Patent Publication Number: US-2011066107-A1

Title: Needle protective device

Description:
This application claims priority to and the benefit of U.S. Provisional Application No. 61/127,742, filed on May 14, 2008, which is incorporated in its entirety in this document by reference. 
    
    
     FIELD OF THE INVENTION 
     This invention relates generally to the field of hypodermic needles, and more specifically, a protective device to reduce inadvertent needlestick incidents. 
     BACKGROUND OF THE INVENTION 
     Infectious diseases can be transmitted to medical personnel and others by way of inadvertent needle sticks. Needlestick injuries occur frequently, most often between the time the medication is injected into the patient and the time the syringe is disposed of. Injuries occur before, during and after the clinical process. Needlestick injuries after use of the needle have been reduced with current needle protective devices, but needlestick injuries remain unaddressed during the clinical process. It is therefore desirable to provide a needle protective device to reduce the number of needlestick incidents during the complete clinical process. 
     SUMMARY OF THE INVENTION 
     According to various embodiments, a needle protective device is provided for reducing inadvertent needle sticks. In one embodiment, the needle protective device comprises a tubular member and an end cap. The device can be activated automatically in a hygienic manner prior to the clinical procedure using conventional clinical techniques such as the forward motion of a needle towards a patient or filling vial while the hands of a user remain safely behind the tip of the needle. In one aspect, upon removal of the needle tip from a patient or filling vial, the hands of the user can remain behind the exposed tip of the needle with automatic, passive encasement of the needle tip. Thus, the automatic passive activation and automatic passive encasement of the tip of the needle can help insure the user that the safety feature is activated and remains in a protective condition throughout the entire clinical process. 
     In one aspect, the tubular member can be formed of resilient flexible material and can be mounted on a needle hub. The tubular member can extend about at least a portion of a needle projecting from the needle hub. In this aspect, the tubular member can be selectively axially movable between a first relaxed position and a second compressed position. When the tubular member is moved from the first relaxed position to the second compressed position, the tubular member can store resilient force. 
     In another aspect, the end cap can be mounted to an end of the tubular member opposite the needle hub. The tubular member can have a plurality of axial slits formed thereon that extend axially over at least a portion of the tubular member. Optionally, the axial slits can be diametrically opposed to each other and can have notches selectively formed along a portion of the edges of the axial slits, which allow portions of the tubular member to controllably bow outwardly when the tubular member is axially compressed such that the end cap is moved axially towards the needle hub. Additionally, the size of the axial slits can increase or decrease the amount of resilient force stored within a compressed tubular member. 
     In one aspect, the end cap can be formed from a rigid material and can define a first chamber that has an opening through which a user of the device can selectively pass the needle tip. In another aspect, the end cap can have one or multiple molded or inserted locking members that interact in a flexible, locking and/or keyed condition to allow at least a portion of a needle one-way directional access into a second chamber in order to lock the needle into the second chamber of the end cap, thus preventing the reuse of the device. In this aspect, the locking member(s) can provide tactile feedback to a user when the needle is in the process of being locked. Additionally, in this aspect, the locking member(s) can interact to support the needle in the open position while guiding the needle during automatic passive activation. 
     In a further aspect, a pierceable protective covering can be attached to, inserted into, or incorporated into the end cap such that the protective covering seals the opening of the end cap. In one aspect, the pierceable protective covering can comprise infection control or aseptic materials. The pierceable protective covering can be selectively pierced by the needle tip as the end cap is moved axially toward the first end of the tubular member when the tubular member is moved from the first relaxed position to the second compressed position. The pierceable protective covering can be formed from a material having a thickness configured to apply a compressive force onto the needle when pierced that is less than the resilient force stored therein the tubular member when the tubular member is moved from the first relaxed position to the second compressed position. Thus, when it is not necessary for a tip of the needle to be exposed, the resilient forces in the compressed tubular member can cause the tubular member to move axially so that the tip of the needle will reside within the first chamber in the end cap. Additionally, the pierceable protective covering can provide a tactile feedback to a user when pierced. 
     In one aspect, the opening in the end cap can be aligned with the tip of the needle. In another aspect, the tubular member can have a skewed end mounted on the needle hub, so that the longitudinal axis of the tubular member is not parallel with the longitudinal axis of the needle. In this aspect, the opening in the end cap can be misaligned with the tip of the needle, thereby requiring a user to move the end cap in order to pass the needle through the opening for use, or into the first chamber in the end cap for user protection. 
     In use, the needle protective device can help reduce the number of inadvertent needlestick injuries. In one embodiment, with the pre-alignment of the needle tip to the opening in the end cap, the device can automatically be passively activated prior to the clinical procedure by a forward or downward pressure on or by any direct contact of the end cap to a second surface, such as, for example and without limitation, the skin of a patient, under pressure. The needle protective device allows users of the device to maintain their hands behind the exposed needle tip throughout the activation and clinical procedures, with automatic, passive activation and/or encasement of the needle tip during drug filling steps, intermediary clinical steps, procedural interruptions, and the like. This passive activation can provide ease of use through direct needle contact to a patient, filling bottle or other biological surfaces. 
     Additional advantages of the invention will be set forth in part in the description that follows, and in part will be obvious from the description, or can be learned by practice of the invention. The advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       In the accompanying drawings which illustrate by way of example preferred embodiments of the invention: 
         FIG. 1  is a side view of a needle protective device and needle assembly according to one embodiment, showing a tubular member, and an end cap. 
         FIG. 2  is a side cross-sectional view of the needle protective device and needle assembly of  FIG. 1 . 
         FIG. 3  is a perspective view of the tubular member of  FIG. 1 . 
         FIG. 4  is a top cross-sectional view of the end cap of  FIG. 2  along line  4 - 4 . 
         FIG. 5  is perspective view of an end cap, according to one embodiment. 
         FIG. 6A  is a side cross-sectional view of a needle protective device showing a tubular member, an end cap, and a pierceable protective covering, according to one embodiment. 
         FIG. 6B  is a bottom cross-sectional view of the needle protective device of  FIG. 6A . 
         FIG. 7  is a top cross-sectional view of an end cap according to one embodiment. 
         FIG. 8  is a top cross-sectional view of an end cap according to one embodiment. 
         FIG. 9  is a top cross-sectional view of an end cap according to one embodiment. 
         FIG. 10  is a top cross-sectional view of an end cap according to one embodiment. 
         FIG. 11  is a side cross-sectional view of an end cap according to one embodiment. 
         FIG. 12  is a perspective view of an end cap according to one embodiment. 
         FIG. 13  is a perspective view of an end cap according to one embodiment. 
         FIG. 14  is a top view of an end cap and protective covering, according to one embodiment. 
         FIG. 15  is a side perspective view of an end cap and protective covering, according to one embodiment 
         FIG. 16  is a side view of a needle protective device and needle assembly according to one embodiment, showing a syringe, a tubular member, and an end cap. 
         FIG. 17  is a side view of a needle protective device and needle assembly according to one embodiment, showing a syringe, a tubular member, and an end cap. 
         FIG. 18  is side view of a needle assembly and tubular member, according to one embodiment. 
         FIG. 19  is side view of a needle assembly and tubular member, according to one embodiment. 
         FIG. 20  is side view of a needle assembly and tubular member, according to one embodiment. 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The present invention can be understood more readily by reference to the following detailed description, examples, drawings, and claims, and their previous and following description. However, before the present devices, systems, and/or methods are disclosed and described, it is to be understood that this invention is not limited to the specific devices, systems, and/or methods disclosed unless otherwise specified, as such can, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular aspects only and is not intended to be limiting. 
     As used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to a “needle” can include two or more such needles unless the context indicates otherwise. 
     Ranges can be expressed herein as from “about” one particular value, and/or to “about” another particular value. When such a range is expressed, another aspect includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another aspect. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint. 
     As used herein, the terms “optional” or “optionally” mean that the subsequently described event or circumstance can or can not occur, and that the description includes instances where said event or circumstance occurs and instances where it does not. 
     As used herein, the term “needle hub” means any needle hub, retractable syringe luer slip or lock collar, or any other syringe/cylinder type hubs needle configuration, wherein a needle is projecting from a hub, retractable syringe, luer slip or lock collar or other cylinder type needle hub device. 
     As used herein, the term “passive activation” means any safety feature wherein a needle protective device is activated through a normal course of a clinical process use, such as, for example and without limitation, forward or downward motions of the tip or needle towards a patient during the clinical injections procedures where the hands and fingers remain behind the needle tip. 
     As used herein, the term “passive encasement” means any safety feature wherein a needle protective device is pre-activated before clinical use thereby providing automatic encasement of the needle tip during and after the clinical risk window, such as, for example and without limitation, during medication draw-up prior to injections, procedural interruptions due to patient instability, and throughout the continuum clinical procedure to disposal. 
     Reference will now be made in detail to the present preferred embodiment(s) of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers are used throughout the drawings to refer to the same or like parts. 
       FIGS. 1 and 2  of the accompanying drawings illustrate one embodiment of a needle protective device  10  and a needle assembly  12 . The needle protective device of this embodiment can comprise a tubular member  14  and an end cap  16 . In another aspect, the needle protective device can further comprise a pierceable protective covering  17  comprising infection control or aseptic materials. The needle assembly can comprise a needle hub  22 , an end rim  24 , and an elongate needle  26  extending from the hub. In this embodiment, the tubular member of the needle protective device can be attached to the needle hub of the needle assembly. 
     Referring to  FIG. 3 , in one aspect, the tubular member  14  can be cylindrical in shape having a circular cross-sectional of substantially constant diameter. It is contemplated, however that the tubular member can be other shapes and that the tubular member cross-sectional shape can also be other shapes, such as, for example, and not meant to be limiting, square, rectangular, or oval. The tubular member  14  can be formed from resilient polymeric materials, such as for example and not meant to be limiting, silicone rubber. In one aspect, the tubular member can have a Shore hardness of between approximately 30-80. In another aspect, the tubular member  14  can withstand gamma or other radiation for sterilization purposes, and can be stable up to a temperature of at least 200 degrees C. The tubular member can also be ultraviolet resistant to a substantial extent. In yet another aspect, at least a portion of the tubular member can be transparent; however, it is contemplated that at least a portion of the tubular member  14  can be color coded to indicate, for example, needle dimensions or other needle properties. It is also contemplated that tubular member can be formed by conventional manufacturing processes, such as, for example and not meant to be limiting, extrusion or injection molding. 
     The tubular member  14  can have a longitudinal axis, a first end  13  and a second end  15 . The first end can be configured for mounting on a needle hub  22 , as will be described below. The second end of the tubular member can be configured for mounting the end cap thereon, as will also be described below. In one aspect, the tubular member can be selectively axially movable between a first relaxed position and a second compressed position, by urging the second end  15  of the tubular member substantially along the longitudinal axis of the tubular member  14  towards the first end  13 . In this aspect, the tubular member can store resilient force when the tubular member  14  is moved from the first relaxed position to the second compressed position. 
     In another aspect, the tubular member  14  can have a gripping means  45  formed thereon. In one aspect, the gripping means can consist of a flange on the tubular member at or adjacent each end. In another aspect, the gripping means can include a plurality of formations disposed about the circumference of the tubular member  14 . These formations can be in various forms, such as, for example and not meant to be limiting, lugs or ribs. As illustrated in  FIG. 3 , the gripping means can comprise a plurality of circumferentially disposed axial ribs  46  extending over at least a portion of the length of the tubular member. The axial ribs can enable the ends of the tubular member to be gripped when these ends are stretched over the needle hub  22  and the end cap  16  during assembly, as will be more fully described below. The axial ribs  46  can be particularly useful in an automated assembly process when they can be releasably engaged with suitable mechanical devices such as clamps to facilitate the required stretching of the tubular member. In a further aspect, the axial ribs can also serve to stiffen the tubular member. 
     In yet another aspect, the first end  13  of the tubular member can be skewed, such that a plane in which the first end is located is not normal to the longitudinal axis of the tubular member  14 . When the skewed first end of the tubular member is mounted to the needle hub  22 , as will be described more fully below, the skew of the first end of the tubular member causes the longitudinal axis of the tubular member  14  to be unparallel to the longitudinal axis of the needle. In this aspect, the second end  15  of the tubular member can be straight, such that a plane in which the second end is located is normal to the longitudinal axis of the tubular member  14 . 
     In still another aspect, the tubular member  14  can have a plurality of axial slits  18  formed thereon. The axial slits can extend axially over at least a portion of the tubular member, and the axial slits can be diametrically opposed to each other. The axial slits  18  can terminate at either end or both ends in substantially circular end notches  20 , configured to reduce tearing of the axial slits which can occur as the ends of the axial slits are placed under tension when the tubular member is axially compressed. In another aspect, notches  50  can be selectively formed along the edges of the axial slits  18  in the tubular member  14 . The notches  50  help ensure that when the tubular member  14  is axially compressed such that the second end  15  of the tubular member  14  is moved axially towards the first end  13  of the tubular member, portions of the tubular member will be disposed to fold or bow outwardly enabling the end cap  16  to be retracted until it encounters the needle hub  22 , as will be described more fully below. In one aspect, the notches  50  can be formed at any location along the slits. In another aspect, the size of the axial slits and/or the end notches  20  and/or the notches  50  can increase or decrease the amount of resilient force stored within a compressed tubular member. For example, an increase in the width and/or length of the axial slits  18  means there can be a corresponding removal of material forming the tubular member  14 , and therefore the amount of resilient force capable of being stored in a compressed tubular member can decrease. In another aspect, mating notches can be formed at any location along the slits. The mating notches, according to one aspect, can be configured to mate or attach to bosses to form a mechanical connection between the tubular member and the mating part to increase the pull force between the tubular member and the mated part. 
     As illustrated in  FIGS. 2 and 4 , in one embodiment, the end cap  16  can be substantially cylindrical in shape, thereby defining a first chamber  28 . The end cap  16  can formed from a relatively hard thermoplastic material, such as, for example and not meant to be limiting, polystyrene. In one aspect, at least a portion of the end cap can be transparent, so that at least a tip  27  of the needle  26  is visible, however, colored end caps are also contemplated. In one aspect, the end cap can be injection molded, though other manufacturing methods are contemplated, as are commonly known in the art. A first end  29  of the end cap can be open, and in one aspect, at least a portion of the second end  31  of the end cap  16  can be closed by a blocking surface  30 . In another aspect, the blocking surface can be sloped or angled such that a user can verify the orientation of the bevel on the tip of the needle by looking only at the end cap. In still another aspect, and as illustrated in  FIG. 6A , the end cap can define a slot  37  configured for receiving an infection control or aseptic material of the pierceable protective covering  17 , described more fully below. In another aspect, the infection control or aseptic materials can be inserted into the slot of the end cap to provide a means to hold or gather infectious materials that come in contact with the needle cannula when in clinical use. 
     In one aspect, an opening  34  can be defined therein the blocking surface of the end cap that is in communication with the first chamber  28 . In this aspect, a passage  32  can extend from the opening  34  in the blocking surface  30  to the first chamber. In one aspect, the opening in the blocking surface can be circular, however, the opening  34  can be other shapes, such as, for example and without limitation, D-shaped, oval, square, and the like. A wall  42  of the passage  32  can extend from the blocking surface in a direction along the longitudinal axis of the end cap, so that the wall of the passage and the blocking surface  30  define a safety chamber  44  for the tip  27  of the needle  26 . In one aspect, the passage can be flared, so that a cross-sectional diameter of the passage  32  decreases as the passage progresses from the opening  34  in the blocking surface  30  towards the first end  29  of the end cap  16 . The flared passage can reduce the likelihood that the tip  27  of the needle  26  can be snagged on the wall  42  of the passage and, in turn, can reduce the likelihood that the tip of the needle can thereby become damaged. In another aspect, as illustrated in  FIGS. 2 and 4 , the passage can have a substantially constant cross-sectional diameter. 
     In one aspect, a flange  36  can extend around at least a portion of an outer wall  21  of the end cap. In another aspect, illustrated in  FIGS. 11-13 , a plurality of flanges can extend around at least a portion of the outer wall  21  of the end cap  16 . In another aspect, a registration tab  48  can be formed on at least a portion of the flange  36  to assist in orientation and location of the end cap  16  in vibrating feed bowls used in an automated assembly process. The inner wall  23  of the first chamber  28  can be formed with one or more guide formations adapted to guide the tip  27  of the needle  26  to the mouth  40  of the passage  32  when the needle is displaced within the end cap, as will be described more fully below. In another aspect, the guide formations can comprise guide ribs  38  that extend in the direction of the longitudinal axis of the end cap. The guide ribs can be substantially parallel to each other. In other aspect, the guide ribs can diverge away from each other as they become closer to the first end  29  of the end cap  16  in order to facilitate guidance of the tip of the needle to the opening  34 . 
     In another embodiment, the end cap  16  can be substantially frustoconical in shape and define a first chamber  28 . In this embodiment, the first end  29  and the second end  31  of the end cap can be open. The second end of the end cap can define opening  34 . The inner wall  23  of the first chamber  28  can be formed with one or more guide ribs  38 . In one aspect, the guide ribs  38  can be substantially parallel to each other. In another aspect, the guide ribs can diverge rearwardly away from each other as they become closer to the first end  29  of the end cap in order to facilitate guidance of the tip of the needle. In yet another aspect, a passage  32  can extend from the opening  34  to the first chamber  28 . In this embodiment with the open second end  31  of the end cap  16 , when assembled as a component of the needle protection device, no alignment of the needle  26  with the opening  34  of the end cap can be necessary in order to expose the needle, as will be described more fully below. Instead, the needle may be exposed by passive activation, as will also be described more fully below. 
     In one aspect, the end cap  16  can be provided with a visual indicator  19 , such as, for example and not meant to be limiting, a colored dot or a raised area, to provide a reference point for users of the needle protective device  10 . The visual indicator can allow a user to quickly ascertain the orientation of the needle relative to the guide ribs  38  and/or opening  34  so that an injection can be administered properly. 
     In another embodiment, and as illustrated in  FIG. 5 , the end cap  16  can comprise a means for selectively confining a portion of the needle to a second chamber  100  of the end cap that is not in communication with the opening  34  of the end cap. For clarity and conciseness, the means for selectively confining a portion of the needle to the second chamber of the end cap will be referred to herein as a locking means. In one aspect, the locking means can be configured such that when the end cap is in use, as described below, the locking means can pre-align the needle tip  27  with the opening  34  of the end cap  16  to allow the needle to exit the first chamber  28  through passive activation using a substantially forward movement on the device  10 . In one aspect, the locking means can be at any location along the longitudinal axis of the end cap. In another aspect, the locking means can allow one-directional movement of the needle  26  so that the tip  27  of the needle can be moved adjacent a blocking surface  30  or an end dam  90 , but can prevent the tip of the needle from being moved away from the blocking surface or the end dam, thereby preventing the needle  26  from exiting the first chamber  28 . In order to activate the locking means, a user can exert a downward and/or a rotational motion on the end cap  16  on a surface, thereby moving the needle through the locking members  102 ,  104 , as will be described below, into the second chamber. After activation, the locking means of the end cap can confine the needle tip  27  to the second chamber  100  of the end cap, wherein the tip  27  of the needle is prevented from exiting the second chamber  100  by the locking means in combination with an end dam  90  or blocking surface  30 . 
     In another aspect, the locking means can provide a user of the device tactile feedback, so that the user can be aware that the needle is locked or in the process of locking without visually seeing this condition. In yet another aspect, the locking means can be configured to support the needle  26  when the needle is in an unlocked position within the end cap  16 . In another aspect, the locking means can be configured to guide the needle during passive activation. In yet another aspect, the locking means can be configured to prevent movement of the needle from the first chamber to the second chamber during passive activation. In still another aspect, the locking means of the end cap can prevent the reuse of a needle after the needle  26  has been locked within the second chamber  100  of the end cap. 
     FIGS.  5  and  7 - 11  illustrate embodiments of an end cap locking means. In one embodiment, illustrated in  FIG. 5 , the locking means can be located at first end  29  of the end cap  16 , though it is contemplated that the locking means could also be located at other positions within first chamber  28  of the end cap. The end cap can be substantially frustoconical in shape, though other shapes, such as substantially cylindrical, are also contemplated. The first end  29  of the end cap can be open, and at least a portion of the second end  31  of the end cap can be closed by end dam  90 , so that opening  34  is defined therein the second end. In one aspect, a passage  32  can extend from the opening  34  to the first chamber  28 . 
     In another aspect, illustrated in  FIG. 9 , a flexible locking arm  92  can have a first end  96  and a second end  98 . In still another aspect, a first guide member  107  can extend from the inner wall of the first chamber transverse to the longitudinal axis of the end cap  16  through at least a portion of the first chamber  28 , and a second guide member  108  can extend from the inner wall of the first chamber transverse to the longitudinal axis of the end cap  16  through at least a portion of the first chamber  28 . The locking arm, first guide member, and second guide member can be formed of the same material of the end cap  16 , though other materials are also contemplated. The first end of the locking arm  92  can be attached to, or alternatively formed integrally with, the inner wall  23  of the first chamber or the first guide member  107 . The locking arm can normally be in a closed position, wherein the second end of the locking arm is in contact with the inner wall of the first chamber  28  or the second guide member  108 . In the closed position, the locking arm  92  can define a second chamber  100 . In one aspect, the locking arm can be configured such that, when the needle protective device  10  is assembled as described below, a needle can be urged against the second end  98  of the locking arm  92 , thereby causing the locking arm to flex away from the inner wall of the first chamber or the second guide member momentarily, allowing the needle to enter the second chamber  100 . In another aspect, the second end  98  of the locking arm can have a tab  93  configured for matingly engaging a notch formed therein the second guide member  108 . In another aspect, the first and second guide members  107 ,  108  can support and guide the needle along the longitudinal axis of the end cap through the first chamber  28  of the end cap. 
     Another embodiment of an end cap locking means is illustrated in  FIGS. 7 and 11 . In this embodiment, the end cap  16  can be substantially frustoconical in shape, though other shapes, such as cylindrical, are also contemplated. First chamber  28  can be defined therein the end cap. The first end  29  of the end cap can be open, and at least a portion of the second end  31  of the end cap can be closed by end dam  90 , so that opening  34  is defined therein the second end. In one aspect, a passage  32  can extend from the opening to the first chamber  28 . A first locking member  102  and a second locking member  104  can be formed of the same material of the end cap  16 , though other materials are also contemplated. The first and second locking members can be flexible, and can be attached to, or alternatively formed integrally with, the inner wall  23  of the first chamber. The first locking member  102  can extend from the inner wall of the first chamber transverse to the longitudinal axis of the end cap  16  through at least a portion of the first chamber  28 . The second locking member  104  can extend from the inner wall  23  of the first chamber transverse to the longitudinal axis of the end cap so that it touches the first locking member  102  at an angle, thereby forming second chamber  100 . 
     In this embodiment, the first locking member  102  and the second locking member  104  can interact such that, when the needle protective device  10  is assembled as described below, a needle can be urged against the second locking member  104 , thereby causing the second locking member to flex away from the first locking member  102  momentarily, allowing the needle to enter the second chamber  100 . Alternatively, a needle can be urged against the first locking member, thereby causing the first locking member to flex away from the second locking member momentarily, allowing the needle to enter the second chamber  100 . In another aspect, and as illustrated in  FIG. 8 , the end cap can comprise a locking means and guide ribs  38 . The guide ribs, as previously described, can support and automatically guide the tip of a needle  26  into alignment with passage  32 . 
     Yet another embodiment of an end cap locking means is illustrated in  FIG. 10 . In this embodiment, the end cap  16  can be substantially frustoconical in shape, though other shapes, such as cylindrical, are also contemplated. First chamber  28  can be defined therein the end cap. The first end  29  of the end cap can be open, and at least a portion of the second end  31  of the end cap can be closed by end dam  90 , so that opening  34  is defined therein the second end. In one aspect, a passage  32  can extend from the opening  34  to the first chamber  28 . A first arcuate locking member  102  and a second arcuate locking member  104  can be formed of the same material of the end cap  16 , though other materials are also contemplated. The first and second arcuate locking members can be attached to, or alternatively formed integrally with, the inner wall  23  of the first chamber. The first arcuate member  102  can extend from the inner wall of the first chamber transverse to the longitudinal axis of the end cap  16  through at least a portion of the first chamber  28 . The second arcuate locking member  104  can extend from the inner wall  23  of the first chamber transverse to the longitudinal axis of the end cap  16  through at least a portion of the first chamber, extending towards the first arcuate member. In one aspect, a gap  109  can be formed between the first and second arcuate locking members. In another aspect, the first and second arcuate locking members can be in contact with each other, so that the gap is not present. In this embodiment, when the needle protective device  10  is assembled as described below, a needle can be urged against the first arcuate locking member  102 , the second arcuate locking member  104 , or both arcuate locking members, thereby causing the arcuate members to momentarily flex away from each other, allowing the needle to be easily moved past the arcuate locking members into the second chamber  100 . 
       FIGS. 1 ,  2 ,  6 A,  6 B,  11 ,  14 , and  15  illustrate embodiments of a pierceable protective covering  17 . In various aspects, the pierceable protective covering can be attached to, inserted into or incorporated into the end cap  16  such that the protective covering seals the opening and/or the passage  32  of the end cap. In one aspect, the pierceable protective covering can comprise infection control or aseptic materials, as known in the arts. In another aspect, the protective covering can be a thin, pierceable material configured to cover the opening  34  of the end cap  16 . The pierceable protective covering can be selectively pierced when, on an assembled device, as will be described more fully below, the end cap  16  is moved axially toward the first end  13  of the tubular member  14  as the tubular member is moved from the first relaxed position to the second compressed position. In one aspect, the protective covering can be formed from a material which can be impregnated with infection control or aseptic materials. In another aspect, the protective covering  17  can be formed from a fibrous material, such as for example and not meant to be limiting, paper, gauze or the like. Alternatively, in still another aspect, the protective covering can be formed from a polymeric material, such as, for example and not meant to be limiting, plastics, rubber or the like. In one aspect, as illustrated in  FIGS. 1 and 2 , the pierceable protective covering  17  can be configured to fit over the end cap. In another aspect, as illustrated in  FIGS. 14 and 15 , the pierceable protective covering can be formed within the opening  34  of the end cap  16 . In still another aspect, the pierceable protective covering can be formed within the first chamber  28  of the end cap, as illustrated in  FIGS. 6A ,  6 B, and  11 . In another aspect, the pierceable protective covering can be inserted into the first chamber  28  of the end cap through the slot  37  of the end cap. 
     In one aspect, the combination of the materials for the protective covering  17  and the thickness of that material can be selected so that, when the protective covering is in use, the compressive force exerted onto the needle  26  by the protective covering is less than the resilient force stored therein the compressed tubular member  14  when it is in the second, compressed position. Thus, the protective covering  17  can exert a compressive, frictional force on the needle that is small enough to allow the needle protective device  10  to move freely axially under forces supplied to the needle protective device by the compressed tubular member. In another aspect, the protective covering  17  can provide a barrier that provides a user of the needle protective device a tactile feeling as the tip of the needle penetrates the protective covering. In this aspect, the user can know the approximate location of the tip  27  of the needle without visually seeing it so that the user can know that there is an exposed needle tip. 
     In another embodiment, the needle protective device  10  can comprise a flexible tubular member  14 , an end cap  16 , and a cover. In one aspect, the cover can be formed from a relatively hard thermoplastic material, such as, for example and not meant to be limiting, polystyrene. The cover can be a hollow tube having a closed end and an open end. The inner diameter of the cover can be dimensioned so that the tubular member  14  and the end cap  16  can fit therein the cover. In another aspect, the cover can have a length dimensioned to extend from the closing wall of the end cap  16  to the needle hub  22 , when the device is assemble, as will be described below. In yet another aspect, the cover can be dimensioned so that the needle is selectively completely enclosed therein, thus maintaining the needle in a sterile condition. 
     In order to assemble the needle protective device, the second end  15  of a tubular member  14  can be frictionally engaged with the first end  29  of an end cap  16  by stretching the second end of the tubular member over the first end of the end cap. In one aspect, the end cap can have a pierceable protective covering  17  over the opening  34  of the end cap. In other aspects, the protective covering can be inserted into the opening or the slot  37  of the end cap. The protective covering can be attached to the end cap by conventional means, such as, for example and not meant to be limiting, adhesives or a friction fitting. 
     The assembled needle protective device  10  can then be inserted onto a needle assembly by stretching the first end  13  of the tubular member  14  over the needle hub  22  until the first end of the tubular member is adjacent the end rim  24 . As illustrated in  FIGS. 18-20 , the tubular member can be stretched over a conventional needle hub, a retractable syringe, luer slip or lock collar, or any other syringe/cylinder type hub needle configuration. In one aspect, the needle hub  22  can be attached to a syringe  200 , which can be a retractable syringe with a needle preassembled. 
     In one aspect, if the first end  13  of the tubular member is skewed, after assembly on the needle protective device onto the needle hub, the longitudinal axis of the tubular member  14  can be unparallel to the longitudinal axis of the needle  26 . With reference to  FIG. 2 , in this aspect, the tip  27  of the needle can be disposed to lie adjacent the blocking surface  30  of the first chamber  28  opposite to the location of the passage  32 . If a cover is to be included, the open end of the cover can be inserted over the end cap and tubular member until it contacts the needle hub. 
     In another aspect, the tubular member  14  can be mounted on the needle hub  22  in such a way that a bevel on the tip of the needle  26  slopes in the opposite direction as the blocking surface  30  of the end cap. Thus, by simply viewing the blocking surface and/or the visual indicator  19 , the user can know that the bevel of the needle is in the correct disposition relative to a patient&#39;s skin. In this aspect, it is not necessary for the user to visually inspect the tip  27  of the needle itself to ensure this result. 
     In use, the needle assembly and thus, the needle protective device  10  can be mounted onto a syringe. In order to administer an injection, if a cover is present, the user can remove it to expose the end cap  16 . If the tip  27  of the needle  26  is pre-aligned with the opening  34  in the second end  31  of the end cap, no alignment by the user is necessary and passive activation of the needle protective device  10  by the user can occur. If the needle is not pre-aligned with the opening  34  in the second end of the end cap, the needle  26  can be substantially co-axially aligned with the passage  32  and the opening  34  in the second end  31  of the end cap. If the end cap has a blocking surface  30  or a end dam  90  the end cap can be moved so that the end cap  16  is displaced sideways until the needle  26  is brought into contact with one of the guide ribs  38  which can automatically guide the tip of the needle into alignment with passage  32 . If the end cap does not have guide ribs, the end cap  16  can be moved until the tip  27  of the needle  26  is aligned with passage  32 . In another aspect, if the needle is not pre-aligned with the opening  34  in the second end of the end cap and if the end cap has a visual indicator  19 , the end cap can be moved until the tip of the needle is aligned with passage by referring to the visual indicator. If the end cap does not have a blocking surface  30  or an end dam  90 , the tip of the needle can be aligned with the passage without being moved by the user. 
     After alignment of the needle with the passage  32  and/or the opening  34  of the end cap, the tubular member  14  can then be axially compressed by the user to urge the second end  15  of the tubular member towards the first end  13  of the tubular member, with the center portion of the tubular member bowing outwardly. As one will appreciate, as the tubular member  14  is axially compressed, the tip  27  of the needle slides through the passage and the opening of the end cap  16 . If a protective covering  17  is present, the needle will pierce the protective covering, which can provide the user a tactile feeling so that the location of the tip of the needle  26  is known. With the needle tip thus exposed, the tip  27  of the needle can be inserted into a patient, filling bottle, or a biological surface, and the tubular member  14  can be released. Resilient forces present in the axially compressed tubular member cause the second end  15  of the tubular member to slide forward and move away from the first end  13  of the tubular member axially, until the blocking surface  30  lies against the patient, filling bottle, or biological surface. 
     At the end of the injection procedure, as the needle  26  is withdrawn from the patient, filling bottle, or other biological surface, resilient forces present in the axially compressed tubular member  14  cause the tubular member to expand axially such that the second end  15  of the tubular member slides forward until the passage  32  in the end cap is extended over the needle  26  and the tip  27  of the needle is located in the first chamber  28 , thereby reducing the likelihood that a user can receive an inadvertent needlestick. In one embodiment, if the end cap  16  has a locking means, as illustrated in  FIGS. 10-13 , after use of the needle is complete and with the needle located within first chamber  28 , the user can laterally move and/or rotate the end cap relative to the needle  26  until the needle is confined to second chamber  100 . In this embodiment, when the needle is in the second chamber, the tip  27  of the needle is opposed to the end dam  90 , and thereby prevented from being extracted from the end cap, thus reducing the likelihood of accidental needle sticks. 
     In another embodiment, as illustrated in  FIG. 16 , the needle protective device  10  can comprise a syringe  80 , a tubular member  14 , and an end cap  16 . In one aspect, the syringe can be a conventional retractable polymeric syringe comprising a generally tubular chamber  82 . The syringe can have threads  84  configured for selective, releasable attachment to a needle hub  22 . A needle  26  can be coupled to and project outwardly from the needle hub. As described above, a tubular member can extend about at least a portion of the needle, and an end cap  16  can be mounted onto the tubular member  14 . In one aspect, the tubular member can be dimensioned so that the tubular member  14 , the end cap, and a protective covering  17 , if present, can be retracted into the chamber  82  of the syringe as the needle assembly is retracted into the chamber of the syringe. In this aspect, the needle can be locked inside the chamber of the syringe to prevent reuse. 
     In another embodiment, as illustrated in  FIG. 17 , the needle protective device  10  can comprise a conventional  80 , a tubular member  14 , and an end cap  16 . In one aspect, the syringe can be a conventional syringe retrofitted with a sliding barrel shield  85 . In this embodiment, the tubular member  14 , needle  26 , and end capl 6  can be dimensioned for encasement within the sliding barrel. The needle protective device can provide passive needle encasement protection during the clinical process, while following the clinical procedure the sliding barrel shield  85  can be locked over the needle protective device preventing the reuse of the needle protective device  10  and safety needle assembly. 
     Although several embodiments of the invention have been disclosed in the foregoing specification, it is understood by those skilled in the art that many modifications and other embodiments of the invention will come to mind to which the invention pertains, having the benefit of the teaching presented in the foregoing description and associated drawings. It is therefore understood that the invention is not limited to the specific embodiments disclosed herein, and that many modifications and other embodiments of the invention are intended to be included within the scope of the invention. Moreover, although specific terms are employed herein, they are used only in a generic and descriptive sense, and not for the purposes of limiting the described invention.