Abstract:
An intravenous catheter system comprises a Y-shape, where one arm includes a needle for catheterization, another accommodates a syringe assembly, and the third is threaded for attachment to IV tubing. A syringe assembly is threadedly attached to the Y for cannulation, after which the needle is withdrawn into a tube and lugs prevent re-exposure of the needle&#39;s point. A basket connector/valve in the third arm substantially prevents flow through the third arm when no IV tubing is attached thereto. An adhesive strip with backing is wrapped around the Y, perpendicular to its axis, and adheres (or, alternatively, is integrally attached) in its middle to the Y. After cannulation, the backing is removed and the ends of the strip are folded to be parallel to the catheter where it attaches to the Y.

Description:
REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of U.S. Provisional Patent Applications 60/894,950, filed Mar. 15, 2007, and 60/914,330, filed Apr. 27, 2007, both with title INTRAVENOUS ACCESS SAFETY DEVICE, the disclosures of which are hereby incorporated by reference. 
     
    
     FIELD 
       [0002]    The present disclosure relates generally to an intravenous safety device, and more particularly relates to a device that provides intravenous access to a patient without the risk of needle stick and without blatant blood exposure. 
       SUMMARY 
       [0003]    Intravenous (“IV”) catheters are commonly used in medical settings to provide fluid replacement, nourishment, and a port for medication administration to a patient. Such catheters commonly consist of a hollow plastic tube that is inserted into the patient&#39;s vein with the assistance of a sharp, hollow, beveled needle that is inserted into the plastic IV catheter. In use, the healthcare worker locates the patient&#39;s vein, punctures the skin and cannulates the vein. The needle is then withdrawn from the catheter and an IV fluid line is connected to the catheter. 
         [0004]    There are several difficulties with this procedure. First, when the needle is withdrawn from the catheter, blood flows freely out onto the patient&#39;s skin and onto the health worker&#39;s hands. Second, the needle itself must be disposed of to avoid the potential of a needle stick occurring. However, the healthcare worker is occupied with connecting the IV quickly to avoid unnecessary blood loss through the catheter and therefore often places the needle temporarily on the patient&#39;s bed or bedside table, where it can get lost or accidentally puncture either the patient or the healthcare worker. It is important to not only prevent blood or fluid leakage after the needle is withdrawn, but also to provide for safe needle encapsulation and ultimate disposal. 
         [0005]    Preventing exposure to blood and blood products is critical because of the possibility that the healthcare worker may be exposed to diseases such as Hepatitis and H.I.V. Multiple devices have been developed in an attempt to minimize this risk. Most deal with the potential for needle sticks by providing various means of encapsulating the needle after IV access is obtained. Several provide either automatic needle withdrawal, such as U.S. Pat. No. 6,547,762, or semiautomatic devices such as U.S. Pat. No. 4,747,831. One disadvantage of these devices is the inability to readjust the catheter if it accidentally dislodges from inside the vein while the needle is being retracted, which is a common occurrence. In these prior art devices the venous catheter cannot be advanced into the vein until the needle is retracted, commonly resulting in a failed vein cannulation. This then requires removal of the catheter and initiating the entire procedure over again, including another unnecessary needle stick to the patient. Other manual devices for encapsulating the needle are often cumbersome or difficult to use, as they make identifying venous access difficult or are unwieldy to operate because of their size or design. 
         [0006]    The problem of backflow of blood through the catheter has not been addressed as frequently. While some attempts have been made to prevent blood or fluid leakage after the needle is withdrawn, such attempts have not provided for safe needle encapsulation and ultimate disposal. 
         [0007]    It would be desirable to have an IV catheter assembly that satisfies the need for easy medication delivery without disrupting the administration of the IV fluid delivery. Multiple “Y” adapters exist, such as U.S. Pat. No. 6,221,065, which can be attached to the IV catheter once it is inserted into the vein. However, these often unduly restrict the flow of fluid through them by their design, and do not allow for “wide open” administration of fluids as is often required in emergency situations. 
         [0008]    It would be desirable to have a device that provides for safe encapsulation of the needle after venous access is obtained, and allows for readjustment of the needle and catheter if necessary to gain optimal cannulation prior to said encapsulation. It would also be desirable if such a device also prevented blatant blood exposure by preventing backflow of blood after the needle is removed from the catheter. It would be further desirable if such a device also provided dual access to the circulatory system in the form of a closed connection with IV fluids and a second port which allowed administration of medications without disrupting the flow of said IV fluids. It would also be desirable if the withdrawal of the needle from the catheter could be accomplished by the medical professional without the use of both hands. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0009]      FIG. 1  is a side perspective view of a first embodiment of the present technology. 
           [0010]      FIG. 2  is an enlarged perspective view of the first embodiment, as shown in  FIG. 1 . 
           [0011]      FIG. 3  is another enlarged perspective view of the first embodiment, as shown in  FIG. 1 . 
           [0012]      FIG. 4  is an enlarged perspective view of the first embodiment, as shown in  FIG. 1 , showing the needle permeating both the syringe assembly membrane and the membrane of the syringe arm of the connector assembly. 
           [0013]      FIG. 5  is a side view of an alternative embodiment that allows one-handed operation. 
           [0014]      FIG. 6  is an enlarged perspective view of the alternative embodiment, as shown in  FIG. 5 . 
           [0015]      FIG. 7  is an end view of the alternative embodiment, as viewed from the right side of  FIG. 5 . 
           [0016]      FIG. 8  is an end view of the alternative embodiment, as shown in  FIG. 5 , showing the relationship between the hollow tube and outer sleeve in isolation. 
           [0017]      FIG. 9  is a cross-sectional view of a syringe arm and adhesive bandage according to a second alternative embodiment. 
           [0018]      FIG. 10  is a perspective view of a syringe arm and adhesive bandage according to the second alternative embodiment. 
           [0019]      FIG. 11  is a plan view of a syringe and adhesive bandage according to the second alternative embodiment. 
           [0020]      FIG. 12  is another plan view of a syringe and adhesive bandage as secured to a patient according to the second alternative embodiment. 
       
    
    
     DESCRIPTION 
       [0021]    For the purposes of promoting an understanding of the principles of the technology and presenting its currently understood best mode of operation, reference will now be made to the embodiments illustrated in the drawings and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the disclosure or claims is thereby intended, with such alterations and further modifications in the illustrated device and such further applications of the principles of the technology as illustrated therein being contemplated as would normally occur to one skilled in the art to which the disclosure relates. 
         [0022]    A first embodiment of the present technology presents a device that provides intravenous access to a patient without the risk of needle stick and without blatant blood exposure. As shown in  FIGS. 1-4 , the present disclosure includes a modified intravenous (“IV”) Y-junction  10  including a syringe arm portion  20 , a catheter portion  30  arranged in opposing alignment with the syringe arm  20 , a fluid-impermeable membrane  25  arranged internally of the syringe arm  20  opposite the catheter end  30 , and an intravenous IV connector arm portion  40 . The IV connector arm  40  is offset preferably at approximately 45 to 60 degrees from the syringe arm  20 , though other embodiments have greater or lesser angles between the two arms. Syringe arm  20  is further provided with external threads  28  for mating with a syringe assembly  100 . The Y-junction  10  could also be mated with syringe apparatuses currently available in the industry. 
         [0023]    As shown in  FIGS. 1 and 3 , syringe assembly  100  comprises a syringe tube  110  having a distal end  110   a  and a plunger end  110   b , a syringe plunger  120  that reciprocates back and forth within the syringe tube  110 , and a hollow hypodermic needle  130  affixed to the distal end  120   a  of syringe plunger  120 . The base  130   b  of the hollow needle  130  has one or more small openings  135  provided therein to allow body fluid such as blood to flow through the hollow needle  130  from its distal end  130   a  and into the internal volume of the syringe tube  110  when the plunger  120  is withdrawn or moved in the direction of reference arrow “a.” As shown in  FIG. 4 , the syringe tube  110  is provided with internal threads  118  adjacent its distal end  110   a  for mating with the external threads  28  of syringe arm  20  to provide a fluid-tight connection therebetween. Provided within the syringe tube  110  set back from its distal end  110   a  is a fluid-impermeable membrane  140 . 
         [0024]    In use, the catheter  30  is connected to a patient through the following means. The distal end  110   a  of syringe  110  is threadably mated with the syringe arm portion  20  of IV Y-junction  10  by means of mated threads  28  and  118  (see  FIG. 4 ). The syringe assembly  100  is packaged with the plunger  120  fully inserted into the syringe tube  110  wherein the needle  130  is positioned forward in the direction of reference arrow “b” and the needle  130  has penetrated the fluid-impermeable membrane  140  and, secondly, the membrane  25  of the syringe arm  120 , extending entirely through catheter  30 , at which point its distal end  130   a  extends beyond the distal end  30   a  of catheter  30 . Thus, when the syringe assembly is ready for use, the plunger  120  carrying the needle  130  is positioned as shown in  FIG. 1 . The needle  130  is inserted into the patient&#39;s vein by a medical professional by conventional method. 
         [0025]    Once the needle  130  is properly located intravenously, the plunger  120  is withdrawn or moved in the direction of reference arrow “a,” thereby leaving catheter  30  positioned within the patient&#39;s vein and allowing body fluid from the patient to pass through the catheter  30  and into the interior volume of the Y-shaped junction  10 . Any fluid passing through the needle  130  escapes through the opening  135  at the base of the needle into the interior volume of the syringe tube  110 . 
         [0026]    When the plunger is fully withdrawn, irreversible locking means  150  deploy to prevent the plunger  120  from re-entering the syringe tube  110  (that is, moving in the direction of reference arrow “b”). The locking means  150  do not deploy until the plunger  120  is fully retracted, generally following use by the medical professional. The locking means  150  may take a variety of forms and various suitable means are known in the art. In one embodiment, means  150  are defined by locking lugs or abutments extending radially outwardly from the long axis of the plunger  120 . As noted above, during the manufacture and packaging of syringe assembly  100 , plunger  120  is positioned within the syringe tube  110  whereby locking lugs  150  have been deflected in order for the syringe plunger  120  to be inserted within the tube  110 . Once the plunger  120  is withdrawn to its maximum retracted position while still positioned within tube  110 , and locking lugs  150  have cleared proximal end  110   b  of tube  110 , lugs  150  rebound or flex back to their original radially outwardly extending posture as shown in  FIG. 4 . In this position locking lugs  150  prevent plunger  120  from being pushed back into tube  110  in the direction of reference arrow “b,” which would result in the distal end  130   a  of needle  130  re-penetrating membrane  140  and extending outside of the assembly  100 , which would present a needle prick hazard. As shown in  FIG. 5 , an inner lip  117  inside the plunger end  110   b  of the tube  110  prevents the plunger  120  from separating from the tube  110 . 
         [0027]    Once the cannulation procedure has been completed, the needle  130  and plunger  120  have been withdrawn from the Y-junction device  10  and the syringe assembly  100  has been disconnected from device  10 , the syringe assembly  100  is ready for proper disposal as medical (sharps) waste, wherein the needle  130  is captured within tube  110  to prevent inadvertent needle pricks. 
         [0028]    While not shown in  FIG. 3 , the plunger  120  reciprocates within the syringe tube  110  in a fluid-tight fashion such that no liquid is able to escape from the interior volume of tube  110 . 
         [0029]    After the above steps are completed, the IV junction device  10  is at that point connected to the patient intravenously, while no IV tubing has yet been connected to the device  10 . Referring now to  FIGS. 1 and 2 , IV tubing  50  can then be connected to the device  10  at IV connector arm  40  via a connector assembly  60 , which comprises the IV connector arm  40  of device  10  and a male IV tubing connector  115  affixed to tubing  50 . As shown more clearly in  FIG. 2 , the IV connector arm  40  is provided with an axial cavity  42  with a lower annular rim  43 . Cavity  42  is further provided with internal threads  44  provided therein for threadably receiving tubing connector  115 . The IV connector arm  40  also includes a liquid-impermeable seal  70  that is biased against the lower surface of rim  43  by a spring-biased device  80  held inside a cylindrical basket-style structure  90  affixed to the underside of the rim  43 . The basket  90  has a solid bottom  92  but is open on its sides, and is affixed to the annular rim  43  by a series of thin vertical rails  100 . 
         [0030]    As noted, IV tubing  50  has a connector  115  that mates with the arm  40  of Y-junction device  10 . Tubing connector  115  has a similar basket structure  111  that is received within axial cavity  42  of arm  40  and eventually within the basket  90  of the arm  40  in a manner that will be described further below. The IV tubing basket  111  has a solid bottom  210  that is connected to an upper portion  212  by a series of thin vertical rail members  214 , but does not involve a seal and bias mechanism such as basket  90  of arm  40  does. Upper portion  212  is an annular surface affixed to the distal end of tubing  50 . Connector  115  is also provided with external threads  112   a  disposed closely adjacent to basket  111 . Canopy  200  fits over connector  115  and makes it easier for a medical worker to connect the connector  115  with the IV connector arm  40 . Canopy  115  has a hollow interior and fits over the IV connector arm  40 . 
         [0031]    In use, as IV tubing  50  and connector end  115  are inserted into the Y-junction device  10  via arm  40  wherein basket  111  of connector  115  is received within the axial cavity  42  of arm  40 , threads  112   a  of connector  115  engage and upon slight rotation form a liquid-tight seal with the female threads  44   a  of cavity  42  to prevent any fluid from flowing or escaping from the interior of arm  40  into the IV tubing  50 . Shortly after threads  44   a  and  112   a  initially engage to form a liquid-tight seal, the lower end  210  of basket  111  first abuttingly engages the seal  70  and begins to bias it downwardly as shown by reference arrows “c,” thereby forming a path “d” allowing fluid to flow into the IV Y-junction  10  and subsequently into the patient&#39;s vein via catheter  30 . As the connector end  115  is threaded onto the short arm  40 , the connector end  115  increasingly biases the seal  70  of basket  90  downwardly. The threads may be continued to be rotated to lock the connector end  115 , and thus the IV tubing  50 , in place. 
         [0032]    The closed system provided thereby will not allow blood or fluid to flow out of either end of the IV Y-junction  10  once it is in position within the patient&#39;s vein. The IV Y-junction  10  will have been pre-primed with saline so as to avoid air emboli when the vein is cannulated and fluid administration begun. A healthcare worker will also have primed the IV tubing  50  and connector end  115  prior to beginning the process of obtaining venous access. 
         [0033]    As shown in  FIGS. 5-8 , an alternative embodiment of the syringe assembly  100 ′ is adapted to fit with the present technology shown in  FIGS. 1-4 . This alternative embodiment allows the healthcare worker to cannulate a patient&#39;s vein without the risk of needle stick and without blatant blood exposure, and to withdraw the needle using a one-handed technique. In this alternative embodiment, the syringe assembly  100 ′ comprises a syringe tube  110 ′ having a distal end  110   a ′ and a plunger end  110   b ′, a syringe plunger  120 ′ that reciprocates within the syringe tube  110 ′, and a hollow hypodermic needle  130 ′ affixed to the distal end  120   a ′ of syringe plunger  120 ′. The base  130   b ′ of the hollow needle  130 ′ has one or more small openings  135 ′ provided therein to allow body fluid such as blood to flow through the hollow needle  130 ′ from the patient&#39;s vein into its distal end  130   a ′ and thereafter into the internal volume of the syringe tube  110 ′ when the plunger  120 ′ is withdrawn or moved in the direction of reference arrow “a.” As shown more particularly in  FIGS. 5 and 6 , the syringe tube  110 ′ is provided with internal threads  118 ′ adjacent its distal end  110   a ′ for mating with the external threads  28  of syringe arm  20  to provide a fluid-tight connection therebetween. Provided within the syringe tube  110 ′ set back from its distal end  110   a ′ is a fluid-impermeable membrane  140 ′. 
         [0034]    Overlying the syringe tube  110 ′ is a sliding sleeve  302  that can reciprocate in an unrestricted manner. Sleeve  302  is attached to the syringe plunger end  120   a ′ at  302   d  as indicated in  FIG. 6 . The distal end of the sliding sleeve  302  adjacent to the distal end  110   a ′ of syringe tube  110 ′ is provided with finger grips  301 , which are defined by raised, roughed, or knurled surfaces that better facilitates a healthcare worker being able to hold the sliding sleeve  302  easily as the needle  130 ′ is being withdrawn from the Y-junction  10  into the hollow syringe tube  110 ′. 
         [0035]      FIG. 7  is an end view of the alternative embodiment of the syringe assembly, showing the spatial relationship between the plunger  120 ′, the syringe tube  110 ′, and the sliding sleeve  302 . Also shown are finger grips  301  and a push pad  300  that is attached to the distal end  110   a ′ of the syringe tube  110 ′. The finger grips  301  are located on both sides of the syringe tube  110 ′, in relation to the push pad  300 . 
         [0036]      FIG. 8  is an end view showing in isolation the relationship between the syringe tube  110 ′ and the sliding sleeve  302 . To prevent or minimize the friction between the syringe tube  110 ′ and the sliding sleeve  302 , several indentions  302   a  are provided in the interior of the sliding sleeve  302 . Indentions  302   a  decrease or minimize the surface-to-surface contact between these two elements, thereby allowing the sliding sleeve  302  to slide outside the syringe tube  110 ′ with minimal effort. 
         [0037]    In operation, a healthcare worker will cannulate the vein in the normal fashion. Once the vein is entered, blood will transverse the hollow needle  130 ′ and enter the hollow tube  110 ′ indicating cannulation. The healthcare worker may withdraw the needle  130 ′ from the catheter  30  and syringe arm portion  20  by placing one finger on the push pad  300  and one or two other fingers on the finger grips  301  of the sliding sleeve  302 . The sliding sleeve  302 , attached at attachment  302   d  to the distal end  120   a ′ of the plunger  120 ′, may then be slid in the direction of reference arrow “a” as shown in  FIGS. 5-6 . As the needle  130 ′ is withdrawn, the catheter  30  may be further advanced into the patient&#39;s vein if necessary by the healthcare worker simply advancing the push pad  300 . Once the needle  130 ′ is fully retracted, a locking apparatus  150 ′ will engage and prevent the needle  130 ′ from re-entering the syringe tube  110 ′. An inner lip  117 ′ disposed inside the plunger end  110   b ′ of the tube  110 ′ prevents the plunger  120 ′ from separating from the tube  110 ′. The healthcare worker may then disconnect the syringe assembly  100 ′ from the syringe arm portion  20  by simply rotating or un-screwing the threaded connectors  28  and  118 ′. 
         [0038]    Generally, in another embodiment, an intravenous catheter system consisting of a modified Y with one arm composed of a sealed system designed to mate with a connector attached to the intravenous (IV) fluid supply. Attached to the short arm end of the tubing is a hypodermic needle and syringe apparatus that extends from outside the Y through a fluid impermeable membrane and into a plastic catheter surrounding the needle outside of the Y tubing. 
         [0039]    The syringe assembly is connected to the Y with threads that mate with corresponding threads on the Y catheter so as to provide a fluid tight seal and allow easy detachment once the needle has been withdrawn into the syringe. The syringe assembly consists of a hollow tube with the above mentioned connector on one end and houses another fluid impermeable membrane through which the needle passes. Inside this tube is a plunger device fully depressed and onto which the needle is permanently attached. The needle is hollow and has openings at its base so that blood can flow through it and into the syringe. Once IV access has been obtained and the plastic catheter is in the vein the plunger and needle are withdrawn into the hollow tube safely enclosing the needle. An attached taping device is then used to stabilize the catheter. When fully withdrawn an irreversible locking device deploys to prevent the plunger from reentering the hollow tube. This feature allows the health care worker the ability to readjust the needle and catheter if necessary to optimize the position of the catheter within the vein without the need of sticking the patient again as would be required with some automatic retractable devices. 
         [0040]    The short arm of the Y is meant for attachment to the IV tubing and solution. It is threaded on the outside so as to mate with the IV tubing. Inside is a system composed of a valve which is held against a rim by a spring-like device held inside a basket-style container. The basket is solid on the bottom and open on the sides. The IV tubing end is manufactured with a similar basket design that mates inside the Y basket. It is open and does not require a seal and spring mechanism. The outside of the IV tubing end is also designed with threads that mate with corresponding threads of the Y connector. When the two connector ends meet and the threads begin to engage, the seal of the Y basket connector is compressed down into the basket by the mated basket of the IV connector. Once fully threaded, the IV basket will be inside the Y basket and the intravenous fluid will flow easily into the catheter and subsequently into the vein of the patient. This closed system will not allow blood to flow out of either end of the Y once it is in the vein and provides two ports, one for IV fluid and one for injection of medications if desired. Other types and combinations of ports appear in various alternative embodiments as will occur to one skilled in the art. 
         [0041]      FIG. 9  is a cross section of the syringe arm portion  20  and the attached adhesive bandage  400  used for securing the syringe arm  20  and intravenous catheter  30  onto the patient. This is important because many times the intravenous access will be lost while the health care worker is attempting to tape down and secure the catheter. The customary process for accomplishing this generally requires the health care worker to tear tape from a roll and attach a section over the body of the catheter. In this embodiment, the health care worker places the tape under the catheter with the adhesive side up to make contact with the underside of the catheter, then folds each side or arm of the tape to allow the adhesive side to make contact with the skin. The final result of this step is a “U” shape of the tape with the two “arms” running parallel with the catheter in the direction of the catheter tip. Another section of tape  500  is then applied with the adhesive side down and covering the catheter and skin in a horizontal fashion as shown in  FIG. 12 . 
         [0042]      FIG. 9  reveals the body of the syringe arm  20  and the adhesive bandage  400 . The bandage  400  is attached to the underside of the syringe arm  20  as indicated at  400   c . Extending from this attachment site are two “arms” consisting of an adhesive surface  400   a  facing up and a non-stick layer  400   b . This layer is loosely attached to the adhesive surface  400   a  and can be easily peeled off by pulling on the flaps  400   bf , thus exposing the adhesive surface  400   a , which then can be used to secure the catheter as shown in  FIG. 11 . A second layer of tape can then be applied over the top of the catheter to further secure the site as shown in  FIG. 12 . The obverse of the adhesive bandage  400  is non-adhesive surface  400   d.    
         [0043]      FIG. 10  illustrates this adhesive apparatus in a more three dimensional view. 
         [0044]    This adhesive bandage  400  is wrapped around the body of the syringe arm  20  and held in this position by a paper band that is easily removed (similar to that found on a roll of stamps) for packaging and during the cannulation of the vein and subsequently unwrapped for the attachment process. In this way, there is no interference from the bandage during the delicate process of inserting the catheter into the vein. 
         [0045]    While the present technology has been illustrated and described in detail in the drawings and foregoing description, the same is to be considered as illustrative and not restrictive in character. It is understood that the embodiments have been shown and described in the foregoing specification in satisfaction of the best mode and enablement requirements. It is understood that one of ordinary skill in the art could readily make a nigh-infinite number of insubstantial changes and modifications to the above-described embodiments and that it would be impractical to attempt to describe all such embodiment variations in the present specification. Accordingly, it is understood that all changes and modifications that come within the spirit of the disclosure are desired to be protected.