Abstract:
A catheter connector system for a subcutaneously placed catheter and method of attaching a catheter to extracorporeal medical equipment. The catheter connector system and method enables proximal trimming of the placed catheter and facilitates precise positioning of both distal and proximal ends of a catheter. The method includes sliding a boot and dilator combination over a portion of a catheter extending from a venipuncture site until a distal end of the boot is positioned in the venipuncture site, removing the dilator from the boot, and trimming a portion of the catheter extending from a proximal end of the boot. A bifurcation assembly may be attached to the proximal end of the boot following trimming of the catheter.

Description:
PRIORITY 
       [0001]    This application is a division of U.S. patent application Ser. No. 12/563,776, filed Sep. 21, 2009, which is a division of U.S. patent application Ser. No. 10/803,513, filed Mar. 18, 2004, now U.S. Pat. No. 7,594,911, each of which is incorporated by reference in its entirety into this application. 
     
    
     BACKGROUND OF THE INVENTION 
       [0002]    It is common to use an implanted catheter to repeatedly access the vascular system of a patient and with the catheter perform repeated therapeutic medical activity. Such therapeutic activity could include the intermittent or continuous infusion of medication and fluids, the periodic sampling of blood, or the continuous withdrawal and return of blood for processing outside of the body of the patient. The catheters used in these activities are referred to as vascular access catheters. 
         [0003]    Before any therapeutic activity can actually commence, however, the vascular access catheter must be implanted in the body of the patient with the distal tip of the catheter residing at the location in the vascular system at which an intended therapeutic activity is appropriate. Typically, most of the length of an implanted vascular access catheter resides within blood vessels of the vascular system, extending from the distal tip of the catheter to a location in the vascular system at which the catheter, by traversing a puncture or incision formed through a wall of the blood vessel in which the catheter is disposed, enters into the surrounding subcutaneous tissue of the patient. The location at which this occurs is referred to as a venipuncture site. Venipuncture sites are classified on the basis of the position of a venipuncture site in relation to the center of the body of the patient. Central venipuncture sites are those that enter the vasculature through the jugular or subclavian veins. Peripheral venipuncture sites typically enter the basilic or cephalic veins of the upper or lower arm. The freedom to select among venipuncture sites is determined largely on catheter size and vein size. Vein size is dependent on patient size and on location within the body, with peripheral veins being smaller than central veins. 
         [0004]    Proximal of the venipuncture site, the implanted catheter extends through the subcutaneous tissue of the patient to emerge through the skin at a location that is referred to as the skin exit site. Most skin exit sites are chosen as being locations at which the proximal end of the implanted catheter can be easily manipulated by medical personnel. Favored among such locations are the neck, the region about the collar bone or chest wall, the upper leg, the upper arm, and the forearm. Occasionally, the skin exit site is somewhat removed from the venipuncture site. Then a significant portion of the length of the implanted catheter must be embedded in the subcutaneous tissue of the patient in a surgically created tunnel that extends from the venipuncture site to the skin exit site. In all instances, a portion of the proximal end of an implanted catheter must remain outside of the body of the patient. It is this portion of an implanted catheter, from the proximal end thereof to the skin access site, that is referred to as the extracorporeal portion of the implanted catheter. 
         [0005]    The extracorporeal portion of an implanted catheter must be capable of being selectively coupled to and uncoupled from the tubing and medical equipment outside the body of the patient that are required for therapeutic activity. Accordingly, the proximal end of virtually all vascular access catheters terminates in a catheter coupling hub that can be secured in fluid communication with such tubing and medical equipment, or can be capped, valved, or clamped closed between periods of actual use. Due to the variation in length of catheter that is required to traverse the subcutaneous and intravascular route from implanted tip location to skin exit site, it often becomes necessary to trim the catheter to an appropriate length. Traditionally, it is the distal end of the catheter that is trimmed as opposed to the proximal end for a number of reasons, including the desire to provide accurate positioning of a pre-connected proximal suture wing hub in a desired location near the venipuncture site. In particular, clinicians are increasingly showing a preference for a stepped-taper or reverse-taper of the hub to be inserted partially into the venipuncture site to affect tamponade and reduce site bleeding. 
         [0006]    Trimming the catheter to an appropriate length is particularly advantageous with respect to peripherally inserted central catheters (PICCs) where precise central venous catheter tip placement at the right atrial (RA), superior vena cava (SVC) junction is imperative to prevent potential thrombosis, traumatic or functional complications. Many types of catheters, however, cannot be distally trimmed due to the special configuration thereof, including, for example, dual lumen catheters with a pre-staggered tip, soft tip catheters, catheters with valved distal ends, etc. In the case of such catheters, a pre-connected hub at the proximal end of the catheter cannot be accurately located at the venipuncture site and, consequently, some length of catheter extends therefrom. This excess catheter length often presents difficulty in dressing the catheter and exposes the catheter to potential damage. Moreover, it is not possible in the placement of catheters having preformed distal tips to achieve tamponade at the venipuncture site. 
         [0007]    Whether or not the catheter has a preformed distal tip, it is advantageous to be able to trim a catheter at its proximal end prior to connection to a coupling hub or other extracorporeal medical equipment because proximal trimming enables physicians to keep inventory low (as several different catheter lengths are unnecessary) and each catheter placed can be customized to the exact length optimal for patient comfort and operability of the catheter. As a result, many types of connection systems have been proposed to couple a proximal end of a catheter to a medical device. 
         [0008]    With particular reference to a catheter that has a been subcutaneously placed, in which an extracorporeal portion is to be connected to a coupling hub, systems such as that shown in  FIG. 1  have been traditionally utilized. As shown, a catheter  20  is attached to a coupling hub  12  through three pre-assembled pieces. The proximal end of the catheter  20  is slid through strain relief sleeve  18 , distal coupling  16  and compression sleeve  14 . The proximal end of the catheter  20  is then slid over the cannula of coupling hub  12 . Distal coupling  16  is snapped into coupling hub  12 , exerting pressure against compression sleeve  14 , which in turn retains catheter  20  on the cannula coupling hub  12 . While such a connection system may be adequate for providing a secure connection, assembly can prove problematic due to the small size of the pieces involved as well as the extremely limited space with which the physician typically has to work. Moreover, the manufacture of several different pieces may lengthen the time to manufacture, as well as the cost associated therewith. 
         [0009]    As mentioned above, in some instances it is preferable to partially insert a catheter hub into the venipuncture site. However, a system has not been previously proposed that will permit precise placement of the non-trimmed distal tip of the catheter subcutaneously while also providing the ability for the proximal hub to be partially inserted into the venipuncture site. Moreover, whereas prior art systems for proximally trimmable single lumen catheters have been proposed, such as depicted in  FIG. 1 , there has not to date been proposed a system for proximally trimmable externalized dual lumen catheters. 
         [0010]    Accordingly, it is an object of the present invention to provide a catheter connector system, which safely and effectively connects a proximal end of a catheter to extracorporeal medical equipment, following placement of the distal end of the catheter in a patient. It is a further object of the present invention to provide a catheter connector system that permits venipuncture tamponade, that reduces assembly time of an associated suture wing, that improves robustness of the externalized catheter by eliminating unprotected catheter portions, that provides the functionality of a repair kit, and that provides a proximally trimmable design for a dual-lumen catheter. 
         [0011]    Various other objectives and advantages of the present invention will become apparent to those skilled in the art as more detailed description is set forth below. 
       BRIEF SUMMARY OF THE INVENTION 
       [0012]    The present invention is directed to a catheter connector system for a subcutaneously placed catheter. The catheter connector system permits proximal trimming of the placed catheter, which is a procedure that provides numerous advantages over traditional methods of trimming catheter distal ends prior to implantation. Further, the catheter connector system of the present invention facilitates precise positioning of both distal and proximal ends of a catheter, which provides enhanced functionability and patient comfort. 
         [0013]    In one embodiment of the present invention, a catheter connector system for a catheter comprises a boot comprising a tapered outer wall having a diameter that decreases toward a distal end thereof, said outer wall enclosing a longitudinally extending lumen, wherein said boot lumen is sized to prevent axial movement of said catheter when said catheter is positioned therein, and a bifurcation assembly, comprising at least one extension leg extending from a proximal end thereof and at least one stem extending from a distal end thereof, wherein said at least one stem is configured to be received into a lumen of said catheter. 
         [0014]    In another embodiment of the present invention, a kit for connecting a catheter to extracorporeal medical equipment comprises a boot comprising a tapered outer wall having a diameter that decreases toward a distal end thereof, said outer wall enclosing a longitudinally extending lumen, wherein said boot lumen is sized to prevent axial movement of said catheter when said catheter is positioned therein, a bifurcation assembly, comprising at least one extension leg extending from a proximal end thereof and at least one stem extending from a distal end thereof, wherein said at least one stem is configured to be received into a lumen of said catheter, and a dilator comprising a shaft having an outer wall enclosing a longitudinally extending lumen, said shaft configured to expand said boot lumen when positioned therein, said dilator lumen configured for slideable movement over said catheter. 
         [0015]    In yet another embodiment of the present invention, a proximally trimmable catheter system comprises a catheter comprising at least one lumen, a boot comprising a tapered outer wall having a diameter that decreases toward a distal end thereof, said outer wall enclosing a longitudinally extending lumen, wherein said boot lumen is sized to prevent axial movement of said catheter when said catheter is positioned therein, a bifurcation assembly, comprising at least one extension leg extending from a proximal end thereof and at least one stem extending from a distal end thereof, wherein said at least one stem is configured to be received into a lumen of said catheter, and a dilator comprising a shaft having an outer wall enclosing a longitudinally extending lumen, said shaft configured to expand said boot lumen when positioned therein, said dilator lumen configured for slideable movement over said catheter. 
         [0016]    In still another embodiment of the present invention, a catheter connector system for an implanted catheter comprises a boot comprising a tapered outer wall, having a diameter that decreases toward a distal end thereof and enclosing a longitudinally extending lumen, and a first connector member positioned at a proximal end thereof, a bifurcation assembly, comprising at least one extension leg extending from a proximal end thereof and a second connector member positioned at a distal end thereof, said second connector member having at least one stem extending therefrom, said stem being configured to be received into a lumen of said catheter, and a clamp configured to lock around said first and second connector members. 
         [0017]    In yet another embodiment of the present invention, a kit for connecting a catheter to extracorporeal medical equipment comprises a boot comprising a tapered outer wall, having a diameter that decreases toward a distal end thereof and enclosing a longitudinally extending lumen, and a first connector member positioned at a proximal end thereof, a bifurcation assembly, comprising at least one extension leg extending from a proximal end thereof and a second connector member positioned at a distal end thereof, said second connector member having at least one stem extending therefrom, said stem being configured to be received into a lumen of said catheter, a clamp configured to lock around said first and second connector members, and at least one obturator, having a rounded tip, positioned through said extension leg and said stem. 
         [0018]    These and other embodiments, features and advantages of the present invention will become more apparent to those skilled in the art when taken with reference to the following more detailed description of the invention in conjunction with the accompanying drawings that are first briefly described. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0019]      FIG. 1  is an exploded view of a prior art catheter connector system. 
           [0020]      FIG. 2  is a perspective view of a catheter connector system according to the present invention. 
           [0021]      FIG. 3  is a cross-sectional view of the boot and catheter of  FIG. 2 , taken along line  3 - 3 . 
           [0022]      FIG. 4  is a partial cut-away view of a boot portion of the catheter connector system of  FIG. 2 . 
           [0023]      FIG. 5  is a cross-sectional view of a dilator used according to the present invention. 
           [0024]      FIG. 6  is a perspective view of a dilator and boot according to the present invention being positioned over the proximal end of a placed catheter. 
           [0025]      FIG. 7  is a perspective view of a dilator and boot according to the present invention being partially inserted into a venipuncture site. 
           [0026]      FIG. 8  is a perspective view of a dilator being removed from a boot. 
           [0027]      FIG. 9  is a perspective view of a boot placed partially into the venipuncture site with the proximal end of the catheter extending therefrom. 
           [0028]      FIG. 10  is a perspective view of a pre-assembled view of the boot and bifurcation assembly of the catheter connector system of  FIG. 2 . 
           [0029]      FIG. 11  is a perspective view of an alternate embodiment of a catheter connector system according to the present invention. 
           [0030]      FIG. 12  is an enlarged view of a clamp according to the present invention. 
           [0031]      FIG. 13  is a perspective view of a collet type connector member according to the present invention. 
           [0032]      FIG. 14  is a longitudinal cross-sectional view of a partially assembled catheter connector system employing the connector member of  FIG. 13 . 
           [0033]      FIG. 15  is an exploded cross-sectional view of a catheter connector system employing the connector member of  FIG. 13 . 
           [0034]      FIG. 16  is a perspective view of an alternate embodiment of a catheter connector system according to the present invention. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0035]    The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. The drawings, which are not necessarily to scale, depict selected preferred embodiments and are not intended to limit the scope of the invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. 
         [0036]    The present invention is directed to a catheter connector system for connecting a catheter to extracorporeal medical equipment. In the embodiments and examples that follow, reference will be made to a catheter connector for a catheter that has been trimmed proximally, following placement thereof in the body of a patient. However, it should be understood that the present invention is not limited to such uses and instead is applicable to any application that requires the connection of a catheter to separate medical equipment as would be apparent to one of skill in the art. Moreover, when discussing the catheter connectors of the present invention in terms of attachment to a patient, it should be understood that attachment can be direct through suturing, medical tape, or other means, or indirect through the use of a StatLock® or other intermediary device. 
         [0037]    In one embodiment according to the present invention, a catheter connector system  100  is illustrated in  FIGS. 2-10 . The catheter connector system  100  includes two primary components, a boot  120  and a bifurcation assembly  130 , and is configured for attachment to a catheter  110  to provide a proximal connection for the introduction and/or withdrawal of fluids thereto. The catheter connector system  100  as illustrated is configured as a two-piece system, which can be assembled by the clinician upon placement of a catheter. It should be appreciated that although the embodiments shown are directed to a dual lumen catheter, similar embodiments directed to single lumen and triple lumen catheters are contemplated (as well as other multi-lumen catheters). More particularly, while the catheter  110  and bifurcation assembly  130  are illustrated in a dual-lumen configuration, the present invention is equally directed to a single lumen configuration, having a single lumen catheter and assembly, and to a triple or multi-lumen configuration, having a triple or multi-lumen catheter and assembly. 
         [0038]    The catheter connector of the present invention can be used for a variety of different types of catheters, such as peripherally inserted central catheters (PICCs), having small or large diameters. In one embodiment, catheter connector system  100  is configured for a PICC, ranging from 3 Fr to 7 Fr in size. While certainly many different materials could be used for each of the primary components of the catheter connector system  100  and catheter  110 , examples of possible materials are polyurethane and silicone (i.e., a soft biocompatible elastomeric material) for the catheter  110  and the boot  120 , and either a soft elastomeric material or a hard plastic material for the bifurcation assembly  130 . 
         [0039]    Referring to  FIG. 2 , the bifurcation assembly  130  includes extension leg tubes  134 ,  136 , which are in fluid communication with catheter lumens  112 ,  114  ( FIG. 3 ) when catheter connector system  100  is fully assembled. The boot  120  includes a main body portion  122  and a pair of suture wings  124  that are configured for attachment to the skin of a patient or a StatLock® or similar device to stabilize the catheter connector system  100 . As shown in the cross-sectional view in  FIG. 3 , the catheter  110  within the boot  120  has lumens  112 ,  114  with a trapezoidal cross-sectional shape. While certainly other cross-sectional shapes are possible, the trapezoidal shape may be advantageous to prevent collapse due to the force exerted on the catheter  110  by the boot  120 . 
         [0040]      FIG. 4  illustrates in partial cut-away view the boot  120 . In this isolated view of the boot  120 , a proximal coupling section  126  can be seen comprising a barbed end. Of course, coupling section  126  can take on a variety of forms, depending on the form of the associated coupling section of the bifurcation assembly  130 , such that the coupling sections together provide a tight connection that will withstand forces associated with the infusion and/or withdrawal of fluid from a patient. The main body portion  122  of boot  120  is fashioned with a reverse-taper or stepped-taper, meaning that the diameter at the proximal end  121  is greater than the diameter at the distal end  123 . This is advantageous because the smaller diameter distal end  123  can be partially inserted into the venipuncture site  102 , as shown in  FIG. 2 , to achieve venipuncture tamponade and reduce site bleeding. Although the taper of main body portion  122  is shown as being very slight with respect to the longitudinal axis L 120  of the boot  120 , forming an angle A 122  therewith, the preferred range is between approximately 1 to 45 degrees with larger tapers being equally within the scope of the present invention. 
         [0041]    The main body portion  122  includes a section distal the suture wings  124 , having a length  1   122  that in one embodiment is in the range of approximately 2.0 cm to 5.0 cm. The boot  120  is formed with a throughgoing lumen  128  and may have a diameter slightly smaller than the diameter of the outer wall of the catheter  110  to create an interference fit therewith. Although certainly various diameters are possible for the lumen  128  and the outer wall of the catheter  110 , in one embodiment the diameter of the lumen  128  is in the range of approximately 0.50 mm to 4.0 mm, while the diameter of the outer wall of the catheter  110  is approximately 0.55 mm to 4.4 mm. The lumen  128  is also sized to receive a dilator, which is used to place the boot  120  over the catheter  110  and into the venipuncture site  102 . 
         [0042]      FIG. 5  illustrates a dilator  140  in cross-section, the dilator  140  including a shaft  142  that has a transition section  146  at a distal end thereof, which is tapered to form a smooth transition for insertion percutaneously into the venipuncture site. In addition, the tip of the transition section  146  may be rounded (e.g., via radio frequency means, thermal means, etc.) The shaft  142  has an outer diameter that is larger than lumen  128  of boot  120  in order to dilate the lumen  128  and provide an interference fit for a tight, smooth transition into the venipuncture site. The dilator  140  also has a throughgoing lumen  148 , which can be slightly larger than the diameter of the outer wall of the catheter  110  to allow slideable movement therealong. In one embodiment, the dilator lumen  148  is at least 0.025 mm greater than the diameter of the outer wall of the catheter  110 . In addition, the dilator  140  has a handle  144  ( FIG. 6 ) positioned at the distal end thereof, the handle  144  having a fin  143  and a base  145 , which together facilitate the handling of the dilator  140 . The fin  143 , base  145 , or both may additionally be equipped with gripping sections to further facilitate the handling of the dilator  140 . The dilator should be formed of a material exhibiting sufficient columnar and radial strength to prevent compression or time/thermal creep and allow advancement into the boot and removal therefrom (e.g., polyurethane, polytetrafluoroethylene (PTFE) and high density polyethylene (HDPE)). In one embodiment, the outer surface of the shaft  142  is lubricated to facilitate removal from the boot  120 . 
         [0043]      FIGS. 6-9  illustrate, in sequence, steps according to the present invention for inserting the boot into the venipuncture site. Referring to  FIG. 6 , the venipuncture site  102  has been established and the catheter  110  has been advanced to a central location, a length of the catheter  110  extending from the venipuncture site  102 . The shaft  142  of the dilator  140  has been pressed into the lumen  128  of the boot  120  (generally performed at the place of manufacture, but can take place on site) and the combination is slid over the catheter  110 , the lumen  148  of the dilator  140  receiving the catheter  110  therethrough.  FIG. 7  shows the next step as the boot  120  and dilator  140  are pressed into the venipuncture site  102 , with the catheter  110  extending from the proximal end of the dilator  140 . Both the reverse-taper of the boot  120  and the transition section  146  of the dilator  140  enable a smooth advancement into the venipuncture site  102 . As stated above, the reverse-taper configuration of the boot shaft  122  provides a tight fit into the venipuncture site and reduces blood loss therethrough. The dilator  140  is then removed from the boot  120 , which is held in place in the venipuncture site, as depicted in  FIG. 8 . As the dilator  140  is removed from the lumen  128  of the boot  120 , the lumen  128 , which was previously expanded due to the larger diameter of the dilator shaft  142 , contracts and forms a tight fit with the catheter  110  remaining therein. Thereafter, the proximal length of the catheter  110  extending from the now placed boot  120  is trimmed (e.g., using medical scissors, a scalpel or other cutting tool) so that the proximal end of the trimmed catheter  110  is flush with the opening in the proximal end of the boot  120 , resulting in the entire external length of the catheter  110  being supported and protected by the boot  120 , as illustrated in  FIG. 9 . 
         [0044]    Referring now to  FIG. 10 , the attachment of the bifurcation assembly  130  is described. Bifurcation assembly  130  includes a coupling section  132 , which is configured for attachment to the proximal coupling section  126  of the boot  120  to provide a securing connection thereto. The coupling section  132  includes a pair of stems  137 ,  139 , which are shaped and sized to fit tightly within lumens  112 ,  114  of catheter  110  to provide a fluid tight connection between the boot  120  and the bifurcation assembly  130 . In one embodiment, the stems are made of metal, although certainly other non-metal materials are also possible. Immediately surrounding the stems  137 ,  139  is a hood  138 , which is configured and shaped to tightly receive proximal coupling section  126  of the boot  120 . Surrounding both stems  137 ,  139  and hood  138  is a cover  133 , which abuts a shoulder  125  at the proximal end  121  of the main body portion  122  upon assembly and has a diameter approximately the same as the diameter thereof. The stems  137 ,  139  extend beyond the cover  133  to enable initial engagement with the catheter lumens  112 ,  114  prior to the remainder of the coupling section  132  coming into contact with the proximal coupling section  126 . 
         [0045]    The bifurcation assembly  130  is assembled onto the boot  120  by sliding the stems  137 ,  139  into the respective lumens  112 ,  114  of the catheter  110 , while providing pressure to the boot  120  to ensure a stationary position. To facilitate this insertion process and prevent damage to the catheter, round-nosed obturators, which are described in more detail below, may be utilized. As the stems  137 ,  139  are received into the lumens  112 ,  114 , the hood  138  receives the barbed portion of the proximal coupling section  126 . The assembly is complete when the cover  133  comes into contact with the shoulder  125  and the proximal coupling section is locked within the hood  138 . The connection between the bifurcation assembly  130  and the boot  120  can be of several different varieties. In one embodiment, the pressing of the proximal coupling section  126  into the hood  138  results in both an audible and tactile indication that the connection is complete. The connection may be permanent, such as the embodiment shown in  FIG. 10 , or alternatively a releasable locking mechanism can be provided. The assembled catheter connector system  100 , as illustrated in  FIG. 2 , provides a secure, fluid-tight connection system that is streamlined and is capable of attachment to the patient. Following complete assembly of the catheter connector system  100 , the catheter is flushed to assure patency and to examine the connection for leaks. Finally, the suture wings  124  are secured to either the skin of the patient or a StatLock® or similar device. 
         [0046]    Catheter connector system  300  is illustrated in  FIG. 16  and is similar to catheter connector system  100 . Catheter connector system  300  includes a bifurcation assembly  330  having a distal coupling section  332  configured to be received within a proximal receiving portion  322  of a boot  320 . The distal coupling section  332  is comprised of an anchoring portion  334 , an enlarged head portion  334 , slots  336  and stems  338 . The slots  336  are shown as being positioned circumferentially about distal coupling section  332  in  90 ° intervals such that distal coupling section  332  comprises four slots. The slots  336  permit the head  334  to compress radially inward as the distal coupling section  332  is pressed into the proximal receiving portion  322  and begins to enter head receiving portion  324 . Of course, any number of slots could be utilized ( 1 ,  2 ,  3 , etc.), depending on a variety of factors (material selection, connection configuration, etc.) in order to maximize the effectiveness of the connection. 
         [0047]    Catheter connector system  300  is assembled similarly to that described above with catheter connector system  100 . Catheter  110  is placed within the patient and, if necessary, may be proximally trimmed to a suitable length. With a portion of the catheter  110  extending from the proximal end of the boot  320 , the stems  338  of the bifurcation assembly  330  are pressed into lumens  112 ,  114  of catheter  110 , after which the distal coupling section  332  is pressed into the proximal receiving portion  322 . When the head  334  has been fully received by head receiving portion  324  (i.e., has been pressed beyond shoulder  326  of head receiving portion  324 ), the geometry thereof permits head  334  to expand outward, at which point there is an audible “click,” effectively locking bifurcation assembly  330  to boot  320 . Once assembled, the portions of the distal coupling section  332  surrounding the stems  338  act to seal the catheter  110  against the stems  338  for a fluid-tight connection. As with catheter connector system  100 , the locking connection of catheter connector system  300  may be permanent or releasable. 
         [0048]    In another embodiment of the present invention, a catheter connector system  200  is illustrated in  FIGS. 11-12 , having a boot  210 , a bifurcation assembly  220  and a clamp  230 . The catheter connector system  200  is shown prior to attachment of the bifurcation assembly  220 , with the boot  210  slid over a catheter  202  and into the venipuncture site  102 , the catheter  110  having been trimmed at its proximal end to lie flush with the proximal end of the boot  210 . The boot  210  has incorporated in its proximal end a connector member  214 , which has a distal portion  215  with grooves to optimize locking connection with the clamp  230 , and a proximal portion  216  having an energized seal design, which in the preferred embodiment is made of a soft material (e.g., silicone with a durometer of  30 ). The boot  210  has a distal taper, which allows it to be slid into the venipuncture site to not only seal the site from extraneous bleeding, but also to protect the extracorporeal portion of the catheter from breakage. 
         [0049]    The bifurcation assembly  220  has a connector member  224  at the distal end thereof, having a similar configuration to that of the distal portion  215  of the connector member  214 . Extending from the connector member  224  are a pair of stems  226 , which can be made of metal or other hard or hardened material, for insertion into the lumens of catheter  110 , similar to that described above in connection with catheter connector system  100 . Also included in the bifurcation assembly  220  is a hub  222  and extension tubes  223 . In one embodiment, the boot body  212  and the bifurcation assembly body  222 , as well as the extension legs  223  are made of a soft elastomer material (e.g., medical grade polyurethanes and silicones). Certainly, however, many materials are possible and would equally be within the scope of the invention. In one embodiment, the bifurcation assembly  220  is shipped pre-assembled to the boot  210 . 
         [0050]    The clamp  230  is in a clamshell configuration having locking opposed halves  234  that are connected by a bottom hinge  232 . The interlocking halves  234  comprise teeth  236 , separated by gaps  238 , the teeth  236  on one half corresponding positionally with the gaps  238  on the opposite half when the clamp  230  is in a closed condition. The teeth  236  and gaps  238  are configured to create an interference fit (i.e., mechanical lock) when in a closed position to prevent inadvertent opening under normal pressures. The interlocking halves  234  also include ring portions  237  on the inside thereof, which create axial compression upon closing around the connector members  214 ,  224  and also ensure the tensile integrity of the assembly. It should be appreciated that, although the clamp  230  is shown in a particular configuration with respect to teeth  236 , ring portions  237  and gaps  238 , many other configurations would be equally within the scope of the present invention, the primary considerations being that the clamp  230  be shaped to lock around the connector members  214 ,  224  of the boot  210  and bifurcation assembly  220  so that inadvertent opening is prevented and to provide a seal against the catheter within the boot connector member  214  as will be described in more detail below. Also incorporated into the clamp  230  are suture wings  239  having openings adapted for attachment to a patient (through either direct means or indirect means as discussed above). The suture wings  239  can be integrally formed with the clamp  230  (e.g., via injection molding) or alternatively may be molded over the interlocking halves  234 . In one embodiment, the interlocking halves  234  are made of a semi-rigid plastic, while the suture wings  239  are made of a soft elastomer material. 
         [0051]    As stated, assembly of the catheter connector system  200  is initiated by placing the catheter  110  within the body of a patient using traditional methods, such that a length of catheter  110  extends from the venipuncture site  102 . Upon confirmation of correct catheter placement, the clinician holds the proximal end of the catheter  110  and slides the boot  210  over the catheter  110  and into the venipuncture site  102 . A dilator may be used to position the boot  210  over the catheter as described above, or other means of positioning the boot  210  over the catheter  110  may be utilized as would be known to one of skill in the art. In one embodiment, an expander is inserted/activated under the distal end of the boot  210  after it has been positioned in the venipuncture site in order to create a seal between the catheter  110  and the boot  210  to prevent blood fluids from wicking between the components and to create a friction fit between the components, which could facilitate assembly thereof. Following positioning of the boot  210  over the catheter  110 , the proximal end of the catheter  110  extending from the connector member  214  of the boot  210  is trimmed, the clinician utilizing the surface of the proximal portion  216  of the connector member  214  as a guide, resulting in a flush outer surface thereof. 
         [0052]    While firmly holding the boot  210 , the bifurcation assembly  220  is then connected to the boot  210  by inserting stems  226  into the lumens of the catheter  110  until the connector members  214 ,  224  meet. As with catheter connector system  100 , in the case of a single lumen catheter, only one stem would be provided; moreover, the cross-sectional shape of the stem may correspond to the cross-sectional shape of the lumen to provide a fluid tight connection. Round-nosed obturators  228  may be employed to facilitate the insertion of the stems  226  into the lumens of the catheter  110  and to prevent material damage during the insertion process, which can occur in small catheters (e.g., 5 Fr or 6 Fr). The obturators  228  are inserted through the extension legs  223  and the lumens within the body  222  of the bifurcation assembly  220  to emerge through the stems  226  ( FIGS. 11 and 14 ). The obturators  228  can be removed after assembly, for example, by using stylets that are insert molded into the obturators  228  and extend past the luer connectors at the proximal end of each extension leg  223 . 
         [0053]    Finally, the clamp  230  is oriented so that the suture wings  239  are parallel to the top and bottom surfaces of the boot  210  and the bifurcation assembly  220  (i.e., the bottom surface being that surface adjacent the skin of the patient) and is closed around the connector members  214 ,  224 . As the clamp  230  closes, the mating surfaces on the connector members  214 ,  224  and the interlocking halves  234  interact to compress the proximal portion  216  of the connector member  214 . The incompressible nature of the material thereof causes the outer diameter of the proximal portion  216  to increase and its inner diameter to decrease. The inside surface of the clamp  230  minimizes the change in the outside diameter and maximizes the decrease in the inside diameter, which equates to a compressive force on the catheter  110 , resulting in a seal against the stems  226  inserted into the lumens thereof. Following locking of the clamp, the obturators are removed and the suture wings  239  are utilized to affix the system  200  to the skin of the patient. 
         [0054]    In one variation of the catheter connector system  200 , a slightly different connector member  240  is utilized, having a collet design as shown in  FIG. 13 . The connector member  240  may be made of a semi-rigid plastic and has a distal portion  242  that is attached to the boot  210  and an insert portion  244  extending from the proximal end of the boot  210 . The bifurcation assembly connector member  224  has a receiving bore to permit entry and locking of the insert portion  244  therein. The insert portion  244  has a frustoconical shape with individual sectioned panels  246  attached to a base  248 . The sectioned panels  246  flex inward as they are received within the bore of the connector member  224 , reducing the inside diameter of the insert portion  244  and thereby creating a compressive seal on the catheter. As the insert portion  244  is received within the bore of the connector member  224 , a snap fit (i.e., a mechanical lock) occurs due to the configuration of the bore as can be seen in  FIG. 14 . All other aspects of assembly of the bifurcation assembly  220  to the boot  210  are as described above. An exploded cross-sectional view of the catheter connector system  200  employing the collet design is shown in  FIG. 15 . 
         [0055]    It should be noted that more attention to detail is required in trimming the proximal end of the catheter when utilizing the collet design, as opposed to the energized seal design, as the insert portion  244  will often be made of a harder material. As a result, haphazard trimming can produce burrs on the face of the insert portion  244 , which could lead to problems. It should further be noted that unlike the energized seal design, the clamp  230  does not impact the sealing operation and instead only serves to keep the bifurcation assembly  220  and boot  210  connected. The seal is created upon insertion of the insert portion  244  into the bore of the connector member  224 . It should be appreciated that when the clamp is closed around the connector members  224 ,  240  in the collet design, an external closure is provided to the mechanical lock created by the insertion of the insert portion  244  into the bore of the connector member  224 , the expected result of which is that the assembled system  200  will have a significantly higher tensile capability than the individual components. 
         [0056]    The present invention has been described above in terms of certain preferred embodiments so that an understanding of the present invention can be conveyed. However, there are many alternative arrangements for a catheter connector not specifically described herein, but with which the present invention is applicable. Although specific features have been provided, the catheter connector of the present invention would equally be embodied by other configurations not specifically recited herein. The scope of the present invention should therefore not be limited by the embodiments illustrated, but rather it should be understood that the present invention has wide applicability with respect to catheter systems generally. All modifications, variations, or equivalent elements and implementations that are within the scope of the appended claims should therefore be considered within the scope of the invention.