Patent Publication Number: US-2002010437-A1

Title: Medical connector

Description:
RELATED PATENT APPLICATIONS  
     [0001] This application is a continuation-in-part application of U.S. patent application Ser. No. 06/543,248, filed Oct. 19, 1983, and entitled “Medical Connector System,” which was a continuation-in-part application of U.S. patent application Ser. No. 06/460,585, filed Jan. 24, 1983, and entitled “Device for Intravenously Introducing Medication Into a Patient,” (now abandoned). These previously filed patent applications, which are incorporated herein by reference and made part of this patent application, disclose the experimental versions of this invention. These experimental versions are also disclosed herein. 
    
    
     
       BACKGROUND OF THE INVENTION  
       [0002] 1. Field of the Invention  
       [0003] This invention relates to medical connectors used in the treatment of the injured or sick, and in particular to a connector for introducing medication into a patient in a safe, convenient way.  
       [0004] 2. Background Discussion  
       [0005] It is a common practice in treating patients, particularly patients who must be cared for under emergency conditions, with medication introduced into the patient intravenously. An intravenous solution, commonly referred to as parenteral liquid, is fed from a container holding this liquid. The liquid flows through tubing into a needle which has been inserted into the patient&#39;s vein. The needle is taped securely to the patient&#39;s body and is not likely to pull loose if the patient moves. Medication needed to sustain the life of the patient, for example, drugs which maintain the blood pressure of the patient at the desired level, are added to the parenteral liquid. The conventional practice is to introduce the medication through a second needle inserted into a sealed entry port in the tubing through which the parenteral liquid flows.  
       [0006] One problem with this conventional practice is that the needle may be pulled loose from the sealed port relatively easily. Such accidental removal of the needle from the sealed port can have very serious consequences and could even lead to the death of the patient. Although many hospitals require nurses to tape the needle securely to the tubing, this is not always done, because taping is a burdensome and time consuming task.  
       [0007] A second problem with the conventional practice is needle sticks. From time to time a nurse in attempting to insert the needle into the sealed entry port will accidentally stick himself or herself with the needle. This often occurs under emergency conditions when the nurse is under pressure to complete this task as quickly as possible. Not only is the accomplishment of the task delayed, but the nurse must stop working and have a blood test performed. Such a test is needed in case the nurse becomes infected, because the hospital will be responsible financially. Consequently, needle sticks not only result in increased hospital cost, but are a possible life treating event to the nurse.  
       [0008] A third problem with the conventional practice is injection. All too often a patient&#39;s life is seriously endangered by bacteria gaining entry into a patient&#39;s blood stream and infecting the patient. In a vast number of cases it is unknown how the bacteria gain entry. We have observed conditions in hospitals and identified that one likely way the bacteria gain entry is by contamination of the needle inserted into the sealed entry port. This happens when the nurse notices that the needle has been pulled loose and simply reinserts it even though it may now have on its surface bacteria picked up by direct contact with, for example, the patient&#39;s bedding. Another possible way that bacteria may gain entry into the patient&#39;s blood stream is through contamination of the tape used to hold the needle to the connector.  
       MAJOR FEATURES OF THE INVENTION  
       [0009] The problems discussed above present a serious health hazard to patients and their nurses. The present invention eliminates these problems and provides a medical connector which is both safe and convenient to use.  
       [0010] There are several features of this invention which contribute to its safety and convenience, no single one of which is solely responsible for these desirable attributes. Many of these features were present in our experimental versions of the invention, which were improved after testing. Without limiting the scope of this invention as expressed by the claims, its more prominent features will now be discussed briefly. After considering this discussion, and particularly after reading the section of this application entitled DETAILED DESCRIPTION OF THE DRAWING, one will understand how the features of this invention provide the attributes of safey and convenience.  
       [0011] One safety feature of this invention is the use of a cap member to enclose the needle to be inserted into the sealed entry port structure. This cap member fits snugly over the entry port structure, connecting with the port structure in a male-female mating relationship. The needle pierces the seal when the cap member is seated on the port structure. This needle is housed deep within a cavity in the cap member that terminates in an open mouth into which the sealed end of the port structure fits. This open mouth is narrow in width so that the finger of the nurse or patient cannot fit into the cavity and contact the needle. Since the needle is so mounted within the cap member, the likelihood of bacterial contamination is avoided or reduced and the nurse is protected against accidental needle sticks.  
       [0012] A second safety feature is provided by the wall design of the cap member and port structure. These walls are of preferably cylindrical configuration and engage each other like a telescope. The interior surface of the wall of the cap member slides over the exterior surface of the wall of the mating port structure, with these walls engaging each other to guide the needle into the center of the seal. This ensures that the needle does not scrape against the inside surface of the wall of the port structure. Particles scraped from this wall could make their way into the patient&#39;s blood stream and result in death. This potentially lethal condition is inherent in the design of conventional devices. But the connector of this invention, with the guideway wall design of the cap member and port structure, ensures that the needle is directed into the center of the seal so that it avoids scraping against the inside surface of the wall of the port structure. This guideway wall design also permits the nurse quickly to connect the cap member to the port structure. This makes the connector of this invention not only more convenient to use, but in emergencies, enables the nurse to administer medication to a patient faster than with conventional devices and doing it without the danger of needle sticks.  
       [0013] A third safety feature of the invention is that a locking mechanism detachably secures the cap member to the port structure. Because of this feature, movement of the patient does not result in accidental removal of the needle from the seal. Although many different types of locking mechanisms may be employed, the preferred one provides a sound upon locking engagement of the cap member and port structure. We have devised such a locking mechanism which produces a sound such as a “click.” This “click” is an audible signal which tells the nurse that the cap member is locked safely to the port structure and cannot be accidentally jarred loose by movement of the patient.  
       [0014] Several embodiments of the invention illustrating all the features of this invention will now be discussed in detail. These embodiments show the invention-being used for administering medication intravenously to a patient. This invention may also be used to administer medication to a patient in other ways, for example, intracranially or intraperitonially.  
     
    
    
     BRIEF DESCRIPTION OF THE DRAWING  
     [0015] The drawing, wherein like numerals indicate like parts, depicts four embodiments of this invention in which:  
     [0016]FIG. 1 is a schematic view illustrating administering medication intravenously to a patient in accordance with conventional practice.  
     [0017]FIG. 2 is a cross-sectional view of a piggyback connector for introducing parenteral liquid and medication intravenously to the patient shown in FIG. 1.  
     [0018]FIG. 3 is a perspective view of the first embodiment of the Medical connector of the present invention which employs a slip-on/twist lock type means for securing the cap member to the port structure.  
     [0019]FIG. 4 is a cross-sectional view of the connector shown in FIG. 3 taken along line  4 - 4  of FIG. 3.  
     [0020]FIG. 4 a  is a perspective view showing how the cap member prevents needle sticks.  
     [0021]FIG. 5 is a perspective view of the second embodiment of the medical connector of the the present invention which employs a snap-on type means for securing the cap member to the port structure.  
     [0022]FIG. 6 is a cross-sectional view of the connector shown in FIG. 5 taken along line  6 - 6  of FIG. 5.  
     [0023]FIG. 7 is an exploded perspective view of the third embodiment of the medical connector of the present invention which employs a snap-on type means for securing the cap member to the port structure.  
     [0024]FIG. 8 is a side elevational view, with sections broken away, of the embodiment shown in FIG. 7. In this FIG. 8 the handle of the locking mechanism attached to the cap member just engages the lip of the port structure.  
     [0025]FIG. 9 is the same view as shown in FIG. 8, except the handle of the locking mechanism is flexed and just about to snap into locking engagement with the lip of the port structure.  
     [0026]FIG. 10 is the same view as shown in FIGS. 8 and 9, except the handle of the locking mechanism is now engaging the lip of the port structure in the locking position.  
     [0027]FIG. 10 a  is the same view as shown in FIGS. 8, 9 and  10 , except the handle of the locking mechanism is flexed to permit removal of the cap member from the port structure.  
     [0028]FIG. 11 is a top plan view of the cap member.  
     [0029]FIG. 12 is a bottom view of the handle of the locking mechanism shown in FIGS. 8 through 11.  
     [0030]FIG. 13 is a side elevational view of the handle of the locking mechanism.  
     [0031]FIG. 14 is a side elevational view of the cap member with the handle of the locking mechanism removed.  
     [0032]FIG. 15 is a top plan view of the cap member with the handle of the locking mechanism removed.  
     [0033]FIG. 16 is an enlarged cross-sectional view of a portion of the hinge of the locking mechanism.  
     [0034]FIG. 17 is an enlarged cross-sectional view of the position of the handle just prior to being secured to the cap member.  
     [0035]FIG. 18 is a cross-sectional view similar to that shown in FIG. 17 depicting the handle coupled to the cap member.  
     [0036]FIG. 19 is a cross-sectional view taken along line  19 - 19  of FIG. 18.  
     [0037]FIG. 20 is a perspective view showing the medical connector of FIG. 7 having one end coupled to a tube extending from a patient&#39;s arm and another end coupled to a tube extending from a container holding medication.  
     [0038]FIG. 21 is a perspective view of a medical connector like that shown in FIG. 7, except the port structure has the lip which engages the handle of the locking mechanism as an integral part of a conventional piggyback connector.  
     [0039]FIG. 22 is a schematic view showing a medical connector of the type shown in FIG. 7 designed to introduce medication into a patient&#39;s chest.  
     [0040]FIG. 23 is a perspective view of a fourth embodiment of the medical connector of this invention which employs a slip-on/twist lock type means for securing the cap member to the port structure.  
     [0041]FIG. 24 is an enlarged cross-sectional view taken along line  24 - 24  of FIG. 23, showing the cap member being connected to the sealed entry port structure. 
    
    
     DETAILED DESCRIPTION OF THE DRAWING  
     [0042] Conventional Connector System  
     [0043] As shown in FIGS. 1 and 2, the current way of intravenously introducing parenteral liquid into a patient is by the conventional feeding system  10 . This feeding system  10  includes a container  12  for the parenteral liquid, a tube  14  extending from the container and connected to a Y or “piggyback” connector  16 , and a tube  18  from the piggyback connector to a needle (not shown) inserted into a vein of the patient. The needle is taped to the patient so that movement of the patient will not result in the needle being pulled from the patient&#39;s vein.  
     [0044] As best illustrated in FIG. 2, medication from the container  20  is introduced through the piggyback connector  16  into the parenteral liquid flowing through the feeding system  10 . This piggyback connector  16  consists of two tubular conduits  22  and  24  which merge into a third tubular conduit  26 . The tubing  14  from the container  12  of parenteral liquid is inserted into the inlet port  28  of the conduit  22  and secured in position, for example, by an adhesive which bonds the external surface of this tube to the internal wall surface of the conduit. There is a stop  30  which limits the extent to which this tube  14  can be inserted into the conduit. In a similar fashion, the tube  18  is secured to the outlet port  32  of the piggyback connector. This tube  18  is inserted into the outlet port  32  until it abuts a stop  34  in the internal wall of the conduit. This tube  18  is secured by an adhesive to the internal wall of the conduit  26 .  
     [0045] The sealed entry port structure of the conventional feeding system  10  is provided by the branch conduit  24  which has a standard latex rubber seal  36  at its inlet port  38  to seal this port. Consequently, bacteria cannot enter the piggyback connector  16  via the inlet port  38  because of the seal  36 . This seal  36  is of conventional design and includes coaxial annular aprons  40  and  42  which fit over the conduit wall  24   a  and grip the external and internal wall surfaces to hold the seal securely to the conduit  24 . A suitable seal may be obtained from the West Company of Phoenixville, Pa.  
     [0046] The medication is introduced into the parenteral liquid flowing through the piggyback connector  16  by a needle  44  which is inserted through the central part of the seal  36  into the branch conduit  24 . This needle  44  is connected by a suitable connector  46  to a tube  48  which is connected to the container  20  (FIG. 1) for the medication. As parenteral liquid flows through the piggyback connector  16  into the inlet port  28  and out the outlet port  32 , the medication is drawn into this stream of liquid, flowing from the container  20  via the tube  48  and through the open tip or end  44   a  of the needle  44  into the parenteral liquid.  
     [0047] After studying FIGS. 1 and 2, the several problems associated with the conventional practice can now be more fully understood. If the patient moves, for example, rolls or moves his or her arm, the needle  44  may be pulled from the seal  36 . If this occurs, the latex seal  36  has sufficient resiliency to close off the hole in the seal produced by the needle  44 . The parenteral liquid will continue to flow into the patient&#39;s system, but the necessary medication is no longer being introduced into it. The consequences of this condition are very grave and, if this condition is unnoticed by the nurse, it could result in the death of the patient or serious complications in the patient&#39;s treatment. Even if the nurse notices that the needle  44  has been removed from the seal  36  and reinserts it into the seal, it is possible that the needle has been contaminated with bacteria. The use of such a contaminated needle  44  is unacceptable, but nevertheless this sometimes happens. The needle  44  may be taped to the conduit  24 , and many hospitals instruct nurses to do this. When this task is done, the needle  44  is secured, but cannot be conveniently removed and then reinserted. And even when taping the needle  44 , if this is not done carefully, the needle may still be contaminated by the nurse touching the needle or the tape being contaminated. Also, because the nurse holds the conduit  24  with one hand while inserting the needle  44 , the nurse may accidentally stick the needle directly into the hand holding this conduit, or stick the needle through the conduit wall  24   a  into this hand.  
     [0048] These problems associated with the conventional practice are eliminated by the several different embodiments of this invention disclosed hereinafter.  
     [0049] First Embodiment of the Invention  
     [0050] As illustrated in FIGS. 3 and 4, the first embodiment of this invention, connector  49 , employs a cap member  50  housing deep within the needle  44 . As will be discussed in greater detail hereinafter, the cap member  50  is secured by a slip-on/twist lock type of locking mechanism to the piggyback connector  16  so that movement of the patient does not result in the needle  44  being pulled from the seal  36 . The parenteral liquid is introduced via the conduit  24 , and the conduit  22  carries the seal  36  that covers the inlet port  28 . In this embodiment, this sealed conduit  28  constitutes the entry port structure  27 . The cap member  50 , is detachably secured to the entry port structure  27 , with the needle  44  penetrating the semi center of the seal  36  when the cap member  50  mates with the port structure  27 .  
     [0051] The cap member  50  comprises a cylindrical connector section  56  having a hollow interior forming the chamber or cavity  52  housing the needle  44 . This needle  44  is disposed lengthwise along the longitudinal axis of the cavity  52  and is centrally located. The cavity  52  has an open mouth  52   a  which allows the cap member to be seated over the port structure  27 . The mouth  52   a,  however, is constricted so that, as illustrated in FIG. 4 a,  it prevents the little finger of a typical adult user from being inserted into the cavity  52 . The tip or end  44   a  of the needle is safely displaced inwardly from the open mouth  52   a  so that even if the user intentionally inserted his or her finger into the open mouth, the tip of the needle would not stick this finger. Typically, the open mouth  52   a  has a maximum width of no greater than about one centimeter, and the minimum distance between the mouth  52   a  and the tip  44   a  is about one centimeter.  
     [0052] The locking mechanism includes the threads  69   a  formed in the end  54  of the interior cavity wall  55  and the threads  69   b  in the exterior wall of the conduit  22 . These threads  69   a  and  69   b  engage upon connection of the cap member  50  to the port structure  27  by screwing the cap member to the conduit  22 . The top of the cap remember  50  has a pair of outwardly extending wings  58  which facilitate screwing the cap member  50  to the conduit  22 . As this is done, the interior wall  55 , sliding over the exterior surface of the conduit  22  guides the needle  44  so that it penetrates the center of the seal  36 . To further ensure that the needle  44  penetrates the center of the seal  36 , the threads  69   b  could be lowered further beneath the seal so that the cap member would fit telescopically over the conduit  22  and then be screwed into position. Thus, the cap member  50 , serving as the female component, and conduit  22 , serving as the male component, mate in a male-female relationship, with the needle  44  always being housed safely within the center of the cavity in an unexposed condition and positioned to pierce the center of the seal  36 .  
     [0053] A spindle  59  is provided to enable the cap member  50  to be screwed onto the port structure  27  without twisting the tube  48 . This spindle  59  is received within an opening  61  within the cap member  50 . The body of the spindle  59  has a cylindrical neck section with a groove  63  in an end which protrudes from the opening  61 . The cylindrical body expands outwardly slightly to provide a shoulder  65  which engages a stop  66  when the spindle  59  is placed in the opening, and a TRU seal C-ring  67  is received in the groove  63  to hold the spindle in position but allowing the cap member to revolve about the spindle as it is screwed onto the port structure  27 .  
     [0054] Along the longitudinal axis of the spindle  59  is a passageway  60 . The tube  48  from the container  20  holding the medication is inserted into the one end  60   a  of the passageway  60  and is bonded to the internal surface of this passageway, for example, by means of an adhesive. The other end  60   b  of the passageway terminates in a threaded connector section  62  to which the needle  44  is secured. This needle has an adapter  64  which has an internal thread which engages the threads of the connector section  62 . The needle  44  extends outwardly from this adapter  64 . Thus, the needle  44  is held secure to the piggyback connector  16 , penetrating the center of the seal  56  with its point  44   a  safely displaced away from the inside wall  55  of the conduit  22 .  
     [0055] This connector  49  embodies many of the features of this invention. For example, the cap member  50  safely houses the needle  44 , and the threads on the guiding walls provide means for detachably securing the cap member to the port structure without taping. But it has several components, and therefore is costly to manufacture, it is time consuming to screw the cap member  50  to the port structure, and it does not provide an audible signal when the cap member is safety secured to the port structure. This later feature is provided by the second and third embodiments of this invention.  
     [0056] Second Embodiment of the Invention  
     [0057] The second embodiment of the present invention, connector  71 , is shown in FIGS. 5 and 6. In this embodiment a cap member  70 , similar to cap member  50 , is simply snapped onto the piggyback connector  16 . The snap-on type locking mechanism of this connector  71  is easier to use and less costly to manufacture than the slip-on/twist type of the first embodiment.  
     [0058] In this embodiment, the cap member  70  includes a hollow cylindrical element  72  which carries on its exterior two clips  74  which have catch tips  76  that snap into a groove  78  in the external wall of the conduit  22 . The clips  74  are mounted by hinges  75  to the element  72 , and are integral with the element  72 . A plug assembly  80  carries the tubing  48  and the needle  44 , which is mounted on an adapter  64  such as shown in FIG. 4. This plug assembly  80  is glued or otherwise bonded to the open end of the cylindrical member  72 . The cap member  70 , including clips  74  and hinges  75 , are molded from the same material, for example, nylon, which is a material having the desired resiliency.  
     [0059] To attach the cap member  70 , one simply slips the member  70  over the conduit  22 . The clips  74  bend outwardly slightly and, when the catch tips  76  of the clips are opposite the groove  78 , the clips snap in place as shown in solid lines in FIG. 6. The centrally mounted needle  44  is guided into the center of the seal  36  by the cap member  70 , which, like a telescope, slides over the tubular conduit  22 . There is shoulder  82  which serves as a stop to limit the movement of the cap member  70 . This shoulder  82  brings the catch tips  76  of the clips into registration with the groove  78 . The hinges  75 , being of the same material as the clips  74 , provide an internal bias or spring action due to the resiliency o the material from which these clips and hinges are made. Consequently, the clips  74  snap into a locking position, locking the cap member to the conduit  22  when the catch tips  76  are in registration with the groove  78 . To release the cap member from the piggyback connector  16 , the clips  74  are simply depressed and the cap member  70  is removed.  
     [0060] One of the features of the slip-on type locking mechanism is that with one simple inwardly push the needle  44  is inserted directly into the center of the seal  36  and the cap member is locked to the port structure. Another feature of this connector  71  is that when the tips  76  of the clips snap into the groove  78  a “click” sound is made by the tips striking the body of the cap member. With repeated use, however, the hinges  75 , due to internal stress produced in the nylon material, loose some of their spring action. Consequently, the tips  76  are not held with sufficient force in the groove  78 , nor do they strike the body of the cap member to produce the desired “click” sound. Moreover, the material will eventually crack along the flex line of the hinge and a break will occur. The reliability of this connector  71  is substantially improved by the third embodiment of this invention which employs a unique locking mechanism.  
     [0061] Third Embodiment of the Invention  
     [0062] As shown in FIG. 7, the third embodiment of this invention, connector  90 , includes a sealed port structure  91  and a cap member  92  having a locking mechanism  94  for detachably securing the cap member  92  to the port structure  91 . The cap member  92  is similar to the cap members of the other embodiments and houses within its cavity  92   a  (FIG. 8) the needle  44 . The cavity  92   a  has a tapered side wall  93  to better direct the needle  44  into the center of the seal  36 .  
     [0063] The port structure  91  is a tubular conduit  102  having, at one end, a reduced diameter nipple  104  over which the seal  36  fits and, at the other end, a tapered barrel  103 . The seal  36  is of the same type employed in conventional devices such as shown in FIG. 2. Material is removed from the barrel  103  to reduce cost. This results in the formation of flutes  103   a  in the barrel  103 . At the base of the barrel  103 , adjacent the end of the port structure  91 , is an annular, disk-like piece which provides a lip  106 . When the cap member  92  is placed over the port structure  91 , a handle  96 , which is a component of the locking mechanism  94 , engages this lip  106 . The handle  96  is hinged to the body  98  of the cap member by a two component hinge  100 .  
     [0064] As best shown in FIGS. 14 and 15, a hook  114  is one component of the hinge  100  and the other component of the hinge is a crossrod  108  (FIG. 18) carried by the handle  96 . The hook  114  projects outwardly from the body  98  of the cap member and has adjacent to it a ramp  116 , which as shown in FIG. 18, holds the crossrod  108  when the handle  96  is attached to the body of the cap member. A section of the crossrod  108  is cut away to provide a miter slot  118  which engages the ramp  116 .  
     [0065] The handle  96  is best shown in FIGS. 12 and 13. It has a pair of spaced apart plates  110  and  112  extending downwardly from the underside of the handle and the crossrod  108  is disposed between these plates, with the opposed ends of the crossrod being integral with the plates. Opposite the crossrod  108  and parallel to it is a third plate  120 , which is integral with the underside of the handle  96  and is at a right angle to and connects with the forward ends of the plates  110  and  112 . Disposed on the underside of the handle  96  between the catch tip  122  and the plate  120  is a clapper bar  126 . The clapper bar  126  produces the “click” sound when it strikes the body  98  of the cap member. This clapper bar  126  extends away from the plate  120  at a right angle and is integral, at one end of the handle, with the catch tip  122  and, at its opposite end, with the plate  120 . The leading edge  124  of the catch tip  122  is beveled to facilitate the slippage of this tip up and over the lip  106  which is also beveled. At the point where the clapper bar  126  merges with the inside of the catch tip  122 , there is a notch  128 , which, as shown in FIG. 10, receives the lip  106  when the handle  96  is in the locking position. At the rearend of the handle  96  is a leaf spring  130  which has one end free and its opposed end integral with the handle  96 . At the free end of the leaf spring  130  are two spaced apart tracks  132  and  134  (FIG. 12). When the handle  96  is attached to the body of the cap member as shown in FIGS. 8 through 10, a finger  136  on the body  98  of the cap member is received within the channel  138  between the tracks  132  and  134 . On the underside of the handle  96  are two downwardly projecting reinforcing strips  140  and  142  (FIG. 12) which provide structural rigidity to the handle.  
     [0066] The way in which the handle  96  is pivotably connected to the cap member  92  by the two component hinge  100  is illustrated by FIGS. 16 through 19. To attach this handle  96  to the body  98  of the cap member, first one positions the handle over the body of the cap member opposite the hook  114  and then moves the handle into contact with the cap member so that the crossrod  108  touches the rearend of the ramp  116 . The spring  130  is depressed at this time. Next, the handle  96  is moved towards the left, as shown in FIG. 17, with the crossrod  108  sliding up the ramp  116  until it engages the leading edge  140  of the hook  114 . The dimension between the edge  142  of the ramp  116  and the edge  140  of the hook  114  is less than the diameter of the crossrod  108 . Consequently, the hook  114  must flex slightly upwardly in a counterclockwise direction, as viewed in FIG. 17, until the crossrod  108  clears the edge  142  of the ramp and snaps into the position shown in FIG. 18. The hook  114  thus returns to the unflexed condition shown in FIG. 18, wrapping around the crossrod  108 . The miter slot  118  then engages the edge  142  of the ramp, with this edge abutting the junction  118   a  of the slot  118  (FIG. 18). The ramp  116  thus holds the crossrod  108  in position, preventing the handle from becoming dislodged from the hook  114  and preventing the handle  96  from tilting to-and-fro about its longitudinal axis. When the handle  96  is so mounted to the body  98  of the cap member, the finger  136  slips into the channel  138  between the tracks  132  and  134  and holds the rearend of the handle so that it does not tend to move laterally. The handle  96  is, however, free to pivot about the hinge  100 .  
     [0067] Unlike the hinges  75  of the second embodiment of this invention, the two component hinge  100  does not break due to fatigue. Thus, in accordance with one feature of connector  90 , the handle  96  may be moved between a locked position (FIG. 10) and unlocked position (FIG. 8) as often as one wishes without breaking. At the same time, the handle  96 , coating with the body  98  of the cap member  92 , generates a “click” sound when the cap member is locked to the port structure  91 . This “click” sound, as best illustrated in FIGS. 9 and 10, occurs when the handle  96  moves between the flexed position shown in FIG. 9 and the locked position shown in FIG. 10.  
     [0068] The connector  90  is highly reliable under actual hospital working conditions, and the way connector  90  is used is best shown in FIGS. 8 through 10 a.  First, the nurse inserts the end of the port structure carrying the seal  36  into the open mouth  93  of the cap member  92  to bring the lip  106  into engagement with the catch tip  122  of the handle  96  as shown in FIG. 8. As this is done, the tapered side wall  93  of the cap member and the tapered barrel  103  slide along each other to direct the needle  44  into the center of the seal  36 . Simultaneously, the beveled edge  124  of the catch tip rides over the beveled lip  106  until the lip just engages the underside edge of this tip as shown in FIG. 9. This causes the handle  96  to rotate in a clockwise direction as viewed in FIG. 9, with the crossroad  108  turning while in the grasp of the hook  114 . There is enough clearance between the miter slot  118  and the edge  142  of the ramp to allow the crossrod to turn sufficiently so the catch tip  122  clears the lip  106 . Thus the handle  96  pivots about the hinge  100 , depressing the spring  130 . With the handle  96  and lip  106  in this position and the spring  130  depressed, as soon as the lip  106  clears the edge of the catch tip  122 , the spring rotates the handle in a counterclockwise direction, moving it to the position shown in FIG. 10 with ample force so that the clapper bar  126  strikes the body  98  of the cap member to produce the “click” sound. This “click” sound is the audible signal which the nurse may rely upon to indicate that the cap member  96  is locked to the port structure  91 . Under certain hospital conditions, particularly in the intensive care unit where there is not a great deal of light, this is an important feature because it provides additional assurance that the cap member  92  is locked to the port structure  91 .  
     [0069] As shown in FIG. 10, with the handle  96  in this locked position, the needle  44  has penetrated the central portion of the seal  36 , directed by the tappered sidewalls of the cavity  92   a  and the barrel  103 . Medication now flows through the connector  90  into the patient. Note, the handle  96  is not depressed as the cap member  92  is slid over the port structure  91 . To remove the cap member  92 , the handle  96  is depressed, moving it to the position shown in FIG. 10 a.  With the handle  96  in this position, the cap member  92  is pulled off the port structure  91 .  
     [0070] Except for the seal  36 , the connector  90  is made entirely of a transparent plastic. The use of a transparent plastic is preferred because this allows the nurse to see that the needle  44  is correctly inserted into the seal  36 , and thus provides additional safety. Also, the use of plastic makes the connector  90  a low cost, disposable item. The plastic most suitable is a polycarbonate made by Cyrolite Industries in Azusa, Calif. sold under the tradename Cyrolite. This plastic, which is commonly employed to make medical devices, has been approved for such uses by the United States Federal Drug Administration.  
     [0071] The connector  90  is particularly adapted to be used in a variety of different applications. For example, as illustrated in FIG. 20, it may be connected directly in line with a container  144  of medication to be supplied intravenously to a patient. In this instance, the cap member  92  has a tube  146  extending from it which has at its one end a male component  148  of a conventional luer lock connector. This male component  148  engages and locks with a mating female luer component  150  attached to the end of a line  146  extending from the container  144 . In a similar manner, the port structure  91  has extending from it a tube  154  which has at its end a female luer component  158  of a second luer lock connector. The male component  156  of this second luer lock connector is attached to the end of a tube  160  that is connected to a needle inserted into the vein of the patient. The luer lock connectors may be obtained from Burron Medical, Inc. in Bethlehem, Pa.  
     [0072]FIG. 21 illustrates the connector  90  integrated into a conventional piggyback connector  162 . The branch line  164  from the piggyback connector  162  has attached to it and integral therewith the port structure  91  including the lip  106  that engages the catch tip  122  of the locking mechanism  94 . Thus, a conventional feeding system  10  employing a piggyback connector may be modified by simply including a lip  106  adjacent the seal  36 . This lip  106  will then serve as the site for detachably connecting the cap member  92  to the piggyback connector  162 .  
     [0073] The connector  90 , as shown in FIG. 22, also lends itself to be used with central venous catheters which are inserted into the chest of the patient. Frequently, patients under home care use such catheters, and consequently, even simpler and safer devices and techniques must be employed. However, a serious problem with such catheters is the way the ends of the lumens or tubes  166  and  168  extending from the patient are sealed. Presently, the ends of these tubes  166  and  168  are sealed using conventional luer locks. When it is time for the patient or the nurse to introduce medication into the catheter, an intermediate portion of the tubes  166  and  168  must be clamped while being connected to the source of medication so that air is not drawn into the blood stream of the patient. Any large intake of air into the patient&#39;s blood stream will seriously injure or even kill the patient. With children, even a small amount of air may be fatal. That is why clamps are used to close off the tubes  166  and  168  until the connection is made with the source of medication. This results in the tubes  166  and  168  wearing out, requiring that they be repaired. Not only is this a dangerous system, but it is extremely inconvenient for the patient or nurse to use.  
     [0074] As illustrated in FIG. 22, the connector system  90  overcomes these difficulties by simply having at each of the respective ends of the tubes  166  and  168  port structures  91 . When the patient needs medication, he or she simply connects two of the cap members  92  to the respective port structures  91 , and when finished, disconnects the cap members. The medication is fed by the needles  44  through the seals  36  and into the respective tubes  166  and  168 . The cap members  92 , when detached, withdraw the needles  44  from the seals  36 , which are self sealing. Thus, the nurse does not need to clamp off the tubes  166  and  168  nor is periodic repair of the tubes required. Since the seal  36  is self-sealing, upon removal of the cap member  92  there is no danger of air being drawn through the port structure  91  into the patient&#39;s blood stream. Consequently, connector  90  is both safer and more convenient to use than the conventional central venous catheters.  
     [0075] The connector  90  is also adapted to be used repeatedly without damaging the seal  36 . Thus it is even more suitable for such applications as illustrated in FIG. 22 than conventional devices, because of the accuracy with which the needle  44  may be repeatedly directed into the center of the seal  36 . When the needle  44  is repeatedly stuck into and withdrawn from the seal  36 , the seal will have numerous holes in it and begin to develop a “swiss cheese” like appearance. Eventually, a core is cut away from the seal by several of these holes interconnecting, rendering the seal useless because it is no longer self-sealing. Consequently, the seal would have a very short life. By carefully controlling the dimensions of the molds used to make connector  90 , the cap member  92  and port structure  91  will be precision made parts. Consequently, with repeated use, the needle  44  will essentially always penetrate the same hole in the seal  36 , thus avoiding the “coring” problem.  
     [0076] Fourth Embodiment of the Invention  
     [0077] The fourth embodiment of this invention, the connector  170 , is illustrated by FIGS. 23 and 24. In connector  170  the port structure  172  is similar to that shown in the other embodiments except it has a pair of pins on opposite sides of its body  178  which co-act with J-type slits  180  and  182  in the sidewall of a cap member  183  housing the needle  44 . These J-type slits  180  and  182  are opposed to each other and provide a guideway for the pins  174  and  176  which slide along these slits as the port structure  172  matingly engages the cap member  183 .  
     [0078] To use this connector system  170 , the nurse aligns the port structure  172  with the open mouth  183   a  of the cap member so that the pins  174  and  176  are in alignment with the entryway to the J-type slits  180  and  182 . Then the nurse pushes the port structure  172  into the open mouth  183   a,  sliding the port structure into the cavity within the cap member  183 . The pins  174  and  176  first engage the entryway of the J-type slits  180  and  182  and then slide along the slits until they reach the base of the slits. At this point, the nurse twists or rotates the cap member  183  and port structure  172  in counter-rotating directions so that the pins  174  and  176  will then slide respectively into the hooks  180   a  and  182   a  of the slits and be secured. This embodiment does not provide an audible signal upon locking the cap member  183  to the port structure  172 , but is very economical to-manufacture.  
     [0079] Function of the Cap Member and Port Structure  
     [0080] As will be appreciated from the above description, the cap member provides several functions in a single structure. (We will no longer refer by number to any one of the components of the invention since we are now discussing in general how the cap member and port structure function to provide the attributes of safety and convenience.) First, the cap member surrounds the needle and provides a housing in which the needle is lodged safely so that needle sticks are avoided. Second, because the needle is so lodged within the housing, if the nurse did, for example, lay the cap member on the patient&#39;s bed, the needle would not come into direct contact with the bedding which might be infested with harmful bacteria. Thus, this arrangement of the needle deep within the cavity in the cap member provides protection for the patient against bacterial contamination and protection for the nurse against accidental needle sticks.  
     [0081] The port structure also provides more than one function. First, it serves as the site to attach the cap member, and, by means of a simple locking element such as a lip, thread, groove, pin or the like, provides an economical way to modify the conventional piggyback connector so that it may be used with the cap member. Second, the combination of a self-sealing seal and adjacent element that locks with the cap member provides a simple way to modify connectors so that they have enhanced safely and convenience.  
     [0082] The cap member and port structure function in combination to direct the needle into the center of the seal, lock these pieces together, and enable quick connection. The nurse or patient simply aligns the sealed end of the port structure with the open mouth of the cap member and pushes the two pieces together. The internal wall of the cap member and the exterior wall of the port structure engage to align the two pieces so that their respective axes coincide, guiding the needle into the center of the seal as they are pushed together. Consequently, the needle does not scrape the inside wall of the port structure so that particles of plastic are not introduced into the patient&#39;s blood stream and the coring problem is virtually eliminated. The cap member and port structure each carry elements of a locking mechanism which engage and lock the pieces together when the needle has pierced the seal, preventing accidental disconnect. Although other geometric forms may be employed, quick connection is facilitated by the cylindrical configuration of the walls of the cap member and port structure and the circular open mouth of the cavity. In particular, the first through third embodiments of this invention are very quickly connected because no extra step is required to align the cap member and port structure. All that the nurse need do is insert the port structure into the open mouth without any special concern for their relative positions, and, when using the second and third embodiments, simply push these two pieces together until the locking mechanism engages. When using the first or fourth embodiments, the extra step of rotating the two pieces relative to each other is required to engage the locking mechanism. When using the forth embodiment, the pins must also first be aligned with the entryways to the J-slits prior to pushing the port structure into the cavity in the cap member.  
     [0083] Because of the features embodied in the cap member and port structure, this invention may be used under normal hospital conditions without creating any additional work for the nurse, while substantially reducing the likelihood of harm to the patient due to carelessness and protecting the nurse against infection and making his or her job easier and faster.  
     SUMMARY  
     [0084] In summary: Our connector is safe because (a) the needle is recessed deeply within the cap member and, therefore, is not likely to be contaminated by bacteria, (b) the cap member and port structure upon engagement guide the needle into the center of the seal, avoiding scraping particles from the inside wall of the port structure, (c) the cap member, housing the needle safely within it, protects the nurse against needle sticks, and (d) the locking of the cap member and port structure together prevents accidental disconnects and (e) the “click” signals the nurse when the connector system is locked securely in position. Our connector is convenient to use because (a) the walls of the cap member and port structure, interacting with each other, provide a guideway for quick connection, (b) the locking mechanism eliminates the burdensome and time consuming task of taping, and (c) the connector is very simple to use so that it is ideal for home care of patients.  
     SCOPE OF THE INVENTION  
     [0085] The above description presents the best mode contemplated of carrying out the present invention as depicted by the four embodiments disclosed. The combination of features illustrated by these embodiments provide the safety and convenience of this invention. This invention is, however, susceptible to modifications and alternate constructions from the embodiments shown in the drawing and described above. Consequently, it is not the intention to limit it to the particular embodiments disclosed. On the contrary, the intention is to cover all modifications and alternate constructions falling within the scope of the invention as generally expressed by the following claims: