Patent Publication Number: US-2020276419-A1

Title: Vascular Access Device and Related Method

Description:
BACKGROUND OF THE INVENTION 
     Known arterial and vascular access procedures are conducted using a cannula needle and guidewire as distinct and separate components. Vascular access procedures may also utilize a separate syringe that is attached to a connecting portion to draw a vacuum on the needle and withdraw blood from the vein when the needle tip is positioned within the vein. The tip of the needle is inserted through the patient&#39;s skin and into the blood vessel (vein or artery), which may be difficult to locate and pierce due to differing patient anatomy. In addition, the proper placement of the needle in the blood vessel may be difficult to confirm due to limited pressure in the blood vessels (particularly in veins), positioning of different blood vessels near each other, patient anatomy and other factors. Appropriately positioning the needle tip in the vein may be facilitated by pulling a vacuum in the needle using a separately attached syringe to draw blood from the vessel, typically a vein, once the tip is positioned in the vessel. This vacuum is typically not required when accessing an artery, as arterial pressure typically causes blood to flow into and out of a proximal end of the needle when the tip is in the artery. When the tip is in the vessel, blood flow visually confirms the appropriate positioning of the needle. Proper positioning may, however, be lost while the medical professional reaches for and attempts to insert a guidewire into the needle or access device. The needle or access device may move such that the tip moves out of the targeted vessel because the patient or needle moves, the medical professional conducts a follow-up step related to the procedure, the medical professional moves the needle or access device while arranging the guidewire or for various other reasons. 
     Once the tip of the needle is positioned in the blood vessel, the physician or medical technician typically inserts a separate guidewire through the needle and into the blood vessel. The guidewire is typically retrieved from a nearby surgical table or other proximate area. The physician&#39;s or medical technician&#39;s movement to retrieve the guidewire can result in movement of the tip of the needle, potentially resulting in the tip moving out of the blood vessel. This movement in reaching or otherwise retrieving the guidewire also slows the procedure, which can be important in trauma situations and for patient comfort. Feeding the guidewire into the proximal end of the needle or connector following retrieval can also be difficult, resulting in additional potential for movement of the tip out of the blood vessel and delay in the procedure. For example, the physician may need to re-start the procedure of positioning the tip of the needle in the vessel if the tip moves out of the vessel or may need to re-arrange the tip back into the appropriate vessel, thereby delaying the procedure and often increasing patient discomfort. Feeding the guidewire into the proximal end of the needle is particularly difficult when the needle has a small diameter at its proximal end, the distal end of the guidewire has a J-shape that is preferably straightened before insertion into the proximal end of the needle and/or the medical professional is rushing the procedure, particularly in trauma situations. 
     Traditional vascular access procedures may be performed in the field using a cannula needle and guidewire as individual components. For some access procedures, typically venous access, a needle is used with a syringe attached to the needle via a needle hub or Luer connection. The needle is inserted into the vessel while drawing back on the syringe plunger to create vacuum so that blood is drawn into the syringe upon access to the vein or as an indication of when the tip of the needle is positioned within the vein (presence of blood indicates the needle is in the vessel). Next, the syringe is removed from the needle, a guidewire is aligned with and inserted into a proximal end of the needle and the guidewire is advanced through the needle into the vessel. The guidewire is urged into the needle such that the guidewire is positioned within the vessel, preferably the vein, as a guide for subsequent instruments. The needle is then removed proximally over the guidewire with a front portion of the guidewire remaining in the vessel and a rear portion of the guidewire extending out of the patient&#39;s skin. The guidewire provides a path for insertion of other devices into the vessel and the other devices are typically used for treatment that is associated with the vessel. This multiple step process and exchange of components, including the needle, syringe, other instrument and guidewire may cause pain for the user and provides multiple opportunities for the needle or guidewire to move or become misaligned, potentially requiring the medical professional to re-start the procedure or realign the components, particularly the tip of the needle before the guidewire is inserted into the vessel. 
     Traditional access procedures using a guidewire also often utilize a cheater, guidewire insertion tool or guidewire straightener into which the distal portion of the guidewire is inserted to straighten the distal portion of the guidewire and to facilitate alignment of the guidewire with the needle and port. The cheater is typically, relatively short, having a length of approximately one inch (1″), and does not include a distal Luer connector that permits connection of the cheater with the proximal end of the needle, which typically has a female Luer connection. The cheater must be held onto the proximal end of the needle by the technician while the guidewire is fed into the needle and the patient. In addition, the relatively short length of the cheater results in a relatively flexible distal portion of the guidewire extending out of the proximal end of the cheater when loaded, which can cause the guidewire to slide or fall out of the cheater unless the technician is holding the guidewire into the cheater. Further, the relatively flexible distal portion of the guidewire may buckle between the proximal end of the cheater and the stiffer portion of the guidewire when the technician initially attempts to urge the guidewire into the needle and patient because the relatively flexible portion of the distal tip of the guidewire is not supported by the cheater. It would be desirable to design, develop and deploy an access device that overcomes these shortcomings of the guidewire cheater and guidewire insertion tool. 
     Access devices have also been developed that include an integrated hypodermic or vascular access needle, and potentially other components, for use specifically in the access procedure. These access devices are typically limited for use with predetermined guidewire sizes that correlate with the size of the integrated hypodermic or vascular access needle. These devices with integrated hypodermic needles also include internal flow channels that permit flow of flash blood and indicate flash from a side surface or side flashport at the body of the device. These internal channels are difficult to clean and/or sterilize after blood or other fluids flow through the internal channels and are not reusable in most situations following an initial flash or blood flow. 
     During the standard Seldinger technique, the needle is inserted through the skin and into the blood vessel. Blood flashes from the needle Luer fitting. At this point, the user typically turns away from the needle momentarily to grab the guidewire and straighten the J-tip at the distal end of the guidewire. More often than not, especially for less experienced users, the needle tip has moved during this step and is no longer in the blood vessel and may have punctured the blood vessel at a second location in addition to the original entry puncture. When the user tries to advance the guidewire, it jams because the needle tip is no longer in the blood vessel. The needle must then be removed from the skin, flushed and another attempt made. Cleaning and sterilization are difficult because of the small diameter of the needle lumen. 
     The preferred access device with a guidewire also addresses the above-described shortcomings of prior art blood vessel access devices and methods. For example, it would be desirable to design, develop and deploy an access device that eliminates the requirement to straighten and insert a very soft guidewire tip into the needle after the tip of the needle is inserted into the patient&#39;s vessel to expedite the vessel access procedure. It would also be desirable to design, develop and deploy an access device that is quickly able to assess whether the tip of the access device is positioned in the patient&#39;s vessel without significant flash blood flow out of the access device that provides an indication of whether the tip is in an artery or a vein. In addition, it would be desirable to design, develop and deploy an access device that has a built-in holder to secure the proximal end of the guidewire to limit the relatively flexible guidewire from touching non-sterile surfaces in the area around the procedure prior to entering the patient. It would further be desirable to design, develop and deploy an access device that may be flushed free of blood after an access attempt and that is able to adapt to various sized hypodermic or vascular access needles that are readily available to the medical provider. 
     BRIEF SUMMARY OF THE INVENTION 
     Briefly stated, the preferred invention is directed to an access device for accessing a lumen of a blood vessel including a body having a distal end, a proximal end, a longitudinal axis, a guidewire channel, a guidewire holder and a flash channel. The guidewire channel extends generally parallel to the longitudinal axis. The guidewire channel is defined at the distal end of the body at an external surface of the body. A needle has a tip, a proximal end and a needle lumen extending to the tip. The proximal end of the needle has a funnel-like port with an internal surface. The proximal end is removably secured to a distal end of the body in an assembled configuration. The internal surface of the proximal end of the needle and the flash channel define a flash lumen. A guidewire has a front end portion that is positioned in the guidewire channel in an initial configuration. 
     In another aspect, the preferred invention is directed to an access device for accessing a lumen of a blood vessel. The access device includes a body, a needle and a guidewire. The body has a distal end, a proximal end, a longitudinal axis and a guidewire channel. The guidewire channel extends generally parallel to the longitudinal axis. The guidewire channel is defined at the distal end of the body and extends toward the proximal end of the body. The guidewire channel opens into a funnel-like port positioned at the proximal end. The funnel-like port has a proximal port diameter that is greater than a distal port diameter. The funnel-like port may be comprised of a Luer fitting, potentially a female slip Luer that is able to connect to a male Luer fitting. The distal port diameter is substantially the same as a guidewire channel diameter. The needle has a tip, a proximal end and a needle lumen extending to the tip. The proximal end of the needle has a funnel-like port with an internal surface. The proximal end is removably secured to the distal end of the body in an assembled configuration. The guidewire has a front end portion. The front end portion is positioned in the guidewire channel in an initial configuration. The guidewire has a guidewire diameter. The guidewire channel diameter is greater than the guidewire diameter. The guidewire channel is configured to facilitate blood flow between the guidewire and an internal surface of the guidewire channel when the guidewire is positioned in the guidewire channel. 
    
    
     
       BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS 
       The foregoing summary, as well as the following detailed description of preferred embodiments of the access device and method of the present application, will be better understood when read in conjunction with the appended drawings. For the purposes of illustrating the access device, there are shown in the drawings preferred embodiments. It should be understood, however, that the application is not limited to the precise arrangements and instrumentalities shown. In the drawings: 
         FIG. 1  is a side perspective view of an access device in accordance with a first preferred embodiment of the present invention; 
         FIG. 2  is a cross-sectional view of the access device of  FIG. 1 , taken along line  2 - 2  of  FIG. 1 ; 
         FIG. 3  is an alternative side perspective view of the access device of  FIG. 1  with a guidewire mounted to the access device; 
         FIG. 4  is a side perspective, cross-sectional view of the access device of  FIG. 1 , taken along line  4 - 4  of  FIG. 3 ; 
         FIG. 5  is cross-sectional view of the access device of  FIG. 1 , taken along line  4 - 4  of  FIG. 3 ; 
         FIG. 6  is a side perspective view of the access device of  FIG. 1  with a hypodermic or vascular access needle mounted to a distal end of the access device; 
         FIG. 7  is a cross-sectional view of the access device of  FIG. 1 , taken along line  7 - 7  of  FIG. 6 ; 
         FIG. 8  is a magnified, top perspective view of the access device of  FIG. 1 , taken from within shape  8  of  FIG. 6 ; 
         FIG. 9  is a cross-sectional view of a portion of the access device of  FIG. 1 , taken along line  9 - 9  of  FIG. 8 ; 
         FIG. 10  is a side perspective view of an access device in accordance with a second preferred embodiment of the present invention; 
         FIG. 11  is a cross-sectional view of the access device of  FIG. 10 , taken along line  11 - 11  of  FIG. 10 ; 
         FIG. 12  is a side perspective view of an access device in accordance with a third preferred embodiment of the present invention; 
         FIG. 12A  is a side perspective view of the access device of  FIG. 12 , with an alternative guidewire holder and a guidewire positioned in the body in a loaded configuration; 
         FIG. 12B  is a magnified front perspective view of a distal end of the access device of  FIG. 12A ; 
         FIG. 12C  is a magnified side elevational view of a body of the access device of  FIG. 12A ; 
         FIG. 13  is a cross-sectional view of the access device of  FIG. 12 , taken along line  13 - 13  of  FIG. 12 ; 
         FIG. 14  is a side perspective view of an access device in accordance with a fourth preferred embodiment of the present invention; 
         FIG. 15  is a cross-sectional view of the access device of  FIG. 14 , taken along line  15 - 15  of  FIG. 14 ; 
         FIG. 16  is a magnified, cross-sectional view of the access device of  FIG. 14 , taken from within shape  16  of  FIG. 15 ; 
         FIG. 17  is a side perspective view of an access device in accordance with a fifth preferred embodiment of the present invention; 
         FIG. 18  is a cross-sectional view of the access device of  FIG. 17 , taken along line  18 - 18  of  FIG. 17 ; 
         FIG. 19  is a magnified, side perspective view of the access device of  FIG. 17 , taken from within shape  19  of  FIG. 17 ; 
         FIG. 20  is a magnified, side perspective view of a portion of the access device of  FIG. 17 , with a proximal portion of a hypodermic or vascular access needle mounted to a distal end of the access device; 
         FIG. 21  is a side perspective view of an access device in accordance with a sixth preferred embodiment of the present invention; 
         FIG. 22  is a cross-sectional view of the access device of  FIG. 21 , taken along line  22 - 22  of  FIG. 21 ; 
         FIG. 23  is a side perspective view of an access device in accordance with a seventh preferred embodiment of the present invention; 
         FIG. 24  is a cross-sectional view of the access device of  FIG. 23 , taken along line  24 - 24  of  FIG. 23 ; 
         FIG. 25  is a side perspective view of an access device in accordance with an eighth preferred embodiment of the present invention; and 
         FIG. 26  is a cross-sectional view of the access device of  FIG. 25 , taken along line  26 - 26  of  FIG. 25 . 
     
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     Certain terminology is used in the following description for convenience only and is not limiting. Unless specifically set forth herein, the terms “a”, “an” and “the” are not limited to one element but instead should be read as meaning “at least one”. The words “right”, “left”, “lower” and “upper” designate directions in the drawings to which reference is made. The words “inwardly” or “distally” and “outwardly” or “proximally” refer to directions toward and away from, respectively, the patient&#39;s body, or the geometric center of the preferred access device and related parts thereof. The words, “anterior”, “posterior”, “superior,” “inferior”, “lateral” and related words and/or phrases designate preferred positions, directions and/or orientations in the human body to which reference is made and are not meant to be limiting. The terminology includes the above-listed words, derivatives thereof and words of similar import. 
     It should also be understood that the terms “about,” “approximately,” “generally,” “substantially” and like terms, used herein when referring to a dimension or characteristic of a component of the preferred invention, indicate that the described dimension/characteristic is not a strict boundary or parameter and does not exclude minor variations therefrom that are functionally the same or similar, as would be understood by one having ordinary skill in the art. At a minimum, such references that include a numerical parameter would include variations that, using mathematical and industrial principles accepted in the art (e.g., rounding, measurement or other systematic errors, manufacturing tolerances, etc.), would not vary the least significant digit. 
     Referring to  FIGS. 1-9 , a first preferred embodiment of an access device of the present invention, generally designated  10 , includes a hub or body  11  with a guidewire channel  11   a , flash channel  11   b , a distal end  11   d , a proximal end  11   e  and a tapered or funnel-like port  11   c  at the proximal end  11   e  extending from the guidewire channel  11   a . A guidewire  13  is movably mountable to the body  11 , preferably within the guidewire channel  11   a , such that a front end  13   a  of the guidewire  13  is positioned within the guidewire channel  11   a  in a loaded configuration. The guidewire channel  11   a  is preferably positioned parallel to and, in the first preferred embodiment, coaxial with a longitudinal axis  14  of the body  11 . The funnel-like port or female Luer fitting  11   c  at the proximal end  11   e  allows the guidewire channel  11   a  to be flushed with a standard syringe, if needed to remove blood during multiple access attempts. 
     The preferred access device  10  also preferably includes a hypodermic or vascular access needle  12  with a distal tip  12   a , a proximal end  12   b  and a needle lumen  12   c . The proximal end  12   b  is removably mountable to the distal end  11   d  of the body  11  and the needle lumen  12   c  is in fluid communication with the guidewire channel  11   a  and the flash channel  11   b  in a loaded and assembled configuration. The distal end  11   d  may be configured in the form of a Luer fitting for connection of the proximal end  12   b  of the access needle  12  to the body  11  by a press fit, preferably a relatively light press fit. A proximal end  12   b  of the needle  12  is preferably comprised of a hub housing that is adapted for removable mounting to the distal end  11   d  of the body  11 . The proximal end  12   b  may be removably attached or secured to the body  11  by a Luer-Lock, threaded connection or other attachment mechanism or method, such as tapering or funnel-like features. The hypodermic or vascular access needle  12  may have different sized and configured needles  12  and may be comprised of a relatively standard hypodermic or vascular access needle  12 , such as eighteen gauge, twenty gauge, twenty-one gauge, twenty-two gauge and other sized needles  12 . When the needle  12  is mounted to the distal end  11   d  of the body  11 , an inner surface  12   d  of the proximal end  12   b  of the needle  12  defines a lumen or flash lumen  12   x  with the flash channel  11   b  of the body  11  ( FIG. 9 ). The flash lumen  12   x  permits flow of blood from within the needle  12  into view of the user at an external, preferably upper surface of the body  11  during use, as will be described in greater detail below. The flash channel is preferably exposed or comprised of a portion of an external surface of the body  11  at or near the distal end  1   d  and defines the flash lumen  12   x  with the internal surface of the proximal end  12   b  of the needle  12 . Removing the needle  12  from the body  11 , thereby provides access to the flash channel  11   b  such that the flash channel  11   b  may be cleaned and/or sterilized by the user after fluid, such as blood flows through the flash lumen  12   x.    
     The body  11  also preferably includes a flash marker  11   f  on the external surface of the body  11  proximate a proximal end of the flash channel  11   b . The flash marker  11   f  of the first preferred embodiment is comprised of an arrow that points toward the flash channel  11   b  indicating where a user should expect to see flash or blood flow when a patient&#39;s vessel is accessed by the distal tip  12   a  during use, as will be described in greater detail below. The needle  12  may also include a bevel marker  12   e  on proximal end  12   b  that is alignable with the flash marker  11   f  to align the flash channel  11   b  with the bevel of the tip  12   a . Aligning the bevel of the tip  12   a  with the flash channel  11   b  provides consistent insertion of the bevel into the patient and orientation of the flash channel  11   b  upwardly toward the user so that the flash in readily identified and relatively easily viewed by a user when the vessel is pierced. 
     In the first preferred embodiment, the body  11  and the needle  12 , including the guidewire channel  11   a  and the needle lumen  12   c  are positioned on and are coaxial with a longitudinal axis  14  of the access device  10 . The needle  12 , needle lumen  12   c , body  11  and guidewire channel  11   a  are not limited to being positioned on or coaxial with the longitudinal axis  14 , but are so configured in the first preferred embodiment. For example, the needle  12  and guidewire channel  11   a  may be positioned on or extend substantially parallel to the longitudinal axis  14 . The needle lumen  12   c  preferably extends between the tip  12   a  and the proximal end  12   b  and tapers or has a funnel-like shat near the proximal end  12   b  at the inner surface  12   d . The needle lumen  12   c  is in fluid communication with the flash lumen  12   x  to facilitate blood flow from the tip  12   a , through the flash lumen  12   x  and out between the body  11  and the proximal end  12   b  of the needle  12  for observation by the user to indicate that the tip  12   a  is positioned in the patient&#39;s vessel. 
     The preferred access device  10  may include a guidewire seal or sealing mechanism (not shown) in the guidewire channel  11   a , preferably near a distal end of the guidewire channel  11   a , that sealingly engages the guidewire  13  in a mounted or loaded configuration. The sealing mechanism preferably limits or prevents fluid flow into the guidewire channel  11   a  from the needle lumen  12   c , but also permits the guidewire  13  to move through the sealing mechanism for introduction into the needle lumen  12   c  and withdraw of the guidewire  13  from the access device  10 . In an initial or loaded configuration, the guidewire  13  is positioned in the guidewire channel  11   a  such the front end  13   a  of the guidewire  13  is positioned proximally relative to or within the sealing mechanism and is advanced through the sealing mechanism during use. The guidewire seal preferably limits or prevents blood flow from the needle lumen  12   c  into the guidewire channel  11   a  when the guidewire  13  is not loaded in the body  11  and when the guidewire seal engages the guidewire  13  in the loaded configuration or when the guidewire  13  is extended through the guidewire seal. The guidewire seal or sealing mechanism is preferably constructed of an elastic material that permits the guidewire  13  to extend therethrough and collapses on itself when the guidewire  13  is removed from the guidewire channel  11   a , although the seal is not so limited. The seal may alternatively be constructed to seal around the guidewire  13  when it is inserted into the guidewire channel  11   a  and generally not seal the guidewire channel  11   a  when the guidewire  13  is removed from the guidewire channel  11   a  or is not in engagement with the guidewire  13 . 
     The guidewire  13  includes the front end portion  13   a  that is preferably pre-loaded into the guidewire channel  11   a  in an initial or loaded configuration ( FIGS. 4-7 and 9 ) such that the guidewire  13  is arranged for quick insertion into the patient when the tip  12   a  is in the vessel, as is described in greater detail below. The front end portion or distal portion  13   a  of the guidewire has a greater flexibility relative to the remaining length or portion of the guidewire  13 , such that the front end portion  13   a  is able to traverse patient&#39;s vessels without puncturing the vessels. In addition, the front end portion  13   a  may have a curved or J-hooked feature at its distal end that is preferably straightened for insertion into the needle  12  and the patient. The front end portion  13   a  is approximately one and one-half to two inches (1½-2″). In the preferred embodiment, the guidewire channel length L G  is at least two and one-half inches (2½″) or longer such that the front end portion  13   a  or distal end portion of the guidewire  13  is constrained in the guidewire channel  11   a  in the loaded configuration, as the guidewire  13  is relatively flexible and may fall out of the guidewire channel  11   a  without this length or buckle when a user attempts to advance the guidewire  13  into the patient&#39;s vessel. The front end portion  13   a  of the guidewire  13 , which has the comparatively high flexibility when compared to the remainder or more proximal portion of the guidewire  13 , is, therefore, positioned within the guidewire channel  11   a  in the loaded configuration with at least some of the more rigid portion of the guidewire  13  also positioned within the guidewire channel  11   a  such that the guidewire  13  is retained in the body  11  without assistance or active force being applied by the technician. The guidewire  13  is, therefore, generally more stable relative to the body  11  when inserted with the entire front end portion  13   a  within the guidewire channel  11   a , as the more flexible front end portion  13   a  is contained within the guidewire channel  11   a.    
     A rear end portion or proximal end of the guidewire  13  may be secured relative to the body  11  or may extend freely from the body  11  in the initial or loaded configuration. The rear end portion may be secured to the body  11  by a guidewire holder  18 , such as the two guidewire holders  18  of the first preferred embodiment that extend from the body  11  and may receive and secure the rear end portion of the guidewire  13  in the initial configuration. The first preferred access device  10  is not limited to including the guidewire holder  18  shown in the first preferred embodiment and may include an alternative mechanism for securing the rear end of the guidewire  13  to the body  11  or may exclude the guidewire holder  18 , without significantly impacting the operation and function of the first preferred access device  10 . The guidewire holder  18  (to store rear or proximal end of guidewire  13 ) preferably prevents the rear end of the guidewire  13  from touching non-sterile objects or from generally uncontrollably moving relative to the body  11  in the loaded configuration. 
     The first preferred access device  10  can be used to gain access to blood vessels, such as the lumens of arteries and veins. The needle  12  having an appropriate size is connected or secured to the body  11  and the guidewire  13  is pre-loaded onto or into the body  11 , preferably in sterile packaging (not shown) associated with the access device  10 . The access device  10  may be supplied to a user as a kit, sterile packaged with the body  11 , needle  12  and guidewire  13  pre-loaded in the body  11  or may be provided as only the body  11  and the medical professional may select an appropriate needle  12  and guidewire  13  for their preferred procedure. The body  11  preferably has the flash channel  11   b  that defined the flash lumen  12   x  with the internal surface  12   d  of the needle  12  that allow for fluid to pass through the needle  12 , into flash lumen  12   x  and out onto an external surface of the body  11 , preferably emerging from the flash channel  11   b  near the flash marker  11   f . The guidewire  13  is preferably pre-loaded such that it can easily be advanced through the needle lumen  12   c  and into the lumen of a vessel when the top  12   a  is properly placed in the vessel. The access device  10  is preferably designed such that the guidewire  13  is slidable through the guidewire channel  12   a  and the needle lumen  12   c , thereby allowing the guidewire  13  to be left in the vessel while the needle  12  and the body  11  are completely removed from the area adjacent the patient during the procedure by backing the body  11  and needle  12  proximally away from and off of the guidewire  13 . 
     In the first preferred embodiment, the body  11  includes the single needle  12  secured or fixed thereto, but is not so limited and multiple needles may be secured to the body  11  to secure access to the blood vessel by inserting multiple needles (not shown) into the patient. The needle  12  is preferably removably mountable to the body  11 , such as by employing a Luer-Lock connection or other tapered connection that permits mounting of variously sized needles  12  to the distal end  11   d  of the body  11 . The needle  12  is also preferably echogenic or includes an echogenic portion in an area approximately one-half to one centimeter (½-1 cm) from the tip  12   a  to permit use of the needle  12  with ultrasound for visualization. The echogenic portion may be integrally formed with the needle  12 , applied to the needle  12  at the echogenic portion or otherwise positioned at the echogenic portion for visualization purposes. The echogenic portion may alternatively be comprised of a radiopaque marker attached or applied to the needle  12  for visualization using radiant energy techniques and mechanisms, such as x-ray. The echogenic portion may also be positioned at or on the tip  12   a . The needle  12  is not limited to including the echogenic portion and may be configured without the echogenic portion, but the echogenic portion is preferred for visualization purposes and may be utilized with any of the preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70 ,  80 , described herein. The needle  12  may also include depth markings on an external surface to provide a visual indication of the depth of the tip  12   a  during insertion into the patient. 
     The first preferred access device  10  also includes the guidewire channel  11   a  and the needle lumen  12   c  positioned generally on or coaxial with the longitudinal axis  14 . The guidewire channel  11   a  and needle lumen  12   c  are not limited to being positioned on or coaxial with the longitudinal axis  14 , as is described in further detail herein. 
     The guidewire channel  11   a  of the first preferred embodiment of the access device  10  preferably extends generally from the proximal end  11   e  to the distal end  11   d  of the body  11 , but is not so limited and may curve or extend at an angle such that the guidewire channel l la does not extend the full length of the body  11 . The guidewire channel  11   a  preferably does extend through the distal end  11   d  of the body  11  such that the guidewire channel  11   a  opens into the needle lumen  12   c  in the initial or assembled configuration. The guidewire  13  may be positioned such that the tip of the front end  13   a  of the guidewire  13  extends out of the guidewire channel  11   a  in the loaded or initial configuration for relatively quick extension into the needle lumen  12   c  when access to the vessel is secured. The guidewire channel  11   a  preferably defines a channel length LG where an outer surface of the guidewire  13  is positioned close or tightly relative to an inner surface of the guidewire channel. The channel length LG is preferably long enough to secure the relatively flexible front end portion  13   a  of the guidewire  13  in the loaded configuration. The front end portion  13   a  may be relatively elastic or flexible relative to the remaining portions of the guidewire  13  to form a J-hook or atraumatic tip of the guidewire  13  in a relaxed configuration. Accordingly, in the loaded configuration, the positioning of the front end portion  13   a  within the relatively straight or constrained guidewire channel  11   a  deforms the front end portion  13   a  from the J-hook or other atraumatic shape. When the front end portion  13   a  is introduced into the vessel, the J-hook or other shaped atraumatic tip flexes to the relaxed configuration to limit punctures to the vessel by a sharp end of the guidewire  13 . The channel length LG is preferably at least two inches (2″), more preferably at least three and one-quarter inches (3¼″), but is not so limited and may be greater than three and one-quarter inches (3¼″) for holding the guidewire  13  in the loaded configuration. The channel length LG is preferably sufficient to stabilize the guidewire  13  within the guidewire channel  11   a  in the loaded configuration, such that at least a portion of the more rigid proximal portion of the guidewire  13  positioned proximally relative to the front end portion  13   a  is within the guidewire channel  11   a  in the loaded configuration. The body  11  is also preferably constructed of a transparent or semi-transparent material, such as a biocompatible, transparent or semi-transparent polymeric material that permits visualization of the guidewire  13  within the guidewire channel  11   a  by the user. The body  11  is not limited to such constructions and may be constructed of an opaque material, such as a biocompatible metal that is able to take on the size and shape of the preferred body  11  and withstand the normal operating conditions of the body  11 . The channel length LG is long enough to fully contain the soft distal end of the guidewire  13  and a portion of the firm main section of the guidewire  13 , thereby preventing the guidewire  13  from buckling during advancement through the guidewire channel  11   a.    
     The first preferred access device  10  facilitates an access procedure for gaining access to the patient&#39;s vessel, but within a single, integrated device, which is an improvement over known prior art devices and systems, particularly with the adaptability of the distal end  11   d  of the body  11  that removably accepts different sized needles  12  and accommodates the flash channel  11   b  on an external surface of the body  11  that may be readily cleaned and/or sterilized. The body  11  is designed such that it is releasably connected to the needle  12  with the pre-loaded guidewire  13  in the guidewire channel  11   a.    
     In operation, the first preferred access device  10  may be packaged in a sterile package or kit with the guidewire  13  loaded in the guidewire channel  11   a . The body  11  may alternatively be separately packaged and the user may select separate needles  12  and guidewires  13  for use with the body  11 . The access device  10  is removed from the package and the needle  12  may be mounted to the distal end  11   d  of the body  11 , thereby forming the flash lumen  12   x . The tip  12   a  is positioned by the physician or medical professional adjacent the patient&#39;s skin near an anatomical region where a predetermined vessel should be located for a particular procedure. The tip  12   a  is inserted into the skin and the physician or medical professional visually inspects the opening or port of the flash lumen  12   x  near the flash marking  12   f  waiting for blood to appear in the flash channel  12   x  or nearly anywhere on external surfaces of the body  11  and needle  12  as the tip  12   a  is urged into the patient. The pressure in the blood vessel forces blood flow into the needle lumen  12   c , into the flash lumen  12   x  and out of the flash channel  11   b  near the tip of the arrow of the flash marker  12   f . The guidewire seal preferably seals or partially seals the guidewire channel  11   a  from the blood flow such that the blood flowing into the needle lumen  12   c  is urged into the flash lumen  12   x . The seal also preferably self-heals or collapses when the guidewire  13  is removed to substantially prevent fluid from flowing out of the guidewire channel  13   a . Once access is gained to the blood vessel, front end portion  13   a  of the guidewire  13  is urged into the needle lumen  12   c  and into the vessel. The front end portion  13   a  may move to its relaxed configuration, such as the J-hook configuration or other atraumatic configuration to limit exposure of the vessel to sharp edges of the guidewire  13 . When the guidewire  13  is positioned within the vessel, the needle  12  and body  11  may slide proximally along the longitudinal axis  14  away from the patient on the guidewire  13 , while the guidewire  13  is retained in the patient and, particularly the lumen of the blood vessel. The guidewire  13  is subsequently used to guide instruments or implants into the vessel for further procedures. 
     The pre-loaded guidewire  13  with its rear end portion secured to the body  11  at the guidewire holder  18  is inserted through the needle  12  and into the vessel, without requiring the physician or medical technician to reach for and insert the guidewire  13  into the guidewire channel  11   a  after gaining access to the vessel because of the pre-loading. The guidewire  13  is preloaded in that the front end portion  13   a  of the guidewire  13  is at least partially positioned in the guidewire channel  11   a  in the initial or loaded configuration ( FIGS. 4-7 and 9 ). The guidewire  13  is urged into the appropriate vessel and the needle  12  and body  11  are then removed over the guidewire  13  away from the patient with the guidewire  13  remaining in the vessel. The guidewire  13  is then utilized to guide additional devices or testing apparatus to the vessel. The body  11  may be adapted for use with variously sized and shaped needles  12  that are removably mountable to the distal end  11   d  of the body  11  and facilitate formation of the flash lumen  12   x  when the needle  12  is mounted to the body  11 . In addition, the adaptability of needle sizes facilitates use of variously sized guidewires  13  with the body  11  so that the user or medical professional may select a preferred size for the needle  12  and the guidewire  13  based on preferences or particular procedures. 
     Referring to  FIGS. 10 and 11 , a second preferred access device  20  has a similar construction to the first preferred access device  10  and like reference numbers are utilized to identify like features of the second preferred access device  20  with a number “2” prefix replacing the “1” prefix to distinguish the features of the access device  10  of the first preferred embodiment from the access device  20  of the second preferred embodiment. 
     The access device  20  of the second preferred embodiment is configured to access a lumen of a blood vessel. The access device  20  of the second preferred embodiment includes a guidewire seal or sealing mechanism  25  in the guidewire channel  21   a  near the distal end  21   d  of the body  21  and near the outlet port of the guidewire channel  21   a . The guidewire seal  25  sealingly engages the guidewire (not shown) in a mounted or loaded configuration. The sealing mechanism  25  limits or prevents fluid flow into the guidewire channel  21   a  from the needle lumen (not shown), but also permits the guidewire to move through the sealing mechanism  25  for introduction into the needle lumen and withdraw of the guidewire from the access device  20 . In an initial or loaded configuration, the guidewire  13  is positioned in the guidewire channel  21   a  such the front end of the guidewire  13  is positioned proximally relative to or within the sealing mechanism  25  and is advanced through the sealing mechanism  25  during use. The guidewire seal  25  preferably limits or prevents blood flow from the needle lumen into the guidewire channel  21   a  when the guidewire is not loaded in the body  21 . When the guidewire seal engages the guidewire  13  in the loaded configuration or when the guidewire  13  is extended through the guidewire seal  25 . The guidewire seal  25  of the second preferred embodiment is positioned at or near the outlet port of the guidewire channel  21   a , but is not so limited and may be positioned anywhere within the guidewire channel  21   a  that limits or prevents flow of fluid through the guidewire channel  21   a  during use. In the initial configuration, the front end portion  13   a  of the guidewire  13  is positioned proximally or at least partially within the guidewire seal  25 , but is not so limited and the access device  20  may be configured without the guidewire seal  25  such that flash flows out of the funnel-like port  21   c  when the vessel is accessed. For example, the second preferred access device  20  may be configured without the guidewire seal  25  and the guidewire channel  21   a  having a greater diameter than the guidewire  13 , such that blood flow or flash flows past the guidewire  13  through the guidewire channel  21   a  and out of the funnel-like port  21   c  to provide a physical and visual indication to the user that the vessel is accessed. 
     The second preferred access device  20  includes the body  21  having the distal end  21   d , the proximal end  21   e , the longitudinal axis  24  and the guidewire channel  21   a . The guidewire channel  21   a  extends generally parallel to the longitudinal axis  24  and extends substantially coaxial to the longitudinal axis  24  in the preferred embodiment. The guidewire channel  21   a  is defined at the distal end  21   d  of the body  21  and extends toward the proximal end  21   e  of the body  21 . The guidewire channel  21   a  opens into the funnel-like port  21   c  at the proximal end  21   e . The funnel-like port  21   c  has a proximal port diameter D P  that is greater than a distal port diameter D D  such that the opening at the distal end  21   d  is relatively large for insertion of the guidewire  13 . The distal port diameter D D  is substantially the same as a guidewire channel diameter D G . The guidewire channel  21   a  defines a channel length L G  that is at least two inches (2″) and more preferably three and one-quarter inched (3¼″) in the second preferred embodiment. The channel length LG is preferably at least two inches (2″) such that the guidewire  13  is retained in guidewire channel  21   a  in the initial configuration while the needle  12  is inserted into the patient&#39;s vessel and while flood flows through the needle  12 , past the guidewire  13  through the guidewire channel  21   a  and out of the funnel-like port  21   c  at the distal end  21   d . The guidewire  13  can then be inserted into the patient&#39;s vessel, once access is gained to the vessel, such that a subsequent device can be guided into the vessel on the guidewire  13 . The funnel-like portion  21   c  of the preferred embodiment tapers from the proximal port diameter D P  to the disport port diameter D D  to provide the expanded diameter for insertion of the front end portion  13   a  into the guidewire channel  21   a . The body  21  of the preferred embodiment also has a substantially consistent body diameter D B  between the proximal end  21   e  and a distal trip transition edge  21   g  proximate the distal end  21   d . The guidewire  13  has a guidewire diameter D 1    
     The second preferred access device  20  also includes the needle  12  with the tip  12   a  having the proximal end  12   b  that is removably mountable to the distal end  21   d  of the body  21 . The guidewire  13  has a guidewire diameter D 1  and the guidewire channel diameter D G  is greater than the guidewire diameter D 1 . The guidewire channel  21   a  is configured to facilitate blood flow between the guidewire  13  and an internal surface  21   g  of the guidewire channel  21   a  when the guidewire  13  is positioned in the guidewire channel  21   a  such that the blood flash flows out of the funnel-like port  21   c  when the vessel is accessed. The body  21  also includes a guidewire holder  28   a ,  28   b  extending form a side of the body  21 . The guidewire holder  28   a ,  28   b  of the second preferred embodiment has a holder channel  29   a ,  29   b  configured to secure the rear end portion of the guidewire  13  in the initial configuration such that the rear end portion is not free to move relative to the body  21  during a procedure. The guidewire holder  28   a ,  28   b  of the second preferred embodiment includes a proximal guidewire holder  28   b  with a proximal holder channel  29   b  and a distal guidewire holder  28   a  with a distal holder channel  29   a . The proximal guidewire holder  28   b  is positioned closer to the proximal end  21   e  than the distal guidewire holder  28   a.    
     Referring to  FIGS. 12-13 , a third preferred access device  30  has a similar construction to the first and second preferred access devices  10 ,  20  and like reference numbers are utilized to identify like features of the third preferred access device  30  with a number “3” prefix replacing the “1” and “2” prefixes to distinguish the features of the access devices  10 ,  20  of the first and second preferred embodiments from the access device  30  of the third preferred embodiment. 
     The access device  30  of the third preferred embodiment includes an integrally formed flash port  31   b  that defines the flash lumen  32   x . The distal end  31   d  of the body  31  is configured for removable mounting to the hypodermic needle  12 , preferably hypodermic needles  12  having different sizes and shapes for various procedures. In use, the blood flash flows through the needle lumen (not shown) into the flash lumen  32   x  and out of the body  31  near the arrowhead of the flash marker  31   f.    
     The body  31  of the third preferred embodiment also includes guidewire alignment markings  37  on an outer surface and the guidewire  13  includes a tip distance marker  13   x  positioned proximally relative to the front end  13   a  of the guidewire  13 . The tip distance marker  13   x  is preferably positioned between the guidewire alignment markings  37  in the mounted or loaded configuration ( FIGS. 12A and 12C ). In the mounted or loaded configuration with the tip distance marker  13   x  positioned between the guidewire alignment marking  37 , the front end  13   a  is positioned near the distal end of the guidewire channel  31   a , but not in the needle lumen (not shown) of the needle  12 . Positioning the front end  13   a  of the guidewire  13  near the distal end of the guidewire channel  31   a , but not within the needle lumen permits blood to flow through the needle lumen when the vessel is punctured by the tip  32   a  while readying the guidewire  13  for relatively quick introduction into the vessel upon identification of blood flash. The guidewire alignment markings  37  are not limited to being comprised of lines on the body  13 , the tip distance marker  13   x  is not limited to being a marking on the guidewire  13  and these components may be comprised of nearly any marker or identification that indicates to the user positioning of the front end  13   a  of the guidewire  13  near the distal end of the guidewire channel  31   a  in the loaded configuration. For example, the front end  13   a  may be positioned in the loaded configuration by aligning a notch (not shown) on the guidewire  13  with an alignment window (not shown) on the body  31 . 
     Referring to  FIGS. 12A-12C , the body  31  may include the continuous guidewire holder  38 , shown in  FIGS. 12A-12C , that receives and holds a rear end portion of the guidewire  13  in the loaded configuration. The guidewire holder  38  of the third preferred embodiment preferably is integrally formed in the body  31  and extends generally parallel to the guidewire channel  31   a , but is not so limited and may be otherwise designed and configured to hold the rear end portion of the guidewire  13  in the loaded configuration. 
     Referring to  FIGS. 14-16 , a fourth preferred access device  40  has a similar construction to the first, second and third preferred access devices  10 ,  20 ,  30  and like reference numbers are utilized to identify like features of the fourth preferred access device  40  with a number “4” prefix replacing the “1,” “2” and “3” prefixes to distinguish the features of the access devices  10 ,  20 ,  30  of the first, second and third preferred embodiments from the access device  40  of the fourth preferred embodiment. 
     The fourth preferred access device  40  includes the body  41  with upper and lower flash channels  41   b ,  41   b  at the distal end  41   d  of the body  41 . Both the upper and lower flash channels  41   b ,  41   b  define flash lumens with the inner surface  12   d  of the needle  12  such that blood flashes from upper and lower surfaces of the body  41  at the proximal portions of the upper and lower flash channels  41   b ,  41   b . The upper and lower flash channels  41   b ,  41   b  permit visualization of the blood flash by the user regardless of the orientation of the body  41  relative to the user during use. 
     Referring to  FIGS. 17-20 , a fifth preferred access device  50  has a similar construction to the first, second, third and fourth preferred access devices  10 ,  20 ,  30 ,  40  and like reference numbers are utilized to identify like features of the fifth preferred access device  50  with a number “5” prefix replacing the “1,” “2,” “3” and “4” prefixes to distinguish the features of the access devices  10 ,  20 ,  30 ,  40  of the first, second, third and fourth preferred embodiments from the access device  50  of the fifth preferred embodiment. 
     In the fifth preferred embodiment, the access device  50  includes a relatively flat flash channel  51   b  at the distal end  51   d  that defines the flash lumen  52   x  with the proximal end  52   b  of the needle. The flash lumen  52   x  is defined by the inner surface  52   d  of the proximal end  52   b  of the needle and the flash channel  51   b  of the body  51 . The relatively flat flash channel  51   b  facilitates relatively simple cleaning and sterilization of the flash channel  51   b  after the needle  12  is removed from the body  51 . The distal end  51   d  is designed and configured for engagement with the multiple hypodermic needles  12  having different shapes and sizes for user preferences or procedures. 
     Referring to  FIGS. 21 and 22 , a sixth preferred access device  60  has a similar construction to the first, second, third, fourth and fifth preferred access devices  10 ,  20 ,  30 ,  40 ,  50  and like reference numbers are utilized to identify like features of the sixth preferred access device  60  with a number “6” prefix replacing the “1,” “2,” “3,” “4” and “5” prefixes to distinguish the features of the access devices  10 ,  20 ,  30 ,  40 ,  50  of the first, second, third, fourth and fifth preferred embodiments from the access device  60  of the sixth preferred embodiment. 
     In the sixth preferred embodiment, the access device  60  includes a slightly wider flash channel  51   b  with end walls and does not include a flash marker at the distal end  51   d.    
     Referring to  FIGS. 23 and 24 , a seventh preferred access device  70  has a similar construction to the first, second, third, fourth, fifth and sixth preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60  and like reference numbers are utilized to identify like features of the seventh preferred access device  70  with a number “7” prefix replacing the “1,” “2,” “3,” “4,” “5” and “6” prefixes to distinguish the features of the access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60  of the first, second, third, fourth, fifth and sixth preferred embodiments from the access device  70  of the seventh preferred embodiment. 
     The seventh preferred body  71  has a generally cylindrical-shape from the distal end  71   d  to the proximal end  71   e  without guidewire holders on the outer surface of the body  71 . The body  71  also does not include a flash marker on the external surface, but is not so limited. 
     Referring to  FIGS. 25 and 26 , an eighth preferred access device  80  has a similar construction to the first, second, third, fourth, fifth, sixth and seventh preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70  and like reference numbers are utilized to identify like features of the eighth preferred access device  80  with a number “8” prefix replacing the “1,” “2,” “3,” “4,” “5,” “6” and “7” prefixes to distinguish the features of the access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70  of the first, second, third, fourth, fifth, sixth and seventh preferred embodiments from the access device  80  of the eighth preferred embodiment. 
     The eighth preferred body  81  also has a generally cylindrical-shape from the distal end  81   d  to the proximal end  81   e  and also includes a flash lumen  82   x  that is integrally defined at the distal end  81   d  of the body  81 . The distal end  81   d  is configured to removably engage the multiple needles  12  for flexibility of the access device  80 . 
     Referring to  FIGS. 1-26 , the preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70 ,  80  are an accessory that may connect to a standard vascular access or hypodermic needle  12 . The preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70 ,  80  also receive a standard guidewire  13  (i.e. 0.018″, 0.025″, 0.035″, 0.038″) and can be offered to be compatible with a range of needle sizes (i.e. 18 ga, 20 ga, 21 ga, 22 ga). 
     In use, when the tip  12   a  of the needle  12  is inserted through the skin into a blood vessel of the patient, the blood passes through the needle and exits from the flash port at the end of the flash lumen  12   x ,  32   x ,  52   x ,  82   x  indicating the needle  12  is in the blood vessel. The preloaded guidewire  13  is then immediately advanced through the guidewire channel  11   a ,  21   a ,  31   a ,  41   a ,  51   a ,  61   a ,  71   a ,  81   a  and the lumen  12   c  of the needle  12  and into the blood vessel. 
     In a preferred example, a standard thirty-five thousandths of an inch (0.035″) or fifty centimeter (50 cm) J-wire is commonly used during the Seldinger technique. The J-tip of the guidewire  13  is preloaded in the guidewire channel  11   a ,  21   a ,  31   a ,  41   a ,  51   a ,  61   a ,  71   a ,  81   a  so the user doesn&#39;t have to fumble with getting the J-wire into the body  11 ,  21 ,  31 ,  41 ,  51 ,  61 ,  71 ,  81  in the delicate moment after the flash of blood has been observed. Once the wire  13  is advance through the needle  12  and exits into the blood vessel, the J-tip resumes its shape, protecting the blood vessel from damage (i.e. perforation). When loaded into the guidewire channel  11   a ,  21   a ,  31   a ,  41   a ,  51   a ,  61   a ,  71   a ,  81   a  the J-tip of the guidewire  13  can&#39;t return to its J-shape in the relaxed configuration until the J-tip exits the distal tip  12   a  of the needle  12 . The J-tip of the guidewire  13  also doesn&#39;t have enough space between the distal end  11   d ,  21   d ,  31   d ,  41   d ,  51   d ,  61   d ,  71   d ,  81   d  of body  11 ,  21 ,  31 ,  41 ,  51 ,  61 ,  71 ,  81  and the inside of the hub of the needle  12  to resume the J-shape 
     The male Luer fitting or cone angle of the distal end  11   d ,  21   d ,  31   d ,  41   d ,  51   d ,  61   d ,  71   d ,  81   d  allows the body  11 ,  21 ,  31 ,  41 ,  51 ,  61 ,  71 ,  81  to stay connected to a standard needle Luer fitting of the needle  12  with a light press fit. 
     In the preferred embodiment, the body  11 ,  21 ,  31 ,  41 ,  51 ,  61 ,  71 ,  81  is constructed of a clear polymeric or plastic material, more preferably a polycarbonate material, so the user can visualize the guidewire  13  at all times during use. The preferred access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70 ,  80  are lightweight so that the balance of the needle  12  is not disturbed during use. The preferred bodies  11 ,  21 ,  31 ,  41 ,  51 ,  61 ,  71 ,  81  can be easily disconnected from the needle  12  and its preferred Luer fitting if desired. The preferred guidewire channel  11   a ,  21   a ,  31   a ,  41   a ,  51   a ,  61   a ,  71   a ,  81   a  can be flushed using a standard syringe at the proximal end, if needed. The trailing end of the guidewire  13  can be inserted into the guidewire holder  18  to prevent the trailing end from touching a non-sterile object during use and from generally flopping around during use. 
     It will be appreciated by those skilled in the art that changes could be made to the embodiments described above without departing from the broad inventive concept thereof. For example, the features of each of the preferred embodiments of the access devices  10 ,  20 ,  30 ,  40 ,  50 ,  60 ,  70 ,  80  may be mixed and matched based on user preferences and for particular procedures. It is understood, therefore, that this invention is not limited to the particular embodiments disclosed, but is intended to cover modifications within the spirit and scope of the present invention as defined by the present disclosure.