Abstract:
A micro-injection molded disposable needle assembly having more than one passageway formed therein to permit the simultaneous drawing and administering of fluids through separate passageways is disclosed. The micro-injection molded disposable assembly includes one or more sensors disposed therein for measuring and monitoring one or more desired body or surrounding environmental conditions. A method of forming the disposable needle from an elastomeric material using micro-injection molding is also disclosed.

Description:
BACKGROUND OF THE INVENTION  
         [0001]    1. Field of the Invention  
           [0002]    The present invention relates to a disposable needle assembly. In particular, the present invention is directed to a micro-injection molded disposable needle assembly having more than one passageway formed therein to permit the simultaneous drawing and administering of fluids through separate passageways. The present invention is also directed to a micro-injection molded disposable assembly having one or more sensors disposed therein for measuring and monitoring one or more desired conditions. The present invention is also directed to a method of forming a disposable needle from an elastomeric material using micro-injection molding.  
           [0003]    2. Description of Related Art  
           [0004]    U.S. Pat. No. 3,610,226 to Albisser discloses a double lumen cannula instrument for the withdrawal of blood over a prolonged period of time. The instrument includes an inner lumen for withdrawing blood and an outer lumen for introducing an anticoagulent diluent. The relative locations of the openings for the inner and outer lumen permit the mixing of the diluent with the withdrawn blood.  
           [0005]    U.S. Pat. No. 5,374,245 to Mahurkar discloses an extruded reinforced multiple-lumen catheter for use in medical applications where fluids must flow simultaneously to and from a patient. Blood is withdrawn for a medical procedure (e.g. dialysis) from the patient through one passageway and returned to the patient through another passageway spaced from the first passageway.  
           [0006]    U.S. Pat. No. 5,607,401 to Humphrey discloses augmented polymeric hypodermic needles and lancets. The polymeric needles and lancets are stiffened by augmenting means, which includes a slideable guard or foam insert so that they are able to pierce the skin. Without the augmenting means, it is not possible for the polymeric hypodermic lancet to pierce the skin.  
           [0007]    U.S. Pat. No. 5,637,399 to Yoshikawa et al. discloses an extruded synthetic resin needle that is reinforced with combustible fibers. The needle provides a single path administering or withdrawing fluids from a patient.  
           [0008]    The prior art described above does not provide for a needle assembly that is capable of prolonged insertion in the patient for both the simultaneous administering of intravenous fluids and the withdrawal of blood without mixing the intravenous fluid with the withdrawn blood. Furthermore, these needle assemblies do not permit the monitoring of the patient without the further insertion of additional needle assemblies or sensors into the patient.  
           [0009]    Various devices for internally monitoring a patient are known. U.S. Pat. No. 3,490,441 to Curtis discloses an intra-arterial blood pressure transducer, which includes a needle that is inserted into a blood vessel. The patient&#39;s blood pressure is measured by measuring the deflection of a sheath surrounding the needle. U.S. Pat. No. 4,665,927 discloses a flexible probe formed from a flexible plastic for sensing and measuring temperature. The probe may take the form of a needle that is inserted into the patient. U.S. Pat. No. 5,568,806 to Cheney et al. discloses a transcutaneous sensor insertion set. The insertion set includes a needle assembly having a sensor assembly for insertion into a patient. Upon insertion, the needle assembly may be withdrawn leaving the sensor assembly in place for monitoring the patient. None of these devices permit the simultaneous insertion and/or withdrawal of fluids while monitoring the patient.  
           [0010]    U.S. Pat. No. 6,032,059 to Henning et al. discloses a fluid sampling device having a needle assembly for sampling of blood and measuring an analyte of interest within the blood. The device includes an analysis device that determines the required amount of drug to be injected in response to the measured analyte without removal of the device from the patient&#39;s body. In operation, the needle assembly is inserted into a blood vessel of the patient. The blood then flows into the needle to contact the sensor assembly. The blood is analyzed. In response to the analysis, a drug dosage is automatically administered through needle assembly. Although U.S. Pat. No. 6,032,059 discloses a needle assembly connected to a sensor assembly, it does not disclose a needle assembly that permits the simultaneous insertion and withdrawal of fluids from the blood stream while performing a sensing operation. Furthermore, the needle assembly is not designed for prolonged insertion the patient.  
         OBJECTS OF THE INVENTION  
         [0011]    It is an object of the present invention to provide a disposable needle assembly that is capable of drawing and administering fluids from a patient.  
           [0012]    It is another object of the present invention to provide a disposable needle assembly that is formed from a non-bioreactive material, which permits implantation in a patient for extended periods of time. The present invention eliminates the need for multiple patient injections.  
           [0013]    It is another object of the present invention to provide a disposable needle assembly that permits the simultaneous administering of intravenous fluids and the drawing of blood.  
           [0014]    It is another object of the present invention to provide a disposable needle assembly that permits the simultaneous administering of intravenous fluids and the drawing of blood without contaminating the blood with the intravenous fluids.  
           [0015]    It is yet another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to withdraw blood from the patient.  
           [0016]    It is another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to administer an intravenous fluid to the patient.  
           [0017]    It is another object of the present invention to provide a disposable needle assembly having a plurality of passageways formed therein, wherein at least one of the passageways is provided to withdraw blood from the patient.  
           [0018]    It is another object of the present invention to provide a micro-injection molded disposable needle assembly having a plurality of passageways formed therein having a passageway for administering an intravenous fluid and a passageway to withdraw blood from the patient, wherein the passageway for withdrawing blood is capable of being flushed with intravenous fluid at predetermined times.  
           [0019]    It is another object of the present invention to provide a disposable needle assembly having at least one sensor located therein for sensing one or more predetermined conditions including but not limited to, chemical agents in the blood stream, blood flow, pressure, and temperature.  
           [0020]    It is another object of the present invention to provide a disposable needle assembly having at least one sensor containing at least one polarographic region for sensing chemical agents in the blood stream.  
           [0021]    It is another object of the present invention to provide a disposable needle assembly having at least one electroconductive sensor for sensing at least chemical agents in the blood stream and temperature.  
           [0022]    It is another object of the present invention to provide a disposable needle assembly having an optical sensor for sensing chemical agents and/or measuring intravenous pressure.  
           [0023]    It is another object of the present invention to provide a disposable needle assembly having a flexible diaphragm for use in connection with the measurement of intravenous pressure.  
           [0024]    It is another object of the present invention to provide a disposable needle assembly having a flexible diaphragm for use in connection with the measurement of a patient&#39;s pulse.  
         SUMMARY OF THE INVENTION  
         [0025]    In response to the foregoing challenges, applicants have developed a needle assembly for use in connection with treating and monitoring a patient. The needle assembly is capable of administering fluids to the patient and also drawing fluids from the patient. The needle is preferably formed by micro-injection molding and is disposable.  
           [0026]    The needle assembly includes an elongated needle shaft having a first end and a second end. The needle assembly includes an insertion tip located at a first end of the elongated needle shaft to facilitate insertion of the needle assembly into a vessel of the patient. The insertion tip is preferably integrally formed with the elongated needle shaft.  
           [0027]    The needle assembly preferably includes at least one fluid drawing passageway formed in the elongated needle shaft for withdrawing fluid from the patient. Each fluid drawing passageway extends from the second end of the elongated needle shaft to a fluid drawing opening in the elongated needle shaft. The fluid (e.g., blood) within the vessel is withdrawn through the fluid drawing passageway. The drawn fluid may be remotely tested. It is also contemplated that the withdrawn fluid can be medically treated and returned to the vessel.  
           [0028]    The needle assembly also preferably includes at least one fluid supply passageway formed in the elongated needle shaft for supplying fluid to the patient. Like the fluid drawing passageway, each fluid supply passageway extends from the second end of the elongated needle shaft to a fluid supply opening in the elongated needle shaft. The fluid introduced into the vessel through the fluid supply passageway may be an intravenous fluid containing nutrients and/or medicaments. It is also contemplated that the fluid supply passageway may return processed blood or plasma to the vessel.  
           [0029]    In accordance with the present invention, the fluid supply opening and the fluid drawing opening are spaced from each other along the length of the elongated needle shaft. The spacing of these openings prevents the mixing of the fluid introduced through the fluid supply opening with the fluid removed from the vessel through the fluid drawing opening. It contemplated that one of the openings is located adjacent the insertion tip, while the other of the openings is spaced from the insertion tip.  
           [0030]    The needle assembly preferably includes at least one sensor assembly disposed within the elongated needle shaft. The at least one sensor assembly senses at least one predetermined condition of the patient. The at least one sensor assembly may gather the necessary information for the performance of routine lab tests. It is contemplated that the sensor assemblies may be used in connection with Chem 21 testing, and complete blood counts (CBC testing). It is also contemplated that the sensor assemblies may be used in connection with the measurement of alcohol, sodium, potassium, and/or magnesium levels in the bloodstream. The sensor assemblies may also be used in connection with the measurement of internal and external pressures in the venous environment. Furthermore, sensor assemblies may be used to sense and measure body temperature and blood flow. This listing of potential tests and measurement of patient conditions is by no means intended to be exhaustive; rather, numerous other tests and procedures are often performed in connection with the injection of a needle in the patient are considered to be well within the scope of the present invention.  
           [0031]    The sensor assembly is preferably disposed within the elongated needle shaft within a sensor passageway formed therein. A sensor is located within the passageway. Numerous sensors are considered to be well within the scope of the present invention including but not limited to optical sensors, temperature sensors, acoustic sensors, pressure sensors (e.g., flexible diaphragms), electrical sensors and chemical sensors. The optical sensor for providing real time visual inspection of the vessel and the blood flow therein. Temperature sensors may be used to measure patient temperature and individual organ temperature. It is also contemplated that the sensor may comprise an electro or chemical sensors. The elongated needle shaft preferably includes at least one recess formed in the outer surface of the shaft. The recesses expose portions of the sensors. It is also contemplated that the above-described sensors may be linked to both visual and audible indicators. For example, an audible indication of blood pressure may be provided in to response to measurement by the sensors.  
           [0032]    The elongated needle shaft of the staged needle is preferably formed from an elastomeric material by micro-injection molding. In order to minimize discomfort to the patient, the elastomeric material has a durometer that is slightly greater than the durometer of flesh. The matching of durometer will reduce the uncomfortable irritation of the target vein. This minimization of discomfort permits the needle assembly to be an inserted position in the patient for longer periods of time, which reduces the number of necessary injections. Because this durometer selection, a molded removable core pin used is in connection with the insertion of the needle assembly into vein. The core pin temporarily increases the stability of the needle assembly during the insertion operation. Upon insertion, the core pin is extracted and disposed of, leaving the needle in place.  
           [0033]    In accordance with the present invention, the elongated needle shaft is connected to a connector assembly. The connector assembly is secured to the second end of the elongated needle shaft. The connector assembly includes at least one inlet port operatively connected to the at least one fluid supply passageway and at least one outlet port operatively connected to the at least one fluid drawing passageway. Furthermore, the necessary connections for the sensor assemblies are located within the connector assembly. This permits the needle assembly to be connected to a control unit or a monitoring device. The connector assembly may be connected to an attachment assembly for releasably securing the needle assembly to the patient. The attachment assembly may be in the form of the arm band or strap used to secure the needle in place on the patient. The needle assembly is preferably disposed at angle with respect to the attachment assembly.  
           [0034]    The present invention is also directed to a method of forming a disposable needle assembly, discussed above. The method includes forming the elongated needle shaft by micro-injection molding. The method further includes forming the connector assembly and securing the connector assembly to the elongated needle shaft. The elongated needle shaft is formed around the at least one sensor assembly. The method further includes forming a removable core pin.  
           [0035]    A method of treating a patient is also contemplated in accordance with the present invention. The method includes inserting a disposable needle assembly into a vessel of the patient. The insertion of the disposable needle assembly may also include the insertion of a molded core insert. The moldable core insert is located within one of the passageways of the elongated needle shaft. The core is preferably located within the passageway that extends from the second end to the first end of the shaft adjacent the insertion tip. The moldable core increases the stability of the needle assembly during the insertion process. Upon insertion of the needle assembly within the vessel, the moldable core insert is removed.  
           [0036]    The method further includes periodically withdrawing a sample of blood from the patient through a first passageway formed in the elongated needle shaft. The removable of a sample of blood permits the analysis of the blood. Furthermore, a supply an intravenous fluid to the patient may be fed through a second passageway formed in the elongated needle shaft. While this removal of blood and supply of fluid is being performed, the patient can also be monitored through at least one sensor assembly located within the needle assembly. This method is especially advantageous when, for example, a patient is being transferred by emergency vehicle to an emergency room. The paramedics can begin administering necessary IV fluids while monitoring the patient with the insertion of a single needle assembly in the patient. Furthermore, many of the testing operations, discussed above, can be begun or completed before the patient arrives at the emergency room.  
           [0037]    Once the testing data is readable, it will be made available to paramedics through a display panel that may be operatively connected to the needle assembly. It is also contemplated that the testing data may be wirelessly transmitted in advance to medical personnel either from an ambulance or critical care unit to a hospital to inform medical staff of the patient&#39;s current physical conditions through different media options. 
       
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0038]    The invention will be described in conjunction with the following drawings in which like reference numerals designate like elements and wherein:  
         [0039]    [0039]FIG. 1 is a schematic view of a disposable needle assembly in accordance with the present invention;  
         [0040]    [0040]FIG. 2 is a side view of the disposable needle assembly of FIG. 1;  
         [0041]    [0041]FIG. 3 is a top view of the disposable needle assembly of FIG. 1;  
         [0042]    [0042]FIG. 4 is a cross sectional view along section lines  4 - 4  of the disposable needle assembly of FIG. 3;  
         [0043]    [0043]FIG. 5 is an end view of the disposable needle assembly of FIG. 1;  
         [0044]    [0044]FIG. 6 is a schematic view of a sensor for use in the disposable needle assembly in accordance with the present invention;  
         [0045]    [0045]FIG. 7 is a schematic view of another sensor for use in the disposable needle assembly in accordance with the present invention;  
         [0046]    [0046]FIG. 8 is a bottom schematic view of the disposable needle assembly connected to an arm band for attachment to a patient in accordance with an embodiment of the present invention;  
         [0047]    [0047]FIG. 9 is a schematic view of the disposable needle assembly connected to an arm band and operatively connected to a control unit;  
         [0048]    [0048]FIG. 10 is a side view of a disposable needle assembly in accordance with another embodiment of the present invention;  
         [0049]    [0049]FIG. 11 is a side view of a disposable needle assembly in accordance with yet another embodiment of the present invention;  
         [0050]    [0050]FIG. 12 is a side view of a disposable needle assembly in accordance with still another embodiment of the present invention;  
         [0051]    [0051]FIG. 13 is a schematic diagram illustrating the flow path of IV fluids within the connector assembly of the needle assembly in accordance with one embodiment of the present invention during administering of IV fluids;  
         [0052]    [0052]FIG. 14 is a schematic diagram illustrating the flow path of IV fluids and blood within the connector assembly of the needle assembly in accordance with one embodiment of the present invention during the initiation of a blood drawing operation;  
         [0053]    [0053]FIG. 15 is a schematic diagram illustrating the flow path of IV fluids and blood within the connector assembly of the needle assembly in accordance with one embodiment of the present invention during the withdrawal of a blood sample during the blood drawing operation;  
         [0054]    [0054]FIG. 16 is a schematic diagram illustrating the flow path of IV fluids and blood within the connector assembly of the needle assembly in accordance with one embodiment of the present invention after the withdrawal of a blood sample;  
         [0055]    [0055]FIG. 17 is a schematic diagram illustrating the flow path of IV fluids and blood within the connector assembly of the needle assembly in accordance with one embodiment of the present invention at the completion of the blood drawing operation;  
         [0056]    [0056]FIG. 18 is a schematic diagram illustrating the flow path of IV fluids within the connector assembly of the needle assembly in accordance with a preferred embodiment of the present invention;  
         [0057]    [0057]FIG. 19 is a schematic diagram illustrating the flow path of IV fluids and medication within the connector assembly of the needle assembly in accordance with the preferred embodiment of the present invention; and  
         [0058]    [0058]FIG. 20 is a schematic diagram illustrating the flow path of IV fluids and blood within the connector assembly of the needle assembly in accordance with a preferred embodiment of the present invention. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0059]    A disposable needle assembly  10  in accordance with the present invention will be described in connection with FIGS.  1 - 5 . The principle behind the disposable needle assembly  10  is a staged needle having an elongated shaft, which is configured in such a way as to allow uncontaminated blood draws while administering IV fluids.  
         [0060]    The disposable needle assembly  10  includes an elongated staged needle  110 . The staged needle  110  is preferably molded from an elastomertic material whose durometer is chosen just above that of flesh to minimize discomfort to the patient. This minimization of discomfort permits the needle assembly  10  to be an inserted position in the patient for longer periods of time, which reduces the number of necessary injections. Suitable elastomeric materials for the construction of the staged needle  110  include polyesters, polyester polypropylene blends, latex, silicone rubber and thermoplastic elastomers. The present invention, however, is not limited to these elastomeric materials; rather, other elastomeric materials are contemplated provided such materials have durometers similar to flesh and will not irritate skin in response to prolonged exposure.  
         [0061]    The elongated staged needle  110  is sized to permit easy insertion into the vein or vessel of the patient. The elongated staged needle  110  is also sized to remain inserted within the vessel for extended periods of time with minimal discomfort. It is contemplated that the elongated needle  110  a length between 2 cm to 4 cm with diameters from 2 mm to 4 mm. The present invention, however, is not limited to these dimensions. Smaller dimensions are contemplated for elongated needles used for neonatal applications. Furthermore, larger dimensions are contemplated for elongated needles used for animal applications.  
         [0062]    The staged needle  110  will now be described in greater detail. The staged needle  110  includes first and second passageways  111  and  112 , which are integrally formed therein. The staged needle  110  has an insertion tip  113  formed in one end thereof. An opposite end of the needle  110  is connected to a connector assembly  120 , described in greater detail below. The insertion tip  113  is shaped to facilitate insertion into the desired vein or vessel of the patient.  
         [0063]    The first passageway or conduit  111  extends through the needle  110  from the connector assembly  120  to an opening  114  adjacent the insertion tip  113 , as seen in FIG. 3. The first conduit  111  is provided to introduce fluids (e.g., intravenous fluid) into the vessel. The present invention, however, is not limited to a single conduit  111  for the purpose of introducing fluids into the vessel; rather, it is contemplated that one or more conduits may be formed in the staged needle  110  for the purpose of supplying fluids to the patient through the vessel. A removable core pin  3 , shown in phantom in FIGS. 4 and 5, is located in the conduit  111  during the insertion operation to strengthen the tip of the needle assembly  10  to facilitate insertion. The present invention is not limited to the core pin  3  being located within the conduit  111 ; rather, it is contemplated that the core pin  3  may be located within the conduit  112  or other suitable passageway formed in the needle assembly  10 . It is further contemplated that the core pin  3  may extend through both the conduit  111  and  112 . Upon insertion of the needle assembly  10  in the vessel, the core pin  3  is removed  
         [0064]    The second passageway or conduit  112  extends through the needle  110  from the connector assembly  120  to an opening  115  spaced from the insertion tip  113 , as seen in FIG. 3. The second conduit  120  is provided to draw a sample of fluid (e.g. blood) from the vessel. The openings  114  and  115  are spaced along the axis of the elongated shaft of the staged needle  110 . The differential location of the openings  114  and  115  permits uncontaminated blood draws while simultaneously administering IV fluids.  
         [0065]    Although the first conduit  111  has been described in connection with the introduction of fluids into the vessel, the present invention is not so limited. It is contemplated that the first conduit  111  may be used to withdraw fluids from the vessel or bloodstream. Furthermore, it is also contemplated that the second conduit  112  may be used in connection with the supply to fluids to the vessel. It is still further contemplated that both the first and second conduits  111  and  112  may be used in connection with the introduction of fluids (e.g., nutrients and medicaments) into the vessel, as described in greater detail below.  
         [0066]    The elongated staged needle  110  is also provided with one or more sensor assemblies. In accordance with the present invention, these sensor assemblies are integrated into the staged needle  110  and include multiple arrays of external and internal sensors  130 . Various sensors are considered to be well within the scope of the present invention including but not limited to optically based sensors, acoustic sensors, pressure based sensors, chemical based sensors, electrical based sensors and temperature based sensors.  
         [0067]    The sensors  130  are located in one or more sensor channels or passageways  116  are formed in the staged needle  110 , as shown in FIGS. 1, 4 and  5 . The passageways  116  extend generally parallel to the conduits  111  and  112  and terminate in a sensor access orifice  117 . The present invention, however, is not limited to passageways  116  that are generally parallel; rather, it is contemplated that the sensor channels may extend in a spiral or zig-zag pattern. As shown in FIGS. 2 and 5, the orifices  117  are located adjacent the opening  115 . With this arrangement, it is possible to test and monitor the blood as it enters the passageway  112 .  
         [0068]    The staged needle  110  further includes one or more dimples or recesses  118  formed along the length of the needle  110 , as shown in FIGS.  2 - 4 . The recesses  118  provide sensory access to the sensors located within the passageways  116 . The recesses  118  are molded on the needle shaft  110 , in such a way as to prevent the collection of bodily fluid born agents (i.e. blood cells). A red blood cell is approximately 5 to 7 micrometers in diameter, a white blood cell approximately 10 micrometers. No protrusions or recesses  118  of sufficient size as to capture blood cells are allowed or cells can be damaged. The area about the sensor region is a continuous curved surface as to not capture and stagnate the blood and of ample size as to prevent shut off of the sensor from the blood flow if it comes in contact with the vein wall. The recesses  118  provide venous fluid contact with the sensor assemblies. A sensor assembly  130  is located in each of the passageways  116 . The sensor assembly  130  may include an optical fiber, examples are described below, or an electrically conductive wire, examples are described below. The sensor assemblies  130  are molded into the staged needle  110  during the manufacture of the needle  110 . The recesses  118  may be formed into the side of needle shaft  110 . It is also contemplated that the outer surface of the needle shaft  110  may include one or more areas having an increased diameter (not shown), the areas between adjacent areas of increased diameter form the recesses  118 .  
         [0069]    Various types of electrical sensors are contemplated, including but not limited to capacitance based sensors, resistance based sensors, amperage based sensors and voltage based sensors. In a capacitance based electrical sensor, the variance in ambient pressure about the sensor will allow a set of parallel plates to vary in position thus changing the capacitance of the sensor. In a resistance based electrical sensor, the variance of a blood borne agent will chemically react with a sensing medium changing the resistance of the medium in such a way as to be able to measure and thus determine the concentration of the agent present. The same effect can be made through changing the resistance of a sensor element through the application of either temperature or pressure. In an amperage based electrical sensor, a blood borne agent will chemically react in the presence of a catalyst present in a sensing medium in such as way as to release valence electrons and thus create a current flow (amperage) in amplitude which is in function with the concentration of the agent present. In a voltage based electronic sensor, a blood borne agent reacts with differing materials present at the tips of the sensing wires thus creating a difference in potential and thus a voltage which can be monitored to determine the concentration of the agent.  
         [0070]    It is contemplated that the needle assembly  10  may connected to a micro-injection molded spectrometer. The spectrometer is used for the color sensing of the polarographic type sensor region within the blood stream. A light source (e.g., white light) is focused down an optic fiber  131 , extending through the staged needle  110  and reflected off of the chemically sensitive node  132 , shown in FIG. 6, which may be provided in orifice  117 . The node  132  is formed from a suitable material that is capable of changing color in response to the presence of a target chemical agent in the blood stream. The white light is reflected back as a particular color. The colored light is reflected off of a diffractive grating and is divided into individual wavelengths. The divided light is struck onto a detector array the pattern of increased and decreased intensities along a distance on the array corresponds to the color of the chemically sensitive node, which in turn corresponds to a density of the target agent in the solution.  
         [0071]    It is also contemplated that the needle assembly  10  may be connected to a single component molded michelson interferometer, which is used to measure venous pressure and pulse rate. The interferometer includes a molded beam splitter element, an optic fiber  131  and a flexible diaphragm  133 , shown in FIG. 7. From a lens element of the interferometer, a light beam is collimated and split into two beams. A first beam is directed to the detector array. A second beam is directed through the staged needle  110  through an optical fiber  131  having diaphragm  133  located at an end thereof. The beam is reflected off of the diaphragm  133  and reflected off of the beam splitter creating an interference pattern with the original beam. The diaphragm geometry is such that when the pressure in the blood stream increases the diaphragm  133  deflects inward shortening the distance the light reflects back. This change in length creates a change in interference pattern, which is easily monitored on the detector array.  
         [0072]    The connector assembly  120  will now be described in greater detail. The connector assembly  120  is secured to the elongated staged needle  110 . The connector assembly  120  includes a supply port  121  operatively connected to the first conduit  111 . The supply port  121  includes a valve assembly  1211  formed therein. It is contemplated that the valve assembly  1211  may be manually or automatically operable to control the flow of fluid into the needle assembly  10 . The connector assembly  120  further includes a draw port  122  operatively connected to the second conduit  112 . The draw port  122  also includes a valve assembly  1221  formed therein. The valve assembly  1221  prevents the flow of fluid from the needle assembly  10  unless an extraction device  2  is connected to the draw port  122 . The medical provider can withdraw a sample of blood through the port  122 . When desired, fluid can also be supplied through the port  122 .  
         [0073]    The connector assembly  120  further includes sensor connector assemblies  123  and  124 , which are operatively coupled to the sensor assemblies  130  provided in the staged needle  110 . The sensor connector assemblies  123  and  124  link the sensor assemblies  130  in the staged needle  110  with sensor components and circuitry located within a mounting assembly  140 . The mounting assembly  140  is preferably formed as an armband, as shown in FIGS. 8 and 9. The present invention, however, is not limited to an arm band construction; rather, various mounting devices including but not limited to belts, sleeves, hook and loop fastener assemblies and tape are considered to be well within the realm of the present invention.  
         [0074]    The connector assembly  120  also includes a valve operating system for switching between operating modes (e.g., solely supplying fluid to simultaneously supplying fluid and drawing blood) and flushing the second conduit  112 , when desired, as shown in FIGS.  13 - 17 . The valve operating system is integrally formed in the connector assembly  120 , as shown in FIG. 8. The valve operating system includes at least one selectively operable valve assembly  125  and  126  and a flushing reservoir  127 . The valve assemblies  125  and  126  are preferably diaphragm valves. The present invention, however, is not limited solely to the use of such valves; rather, it is contemplated that other valves including but not limited to butterfly valves, knife valves and pinch valves may be used.  
         [0075]    In accordance with a first embodiment of the connector assembly  120  illustrated in FIGS.  13 - 17 , when it is desirable to supply fluids to the patient through both conduits  111  and  112 , the valve assemblies  1211  and  1221  are operated to permit the flow of fluid through the connector assembly  120  to both conduits  111  and  112 , as shown in FIG. 13. The valve assembly  1211  is in an open position to permit the flow of fluid F through a first passageway  128  into the first conduit  111  of the staged needle  110 . The first passageway  128  is operatively coupled to a second passageway  129  through the valve assembly  126 . The second passageway  129  is operatively connected to the second conduit  112 . When it is desired to supply fluids through both conduits  111  and  112 , the valve assembly  1221  is in a closed position to prevent the flow of fluid out of port  122 . The valve assembly  126  is in a first open position to permit the flow of fluid from the first passageway  128  into the second passageway  129 , as shown in FIG. 13. With this arrangement, the IV fluid may be supplied to the patient through conduit  111  and  112 . It is contemplated that the same fluid may flow through both conduits or that different fluids may flow through the different conduits. When is it desired to supply different fluids through the conduits  111  and  112 , the valve assembly  126  remains in a closed position such that fluid from the first passageway  128  does not flow into the second passageway  129 . The valve assembly  1221  is an open position to permit the flow of fluid through port  122  into the second passageway  129 .  
         [0076]    When it is desired to draw blood B from the patient, the fluid contained in the conduit  112  and the second passageway  129  must be cleared to avoid contamination and mixing with the blood sample. To clear the conduit  112  and the second passageway  129 , the valve assembly  126  is operated to a second operating position to cut of the supply of fluid from the first passageway  128 . When in the second operating position, the valve assembly  126  opens a fluid pathway between the second passageway  129  and the flushing reservoir assembly  127 , as shown in FIG. 14. Blood and any remaining fluids in the second passageway  129  is permitted to flow into the flushing reservoir  127 .  
         [0077]    Once the flushing reservoir assembly  127  is full, the valve assembly  126  is moved to a closed position, whereby fluid is not permitted to flow from the first passageway  128  or the flushing reservoir assembly  127  into the second passageway  129 , as shown in FIG. 15. The flushing reservoir assembly  127  is of sufficient size to contain the mixture of blood and fluid such that uncontaminated blood remains in the second passageway  129 . The extraction device  2  is then brought into contact with the port  122  and the valve assembly  1221  is opened to permit the withdrawal of the blood sample from the second passageway  120 .  
         [0078]    Once the blood sample has been withdrawn, the flow of fluid through the second passageway  129  can be reinstated. The valve assembly  126  is returned to the second operating position to permit the flow of the blood and fluid mixture in the reservoir assembly  127  into the second passageway  129 . The valve assembly  125  is then operated to an open position to permit the flow of fluid from the first passageway  128  into the flushing reservoir assembly  127 , as shown in FIG. 16. The fluid flows from the first passageway  128  through the flushing reservoir assembly  127  into the second passageway. After a sufficient amount of time so that the mixture of blood and fluid is removed from the flushing reservoir assembly  127 , the valve assembly  126  is operated to a closed position to cut off the flow of fluid into the flushing reservoir assembly  127 . The contents of the flushing reservoir assembly  127  then empty into the second passageway  128 . Once the flushing reservoir assembly  127  is substantially empty, as shown in FIG. 17, the valve assembly  126  is switched to the first operating position such that fluid flows from the first passageway  128  through the valve assembly  126  into the second passageway  129 .  
         [0079]    In accordance with a second preferred embodiment of the connector assembly  120  illustrated in FIGS.  18 - 20 , when it is desirable to supply fluids to the patient through both conduits  111  and  112 , the valve assemblies  1211  and  1221  are operated to permit the flow of fluid through the connector assembly  120  to both conduits  111  and  112 , as shown in FIG. 18. The valve assembly  1211  is in an open position to permit the flow of fluid F through a first passageway  128  into the first conduit  111  of the staged needle  110 . The first passageway  128  is operatively coupled to a second passageway  129  through the valve assembly  125 . The second passageway  129  is operatively connected to the second conduit  112 . When it is desired to supply fluids through both conduits  111  and  112 , the valve assembly  1221  is in a closed position to prevent the flow of fluid out of port  122 . The valve assemblies  125  and  126  are opened to permit the flow of fluid from the first passageway  128  into the second passageway  129 , as shown in FIG. 18. With this arrangement, the IV fluid may be supplied to the patient through conduit  111  and  112 . It is contemplated that the same fluid may flow through both conduits or that different fluids may flow through the different conduits. When is it desired to supply different fluids through the conduits  111  and  112 , the valve assembly  126  remains in a closed position such that fluid from the first passageway  128  does not flow into the second passageway  129 . The valve assembly  1221  is an open position to permit the flow of fluid through port  122  into the second passageway  129 .  
         [0080]    As shown in FIG. 19, when it is desired to draw blood B from the patient, the fluid contained in the conduit  112  and the second passageway  129  must be cleared to avoid contamination and mixing with the blood sample. To clear the conduit  112  and the second passageway  129 , the valve assembly  125  is closed to cut of the supply of fluid from the first passageway  128 . The flushing reservoir assembly  127  is evacuated by either compressing a flexible camber, shown in 1, or by actuating a plunger assembly to withdraw the fluid contained therein. When the flushing reservoir assembly  127  is evacuated, a mixture BF of fluid and blood within the passageway  129  and the conduit  112  is allowed to flow into the assembly  127 . The volume of the assembly  127  is greater than the combined volumes of passageway  129  and conduit  112 , such that assembly  127  contains the mixture of blood and fluid and the passageway  129  contains only blood. The valve assembly  126  is closed to prevent the flow of the mixture of blood and fluid from the assembly  127  into the passageway  129 . The extraction device  2  is then brought into contact with the port  122  and the valve assembly  1221  is opened to permit the withdrawal of the blood sample from the second passageway  120 .  
         [0081]    Once the blood sample has been withdrawn, the flow of fluid through the second passageway  129  can be reinstated. The valve assembly  126  is opened to permit the flow of the blood and fluid mixture in the reservoir assembly  127  into the second passageway  129 . The valve assembly  125  is then operated to permit the flow of fluid from the first passageway  128  into the flushing reservoir assembly  127 , as shown in FIG. 16. The fluid flows from the first passageway  128  through the flushing reservoir assembly  127  into the second passageway.  
         [0082]    When it is desired to administer medication, the valve assembly  126  is closed to prevent the flow of fluid through the second passageway  129 , as shown in FIG. 20. Medication M may be administered through port  122  into the second passageway  129 .  
         [0083]    As shown in FIG. 8, the needle assembly  10  is connected to the mounting assembly  140 . The mounting assembly  140  is operatively linked to a control unit  160  through a communication link or tether  150 , as shown in FIG. 9.  
         [0084]    The mounting assembly  140  provides the interface between the controller/data logger associated with the control unit  160  and the disposable needle  110 . Imbedded into the mounting assembly  140  are the actuators for the manipulation of the valves  125  and  126  and the reservoir assembly  127 . A detector array (not shown) with required associated circuitry is also embedded into the mounting assembly  140  to create a connection with the sensor connectors  123  and  124 . Additionally, the mounting assembly  140  includes circuitry formed therein for interaction with the control unit  160 .  
         [0085]    The control unit  160  may be a portable handheld unit that may be connected to the patient  1  through a strap or band  161 , as shown in FIG. 9. It is also contemplated that the control unit  160  may a larger stationary computer controlled monitoring device, or may be connected into other standard monitoring equipment or by a dedicated hardware device.  
         [0086]    The control unit  160  performs numerous functions. For example, the control unit  160  provides a visual indication of bodily functions based on the interpretation of the signals from the sensors located in the staged needle  110 . Furthermore, the control unit  160  may store and generate a log of the data collected from the sensors for later analysis. The control unit  160  may operate one or more alarms if predetermined vitals of the patient fall below or above accepted levels. The control unit  160  may further automatically operate the valve assemblies located in the connector assembly  120  and the mounting assembly  140  to automatically perform sensing operations and administer fluids to the patient. The control unit  160  further provides a link to the patient&#39;s medical history and other records, either through wireless communications, infrared communications, or physical connection for the transmission of sensor data and archiving of patient history.  
         [0087]    Another embodiment of the disposable needle assembly will now be described in connection with FIG. 10. The disposable needle assembly  20  includes an elongated needle  210  having an elongated shaft. Like the staged needle  110 , the elongated needle  210  is preferably molded from an elastomertic material whose durometer is chosen just above that of flesh to minimize discomfort to the patient. The elongated needle  210  includes first and second passageways  211  and  212 , which are integrally formed therein. The elongated needle  210  has an insertion tip  213  formed in one end thereof. An opposite end of the needle  210  is connected to a connector assembly  120 , described above.  
         [0088]    The first passageway or conduit  211  extends through the needle  210  from the connector assembly  120  to an opening  214  adjacent the insertion tip  213 , as seen in FIG. 10. Like the first conduit  111 , the conduit  211  is provided to introduce fluids into the vessel. The second passageway or conduit  212  extends through the elongated needle  210  from the connector assembly  120  to an opening  215  spaced from the insertion tip  213 . The second conduit  120  is provided to draw a sample of fluid (e.g. blood) from the vessel. The second conduit  212  extends around the first conduit  211 . The differential location of the openings  214  and  215  permits uncontaminated blood draws while simultaneously administering IV fluids. The sensors in assembly  20  are located internally and externally in the second passageway or conduit  212  and internally on conduit  211 .  
         [0089]    Yet another embodiment of the disposable needle assembly will now be described in connection with FIG. 11. The disposable needle assembly  30  includes an elongated needle  310  having an elongated shaft. Like the needles  110  and  210 , the elongated needle  310  is preferably molded from an elastomertic material whose durometer is chosen just above that of flesh to minimize discomfort to the patient. The elongated needle  310  includes first and second passageways  311  and  312 , which are integrally formed therein. The elongated needle  310  has an insertion tip  313  formed in one end thereof. An opposite end of the needle  310  is connected to a connector assembly  120 , described above.  
         [0090]    The first passageway or conduit  311  extends through the needle  310  from the connector assembly  120  to an opening  314  adjacent the insertion tip  313 , as seen in FIG. 11. The second passageway or conduit  312  extends through the elongated needle  310  from the connector assembly  120  to an opening  315  spaced from the insertion tip  313 . The first and second conduits  311  and  312  are located in a generally side-by-side relationship. A wall  316  extends between the conduits  311  and  312 . An end portion of the wall  316  forms the insertion tip  313 . The sensors in assembly  30  are located internally and externally in the second passageway or conduit  312  and internally on conduit  311 .  
         [0091]    Still another embodiment of the disposable needle assembly will now be described in connection with FIG. 12. The disposable needle assembly  40  has a construction similar to the needle assembly  10 . In this arrangement, an additional conduit  410  is provided having a valve assembly  411 . The valve assembly  411  permits the sealing off of the conduit at predetermined times in the event of use of medical equipment or drug delivery that may be incompatible with an IV solution. The conduit is contemplated to be “flushed” or swept with the IV or saline solution. The port would delivery all present venous medicinal fluids such as heart medication, chemotherapy drugs, either liquids or solid delivery i.e. capsules.  
         [0092]    The manufacture of the elongated shaft of the disposable needle assemblies  10 ,  20 ,  30  and  40  will now be described. In accordance with a preferred embodiment of the present invention, the elongated shaft of the disposable needle assembly is formed by micro-injection molding. Micro-injection molding is similar to traditional molding processes in many ways. The molding material is melted in a chamber. An amount of the material is ejected from the chamber through a nozzle into a mold tool. The material moves through a series of channels called runners to reach the void called a cavity, which is the negative of the molded part. The molding material is allowed to cool, creating a solid component. The mold tool opens and the part is ejected from the cavity. The tool closes and the process is repeated.  
         [0093]    Micro-injection molding technology offers milligram control on shot size and millisecond control on injection times. In micro-injection molding, the components and runner system are extremely small, only a small amount of material is melted at any one time. In some instances, only a few grams may be melted. Most thermoplastics if held at elevated temperatures for extended periods will degrade and the properties of the final product will be compromised. Furthermore, it is very important that the material does not cool before it is moved in the mold. The precise amount of molding resin is moved into the mold before a cold front is allowed to form on the material. The absence of the cold front allows for better knitting of the material, allows for thinner walls, and greatly reduced molded in stresses.  
         [0094]    The formation of the elongated needle  10 ,  20 ,  30  and  40  will now be described. In accordance with the present invention, the sensor assemblies  130  and the removable core pin  3  are formed. The sensor assemblies  130  (e.g., the optical sensors) and the core pin  3  may be formed by micro-injection molding. The sensor assemblies  130  and the core pin  3  are located with in the mold for forming the needle shaft. The material forming the needle shaft is then heated and injected into the mold. The material is over molded over the sensor assemblies  130  and the core pin  3 . In order to prevent melting of the sensor assemblies  130  and the core pin  3  during the molding of the needle shaft, the materials forming these components must have a melting temperature that is at least 50° F. higher than the melting temperature of the material forming the needle shaft.  
         [0095]    The present invention is not limited to the method described above; rather, it is contemplated that other forms of micro-injection molding may be employed. For example, it is contemplated that liquid injection molding may be employed. The component materials forming the needle shaft are mixed and injected into the mold. The mold is then heated to heat the materials. The mold and the needle shaft are then cooled, such that the needle shaft cures.  
         [0096]    It will be appreciated that numerous modifications to and departures from the preferred embodiments described above will occur to those having skill in the art. The present invention is not limited to the above-described uses. Thus, it is intended that the present invention covers the modifications and variations of the invention, provided they come within the scope of the appended claims and their equivalents.