Abstract:
A needle guide assembly for vein access including (a) a guide having a convex portion, a concave portion, an aperture and a stabilization means for stabilizing a vein against moving away and escape puncture, where the concave portion and the convex portion meet each other to define the aperture between the concave portion and the convex portion, each of the convex portion and the concave portion extending away from the aperture in opposite directions from each other in a tapering manner and terminating the tapering at respective locations away from the peripheral edge, the convex portion being made of a transparent or translucent material, the stabilization means being a pair of elongated indentations that extend substantially parallel to each other and between which are the convex portion, the concave portion and the aperture, and (b) a retaining means for retaining the guide to skin. A venipuncture method is includes retaining the needle guide assembly onto the skin of a patient and using the needle guide assembly to guide a needle to puncture the skin and access a vein.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims priority from provisional application Ser. No. 61/648,585 filed Oct. 7, 2013 and PCT Application No. PCT/US14/059576 filed on Oct. 7, 2014 and Ser. No. 14/652,243 filed Jun. 15 2015. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to medical products and methods of their use, and more particularly to a needle guide assembly and method of venipuncture, is through which needles can be easily and accurately placed into a patient&#39;s vein with improved vein stabilization. 
       BACKGROUND OF THE INVENTION 
       [0003]    Intravenous access is a ubiquitous component of some of the most common medical treatments and procedures. Most common access is a percutaneous injection via piercing the skin with a hollow needle inserted into a vein, whether the vein is in the person&#39;s hand, arm, groin, neck or other body part. Venipuncture to obtain a blood sample is most commonly obtained from the median cubital vein, which lies within the cubital fossa anterior to the elbow, as this vein lies close to the surface of the skin so it is easily accessible while not surrounded by many nerves so as to minimize the pain for the individual. 
         [0004]    Phlebotomy via venipuncture occurs hundreds of millions of time per year worldwide, if not a billion. Accessing a vein is critical, because veins are the conduit through which medical professionals draw blood from as well as inject fluids into a patient&#39;s circulatory system. 
         [0005]    Most common reasons for venipuncture is to obtain blood for diagnostic purposes, to monitor levels of blood components, and to administer therapeutic treatments such as medications (e.g., intravenous antibiotics), nutrition, or chemotherapy for cancer patients. Other reasons for venipuncture include removing blood due to excess levels of iron (e.g., chelation therapy) or erythrocytes (i.e., red blood cells) or to collect blood for later uses such as donor blood and transfusions. All of these processes require access to a vein via venipuncture. 
         [0006]    During conventional venipuncture the user (e.g., phlebotomist, nurse, doctor or other medical personnel) positions the needle to be inserted over the chosen vein at an angle so as to make sure the needle does not puncture the vein and exit the vein on the other side, thus not being in contact with the blood supply within the vein. The user&#39;s goal is to position the needle tip within the vein so that there is access to the blood within the vein, whether for blood collection or for insertion of medication, fluids or other compositions into the blood supply of the individual or patient. However, this goal may be complicated as the vein chosen for the venipuncture is typically supported by fatty tissue in the cells that make up the connective tissue, and the chosen vein may lie between the skin and the underlying muscle or bone. So typically the user elies upon visual cues to locate the vein and perform the venipuncture. 
         [0007]    Further, the user may position a tourniquet at a location such that the blood increases below the tourniquet and the vein “throbs” making it easier to locate and puncture. The user may also touch and feel the skin of the individual or patient and attempt, to locate the vein in this manner, together with a visual observation. 
         [0008]    Once the needle tip is inserted into the skin the user may also use tactile senses by trying to “feel” where the needle tip is in relation to the vein. Since the needle tip is inserted into the skin layer, it passes through the fatty tissue layer and into the wall of the vein which acts as a third layer. Depending on the resistance felt by the user, the needle angle may be adjusted as well in order to puncture the vein wall without passing through to the other side, of the vein and ensuring contact with the blood within the vein. Once the needle tip is successfully within the vein and in contact with the blood the needle angle may be adjusted depending on the connection at the other end of the needle such as a vacuum bottle for blood collection or an intravenous liquid for insertion into the blood flow of the individual or patient. 
         [0009]    In certain instances the individual patient may experience anxiety or even pain depending on the needle tip diameter, the structure of the individual&#39;s veins and whether his or her veins have a tendency to, collapse when punctured, and the experience level of the user performing the venipuncture. If the venipuncture is not successful there may be repeated attempts until successful completion. Multiple attempts may add to the pain and the anxiety of the individual or patient, especially for a pediatric patient, elderly patient, a special needs individual, or a person with anxiety issues. 
         [0010]    One problem which may occur during the venipuncture is movement of the vein targeted for puncture. As the vein is often difficult to hold steady the vein itself being targeted for puncture may roll or move sideways. Further, the needle tip itself on insertion into the skin layer may in fact push the vein to the side and out of the path of the needle tip itself. The patient may also move the body part where the venipuncture is being performed. Upon any of these problems the venipuncture is not successful and further attempts must be made resulting in certain trauma to the individual or patient&#39;s skin layer and layers below, as well as to the individual&#39;s psyche and anxiety. 
         [0011]    In certain circumstances the user may try to use his or her own finger applying pressure to the patient&#39;s body part so as to secure the vein from movement, but then the user is exposed for any subsequent sudden movement by the patient and possible puncture of the needle into the user&#39;s finger rather than puncturing the vein. 
         [0012]    Vein access is critically important especially in patients who need continual access to their circulatory system, such as patients receiving chemotherapy or dialysis. Renal failure is a prevalent chronic disease in the United States with approximately 600,000 patients. The term renal failure refers to the inability of the patient&#39;s kidneys to properly rid the patient&#39;s blood supply of waste products such as creatinine, urea, and free water. The most common treatment for this condition is hemodialysis. Hemodialysis (or commonly referred to as dialysis) is the process of extra-corporally removing the waste product from the blood supply by circulating the patient&#39;s blood through a dialysis machine, which “purifies” the blood of unwanted waste materials and returns the blood to the patient. 
         [0013]    There are various techniques in which dialysis is done, but the more desirable and common technique is through what is known as an AV fistula. For the purposes of dialysis, an AV for Arterial Venous) fistula is a surgical procedure to connect the vein and artery. The AV fistula is accessed by inserting two needles, one needle for drawing the blood to circulate through the dialysis machine and a second needle to return to blood back into the patient. 
         [0014]    One common complication with this procedure occurs when the vein is not fully dilated—the needle often does not puncture the vein properly and causes blood to extravasate, causing the swelling and hematoma formation. Worse, improperly puncturing the AV fistula can actually damage the AV fistula making recannulation not possible. Apart from the destruction of the fistula, the patient suffers from pain and discomfort especially from the hematoma. Ideally, the needle should enter the vein directly only piercing the vein where it entered. By entering directly into the vein and not puncturing the side or back walls of the vein, the needle can access the AV fistula and allow the dialysis to commence with minimal extravasation and the morbidities associated with it. 
         [0015]    Further problems occur with the angle of insertion of the needle into the vein. The needle must be inserted at a certain angle so as to puncture the vein but not the lower wall of the vein while the needle remains at an optimum angle so that the blood can flow freely into the collection vehicle and quickly to have the venipuncture procedure successfully complete. The needle must also be secured during the venipuncture so that the needle angle does not vary during the procedure affecting the collection and possibly incurring pain and injury to the patient. 
         [0016]    Thus, there exists a need for a guide to assist in the proper insertion of a needle into a vein. While certain vein guides have been the subject of patents and applications, they have notable problems. For instance, they may be too binding and constricting on the patient, especially an elderly, pediatric or anxious patient. They may also be too large and wieldy to use easily in a clinic or blood collection site such as Quest Diagnostics, Inc. or Laboratory Corporation of America (LabCorp). 
         [0017]    A further need exists for a vein stabilizer for use during venipuncture. There is a continuing need for a vein guide which assists in the angle of insertion of the needle into the target vein. 
         [0018]    A further need exists for a vein guide which also improves the stabilization of the target vein so that the vein does not roll during the venipuncture procedure. 
         [0019]    Yet a further need exists for a cheaper and easily available guide which may be used by hospitals, clinics and even small individual doctor&#39;s offices. A further need exists for a guide which is flexible and not constricting on a patient while in use. A further need exists for a guide which secures the needle once inserted into the individual&#39;s body part. 
         [0020]    These and other needs are met by the present invention including a I. 5  needle guide assembly apparatus for vein access and method of use. Other advantages of the present invention will become apparent from the following description and appended claims. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0021]      FIG. 1  is one embodiment of a needle guide assembly for vein access of the present invention. 
           [0022]      FIG. 2  is one embodiment of a guide slide assembly of the present invention. 
           [0023]      FIG. 3  is an exploded view of one embodiment of the present invention. 
           [0024]      FIG. 4  is a further embodiment of the present invention. 
           [0025]      FIG. 5  is an embodiment of the present invention and a needle ready for use with the present invention. 
           [0026]      FIG. 6  is an embodiment of the present invention in use on an arm of a patient and showing a needle in use with the present invention. 
           [0027]      FIG. 7  is another embodiment of the present invention including a pair of stabilization means. 
           [0028]      FIG. 8  is a side view of the embodiment of the present invention of  FIG. 7 . 
           [0029]      FIG. 9  is another embodiment of the present invention including a pair of stabilization means and an angled support. 
           [0030]      FIG. 10  is another embodiment of the present invention including a is pair of stabilization means and a securing tab showing the needle inserted within the present invention. 
           [0031]      FIG. 11  is another embodiment of the present invention including a pair of stabilization means and an angled support and a securing tab with a needle hub having a locking means. 
           [0032]      FIG. 12  is another embodiment of the present invention including a pair of stabilization means and an angled support and a securing tab with a needle hub having a locking means. 
           [0033]      FIG. 13  is a zoomed view of the present invention of  FIG. 12 . 
           [0034]      FIG. 14  is another embodiment of the present invention including a pair of stabilization means and an angled support and a securing tab and a locking means for connection to a needle hub. 
       
    
    
     SUMMARY OF THE INVENTION 
       [0035]    This invention provides an apparatus for guiding a needle into a vein. The invention further provides an apparatus for securing an inserted needle into a vein during venipuncture. The invention further provides for a method of use including venipuncture. 
         [0036]    The invention includes a needle guide assembly for vein access. The vein access needle guide assembly is the conduit through which the needle is guided, inserted and may be secured during venipuncture. A portion of the vein access needle guide assembly may be transparent or translucent to allow the user performing the venipuncture to properly align the needle with the target vein in n individual or patient. In one embodiment, the vein access needle guide assembly apparatus includes a retaining means such as an adhesive backed plastic piece with an aperture such as a hole, functioning as a guide, in the middle of the plastic piece. In this embodiment the aperture may have a “track” that when aligned properly above the targeted vein or even a fistula, would guide the needle into the vein at the proper angle, therefore reducing the risk of extravasation. In this embodiment the retaining means further includes a pair of stabilizing means and may optionally include an angled, support in line with the aperture to support the needle when inserted as well as an optional tab or locking means to secure the vein access needle guide assembly to the inserted needle. The vein access needle guide assembly may include additional portions joined on each side of a guide slide assembly to secure the vein access needle guide assembly to the patient&#39;s skin when in use, which have an adhesive backing or other configuration to be affixed onto the skin. 
         [0037]    The method of use of the invention includes placing the inventive vein access needle guide assembly onto the body part of the individual or patient at the location of the target vein or fistula, retaining the vein access needle guide assembly on the skin such as by adhesion, inserting the needle into the groove and aperture of the vein access needle guide assembly, puncturing the vein while at the same time securing the needle in place within the vein while extending out of the skin. Optionally if a locking means is included in the inventive vein access needle guide assembly the user will lock the inserted needle to the locking means. 
         [0038]    Other embodiments of the inventive apparatus and method are disclosed below. 
       DETAILED DESCRIPTION OF THE INVENTION 
       [0039]    Reference will now be made to the drawings wherein like reference numerals may identify similar structural features or aspects of the subject invention. For purposes of explanation and illustration, and not limitation, a view of an exemplary embodiment of the needle guide assembly for vein access is shown in  FIG. 1  and is designated generally by reference character  100 . Other embodiments of the vein access needle guide assembly and methods in accordance with the invention, or aspects thereof, are provided in  FIGS. 2 through 14 . 
         [0040]    Referring now to  FIGS. 1 through 6 , a vein access needle guide assembly  100  is shown to have a guide slide assembly  110  including a guide slide comprising a concave portion  120  and a convex portion  130 . The guide slide assembly  110  may be made out of a rigid or semi-rigid material and could be translucent, or transparent. The guide slide assembly  110  has convex  130  and concave  120  portions to accommodate and guide a needle as it is inserted into the patient. Further, the convex portion  130  of the guide slide assembly  110  may secure the needle as it will overlay the needle when inserted into the patient&#39;s skin during the venipuncture. In certain embodiments the convex and concave portions may be reversed, or only one portion may be included, either the convex portion alone or the concave portion alone. 
         [0041]    The vein access needle guide assembly  100  further includes a retaining means such as at least one adhesive side strap  140  which secures the vein access needle guide assembly  100  to the skin of the patient when in use. The adhesive side strap  140  may be comprised of a polymer film, plastic, nonwoven or woven material, or is the material may be combinations thereof. This material is preferably non-absorbent or essentially non-absorbent and preferably flexible. The adhesive of the adhesive side strap  140  should be capable of maintaining the adhesive property when wet given the possibility of blood or liquid medications being in contact with the vein access needle guide assembly  100  when in use. The adhesive may be contained on the adhesive side strap  140  itself or the adhesive may be applied to both the adhesive side strap  140  and guide slide assembly  110  in the same step when producing the vein access needle guide assembly  100 . Such difference may be seen in  FIGS. 3 and 4  wherein the adhesive layer  150  is either a longer strip layer below the adhesive side strap  140  and guide slide assembly  110  while above the paper layer  160 , as shown in  FIG. 3 . In another embodiment the adhesive is broken into portions and located only below the guide slide assembly  110 , as the adhesive side strap  140  is provided with a separate adhesive layer prior to assembly of the vein access needle guide assembly  100 . In certain embodiments the adhesive layer  150  may have an opening or aperture which corresponds with the aperture  125  of the guide slide assembly  110 , or may be smaller or may be larger than the aperture  125 , or even have a multiple of openings. In one embodiment the opening or aperture in the adhesive layer  150  is of a size such that the convex portion opening is unencumbered (La, is afforded clear access) through the adhesive layer  150  so as to permit entry of the needle tip for reaching the skin. In yet another embodiment the adhesive layer  150  may be a solid layer below the aperture  125 . In an alternate embodiment the adhesive layer  150  may be as shown in  FIG. 4 . 
         [0042]    The adhesive side strap  140  includes a layer of adhesive on the bottom to adhere to the patient&#39;s skin when in use. The adhesive may be acrylic, polymeric or any natural or synthetic adhesive capable of adhering to a patient&#39;s skin when in use and either re-adhering or capable of being removed from the patients skin with some force but not enough to remove the skin layer of the patient. Any combinations of the adhesives named and those known in the art may be used. In general any retaining means may be employed which is capable of retaining the needle guide assembly to the skin of the patient while in use. 
         [0043]    The vein access needle guide assembly  100  may be produced in a plurality of sizes, with different sized guide slide assemblies  110  to accommodate the different standard needle gauges used by medical professionals. One example is a rectangular vein access needle guide assembly with dimensions of about 5 mm to about 50 mm wide and about 10 mm to about 100 mm long with the concave portion  120  and convex portion  130  forming an aperture  125  with a diameter of about 0.5 mm to about 10 mm. These dimensions may be changed depending on the patient&#39;s size and the size of the needle. For example, the size may be changed dependent on the target patient, such as children compared to adults. In one example the dimensions are about 10 mm to about 30 mm wide and about 45 mm to about 75 mm long with the concave portion  120  and convex portion  130  forming an aperture  125  with a diameter of about 1.0 mm to about 3.5 mm. 
         [0044]    The angle of the guide slide  110  is to be configured to appropriately guide the needle into the vein without causing extravasation. Those appropriately trained in the art will appreciate that if a needle is inserted at the wrong angle or too far within a vein that it will damage the vein wall, causing discomfort, bruising, and even hematoma. 
         [0045]      FIG. 2  shows the guide slide assembly  110  in more detail. The guide slide assembly  110  has a concave portion  120  and convex portion  130  forming an aperture  125 . The aperture  125  may be defined only by the edges of each of the concave portion  120  and convex portion  130  or it may be larger when viewed from a top view. The guide slide assembly  110  may optionally include one or more guide notches  170 . In a further embodiment shown in  FIG. 5  the guide slide assembly  110  may include a directional indicator  175 , which may be a graphic, such as an arrow pointing in the direction for the user to insert the needle into the vein access guide slide assembly  100 . The direction indicator  175  could be comprised of words such as “INSERT HERE” or “UP” or any combination of graphics and/or words. 
         [0046]    In an alternate embodiment of the guide slide assembly  110  only a concave portion  120  is included to guide the needle into the patient&#39;s skin when in use. In this embodiment the remaining portion of the guide slide assembly  110  is flat and flush with the surface of the patient&#39;s skin. Again, an optional graphic may be included. In yet another embodiment of the guide slide assembly  110  has a concave portion  120  which is formed to extend beneath the underside of the guide slide assembly  110 . In a further embodiment the concave portion  120  may be formed as a depression in the guide slide assembly  110 . Other combinations are possible. 
         [0047]    Reference character  110  of  FIGS. 3 and 4  is a vein access needle guide is assembly with adhesive-backed side straps  140  shown; such an assembly would further allow the vein access needle guide assembly  100  to affix securely atop the patient&#39;s skin without slipping off.  FIG. 3  shows one embodiment of the vein access needle guide assembly  100  with the guide slide assembly  110  in a position on top of the adhesive-backed side straps  140  while  FIG. 4  is a different embodiment of the vein access needle guide assembly  100  wherein the guide slide assembly  110  is in a position with the edges of one distal end affixed below a distal end of the adhesive-backed side straps  140 . 
         [0048]      FIG. 3  is an exploded view of one embodiment of the vein access needle guide assembly  100  with the different parts shown. The vein accessible needle guide assembly  100  with two side straps  140  to be affixed on each side of a distal end of the guide slide assembly  110  is shown with an adhesive layer  150  as well as a paper liner layer  160  that protects the adhesive portion until use. It may be preferable that the paper liner layer  160  have off-set peel, tabs (not shown). 
         [0049]      FIG. 5  shows a needle entering into the vein access needle guide with side straps  110  that are affixed atop of a patient&#39;s skin. It can be noted that the needle slide  110  is aligned atop of the vein so that when a needle is inserted it will enter the cannula of the vein. 
         [0050]    A needle is also shown in  FIG. 5  where the needle tip  190  is on the edge of the concave portion  120  of the guide slide assembly  110  but not within the aperture  125 . The needle may be any conventional needle having a needle tip  190  of various diameters capable of insertion into the aperture  125 . The needle shown in  FIGS. 5 and 6  is one example of a needle and in this embodiment is a winged-tip butterfly needle including a winged stabilizer  185 . Some examples of needle tip  190  diameters are about 1.8 mm to about 22 mm These dimensions may change depending on the size of the needle. In use, the needle is moved in a direction to correspond to the flow of blood in the target vein, and in this instance is moved such that the needle tip  190  is aligned with the concave portion  120  of the guide slide assembly  110  and moves into the aperture  125  and is inserted into the patient&#39;s skin, with the convex portion  130  and the entire guide slide assembly  110  and the vein access needle guide assembly  100  securing the needle while in use. 
         [0051]    Another embodiment of the present invention is shown in  FIG. 7  wherein the guide slide assembly  110  of the vein access needle guide assembly  100  includes a pair of stabilization means. The stabilization means are a concave indentation  300 , in this embodiment an oval shaped concave indentation  300  is parallel to the concave portion  120 , convex portion  130 , and aperture  125 . It is preferred that there be a pair of stabilization means  300 , one located on each side of the concave portion  120 , convex portion  130 , and aperture  125 . The stabilization means  300  acts to stabilize the target vein so that it is less likely to roll or move away from the needle, escaping puncture during the venipuncture procedure. To prevent rolling, firm pressure is applied below and to the side of the vein to stabilize it as the needle is inserted. The stabilization means  300  may so act as a stabilizer of the target vein during the venipuncture procedure. It is envisioned that the stabilization means  300  could also be a series of smaller round concave indentations or other known shapes and sizes. 
         [0052]      FIG. 8  is a side view of the embodiment of the present invention as shown in  FIG. 7 . The concave and convex features of the guide slide assembly  110  are shown including the convex portion  130 , the concave portion  120 , and the pair of stabilization means  300 . 
         [0053]    Yet another embodiment of the present invention is shown in  FIG. 9  wherein the guide slide assembly  110  of the vein access needle guide assembly  100  includes a pair of stabilization means  300  and an angled support  310 . The angled support  310  is convex and is preferably angled so as that the inserted needle has an optimum angle for puncturing the patient&#39;s skin and vein, while not passing through the vein&#39;s lower wall and at the same time encouraging free flow of the blood for collection during venipuncture. The angle of the angled support  310  may be between about 5° to about 90°. The angled support  310  may be in the shape of a bump, oval, triangle, or any other shape which is capable of supporting a needle during venipuncture. The angled support  310  could be a shape such that the middle has a notch or indentation (such as the shape of a “U” when viewed from the side) to better secure the needle during venipuncture. 
         [0054]    To better secure the needle during venipuncture a tab  180  is shown in  FIGS. 10 and 11 . The shape of the tab  180  is attached to one end of the guide slide assembly  110  nearest to the concave portion  120  which is the location of the needle during use in venipuncture. The tab  180  defines an opening for insertion of the needle during venipuncture and the diameter of the tab  180  may vary depending on the diameter of the needle being inserted during venipuncture. The tab  180  may be any shape with the shape shown in  FIG. 10  as a semi-circle. It is envisioned that the tab  180  could be in the shape of a square, rectangle, triangle, or any other shape with an opening for the insertion of a needle during venipuncture. The tab  180  is especially useful when the guide slide assembly  110  includes an angled support  310  so that the inserted needle resting on, the angled support  310  is further secured by the tab  180  above the needle. The tab  180  may be made out of a rigid or semi-rigid material and could be translucent or transparent. The tab  180  may be comprised of a polymer film, plastic, nonwoven or woven material, or the material may be combinations thereof. 
         [0055]    A further safety feature includes a locking means. In one embodiment the locking means includes a set of teeth-like features on the end of a needle hub  220 , as shown in  FIGS. 12 and 13 . The needle  200  is shown already inserted into the tab  180  and the aperture  125  (not shown) and is supported by the convex portion  130  the angled support  310  and the tab  180 . In this embodiment, as shown in more detail in  FIG. 13 , the upper end of the tab  180  includes an aperture through which the teeth  250 ,  260  are inserted with the teeth extending in an upward direction in this embodiment, though the opposite direction is also possible. Once the teeth  250 ,  260  are inserted in this embodiment the tab  180  rests within the lower portion of the teeth  260  and the upper portion of the teeth  250  locks against the tab  180 . A series of teeth  250 ,  260  are included so that the needle hub  220 , when moved in a downward direction as the needle  200  is inserted into the vein access needle guide assembly  100 , moves in a direction such that the teeth  250 ,  260  pass in one direction and cannot be retracted out of the aperture in the tab  180 . Thus the needle  200  is locked into the inventive vein access needle guide assembly  200 . The locking means, for example the teeth  250 ,  260 , may be comprised of the same or not the same material as the tab  180 . The locking means, for example the teeth  250 ,  260 , may be made out of a rigid or semi-rigid material and could be translucent or transparent. The locking means, for example the teeth  250 ,  260 , may be comprised of a polymer film, plastic, nonwoven or woven material, or the material may be combinations thereof. 
         [0056]    Another embodiment of the invention and of another locking means is shown in  FIG. 14  wherein the tab  180  includes a horizontal member  280  which on its distal end has a downward vertical member  285  which can rest or lock within an aperture  270  in the needle hub  220 . The needle  200  is shown already inserted into the tab  180  and the aperture  125  (not shown) and is supported by the convex portion  130 , the angled support  310  and the tab  180 . In this embodiment the upper end of the tab  180  includes a horizontal member  280  which is located on the opposite side of the tab extending away from the guide slide assembly  110 . The horizontal member  280  has a distal end including a downward vertical member  285  which either rests on a needle hub  220  or fits into and locks within an aperture  270  on the top of a needle hub  220 . Once the vertical portion of the horizontal member  285  is inserted into the aperture  270  it cannot be retracted out easily and thus the needle  200  cannot be retracted out easily. Thus the needle  200  is secured and/or locked into the inventive vein access needle guide assembly  200 . The horizontal member  280  may be comprised of the same or not the same material as the tab  180 . The locking means, for example the horizontal member  280  may be made out of a rigid or semi-rigid material and could be translucent or transparent. The locking means, for example the horizontal member  280  may be comprised of a polymer film, plastic, nonwoven or woven material, or the material may be combinations thereof. Other locking means may be employed and the two embodiments herein are mere examples and not limiting to the actual locking means or mechanisms used in each iteration of the inventive vein access needle guide assembly  100 . 
         [0057]    It is envisioned that the vein access needle guide assembly  100  would be packaged in a sterilized package, either as a stand-alone product or in combination with multiple needle guides or other products such as a needle. Other kits including the vein access needle guide assembly  100  could include a cleansing agent in a sterile package, a tourniquet (or a cuff as disclosed in co-pending Provisional Application 62/207,088 entitled “Vein Identifier Assembly And Methods Of Use”), the vein access needle guide assembly  100 , a needle (including a needle having a needle hub  220  with either an aperture  270  or a locking means  250 ,  260 ), a piece of sterile gauze and a sterile bandage. 
         [0058]    A method of venipuncture using the inventive vein access guide assembly  100  may include a number of steps. First, the target vein is chosen (if an AV fistula is not the target location) such as on the outside of the forearm, on the back of the hand, in the antecubital fossa or any other body location. Next, the skin on the patient located where the user wants to access the vein is cleaned by a cleansing agent. The cleansing agent used to prepare the insertion site may be iodine, povidone-iodine, or ethyl alcohol. The cleansing agent may be an alcohol swab, preferably 70% isopropyl alcohol. The vein is palpated, and to dilate the vein a tourniquet may be wrapped around the arm proximal to the intended site of puncture. Optionally a tourniquet or other constricting means may be placed at a location near the target vein so that the target vein protrudes or is more easily visualized or subject to tactile manipulation and touch. The patient may be asked to pump his or her fist if the target vein is located in the arm. 
         [0059]    Next, if the vein access needle guide  100  is packaged in a sterile packaging, then packaging is opened. The vein access guide assembly  100  is aligned with the target vein such that, the concave portion  120  is aligned with the flow of the blood in the target vein as the inserted needle would also align with the blood flow. The paper liner layer  160  is peeled back exposing the adhesive layer  150  and the vein access needle guide  100  is affixed atop the patient&#39;s skin, appropriately aligning over the target vein, preferably with the needle guide slide  110  located over the target vein and if including the stabilization means  300  such stabilization means  300  is optionally located on each side of the target vein. As shown in  FIGS. 6 and 10-14 , a needle tip  190  is inserted into the guide slide  110  to access the vein and the concave portion  120  secures the needle tip  190 . The angle of the needle tip  190  may be between about 5° to about 90°, preferably about 10° to about 40°, and more preferably about 15° to about 30°, dependent on the diameter of the needle tip and the size of the target vein  400 . If the guide slide assembly includes the angled support  310  the distal end  210  of the needle  200  is supported at the chosen angle. After the skin is punctured, little resistance should be felt by the user as the needle tip  190  should pass through the subcutaneous tissue, but a sudden slight resistance may be felt as the needle tip  190  hits the wall of the vein. At this point the needle tip  190  may be cautiously advanced, with the needle  200  held nearly flush with the skin as the needle  200  is in the concave portion  120  of the guide slide assembly  110  and secured by the convex portion  130 . Slight upward pressure applied by the user and the guide slide assembly  110  itself may aid in keeping the needle tip  190  in the target vein  200  as the needle tip  190  is advanced into the lumen of the target vein  200 . A successful venipuncture results in blood flowing back into the hub  220  of the needle  200  or into the catheter or vacuum tube ( 240 ) attached to the distal end  210  of the needle  200 , and the needle tip  190  usually can be felt to be in the vein. If these signs are absent, the needle tip  190  is not in the target vein  400 , in which case it is usually best to remove the needle  200 , apply pressure to the puncture site, and start the procedure again, using new equipment. 
         [0060]    If the user has an alternate embodiment of the inventive vein access needle guide assembly  100  including an angled support  310 , the tab  180 , and/or locking means (either the combination of  250 ,  260  or the combination of  270 ,  280 ,  285  or any other locking means), then the vein access guide assembly  100  is aligned with the target vein such that the concave portion  120  is aligned with the flow of the blood in the target vein as the inserted needle would also align with the blood flow. The paper liner layer  160  is peeled back exposing the adhesive layer  150  and the vein access needle guide  100  is affixed atop the patient&#39;s skin, appropriately aligning over the target vein, preferably with the needle guide slide  110  located over the target vein and each of the pair of stabilization means  300  located on each side of the target vein. A needle tip  190  is inserted into the opening of the tab  180  and through into the aperture  125  of the guide slide  110  to access the vein with the distal end  210  of the needle  200  resting on the convex portion  130  with the concave portion  120  and tab  180  securing the needle  200 . If the guide slide assembly includes the angled support  310  the distal end  210  of the needle  200  is supported at the chosen angle. After the skin is punctured, little resistance should be felt by the user as the needle tip  190  should pass through the subcutaneous tissue, but a sudden slight resistance may be felt as the needle tip  190  hits the wall of the vein. At this point the needle tip  190  may be cautiously advanced, with the needle  200  held nearly flush with the skin as the needle  200  is in the concave portion  120  of the guide slide assembly  110  and secured by the convex portion  130  and the tab  180 . Slight upward pressure applied by the user and the guide slide assembly  110  itself may aid in keeping the needle tip  190  in the target vein  200  as the needle tip  190  is advanced into the lumen of the target vein  200 . If the embodiment of the vein access needle guide assembly  100  includes a locking means such means may be activated so that the needle hub  220  is secured or locked with the tab  180 . For instance, if the locking means is a series of teeth  250 ,  260  located on a distal end of the needle hub, such teeth  250 ,  260  are inserted into an aperture located on the top potion of the tab  180  and when the needle tip  190  is located within the target vein at the chosen angle and depth, the needle  200  is locked to the inventive vein access needle guide assembly  100  as the bottom of the aperture rests within the horizontal portion  260  of the tooth and the upper portion of the aperture rests against the vertical portion  250  of the tooth. Thus the needle  200  is locked into the inventive vein access needle guide assembly  100 . If in the alternate, the locking means includes an aperture  270  in the upper distal end of the needle hub  220  into which a vertical portion  285  of a horizontal member  280  on the tab  180  extending away from the guide slide assembly  110 , such locking means is activated when the needle tip  190  is inserted into the opening of the tab  180  and the aperture  125  of the guide slide assembly  110  and the vertical member  285  slides against the upper side of the needle hub  220  until it falls within the aperture  270  such that the entire needle  200  cannot be retracted out of the inventive vein access needle guide assembly. A successful venipuncture results in blood flowing back into the hub  220  of the needle  200  or into the catheter or vacuum tube  240  attached to the distal end  210  of the needle  200 , and the needle tip  190  usually can be felt to be in the vein. 
         [0061]    In a successful venipuncture using the inventive vein access needle guide assembly  100 , the user now has access to the patient&#39;s vein and blood may be drawn and fluids or medication put into the circulatory system. At a later time the needle  200  is removed from the patient&#39;s vein by the user, the vein access needle guide assembly  100  is removed, and optionally a sterile piece of gauze, and a conventional adhesive bandage is placed atop the location on the patient&#39;s skin where the vein was accessed to provide pressure until the local bleeding stops. 
         [0062]    The inventive method may be used to obtain blood for diagnostic purposes, to monitor levels of blood components, to administer therapeutic treatments such as medications (e.g., intravenous antibiotics), nutrition, or chemotherapy for cancer patients. Other uses of the inventive venipuncture method and other uses for inventive vein access needle guide assembly  100  include removing blood due to excess levels of iron (e.g., chelation therapy) or erythrocytes (Le., red blood cells) or to collect blood for later uses such as donor blood and transfusions. Other uses may be contemplated if relating to insertion of a needle into a patient&#39;s skin to access a vein. 
         [0063]    The inventive vein access needle guide assembly  100  assists the user in the proper insertion of a needle into a vein. The inventive vein access needle guide assembly  100  is portable and does not impinge on the patient&#39;s skin but rather is easily placed on the patient&#39;s skin in the location of the target vein and is retained on the skin sufficiently for the venipuncture and securing of the needle without being so secure that the user cannot remove the vein access needle guide assembly  100  easily with minimal force. 
         [0064]    Further, the vein access needle guide assembly  100  of the present invention stabilizes the target vein during venipuncture and may reduce the occurrence of a “rolling” vein during venipuncture. The vein access needle guide assembly  100  of the present invention supports the inserted needle at a certain angle to provide improved venipuncture and collection of a blood sample. The vein access needle guide assembly  100  of the present invention provides a more secure venipuncture based on the support, securing and possible locking of the needle to the inventive vein access needle guide assembly during the procedure resulting in less movement of the needle during the procedure and potentially less pain and injury to the patient and potentially quicker procedure of the actual blood draw. The vein access needle guide assembly  100  of the present invention may lessen anxiety and pain for the patient in that that vein access needle guide assembly  100  is small and pliable while also assisting in the venipuncture which results in a quicker venipuncture process, as well as a more accurate process. Further, the user may experience less anxiety also based on the needle guide slide  710  of the inventive vein access needle guide assembly  700  and being able to easily access the target vein and not having to rely on the user&#39;s own visual cues or tactile impressions such that the risk of puncture of the user&#39;s finger is lessened or even totally removed. 
         [0065]    Further, the inventive method and inventive vein access needle guide assembly  700  may be used in venipuncture related to a fistula, including an AV fistula. The patient may therefore experience less pain and the user experience a quicker and/or easier and/or more accurate and less stressful, venipuncture of the skin surrounding the AV fistula. 
         [0066]    The inventive method and inventive vein access needle guide assembly  100  may be cheaper and more easily available than current vein guide apparatuses and thus may be used by hospitals, clinics and even small individual doctor&#39;s offices. 
         [0067]    The invention has been described in terms of embodiments thereof, but is more broadly applicable as will be understood by those skilled in the art. The scope of the invention is only limited by the following claims.