Abstract:
An artery stabilizing syringe conveyor is provided for facilitating the insertion of the needle of a syringe into a targeted artery. A pair of stabilizer fingers holds the artery in place while a syringe (held by a syringe holder) is maneuvered down the slot of a housing structure which is connected to the stabilizer fingers. After sufficient blood is obtained, the technician is able to slide the syringe back up the slot, placing the needle within the protective walls of the housing for safety. A syringe lock holds the syringe in place. The blood receptacle component of the syringe may be separated from the device, leaving the needle locked within the housing for safety. An alternative embodiment provides a shaft, rather than a housing, to slidably retain the syringe holder, and a needle shield provides protection from the sharp tip of the needle.

Description:
[0001]    This application claims the benefit of U.S. Provisional Application No. 60/788,747 filed on Mar. 30, 2006. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    1. Field of Invention 
         [0003]    This invention relates generally to vascular stabilizer devices, specifically to an artery stabilizer device with a needle-shielding syringe conveyor. 
         [0004]    2. History of Technology 
         [0005]    In order to insert the needle of a syringe into a targeted artery, a medical technician will often struggle with instability of the artery during the procedure; the artery may tend to move away from an incoming needle. A second problem is that the artery may be hard to locate. A third common problem is that safety is jeopardized by an over-exposed needle. A fourth problem is that it is difficult to maintain a straight path of insertion. A fifth problem is that it is impossible to keep exposed fingers away from the puncture site. The present invention solves these problems. 
         [0006]    The withdrawal of arterial blood from a patient is a common procedure in today&#39;s health care settings. Arterial blood gas, or “ABG” analysis serves to provide vital information concerning the respiratory status of the patient. Blood is drawn anaerobically from an artery such as the radial, brachial, femoral, or dorsalis pedis artery, via a percutaneous needle puncture. The preferred site is the radial artery. A blood specimen is collected for direct measurement of the partial pressures of carbon dioxide (PaCO2) and oxygen (PaO2), hydrogen ion activity (pH), total hemoglobin (Hbtotal), oxyhemoglobin saturation (HbO2), and the dyshemoglobins carboxyhemoglobin (COHb) and methemoglobin (MetHb). Sampling typically may only be performed by trained and certified health care personnel. 
         [0007]    A modified Allen Test (collateral circulation test) should always be performed by a technician before the technician inserts a needle into a patient&#39;s radial artery. The Allen Test determines if blood is capable of flowing through the ulnar artery. The ulnar artery is the only other source of blood to the hand aside from the radial artery. A negative test result is indicative of inadequate collateral blood supply to the hand and requires the selection of another location as the site for arterial access. 
         [0008]    To obtain an arterial blood sample, the technician will first determine the precise location in which to insert the needle of a syringe into the artery of the patient. Once an appropriate site is located, the needle is inserted by the technician into the selected artery until the artery is penetrated and the syringe&#39;s blood receptacle fills with sufficient blood. Then, the needle is removed from within the artery, the wound is dressed, and the needle is capped to prevent needle injuries. The arterial blood draw process is difficult and prone to errors, even when the technician has ample experience. Because of the traumatic nature of the procedure, and the large number of complications that may arise, it is important for the technician to try to obtain the arterial blood properly and effectively on the first attempt. Prior art has seriously failed to provide technicians with adequate means to obtain a successful arterial blood sample regularly on the first attempt. 
         [0009]    An unrestrained artery may tend to move away from an incoming needle, particularly in older patients whose skin has lost elasticity. A loss of elasticity in the skin creates a loss of stability around the artery, which allows the artery to roll around under the surface of the skin. It is possible for a needle tip to push the artery away from its path, causing the technician to miss the targeted artery completely. The present invention solves this problem by providing an artery stabilizer to hold the artery in place. 
         [0010]    Currently, the technician will press her or his finger over the anticipated arterial puncture site and then estimate where the artery lies under that finger; it is a rough estimate and the technician often miscalculates. Alternatively, the technician may place two fingers over the artery and attempt to hold the artery between the fingertips, inserting the needle between the two fingertips to penetrate the artery. This method has its limitations; the technician should have a tight pair of gloves, cannot have long finger nails, and will rely on bulky fingertips to pinpoint a relatively thin artery between them, and this technique is impossible to use on infants and small children. The present invention uses an artery stabilizer to hold the artery within two integrated stabilizer fingers at the base of the device, and it partially occludes the artery during use; this creates an augmented pulse at the site where the needle will enter the artery, simplifying palpation of the artery and vastly diminishing the labor involved in identifying where to insert the needle. The artery stabilizer further allows the technician to keep any of the technician&#39;s exposed extremities substantially away from the puncture site while inserting the needle into the targeted artery, thus improving safety. 
         [0011]    Because of low blood pressure, a patient&#39;s pulse may be weak and hard to locate. It is sometimes necessary for the technician to perform an arterial puncture “blindly,” merely stabbing the site where the technician considers the best option for obtaining arterial access. The present invention helps to create an augmented pulse that is palpable even in cases of low blood pressure. 
         [0012]    Most ABG protocols allow a technician to try three consecutive needle insertions without removing the needle tip beyond the subcutaneous tissue. As the angle of insertion changes within the dermis, the needle slices through the tissue in its path, and may even lacerate the artery. Any change in the angle of needle insertion can inflict severe pain onto a conscious patient. Because of the structural design of the present invention, a straight, unswerving path of needle insertion into the artery is achieved. Currently, the often unsteady hand of the technician is used to guide the syringe needle down into the artery. A nervous hand can become quite jittery, and even a calm hand does not guarantee a straight path of insertion into and out of the vessel. The present invention provides a considerable improvement in this regard; pressing the artery stabilizer, at the base of the invention, down near the puncture site provides stability to the hand of the technician. The straight slot within the housing, which supports the syringe, vastly improves the likelihood of a direct and controlled line of insertion and extraction of the needle during a blood draw procedure, minimizing pain and trauma within the patient&#39;s dermal tissues and artery. 
         [0013]    Often, the unrestrained nature of the current methods for inserting a needle into an artery causes the needle to become accidentally extracted from within the artery during a blood draw attempt, causing a cessation of blood flow. The present invention prevents this common mishap, by providing a solid, steady housing within which the syringe is securely held in place during the procedure. 
         [0014]    According to standard ABG protocols, a needle should enter an artery at a steady angle of approximately 45 degrees in relation to the artery distal the heart near the insertion site; prior art relies on the technician to maintain that angle without any support. A proper angle of needle insertion is assured using the present invention, as a result of the base of the stabilizer fingers being properly angled in relation to the housing slot within which the syringe is maneuvered. 
       BACKGROUND OF THE INVENTION—PRIOR ART 
       [0015]    Generally, prior art may include devices which guide a syringe into and out of a blood vessel, and also any device which is designed to stabilize a blood vessel during a needle puncture of that vessel. Most precisely, prior art includes any device which stabilizes an artery during the insertion of a needle into the artery. 
         [0016]    The number of devices within the realm of prior art related specifically to artery stabilizer devices is currently very limited. One such device, described by Ayer, is an invention which presses two protrusions down on each side of a targeted portion of a radial artery in order to hold the artery in place and prevent the artery from moving away from an incoming needle. The Ayer device requires a band to be strapped around the wrist of the patient. This band may tend to occlude the ulnar artery and thus restrict vital collateral blood flow through the ulnar artery to the hand. If the radial artery becomes occluded during the blood draw procedure, complete absence of blood flow to the hand can result, causing tissue trauma or death within that extremity. The current invention does not require a band to be secured around the wrist; more advantageously, the invention is held in place by the technician, thereby eliminating the risk of impeding the collateral blood flow through the ulnar artery when the radial artery is targeted. Another benefit over the Ayer device is that the present invention may be used on any artery, not just the radial artery. Unlike the Ayer device, the present invention includes a syringe conveyor to help guide the needle of the syringe steadily into and out of the artery. Another limitation of the Ayer device is that it maintains a constant pressure over the targeted artery. As a result, it is not possible to reduce that pressure when it is time to withdraw the needle from the puncture site; the augmented pulse pressure can cause increased blood spillage out of the wound when the needle is removed. The present invention allows the technician to release the pressure over the artery before removing the needle from the puncture site. 
         [0017]    Most of the devices within the realm of prior art do not address the issue of safety adequately. Most syringes require the integrated needle to be exposed during much of the procedure; this can be hazardous to technicians and patients if the syringes are handled improperly or unsteadily, as may commonly occur in emergency situations. Needle sticks are the most frequent source of transmission of blood borne disease in healthcare workers. In most of the devices of prior art, the needle is exposed before and after the insertion procedure and there are no means provided to protect personnel from contacting the needle during the procedure. Some devices allow needle retraction into a protective enclosure after a successful blood draw, but these devices don&#39;t go far enough to prevent injuries, nor do they provide an artery stabilizer for stability and ease of use. With the present invention, the needle is exposed for only a brief instant during a blood draw procedure; the needle is lowered and exposed only after the device has been set over the targeted insertion site. Immediately after sufficient blood is obtained, the needle is safely withdrawn out of the artery and back into the protective walls of the housing. 
         [0018]    Several devices have been proposed for stabilizing a vein for venipuncture, but none of the devices provide proper support for arterial puncture. For arterial puncture, the blood vessel stabilizer portion of the device should be relatively small to accommodate the limited space over the radial artery near the hand, it should be shaped to facilitate palpation of the targeted puncture site by the technician, and it should be shaped to allow the insertion of a needle proximal the patient&#39;s heart in relation to the stabilizer. The device should be designed to allow a proper angle of needle passage into the artery, and it should be easily removed from the puncture site; it cannot be bound or taped down during use. These features are all present in the current invention. 
         [0019]    Unlike many of the devices of prior art, the present invention allows the use of any one of a large number of available syringes. The blood receptacle portion of the employed syringe may be detached from the needle and then capped with a syringe plug for transport. The current invention, with the needle safely held within its protective walls, can be discarded in a proper disposal container. The present invention may also implement an adjustable artery stabilizer to accommodate various sizes of targeted arteries. 
         [0020]    One possible embodiment of the current invention has a blood receptacle which is not required to be detached from the needle. Following a blood draw, the needle is locked safely within the housing and the entire device is then transported for blood analysis. The technician removes a plug which caps the blood receptacle, to access the blood for analysis. 
       OBJECTS AND ADVANTAGES 
       [0021]    Accordingly, several objects and advantages of the present invention include providing an artery stabilizing syringe conveyor which: 
         [0022]    (a) holds a targeted artery in place for the insertion of a needle into the artery. 
         [0023]    (b) isolates the artery and creates an augmented pulse for easy identification of its location. 
         [0024]    (c) can be used with a large variety of existing syringes. 
         [0025]    (d) supports a syringe and renders a straight path of needle penetration into and withdrawal from an artery. 
         [0026]    (e) allows the needle of the syringe to be immobilized safely within the protective walls of the integrated housing or shield. 
         [0027]    (f) is held in place by the technician using only one hand. 
         [0028]    (g) assures a proper angle of needle insertion into the artery. 
         [0029]    (h) allows unrestricted blood flow through the ulnar artery. 
         [0030]    (i) helps the technician to keep the tip of the needle steadily within the artery. 
         [0031]    (j) shields the technician&#39;s fingers from the sharp needle tip during use, to prevent injury. 
         [0032]    (k) is inexpensive to manufacture, simple and intuitive to use, disposable, light-weight, and reusable if cleaned and disinfected properly. 
         [0033]    (l) can be used on any individual of any age and size, and on any suitable artery. 
         [0034]    (m) minimizes the need for multiple needle insertion attempts to penetrate the artery. 
         [0035]    (n) allows the technician to regulate the pressure of the device over the artery, and to release the pressure before removing the needle from that artery. 
         [0036]    (o) allows the technician to alter the width between each stabilizer finger. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0037]      FIG. 1A  is a perspective view of the invention, with a syringe attached to the syringe holder and lowered within the housing so that the needle of the syringe is exposed past the artery stabilizer. 
           [0038]      FIG. 1B  is a transparent planar view of the device in  FIG. 1A . 
           [0039]      FIG. 2  is a perspective view of an alternative embodiment with a detachable artery stabilizer. 
           [0040]      FIG. 3A  is an enlarged partial perspective view of an alternative syringe arm which utilizes a locking tooth which locks within a series of notches cut into the housing. 
           [0041]      FIG. 3B  is a lower perspective view showing how a syringe is attached to the needle holder part of the syringe holder. 
           [0042]      FIG. 3C  is an upper perspective view showing how a syringe is attached to the needle holder part of the syringe holder. 
           [0043]      FIG. 4  is a transparent perspective view of an alternative needle holder. 
           [0044]      FIG. 5A  is a perspective view of an alternative syringe used in an alternative embodiment. 
           [0045]      FIG. 5B  is a perspective view of the alternative embodiment referred to in the description for  FIG. 5A . 
           [0046]      FIG. 6A  is an upper perspective view of another alternative embodiment. 
           [0047]      FIG. 6B  is a lower perspective view of the embodiment in  FIG. 6A   
           [0048]      FIG. 7  is a perspective view of another alternative embodiment, including an exploded partial view of the syringe lock. 
           [0049]      FIG. 8  is a slightly enlarged lower perspective view of another alternative embodiment which includes a removable gauze holder. 
           [0050]      FIG. 9A  is a perspective view of an alternative syringe conveyor utilizing a series of notches to lock in place the syringe arm and attached syringe holder. 
           [0051]      FIG. 9B  is an enlarged rear perspective view of the syringe arm connected to the syringe holder of the device shown in  FIG. 9A . 
           [0052]      FIG. 10  is an enlarged lower rear perspective view of an alternative artery stabilizer with each stabilizer finger situated within a track to allow adjustability of the distance between each finger. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0053]    Referring now to the drawings,  FIGS. 1A-10  represent various embodiments and designs of the present invention. Each embodiment utilizes the novel feature of combining an artery stabilizer with a needle shielded syringe conveyor. Turning first to  FIG. 1A , artery stabilizer  10  includes base  12  and stabilizer fingers  14  and  16 ; stabilizer fingers  14  and  16  emanate from base  12 . A targeted artery is positioned by the technician between fingers  14  and  16 . Alternatively, only one finger protrudes from base  12 ; the single finger would hold only one side rather than both sides of a targeted artery. Housing  18  is attached to base  12 . Stabilizer fingers  14  and  16  serve to stabilize both a targeted artery and housing  18  during use. Slot  20  runs through housing  18 . Syringe  22  is situated within slot  20  and lowered within slot  20  by the technician to guide needle  24  down into the targeted artery; needle  24  passes distal and between the tips of fingers  14  and  16  as shown. The bottom surface of each stabilizer finger (the part that contacts the patient) is angled relative to slot  20 . The angle may be  45  degrees or any other angle suitable for the procedure. Housing bridge  26  connects each side of housing slit  28 . Syringe arm  30  emanates through housing slit  28  from inside of slot  20  for access by the technician. A syringe may be supplied with the device, or alternatively, the device can be manufactured and distributed without a syringe; the device is capable of utilizing any of a large number of existing syringes, as will be made evident in the following discussion. Each embodiment of this invention is capable of being reused if it is cleaned and disinfected properly by qualified personnel. The device can be made of any transparent or semi-transparent solid material, like plastic. 
         [0054]    Looking now at  FIG. 1B , syringe holder  32  retains syringe  22  within slot  20 . The device can be configured to retain any one of a large variety of syringes having various sorts of needles and various sorts of blood receptacles, including multi-chamber blood receptacles, capillary pipettes, and flexible tubes. Syringe arm  30  attaches to syringe holder  32  at point  34 . Locking tooth  36  protrudes from syringe arm  30 . Locking tooth  36  is designed to engage into housing bridge notch  38  to lock arm  30  in place when each is properly aligned. 
         [0055]    Turning next to  FIG. 2 , artery stabilizer  40  is detachable from housing  42 . Artery stabilizer  40  can be inserted into or removed from within slot  44 ; this facilitates the manufacturing and assembly of the device, and also provides an option for a technician to reuse the device by installing a clean new artery stabilizer for each patient. The locking tooth (not visible) is locked within housing bridge notch  46  while syringe arm  48  is positioned as shown. The technician would press down on syringe arm  48  to disengage the locking tooth from within notch  46 . Swivel hinge  50  allows the technician to position housing  42  in multiple positions coaxially relative to the stabilizer fingers, allowing for left or right hand use. 
         [0056]    Looking at  FIG. 3A , syringe arm  52  is attached to syringe holder  54  and includes locking tooth  53  which engages within one notch of the series of notches  56  which are cut along a linear path within housing  57  near slit  58 ; this acts as a syringe lock because syringe arm  52  is locked in place within the notch, thereby holding syringe holder  54  in place. The technician presses down finger contact  59  to elevate tooth  53  from within the notch, freeing syringe holder  54  to be moved up or down the housing slot. 
         [0057]    Turning now to  FIG. 3B , syringe holder  54  is designed to retain syringe blood receptacle  60  at one end and needle hub  62  at the opposite end. Syringe holder  54  includes needle holder  64  (which includes needle adapter tip  65 ) and is implemented with a threaded connector designed to retain needle hub  62 ; hub  62  may be screwed onto or off of needle adapter tip  65 . An alternative sort of needle adapter tip does not have threads, and the needle hub is simply pressed onto the needle adapter tip until it is seated there securely. The needle hub of a needle may alternatively be permanently molded within the needle holder by the manufacturer. The syringe may be installed at the factory by the manufacturer, or by the technician prior to use. 
         [0058]    Turning to  FIG. 3C , needle holder  64  includes hub  66  over which the needle adapter tip of blood receptacle  60  can be interlocked. This embodiment allows a needle adapter tip with threads to screw over hub  66 . An alternative design allows a needle adapter tip without threads to be simply pressed into place within the aperture of hub  66 . As an alternative, a capillary pipette can be accommodated with an appropriately shaped hub here. Any of a multitude of syringes can be accommodated with an appropriately modified syringe holder and needle holder. Syringe holder wall  68  holds needle holder  64  within syringe holder shell  70 . 
         [0059]    Turning next to  FIG. 4 , alternative needle holder  72  retains a syringe in a different manner than the one in  FIG. 3B  and  FIG. 3C . A needle is inserted through the opening at the top end  74  of needle hub holder  76  until needle hub  77  is securely seated within needle hub holder  76 . Hub holder  76  may be composed of a rubbery material which expands just enough to allow a snug fit of hub  77  within hub holder  76 , or it may be a solid material which may further be detailed with ridges or knobbies to grip hub  77 . Hub holder  76  is tapered so that the bottom end  78  is narrower than top end  74  for a snug fit around hub  77 . In this embodiment, which utilizes a rubber hub holder, hub holder  76  is nested within hub holder shell  80 . When properly installed, the top end of needle hub  77  is left protruding above hub holder  76  to allow the technician to remove a syringe blood receptacle from needle hub  77 . To clarify, the drawing shows only part of the syringe holder; hub holder shell  80  would be connected to the syringe holder wall of the syringe holder in the actual device. 
         [0060]    Looking at  FIG. 5A  now, special syringe  84  includes blood receptacle  86  and needle  88 . Access port plug  90  covers an access port (not shown) at the top end of blood receptacle  86 . Air vent  92  is situated within plug  90 . 
         [0061]    Turning to  FIG. 5B , syringe arm  94  is attached to blood receptacle  86 . Syringe arm  94  is contacted by the technician to maneuver the syringe within slot  96  of housing  98 . The access port plug would be exposed above top end  100  of housing  98  when locking tooth  102  is engaged within housing bridge notch  104 , and needle  88  would be safely positioned within housing  98  to prevent injuries. Locking tooth  102  is engaged by the technician over the top of notch  104 , rather than beneath notch  104 , in this embodiment. To disengage the lock, the technician would lift up tip  106  in order to extract tooth  102  from notch  104 , and then the technician would slide syringe arm  94  down to eventually maneuver needle  88  into the targeted artery. A needle tip plug can be added to prevent blood leakage out of the needle tip when the access port plug is removed from the access port. 
         [0062]    Turning now to  FIG. 6A , syringe  108  is attached to a syringe holder within housing  112 . Syringe arm  114  is attached to the syringe holder and slides up and down housing  112  within track  116 . When syringe arm  114  is maneuvered all the way it can travel up housing  112 , syringe arm  114  locks in place there, holding needle  110  safely within the protective walls of housing  112 . The technician presses down on finger hold platform  118  to press artery stabilizer  120  down over a targeted artery. 
         [0063]    Referring now to  FIG. 6B , syringe arm  114  passes through housing slit  119  and connects to syringe holder  122 . Slit  119  is cut within housing  112 . Alternatively, syringe holder  122  can travel within a track cut within the interior of housing  112 , or the inside of housing  112  can have a unique shape through which a similarly shaped syringe holder can be conveyed. A syringe may be supplied and installed with the device by the manufacturer, or the technician may be responsible for installing one of a variety of syringes prior to use. 
         [0064]    Looking at  FIG. 7 , syringe holder  126  is slidably connected to shaft  130 . Alternatively, syringe arm  128  can hold syringe holder  126  slidably on shaft  130 . Track  132  allows syringe holder  126  and syringe arm  128  to be moved up and down shaft  130 . Syringe lock  133  allows for automatic engagement of tooth  134 , which is integrated on syringe arm  128 , within notch  136 ; this holds the needle of a syringe locked in place behind needle shield  138 . Notch  136  is cut within shaft  130 . Prior to use, the technician inserts a syringe down through the upper opening  140  of needle holder  127  so that the needle passes through the opening and the hub of the needle becomes securely seated within needle holder  127 . Alternatively, the device can be precompiled with a syringe by the manufacturer. The technician can press down on shield  138  to lodge artery stabilizer  142  over a targeted artery. 
         [0065]    Referring next to  FIG. 8 , shaft  144  is shorter than the shaft in  FIG. 7  to illustrate that its length can be any one of various lengths. Finger-hold platform  146  protrudes from its connection to shaft  144 . The technician presses down platform  146  to apply artery stabilizer  148  over a targeted artery. Gauze dressing member  150  includes gauze pad  152  which is attached to the bottom of gauze holder  154 . Gauze dressing member  150  can be installed or removed from within gauze holder track  156  which is integrated beneath platform  146 . Gauze holder edges  158  are shaped to slide into gauze track  156 . After the needle insertion procedure, the technician can move the device over the wound and apply gauze pad  152  on the wound to dress it. By retaining graspable tabs  160 , the technician can slide the rest of the device off of dressing member  150 , leaving just dressing member  150  over the wound. Dressing member  150  can then be taped down over the wound. 
         [0066]    Looking at  FIG. 9A  now, syringe holder  166  can be locked in place in multiple locations as a result of the series of notches  168  cut within shaft  170 . Syringe arm  172  is pressed down by the technician to release an integrated tooth from its position within one of the notches. One of the technician&#39;s fingers, preferably a thumb, is held in place between flexible clip  174  and the top surface  176  of platform  178 , helping the technician wield the device during the procedure. As with prior embodiments, a syringe is installed within syringe holder  166  by the technician or the manufacturer. The tip of the needle of the syringe would be situated safely under the protective walls of needle shield  180  before and after the needle insertion procedure for safety. Syringe holder track  182  holds syringe holder  166 . 
         [0067]    Turning next to  FIG. 9B , syringe holder  166  includes protrusions  167  which would fit within the syringe holder track (not shown). Syringe arm  172  is attached to each side of syringe holder  166  by hinge  184 . Tooth  186  moves upward as syringe arm  172  is pressed down by the technician, freeing syringe holder  166  for movement up or down the shaft (not shown). 
         [0068]    Turning finally to  FIG. 10 , stabilizer fingers  190  are slidably situated within artery stabilizer adjustment track  192  so that the distance between each finger can be altered to accommodate various sizes of targeted arteries. It can be designed as a more complex apparatus, such as one which requires the technician to turn a knob to alter the distance between each finger, but a simple one is shown here for ease of illustration.