Abstract:
Devices and methods for managing a portion of an intravascular catheter which is extending from the body of a patient under operating room conditions (e.g., while a physician is wearing surgical gloves). A catheter in accordance with one embodiment of the present invention includes a catheter shaft having a proximal end and a distal end, and a keeper fixed to the catheter proximate a proximal end thereof The keeper includes one or more inside surfaces defining a channel which is adapted to entrap a straight portion of the catheter shaft. The keeper also includes a passageway which is adapted to allow a curved portion of the catheter to pass into the channel of the keeper.

Description:
FIELD OF THE INVENTION 
     The present invention relates generally to catheters for performing medical procedures. More particularly, the present invention relates to methods and devices for managing a portion of the catheter which extends from the body of a patient under operating room conditions (e.g., while the physician is wearing surgical gloves). 
     BACKGROUND OF THE INVENTION 
     Intravascular catheters are currently utilized in a wide variety of minimally invasive medical procedures. Generally, an intravascular catheter enables a physician to remotely perform a medical procedure by inserting the catheter into the vascular system of the patient at an easily accessible location and navigating the tip of the catheter to a desirable target site. By this method, virtually any target site in the patient&#39;s vascular system may be remotely accessed, including the coronary, cerebral, and peripheral vasculature. 
     Intravascular catheters are often used in conjunction with a guidewire. When this is the case, the guidewire may be advanced through the patient&#39;s vasculature until its distal tip has reached a desired target location. In many cases, the guidewires path through the vascular system will be tortuous, requiring the guidewire to change direction many times. By pushing and rotating the proximal end of the guidewire outside of the patient, the physician is able to direct the distal end of the guidewire to the desired target site. Once the distal portion of the guidewire is proximate the desired location, the catheter may be threaded onto the guidewire and urged distally until the distal end of the catheter is proximate the target location. The catheter often has been unpackaged and prepared for use prior to this point. After being prepared, but prior to actual use, the catheter must be laid out and kept sterile without being put back in the original package. It is often useful to be able to coil the catheter in order to facilitate handling and save space either laying out or hanging up the catheter, because of the length of the catheter (typically over 1 meter long). 
     Typically, the catheter enters the patient&#39;s vasculature at a convenient location such as a blood vessel in the neck or near the groin. Once the distal portion of the catheter has entered the patient&#39;s vascular system, the physician may urge the distal tip forward by applying longitudinal forces to the proximal portion of the catheter. In order for the catheter to effectively communicate these longitudinal forces and resist kinking, the proximal portion of many intravascular catheters is made relatively stiff. 
     The path taken by a catheter through the vascular system is often tortuous, requiring the catheter to change direction frequently. In some cases, it may even be necessary for the catheter to double back on itself. In order for the catheter to conform to a patient&#39;s tortuous vascular system, the distal portion of many intravascular catheters is very flexible or floppy. 
     The distance between the access site and the target site is often in excess of 100 cm. In order to assure that the physician will have access to the proximal end of the catheter when the distal end of the catheter is disposed near the target site, many intravascular catheters are relatively long. For example, a catheter shaft may have a length from about 70 cm to about 150 cm. 
     While the distal end of an intravascular catheter is being advanced into the body of a patient, a proximal portion of the catheter extends outside the body of the patient. During this procedure, care must be taken to assure that the proximal portion of the catheter remains inside the sterile field. If the proximal portion of the catheter were allowed to touch a non-sterile surface (e.g., the floor), the contaminated intravascular catheter would need to be discarded and replaced. The discarding of a contaminated intravascular catheter and replacing it with a new, sterile one adds expense to the surgical procedure. More critically, the replacement procedure adds time to the procedure. In some cases, the duration of the procedure may be substantially extended. For example, a dilation catheter may need to be “prepped” before it is used. This preparation procedure may include the time consuming steps of evacuating air from the device and back filling the device with a fluid. A longer procedure is inherently more expensive; but more importantly, a longer procedure may present a greater risk to the patient. 
     Intravascular catheters may be utilized for various diagnostic and/or therapeutic purposes. One example of a therapeutic use for an intravascular catheter is percutaneous transluminal angioplasty (PTA). An angioplasty procedure typically involves the use of a dilation catheter. The dilation catheter is typically advanced through the vasculature of a patient until a balloon portion of the dilation catheter is positioned proximate the restriction in the diseased vessel. The balloon is then inflated, and the restriction in the vessel is opened. In some cases, multiple restrictions may be opened utilizing a single dilation catheter. When this is the case, the dilation catheter may be partially or completely withdrawn from the body of the patient. When the catheter is withdrawn, care must be taken to assure that the catheter remains inside the sterile field. 
     As described above, the proximal portion of many intravascular catheters is quite stiff. Because the distal portion of these catheters is typically stiff, intravascular catheters are biased to assume a straight shape and will not readily remain in a coiled configuration. In some cases, it is necessary for an assistant to hold the proximal portion of the catheter while it is being introduced or withdrawn from a patient. The assistant may manually coil the proximal portion of the intravascular catheter and hold it in a coiled configuration. The addition of an assistant to the surgical environment to hold the catheter proximal portion is quite costly. The physicians and other personnel involved in a surgical procedure also must wear surgical gloves for the duration of the procedure. In many cases, a “double-gloving” procedure is used. The wearing of surgical gloves inhibits the surgeon&#39;s ability to manipulate small objects. 
     SUMMARY OF THE INVENTION 
     The present invention relates generally to catheters for performing medical procedures. More particularly, the present invention relates to methods and devices for managing a portion of the catheter which is extending from the body of the patient under operating room conditions (e.g., a sterile field while the physician is wearing surgical gloves). Methods and devices in accordance with the present invention may also be utilized to manage a shaft of the catheter after the catheter is unpacked, but prior to use in a surgical procedure. 
     A catheter in accordance with one embodiment of the present invention includes a catheter shaft having a proximal end and a distal end, and a keeper fixed to the catheter proximate the proximal end thereof. The keeper includes one or more inside surfaces defining a channel which is adapted to entrap a straight portion of the catheter shaft. The keeper also includes a passageway which is adapted to allow a portion of the catheter shaft which has been urged into a curved shape to pass into the channel of the keeper. 
     In one method in accordance with the present invention, the catheter shaft may be urged into a curved shape by exerting one or more pushing forces on the catheter shaft. For example, a physician may push on the catheter shaft with a gloved thumb. In another method in accordance with the present invention, a loop may be formed with the catheter shaft. In this method, a portion of the loop may be passed through the passageway and into the channel of the keeper. This embodiment of the present invention enables the physician to capture a portion of the shaft within the keeper without manipulating or deforming the keeper. An advantage of this method is that a physician is able to perform the required steps easily, even while wearing two pairs of surgical gloves. 
     A catheter in accordance with an additional embodiment of the present invention includes a catheter shaft having a proximal end and a distal end, and a keeper fixed to the catheter proximate a proximal end thereof. The keeper includes a first arm and a second arm defining an aperture. In one method in accordance with the present invention, the catheter shaft is placed in a first position between the first arm and the second arm. The catheter shaft may be twisted and moved to a second position within the aperture defined by the first arm and the second arm. Preferably, the first arm and the second arm releasably trap the catheter shaft when it is disposed within the aperture of the keeper. It should be noted that a physician may position the catheter shaft in the first position and the second position without manipulating the keeper directly. For example, a physician may grasp a hub of the catheter in one hand and a portion of the catheter shaft in a second hand. The catheter shaft has sufficient length that it may be grasped between the palm and fingers of a hand. The keeper of this embodiment allows a physician to capture a portion of the catheter shaft easily, even when wearing two pairs of surgical gloves. 
     A catheter in accordance with yet another embodiment of the present invention includes a catheter shaft having a proximal end and a distal end. The catheter also includes a hub and a keeper which is fixed to the hub. In a preferred embodiment, the keeper is adapted to clip onto the hub. An advantage of this embodiment is that the keeper can be used in conjunction with existing catheters with no modification to the hub. Embodiments of the catheter have also been envisioned in which the keeper and the hub are formed from the same material, for example, by injection molding. The keeper includes one or more tabs. A portion of the catheter shaft may be urged between the tab and the hub. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     FIG. 1 is a plan view of a proximal portion of a catheter having a keeper in accordance with the present invention; 
     FIG. 2 is a cross-sectional view of the catheter of FIG. 1; 
     FIG. 3 is a plan view of the catheter of FIG.  1  and FIG. 2; 
     FIG. 4 is a plan view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 5 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 6 is a plan view of a proximal portion of a catheter having a keeper in accordance with the present invention; 
     FIG. 7 is a cross-sectional view of the catheter of FIG. 6; 
     FIG. 8 is a plan view of the catheter of FIG.  6  and FIG. 7, in which a shaft of the catheter has been urged into a curved shape; 
     FIG. 9 is a plan view of a proximal portion of a catheter having a keeper in accordance with the present invention; 
     FIG. 10 is a cross-sectional view of the catheter of FIG. 9; 
     FIG. 11 is a plan view of a proximal portion of a catheter having a keeper in accordance with the present invention; 
     FIG. 12 is an additional plan view of the catheter of FIG. 11; 
     FIG. 13 is an additional plan view of the catheter of FIG.  1  and FIG. 12, in which a portion of the catheter is cut away to illustrate that a loop formed from the catheter shaft may readily pass through an entrance portion of the keeper; 
     FIG. 14 is an additional plan view of the catheter of FIG. 11, FIG. 12, and FIG. 13, in which a plurality of turns formed by the catheter shaft are trapped by the keeper; 
     FIG. 15 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 16 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 17 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 18 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 19 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 20 is a perspective view of an additional embodiment of a catheter having keeper in accordance with the present invention; 
     FIG. 21 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 22 is a cross-sectional view of the catheter of FIG. 21; 
     FIG. 23 is a cross-sectional view of the catheter of FIG.  21  and FIG. 22; 
     FIG. 24 is a perspective view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 25 is a plan view of an additional embodiment of a catheter having a keeper in accordance with the present invention; 
     FIG. 26 is a cross-sectional view of the catheter of FIG. 25; 
     FIG. 27 is a perspective view of an additional embodiment of a keeper in accordance with the present invention; 
     FIG. 28 is a perspective view of the keeper of FIG. 27; 
     FIG. 29 is a plan view of an additional embodiment of a catheter in accordance with the present invention; 
     FIG. 30 is a plan view of an additional embodiment of a catheter in accordance with the present invention; 
     FIG. 31 is a plan view of a catheter and a keeper in accordance with the present invention; 
     FIG. 32 is a plan view of the keeper of FIG. 31; 
     FIG. 33 is a plan view of the keeper of FIG.  31  and FIG. 32; 
     FIG. 34 is a plan view of an additional embodiment of a keeper in accordance with the present invention; and 
     FIG. 35 is a plan view of the keeper of FIG.  34 . 
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     The following detailed description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. In some cases, the drawings may be highly diagrammatic in nature. Examples of constructions, materials, dimensions, and manufacturing processes are provided for various elements. Those skilled in the art will recognize that many of the examples provided have suitable alternatives which may be utilized. 
     FIG. 1 is a plan view of a proximal portion of a catheter  100 . Catheter  100  includes a catheter shaft  102 . A hub  104  is disposed about a proximal end of catheter shaft  102 . In order to facilitate the handling of catheter  100 , catheter shaft  102  may be wound into a coiled configuration. In a preferred embodiment, catheter shaft  102  is resilient. When catheter shaft  102  is wound into a coiled configuration, catheter shaft  102  is biased to return to a substantially straight shape. Catheter  100  includes a keeper  106  which is adapted to secure catheter shaft  102  in a coiled configuration. 
     Keeper  106  includes an entrance portion  120  and a capturing portion  122 . Keeper  106  includes a first wall  124 , a second wall  126 , and an opening  130  disposed between first wall  124  and second wall  126 . In a preferred embodiment, opening  130  is adapted to accept a portion of catheter shaft  102  which has been urged into a curved shape. First wall  124  defines a first surface  132 ,and second wall  126  defines a second surface  134 . 
     Keeper  106  also includes a third wall  128 . Third wall  128  defines a third surface  136  facing opening  130  of keeper  106 . Keeper  106  also includes a projection  142  extending beyond third surface  136  defined by third wall  128 . In the embodiment of FIG. 1, projection  142  extends in the general direction of opening  130 . 
     FIG. 2 is a cross-sectional view of catheter  100  of FIG.  1 . In FIG. 2, it may be seen that projection  142  extends into opening  130  of keeper  106  and that projection  142  defines a fourth surface  138 . In the embodiment of FIG. 2, a captured portion  144  of catheter shaft  102  is disposed between first surface  132  defined by first wall  124  and third surface  136  defined by third wall  128 . In FIG. 2, it may be appreciated that keeper  106  includes a fifth surface  140  extending between third surface  136  and first surface  132  defined by first wall  124 . In the embodiment of FIG. 2, fifth surface  140  comprises a portion of an outer surface  146  of hub  104 . 
     In the embodiment of FIG. 2, captured portion  144  of catheter shaft  102  is disposed between fourth surface  138  and fifth surface  140 . In the embodiment of FIG.  1  and FIG. 2, first surface  132 , second surface  134 , third surface  136 , fourth surface  138 , and fifth surface  140  define a channel  150 . In a preferred embodiment, channel  150  of keeper  106  is adapted to accept catheter shaft  102 . Entrance portion  120  and capturing portion  122  of keeper  106  are also shown in FIG.  2 . 
     FIG. 3 is a plan view of catheter  100  of FIG.  1  and FIG.  2 . As in the embodiment of FIG. 2, a captured portion  144  of catheter shaft  102  is disposed within channel  150  of keeper  106 . In the embodiment of FIG. 3, catheter shaft  102  is disposed in a coiled configuration including a loop  148 . In the embodiment of FIG. 3, a plane defined by loop  148  is generally orthogonal to the plane of FIG.  3 . As mentioned previously, in a preferred embodiment, catheter shaft  102  is resilient and biased to assume a substantially straight configuration. Catheter shaft  102  may be urged into a curved configuration to aid in positioning captured portion  144  of catheter shaft  102  within channel  150  of keeper  106 . 
     FIG. 4 is a plan view of an additional embodiment of catheter  100 . As in the previous embodiment, catheter  100  includes a keeper  106  comprising a first wall  124 , a second wall  126 , and an opening  130  therebetween. Keeper  106  also includes a third wall  128  and a projection  142  extending from third wall  128  towards opening  130 . In the embodiment of FIG. 4, there is a gap  152  between an end  154  of projection  142  and a plane extending between first wall  124  and second wall  126 . Gap  152  has a width of G. Catheter shaft  102  of catheter  100  has a diameter of D. In a preferred embodiment of catheter  100 , the diameter of catheter shaft  102  is greater than the width of gap  152 . 
     FIG. 5 is a perspective view of an additional embodiment of a catheter  200  in accordance with the present invention. Catheter  200  includes a catheter shaft  202  and a hub  204  disposed about a proximal end  254  of catheter shaft  202 . A strain relief  256  is disposed about catheter shaft  202  proximate hub  204 . In the embodiment of FIG. 5, a keeper  206  is fixed to hub  204  of catheter  200 . 
     Keeper  206  includes a first wall  224 , a second wall  226 , and an opening  230  disposed between first wall  224  and second wall  226 . First wall  224  and second wall  226  define a first plane  272 . Keeper  206  also includes a third wall  228  defining a second plane  274 . A projection  242  extends beyond third wall  228  in the general direction of opening  230 . Projection  242  defines a third plane  276 . In the embodiment of FIG. 5, an end  254  of projection  242  is generally aligned with first plane  272 . 
     Keeper  206  includes a fifth surface  240  extending between first plane  272  and second plane  274 . Fifth surface  240  defines a forth plane  278 . First plane  272 , second plane  274 , third plane  276 , and forth plane  278  define a channel  250 . In a preferred embodiment, channel  250  of keeper  206  is adapted to accept a portion of catheter shaft  202 . In the embodiment of FIG. 5, channel  250  has a generally polyhedral shape. 
     FIG. 6 is a plan view of an additional embodiment of a catheter  300  in accordance with the present invention. Catheter  300  includes a keeper  306  which is adapted to entrap a portion of a catheter shaft  302  of catheter  300 . Keeper  306  includes a first wall  324 , a second wall  326 , and an opening  330  disposed between first wall  324  and second wall  326 . First wall  324  defines a first surface  332  and second wall  326  defines a second surface  334 . Keeper  306  also includes a third wall  328  and a projection  342  extending beyond a third surface  336  defined by third wall  328 . In the embodiment of FIG. 6, projection  342  extends in the general direction of opening  330 . Projection  342  defines a fourth surface  338  and an end surface  358 . A fifth surface  340  extends between third wall  328  and first wall  324 . In a preferred embodiment of catheter  300 , first surface  332 , second surface  334 , third surface  336 , fourth surface  338 , and fifth surface  340  define a channel  350  which is adapted to entrap a portion of catheter shaft  302 . 
     In the embodiment of FIG. 6, keeper  306  includes an entrance portion  320  including a passageway  360 . As shown in FIG. 6, passageway  360  is defined by first surface  332  of first wall  324 , second surface  334  of second wall  326 , and end surface  358  of projection  342 . In a preferred embodiment, passageway  360  is adapted to accept a portion of catheter shaft  302  which has been urged into a curved shape. Also in a preferred embodiment, a portion of catheter shaft  302  may pass through passageway  360  into channel  350 . 
     FIG. 7 is a cross-sectional view of catheter  300  of FIG.  6 . In the embodiment of FIG. 7, a captured portion  344  of catheter shaft  302  is disposed within channel  350  of keeper  306 . In FIG. 7, it may be appreciated that keeper  306  includes an entrance portion  320  including a passageway  360 , and a capturing portion  322  including channel  350 . 
     FIG. 8 is a plan view of an additional embodiment of catheter  300  of FIG.  6  and FIG.  7 . In the embodiment of FIG. 8, a portion of catheter shaft  302  has been positioned proximate passageway  360  of keeper  306 . A force F has been applied to catheter shaft  302  forming a curved portion  362  of catheter shaft  302 . Force F may be applied to catheter shaft  302 , for example, by pushing on catheter shaft  302  with a gloved thumb. In a method in accordance with the present invention, curved portion  362  of catheter shaft  302  may pass through passageway  360  of entrance portion  320  into channel  350  of capturing portion  322 . 
     FIG. 9 is a plan view.of an additional embodiment of a catheter  400  having a catheter shaft  402 . Catheter  400  includes a keeper  406  having a passageway  460 . In the embodiment of FIG. 9, passageway  460  comprises an arcuate slot  464 . 
     FIG. 10 is a cross-sectional view of catheter  400  of FIG.  9 . In FIG. 10, it may be appreciated that keeper  406  comprises a first wall  424  having an inside surface  466 . Inside surface  466  of first wall  424  defines a channel  450 . In the embodiment of FIG.  9  and FIG. 10, channel  450  is generally cylindrical in shape. In FIG. 10, it a may also be appreciated that arcuate slot  464  of passageway  460  is defined by first wall  424 . In a preferred embodiment of FIG. 10, passageway  460  is adapted to allow a portion of catheter shaft  402  to pass through passageway  460  while it is urged into a curved shape. Once catheter shaft  402  is disposed within channel  450 , it may be allowed to return to a straight shape. 
     FIG. 11 is a plan view of an additional embodiment of a catheter  500  in accordance with an additional embodiment of the present invention. Catheter  500  includes a catheter shaft  502 , a hub  504 , and a keeper  506 . In the embodiment of FIG. 11, keeper  506  is fixed to hub  504 . Embodiments of the present invention have been envisioned in which keeper  506  is fixed to other portions of a catheter. Examples of portions of a catheter include the catheter shaft and a catheter strain relief. Keeper  506  comprises a keeper member  568  defining an opening  530 . 
     FIG. 12 is an additional plan view of catheter  500  of FIG.  11 . In FIG. 12, it may be appreciated that keeper member  568  of keeper  506  forms an entrance portion  520  and a capturing portion  522  of keeper  506 . 
     FIG. 13 is a plan view of an additional embodiment of catheter  500  of FIG.  11  and FIG.  12 . In the embodiment of FIG. 13, catheter  500  includes a first loop  548  formed from catheter shaft  502 . First loop  548  may be held in a general coiled shape by the double-gloved hand of a physician (not shown). In FIG. 13, it may be appreciated that a curved portion  562  of first loop  548  may pass through entrance portion  520  of keeper  506  into capturing portion  522  of keeper  506 . It should be noted that a physician may position catheter shaft  502  within capturing portion  522  of keeper  506  without manipulating or deflecting keeper  506 . For example, a physician may-grasp a proximal portion of catheter  500  in one hand and first loop  548  in a second hand. Once first loop  548  is disposed within capturing portion  522  of keeper  506  it may be rotated to the position shown in FIG.  14 . 
     FIG. 14 is a plan view of an additional embodiment of catheter  500  of FIG. 11, FIG. 12, and FIG.  13 . The plane of FIG. 14 is generally orthogonal to the plane of FIG.  13 . In the embodiment of FIG. 14, a first loop  548  and a second loop  570  formed from catheter shaft  502  are disposed within capturing portion  522  of keeper  506 . 
     FIG. 15 is a perspective view of an additional embodiment of a catheter  602  in accordance with the present invention. Catheter  602  includes a hub  604  and a strain relief  606 . Strain relief  606  defines a groove  608 . Catheter  602  also includes a keeper  610  having a groove engaging portion  612  Which is adapted to be disposed in groove  608  of strain relief  606 . Keeper  610  includes a first arm  614  and a second arm  616 . Keeper  610  also includes an aperture  618  defined by first arm  614  and second arm  616 . 
     In one method in accordance with the present invention, a catheter shaft  600  (shown with phantom lines) of catheter  602  is placed in a first position  620  between first arm  614  and second arm  616 . Catheter shaft  600  may be twisted and moved to a second position  622  shown in FIG.  15 . When catheter shaft  600  is in second position  622 , it is disposed within aperture  618  of keeper  610 . In a preferred embodiment, first arm  614  and second arm  616  releasably trap catheter shaft  600  when it is disposed within aperture  618 . 
     It should be noted that a physician may position catheter shaft  600  in first position  620  and second position  622  without manipulating keeper  610  directly. For example, a physician may grasp hub  604  in one hand and catheter shaft  600  in a second hand. Catheter shaft  600  has sufficient length that it may be grasped between the palm and fingers of a hand. Keeper  610  allows a physician to capture a portion of catheter shaft  600  easily, even when wearing two pairs of surgical gloves. 
     FIG. 16 is a perspective view of an additional embodiment of a catheter  624  in accordance with the present invention. Catheter  624  includes a hub  626  and keeper  628  which is fixed to hub  626 . In a preferred embodiment, keeper  628  is adapted to clip onto hub  626 . An advantage of this embodiment is that keeper  628  can be used in conjunction with existing catheters with no modification to the hub. Embodiments of catheter  624  have also been envisioned in which keeper  628  and hub  626  are formed from the same material, for example, by injection molding. 
     Keeper  628  includes a plurality of tabs  630 . In the embodiment of FIG. 16, each tab  630  includes a ramp surface  632 . A catheter shaft  600  (shown with phantom lines) of catheter  624  may be urged between a tab  630  and hub  626 . It should be noted that a physician may position catheter shaft  600  between tab  630  and hub  626  without manipulating keeper  628  directly. For example, a physician may grasp hub  626  in one hand and catheter shaft  600  in a second hand. Catheter shaft  600  has sufficient length that it may be grasped between the palm and fingers of a hand. Keeper  628  allows a physician to capture a portion of catheter shaft  600  easily even when wearing two pairs of surgical gloves. In FIG. 16, it may be appreciated that hub  626  and keeper  628  each define a plurality of grooves  634 . Catheter shaft  600  (shown with phantom lines) of catheter  624  may be urged into grooves  634 . Embodiments of the catheter  624  have been envisioned in which keeper  628  includes grooves  634 , and hub  626  does not. Likewise, embodiments of catheter  624  have been envisioned in which hub  626  includes grooves  634 , and keeper  628  does not. 
     In the embodiment of FIG. 16, each tab  630  is generally parallel to a central axis of hub  626 . Embodiments of the present invention have been envisioned in which tab  630  are generally orthoginal to a longitudinal axis of hub  626 . In this envisioned embodiment the portion of catheter shaft  600 , shown in FIG. 16, would run generally parallel to the longitudinal axis of hub  626  rather than crossing over hub  626  as shown in FIG.  16 . 
     FIG. 17 is a perspective view of an additional embodiment of a catheter  636  in accordance with the present invention. Catheter  636  includes a hub  638  and keeper  640  which is fixed to hub  638 . In a preferred embodiment, keeper  640  is adapted to clip onto hub  638 . An advantage of this embodiment is that keeper  640  can be used in conjunction with existing catheters with no modification to the hub. Keeper  640  includes a jaw  642  and an ear  644 . 
     A catheter shaft  600  (shown with phantom lines) of catheter  636  may be trapped between jaw  642  and hub  638 . In one method in accordance with the present invention, a physician may apply pinching forces P and P′ to ear  644  and hub  638 , respectively, as shown in FIG.  17 . In this exemplary method, the application of forces P and P′ will enlarge a gap  646  between jaw  642  and hub  638 . When gap  646  is enlarged, catheter shaft  600  may be positioned between jaw  642  and hub  638  with substantially zero insertion force. Once catheter shaft  600  is in the desired position, forces P and P′ may be removed, allowing jaw  642  to close onto catheter shaft  600 . 
     In the embodiment of FIG. 16, jaw  642  is disposed generally parallel to a longitudinal axis of hub  638 . Embodiments of keeper  640  have been envisioned in which jaw  642  is disposed in an orthogonal arrangement relative to a longitudinal axis of hub  638 . In this envisioned embodiment, catheter shaft  600  coils of catheter shaft  600  would be disposed generally parallel to the longitudinal axis of hub  638  rather than crossing over hub  638  as shown in FIG.  17 . 
     FIG. 18 is a perspective view of an additional embodiment of a catheter  648  in accordance with the present invention. Catheter  648  includes a hub  650 , a strain relief  652 , and a keeper  654 . Keeper  654  comprises a ribbon  656  having a fixed end  658  which is fixed to strain relief  652 , for example, by over-molding. In the embodiment of FIG. 18, ribbon  656  comprises a web  660  and a plurality of wires  662 . 
     In one method in accordance with the present invention, a coil  664  may be formed from a catheter shaft  600  of catheter  648 . In this method, coil  664  may be positioned proximate strain relief  652  and ribbon  656  of keeper  654  may be wrapped around a portion catheter shaft  600 . This method may be utilized by a physician to aid in managing catheter shaft  600  by keeping a portion of catheter shaft  600  in a coiled configuration. 
     In the embodiment of FIG. 18, a plurality of turns have been formed around hub  650  by ribbon  656 . In the embodiment of FIG. 18, the turns of ribbon  656  generally overly one another. Embodiments of keeper  654  have also been envisioned in which the multiple turns of ribbon  656  are longitudinally disposed along the length of hub  650 , strain relief  652 , and catheter shaft  600 . In this envisioned embodiment, multiple wraps of ribbon  656  may serve to hold multiple coils of catheter shaft  600  in a relatively tight bundle. 
     FIG. 19 is a perspective view of an additional embodiment of a catheter  668  in accordance with the present invention. Catheter  668  includes a hub  670 , a strain relief  672 , and a catheter shaft  600 . Catheter  668  also includes a keeper  674  which is fixed to catheter  668  between hub  670  and strain relief  672 . Keeper  674  comprises a filament  676  having a fixed end  678  and a free end  680 . A radial enlargement or bulbous end  682  is disposed about free end  680  of filament  676  to lock the keeper  674  in a closed position. To allow this to function, keeper  674  also includes a bifurcation  684  which is adapted to receive a portion of bulbous end  682  and filament  676 . In a preferred embodiment, filament  676  is comprised of an elastomeric material. Examples of materials which may be suitable in some applications include silicone rubber and thermoplastic elastomer (TPE). 
     In one method in accordance with the present invention, a portion of catheter shaft  600  may be positioned proximate strain relief  672  and filament  676  may be looped over catheter shaft  600 , trapping catheter shaft  600  against strain relief  672 . In a preferred method, filament  676  may be stretched and bulbous end  682  may be positioned proximate bifurcation  684 . In this preferred method, tension from filament  676  will urge bulbous end  682  into a recess  686  in bifurcation  684 . 
     Embodiments of keeper  674  have been envisioned in which filament  676  makes multiple wraps around strain relief  672 , and/or hub  670 , and catheter shaft  600 . The multiple wraps of filament  676  may be disposed longitudinally along the length of strain relief  672 , hub  670 , and catheter shaft  600 . Disposing multiple wraps of filament  676  longitudinally may serve to retain multiple coils of catheter shaft  600  in a tight bundle. 
     FIG. 20 is a perspective view of an additional embodiment of a catheter  688  in accordance with the present invention. Catheter  688  includes a hub  690 , a strain relief  692 , and a catheter shaft  600 . Hub  690  of catheter  688  defines a plurality of slots  694 . Hub  690  also forms a slide  696 . A gate  698  is disposed in sliding engagement with slide  696  of hub  690 . 
     In the embodiment of FIG. 20, each slot  694  includes an entry portion  700  and a capturing portion  702 . Gate  698  is adapted to obstruct entry portion  700  of each slot  694  when it is slid in the direction indicated by the arrows in FIG.  20 . Gate  698  defines a groove  706 . Slide  696  includes a rib  704  which is adapted to be received within groove  706 . In a preferred embodiment, groove  706  and rib  704  cooperate to lock gate  698  in a position which obstructs entry portion  700  of each slot  694 . 
     FIG. 21 is a perspective view of an additional embodiment of a catheter  708  having a keeper  710 . Keeper  710  includes a flange  712 , a ring  714 , and a washer  716 . As shown in FIG. 21, flange  712  and washer  716  define a slot  718 . A portion of a catheter shaft  600  of catheter  708  is disposed within slot  718 . In a preferred embodiment, ring  714  is adapted to be urged distally, creating a friction fit between washer  716  and catheter shaft  600 . 
     FIG. 22 is a cross-sectional view of keeper  710  of FIG.  21 . In FIG. 22, it may be appreciated that ring  714  includes a female thread  719 . Female thread  719  of ring  714  engages a male thread  720  defined by hub  724 . Ring  714  may be rotated to adjust the width of slot  718  defined by flange  712  and washer  716 . Ring  714  may also be utilized to pinch catheter shaft  600  between flange  712  and washer  716 . 
     FIG. 23 is a cross-sectional view of keeper  710  of FIG.  21  and FIG.  22 . In FIG. 23, it may be appreciated that hub  724  includes a flat  726  disposed proximate male thread  720 . Washer  716  includes a generally D-shaped hole  722  which is adapted to accept male thread  720  and flat  726  of hub  724 . In a preferred embodiment, flat  726  of hub  724  and D-shaped hole  722  of washer  716  cooperate to preclude washer  716  from rotating. 
     FIG. 24 is a perspective view of an additional embodiment of a catheter  728  in accordance with the present invention. Catheter  728  includes a hub  730  disposed about a proximal portion of a catheter shaft  600  of catheter  728 . Hub  730  of catheter  728  defines a plurality of slots  732 . A locking member  738  is disposed in pivotal engagement with hub  730 . Locking member  738  includes a plurality of wings  734 . A plurality of tangs  736  project from each wing. In a method in accordance with the present invention, a portion of catheter shaft  600  may be trapped between hub  730  and a wing  734 . In the embodiment of FIG. 24, each slot  732  defined by hub  730  is adapted to accept a tang  736 . 
     FIG. 25 is a perspective view of an additional embodiment of a catheter  740  in accordance with the present invention. Catheter  740  includes a catheter shaft  600  and a port  742 . In the embodiment of FIG. 25, a keeper  746  is releasably coupled to port  742  of catheter  740 . In a preferred embodiment, port  742  comprises a male luer fitting  744  and keeper  746  includes a female luer fitting  744 . Keeper  746  also includes a keeper body  756  defining a lumen  748 . In the embodiment of FIG. 25, a portion of catheter shaft  600  is disposed within lumen  748 . 
     FIG. 26 is a cross-sectional view of catheter  740  of FIG.  25 . In FIG. 26, it may be appreciated that keeper  746  includes a catheter fixing mechanism  750 . Catheter fixing mechanism  750  includes a jam  752  and a jam motion control  754 . Jam motion control  754  includes a male thread  758  defined by keeper body  756  and a female thread  768  defined by a knob  760 . A shaft  762  extends between knob  760  and jam  752 . Catheter shaft  600  may be fixed within lumen  748  of keeper  746  by rotating knob  760  of jam motion control  754  in a first direction until jam  752  contacts catheter shaft  600 . Catheter shaft  600  may be release by rotating knob  760  in a second direction. 
     FIG. 27 is a perspective view of an additional embodiment of a catheter  770  in accordance with the present invention. Catheter  770  includes a catheter shaft  600 . A keeper  772  is fixed to a portion  774  of catheter  770 . Keeper  772  includes a first leg  776 , a second leg  778 , and a crotch  780  extending between first leg  776  and second leg  778 . Keeper  772  also includes a latch  782  which is adapted to trap a portion of catheter shaft  600 . Latch  782  includes a door  790  which is coupled to first leg  776  by a hinge  784 . In the embodiment of FIG. 27, door  790  includes a groove  786  and first leg  776  includes a groove  788 . A portion of catheter shaft  600  is trapped between door  790  of latch  782  and first leg  776 . The position of door  790  in FIG. 27 may be generally referred to as a closed position. 
     Embodiments of keeper  772  have been envisioned in which door  790  includes a plurality of grooves  786  and first legs  776  includes a plurality of grooves  788 . In these envisioned embodiments, keeper  772  may retain a plurality of turns of catheter shaft  600 . 
     FIG. 28 is a perspective view of an additional embodiment of keeper  772  of FIG.  27 . In the embodiment of FIG. 28, door  790  has been moved to an open position. In FIG. 28, it may be appreciated that latch  782  includes a clasp member  792 . First leg  776  includes a clasp member receiver  794 . In a preferred embodiment, clasp member  792  and clasp member receiver  794  cooperate to releasably hold door  790  in the closed position. In the embodiment of FIG. 28, keeper  772  has been removed from portion  774  of catheter  770 . Embodiments of keeper  772  have been envisioned in which keeper  772  is adapted to be fixed to various objects, for example, a table. 
     FIG. 29 is a plan view of an additional embodiment of a catheter  948  in accordance with the present invention. Catheter  948  includes a hub  950 , a strain relief  952 , and a keeper  954 . Keeper  954  comprises a ribbon  956  having a fixed end which is fixed to hub  950 . A coil  964  is formed from a catheter shaft  900  of catheter  948 . In the embodiment of FIG. 29, a portion of coil  964  is disposed between a plurality of projections  902 . A plurality of turns  904  of ribbon  956  are disposed about a portion of catheter shaft  900  and a portion of hub  950 . Turns  904  of ribbon  956  are longitudinally disposed along the length of hub  950 . 
     FIG. 30 is a plan view of an additional embodiment of a catheter  1168  in accordance with the present invention. Catheter  1168  includes a catheter shaft  1100  and a hub  1170  having a plurality of projections  1102 . In the embodiment of FIG. 30, a portion of catheter shaft  1100  is disposed between a plurality of projections  1102 . Catheter  1168  also includes a keeper  1174  comprising a filament  1176  having a fixed end  1178  and a free end  1180 . Fixed end  1178  of filament  1176  is fixed to a ring  1106  which is disposed about a portion of hub  1170 . A radial enlargement or bulbous end  1182  is disposed about free end  1180  of filament  1176  to lock the keeper  1174  in a closed position. Hub  1170  defines an aperture  1122  which is adapted to receive a portion of bulbous end  1182  and filament  1176 . In a preferred embodiment, filament  1176  is comprised of an elastomeric material. Examples of materials which may be suitable in some applications include silicone rubber and thermoplastic elastomer (TPE). A plurality of wraps  1108  of filament  1176  are disposed about a portion of catheter shaft  1100  and a portion of hub  1170 . It may be noted in FIG. 30 that wraps  1108  of filament  1176  are longitudinally disposed along the length of hub  1170 . 
     FIG. 31 is a plan view of an additional embodiment of a catheter  1348  in accordance with the present invention. Catheter  1348  includes a hub  1350  and a shaft  1300  forming a plurality of coils  1364 . In a preferred embodiment, shaft  1300  of catheter  1348  is held in a coiled configuration by a keeper  1374 . 
     FIG.  32  and FIG. 33 are plan views of keeper  1374  of FIG.  31 . Keeper  1374  includes a body member  1310  and a plurality of tangs  1312 . As shown in FIG. 32, tangs  1312  and body member  1310  define a plurality of cavities  1314 . In a preferred embodiment, keeper  1374  comprises an injection molded thermoplastic material. 
     FIG.  33  and FIG. 34 are plan views of an additional embodiment of a keeper  1574  in accordance with the present invention. Keeper  1574  includes a body member  1510  and a plurality of slots  1516  defining a plurality of tabs  1518 . As best seen in FIG. 34, tabs  1518  and body member  1510  define a plurality of interstitial spaces  1520 . In a preferred embodiment, keeper  1574  is adapted to accept a catheter shaft within interstitial spaces  1520  and retain the catheter shaft therein. 
     Having thus described the preferred embodiments of the present invention, those of skill in the art will readily appreciate that yet other embodiments may be made and used within the scope of the claims hereto attached. Numerous advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Changes may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The invention&#39;s scope is, of course, defined in the language in which the appended claims are expressed.