Abstract:
A catheter unit comprising a catheter having a hub, a connector and catheter, the connector comprising a first port, a second port, and third port. The first port, located at the proximal end of the connector and protruding from the connector, is coupled to a lock member. The second port, located within a cylindrical portion of the connector, is adapted to receive a guidewire. The third port is located at the distal end of the connector.

Description:
BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates generally to medical devices and more particularly to a connector such as a hub of a catheter. 
     2. Description of Related Art 
     Despite significant advances made in intravascular devices such as catheters, blood or other bodily fluids that collects in a flash chamber may escape from a catheter thereby potentially exposing a healthcare worker or another person to blood-borne pathogens. In view of the potential of healthcare workers contacting blood borne pathogens such as HIV and hepatitis, there exists a need to provide catheters that reduce this risk. Although existing devices are capable of reducing the risk that a person will contact blood-borne pathogens through inadvertent needle trauma, these prior devices or apparatus are not capable of being used with all types of catheters. Accordingly, there remains a need for the development of additional needle blunting devices and/or apparatus for preventing or reducing the risk of exposure to blood or other bodily fluids due to fluid escaping from the catheter. 
     Connectors for catheters are known in the art as shown by U.S. Pat. No. 5,357,961 issued to Fields. However, several disadvantages exist to using a Y-shaped connector or a L-shaped connector. First, these types of shapes of the connectors are bulky and may be caught in the dressing or clothing of a patient. If a catheter is caught on a dressing or some type of material, the catheter generally remains in its position while the patient moves. This results in discomfort to the patient. Second, the hub is bulky and is more difficult to handle by a health care worker. Third, conventional flushable hubs require more complex parts to be functional. For example, the leg of the L- shaped or Y-shaped hub causes the manufacturing process to be more complex. Fourth, the complexity of the process of manufacturing the L-shape and Y-shape connector is costly. Accordingly, it is desirable to produce a connector that addresses the problems associated with conventional connectors. 
     SUMMARY OF THE INVENTION 
     A catheter unit comprising a catheter having a hub and connector, the connector comprising a first port, a second port, and third port. The first port, located at the proximal end of the connector and protruding from the connector, is coupled to a lock member. The second port, located within a middle portion of the connector, is adapted to receive a guidewire. The third port is located at the distal end of the connector. Additional features, embodiments, and benefits will be evident in view of the figures and detailed description presented herein. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     The features, aspects, and advantages of the invention will become more thoroughly apparent from the following detailed description, appended claims, and accompanying drawings in which: 
     FIG. 1 is a side view of an embodiment of an intravascular assembly in accordance with the present invention; 
     FIG. 2 is an enlarged sectional view of a hub in the present invention; 
     FIG. 3 is an enlarged view of the same hub as in FIG. 2; and 
     FIG. 4 is a side view of an embodiment of an intravascular assembly in accordance with the present invention; 
     FIG. 5 is another embodiment of the invention wherein the hub has a guidewire port that protrudes from the hub. 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description and the accompanying drawings are provided for the purpose of describing and illustrating presently preferred embodiments of the invention only, and are not intended to limit the scope of the invention in any way. 
     With reference to one embodiment of the invention shown in FIG. 1, there is provided assembly  10  that may be used to facilitate percutaneous insertion of an intravascular cannula, tube, and catheter  20 . Intravascular assemblies include a variety of catheters such as peripherally central catheters (PICC) that allow for repeated access to the patient&#39;s vascular or venous system. Intravascular assembly  10  comprises a catheter  20 , an introducer assembly  30 , a male leur  40 , a wire sealed tube  50 , a female leur lock  60 , and a connector  80 . 
     PICC  25  comprises a hub  82  and catheter  20 . Hub  82  and catheter  20  are fastened together to form a continuous and leakless assembly. Catheter  20  may be constructed of polyurethane, silicone rubber, or any other suitable material. PICC  25  is connected to a 3-way connector  80  by hub  82  sliding over the 3-way connector&#39;s outlet port  32 . Hub  82  has appropriate dimensions allowing it to be securely fitted to outlet port  32 . Outlet port  32  is in communication between the 3-way connector  80  and the proximal end of PICC  25 . Connector  80  is also coupled to female leur lock  60  using conventional methods such as female leur lock  60  having a cylindrical portion that has an outer diameter smaller than the inner diameter of connector  80 . Inlet port  62  of connector  80  is secured to syringe  85  for PICC  25  as shown in FIG.  4 . 
     As shown in FIGS. 2 and 3, connector  80  has three ports—a guidewire port  52  that is located on the side of connector  80 , an inlet port  62 , and an outlet port  32 . All three ports are preferably integral to each other and form a cavity. 
     One advantage to having connector  80  configured without an L-shape or Y-shape is that the catheter is easier to use especially when the catheter is repetitively used as in a PICC. This is due to the ease of inserting the catheter into the patient without obstruction. Flushing the intravascular assembly while moving the catheter through a patient&#39;s body is made easier by a connector configured without an L-shape or Y-shape. Another advantage of the invention is that an intravascular assembly that uses the connector is more easily “site cleaned” by a health care worker. For example, when the hub is in use, the hub should be cleaned to minimize the risk of infection. The various embodiments of the invention, by using an inline design, is more easily cleaned than conventional flushable guide wire hubs because there is no Y-leg or L-leg off of the connector. Another advantage to the device is that there are fewer and less complicated parts to manufacture. Therefore, there is a reduced risk of quality defects in the part because of the less parts needed making the device generally easier to manufacture. This in turn reduces the cost of manufacturing the device. Another advantage relates to the ease of using the device compared to conventional devices. Accordingly, the risk of misusing the device by a health care worker is reduced. Note that variations to the connector may consist of any modification to any type of design that eliminated the L-leg or Y-leg to the connector. 
     Connector  80  and catheter  20  are fastened together to form a continuous and generally leak-proof assembly. Catheter  20  can be constructed of any suitable material, such as polyurethane, silicone rubber, or other suitable self sealing material. 
     To insert intravascular assembly  10  of FIG. 4 into a patient, guidewire  70  is run through the length of catheter  20 . Guidewire  70  stiffens catheter  20  which allows the guidewire  70  to make its way through a patient&#39;s vascular system. Guidewire  70  comprises a hydrophilically coated stylet. Guidewire  70  may or may not have a handle at one end. However, it is preferred that guidewire  70  have a handle to make it easier to grip guidewire  70  while inserting catheter  20  through guidewire  70 . 
     Guidewire  70  passes through port  52  of connector  80  into guidewire hub  82 . Connector  80  is configured to receive guidewire  70  at an angle of less than 45°. Connector  80  may be comprised of a polymer such as plastic, polycarbonate, polyvinyl chloride, or other suitable material. Guidewire  70  then advances through hub  82  into catheter  20 . When completely inserted, guidewire  70  rests against the side of hub  82 . The initial guidewire  70  length is selected such that when it is completely inserted, its proximal tip rests approximately a ¼ inch from the catheter&#39;s  20  proximal tip. This in turn provides additional protection from vein puncture or irritation from guidewire  70 . 
     Guidewire  70  passes through wire sealed tube  50 . Wire sealed tube  50  has a seal disposed therein such that it makes a watertight seal around guidewire  70 . After guidewire  70  is placed through connector  80 , it can slide its full length through the wire sealed tube  50 , indentation  45 , and the male swivel leur  40 . Wire sealed tube  50  provides a slight resistance to the movement of guidewire  70 . This resistance in wire sealed tube  50  prevents guidewire  70  from being moved too quickly through connector  80  and catheter  20  thereby in reducing a patient&#39;s discomfort by having a guidewire  70  move too quickly. 
     Port  62 , used for flushing intravascular assembly  10 , provides a means for connecting a syringe  85 . Syringe  85  is connected to port  62  as shown in FIG.  4 . 
     Syringe  85  is filled with flushing solution that may include saline, or other suitable solution. After syringe  85  is coupled to port  62 , the flushing solution can be injected into the connector  80 . It will be appreciated that syringe  85  will not inject the flushing fluid until a device such as a plunger to the syringe is depressed. 
     Flushing assembly  10  is generally recommended with an aqueous solution before, during, and after catheter insertion to assist in the movement of the catheter through the body and also to check for catheter patency. Additionally, the chances of clotting occurring in the patient are reduced when a catheter is flushed while moving through the body. Catheter  20  has been properly flushed before insertion into a patient&#39;s body when drops of flushing solution begin to emerge from catheter  20 . 
     A user may then determine how long catheter  20  needs to be in order for the tip of the catheter to reach the desired location within a patient. The user may measure the distance between the insertion site and the desired tip location. If the necessary length for the catheter tip location is shorter than the length of the catheter  20 , catheter  20  must be trimmed or cut to the correct length. 
     Guidewire  70  is then placed next to the body of the user and the user grips neck  64 . Guidewire  70  is withdrawn through wire sealed tube  50  so that guidewire  70  is within the necessary length of catheter  20 . Catheter  20  portion of assembly  10  may be trimmed using sterile scissors taking care to avoid cutting the guidewire  70 . Note that approximately one half of an inch of catheter  20  should remain that has no guidewire within it. The resulting assembly  10  has a catheter  20  of proper length. Because guidewire  70  has been withdrawn from assembly  10 , the guidewire handle will no longer rest against a user and a portion of the guidewire  70  will no longer be within the connector  80 . 
     After trimming the catheter  20 , but before installation, assembly  10  may be flushed again. Flushing prior to installation allows the user to recheck catheter patency and allows removal of any residue created during catheter  20  trimming. 
     It may be necessary to flush the catheter guidewire flushing apparatus  10  during insertion of the catheter. Flushing during installation can also assist in removing blood or other bodily fluids that may accumulate inside the lumen of assembly  10 . Once installed in the patient, guidewire  70  can be left in assembly  10  in order to verify placement through radiographically. After verification, guidewire  70  is removed from assembly  10 . In order to remove guidewire  70 , guidewire&#39;s proximal end is pulled. If resistance is felt, assembly  10  should be flushed. The flushing solution lubricates the guidewire  70 . Assembly  10  allows for flushing to take place without any guidewire  70  manipulation and at any time. Additionally, flushing may occur with a PICC assembly without having to reattach the syringe containing flushing solution. 
     FIG. 5 shows another embodiment of a connector used in an intravascular assembly. Connector  100  has an inlet port  150 , a guidewire port  140 , and an outlet port  130 . Connector  100  has a wall  110  thickness of approximately 0.035 to 0.050 inches. The hub (not shown in FIG. 4) has an inner cavity that is substantially circular or elliptical in shape at the proximal portion of the connector  100  and the inner diameter of the hub narrows at the distal end of the hub. The inner diameter of inlet port  150 , guide port  140 , and outlet port  130  is 0.169 inches, 0.050 inches, 0.070 inches, respectively. While moving in the distal direction of connector  100 , the lower portion of connector  100  begins to taper. Guidewire port  140  protrudes from the bottom portion of connector  100  approximately in the range of 0.10 to 0.15 inches. Guidewire port  140  slightly is also coupled to a syringe and operates in a similar fashion as that described above. 
     The ports described in connector  100  perform the same function as that which was described above. One of the advantages to a substantially spherical in shape connector is that it allows the intravascular assembly to move with greater ease when the patient moves and reduces the opportunity of connector  100  being caught in bedding or other like materials as that which happens with an L-shape or a Y-shape connector. 
     Connector  100  is coupled to a female leur lock  60  and to hub  82 . Hub  82  is further coupled to PICC  25  which includes a catheter  20 . It should be noted that connector  100  is secured to female leur lock  60  using conventional methods such as a snap fit or an adhesive. Furthermore, connector  100  is connected to hub  82  by hub  82  fitting securely within the inner diameter of connector  100 . Conventional methods are used to attach hub  82  with connector  100 . 
     In the preceding detailed description, the invention is described with reference to specific embodiments thereof. It will, however, be evident that various modifications and changes may be made thereto without departing from the broader spirit and scope of the invention as set forth in the claims. The specification and drawings are, accordingly, to be regarded in an illustrative rather than a restrictive sense.