Abstract:
Techniques disclosed herein include a disposable safety needle assembly and safety enclosure for internally shielding a used or contaminated needle. The needle assembly has a needle cannula slidably disposed within a safety enclosure. The safety enclosure includes an internally disposed flexible safety member. The flexible safety member has face portion transversely situated and having a safety feature disposed to the needle and that slides thereon. Retracting the needle within the safety enclosure to a point wherein the sharp tip of the needle is beyond the needle protection section of the flexible member causes the protection section to travel transversely to the direction of motion of the needle. As a result, the safety feature receives the sharp tip of the needle and prevents the needle from exiting the enclosure, thereby maintaining the needle safely after use.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
     This application is a Non-Provisional utility patent application claiming priority to U.S. Provisional Patent application Ser. No. 61/206,333 filed Jan. 29, 2009 and is incorporated herein by reference. 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     This invention generally relates generally to medical safety devices and in particular to a disposable safety needle having an enclosure means. 
     2. Description of the Related Art 
     Fluid collection sets, catheters, and intravenous infusion sets are typically used to collect bodily fluids from a patient or to infuse liquids into a patient. These devices typically include a length of flexible plastic tubing with a proximal end connected to a plastic fitting and a distal end connected to a needle, or in the case of a catheter, a tubular assembly. In practice, fluid is transferred via the plastic tubing either to or from the needle or tubular assembly. 
     Accidental sticks with a needle cannula can be not only painful but can also transmit disease from a patient to medical personnel. Similarly, catheters may retain fluids when they are removed from a patient and transmit disease via these fluids if passed to medical personnel. As a result, nearly all needle assemblies and other sharp medical implements are employed with an apparatus for enclosing the sharp tip of the needle or tubular assembly both prior to and after use. 
     Protection prior to use is typically achieved by a rigid plastic tube that surrounds a portion of the needle including the sharp edge. This rigid tube typically has a proximal end frictionally mounted to or near the hub and a distal end that extends beyond the distal end of the piercing element. The rigid tube itself surrounds the needle and prevents contact with the needle point until it is removed. Once removed, the plastic tube is discarded immediately prior to use of the piercing element. 
     One prior art form of protecting the needle after use is the use of a tubular shield that can be telescoped relative to both the hub and piercing element from a proximal position where the piercing element is exposed to a distal position where the piercing element is safely within the tubular shield. Shields of this type typically include means for releasably holding the shield in its proximal position and for holding the shield more securely in its distal position. Some devices include a spring for generating relative movement between the shield and the piercing element. In some instances the piercing element is withdrawn proximally into the shield. 
     However, this prior art method requires movement of the hands of the medical provider toward the exposed needle and therefore may allow needle stick injuries during the recapping. 
     IN addition, a small volume of blood or other bodily fluid may remain in or on a piercing element after the piercing element has been withdrawn from the patient or when a catheter is removed from a patient. This residual fluid may splatter as the piercing element is retracted rearward into the prior art shield. In general, the larger the bore of the needle, the larger the acceleration of the needle in the proximal direction, and any transverse acceleration may result in the splatter of the residual bodily fluid. 
     The prior art has worked to reduce the likelihood of such splatter. In one example, an indwelling injector needle assembly has the hub slide along an inner periphery of the holder between a first position near the distal end of the holder and a second position near a proximal end of the holder. The latching mechanism is formed in and disposed between the hub and the holder so that the hub is inhibited from moving from the first position toward the second position, and vice versa. The needle edge can be retracted within the holder while remaining fixed to a patient&#39;s skin. 
     However, this form of the prior art has at least one problem. This structure includes a non-rotating needle. As is known in the art, a rotatable needle is preferable to a non-rotatable needle in order to maximize blood or fluid flow to or from a vessel in which the needle is inserted. The prior art device prevents the needle from being rotated after cannulation. The needle and hub cannot rotate relative to the cylindrical holder due to the lug being slidably engaged with the guide groove in the hub. Therefore the needle cannot be rotated when needed after cannulation in order to maximize blood or fluid flow to or from the vessel. 
     Another prior art device describes a system which provides a snap-on exterior mounted enclosing guard can be added to a needle assembly. A spring forms an essential element of this safety needle assembly. In particular, the spring includes an turned in flange which is described as imperforate, such that it acts as a blocking flange. The enclosing guard, by way of the imperforate blocking flange, upon the withdrawal of the needle from the blood donor or patient, blocks the contaminated needle point. 
     Thus, this prior art device is limited in its use of materials and design in that the flange must be imperforate in order to prevent the needle tip from coming into contact with any worker. However, the enclosing guard is in proximate relation to and actually touches the needle cannula while it is being withdrawn from the patient. Thus, this assembly can become contaminated itself. Although the needle point is blocked, the system may still contaminate the worker by the blood or fluid which is on the enclosing guard. 
     Thus, what is needed is a safety needle device that allows for the maximum blood or fluid flow to or from the vessel, and overcomes the limitations of the prior art. 
     SUMMARY OF THE INVENTION 
     The present invention addressed the problem of potential worker contamination both by needle stick and accidental exposure without needle stick. A new system and enclosure means is provided which prevents the needle from exiting the enclosure once it has been withdrawn from the patient, shields the needle point and simultaneously isolates the locking member from contact with the worker and any other patient or person in proximity to the patient. In addition, the system and enclosure of the present invention also prevents the medical care giver from accidentally coming in contact with body fluid of the patient. 
     The needle assembly has a needle cannula which is longitudinally disposed within a safety enclosure and slidably maintained therein. The safety enclosure incorporates an internally disposed flexible member situated along the longitudinal plane, having a needle protection section transversely disposed to the needle cannula and cooperatively sliding thereon. The needle protection section can either be imperforate, in which case a detent is advantageously disposed thereof to capture the tip of the needle cannula, or it can be perforate, in which case the perforation is of a diameter less than the diameter of the cannula such that it can capture and retain the tip of the cannula. Retraction of the needle cannula within the safety enclosure to a point wherein the sharp tip of the needle cannula is beyond the needle protection section of the flexible member causes the protection section to travel transversely to the direction of motion of the needle cannula and block the sharp tip from exiting the enclosure, thereby maintaining the needle safely after use and preventing the accidental exposure with the patient&#39;s body fluids. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       Aspects of the present invention are pointed out with particularity in the appended claims. The present invention is illustrated by way of example in the following drawings in which like references indicate similar elements. The following drawings disclose various embodiments of the present invention for purposes of illustration only and are not intended to limit the scope of the invention. For purposes of clarity, not every component may be labeled in every figure. In the figures: 
         FIG. 1  is a cross sectional view incorporating an embodiment of the present invention in a use position; 
         FIG. 2  is a cross sectional view incorporating an embodiment of the present invention the safety position; 
         FIG. 3  is top view of the flexible safety member according to an embodiment of the invention located; 
         FIG. 4  is a top view of an apparatus incorporating an embodiment of the present invention; 
         FIG. 5  is cross sectional view of a first embodiment of the safety feature of the present invention; and 
         FIG. 6  is a cross sectional view of a second embodiment of the safety feature of the present invention. 
     
    
    
     DETAILED DESCRIPTION 
     The following detailed description sets forth numerous specific details to provide a thorough understanding of the invention. However, those skilled in the art will appreciate that the invention may be practiced without these specific details. In other instances, well-known methods, procedures, components, protocols, processes, and circuits have not been describe in detail so as not to obscure the invention. 
     Certain terminology may be used in the following description for convenience only and is not limiting. The words “lower” and “upper” and “top” and “bottom” designate directions only and are used in conjunction with such drawings as may be included to fully describe the invention. The terminology includes the above words specifically mentioned, derivatives thereof and words of similar import. 
     Where a term is provided in the singular, the inventors also contemplate aspects of the invention described by the plural of that term. As used in this specification and in any claims, the singular forms “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise, e.g. “a derivative work”. Thus, for example, a reference to “a method” includes one or more methods, and/or steps of the type described therein and/or which will become apparent to those persons skilled in the art upon reading this disclosure. 
     Unless defined otherwise, all technical, legal, copyright related and scientific terms used herein have the same meaning or meanings as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, the preferred methods, constructs and materials are described herein. All publications mentioned herein, whether in the text or by way of numerical designation, are incorporated herein by reference in their entirety. Where there are discrepancies in terms and definitions used by reference, the terms used in this application shall have the definitions given herein. 
     The term “variation” of an invention includes any embodiment of the invention, unless expressly specified otherwise. A reference to “another embodiment” in describing an embodiment does not necessarily imply that the referenced embodiment is mutually exclusive with another embodiment (e.g., an embodiment described before the referenced embodiment), unless expressly specified otherwise. 
     The terms “include”, “includes”, “including”, “comprising” and variations thereof mean “including but not limited to”, unless expressly specified otherwise. The term “consisting of” and variations thereof includes “including and limited to”, unless expressly specified otherwise. 
     The terms “a”, “an” and “the” mean “one or more”, unless expressly specified otherwise. The term “plurality” means “two or more”, unless expressly specified otherwise. The term “herein” means “in this patent application, including anything which may be incorporated by reference”, unless expressly specified otherwise. The phrase “at least one of”, when such phrase modifies a plurality of things (such as an enumerated list of things) means any combination of one or more of those things, unless expressly specified otherwise. 
     The phrase “based on” does not mean “based only on”, unless expressly specified otherwise. In other words, the phrase “based on” describes both “based only on” and “based at least on”. The term “represent” and like terms are not exclusive, unless expressly specified otherwise. 
     The term “whereby” is used herein only to precede a clause or other set of words that express only the intended result, objective or consequence of something that is previously and explicitly recited. Thus, when the term “whereby” is used in a claim, the clause or other words that the term “whereby” modifies do not establish specific further limitations of the claim or otherwise restricts the meaning or scope of the claim. 
     The terms “such as”, and/or “e.g.” and like terms means “for example”, and thus does not limit the term or phrase it explains. 
     The term “determining” and grammatical variants thereof (e.g., to determine a price, determining a value, determine an object which meets a certain criterion) is used in an extremely broad sense. The term “determining” encompasses a wide variety of actions and therefore “determining” can include calculating, computing, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Also, “determining” can include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory) and the like. Also, “determining” can include resolving, selecting, choosing, establishing, and the like. It does not imply certainty or absolute precision, and does not imply that mathematical processing, numerical methods or an algorithm process be used. Therefore “determining” can include estimating, predicting, guessing and the like. 
     In the embodiments that follow, the safety needle assembly has a needle cannula that is slidably disposed within a safety enclosure. The safety enclosure incorporates an internal safety cover situated along the longitudinal axis of the needle cannula, having a needle protection face section transversely disposed to the needle cannula. The needle protection face section can either be imperforate, in which case a detent is disposed thereon to capture the tip of the needle cannula, or it can be perforate, in which case the perforation through the protection face has a diameter less than the diameter of the needle cannula. In this way, the needle cannula is captured and retained within the safety enclosure. 
     With respect to  FIGS. 1 and 2 , a safety needle assembly  100  is provided that includes a needle cannula  102  suitable for the insertion or removal of fluids to or from a patient. The needle cannula  102  includes a tapered point  104  and a proximal end  105 . The proximal end  105  of the needle cannula  102  is attached to a piece of flexible tubing  106  via a connector  109  or through the use of a bonding material as is known in the art. 
     A safety enclosure  108  includes a forward face  112  having an orifice  112   a  and a distal end  114  and orifice  116  as well. The orifices  112   a  and  116  are both sized and configured to allow the tapered point  104  and the body of the needle cannula  102  to slidably pass therethrough. A base portion (hub, hub portion)  110  of the safety needle assembly is secured to the flexible tubing  106 . The base portion (hub, hub portion)  110  includes a front face  120  and an orifice  122 . Orifice  122  is also sized and configured to allow the body of the needle cannula  102  to pass slidably therethrough. 
     The safety enclosure  108  includes an interior portion  124  that includes a base portion  126  that extends a portion of the longitudinal length of the safety enclosure  108 , but does not extend the entire length. The base portion  126  includes a glide canal  128  into which the needle cannula  102  is disposed within. Thus, the needle cannula  102  is slidably and securely disposed within the safety enclosure  108 . 
     Disposed within the interior portion  124  of the safety enclosure  108  is a first base portion  130  on which a flexible safety cover  132  is disposed. As will be discussed in more detail below, the flexible safety cover  132  includes a face portion  134  that includes a safety feature  136  and in which the face portion  134  is disposed in a generally downward direction by bend  138 . The safety cover  132  is biased in a generally downward direction such that so long as the needle cannula  102  is touching the safety cover front face  134 , the safety cover  132  will not move. When the needle cannula  102  is moved such that it is no longer touching the front face  134 , the safety cover  132  and front face  134  will move in the downward direction shown by arrow  139  and depicted in  FIG. 1 . 
     The safety cover  132  is depicted in  FIG. 3  includes the front face  134 , safety feature  136 , and first bend  138 . In addition, the safety cover  132  further includes notch  202  and rear portion  204 . With reference again to  FIGS. 1 and 2 , the interior portion  124  further includes a second base portion  144 . The second base portion  144  is sized and configured to be disposed within notch  202 . In this way, movement of the safety cover separate and distinct from the safety enclosure  108  is prevented. The safety cover  132  is affixed to the first base portion  130  via the cooperating post  140  and hole  206 . 
     As depicted in  FIG. 1 , the needle cannula is shown in its extended configuration in which it is to be used to insert or remove fluids from a patient. In this configuration, the safety enclosure  108  is removably secured to the base portion (hub, hub portion)  110  via a hooking mechanism described below. As depicted in  FIGS. 1 ,  2 , and  4  the base portion (hub, hub portion)  110  includes a pair of posts  142  having a notch  145  disposed therebetween. The safety enclosure  108  includes a hook portion  146  (or latch  146 ) that extends longitudinally from the top surface  148  of the safety enclosure  108  that is sized and configured to cooperate with posts  142  and notch  145  to securely and yet removably secure the safety enclosure  108  to base portion (hub, hub portion)  110 . The hook portion  146  latches with the notch  145  to prevent any motion of safety enclosure  108 , thus preventing the accidental uncovering of the needle cannula  102 . The hook portion  146  is also sized and configured to allow a medical care giver to use the present invention in a one-handed operation. By unlatching the hook  146  and sliding the safety enclosure to cover the needle tip (tapered point)  104  using the same hand, the danger of accidently contacting the needle tip  104  is greatly reduced. 
     In the configuration depicted in  FIG. 1 , the needle cannula  102  is preventing the downward motion of the front face  134 . In this configuration, the needle cannula  102  is extended beyond the front face  134  of the safety enclosure  108  and is ready for use. As can be seen, interior area  149  within the safety enclosure  108  is sized and configured to receive the front face  134  of the safety cover  132 . 
     As depicted in  FIGS. 2 and 4 , the needle cannula  102  has been withdrawn into the safety enclosure  108  and the safety cover  132  is now free to move laterally such that the front face  134  is disposed in front of the tapered point  104 . In addition, the hub portion (base portion, hub)  110  and safety enclosure  108  are prevented from moving beyond a suitable length by flexible member  150  that is attached to both the hub (hub portion, base portion)  110  and safety enclosure  108 . Flexible member  150  is also known as flexible coupling  150  or extensible retainer  150 . In addition, as depicted in  FIG. 4 , flexible wings  402  may be attached to the safety enclosure  108  to allow easier use by medical personnel that may bend the wings  402  upward to facilitate grasping the safety enclosure  108  and then used to provided a surface for taping the safety enclosure  108  to a patient&#39;s skin to secure the needle cannula  102  within the patient. In addition, to prevent the safety enclosure  108  from traveling too far and sliding off the end of the needle tip  104 , a pair of flexible tethers  404  may be coupled to the base portion (hub, hub portion)  110  and the safety enclosure  108  or the flexible wings  402 . These flexible tethers  404  comprise the flexible coupling. As further shown in  FIGS. 5 and 6 , the tapered point  104  is received in the safety feature  136 . In one embodiment, the safety cover  132  is imperforate and the front face  134  includes a detent  602  that is sized configured to receive the tapered point  104  of needle cannula  102  and prevent its movement within the safety enclosure  108 . In another embodiment, the safety cover  132  is perforate and front face  134  includes an orifice  502  that is sized and configured to receive only the tip of the tapered point  104  and thereby prevents movement of the needle cannula  102  within the safety enclosure  108 . In either embodiment, since the safety cover  132  is internal to the safety housing  108 , any fluid which contacts it while it is traveling along the length of the cannula will be maintained within the enclosure. 
     Once enclosed, the practitioner and others are shielded from any accidental stabs from the tapered point  104 . Similarly, since the safety cover  132  is internal to the safety enclosure  108 , any fluid which contacts it while it is traveling along the length of the needle cannula  102  will be maintained within the safety enclosure  108 . However, this shielding function would be frustrated if the proximal end of the safety enclosure  108  was capable of moving distally beyond the distal end of the needle cannula  102 , i.e., past the sharp point. The extensible retainer  150  connects the safety enclosure  108  to the hub  110 . As the safety enclosure  108  moves distally along the needle cannula  102 , the extensible retainer  150  extends up to, but not beyond, a predetermined length. The extensible retainer  150  thus provides an extensible length beyond which the safety enclosure  108  may not distally extend. 
     The needle cannula  102  may be any form of needle cannula suitable for a particular usage. For example, the needle cannula  102  may be a Quincke type spinal needle having a gauge in the range from about 12 to 27 and in lengths from about 1″ to 7″, or the needle cannula  102  may be a Whitacre type spinal having a gauge from about 22 to 27 lengths from about 3½″ to 5″. Of course, other types of spinal needles could be used. The needle cannula  102  may also be an epidural needle having a gauge of about 17 to 22 and 2 to 3 inches in length. The needle cannula  102  may also be a fistula needle for dialysis or a blood drawing needle in a blood drawing device as well. These needle cannulas  102  are exemplary only, and it will be understood that the present invention is not limited to a particular needle gauge, type or length. 
     As discussed above, the needle cannula  102  has a proximal end  105  fixed to the base portion (hub, hub portion)  110 , and a distal end that terminates at a sharp tapered point  104 . It will be appreciated that the distal end does not necessarily have to terminate at a sharp tapered point  104 , and the distal end may have a blunt tip, for instance for use in catheters. The base portion (hub, hub portion)  110  may be any suitable device known in the art, and may have flanges adapted to mate with a locking luer collar, for example. Other types of base portion (hub, hub portion)  110  are possible, such as providing a screw cap adapted to screw onto a corresponding male member of a medical device, which may be a syringe, catheter, etc. Alternatively, the base portion (hub, hub portion)  110  may be the base of a syringe to which the needle assembly is permanently attached. Any method known in the art may be used to fix the hub (hub portion, base portion) onto the proximal end of the cannula, such as adhesives, welding, mechanical engagement or the like. 
     The safety housing  108  may be sized and configured for various usages. For example, the safety cover  108  may be substantially rectangular in shape, and made of plastic, metal or any other sufficiently tough material that can resist puncturing by the point of the cannula. The safety housing  108  has an outer surface, which may be either smooth or provided with a roughened surface to provide a gripping surface for the user. The housing also may have a down-clip member that may be used to permit gripping and placement of the system by the user. In particular, the down-clip member may be employed to effectuate such action rather than using the wings or flanges, which may not provide the same positive gripping surface and control as use of the down-clip member. 
     In addition, although the outer surface of the safety housing  108  is preferentially solid, it will be appreciated that the outer surface may also have openings, such as holes, slits, or the like to reduce on material costs, but that any such opening should not permit access to the bodily fluid or permit escape of that fluid. For purposes of this disclosure, such a configuration is still considered to cover that portion of the cannula over which such the safety housing  108  is disposed. 
     It should be appreciated that other variations to and modifications of the above-described apparatus for protecting a needle cannula may be made without departing from the inventive concepts described herein. Accordingly, the invention should not be viewed as limited except by the scope and spirit of the appended claims. 
     One embodiment can include an apparatus for securing and protecting the tip of a needle, the needle having a body portion and a diameter, the apparatus comprising: a safety enclosure having an interior space, a first base, a pair of second bases, a longitudinal axis, the needle being slidably disposed within the interior space of the safety enclosure; a base portion; a flexible member having a length, the base portion being flexibly connected to the safety enclosure by the flexible member; a flexible safety member having a face portion, a bendable portion, first and second notches, and rear portion, the flexible safety member being disposed substantially longitudinally within the interior space wherein the rear portion is firmly attached to the first and second notches are sized and configured to receive the pair of second bases, the bendable portion being bent such that the face portion is disposed substantially transversely within the interior space, wherein the bent portion biases the face portion in the transverse direction; the face portion including a safety feature sized and dimensioned to receive the tip of the needle; the safety enclosure having two positions, a use position and a safe position; the use position in which the tip of the needle extends beyond the interior of the safety enclosure and the face portion is prevented from movement by the needle; the safe position in which the safety enclosure is moved such that the tip of the needle is brought into the interior of the safety enclosure to a safe position where the tip of the needle is brought further into the interior than the face portion of the flexible safety member, wherein the face portion is able to move transversely and to cover the tip of the needle, wherein the tip of the needle is received by the safety feature. 
     The safety feature can comprise an orifice in the face portion of the flexible safety member that is sized and dimensioned to receive the tip of the needle. The orifice of the safety feature can have a diameter that is less than the diameter of the needle body. The flexible safety member can be constructed of material that has sufficient strength to prevent the tip of the needle from further expanding the diameter of the orifice of the safety feature. The safety feature can comprise an indent in the face portion of the flexible safety member that is sized and dimensioned to receive the tip of the needle. The indent of the safety feature has a diameter that is less than the diameter of the needle body. The flexible safety member can be constructed of material that has sufficient strength to prevent the tip of the needle from further expanding the diameter of the orifice of the safety feature. The safety enclosure can be substantially a rectangular parallelepiped in shape. The rectangular parallelepiped can be a rectangular cuboid. The safety enclosure can be substantially cylindrical in shape. The safety enclosure can be constructed of a material having sufficient strength to resist being punctured by the tip of the needle. The apparatus can further include a piece of hollow tubing having an outer surface, the hollow tubing being mechanically attached to the needle to be in fluid communication with the tip of the needle, the base portion being fixedly disposed about the outer surface of the hollow tubing. The hollow tubing can be flexible. The apparatus can further include a piece of hollow tubing having an outer surface, the hollow tubing being bonded to the needle to be in fluid communication with the tip of the needle, the base portion being fixedly disposed about the outer surface of the hollow tubing. The hollow tubing can be flexible. The apparatus can further include a flexible coupling having a predetermined length, the flexible coupling having two ends, one end being coupled to the base portion and the second end being coupled to the safety enclosure. The flexible coupling can comprise first and second flexible tethers, each of the first and second flexible tethers being coupled between the base portion and the safety enclosure. 
     Another embodiment includes an apparatus for securing and protecting the tip of a needle, the apparatus comprising: a needle having a body portion and a diameter; a safety enclosure having an interior space, a first base, a pair of second bases, a longitudinal axis, the needle being slidably disposed within the interior space of the safety enclosure; a base portion; a flexible member having a length, the base portion being flexibly connected to the safety enclosure by the flexible member; a flexible safety member having a face portion, a bendable portion, first and second notches, and rear portion, the flexible safety member being disposed substantially longitudinally within the interior space wherein the rear portion is firmly attached to the first and second notches are sized and configured to receive the pair of second bases, the bendable portion being bent such that the face portion is disposed substantially transversely within the interior space, wherein the bent portion biases the face portion in the transverse direction; the face portion including a safety feature sized and dimensioned to receive the tip of the needle; the safety enclosure having two positions, a use position and a safe position; the use position in which the tip of the needle extends beyond the interior of the safety enclosure and the face portion is prevented from movement by the needle; the safe position in which the safety enclosure is moved such that the tip of the needle is brought into the interior of the safety enclosure to a safe position where the tip of the needle is brought further into the interior than the face portion of the flexible safety member, wherein the face portion is able to move transversely and to cover the tip of the needle, wherein the tip of the needle is received by the safety feature. The needle can be a fistula needle, whereby the fistula needle may be used for dialysis. The needle can be a blood drawing needle, whereby the blood drawing needle may be used for drawing blood from a patient.