Abstract:
An improved disconnect device suitable for use with an IV tube or other medical tubing device which can be either manually disconnected or automatically disconnected by the application of an axial force sufficiently low to prevent patient injury; which can be sterilely reattached after disconnection; which allows fluid flow in either direction; which shuts off fluid flow from both directions when disconnected; and which can be simply and inexpensively manufactured and assembled with techniques common to the injection molding, and medical products manufacturing industry.

Description:
TECHNICAL FIELD OF THE INVENTION  
       [0001]     The present invention relates to the field of fluid transfer systems and, in particular, to an assembly for disconnecting and reconnecting fluid flow through a fluid transfer system.  
       BACKGROUND AND SUMMARY OF THE INVENTION  
       [0002]     Various types of fluid-conducting tubes are commonly used for directing fluid into or withdrawing fluids from a patient. These types of devices, collectively referred to herein as medical tubing devices, can be used, for example, to deliver medications, to withdraw fluids such as blood, or to monitor various parameters of a patient&#39;s vascular system. One such device, referred to as an intravascular (IV) administration device, allows a medical practitioner to introduce therapeutic agents, medications, nutrients, and various other fluids directly into the blood stream of a patient.  
         [0003]     A typical prior art IV administration device is shown in  FIG. 1 . Such a device typically consists of an over the needle catheter  10  which is inserted into a vein or artery, usually in the patient&#39;s arm  11 . The needle (not shown) is then removed and catheter  10  inserted completely into the blood vessel. The healthcare provider commonly uses surgical tape  12  to maintain the position of the catheter on the skin of the patient. One end of a flexible tube called an IV line  14  is then attached to the catheter and the other end is attached to a fluid reservoir  16 , allowing fluid to flow directly from the reservoir into the patient&#39;s bloodstream. The fluid typically either drains from a reservoir positioned above the patient to feed under gravity or is delivered via an infusion pump.  
         [0004]     In some uses, IV catheters can be utilized for a relatively short duration, for example, hours or for a few days. In other cases, IV catheters may be utilized for much longer durations, weeks or even months. Once these types of medical tubing lines are in place, it is difficult to remove and replace them. For example, removing and replacing an IV line typically requires another needle stick. This will subject the patient to increased pain. Also, certain patients have inadequate veins or compromised health conditions, which may make an additional stick difficult. Not only does this increase the discomfort to the patient, chances of accidental medical personnel sticks and exposure to blood borne pathogens are also increased.  
         [0005]     Certain IV administration devices, such as a central line or peripherally inserted central catheter (PICC) require a surgical procedure to insert the catheter into the patient. A central line is a thin flexible silicone tube or catheter, the tip of which is placed in one of the large veins deep in the chest, such as the superior vena cava. The central line is put in under either a local or a general anesthetic. The outside end of the line is on the chest, just above one or other nipple. It then tracks under the skin for a little way before going into a large vein just behind the collarbone. From there it goes into the superior vena cava. With a PICC line, a more recent development, a catheter is inserted into one of the large veins in the arm (usually near the bend of the elbow) and from there it is threaded into the superior vena cava. Once the PICC line is in place, it will usually be taped firmly to a patient&#39;s skin with a special transparent dressing to stop the catheter from moving around or coming out of the vein. In the case of either a central line or PICC line, if the line is unintentionally pulled, the patient may have to undergo additional surgery or radiological procedures in order to re-insert the device.  
         [0006]     Whatever the type of medical tubing device used, additional difficulties arise for patients that are ambulatory or for confused and pediatric patients. Ambulatory patients typically have to contend with medical tubing lines and fluid reservoirs when moving from one location to another. Active patients sometimes inadvertently catch tubing lines on an object, while confused or pediatric patients can pull on tubing in an attempt to remove a device. Health care workers or visitors can sometimes trip or become tangled in tubing while caring for the patient, causing injury to both the patient and the person entangled.  
         [0007]     When these types of forces are applied to a medical tubing device, such as an IV line, the tubing itself typically does not break. Instead, the force is transferred along the tubing to the insertion point into the patient&#39;s body. In the case of a typical IV device, this means that a pull on the tubing can, in turn, pull on the IV catheter resulting in significant pain to the patient. In some cases, the catheter can actually be pulled out of the patient, interrupting the flow of medication or other fluid and necessitating another needle stick to reinsert a catheter. For medical tubing devices such as drainage catheters, central line, or PICC line, the patient might have to undergo additional surgical or radiological procedures. These additional procedures add to patient discomfort, increase medical costs, and expose patients to additional risk of infection.  
         [0008]     The typical medical tubing device is unified and not designed to provide easy disconnection or automatic fluid flow interruption in the event of disconnection. A number of disconnect devices which interrupt fluid flow by way of a valve or other device have been described in the prior art. All of the valved disconnect devices described to date, however, suffer from design characteristics that limit their usefulness for medical tubing devices. Hence, there is a need for an improved technique to allow an IV or other medical tubing device to be either manually disconnected or to automatically disconnect at a force sufficiently low to prevent patient injury and then to be sterilely reattached without replacing the device and without subjecting the patient to another needle stick or medical procedure.  
         [0009]     Valved assemblies for use in medical tubing devices are known in the prior art. Such devices are described, for example, in U.S. Pat. No. 6,036,171 to Weinheimer et al. for “Swabbable Valve Assembly,” in U.S. Pat. No. 5,700,248 to Lopez for “Medical Valve with Tire Seal,” and in U.S. Pat. No. 5,137,524 to Lynn et al. for “Universal Intravenous Connector with Dual Catches.” Many such devices connect by way of a needle piercing a septum. Thus, such devices generally only allow fluid flow in one direction. Also, repeated piercing of the needle through the septum can damage the septum, resulting in leaks or in the introduction of material from the septum into the flow line. Further, even where a needle and septum arrangement is not employed, these types of devices typically only shut off fluid flow in one direction when disconnected. Finally, none of these designs allows for automatic disconnection if a predetermined force is applied to the tubing.  
         [0010]     A valved assembly that does allow for automatic disconnection is described in U.S. Pat. No. 5,820,614, to Erskine et al. for “Disconnect for Medical Access Devices.” However, this device, due to a number of design limitations, does not adequately address many of the common problems with the use of IV lines that are encountered in the modern medical facility.  
         [0011]     For example, the Erskine design does not adequately provide for intentional manual disconnection. The only method for intentionally disconnecting the device is to apply a distal axial load to the connector or tubing, thus pulling the connector apart. As a result, each disconnect—whether intentional or automatic—will cause additional wear on the collar and shoulder latching assembly, which will decrease the number of additional times that the device may be disconnected and reconnected before the latching assembly is worn out. The use of a spring in the design increases the cost of the device due to the cost of the spring and the increased assembly time. The presence of the spring and the chamber housing the spring also increases the possibility of bacterial contamination. In the event that fluid seeps into the spring housing, a stagnant fluid pool could be created allowing bacteria to reproduce. Because the septa are located behind (distal to) the connecting mechanism, the Erskine design does not permit easy access to critical sites that must be disinfected by swabbing with alcohol or other appropriate disinfectant solution. Further, the design of the piercing cannula subjects the septum to abrasive forces which degrade the material and lead to significant generation of debris which may be transported into the patient.  
         [0012]     Although there are also numerous break-away hose connectors known and used in other fields, such as the gasoline-dispensing device described in U.S. Pat. No. 4,905,733, these devices do not permit easy disinfection, which is critical in medical devices. In the above cited patent, a ball mechanism is mounted within the latch. This mechanism is exposed to the fluid. The non-smooth surface prevents easy “swabbability” or disinfection of the device, thereby rendering the design unsuitable for the medical field.  
         [0013]     Hence, there is a need for an improved technique to allow an IV or other medical tubing device to be either manually disconnected or to automatically disconnect at a force sufficiently low to prevent patient injury and then to be sterilely reattached without necessitating another needle stick or medical procedure to replace the device; which allows fluid flow in either direction; which shuts off fluid flow from both directions when disconnected; and which can be simply and inexpensively manufactured and assembled with techniques common to the injection molding, and medical products manufacturing industry. The disconnection device described below derives new and unique benefits from a combination of valving and latching elements not revealed before.  
       SUMMARY OF THE INVENTION  
       [0014]     An object of the invention, therefore, is to provide an improved disconnect device suitable for use with an IV tube or other medical tubing device which can be either manually disconnected or automatically disconnected by the application of an axial force sufficiently low to prevent patient injury. Another object of the invention is to provide an improved disconnect device which can be easily disinfected and reconnected without subjecting the patient to another needle stick or medical procedure or the need to replace the medical tubing device.  
         [0015]     The foregoing has outlined rather broadly the features and technical advantages of the present invention in order that the detailed description of the invention that follows may be better understood. Additional features and advantages of the invention will be described hereinafter. It should be appreciated by those skilled in the art that the conception and specific embodiments disclosed may be readily utilized as a basis for modifying or designing other structures for carrying out the same purposes of the present invention. It should also be realized by those skilled in the art that such equivalent constructions do not depart from the spirit and scope of the invention as set forth in the appended claims. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0016]     For a more complete understanding of the present invention, and the advantages thereof, reference is now made to the following descriptions taken in conjunction with the accompanying drawings, in which:  
         [0017]      FIG. 1  shows a typical prior art IV administration device.  
         [0018]      FIG. 2  is a cross-sectional view of a disconnect device according to the present invention with the male and female connectors disengaged.  
         [0019]      FIG. 3A  is a cross-sectional view of the penetration tube of the disconnect device of  FIG. 2 .  
         [0020]      FIG. 3B  is a perspective view of the penetration tube of the disconnect device of  FIG. 2 .  
         [0021]      FIG. 3C  is another perspective view of the penetration tube of the disconnect device of  FIG. 2 .  
         [0022]      FIG. 4A  is a cross-sectional view of the male and female stopples of the disconnect device of  FIG. 2 .  
         [0023]      FIG. 4B  is a cross-sectional view of the assembled male stopple and penetration tube of the disconnect device of  FIG. 2 .  
         [0024]      FIG. 5  is a cross-sectional view of the disconnect device of  FIG. 2  with the male and female connectors fully engaged.  
         [0025]      FIG. 6A  is a cross-sectional view of the male connector of  FIG. 2  showing the manual disconnect feature.  
         [0026]      FIG. 6B  is different cross-sectional view of the male connector of  FIG. 2 .  
         [0027]      FIG. 6C  is a perspective view of the male connector of  FIG. 2 .  
         [0028]      FIG. 7A  is a perspective view of one embodiment of a disconnect device according to the present invention with the male and female connectors disengaged but oriented for proper attachment.  
         [0029]      FIG. 7B  is a perspective view of one embodiment of a disconnect device according to the present invention with the male and female connectors fully engaged.  
         [0030]      FIG. 8  is a perspective view of one embodiment of a disconnect device according to the present invention showing a different pattern of alignment wings and grooves. 
     
    
     DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS  
       [0031]     A preferred embodiment of this invention provides a novel apparatus allowing an IV tube or other medical tubing device to be either manually disconnected or to automatically disconnect at a force sufficiently low to prevent patient injury and then to be reattached without necessitating another needle stick or medical procedure or the need to replace the device.  
         [0032]     In accordance with one aspect of a preferred embodiment of the present invention, the design of the apparatus allows fluid flow across a fluid delivery tubing device to be quickly disconnected without significant leakage of fluid.  
         [0033]     In accordance with another aspect of a preferred embodiment of the present invention, the design of the apparatus allows fluid flow across a fluid delivery tubing device to be automatically disconnected if a force above a certain threshold is applied to the apparatus itself or to the fluid delivery line.  
         [0034]     In accordance with another aspect of a preferred embodiment of the present invention, the design of the apparatus prevents any significant fluid leakage and prevents the introduction of foreign substances or contaminants into the fluid supply when fluid flow is disconnected.  
         [0035]     In accordance with another aspect of a preferred embodiment of the present invention, the design of the apparatus allows disconnected fluid flow across a fluid delivery tubing device to be reconnected after appropriate disinfection of connecting surfaces.  
         [0036]     In accordance with another aspect of a preferred embodiment of the present invention, the design of the apparatus allows different sets of connectors with distinct geometric configurations to provide for a means of preventing improper connections in a multiple connection environment.  
         [0037]     In accordance with another aspect of a preferred embodiment of the present invention, the design of the apparatus allows for an alarm when fluid flow is disconnected.  
         [0038]     Particular embodiments of the present invention are directed to an apparatus for connecting and disconnecting opposite ends of a liquid flow line. Although much of the following description is directed toward medical tubing devices, the apparatus could equally be utilized with any type of liquid flow device. Hence, the scope of the present invention should not be limited to a disconnect device for medical tubing devices. In this application, the terms “valve,” “septum,” and “stopple” will be used interchangeably to refer to devices for opening, closing, or modifying the flow of a fluid through a tube, outlet, inlet, or the like. Further, in this application, the term “proximal” will be used to designate the end of the connector nearest the opposing connector and the term “distal” will be used to designate the end of the connector furthest from the opposing connector. The term “distal axial force” will be used to describe force applied along the longitudinal axis of the connector, parallel to the fluid flow, in a direction that pulls the two opposing connectors apart. It will be assumed for the sake of simplicity that fluid flow occurs from the male connector to the female connector. However, it will be apparent to those skilled in the art that when the two connectors are engaged fluid can flow in either direction and from either connector.  
         [0039]      FIG. 2  is a cross-sectional view of a disconnect device according to the present invention. In a preferred embodiment, the disconnect device comprises two connectors, a female connector  102  and a male connector  104 . Each connector can be attached to corresponding sections of a medical tubing line (not shown). For example, female connector  102  could be connected to one end of a length of IV tubing and the other end connected to the catheter inserted into a patient&#39;s bloodstream; and male connector  104  could be connected to one end of a second length of IV tubing with the other end of the second length connected to a fluid reservoir containing therapeutic agents, medications, nutrients, or various other fluids. Alternatively, either the female connector  102  or the male connector  104  could be connected directly to the catheter inserted into a patient&#39;s body.  
         [0040]     In another preferred embodiment, either the female connector  102  or the male connector  104  could be either permanently bonded to the catheter inserted into the patient or manufactured as a part of said catheter. Alternatively, the other connector could be permanently bonded to the supply or drainage tubing. In this embodiment, the luer lock connectors described below could be eliminated resulting in a significant reduction in the outer diameter of the connectors.  
         [0041]     In the disengaged view of  FIG. 2 , the male and female connectors are disposed generally opposite each other. Female connector  102  comprises a female connector housing  108 , which contains luer body  106  and female connector stopple  310 . Female connector housing  108  is generally cylindrical in shape and includes stopple support  111 , external female connector detents  110 , and internal luer lock threads  112 .  
         [0042]     Male connector  104  comprises a male connector housing  122 , which contains penetration tube  202  and male connector stopple  320 . Male connector housing  122  is also generally cylindrical in shape and includes male connector detents  118  and internal sealing support  126 .  
         [0043]     Preferably, male connector housing  122  is formed from a material that has a high degree of flexibility and lubricosity such as high-density polyethylene. Female connector housing  108 , luer body  106 , and penetration tube  202  can be formed from a thermo-plastic material such as high-impact polystyrene. Female connector stopple  310  and male connector stopple  320  can be formed from a resilient elastomeric material such as rubber or a silicon elastomer.  
         [0044]      FIG. 3A  is a cross-sectional view of the penetration tube  202  of the disconnect device of  FIG. 2 .  FIG. 3B  is a perspective view of the penetration tube of the disconnect device of  FIG. 2  as seen from the side.  FIG. 3C  is a perspective view of the penetration tube of the disconnect device of  FIG. 2  as seen from the distal end. Penetration tube  202  preferably has a generally cylindrical base  204 , which can be threaded with external luer threads  206 , and a generally conical tip  208  with fluid transfer opening  210  and cap  212 . Optionally, cylindrical base  204  can be hermetically attached to tubing eliminating the need for luer threads  206 . At its apex, conical tip  208  is topped by cap  212 , which preferably has a smooth or blunt proximal surface. External luer threads  206  on penetration tube base  204  can be used to connect a fluid transfer line such as a conventional IV line. The interior of base  204  and tip  208  are continuous such that liquid flowing into base  204 , for example fluid flowing through an IV line, passes into tip  208  and exits through one or more fluid transfer openings  210 .  
         [0045]     Referring also to  FIG. 6A  and  FIG. 6B , penetration tube  202  can be held in place in male connector housing  122  by tube retainer latches  215 . In a preferred embodiment, when penetration tube  202  is mounted into male connector housing  122 , tube retaining latches  215  compress as tube retainer ring  214  passes, then expand to lock into latch grooves  302  located on the distal surface of tube retainer ring  214 , thereby holding tube  202  in its final position. Alternatively, tube  202  can be held in connector housing  122  with adhesive bonding or sonic welding. Retaining collar  322 , the flange portion at the distal end of stopple  320  as discussed below, is compressed between the proximal surface of tube retainer ring  214  and a sealing bead  217  on the interior surface of internal sealing support  126 . Preferably, the connection between penetration tube  202  and male connector housing  122  is capable of withstanding an axial load of 25N in accordance with International Standard ISO 594-1 (1986 ed., Reference No. ISO 594/1-1986(E)) as published by the International Organization for Standardization, Case postale 56, CH-1211 Geneva 20, Switzerland.  
         [0046]      FIG. 4A  is a cross-sectional view of the male and female stopples of the disconnect device of  FIG. 2 . Both the male and female stopples comprise valves that are normally biased so as to block any fluid flow through either connector when the male and female connectors are disengaged. Male connector stopple  320  is generally spool shaped with a cylindrical center section  321  and flange portions formed at either end of the cylindrical section. The flange portion at the distal end of stopple  320  forms retaining collar  322 . The flange portion at the proximal end of stopple  320  forms male septum  323 , with formed hole  324  located in the center of male septum  323 .  
         [0047]     Male connector stopple  320  can be mounted in male connector housing  122  by compressing retaining collar  322  and pulling the compressed ring through the center opening in internal sealing support  126  and toward the distal end of male connector housing  122 . As shown in  FIG. 4B , penetration tube  202  is seated inside stopple  320  oriented so that tip of penetration tube  202  is proximal to its base. In a preferred embodiment, cap  212  passes through formed hole  324  and protrudes slightly from the proximal surface of male septum  323 . This arrangement provides for a tight seal while at the same time minimizing damage to the septum that could result from repeated piercing of the septum by the tip of the penetration tube  202 . The proximal sealing surface of penetration tube  202  compresses retaining collar  322  against the distal surface of internal sealing support  126 . The connection at the joint between the penetration tube  202 , male stopple retaining collar  322 , and the distal surface of internal sealing support  126  should preferably be capable of sealing water pressure at 300 kPa in accordance with Part  5 . 2  of the International Standard ISO 594-2 (1998 ed., Reference No. ISO 594-2: 1998(E)) as published by the International Organization for Standardization, Case postale 56, CH-1211 Geneva 20, Switzerland.  
         [0048]     Female connector stopple  310  is also generally spool shaped with a cylindrical center section  311  and flange portions formed at either end of the cylindrical section. The flange portion at the distal end of stopple  310  forms sealing ring  312 . The flange portion at the proximal end of stopple  310  forms female septum  313  with slit  314 . Referring also to  FIG. 2 , female connector stopple  310  is held in place by female stopple support  111 . Stopple  310  can be mounted, for example, by compressing sealing ring  312  and pushing it through the center of stopple support  111 . Stopple support  111  thus fits inside a retaining groove formed by the cylindrical and flange portions of stopple  310 .  
         [0049]     Referring again to  FIG. 2 , luer body  106  is inserted into the distal end of female connector housing  108  and oriented so that fluid chamber  144  is proximal to luer taper  143 . Luer body  106  can be held in place, for example, by compressible luer retaining latches  148  formed on the exterior surface of luer body  106  just proximal to luer body shoulder  150 . In a preferred embodiment, as luer body  106  is inserted, luer retaining latches  148  press against the interior surface of female connector housing  108 . Luer retaining latches  148  are compressed as luer body  106  is pressed into female connector housing  108  and then expand into mounting cavities  149  to hold luer body  106  in its final position. Once luer body  106  is fully inserted into female connector housing  108 , luer sealing ring  146  at the proximal base of fluid chamber  144  presses against the distal surface of female stopple sealing ring  312 , thus compressing sealing ring  312  against the distal surface of female stopple support  111  and forming a tight fluid seal.  
         [0050]      FIG. 5  is a cross-sectional view of the disconnect device of  FIG. 2  with the male and female connectors fully engaged. When disengaged, the stopples of both connectors are biased so as to block any fluid flow through either connector. In order to engage the connectors and overcome the stopples&#39; normal bias thereby allowing fluid flow through the connectors, the male and female connectors are first brought into approximate center alignment so that the proximal surface of female connector septum  313  is in contact with the proximal surface of male connector septum  323 . As discussed in greater detail below, alignment features in the connectors can be used to ensure proper orientation. As shown in  FIG. 4A , both female septum  313  and male septum  323  have slightly concave surfaces. As a result, when the septa are brought together the concave edges will compress thus creating a slight suction force sealing the surfaces of the septa together.  
         [0051]     As the connectors are pushed together, female connector stopple  310  is held in place by female stopple support  111 . The cylindrical center section  321  of male connector stopple  320  is formed with collapsible sidewalls, which allow male connector stopple  320  to compress axially towards the distal end of the tip  208  of penetration tube  202 . Formed hole  324  in male septum  323  expands radially to accommodate and seal around the increasing diameter of tip  208  as male connector stopple  320  is compressed. At the same time, tip  208  pierces the slit  314  in female septum  313  and inserts into fluid chamber  144  of luer body  142 . Preferably, penetration tube  202  has a smooth or blunt end which minimizes coring damage to the septum that could result from repeated piercing of the septum by a penetration member with sharper edges such as the tube or cylinder designs taught by the prior art. Slit  314  in female septum  313  also expands radially to accommodate and seal around the increasing diameter of tip  208  as the tip is inserted. When male connector stopple  320  is completely compressed, fluid transfer opening  210  extends at least partially into fluid chamber  144 , thus allowing fluid to flow from a fluid source (not shown) through penetration tube  202 , into fluid chamber  144 , and then out into the downstream portion of the fluid-delivery device (not shown). In a preferred embodiment, formed hole  324  displaces radially when tip  208  extends through it, and therefore does not deform the male septum  323  outward into the female septum  313 , which helps maintain the fluid tight seal between the two septa and also lowers the required attachment force.  
         [0052]     As discussed in greater detail below, once the connectors are brought together in the fully engaged position, female connector detents  110  and male connector detents  118  engage to hold the connectors in place and maintain fluid connection. Although the detents described in this embodiment are essentially latches with lips and opposing faces that catch to hold the detents together, skilled persons will recognize that a number of different types of detents could be used, including but not limited to additional latching mechanisms such as magnetic, adhesive, or hook and loop connections. In a preferred embodiment, engagement of the female connector detents  110  and male connector detents  118  will result in an audible “click” indicating the proper engagement of the two components. In this locked position, fluid can flow from penetration tube base  204  to penetration tube tip  208 , out through fluid transfer opening  210 , into fluid chamber  144  of luer body  142 , and then into a fluid delivery tube attached to luer body  142 .  
         [0053]      FIG. 6A  is a cross-sectional view of the male connector of  FIG. 2  showing an embodiment of a manual disconnect feature according to the present invention.  FIG. 6B  is a different cross-sectional view of the male connector of  FIG. 2  at a plane  90  degrees from the cross-section shown in  FIG. 6A .  FIG. 6C  is a perspective view of the male connector of  FIG. 2 . Referring also to  FIG. 7A and 7B , in this preferred embodiment, disconnect slots  218  extend the entire length of male connector housing  122 , essentially dividing male connector housing  122  into two halves connected by mounting hinges  123 . In a preferred embodiment, interior sealing support  126 , discussed above, can also serve as such a mounting hinge. In a preferred embodiment, the application of inward force on the distal end of male connector housing  122  at points approximately 90 degrees from the disconnect slots  218  can cause the two halves of male connector housing  122  to pivot at mounting hinge  123 . This application of force will narrow the width of disconnect slots  218  at the distal end of male connector housing  122  while simultaneously expanding the width of disconnect slots  218  at the proximal end of male connector housing  122 . Sufficient expansion of the proximal end of disconnect slots  218  will cause female connector latch  110  and male connector latch  118  to disengage.  
         [0054]     Such an application of force can be accomplished, for example, by squeezing together finger grip  602  and corresponding opposite finger grip  604 . Once the male and female connector detents are disengaged, male connector stopple  320 —which is in a compressed state when the two connectors are engaged—will expand axially towards the proximal end of the tip  208  of penetration tube  202 . Formed hole  324  in male septum  323  contracts radially to retain a seal around the decreasing diameter of tip  208  as male connector stopple  320  is expanded.  
         [0055]     The expansion of male connector stopple  320  serves to apply pressure against the proximal surface of female connector septum  313 , thus pushing female connector  102  away from penetration tube  202  and removing tip  208  from fluid chamber and female septum slit  314 . Slit  314  will then reseal preventing any fluid back-flow. When male connector stopple  320  is completely expanded, the perimeter of cap  212  again seals formed hole  324  in male connector septum  323  at a point proximal to fluid transfer opening  210 , thus preventing any further flow through male connector  104 . In order to completely disengage the connectors, the male and female connectors must be pulled apart with sufficient additional force to overcome the slight suction force resulting from the concave surface of the two septa, as discussed above.  
         [0056]     In a preferred embodiment, the disconnect device of the present invention can also serve as a break-away device allowing automatic disconnection when sufficient distal axial force is applied to either the fluid delivery device or the disconnect device. The application of sufficient distal axial force to the fully engaged disconnect device shown in  FIG. 5  can pull female connector detents  110  past male connector detents  118 , thus disconnecting the two connectors and shutting off fluid flow. By varying the materials used in construction of the connector bodies, varying the amount of overlap between female connector detents and male connectors detents when the connectors are fully engaged, and varying the angle of the latch faces of female connector latch  110  and male connector latch  118 , the distal axial force required to separate the male and female connectors can be varied. Selection of a disengagement force which is less than a certain threshold—for example, a threshold less than the force required to pull an IV catheter out of a patient&#39;s bloodstream or the force required to pull a drainage catheter out of the patient—would allow the disconnect device to separate before the force resulted in injury to the patient.  
         [0057]     In a preferred embodiment of the present invention, after either manual or automatic disengagement, the disconnect device can be easily disinfected so that the device can be reconnected and the fluid flow restored without introducing any pathogens or contaminants into the fluid supply. Referring again to  FIG. 2 , the illustrated embodiment comprises male and female proximal septa surfaces that are easily accessible when the connectors are disengaged. The surfaces of these septa can, for example, be disinfected via the application of a conventional disinfecting solution with a swab or other means.  
         [0058]     In a preferred embodiment of the present invention, a conventional proximity switch or contact can be placed at or near the male and female connector stopples to alert health care personnel of a disconnection by, for example, sounding an audible alarm.  
         [0059]      FIG. 7A  is a perspective view of one embodiment of a disconnect device according to the present invention with the female connector  102  and male connector  104  disengaged but oriented for proper attachment.  FIG. 7A  also shows female connector latch  110  and male connector latch  118  which can be engaged to hold the connectors in place.  FIG. 7B  is a perspective view of one embodiment of a disconnect device according to the present invention with the female connector  102  and male connector  104  fully engaged. Anti-rotation alignment wings  216  formed on female connector housing  108  can be aligned with corresponding anti-rotation grooves or slots formed in male connector housing  122 . Once the female connector  102  and male connector  104  are fully engaged, the anti-rotation wings can serve to prevent the female connector  102  from rotating relative to the male connector  104 . This allows the assembled connector to be gripped to tighten the male and female luer connectors in order to attach tubing to the female connector  102  and/or male connector  104 . In the embodiment shown in  FIG. 7A  and  FIG. 7B , disconnect slots  218  serve as anti-rotation grooves.  
         [0060]     Although the illustrated embodiment has two anti-rotation alignment wings  216  located  180  degrees apart, skilled persons will recognize that different numbers and orientations of corresponding alignment wings and grooves can be utilized. Different alignment sets could be used for different types of fluid transfer lines, such as for example IV lines and drainage lines, to prevent accidental connection of the wrong fluid transfer lines in a multiple connection environment. Other systems could easily be employed to prevent accidental connection of different fluid lines, including for example different sets of connectors with distinct geometric configurations or different patterns of interlocking pins and holes on the male and female housings.  
         [0061]     Optionally, tubing can be permanently bonded to female connector  102  and/or male connector  104 , eliminating the need for any anti-rotation means. In that case, however, different alignment sets as discussed above could still be employed to prevent accidental connection of different fluid lines.  
         [0062]      FIG. 8  is a perspective view of one embodiment of a disconnect device according to the present invention showing a different pattern of alignment wings and grooves. In order to attach the connector shown in  FIG. 8 , alignment wing  802  must be lined up with alignment groove  804 . As shown in  FIG. 7A  and  FIG. 7B , alignment wings  216  can be lined up with disconnect slots  218 , which in this instance also serve as alignment grooves. As the male and female connectors are engaged, alignment wing  802  will slide into alignment groove  804  and alignment wings  216  will slide into disconnect slots  218 . If different patters of alignment wings and grooves were employed for different fluid transfer lines, mismatched male and female connectors could not be engaged thus preventing accidental connection of the wrong fluid transfer lines in a multiple connection environment.  
         [0063]     Although the present invention and its advantages have been described in detail, it should be understood that various changes, substitutions and alterations can be made to the embodiments described herein without departing from the spirit and scope of the invention as defined by the appended claims. Moreover, the scope of the present application is not intended to be limited to the particular embodiments of the process, machine, manufacture, composition of matter, means, methods and steps described in the specification. As one of ordinary skill in the art will readily appreciate from the disclosure of the present invention, processes, machines, manufacture, compositions of matter, means, methods, or steps, presently existing or later to be developed that perform substantially the same function or achieve substantially the same result as the corresponding embodiments described herein may be utilized according to the present invention. Accordingly, the appended claims are intended to include within their scope such processes, machines, manufacture, compositions of matter, means, methods, or steps.