle guard and hub may eliminate such weak points. Thus, an integral needle guard and hub may reduce the risk of the needle guard unintentionally breaking apart from the hub during use. However, some embodiments may not have an integral needle guard and hub. In still other embodiments, the hinged end of the needle guard and the hub may be integral, but not the entirety of the needle guard. For example, in embodiments having a first side having a mating surface and a second side with a longitudinal groove, the first side of the needle guard may be integral with the hub while the longitudinal groove in the second side of the needle guard is formed of a separate piece of material. Conversely, the longitudinal groove of the second side of the needle guard may be formed of side members that are integral with the hub while portions of the mating surface of the first side of the needle guard are formed of a separate piece of material. Having one side of the needle guard formed of a separate piece of material may be advantageous because the hinged end may still be integral with the hub, thereby insuring that the living hinge is as strong as possible. However, molding two separate pieces allows a variety of shapes and structures to be formed. Thus, a non-integral needle guard and hub may facilitate molding the most desirably shaped needle guard without reducing the strength of the living hinge.

[0088] The syringe may be removably connected to the rest of the needle guard assembly. This allows for the user to detach the syringe from the rest of the needle guard assembly after the needle has been used and the needle guard has been placed in the closed position. The needle guard and the enclosed needle may then be disposed of in a puncture resistant biohazard container. However, the syringe likely will not have to be disposed of as a biohazard. Sharps and biohazard disposal is more costly than other forms of disposal. Thus, the removable connection between the hub and the syringe may allow the syringe to be disposed of at a reduced cost while minimizing the risk of accidental needle sticks.

[0089] The needle guard may be made from a clear or translucent plastic material that is sufficiently flexible to allow it to bend without breaking, but has sufficient rigidity to maintain its shape. The use of a clear or translucent plastic may allow the user to visually confirm that the needle is secured within the protective end of the needle guard when the needle is in the closed position. The use of a flexible material may allow the living hinge to flex without breaking. In addition, flexibility is important for embodiments having a narrow section along the longitudinal groove because it allows the side members of the longitudinal groove to flex to accommodate the needle. However, the material must also be sufficiently rigid to maintain its shape and to protect a user from the sharp distal tip of a needle when the needle guard is in the closed position. Suitable materials include polypropylenes, polyurethanes, and other similar polymers. The needle guard, hub and syringe may be made from any other suitable material known in the art. [0090] The above described embodiments of the needle guard assembly may be useful for preventing accidental needle sticks. During use of the needle, the mating surface of the needle guard may allow the needle guard to rest adjacent, or even abut, the syringe. This insures that the needle guard is not hanging loose such that it may be unintentionally snagged during a medical procedure. The living hinge of the embodiments of the needle guard assembly may be advantageous because it will not break easily. This insures that the needle guard does not break off of the needle guard assembly and thus minimizes the risk of an accidental needle stick. The use of a living hinge is also advantageous because the types of materials that may be used to form a living hinge typically have sufficient rigidity to shield a sharp needle without being punctured by the needle.

[0091] While preferred embodiments of the invention have been described, it should be understood that the invention is not so limited, and modifications may be made without departing from the invention. The scope of the invention is defined by the appended claims, and all devices that come within the meaning of the claims, either literally or by equivalence, are intended to be embraced therein. Furthermore, the advantages described above are not necessarily the only advantages of the invention, and it is not necessarily expected that all of the described advantages will be achieved with every embodiment of the invention.

Claims

Claims:

1. A needle guard assembly, the assembly comprising:

a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is configured to attached to a needle and the proximal end of the hub is configured to attached to a syringe; and

a needle guard having a hinged end and a protective end, the hinged end of the needle guard being pivotally mounted on the hub by a living hinge, the needle guard having a first side having a mating surface for interaction with a syringe and a second side having a longitudinal groove, the longitudinal groove comprising opposing walls,

wherein the needle guard is movable between an open position in which a portion of the mating surface of the first side of the needle guard abuts a syringe and a closed position in which at least a portion of the longitudinal groove of the second side of the needle guard fits around at least a portion of a needle, wherein in the closed position, at least an entirety of a sharp end of the needle is disposed within the longitudinal groove of the protective end such that the sharp end of the needle is in contact with at least a portion of the walls and does not extend outside of the longitudinal groove.

2. The needle guard assembly according to claim 1, wherein the living hinge has a default position corresponding to the needle guard being in the closed position.

3. The needle guard assembly according to claim 1, wherein the longitudinal groove is sealed at the protective end of the needle guard.

4. The needle guard assembly according to claim 2, wherein the longitudinal groove is sealed by a cap at the protective end of the needle guard.

5. The needle guard assembly according to claim 1, further comprising a needle connected to the distal end of the hub.

6. The needle guard assembly according to claim 1, further comprising a syringe connected to the proximal end of the hub.

7. The needle guard assembly according to claim 1, wherein the longitudinal groove has a greater depth near the hinged end of the needle guard than at the protective end of the needle guard.

8. The needle guard assembly according to claim 6, wherein the proximal end of the hub is removably connected to the syringe by mated threading.

9. The needle guard assembly according to claim 1, wherein the first side of the needle guard is integral with the hub.

10. The needle guard assembly according to claim 1, wherein the needle guard is integral with the hub.

11. The needle guard assembly according to claim 1, wherein the needle guard is pivotally mounted on the center portion of the hub.

12. The needle guard assembly according to claim 1, wherein the needle guard is pivotally mounted on the proximal end of the hub.

13. The needle guard assembly according to claim 1, further comprising a tab extending from the protective end of the needle guard, wherein the tab may be used to grasp the needle guard when it is in the open position and move the needle guard toward the closed position.

14. The needle guard assembly according to claim 1, further comprising:

a needle connected to the hub, the needle having an outer diameter;

an opening formed by the longitudinal groove of the needle guard, the opening being generally at least as wide as the outer diameter of a needle; and

at least one narrow section along the opening that is slightly narrower than the outer diameter of the needle,

wherein the opening is sized to allow at least a portion of the needle to pass into the longitudinal groove as the needle guard is moved into the closed position and the at least one narrow section is sized to keep the needle from slipping out of the

longitudinal groove absent pressure.

15. A needle guard assembly, the assembly comprising:

a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is configured to be attached to a needle and the proximal end of the hub is configured to be attached to a syringe;

a needle guard pivotally mounted on the hub by a living hinge, the needle guard having a back side and a front side; and

a longitudinal groove in the front side of the needle guard comprising opposing walls,

wherein the needle guard is movable between an open position in which a portion of the back side of the needle guard is adjacent to the surface of a syringe and a closed position in which at least a portion of the longitudinal groove of the front side of the needle guard fits around at least a portion of a needle, wherein, in the closed position, at least an entirety of a sharp end of the needle is disposed within the longitudinal groove such that the sharp end of the needle is in contact with at least a portion of the walls and does not extend outside of the longitudinal groove.

16. The needle guard assembly according to claim 15, further comprising: at least one pair of curved arms extending from the needle guard, wherein the arms are configured to fit around at least a portion of a syringe when the needle guard is in an open position.

17. A needle guard assembly, the assembly comprising:

a hub having a proximal end, a center portion and a distal end, wherein the distal end of the hub is configured to be attached to a needle;

a syringe having a proximal end and a distal end;

a connector ring between the distal end of the syringe and the proximal end of the hub;

a needle guard pivotally mounted on the connector ring by a living hinge, the needle guard having a back side and a front side with a longitudinal groove, the longitudinal groove comprising opposing walls;

18. The needle guard assembly according to claim 17, wherein the living hinge has a default position corresponding to the needle guard being in the closed position.

19. The needle guard assembly according to claim 17, wherein the back side of the needle guard has a mating surface for interaction with the syringe.

20. The needle guard assembly according to claim 17, wherein the connector ring is removably connected to the distal end of the syringe and the proximal end of the hub by threading.

21. The needle guard assembly according to claim 17, wherein the distal end of the syringe is connected to the proximal end of the hub and the connector ring rests between the distal end of the syringe and the proximal end of the hub.